(IMMU) Starts Phase III Clinical Trial of Clivatuzumab Tetraxetan in Pancreatic Cancer

MORRIS PLAINS, N.J., Jan. 9, 2014  — Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced first patient dosing in the Company’s Phase III registration study of its pancreatic cancer drug, yttrium-90 (⁹⁰Y)-clivatuzumab tetraxetan.

The PANcreatic Cancer RadioImmunotherapy Trial-1 (PANCRIT-1) is a double-blind, randomized study aimed to evaluate the safety and efficacy of ⁹⁰Y-clivatuzumab tetraxetan combined with low-dose gemcitabine and best supportive care in patients with metastatic pancreatic cancer who have received at least two prior therapies, one of which must have been a gemcitabine-containing regimen. The primary endpoint of this study is overall survival (OS).

In a recently completed Phase Ib clinical trial in the same patient population with relapsed pancreatic cancer, the combination of ⁹⁰Y-clivatuzumab tetraxetan and low-dose gemcitabine produced a median OS of 4.0 months (6 of 27 subjects were alive 9 months after first dose) with a manageable safety profile. That was statistically significant (p = 0.021) compared to the median OS of 2.8 months when patients were treated with ⁹⁰Y-clivatuzumab tetraxetan alone. Additionally, there were 2 partial responders in the combination arm. More importantly, the rapid enrollment of the Phase Ib study demonstrated an unmet medical need for treatment options for patients in this late-stage setting.

“This is a major milestone for the Company and for the clinical development of ⁹⁰Y-clivatuzumab tetraxetan,” remarked Cynthia L. Sullivan, President and Chief Executive Officer. “If the results from the Phase Ib study are confirmed by the PANCRIT-1 trial, clivatuzumab tetraxetan could become the first antibody-directed radiation therapy approved to treat patients with solid tumors. We plan to complete patient accrual in the first half of 2015,” Ms. Sullivan added.

About PANCRIT-1

The PANCRIT-1 trial was designed to enroll approximately 440 patients with metastatic pancreatic cancer. A majority of these patients will be recruited at clinical trial sites across the U.S., with additional sites in Canada, Europe and Israel participating. Eligible patients will be randomized 2 to 1 to the treatment arm of 3 doses of ⁹⁰Y-clivatuzumab tetraxetan plus 4 doses of gemcitabine at 200 mg/m² per cycle or placebo plus low-dose gemcitabine. All patients will receive best supportive care. Treatments are administered during the initial 4 weeks of each 7-week cycle, and may be repeated up to a maximum of 6 cycles.

About Clivatuzumab Tetraxetan

Clivatuzumab tetraxetan contains a humanized, highly specific antibody that targets a mucin antigen found on pancreatic cancer cells, and is conjugated to a linker that facilitates complexing with radiometals. This mucin has been found by tissue staining to be present on about 85% of pancreatic cancers but is not found on normal pancreas or tissue from patients with pancreatitis. When the antibody-linker complex is radiolabeled with yttrium-90, this enables delivery of high intensity, deep penetrating radiation directly to the pancreatic tumor cells and the addition of gemcitabine acts as a radiosensitizer to increase the anti-tumor activity. ⁹⁰Y-clivatuzumab tetraxetan has received Orphan Drug designation in both the U.S. and Europe, and fast track designation in the U.S. for the treatment of patients with pancreatic cancer.

In earlier clinical trials, ⁹⁰Y-clivatuzumab tetraxetan has produced encouraging results in combination with gemcitabine in newly-diagnosed pancreatic cancer patients or alone in the relapsed population.^1,2

About Pancreatic Cancer

According to the American Cancer Society, an estimated 45,220 Americans were diagnosed with pancreatic cancer in 2013, making it the 10th most common cancer diagnosis among men and the 9th most common among women in the U.S. It is, however, the fourth leading cause of cancer death among both men and women nationwide, with approximately 38,460 deaths expected, or about 7% of all cancer deaths.

Currently, only 2 percent of patients diagnosed with pancreatic cancer are alive 5 years later. Gemcitabine alone or in combination with Tarceva or Abraxane are the only FDA-approved front-line treatments for patients with late-stage pancreatic cancer. There are no FDA-approved therapies for patients that relapse and there are few treatment options available.

References

1. Ocean A.J., Pennington K.L., Guarino M.J. et al. Fractionated radioimmunotherapy with ⁹⁰Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A Phase I trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.
2. Gulec S.A., Cohen S.J., Pennington K.L. et al. Treatment of advanced pancreatic carcinoma with ⁹⁰Y-clivatuzumab tetraxetan: a Phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

About Immunomedics

Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. Our lead product candidate, epratuzumab, is currently in two Phase III clinical trials in lupus. In oncology, clivatuzumab tetraxetan labeled with a radioisotope is in a Phase III pivotal trial in advanced pancreatic cancer patients. Other solid tumor therapeutics in Phase II clinical development include 2 antibody-drug conjugates, IMMU-132 (anti-TROP-2-SN-38) and IMMU-130 (anti-CEACAM5-SN-38). We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making fusion proteins and multifunctional antibodies. DNL™ is being used particularly to make bispecific antibodies targeting cancers and infectious diseases as a T-cell redirecting immunotherapy, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies. We believe that our portfolio of intellectual property, which includes approximately 242 active patents in the United States and more than 400 foreign patents, protects our product candidates and technologies. Our strength in intellectual property has resulted in the top-10 ranking in the 2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology and Pharmaceuticals category. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.

This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company’s control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on UCB for the further development of epratuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Dr. Chau Cheng
         Senior Director, Investor Relations & Grant Management
         (973) 605-8200, extension 123
         ccheng@immunomedics.com

(CRDC) Receives 510(k) Clearance For MicroCutter XCHANGE™

(SGMO) and Biogen Idec Global Collaboration for Hemoglobinopathies Treatments

–Partnership to Focus on Developing Novel Therapies for Sickle Cell Disease and Beta-Thalassemia–

CAMBRIDGE, Mass. and RICHMOND, Calif., Jan. 9, 2014  — Biogen Idec (NASDAQ:BIIB) and Sangamo BioSciences, Inc. (NASDAQ: SGMO) announced today an exclusive worldwide collaboration and license agreement focused on the development of therapeutics for hemoglobinopathies, inherited conditions that result from the abnormal structure or underproduction of hemoglobin. The agreement will enable Biogen Idec to further enhance its expertise in non-malignant hematology by leveraging Sangamo’s proprietary genome-editing technology platform to develop treatments targeting sickle cell disease (SCD) and beta-thalassemia.

(Logo:  http://photos.prnewswire.com/prnh/20140109/SF43275LOGO)

(Logo: http://photos.prnewswire.com/prnh/20130102/SF35903LOGO)

“Our collaboration with Sangamo is expected to help us expand our capabilities to develop treatments for people with serious, inherited hematologic conditions,” said Douglas E. Williams, Ph.D., Biogen Idec’s executive vice president of research and development. “Building upon emerging science related to fetal hemoglobin regulation, we intend to develop Sangamo’s novel gene-editing technology to create a single approach that has the potential to functionally cure both sickle cell disease and beta-thalassemia.”

Sangamo’s proprietary zinc finger nuclease (ZFN) genome-editing technology enables multiple pathways to treat SCD and beta-thalassemia. The technology can be used to precisely target and knock out key regulators of gene expression, or can be used to precisely insert a new corrective gene to replace the defective copy.

“We are delighted to partner our hemoglobinopathies programs with Biogen Idec,” said Edward Lanphier, Sangamo’s president and chief executive officer. “Biogen Idec is a leader in drug development and has a history of successfully translating cutting edge science into treatments that provide life-changing clinical benefit for patients. This alliance is further validation of our ZFP platform as a transformative technology and accelerates our goal of developing a novel class of therapeutics which has the potential to revolutionize the treatment of genetic diseases.”

Under the terms of the agreement, Sangamo is responsible for all research and development activities through the first clinical proof of concept trial in beta-thalassemia, and both companies will perform activities to enable submission of an Investigational New Drug (IND) application for SCD. Biogen Idec will be responsible for subsequent worldwide clinical development and commercialization of products arising from the alliance. Sangamo retains an option to co-promote any licensed product to treat SCD and beta-thalassemia in the United States.

Biogen Idec will provide Sangamo with an upfront payment of $20 million and will reimburse Sangamo for its internal and external research and development program-related costs. Sangamo may also receive additional payments of approximately $300 million based on the achievement of certain development, regulatory, commercialization and sales milestones, as well as double digit royalties on product sales.

The transaction has been approved by the boards of directors of both companies and is subject to customary closing conditions including expiration of the applicable waiting period under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 in the United States.

About Sangamo’s ZFN Therapeutic Approach to Hemoglobinopathies

Sangamo’s proprietary ZFN genome-editing technology enables multiple approaches to the correction of SCD and beta-thalassemia. Both diseases manifest after birth, when patients switch from producing functional fetal gamma-globin to a mutant form of adult beta-globin, which results in their condition. Naturally occurring increased levels of therapeutic fetal hemoglobin have been shown to reduce the severity of both SCD and beta-thalassemia disorders in adulthood. In hematopoietic stem cells (HSCs), Sangamo’s genome editing can be used to precisely disrupt key transcriptional regulators to reverse the switch from expression of the mutant adult beta-globin back to the production of functional fetal gamma-globin, or the technology can be used to precisely insert a new corrected beta-globin gene to replace the defective copy. Data from this program were recently presented at the 55th Annual Meeting of the American Society of Hematology (ASH).

A bone marrow transplant (BMT), of HSCs from a “matched” related donor (allogeneic BMT) is curative for both diseases. However, this therapy is limited due to the scarcity of matched donors and the significant risk of Graft versus Host Disease (GvHD) after transplantation of the foreign cells. By performing genome editing in HSCs that are isolated from and subsequently returned to the same patient, an autologous HSC transplant, Sangamo’s approach eliminates both the need for a matched donor and the risk of acute and chronic GvHD. The ultimate goal of this approach is to develop a one-time curative treatment for SCD and beta-thalassemia.

In May 2013, Sangamo was awarded a $6.4 million Strategic Partnership Award from the California Institute for Regenerative Medicine (CIRM) to develop this potentially curative ZFP Therapeutic for beta-thalassemia. The four-year grant provides matching funds for preclinical work that will support an IND application and a Phase 1 clinical trial in transfusion-dependent beta-thalassemia patients, which will be carried out at Children’s Hospital & Research Center Oakland, and City of Hope.

About Hemoglobinopathies

Mutations in the genes encoding beta-globin, a subunit of the oxygen-carrying protein of red blood cells, lead to the hemoglobinopathies SCD and beta-thalassemia. The mutation in beta-globin that gives rise to SCD causes the red blood cells to form an abnormal sickle or crescent shape making them adherent, fragile and less able to deliver oxygen to tissues, and they can become lodged in small blood vessels and interrupt healthy blood flow. These problems further decrease the amount of oxygen flowing to body tissues. Almost all patients with SCD have painful episodes (called crises), which can last from hours to days, and have progressive organ damage, resulting in shortened lifespan. Current standard of care is to manage and control symptoms, and to limit the number of crises. Current treatments, including blood transfusions, iron-chelation therapy and administration of hydroxyurea, pain medications and antibiotics, do not address the underlying cause of disease, and life expectancy remains substantially reduced in patients with SCD. The CDC estimates that there are currently 90,000 to 100,000 Americans living with SCD which occurs in approximately 1 out of every 500 African-American births and 1 out of every 36,000 Hispanic-American births.

There are several forms of beta-thalassemia caused by mutations in the beta-globin gene; broadly the disorder results in excessive destruction of red blood cells leading to life-threatening anemia, enlarged spleen, liver and heart, and bone abnormalities. Beta-thalassemia major is a severe form of thalassemia that requires regular, often monthly, blood transfusions and subsequent iron-chelation therapy to treat iron overload. The CDC estimates that 2,000 people have beta-thalassemia in the United States, and an unknown number carry the genetic trait and can pass it on to their children. Thalassemia is most common among people of Mediterranean descent and is also found among people from the Arabian Peninsula, Iran, Africa, Southeast Asia and Southern China.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $5 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Sangamo

Sangamo BioSciences, Inc. is focused on research and development of novel DNA-binding proteins for therapeutic gene regulation and genome editing. The company has ongoing Phase 2 and Phase1/2 clinical trials to evaluate the safety and efficacy of a novel ZFP Therapeutic® for the treatment of HIV/AIDS. As part of its acquisition of Ceregene Inc., Sangamo acquired a fully-enrolled and funded, double-blind, placebo-controlled Phase 2 trial to evaluate NGF-AAV (CERE-110) in Alzheimer’s disease. Sangamo’s other therapeutic programs are focused on monogenic diseases, including hemophilia, Huntington’s disease and hemoglobinopathies such as sickle cell disease and beta-thalassemia. Sangamo’s core competencies enable the engineering of a class of DNA-binding proteins known as zinc finger DNA-binding proteins (ZFPs).Engineering of ZFPs that recognize a specific DNA sequence enables the creation of sequence-specific ZFP Nucleases (ZFNs) for gene modification and ZFP transcription factors (ZFP TFs) that can control gene expression and, consequently, cell function. Sangamo has entered into a strategic collaboration with Shire AG to develop therapeutics for hemophilia, Huntington’s disease and other monogenic diseases and has established strategic partnerships with companies in non-therapeutic applications of its technology including Dow AgroSciences and Sigma-Aldrich Corporation. For more information about Sangamo, visit the company’s website at www.sangamo.com. ZFP Therapeutic® is a registered trademark of Sangamo BioSciences, Inc.

Biogen Idec Safe Harbor Statement

This press release contains forward-looking statements, including statements about Biogen Idec’s expectations and goals to develop treatments for people with serious, inherited hematologic conditions, including sickle cell disease and beta-thalassemia, through its collaboration with Sangamo. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty inherent in the regulatory review process and satisfaction of the other closing conditions of the transaction, risks and uncertainties associated with drug development and commercialization, Biogen Idec’s dependence on third parties over which it may not always have full control, and the other risks and uncertainties that are described in the Risk Factors section of Biogen Idec’s most recent annual or quarterly report filed with the Securities and Exchange Commission.These statements are based on current beliefs and expectations and speak only as of the date of this press release. Biogen Idec does not undertake any obligation to publicly update any forward-looking statements.

Sangamo Safe Harbor Statement

This press release may contain forward-looking statements based on Sangamo’s current expectations. These forward-looking statements include, without limitation, references to the research and development of novel ZFNs, potential therapeutic applications of the ZFN technology for the treatment of hemoglobinopathies, SCD and beta-thalassemia and potential milestone, royalty and other payments under the collaboration agreement. Actual results may differ materially from these forward-looking statements due to a number of factors, including technological challenges, uncertainties and risks relating to clinical trials, compliance with regulatory and other requirements, the ability of Sangamo to develop commercially viable products and technological developments by our competitors. See the SEC filings, and in particular, the risk factors described in Sangamo’s Annual Reports on Form 10-K and most recent Quarterly Reports on Form 10-Q. Sangamo does not assume any obligation to update the forward-looking information contained in this press release.

(ICPT) 2013 Year-End Update and 2014 Anticipated Milestones

NEW YORK, Jan. 9, 2014 — Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) (Intercept), today provided a clinical update on obeticholic acid (OCA), a novel bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR), currently being developed in a Phase 3 trial for primary biliary cirrhosis (PBC), as well as Phase 2 trials for several chronic indications including nonalcoholic steatohepatitis (NASH), portal hypertension and bile acid diarrhea (BAD), together with projected 2014 anticipated milestones. Intercept will hold a conference call and audio webcast today at 4:30 p.m. ET to review this information with details provided below.

“2013 was an important year for Intercept as we continued to advance OCA in PBC, NASH and other indications with promising clinical data suggesting that, in keeping with its potent FXR agonist properties, OCA could potentially be used to treat a number of chronic liver and intestinal diseases,” said Mark Pruzanski, M.D., Chief Executive Officer of Intercept. “We recently finished the double-blind phase of our Phase 3 POISE trial in PBC and are happy to see that a vast majority of the patients completing the 12 months have opted to cross over to the five year long term safety extension open-label phase of the trial. Together with the FLINT results announced earlier today, Intercept has obtained positive clinical data in all six Phase 2 clinical trials completed to date in five different indications. We’re looking forward to a pivotal year in 2014, with clinical data awaited from POISE and FLINT, followed by the anticipated completion of the NDA and MAA filings for PBC by year end.”

Summary of Recent Program Updates and 2014 Anticipated Milestones

— PBC Program:

• POISE Double-Blind Phase Completed; Top-line Results Expected in 2Q 2014
• More than 95% Enrollment into Long-Term Safety Extension of POISE Trial
• Supergroup Final Data Support Utility of POISE Surrogate Endpoint; Phase 3 Confirmatory Trial to be Initiated in 2Q 2014
• NDA and MAA Filings for OCA in PBC Anticipated End of 2014

— Proof of Concept Trials in Portal Hypertension (PESTO) and Bile Acid Diarrhea (OBADIAH) Completed; Double-Blind Phase 2b Trial in Each Indication to be Initiated in 2H 2014

— Double-Blind Phase 2 Trial to be Initiated in Primary Sclerosing Cholangitis in 2H 2014

— Phase 1 Trial for INT-767, Dual FXR and TGR5 Agonist, to be Initiated in 4Q 2014

POISE: Phase 3 Trial in Primary Biliary Cirrhosis

Double-Blind Phase Completed with Strong Enrollment into Long-Term Safety Extension Phase

POISE is a double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of a once daily dose of OCA in PBC patients with an inadequate therapeutic response to, or who are unable to tolerate, ursodiol. In December 2013, the last patient follow-up visit was completed, marking the conclusion of the double-blind phase of the POISE trial. Of the 217 patients randomized, 19 patients (approximately 9%) discontinued early, including seven patients (approximately 3%) who did so due to pruritus. Top-line results from the double-blind phase of the POISE trial are expected to be available in the second quarter of 2014.

Patients completing the double-blind phase have had the option to continue in an open-label, long-term safety extension (LTSE) phase for another five years, during which all patients will receive OCA treatment with daily doses starting at 5 mg and potentially titrating up to 25 mg a day, as clinically indicated. Of the 198 patients who completed the double-blind phase, more than 95% continued in the LTSE phase of the trial.

Global PBC Study Group (Supergroup)

Data from over 6,100 PBC patients collected and pooled by an independent group of 15 academic medical centers across eight countries have been analyzed by the Global PBC Study Group, or Supergroup, and key data were presented at the 2013 AASLD conference by the Supergroup. These and additional analyses confirm that the surrogate biochemical endpoint used in POISE (i.e., alkaline phosphatase (ALP) < 1.67x upper limit of normal (ULN) and normal bilirubin) is strongly predictive of clinical outcomes in PBC patients. Specifically, the analyses demonstrated that patients who failed to meet the POISE trial primary endpoint after one year of ursodeoxycholic acid (UDCA) treatment had approximately two times greater chance of dying or requiring a liver transplant.

Based on these additional analyses, Intercept has submitted a design for its anticipated confirmatory trial to FDA for review. If subsequent discussions result in general agreement concerning the appropriate design of the trial without undue delay, Intercept intends to initiate the confirmatory trial in the second quarter of 2014.

PESTO: Phase 2a Trial in Portal Hypertension

Recently Completed Open-Label Trial Supports Initiation of Double-Blind Trial in Portal Hypertension

PESTO is an open-label, multi-center Phase 2a trial evaluating the safety and efficacy of OCA administered to alcoholic cirrhotic patients for approximately seven days at daily doses of 10 mg and 25 mg for the treatment of portal hypertension. The rationale for the PESTO trial is based on previously published results in animal models of cirrhosis, demonstrating that short term OCA therapy can reverse portal hypertension via a local nitric oxide induced mechanism with no concomitant change in systemic blood pressure.

Preliminary data from PESTO indicate that approximately 50% of patients evaluated for efficacy in the combined dose groups demonstrated a clinically significant reduction in hepatic venous pressure gradient (HVPG) reflective of a lowered risk of variceal bleeds. Systemic mean arterial blood pressure, already adversely low in cirrhotic patients, was unchanged at the end of therapy.

Detailed results obtained by the lead investigator, Raj Mookerjee, M.D., at the primary center (University College London) conducting the PESTO trial have been submitted for presentation at the upcoming International Liver Congress of the European Association for the Study of the Liver (EASL) in April 2014.

Intercept plans to initiate a multi-center, double-blind, placebo-controlled, randomized Phase 2b clinical trial focusing on HVPG as an endpoint in patients with liver cirrhosis and portal hypertension in the second half of 2014.

OBADIAH: Phase 2a Trial in Primary and Secondary Bile Acid Diarrhea

Recently Completed Open-Label Trial Supports Initiation of Double-Blind Trial in Secondary BAD

OBADIAH is an investigator-initiated open-label Phase 2a trial evaluating the safety and efficacy of OCA in the treatment of primary and secondary bile acid diarrhea, with Professor Julian Walters at Imperial College London acting as Principal Investigator. The trial demonstrated that OCA increased levels of fibroblast growth factor 19 (FGF19) with concomitant clinical improvement over a two-week treatment period in patients with primary BAD (pBAD) and in patients with secondary bile acid diarrhea due to Crohn’s disease (sBAD), with no response shown in a control group consisting of IBS-D patients with normal FGF19 levels. The data also show that increased length of prior ileal resection reduced response to OCA treatment in Crohn’s patients suffering from sBAD.

Detailed results from OBADIAH have been submitted for presentation at Digestive Disease Week in May 2014. Intercept plans to initiate a multi-center, double-blind, placebo-controlled, randomized Phase 2b clinical trial of OCA in Crohn’s patients with sBAD in the second half of 2014.

Phase 2 Trial in Primary Sclerosing Cholangitis

Intercept plans to initiate a multi-center, double-blind, placebo-controlled, randomized Phase 2 clinical trial of OCA in primary sclerosing cholangitis (PSC) in the second half of 2014. PSC is a chronic autoimmune liver disease that could eventually lead to cirrhosis, liver failure and death. As with PBC, studies have shown that patients with PSC who have reduced or normal levels of ALP have significantly improved long-term clinical outcomes. Although there is no approved treatment of PSC, patients are commonly treated with ursodiol. The prevalence of PSC is estimated to be approximately one-third that of PBC, with approximately 60% of cases occurring in men and typically 75% of PSC patients also having associated ulcerative colitis.

Phase 1 Trial of INT-767

INT-767 is an orally-administered dual FXR and TGR5 agonist that, similar to OCA, is derived from the primary human bile acid chenodeoxycholic acid (CDCA). This product has been tested in numerous animal models of chronic liver, intestinal and kidney diseases and has demonstrated preclinically potent anti-fibrotic and anti-inflammatory properties. Intercept is completing IND-enabling studies for INT-767, with the intention to submit an IND and initiate Phase 1 trials in the fourth quarter of 2014.

Today’s Conference Call and Webcast at 4:30 p.m. ET

Intercept will hold a conference call and audio webcast today at 4:30 p.m. ET. The live event will be available on the investor page of the Intercept website at http://ir.interceptpharma.com or by calling (855) 232-3919 (domestic) or (315) 625-6894 (international) five minutes prior to the start time. A replay of the call will be available on the Intercept website approximately two hours after the completion of the call and will be archived for two weeks.

About Intercept

Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat orphan and more prevalent liver diseases utilizing its expertise in bile acid chemistry. The company’s lead product candidate, obeticholic acid (OCA), is a bile acid analog and first-in-class agonist of the farnesoid X receptor (FXR). OCA is initially being developed for the second line treatment of primary biliary cirrhosis (PBC) in patients with an inadequate response to, or who are unable to tolerate, ursodiol, the only approved therapy for this indication. OCA has received orphan drug designation in both the United States and Europe for the treatment of PBC. Intercept owns worldwide rights to OCA outside of Japan and China, where it has out-licensed the product candidate to Dainippon Sumitomo Pharma. For more information about Intercept, please visit the Company’s website at: www.interceptpharma.com.

Safe Harbor Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the statements regarding the Company’s anticipated outlook and milestones for 2014; potential application of OCA in liver, gastrointestinal and other indications; relationship between the endpoints being investigated and adverse clinical outcomes in the related indication; the clinical utility of the selected endpoints and any potential consensus relating thereto; the acceptance by regulatory authorities of the trial endpoint or results; clinical, preclinical and regulatory developments for our product candidates; the anticipated timeframe for the commencement, completion and receipt of results from Intercept’s clinical trials and for the making of regulatory submissions; the anticipated results of our clinical and preclinical trials and other development activities; and our strategic directives under the caption “About Intercept.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and results of Intercept’s development activities, preclinical studies and clinical trials; the timing of and Intercept’s ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates it may develop, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; Intercept’s plans to research, develop and commercialize future product candidates; the election by Intercept’s collaborators to pursue research, development and commercialization activities; Intercept’s ability to attract collaborators with development, regulatory and commercialization expertise; Intercept’s ability to obtain and maintain intellectual property protection for its product candidates; Intercept’s ability to successfully commercialize its product candidates; the size and growth of the markets for Intercept’s product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in the United States and other countries; the performance of third-party suppliers and manufacturers; Intercept’s ability to obtain additional financing; Intercept’s use of the proceeds from its initial public offering in October 2012 and follow-on offering in June 2013; the accuracy of Intercept’s estimates regarding expenses, future revenues, capital requirements and the need for additional financing; the loss of key scientific or management personnel; and other factors discussed under the heading “Risk Factors” contained in Intercept’s annual report on Form 10-K for the year ended December 31, 2012 filed on April 1, 2013 as well as any updates to these risk factors filed from time to time in Intercept’s other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intercept undertakes no duty to update this information unless required by law.

CONTACT: Barbara Duncan or Senthil Sundaram
         Intercept Pharmaceuticals
         1-646-747-1000

(VNRX) Presents at MicroCapClub Invitational

Company Invites Investors to View Presentation

(IPWR) Appoints Global Energy Executive, R. Daniel Brdar, CEO and Chairman of the Board

Paul Bundschuh Assumes Role of President and Chief Commercial Officer

(IMRS) Nearly 13,000 patients have benefited from VISIUS iMRI

2014 procedures expected to increase 31% over 8-year total as intraoperative MRI utilization expands to improve outcomes in growing number of neurosurgical applications

MINNEAPOLIS, Jan. 8, 2014  – IMRIS Inc. (NASDAQ: IMRS) (TSX: IM) (“IMRIS” or the “Company”) today announced that an internal study of 40 worldwide VISIUS^® Surgical Theatre hospital customers indicates that nearly 13,000 patients have been treated using intraoperative MRI (iMRI) since the first installation in 2005. Four of 27 US hospitals – located in Boston, MA; St. Louis, MO; and Minneapolis and St. Paul, MN – currently using VISIUS iMRI are approaching 1,000 cases performed.

Dr. Frederick Boop, Co-director of the Le Bonheur Neuroscience Institute in Memphis, TN, credits VISIUS iMRI with reducing reoperation rates. “Intraoperative MRI is an important tool in our pediatric program by allowing us to get a more complete removal of these tumors and better overall visualization without moving the patient and knowing we won’t have to bring the patient back for another operation,” he said.

With more installations coming online and procedure numbers growing steadily, IMRIS President and CEO Jay D. Miller said the company estimates the volume will be almost 17,000 by the end of 2014, an increase of roughly 31% in one year over the previous eight years. “With increasing adoption and utilization, more neurosurgeons and hospitals are recognizing the decision support advantage of enhanced visualization in the intraoperative setting and reduced risks associated with not moving patients for imaging,” he said.

“The top neurosurgical hospitals are making the IMRIS solution their standard of care and not only increasing the number of procedures completed in the suite,” Miller added, “but also expanding the types of applications and conditions other than various brain tumors, such as epilepsy, Parkinson’s disease, stroke intervention, aneurysm, and Chiari malformation, and other neurological procedures using deep brain stimulation, ablation and other technologies with iMR. Also, the recent addition of VISIUS iCT expands our solution into spinal conditions, trauma and intricate reconstructions.”

Inside a VISIUS Surgical Theatre equipped with either high-field iMRI or 64-slice intraoperative Computed Tomography (iCT), surgeons have on-demand access to real-time data and state-of-the-art imaging, during the procedure from the operating room (OR) table. IMRIS is the only company that offers an MRI and CT imaging solution where the scanner moves on ceiling-mounted rails to enter or exit the OR which mitigates known risks of moving critically-ill patients.

Unlike other systems, no heavy imaging equipment needs to be wheeled into the room nor does the patient need to be moved to an adjacent imaging room from the OR. The surgeon can visualize, evaluate and confirm results while modifying treatment without case interruption. Developed for neurosurgery and spinal surgery, the systems are also intended to provide physicians with state-of-the-art image quality with access to a full range of software applications.

Surgeons using iMRI for brain tumor removal have reported outcomes of more complete resection¹ and reduced pediatric re-operation² rates. Data published in 2011 showed 93 percent of iMRI glioma cases achieved gross or near total resection compared to 65 percent for non-iMRI cases in the same timeframe.¹  A separate study indicated the need for repeat surgeries decreased with eight percent of non-iMRI patients requiring re-surgery within two weeks post procedure compared to zero re-surgeries for iMRI patients. ²

About IMRIS
IMRIS (NASDAQ: IMRS; TSX: IM) is a global leader in providing image guided therapy solutions through its VISIUS Surgical Theatre – a revolutionary, multifunctional surgical environment that provides unmatched intraoperative vision to clinicians to assist in decision making and enhance precision in treatment. The multi-room suites incorporate diagnostic quality high-field MR, CT and angio modalities accessed effortlessly in the operating room setting. VISIUS Surgical Theatres serve the neurosurgical, spinal, cardiovascular and cerebrovascular markets and have been selected by 56 leading medical institutions around the world.

References:

1. Chicoine MR, Lim CCH, Evans JA, Singla A, Zipfel GJ, Rich KM, Dowling JL, Leonard JR, Smyth MD, Santiago P, Leuthardt EC, Limbrick DD, Dacey RG : Implementation and Preliminary Clinical Experience with the Use of Ceiling Mounted Mobile High Field Intraoperative Magnetic Resonance Imaging Between 2 Operating Rooms, ACTA Neurochirgica suppl. 2011;109:97-102.
2. Shah MN, Leonard JR, et al. Intraoperative magnetic resonance imaging to reduce the rate of early reoperation for lesion resection in pediatric neurosurgery. J Neurosurg Pediatrics. 9:259-264, 2012.

SOURCE IMRIS Inc.

Image with caption: “Hospitals utilizing IMRIS VISIUS intraoperative MRI have completed nearly 13,000 procedures since the initial installation in 2005, including four in the US that expect to reach 1,000 procedures in 2014. (CNW Group/IMRIS Inc.)”.

(MNGA) Distributor Signs Development Contract with Italian National Energy Agency

Italian National Alternative Energy Laboratory to Perform Tests on MagneGas

TAMPA, Fla., Jan. 8, 2014  — MagneGas Corporation (“MagneGas” or the “Company”) (NASDAQ: MNGA), the developer of a technology that converts liquid waste into hydrogen-based fuels, announces that its Italian Distributor, “Nuova MagneGas Italia” has signed a contract with the Italian National Alternative Energy Laboratory to perform various tests on MagneGas fuels.

ENEA (http://old.enea.it/com/ingl/) the Italian National Agency for New Technologies, Energy and Sustainable Economic Development, recently signed a contract with Nuova MagneGas Italia to perform testing of the gasification of various feedstocks and certification of internal combustion engine operation. These tests will initiate in February of 2014 and are expected to take 180 days to complete.  Any MagneGas equipment sales in Europe will be sourced from MagneGas Corp in the United States.

“ENEA is seen as one of the leading alternative energy and economic development agencies in Europe with over 500 engineers dedicated to energy and other fields. This development contract will accelerate the validation and acceptance of MagneGas™ fuel at a national and European level,” commented Giovanni Cocchiaro, CEO of MagneGas Italy, Nuova MagneGas Italia.

“ENEA’s United States equivalent would be the National Renewable Energy Laboratory of the Department of Energy so this is a significant development for the validation of the MagneGas technology in Europe and worldwide.  Therefore, the entire MagneGas family is very pleased to have entered into a development contract with ENEA which will be able to validate several applications for Italy and Europe as a whole.  Any equipment sales from Europe will be sourced from the United States, which would have a direct impact on MagneGas,” stated Ermanno Santilli CEO of MagneGas Corp.

The MagneGas IR App is now available for free in Apple’s App Store for the iPhone or iPad http://bit.ly/AfLYww and at Google Play http://bit.ly/Km2iyk for Android mobile devices.

To be added to the MagneGas investor email list, please email pcarlson@kcsa.com with MNGA in the subject line.

About MagneGas Corporation
Founded in 2007, Tampa-based MagneGas Corporation (NASDAQ: MNGA) is the producer of MagneGas, a natural gas alternative and metal working fuel that can be made from certain industrial, municipal, agricultural and military liquid wastes following the receipt of appropriate governmental permits.

The Company’s patented Plasma Arc Flow process gasifies liquid waste, creating a clean burning hydrogen based fuel that is essentially interchangeable with natural gas. MagneGas can be used for metal working, cooking, heating, powering bi fuel automobiles and more. For more information on MagneGas, please visit the Company’s website at www.MagneGas.com.

FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements relate to future events, including our ability to raise capital, or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The Company is currently using new ethylene glycol to produce fuel until proper permits to process used liquid waste have been obtained.

For a discussion of these risks and uncertainties, please see our filings with the Securities and Exchange Commission. Our public filings with the SEC are available from commercial document retrieval services and at the website maintained by the SEC at http://www.sec.gov.

(CYTR) Aldoxorubicin in Advanced Soft Tissue Sarcomas, Global Phase 2b Clinical Results Good

CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported positive results from additional statistical analyses that further support the previously announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS).

Additional analysis determined hazard ratios for the primary endpoint of progression-free survival (PFS) by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. The hazard ratio for investigator-read scans is 0.37 (95% confidence interval, range of 0.212 to 0.643) (p=0.0004), reflecting a 63% reduction in the risk of disease progression; and the hazard ratio for central lab scans is 0.59 (95% confidence interval, range of 0.36 to 0.96) (p=0.034), reflecting a 41% reduction in the risk of disease progression. Hazard ratios – the likelihood that the study endpoint (in this case tumor progression) will be reached during a given period – are an important measure of the reliability and uniformity of the absolute data for PFS, as presented below. Hazard ratios where the upper limit is less than 1 indicate that there is a significant difference between the two study groups.

CytRx also reported that a Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology (ASCO) Meeting in June, 2014 in Chicago, Illinois.

CytRx President and CEO Steven A. Kriegsman commented, “Because of the tremendous potential for aldoxorubicin to treat soft tissue sarcomas and other common cancers, it is important that we present the initial trial analyses in a timely manner. We are very pleased that additional statistical analyses strongly support the earlier top-line results, which reinforces our confidence in the ability of our linker technology to target the release of doxorubicin directly at the site of cancer.”

As initially reported on December 11, 2013, both the investigator assessment and central lab review showed subjects treated with aldoxorubicin demonstrated highly statistically significant better clinical outcomes than those receiving standard doxorubicin therapy for STS. Specifically, both assessments showed an unambiguous 80% to 100% improvement in PFS among patients treated with aldoxorubicin.

In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin patients versus 4.7 months for doxorubicin patients (p=0.0002), while the blinded central lab review indicated that median PFS for aldoxorubicin patients was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months, compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded central lab review, 46.8% of aldoxorubicin patients had not progressed at 6 months, compared with 23.7% of doxorubicin patients (p=0.038).

About the Global Phase 2b Clinical Trial Design

The study examined 123 subjects who received either aldoxorubicin or doxorubicin in a 2:1 randomization, respectively. Aldoxorubicin was administered to 83 subjects at a dosage of 350 mg/m² (doxorubicin equivalents of 260 mg/m²) as a 30-minute intravenous infusion on Day 1 of each cycle, while doxorubicin (75 mg/m²) was administered to 40 subjects as a 5-30 minute infusion on Day 1 of each cycle. A cycle of therapy was defined as a 3-week (21-day) period. Multiple cycles were administered until the subject was withdrawn from therapy or until a maximum of 6 cycles were administered. CT scans were obtained every 6 weeks to assess tumor response and progression, and adverse events were collected in a case report form.

About Soft Tissue Sarcoma

STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of STS; and in 2013 more than 11,400 new cases will be diagnosed in the U.S., and approximately 4,400 Americans will die from STS. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 500 mg/m². Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2 g/m².

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin (formerly known as INNO-206), its improved version of the widely used chemotherapeutic agent doxorubicin. CytRx has completed a global Phase 2b clinical trial with aldoxorubicin as a first-line therapy for soft tissue sarcomas, a Phase 1b/2 clinical trial primarily in the same indication, a Phase 1b study of aldoxorubicin in combination with doxorubicin in subjects with advanced solid tumors and a Phase 1b pharmacokinetics clinical trial in subjects with metastatic solid tumors. CytRx plans to initiate under a special protocol assessment a pivotal Phase 3 global trial with aldoxorubicin as a therapy for subjects with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. CytRx has initiated a Phase 2 clinical trial with aldoxorubicin in subjects with late-stage glioblastoma (brain cancer), and plans to initiate a Phase 2 clinical trial in HIV-related Kaposi’s sarcoma. CytRx plans to expand its pipeline of oncology candidates based on a linker platform technology that can be utilized with multiple chemotherapeutic agents and may allow for greater concentration of drug at tumor sites. CytRx also has rights to two additional drug candidates, tamibarotene and bafetinib. CytRx completed its evaluation of bafetinib in the ENABLE Phase 2 clinical trial in high-risk B-cell chronic lymphocytic leukemia (B-CLL), and plans to seek a partner for further development of bafetinib. For more information about CytRx Corporation, visit www.cytrx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks relating to the outcome, timing and results of CytRx’s clinical trials, the risk that the results of any future human testing of aldoxorubicin, including the final data from the Phase 2b clinical testing of aldoxorubicin as a first-line treatment in patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy, might not produce objective response or safety results similar to the data described in this press release, risks related to CytRx’s ability to manufacture its drug candidates in a timely fashion, cost-effectively or in commercial quantities in compliance with stringent regulatory requirements, risks related to CytRx’s need for additional capital or strategic partnerships to fund its ongoing working capital needs and development efforts, including the Phase 3 clinical development of aldoxorubicin, and the risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(LEDS) C35 LEDs Create Stunning Accents in Twenty First Light’s Hotel Alpha Project

Dramatic Facade Lighting Delivers 70% Energy Savings

CHUNAN, Taiwan, Jan. 7, 2014  — The tourist hotel complex (THC) Alpha in Moscow recently received a dramatic new façade wall-wash from Twenty First Light ltd, a Russian manufacturer of LED luminaire solutions, using SemiLEDs Corporation (Nasdaq:LEDS), C35 color and warm white LEDs. With substantial product support from SemiLEDs, Twenty First Light developed three types of saturated purple and warm white spotlights for the project to achieve both a powerful visual impact and high reliability for the distinctive lighting scheme.

“THC Alpha is a high profile landmark in Moscow, and as such, this was a high-exposure project for Twenty First Light that demanded a solution which would start out visually appealing, and then stay that way over the life of the installation,” commented Sergey Stakharny, Director of Twenty First Light. “It was very important to us that the LED manufacturer both understood what we were trying to achieve, and would provide flexible support that minimized our engineering challenge while streamlining the project and maximized the reliability of the installed luminaires. SemiLEDs was able to meet those needs, contributing to the success of this program.”

Twenty First Light tackled the project by developing three distinct types of luminaires, including 40W saturated purple spotlights for the individual balconies on the building’s side, as well as narrow-beam 100W purple and 70W warm white spotlights illuminating the building façade for a color-fade effect from bottom to top. In addition, a series of prototype 150W RGB color-changing spotlights, also based on SemiLEDs C35 LEDs, were developed to allow on-site testing of different hue and saturation effects. With the final selection being a saturated purple, Twenty First Light was able to optimize the performance and value by engineering a static combination of blue and red LEDs matching the specified and tested shade. The LEDs were surface mounted on a single aluminum array plate, and supplemented by secondary optics to achieve a 10-degree beam angle. The 100W purple and 70W warm-white spotlights respectively replaced 400W and 250W high pressure sodium lamps netting over 70% energy savings.

“We were very pleased to support Twenty First Light in the development of these customized luminaires constructed around SemiLEDs C35 family of LEDs,” commented Dr. Ilkan Cokgor, Executive VP of Sales and Marketing for SemiLEDs. “One big promise of LEDs is to enable the kind of design flexibility that Twenty First Light devised, allowing the end-specifier to see a dynamic test luminaire for color selection, and then translating that into a cost-optimized, and highly reliable production solution set. That flexibility demands a wide product offering, robust technology, and a manufacturer that has the ability to interact with the luminaire designers with individualized support. It’s what distinguishes SemiLEDs as both a technology and solutions leader.”

Images: http://www.veriphos.com/client/semileds/thc-alpha/

About SemiLEDs Corporation

SemiLEDs develops and manufactures LED chips and LED components primarily for general lighting applications, including street lights and commercial, industrial and residential lighting, along with specialty industrial applications such as ultraviolet (UV) curing, medical/cosmetic, counterfeit detection, and horticulture. SemiLEDs sells blue, green and UV LED chips. For product information, please visit www.semileds.com, email sales@semileds.com, or tel +866 (37) 586-788 (Taiwan)

About “Twenty First Light” ltd

Founded in 2010, “Twenty First Light” ltd. is a Russian manufacturer of LED products for the industrial, administrative, street and architectural lighting. Notable projects include Lighting RZD car repair workshops, Lighting Machinery & Industrial Group N.V. workshops, and “Neoflowers” Shop design lighting in Vremena Goda Galleries. Visit www.21svet.ru or www.21light.ru

Forward Looking Statements

This press release contains statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact could be deemed forward-looking, including, but not limited to, any projections of future revenues, income, margins or other financial information; any statements about historical results that may suggest trends for SemiLEDs’ business; any statements of the plans, strategies and objectives of management for future operations; any statements of expectation or belief regarding recovery of the LED industry, market opportunities and other future events or technology developments; any statements regarding SemiLEDs’ position to capitalize on any market opportunities; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are based on current expectations, estimates, forecasts and projections of future SemiLEDs’ or industry performance based on management’s judgment, beliefs, current trends and market conditions and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. SemiLEDs’ Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) and other SemiLEDs filings with the SEC (which you may obtain for free at the SEC’s website at http://www.sec.gov) discuss some of the important risks and other factors that may affect SemiLEDs’ business, results of operations and financial condition. SemiLEDs undertakes no intent or obligation to publicly update or revise any of these forward looking statements, whether as a result of new information, future events or otherwise, except as required by law.

CONTACT: Media contact:
         Veriphos Communications
         +1 512-257-9888
         tomg@veriphos.com

         Corporate Communications:
         Connie Chen
         +886 (37) 586-788 ext 8121
         connie.chen@semileds.com

(PCYC) Independent Data Monitoring Committee recommends Phase III study of IMBRUVICA™

SUNNYVALE, Calif., Jan. 7, 2014  — Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that an Independent Data Monitoring Committee (IDMC) unanimously recommended that the Phase III RESONATE study, PCYC-1112-CA, a head-to-head comparison of IMBRUVICA^TM (ibrutinib) versus ofatumumab, be stopped early because the primary and a key secondary endpoint of the study have been met. At the planned interim analysis, the Phase III RESONATE study demonstrated that IMBRUVICA showed a statistically significant improvement in progression-free survival (the primary endpoint of the study, which was evaluated by an independent review committee) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Further, IMBRUVICA  showed statistically significant improvement in overall survival (a key secondary endpoint of the trial). The safety profile of IMBRUVICA was acceptable and consistent with prior clinical experience.  The IDMC recommended that the sponsor provide access to IMBRUVICA  for subjects on the ofatumumab arm.

“We are very pleased with the vigilance and professional expertise that our IDMC exercised in monitoring this study.  The results seen at the interim analysis of the RESONATE trial are robust and consistent,”  said Fong Clow, Sc. D, Senior Vice President of Biometrics at Pharmacyclics.

Pharmacyclics has informed the U.S. Food and Drug Administration (FDA) of the recommendations of the IDMC. Similarily, Janssen, the co-developer of IMBRUVICA, has informed the European Medicines Agency  (EMA). Both companies are engaging in a dialogue with the Health Authorities to define the next regulatory steps and anticipate providing a comprehensive RESONATE study report to them within the coming months.

“I am tremendously proud of the accomplishment of the Pharmacyclics team for their effort and execution as well as the collaboration with the clinical sites toward this high quality study. This collaboration resulted in expeditious enrollment, and rapid data collection and analysis.  This global study involving 391 patients was conducted at more than 70 clinical sites in 10 countries,” said Maria Fardis, PhD, Chief of Oncology Operations and Alliances at Pharmacyclics.

“We express our appreciation to the patients, the investigators and the entire Pharmacyclics and Janssen teams for overcoming the barriers and challenges associated with this exciting scientific outcome,” said Robert Duggan, Chief Executive Officer and Chairman of the Board of Pharmacyclics.

The company anticipates that the detailed data analysis from this RESONATE Phase III study will be presented at an upcoming oncology conference.

About RESONATE

RESONATE is a randomized, multicenter, open-label Phase III study of single agent  IMBRUVICA (ibrutinib) versus single agent ofatumumab in patients with relapsed or refactory CLL or relapsed or refractory SLL with measurable nodal disease and who were not eligible for treatment with purine analog-based therapy. The study enrolled 391 patients who had received at least one prior therapy. Patients were randomized to receive 420 mg of IMBRUVICA orally once daily or intravenous doses of ofatumumab over the course of 24 weeks until disease progression or unacceptable toxicity. Patients randomized to the ofatumumab arm who experienced disease progression were evaluable for consideration of subsequent IMBRUVICA therapy.

About CLL/SLL

CLL, a B-cell malignancy, is a slow-growing blood cancer of the white blood cells (lymphocytes), most commonly from B-cells. CLL is the second most common adult leukemia. Approximately 16,000 patients in the U.S. are diagnosed each year with CLL. The prevalence of CLL is approximately 113,000 in the U.S. CLL is a chronic disease that predominantly occurs in the elderly with a five-year survival of approximately 82 percent. Patients commonly receive multiple lines of treatment over the course of their disease. When cancer cells are located mostly in the lymph nodes, the disease is called SLL. CLL and SLL are considered to be different manifestations of the same underlying disease; they share similarities in signs and symptoms, genetic features, disease progression and treatment.

About IMBRUVICA

IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is based on overall response rate (ORR). An improvement in survival or disease-related symptoms has not been established. For more information about IMBRUVICA, including the full prescribing information, please visit www.IMBRUVICA.com. IMBRUVICA is a first-in-class, oral therapy and is a new agent that inhibits a protein called Bruton’s tyrosine kinase (BTK). BTK is a key signaling molecule of the B-cell receptor signaling complex that plays an important role in the survival of malignant B cells. IMBRUVICA blocks signals that tell malignant B cells to grow and divide uncontrollably. It is one of the first medicines to receive FDA approval via the new Breakthrough Therapy Designation pathway, enabling Pharmacyclics to rapidly bring this medicine to patients in need.

About Pharmacyclics

Pharmacyclics^® is a biopharmaceutical company focused on developing and commercializing innovative small-molecule drugs for the treatment of cancer and immune mediated diseases. Our mission and goal is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious unmet medical healthcare needs; and to identify promising product candidates based on scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and pursue commercialization and/or development partners when and where appropriate.

Pharmacyclics has three product candidates in clinical development and several preclinical molecules in lead optimization. The company is committed to high standards of ethics, scientific rigor, and operational efficiency as it moves each of these programs to viable commercialization.

To date, 9 Phase III trials have been initiated with IMBRUVICA (ibrutinib) and a total of 38 trials are currently registered on www.clinicaltrials.gov. Janssen Biotech, Inc. and Pharmacyclics entered a collaboration and license agreement in December 2011 to co-develop and co-commercialize IMBRUVICA.

Pharmacyclics is headquartered in Sunnyvale, California and is listed on NASDAQ under the symbol PCYC. To learn more about how Pharmacyclics advances science to improve human healthcare visit us at www.pharmacyclics.com.

The following safety information is described in the package insert for the use of IMBRUVICA in patients with mantle cell lymphoma who have received at least one prior therapy:

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Hemorrhage – 5% of patients with MCL had ≥ Grade 3 bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria). Bleeding events including bruising of any grade occurred in 48% of patients with MCL treated with 560 mg daily. The mechanism for the bleeding events is not well understood. Consider the benefit-risk of IMBRUVICA in patients requiring antiplatelet or anticoagulant therapies and the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections – Fatal and non-fatal infections have occurred. At least 25% of patients with MCL had infections ≥ Grade 3, according to NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor patients for fever and infections and evaluate promptly.

Myelosuppression – Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients. These included neutropenia (29%), thrombocytopenia (17%) and anemia (9%). Monitor complete blood counts monthly.

Renal Toxicity – Fatal and serious cases of renal failure have occurred. Treatment-emergent increases in creatinine levels up to 1.5 times the upper limit of normal occurred in 67% of patients and from 1.5 to 3 times the upper limit of normal in 9% of patients. Periodically monitor creatinine levels. Maintain hydration.

Second Primary Malignancies – Other malignancies (5%) have occurred in patients with MCL who have been treated with IMBRUVICA, including skin cancers (4%) and other carcinomas (1%).

Embryo-Fetal Toxicity – Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS

The most commonly occurring adverse reactions (≥ 20%) in the clinical trial were thrombocytopenia*, diarrhea (51%), neutropenia*, anemia*, fatigue (41%), musculoskeletal pain (37%), peripheral edema (35%), upper respiratory tract infection (34%), nausea (31%), bruising (30%), dyspnea (27%), constipation (25%), rash (25%), abdominal pain (24%), vomiting (23%) and decreased appetite (21%).

*Treatment-emergent decreases (all grades) of platelets (57%), neutrophils (47%) and hemoglobin (41%) were based on laboratory measurements and adverse reactions.

The most common Grade 3 or 4 non-hematological adverse reactions (≥ 5%) were pneumonia (7%), abdominal pain (5%), atrial fibrillation, diarrhea (5%), fatigue (5%), and skin infections (5%). Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients.  Ten patients (9%) discontinued treatment due to adverse reactions in the trial (N=111).

The most frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred in 14% of patients.

DRUG INTERACTIONS

CYP3A Inhibitors – Avoid concomitant administration with strong or moderate inhibitors of CYP3A. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

CYP3A Inducers – Avoid co-administration with strong CYP3A inducers.

SPECIAL POPULATIONS – Hepatic Impairment – Avoid use in patients with baseline hepatic impairment.

Because everyone is different, it is not possible to predict what side effects any one patient will have. Patients with questions or concerns about side effects should talk to their doctor.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.

For more information please read the IMBRUVICA Full Prescribing Information at www.IMBRUVICA.com.

NOTE: This announcement may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements, among others, relating to our future capital requirements, including our expected liquidity position and timing of the receipt of certain milestone payments, and the sufficiency of our current assets to meet these requirements, our future results of operations, our expectations for and timing of ongoing or future clinical trials and regulatory approvals for any of our product candidates, and our plans, objectives, expectations and intentions. Because these statements apply to future events, they are subject to risks and uncertainties. When used in this announcement, the words “anticipate”, “believe”, “estimate”, “expect”, “expectation”, “goal”, “should”, “would”, “project”, “plan”, “predict”, “intend”, “target” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to us and are subject to a number of risks, uncertainties and other factors that could cause our actual results, performance, expected liquidity or achievements to differ materially from those projected in, or implied by, these forward-looking statements. Factors that may cause such a difference include, without limitation, our need for substantial additional financing and the availability and terms of any such financing, the safety and/or efficacy results of clinical trials of our product candidates, our failure to obtain regulatory approvals or comply with ongoing governmental regulation, our ability to commercialize, manufacture and achieve market acceptance of any of our product candidates, for which we rely heavily on collaboration with third parties, and our ability to protect and enforce our intellectual property rights and to operate without infringing upon the proprietary rights of third parties. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements and no assurance can be given that the actual results will be consistent with these forward-looking statements. For more information about the risks and uncertainties that may affect our results, please see the Risk Factors section of our filings with the Securities and Exchange Commission, including our transition report on Form 10-K for the six month period ended December 31, 2012 and quarterly reports on Form 10-Q. We do not intend to update any of the forward-looking statements after the date of this announcement to conform these statements to actual results, to changes in management’s expectations or otherwise, except as may be required by law.

(PLUG) to Develop Fuel Cell Range Extenders for FedEx

LATHAM, N.Y., Jan. 7, 2014  — Plug Power Inc. (Nasdaq:PLUG), a leader in providing clean, reliable energy solutions, today announced it will develop hydrogen fuel cell range extenders for 20 FedEx Express electric delivery trucks, allowing FedEx Express to nearly double the amount of territory the vehicles can cover with one charge.

This $3 million project is funded by the US Department of Energy (DOE) and includes project partners FedEx Express, Plug Power and Smith Electric Vehicles. The resulting hybrid vehicles will be powered by lithium-ion batteries and a 10-kilowatt Plug Power hydrogen fuel cell system. The fuel cell solution is based on Plug Power’s GenDrive Series 1000 product architecture.

Currently, electric delivery trucks are limited to traveling about 80 miles per charge. By doubling the vehicle range, Plug Power’s range extender makes battery-based electric vehicles feasible for nearly all delivery routes. It is an enabling technology that makes electric-powered delivery vehicles a viable solution for a wide range of applications, including parcel delivery trucks, taxis, post office trucks and port vehicles.

Customer interest in this technology provides Plug Power with a market expansion opportunity that leverages its existing technology-set and industry-leading hydrogen fuel cell experience with development funds provided by the DOE. Through successful trials and execution with FedEx Express, Plug Power will display how its range extender solution increases delivery fleet efficiency to over 50% coupled with an approximately 35 to 40% decrease in fuel expenses, when compared to diesel trucks.

“Early customer experiences with electric delivery vehicles have been overwhelmingly positive. But only 1% of these vehicles are electric today; we think that this range extender provides the added distance and quick refueling capabilities needed to really grow this market,” said Andy Marsh, Plug Power CEO. “Plug Power’s expertise in the materials handling market – where we have more than 90% market share – is an ideal base on which to build this technology. We thank the DOE for selecting us and look forward to working with our partners to help this market take off.”

About Plug Power Inc.

The architects of modern fuel cell technology, Plug Power is revolutionizing the industry with cost-effective power solutions that increase productivity, lower operating costs and reduce carbon footprints. Long-standing relationships with industry leaders forged the path for Plug Power’s key accounts, including Walmart, Sysco, P&G and Mercedes. With more than 4,000 GenDrive units deployed to material handling customers, accumulating over 16 million hours of runtime, Plug Power manufactures tomorrow’s incumbent power solutions today. Additional information about Plug Power is available at www.plugpower.com.

Plug Power Inc. Safe Harbor Statement

This communication contains statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements contain projections of our future results of operations or of our financial position or state other forward-looking information. These forward-looking statements include, without limitation, statements regarding financial expectations for the fourth quarter of 2013 and the year 2014, growth prospects for future orders, bookings and revenues, EBITDA projections, reductions in material and service costs and alternative supply sources. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Investors are cautioned not to unduly rely on forward-looking statements because they involve risks and uncertainties, and actual results may differ materially from those discussed as a result of various factors, including, but not limited to: the risk that we continue to incur losses and might never achieve or maintain profitability, the risk that we expect we will need to raise additional capital to fund our operations and such capital may not be available to us; the risk that we do not have enough cash to fund our operations to profitability and if we are unable to secure additional capital, we may need to reduce and/or cease our operations; the risk that a “going concern” opinion from our auditors, KPMG LLP, could impair our ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives; the recent restructuring plan we adopted may adversely impact management’s ability to meet financial reporting requirements; our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue; the risk that pending orders may not convert to purchase orders; the risk that our continued failure to comply with NASDAQ’s listing standards may result in our common stock being delisted from the NASDAQ stock market, which may severely limit our ability to raise additional capital; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the actual net cash used for operating expenses may exceed the projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our GenDrive systems; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to improve system reliability for our GenDrive systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; and other risks and uncertainties discussed under “Item IA—Risk Factors” in Plug Power’s annual report on Form 10-K for the fiscal year ended December 31, 2012, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2013 and as amended on April 30, 2013 and the reports Plug Power filed from time to time with the SEC. These forward-looking statements speak only as of the date on which the statements were made and are not guarantees of future performance. Except as may be required by applicable law, we do not undertake or intend to update any forward-looking statements after the date of this communication.

CONTACT: Press Contact
         Teal Vivacqua
         Plug Power Inc.
         518.738.0269
         media@plugpower.com

(LIVE) Capturing Restaurants in Large Numbers Over Groupon and LivingSocial

(VNRX) MissionIR Releases Exclusive Audio Interview With CEO Cameron Reynolds

(ATNM) to Present at Biotech Showcase™ 2014

Actinium Pharmaceuticals, Inc. (OTCQB: ATNM.OB) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that Dr. Kaushik J. Dave, President and CEO, will present at the Biotech Showcase™ 2014 conference from January 13^th to 15^th, 2014. Dr. Dave will present a corporate update on Monday, January 13, 2014 at 4:30 pm Pacific.

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (ATNM.OB) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy is based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical Iomab™-B will be used in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company is conducting a single, pivotal, multicenter Phase 3 clinical study of Iomab™-B in refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55 with a primary endpoint of durable complete remission. The company’s second program, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial. For more information, please visit www.actiniumpharmaceuticals.com.

For more information:

Visit our web site www.actiniumpharmaceuticals.com

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

(EONC) Quadruples Telecommunications Patent Portfolio

(ETAK) to Present at the Sidoti & Company Semi-Annual Microcap Conference in NY

OKLAHOMA CITY, Jan. 6, 2014  — Elephant Talk Communications Corp. (NYSE MKT: ETAK), a leading international provider of Software Defined Network Architecture (Software DNA™) platforms and cyber security solutions, today announced that Steven van der Velden, Chairman and CEO, will present at the Sidoti & Company Semi-Annual Microcap Conference in New York City on January 13, 2014.

About Elephant Talk:
Elephant Talk Communications Corp. (NYSE MKT: ETAK), is a leading international provider of mobile proprietary Software Defined Network Architecture (Software DNA™) platforms for the telecommunications industry.  The company empowers Mobile Network Operators (MNOs),  Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, superior Industry Expertise and high quality Customer Service without substantial upfront investment. Elephant Talk counts several of the world’s leading Mobile Operators amongst its customers, including Vodafone, T-Mobile, Zain and Iusacell. Visit: www.elephanttalk.com.

About ValidSoft:
ValidSoft provides advanced mobile- and cloud-security solutions. The company’s custom-built sophisticated multi-factor authentication platform (SMART™) takes full advantage of telecommunications and includes a leading proprietary voice biometric engine. The platform combats electronic fraud and safeguards consumer privacy across internet, mobile banking, card, mobile and fixed line telecommunication channels. The company counts some of the largest financial institutions among its customers. ValidSoft is the only security software company in the world that has been granted three European Privacy Seals. Visit: www.validsoft.com.

Media Contacts:

Investor Relations:
Steve Gersten
Elephant Talk Communications Corp.
+ 1 813 926 8920
Steve.Gersten@elephanttalk.com

Thomas Walsh
Alliance Advisors
+ 1 212 398 3486
twalsh@allianceadvisors.net

US – Public Relations: Michael Glickman
MWG CO
(917) 596.1883
mike@mwco.net

(CTIC) PIXUVRI® Receives Positive Final Appraisal Determination from NICE

– PIXUVRI Deemed Cost Effective for Patients with Multiply Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (NHL) –

SEATTLE, Jan. 6, 2014  — Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported that the National Institute for Health and Care Excellence (NICE), the independent body responsible for driving improvement and excellence in the health and social care system in the United Kingdom (UK), has issued its Final Appraisal Determination (FAD) for PIXUVRI^® (pixantrone). The positive final draft guidance determines PIXUVRI cost effective and recommends funding the treatment as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (aggressive B-cell NHL), which includes diffuse large B-cell lymphoma (DLBCL). CTI estimates that there are approximately 1,600 to 1,800 people in the UK diagnosed with multiply relapsed aggressive B-cell NHL per year.

James A. Bianco, M.D., President and Chief Executive Officer of CTI stated, “The positive recommendation by NICE for the funding of PIXUVRI means that physicians in England and Wales now have access to the only approved therapy for their patients with aggressive B-cell NHL in the third- and fourth-line salvage setting.”

The NICE Appraisal Committee reviewed CTI’s updated data analysis showing PIXUVRI’s cost effectiveness and recommended the treatment as an option for certain people with histologically confirmed aggressive B-cell NHL who have previously received rituximab and are receiving PIXUVRI as a third- or fourth-line treatment.

The FAD further recommends the prescription of PIXUVRI for as long as CTI makes the Patient Access Scheme (PAS) available. The PAS is a confidential pricing and access agreement with the UK’s Department of Health.

The FAD forms the basis of the final guidance to the NHS in England and Wales and is expected to be published in February 2014. Once the final guidance is published, the NHS must fully implement it within 90 days. CTI expects to officially launch PIXUVRI in England and Wales in early spring, when the FAD has been largely implemented.

Professor John Radford, a lymphoma expert at The University of Manchester and The Christie NHS Foundation Trust in Manchester – both part of the Manchester Cancer Research Centre said, “DLBCL is the most common type of aggressive NHL and despite undoubted progress over the last 10 years resulting from the introduction of better first-line therapy, the disease still recurs in some patients. The recent recommendation by NICE for the funding of PIXUVRI provides an additional treatment option for these patients and is a welcome development.”

Professor Finbarr E. Cotter, Professor of Haematology and Chair of Experimental Haematology, Centre for Haemato-Oncology, Barts Cancer Institute, and representative for the British Society for Haematology (BSH) commented, “The availability of PIXUVRI means physicians will be able to extend an approved salvage regimen to those patients that fail second- or third-line therapy. The data from the pivotal EXTEND Phase 3 trial of PIXUVRI clearly indicate that this drug is effective in heavily pretreated patients with relapsed or refractory aggressive NHL.”

About PIXUVRI (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. Unlike related compounds, PIXUVRI forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite — both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow PIXUVRI to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity.

In May 2012, the European Commission (EC) granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. PIXUVRI does not have marketing approval in the United States.

About NHL

NHL is the sixth most common cancer in the UK; in 2010, 12,180 people were diagnosed with the disease.¹ NHL is caused by the abnormal proliferation of lymphocytes, cells that are key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main forms—aggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly.

There are many subtypes of NHL, but aggressive B-cell NHL is the most common and accounts for about 55 percent of NHL cases.² After initial therapy for aggressive NHL with anthracycline-based combination therapy, one-third of patients typically develop progressive disease.³ Approximately half of these patients are likely to be eligible for intensive second-line treatment and stem cell transplantation, although 50 percent are expected not to respond.³ For those patients who fail to respond or relapse following second-line treatment, treatment options are limited, and usually palliative only.³

About Conditional Marketing Authorization

Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for PIXUVRI, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has accepted PIX306, CTI’s ongoing randomized controlled Phase 3 clinical trial, which compares PIXUVRI-rituximab to gemcitabine-rituximab in patients who have relapsed after one to three prior regimens for aggressive B‑cell NHL and who are not eligible for autologous stem cell transplant. As a condition of approval, CTI has agreed to have available the PIX306 clinical trial results by June 2015.

About Cell Therapeutics, Inc.

CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company committed to the development and commercialization of an integrated portfolio of oncology products aimed at making cancer more treatable. CTI is headquartered in Seattle, WA. For additional information and to sign up for email alerts and get RSS feeds, please visit www.CellTherapeutics.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. Such statements include, but are not limited to, statements regarding the expected number of people in the UK with multiply relapsed aggressive B-cell NHL per year, expectations with respect to the development of CTI and its product and product candidate portfolio, the expected benefits and effectiveness of PIXUVRI, NICE’s processes, pricing arrangements and the cost-effectiveness and availability of PIXUVRI to patients in the UK. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the outcome of preclinical and clinical studies, that CTI may not obtain reimbursement for PIXUVRI in certain markets in the European Union as planned, that the conditional marketing authorization for PIXUVRI may not be renewed, that the second Phase 3 clinical trial of pacritinib will not occur as planned, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI may experience delays in the commencement of preclinical and clinical studies, risks related to the costs of developing, producing and selling PIXUVRI, pacritinib, and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, that CTI will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation as well as other risks listed or described from time to time in CTI’s most recent filings with the Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

References:
1. Cancer Research UK http://www.cancerresearchuk.org/cancer-info/cancerstats/incidence/commoncancers/ Accessed April 2013.
2. Harris NL, et al. Ann Oncol. 1999;10(12):1419-32
3. Friedberg ASH Education Book 2011;1:498-505

Contacts:

Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com

Ed Bell
+1 206.282.7100
ebell@ctiseattle.com

In Europe
CTI Life Sciences Limited, Milan Branch
Laura Villa
E: lvilla@cti-lifesciences.com
T: +39 02 89659706
http://www.celltherapeutics.com/italiano

(PPHM) Receives FDA Fast Track Designation for Bavituximab in Lung Cancer

SUNRISE Pivotal Phase III Trial of Bavituximab in Second-Line NSCLC Underway

(OXBT) Announces Key Details of Phase 3 Trial Protocol for levosimendan

Oxygen Biotherapeutics, Inc. (“OBI”) (NASDAQ: OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that the protocol of their phase 3 trial for levosimendan has been published on ClinicalTrials.gov, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Heart Surgery on Cardiopulmonary Bypass.” http://www.clinicaltrials.gov/ct2/show/NCT02025621?term=levosimendan&rank=12

Oxygen Biotherapeutics previously announced that it had selected Duke University’s Duke Clinical Research Institute (DCRI) to conduct the Phase 3 trial of the levosimendan. The Phase 3 trial will be conducted in approximately 50 major cardiac surgery centers in North America. The trial will enroll patients undergoing coronary artery bypass grafts (CABG) and/or mitral valve surgery who are at risk for developing low cardiac output syndrome (LCOS). The trial is a double blind, randomized, placebo controlled study seeking to enroll 760 patients.

The number of patients to be enrolled in the trial is an estimate. This is an event driven trial, and will be stopped when the event rate reaches that identified in the study power calculations. Thus, the number of patients could be less than 760 or higher if the event rate is higher or lower than expected.

The protocol includes a review of the control arm event rate for the first 200 patients randomized in the trial. The study population can be enriched to a higher percentage of patients with a greater degree of left ventricular dysfunction to increase the control event rate.

Two interim analyses will test for efficacy or futility after 50% and 70% of the planned primary endpoint events have been recorded.

John Kelley, CEO of Oxygen Biotherapeutics stated: “We are excited to communicate the details of our innovative and efficient trial design , and we look forward to enrolling the first patients in this important trial later this year.”

About Levosimendan

Levosimendan was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland. Levosimendan is a calcium sensitizer developed for intra-venous use in hospitalized patients with acutely decompensated heart failure. It is currently approved in over 50 countries for this indication and not available in the United States. It is under development in North America for reduction in morbidity and mortality of cardiac surgery patients at risk of low cardiac output syndrome (LCOS). The acquisition brings to Oxygen Biotherapeutics not only the exclusive rights in North America to develop and commercialize levosimendan for the specific indication of prevention and treatment of LCOS, but also the FDA’s approval of Fast Track status for a Phase 3 trial, and the FDA’s SPA which represents agreement with the Phase III clinical trial’s study protocol. The FDA has provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication.

About Oxygen Biotherapeutics

Oxygen Biotherapeutics, Inc. is developing medical products for the acute care market. The company recently acquired the North American rights to develop and commercialize levosimendan. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS). In addition, the FDA has agreed to a Phase 3 protocol design under Special Protocol Assessment (SPA), and provided guidance that a single successful trial will be sufficient to support approval of levosimendan in this indication. The company also has developed a proprietary perfluorocarbon (PFC) therapeutic oxygen carrier called Oxycyte^® that is currently in clinical and preclinical studies for intravenous delivery for indications such as traumatic brain injury, decompression sickness and stroke.

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, the finalization of definitive agreements with DCRI, matters beyond the company’s control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its quarterly report on Form 10-Q filed on December 17, 2013, and annual report on Form 10-K filed on June 26, 2013, as well as its other filings with the SEC. The company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

(NBIX) Announces Positive Results of VMAT2 Inhibitor NBI-98854 in Kinect 2 Study

Plans to submit end of phase II meeting request to FDA Company to host conference call and webcast Monday, January 6th at 5:00pm ET / 2:00pm PT

SAN DIEGO, Jan. 6, 2014  — Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a small molecule VMAT2 inhibitor, showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms in the Phase IIb Kinect 2 study. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 as assessed by central blinded video raters.

At Week 6, AIMS scores were reduced by 2.6 points in the NBI-98854 intention-to-treat (ITT) group compared to a reduction of 0.2 points in the placebo arm (p<0.001). Additionally, the responder rate (>= 50% improvement from baseline) was 49% in the NBI-98854 ITT group compared to 18% in placebo (p=0.002). In the per-protocol (PP) group AIMS scores were reduced by 3.3 points for those subjects taking NBI-98854 (p<0.001), with a corresponding responder rate of 59% (p<0.001).

“The profound response in this Kinect 2 study demonstrates the potential of NBI-98854 as both a safe and highly effective treatment for patients suffering from tardive dyskinesia,” said Christopher F. O’Brien, Chief Medical Officer of Neurocrine Biosciences. “It is clear from these results that the use of blinded central AIMS raters coupled with the ability to titrate up to 75 mg of NBI-98854 were both critical to the success of this trial.”

The improvement in Week 6 AIMS was also corroborated by the Clinical Global Impression–Tardive Dyskinesia (CGI-TD). Treating clinicians determined that approximately 67% of the subjects taking NBI-98854 were “much improved” or “very much improved” at Week 6 compared to only 16% of the placebo subjects (p<0.001) in this pre-specified key secondary efficacy endpoint.

“The data from this Kinect 2 study allows us to submit an End of Phase II meeting request as well as finalize the initial draft of a Phase III protocol, both of which we anticipate filing with the FDA in the first half of 2014,” said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine. “Our Phase II studies of NBI-98854 have served to define the study population, elucidate the primary endpoint, refine our dosing regimen and provide the necessary efficacy and safety data to enable pivotal studies.”

The pre-specified statistical analysis plan included three data sets: a safety set (all subjects with at least one dose), an ITT set (all subjects who had an AIMS assessment at Week 6) and a PP set (all ITT subjects except those with no detectable drug levels at the evaluation time point). The table below summarizes the primary endpoint, LS Mean change-from-baseline AIMS, for both the ITT and PP populations at Week 6, as well as the responder analyses.

* a responder is defined as 50% or greater reduction in AIMS

The table below summarizes the key secondary endpoint, CGI-TD, for both the ITT and PP populations at Week 6.

*a responder is defined as “much improved” or “very much improved” (a “2” or “1”, respectively) on the CGI-TD.  A “4” on the CGI-TD indicates “no change”

Subject Profile

The Kinect 2 study randomized 102 subjects. At Week 6, the ITT population included 44 placebo subjects and 45 subjects who were randomized to NBI-98854. By Week 6, approximately 70% of the ITT population, randomized to NBI-98854, were titrated to the 75 mg dose, approximately 20% were titrated to the 50mg dose and the remaining subjects received 25 mg of NBI-98854. At Week 6 the PP population consisted of 44 placebo subjects and 34 subjects randomized to NBI-98854. The PP Week 6 final titrated dose level of NBI-98854 was similar to that of the ITT population. The PP population excluded eleven subjects whose plasma concentrations of NBI-98854 were below the lower limit of quantitation (i.e., not detectable). Given the timing of serum samples collections and the pharmacokinetic profile of NBI-98854, it was determined that these subjects had not ingested the study drug.  The subjects in the Kinect 2 study had moderate to severe tardive dyskinesia with a mean baseline video AIMS score of 8.0. Similar to previous studies, the average age of the trial participants was 56 years with an average age at onset of tardive dyskinesia of 49 years. Approximately 60% of the subjects were male.

Safety Profile

In this study NBI-98854 was generally safe and well tolerated. During the six-week treatment period the frequency of treatment-emergent adverse events was 33% for placebo and 43% for NBI-98854. There were no drug related serious adverse events. The most common treatment emergent adverse events were fatigue in five subjects (9.8%) randomized to NBI-98854 vs. two subjects (4.1%) in the placebo group, and headache reported by four subjects (7.8%) on NBI-98854 vs. two subjects (4.1%) on placebo. Discontinuation rates were similar in both the NBI-98854 and placebo treatment groups with five per study arm (none of which were study drug related).

Participants were assessed utilizing the Barnes Akathisia Ratings Scale (BARS) for akathisia and the Simpson-Angus Scale (SAS) for parkinsonism. Both of these scales documented minimal symptoms at baseline and there was no worsening during the six weeks of treatment. Clinical hematology, chemistry and ECG monitoring indicated no emergent safety signals.

There were no drug-drug interactions identified in subjects who were utilizing a range of psychotropic and other concomitant medications.

Next Steps for NBI-98854

Data from the Kinect 2 study will be integrated with the Kinect study data to inform the ultimate design of the next study, Kinect 3. The Company will work with its consultants and scientific advisors to expand and refine the pharmacokinetic/pharmacodynamic models as well as to complete the remaining safety and efficacy analyses from both Kinect and Kinect 2. These data will form the basis for an End of Phase II briefing package along with the proposed Phase III protocol.

Kinect 2 Study Design

The Kinect 2 Study was a randomized, parallel, double-blind, placebo-controlled, dose titration Phase IIb clinical trial utilizing the capsule formulation of NBI-98854 in moderate to severe tardive dyskinesia patients with an underlying mood disorder (e.g., bipolar disorder), schizophrenia or schizoaffective disorder, or a gastrointestinal disorder with exposure to metoclopramide. This 100 subject study assessed once-daily NBI-98854 over a six-week placebo-controlled dosing period. Half of the randomized subjects received placebo and half received NBI-98854. The NBI-98854 dosing regimen began with a once-daily dose of 25 mg for the initial two weeks. At the completion of the initial two weeks of dosing, based on certain efficacy and safety criteria, patients were titrated to a once-daily 50 mg dose, or continued on the once-daily 25 mg dose for the following two-week period. At the completion of the second two weeks of treatment another efficacy and safety assessment was performed and patients were eligible to be titrated to a once-daily 75 mg, 50 mg or 25 mg dose for the final two weeks of treatment. The primary endpoint of the study was a comparison of placebo vs. active scores utilizing the AIMS at the end of Week 6 by blinded central raters.

About the Abnormal Involuntary Movement Scale (AIMS)

The AIMS is a structured neurological examination that was developed in 1976 and has been used extensively in movement disorder assessments. It consists of ten distinct ratings of regional involuntary body movements that are scored on a zero to four scale with zero being rated as none and four being rated as severe. The primary endpoint of the Kinect 2 Study is the video AIMS total dyskinesia score, items one through seven which rate facial, extremity and trunk movement severity as assessed by blinded central raters. The raters were movement disorder neurologists with expertise in dyskinesia assessment.

About Tardive Dyskinesia

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities: lip smacking, grimacing, tongue protrusion, facial movements or blinking, puckering and pursing of the lips, or involuntary movements of the limbs. These symptoms are rarely reversible and there is currently no approved treatment.

About NBI-98854

VMAT2 is a protein concentrated in the human brain that is primarily responsible for re-packaging and transporting monoamines (dopamine, norepinephrine, serotonin, and histamine) in pre-synaptic neurons. NBI-98854, developed in the Neurocrine laboratories, is a novel, highly-selective VMAT2 inhibitor that modulates dopamine release during nerve communication, while at the same time having minimal impact on the other monoamines, thereby reducing the likelihood of “off target” side effects.  NBI-98854 is designed to provide low, sustained, plasma and brain concentrations of active drug to minimize side effects associated with excessive monoamine depletion. The Company has completed nine-month in-vivo toxicology studies to support longer dosing regimens in humans.

NBI-98854 may also be useful in other disorders such as Huntington’s chorea, schizophrenia, Tourette’s syndrome, and tardive dystonia.

Conference Call and Webcast Information

The Company will host a live conference call and webcast to provide additional details of this study on, Monday January 6, 2014 at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants can access the live conference call by dialing  800-894-5910 (US) or 785-424-1051 (International) using the conference ID: NBIX. The call can also be accessed via the webcast through the Company’s website at http://www.neurocrine.com. Slides will also be made available through www.neurocrine.com for the conference call and webcast. If you are unable to attend the webcast and would like further information on this announcement please contact the Investor Relations Department at Neurocrine Biosciences at (858) 617-7600. A replay of the Conference Call will be available approximately one hour after the conclusion of the call by dialing 800-688-4915 (US) or 402-220-1319 (International) using the conference ID: NBIX. The call will be archived for three weeks.

About Neurocrine Biosciences

Neurocrine Biosciences, Inc. is a clinical stage drug discovery company primarily focused on neurological and endocrine based diseases and disorders. The Company discovers and develops innovative pharmaceuticals, in diseases with high unmet medical needs or where the existing drug classes are inadequate, through a disciplined yet entrepreneurial process. Utilizing a portfolio approach to drug discovery, Neurocrine has multiple small molecule drug candidates at various stages of pharmaceutical development. Neurocrine’s two lead late stage clinical programs are elagolix, a GnRH antagonist for women’s health that is partnered with AbbVie Inc., and a wholly owned VMAT2 inhibitor for the treatment of movement disorders. Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.

In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine’s business and finances in general, as well as risks and uncertainties associated with the Company’s VMAT2 program and Company overall. Specifically, the risks and uncertainties the Company faces with respect to the Company’s VMAT2 program include, but are not limited to; risk that NBI-98854 will not proceed to later stage clinical trials and risk that the Company’s clinical trials will fail to demonstrate that NBI-98854 is safe and effective. With respect to its pipeline overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company’s dependence on contract manufacturers for clinical drug supply; risks associated with the Company’s dependence on corporate partners for development, commercial manufacturing and marketing and sales activities for the Company’s partnered programs; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company’s products; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2012 and on Form 10-Q for the quarter ended September 30, 2013. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

(QUNR) Air Ticket Bookings Exceed 60,000 in a Day

Company Also Named Top Ticket Booking App by Downloads and Usage

BEIJING, Jan. 3, 2014  — Qunar Cayman Islands Limited (Nasdaq:QUNR) (“Qunar” or the “Company”), China’s leading search-based travel commerce platform, today announced that it achieved a single-day record for air ticket bookings, with more than 60,000 over the New Year holiday.

The Company also provided updates on progress of its mobile strategy. Qunar’s mobile hotel bookings reached 50% of total hotel bookings, while its mobile taxi-booking service, Cheche, has expanded coverage to over 42 cities in China. The announcement followed the publication of reports by CTCNN which named Qunar the leading app by November downloads, and by TalkingData which names the Company the market leader for both December mobile app user coverage and usage rates for Android devices.

In a report issued on Tuesday, Deutsche Bank analyst Alan Hellawell also noted that Qunar Travel has become the most popular ticket-booking app in China. According to a research survey conducted by Enfodesk, 63.6% of respondents named Qunar Travel as the most frequently used ticket-booking app for air-ticket bookings, train-ticket bookings and tourist attraction-related bookings, followed by 54.5% for its closest competitor.

Qunar has taken steps to improve its mobile offering with recent moves such as connecting its popular travel app to social media service WeChat’s mobile payment system and launching voice recognition for hotel search.

About Qunar

Qunar Cayman Islands Limited is the leading search-based commerce platform for the travel industry in China. Qunar’s goal is to empower Chinese travelers to define their travel experience. Founded in May 2005 and headquartered in Beijing, Qunar is committed to providing travelers with a one-stop travel information source on both PC and mobile devices. The Company enables travelers to find the best-value deals by aggregating and processing highly fragmented travel product information from tens of thousands of travel service providers into an organized and user-friendly display through its proprietary technology. According to research firm iResearch, Qunar has ranked No. 1 among all non-state-owned online travel companies in China in terms of monthly unique visitors since November 2010. Qunar’s mobile application “Qunar Travel” was ranked the most frequently used mobile travel application in China by China Internet Network Information Center in September 2012.

Leveraging its large user base and advanced technologies, the Company provides an attractive value proposition to its customers, which include travel service providers and display advertisers.

Qunar means “where to go” in Mandarin Chinese.

CONTACT: For more information, please contact:

         China
         Jenna Qian
         Qunar
         Tel: +86-10-5760-3609
         press@qunar.com

         Nick Beswick
         Brunswick Group
         Tel: +86-10-5960-8600
         Email: qunar@brunswickgroup.com

         U.S.
         Cindy Zheng
         Brunswick Group
         Tel: +1-212-333-3810
         Email: qunar@brunswickgroup.com

(LCAV) Reports Fourth Quarter Procedure Volume up 4% Over Prior Year

Marks Second Consecutive Quarter of Year-over-Year Growth Financial Results Conference Call Set for February 18th at 10:00 a.m. Eastern Time

CINCINNATI, Jan. 3, 2014  — LCA-Vision Inc. (NASDAQ: LCAV), a leading provider of laser vision correction services under the LasikPlus^® brand, today reported that 12,033 procedures were performed during the fourth quarter of 2013, an increase of 4% over the 11,613 procedures performed during the fourth quarter of 2012.  This is the second consecutive quarter of year-over-year growth in procedure volume.

Michael Celebrezze, chief executive officer of LCA-Vision, said, “Although the quarter started off slowly with sluggish appointment bookings during the federal government shutdown in October, we are very encouraged by the strong rebound in our business during the remainder of the fourth quarter. Our team worked hard to increase procedure volume for the second consecutive quarter, reversing the negative comparisons we experienced in the first half of the year.  With the cost savings initiatives instituted throughout the year, coupled with revenue increases in the second half, we expect to report a significant improvement in financial performance from our core LASIK business in 2013.”

LCA-Vision will release fourth quarter 2013 financial results prior to the market open on Tuesday, February 18, 2014, with a conference call and webcast to follow at 10:00 a.m. Eastern time.

To access the conference call, dial 866-322-1352 (within the United States and Canada) or 706-643-6246 (international callers). The webcast will be available at the investor relations section of LCA-Vision’s website. A replay of the call and webcast will begin approximately two hours after the live call has ended. To access the replay, dial 855-859-2056 (within the United States and Canada) or 404-537-3406 (international callers) and enter the conference ID number: 29984536.

About LCA-Vision Inc./LasikPlus^®
LCA-Vision Inc., a leading provider of laser vision correction services under the LasikPlus^® brand, operates 61 LasikPlus^® vision centers in the United States: 52 full-service LasikPlus^® fixed-site laser vision correction centers and nine pre- and post-operative LasikPlus^® satellite centers. Since U.S. approval, more than 1.3 million laser vision correction procedures have been performed at the company’s vision centers.

For Additional Information

(PXLW) Skyworth Selects PA168 MotionEngine Processors for Ultra HD 4K TVs

Pixelworks, Inc. (NASDAQ: PXLW), an innovative provider of video display processing technology, today announced that its PA168 MotionEngine™ video display processor has been selected to power Skyworth’s Ultra HD 4Kx2K Dual Core Android 3D Smart TVs. These new high-end flat panels will deliver the very highest picture quality and an immersive TV viewing experience for the Chinese market.

“Pixelworks is very pleased to work with Skyworth to lead the way in delivering Ultra HD 4Kx2K TVs to the China market,” said Graham Loveridge, SVP Strategic Marketing and Business Development of Pixelworks. “The combination of unprecedentedly high resolution, price point, and superior video display processing will quickly affirm Skyworth’s leadership position in this all-important market.”

Pixelworks’ PA168 MotionEngine was designed from the ground up to address the Ultra HD market and solves the most complex and persistent problems associated with displaying video at high resolutions and refresh rates. Pixelworks’ advanced video display solutions include patented Motion Estimation and Motion Compensation (MEMC) technologies and the industry’s only Halo-Free Frame Rate Conversion (FRC).

“Skyworth’s choice of Pixelworks’ video display processor enables unparalleled video performance in our Ultra HD 55E780U Dual-Core Android Smart TV at a very compelling price point,” said a Skyworth company spokesperson. “We believe this industry-leading technology differentiates our products, delivering greater value and quality to our Chinese consumers.”

The PA168 MotionEngine contains a combination of industry-leading technical capabilities, including Pixelworks’ 6^th generation Halo-Free FRC technology; an innovative cascading architecture that allows platforms to be scaled for significantly higher resolutions and refresh rates; proprietary n2m™ technology for smooth playback of low-frame internet video content, support for major 3D formats; and real-time 2D to 3D conversion.

For additional information on new products, as well as product demos, please contact your local Pixelworks office (http://www.pixelworks.com/locations.php) to obtain an invitation.

About Pixelworks, Inc.

Pixelworks creates, develops and markets video display processing technology for digital video applications that demand the very highest quality images. At design centers around the world, Pixelworks engineers constantly push video performance to keep manufacturers of consumer electronics and professional displays worldwide on the leading edge. The company is headquartered in San Jose, CA.

For more information, please visit the company’s Web site at www.pixelworks.com.

Note: Pixelworks, the Pixelworks logo and MotionEngine are all registered trademarks of Pixelworks, Inc.

About Skyworth

Skyworth Digital Holdings Ltd. (HKEX stock code:0751) established in 1988. It is the leading PRC TV manufacturer based in Shenzhen, with a mission to be the No. 1 Display Technology in the PRC. Skyworth is specialized in TV production with a focus on high-end digital products, including LCD TV, HD CRT TV, slim CRT TV, Plasma TV, digital set-top box, mobile phones, car electronics, security monitors and small size LCD modules. In 2006/07, Skyworth’s total sales volume of TV and group turnover reached 8.6 million units and HK$12.6 billion, respectively. According to the survey conducted by Gfk Asia Pte. Ltd. in 2006, Skyworth ranked No. 1 among national and foreign brands in terms of sales amount in 100 major cities in the PRC. In December 2003 Skyworth firstly launched the self-developed V12 digital engine for high definition TV in China. In 2004-2005, 6 basic colors technology has been widely applied to Skyworth’s TV. In May 2006, the Group introduced the recordable LCD TV, 3G-USB LCD TV, auto-adjustable LCD backlight technology in September 2006 and the stabilizing technology to improve the response time of motion pictures and CooCaa TV in the first and third quarter of 2007, respectively. Being the first PRC TV manufacturer explored the overseas market in 1993, Skyworth’s quality OEM products have been recognized by international brands. Overseas markets contributed 9.7% in total turnover in 2006/07. Skyworth’s R&D is led by experienced electronics engineers and it cooperates with well-known suppliers: Real Media Networks, Trident, Pixelworks, Texas Instruments, LG, Fujitsu and Epson in application software, industrial design and plant management. Skyworth’s Science Industrial Park with a total area of over 640,000 square meters, located in Shiyan, Shenzhen, has commenced production of flat-panel TV and high-end electronics products in October 2006. Meanwhile, the new regional production plant at Ruyi district of Huhhot, Inner Mongolia has also started operation. The two new plants give Skyworth additional production capacity of totally 4 million units. Skyworth was listed on The Stock Exchange of Hong Kong Limited (0751) in April 2000. Please visit http://www.skyworth.com for more information.

(FEYE) Announces Acquisition of Mandiant

Combination Creates Industry-leading Vendor With a Complete Solution for Detecting, Resolving, and Preventing Advanced Threats

MILPITAS, Calif., Jan. 2, 2014  — FireEye (Nasdaq:FEYE), the leader in stopping today’s advanced cyber attacks, announced today that it has acquired privately held Mandiant, the leading provider of advanced endpoint security products and security incident response management solutions. The acquisition, which recognizes the ever-increasing intensity of cyber attacks and follows nearly two years of collaboration, creates the industry’s leading advanced threat protection vendor with the ability to find and stop attacks at every stage of the attack life cycle. The transaction closed on December 30, 2013.

The combination of FireEye and Mandiant brings together two highly complementary companies, each a recognized leader and innovator in security, and creates an organization uniquely qualified to meet organizations’ needs for real-time detection, contextual threat intelligence, and rapid incident response. FireEye pioneered the use of virtual machine technology in security with the introduction of its purpose-built virtual machine-based Multi-Vector Virtual Execution (MVX) engine. With more than two million virtual machines deployed worldwide, the company’s virtual machine-based Web, email, data center, and mobile security solutions provide real-time, dynamic threat protection to more than 1,500 government, enterprise, and small and mid-sized customers.

Mandiant is an acknowledged leader in endpoint security, incident response, and remediation, with more than two million endpoints installed globally. As a trusted security advisor to more than one-third of the Fortune 100, Mandiant’s experts have responded to hundreds of high-profile security incidents and bring deep security and incident response expertise to FireEye. The combined organization unifies the critical components required to provide state-of-the-art cyber security: the most complete library of actionable threat intelligence on advanced threats and a product suite that can apply that intelligence to detect and prevent attacks on both the network and on endpoints.

This powerful combination of security products and threat intelligence is enhanced by expert security consulting, incident response, and managed security services enabling organizations to improve their security posture and resolve security incidents whenever and wherever they arise.

“Organizations today are faced with knitting together a patchwork of point products and services to protect their assets from advanced threats,” said David DeWalt, chairman of the board and chief executive officer of FireEye. “Together, the size and global reach of FireEye and Mandiant will enable us to innovate faster, create a more comprehensive solution, and deliver it to organizations around the world at a pace that is unmatched by other security vendors.”

Mandiant expands FireEye’s ability to stop advanced attacks at the earliest phases of the attack life cycle with:

• Endpoint Threat Detection, Response, and Remediation Products
  Mandiant pioneered and continues to lead the industry for endpoint-based advanced threat detection and response. Mandiant’s endpoint products, which are already integrated with the FireEye platform, enable security teams to make faster, more accurate decisions about potential security incidents while eliminating blind spots by connecting the dots with the FireEye network-based threat detection and prevention platform.
• Advanced Threat Intelligence
  Mandiant brings unrivaled depth in intelligence on next-generation attacks, which is continually gathered from ongoing monitoring of more than two million endpoints and by incident response and remediation teams who serve on the front lines combating the most advanced attacks. When this depth of threat intelligence is paired with the breadth of the FireEye real-time threat intelligence gathered from more than two million virtual machines, organizations will have unmatched detection and contextual information about attempted attacks, including the level of risk, the identity of the attackers, and the intended target of the attack.
• Incident Response and Security Consulting Services
  Endpoint protection, security incident response, and remediation have been Mandiant’s primary focus and expertise since its inception. Mandiant’s extensive team of highly skilled incident response experts has performed hundreds of incident response investigations across all industries and at organizations of all sizes. In addition, Mandiant brings its Mandiant Managed Defense monitoring service to FireEye. The addition of these skills and expertise significantly expand the ability of FireEye to offer value-added services on the FireEye Oculus platform.

Mandiant has been a strategic alliance partner of FireEye since April 2012. The combination of the two companies is a natural extension of this partnership and their integrated product offering, which both companies announced in February 2013.

Kevin Mandia, Mandiant’s founder and chief executive officer prior to the acquisition, has been appointed by the FireEye board of directors to the position of senior vice president and chief operating officer of FireEye. Mr. Mandia has been profiled on the cover of Fortune magazine and recognized by Foreign Policy magazine as one of the 100 leading global thinkers of 2013.

“The combination of FireEye and Mandiant will deliver end-to-end protection and meaningful value to customers,” said Mr. Mandia. “By joining FireEye and Mandiant, we will be able to deliver fully integrated products and services that help organizations protect themselves from attacks. The combined product portfolio will cover all the major attack points within an organization, and our expanded services capacity will allow us to quickly pivot to incident response when necessary to reduce the impact of security breaches.”

Mandiant will be integrated with FireEye to provide global services and cloud solutions, including security consulting, incident response, and managed services. Mandiant’s endpoint threat detection and response products will be incorporated as a core element of the FireEye Oculus platform.

Financial Terms of the Transaction

The acquisition was approved by the shareholders of Mandiant and the boards of directors of both companies. Under the terms of the merger agreement, FireEye will issue an aggregate of 21.5 million shares and options to purchase shares of FireEye stock and pay approximately $106.5 million of net cash in the transaction to the former Mandiant security holders. In addition, FireEye granted certain performance-based retention equity incentives.

Webcast and Conference Call Information

FireEye will host a live webcast with slides to discuss the transaction on January 2, 2014 at 2:00 P.M. Pacific time (5:00 P.M. Eastern time). The webcast may be accessed from the Investor Relations section of the FireEye website at http://investors.FireEye.com. Additionally, interested parties may access an audio-only conference call by dialing toll free 1-877-312-5521 within the U.S., or 1-678-894-3048 from international locations.

The archived webcast will be available via the Investor Relations section of the FireEye website at http://investors.FireEye.com. A conference call replay will be available approximately one hour after the conclusion of the event on January 2 through January 9, 2014 by dialing toll free 1-855-859-2056 within the U.S. or 1-404-537-3406 from international locations, and entering conference code 30005211.

About FireEye, Inc.

FireEye has invented a purpose-built, virtual machine-based security platform that provides real-time threat protection to enterprises and governments worldwide against the next generation of cyber attacks. These highly sophisticated cyber attacks easily circumvent traditional signature-based defenses, such as next-generation firewalls, IPS, anti-virus, and gateways. The FireEye Threat Prevention Platform provides real-time, dynamic threat protection without the use of signatures to protect an organization across the primary threat vectors and across the different stages of an attack life cycle. The core of the FireEye platform is a virtual execution engine, complemented by dynamic threat intelligence, to identify and block cyber attacks in real time. FireEye has over 1,500 customers across more than 40 countries, including over 100 of the Fortune 500.

About Mandiant

Mandiant was founded in 2004. The company was named “Best Security Company” by SC Magazine in 2012 and 2013 and counts more than 33 percent of the Fortune 100 as clients. Bloomberg BusinessWeek profiled Mandiant as the “go-to responder for cyber-espionage attacks”, and the company received widespread coverage in February 2013 for its report, “APT1: Exposing One of China’s Cyber Espionage Units”, which traced attacks on 141 companies to Unit 61398 of the People’s Liberation Army, supporting allegations of China’s involvement in state-sponsored espionage.

Forward-Looking Statements

This press release contains forward-looking statements about the expectations, beliefs, plans, intentions and strategies of FireEye relating to FireEye’s acquisition of Mandiant. Such forward-looking statements include statements regarding future product offerings; expected benefits to FireEye, Mandiant and their respective customers; expected financial impact of the acquisition on FireEye; and plans regarding Mandiant and Mandiant personnel. These statements reflect the current beliefs of FireEye and are based on current information available to us as of the date hereof, and we do not assume any obligation to update the forward-looking statements provided to reflect events that occur or circumstances that exist after the date on which they were made. The ability of FireEye to achieve these business objectives involves many risks and uncertainties that could cause actual outcomes and results to differ materially and adversely from those expressed in any forward-looking statements. These risks and uncertainties include the failure to achieve expected synergies and efficiencies of operations between FireEye and Mandiant; the ability of FireEye and Mandiant to successfully integrate their respective market opportunities, technology, products, personnel and operations; the failure to timely develop and achieve market acceptance of combined products and services; the potential impact on the business of Mandiant as a result of the acquisition; the loss of any Mandiant customers; the ability to coordinate strategy and resources between FireEye and Mandiant; the ability of FireEye and Mandiant to retain and motivate key employees of Mandiant; general economic conditions; as well as those risks and uncertainties included under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Form 10-Q filed with the Securities and Exchange Commission on November 14, 2013 for the quarter ended September 30, 2013, which is available on the Investor Relations section of our website at investors.FireEye.com and on the SEC website at www.sec.gov.

© 2014 FireEye, Inc. All rights reserved. FireEye, Multi-Vector Virtual Execution and Oculus are registered trademarks or trademarks of FireEye, Inc. in the United States and other countries. All other brands, products, or service names are or may be trademarks or service marks of their respective owners.

CONTACT: Investor Contact
         Kate Patterson
         FireEye, Inc.
         kate.patterson@fireeye.com
         408-321-4957

         Media Contact
         Vitor De Souza
         FireEye, Inc.
         vitor.desouza@fireeye.com
         415-699-9838

(SEED) to Announce Fiscal 2013 Annual Financial Results on January 8th

BEIJING, Jan. 3, 2014 — Origin Agritech Limited (NASDAQ: SEED) (“Origin” or the “Company”), a technology-focused supplier of crop seeds in China, today announced that the Company will report results for its fiscal year 2013 ended September 30, 2013, before the market opens on Wednesday, January 8, 2014.

The Company will host a teleconference on January 8, 2014, at 8:00 a.m. ET / 9:00 p.m. Beijing time to discuss the results. To participate in the call, please dial +1-877-870-4263 in North America, or +1-412-317-0790 internationally, approximately 5 minutes prior to the scheduled start time.

A replay of the call will be available shortly after the conference call through 9:00 a.m. ET on February 15, 2014. The replay dial-in numbers are: U.S. toll free number +1-877-344-7529, or the international number is +1-412-317-0088; using Conference Number “10038866” to access the replay.

About Origin

Founded in 1997 and headquartered in Zhong-Guan-Cun (ZGC) Life Science Park in Beijing, Origin Agritech Limited (NASDAQ GS: SEED) is China’s leading agricultural biotechnology company, specializing in crop seed breeding and genetic improvement, seed production, processing, distribution, and related technical services. Leading the development of Genetically Modified (GM) technology, Origin Agritech’s phytase corn was the first transgenic corn to receive the Bio-Safety Certificate from China’s Ministry of Agriculture. Over the years, Origin has established a robust GM seed pipeline including products with glyphosate tolerance and pest resistance (Bt) traits. Origin operates production centers, processing centers and breeding stations nationwide with sales centers located in key crop-planting regions. Product lines are vertically integrated for corn, rice and canola seeds. For further information, please log on to the Company’s website at: www.originseed.com.cn.

Forward Looking Statement

This release contains forward-looking statements. All forward-looking statements included in this release are based on information available to us on the date hereof. These statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results to differ materially from those implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “targets,” “goals,” “projects,” “continue,” or variations of such words, similar expressions, or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Neither we nor any other person can assume responsibility for the accuracy and completeness of forward-looking statements. Important factors that may cause actual results to differ from expectations include, but are not limited to, those risk factors discussed in Origin’s filings with the SEC including its annual report on Form 20-F to be filed. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACT:

Origin Agritech Limited
Dr. James Chen
Chief Financial Officer
james.chen@originseed.com.cn

or

Kay Liu
Investor Relations
ke.liu@originseed.com.cn
+86-138-1193-7764

(CSIQ) Completes the Sale of Mississippi Mills Solar Power Plant to TransCanada

GUELPH, Ontario, Jan. 2, 2014 — Canadian Solar Inc. (the “Company”, or “Canadian Solar”) (NASDAQ: CSIQ), one of the world’s largest solar power companies, today announced that its wholly owned subsidiary, Canadian Solar Solutions Inc., has completed the sale of Mississippi Mills, a 10 megawatt AC solar power plant valued at over C$61.0 million to TransCanada Corporation (TSX, NYSE: TRP) (“TransCanada”) on December 31, 2013

“This is the fourth of nine solar power plants totaling 86MW AC that we agreed to build and sell to TransCanada for approximately C$500 million,” said Dr. Shawn Qu, Chairman and Chief Executive Officer of Canadian Solar. “Our ability to successfully execute on this multi-facility project reflects the strength of Canadian Solar’s team and our partners. This should give investors added confidence in our ability to execute on our broader late-stage project backlog, which now stands at over 1.0 GW.”

The Mississippi Mills 10 megawatt AC solar power plant is located in the town of Mississippi Mills in Eastern Ontario. Canadian Solar Solutions Inc. will provide turnkey engineering, procurement and construction services to each of the nine projects. This latest sale follows the previously announced closing of the sale of Brockville 1 on June 28, 2013, in addition to Brockville 2 and Burritts Rapids on September 30, 2013.

About TransCanada

With more than 60 years’ experience, TransCanada is a leader in the responsible development and reliable operation of North American energy infrastructure including natural gas and oil pipelines, power generation and gas storage facilities. TransCanada operates a network of natural gas pipelines that extends more than 68,500 kilometres (42,500 miles), tapping into virtually all major gas supply basins in North America. TransCanada is one of the continent’s largest providers of gas storage and related services with more than 400 billion cubic feet of storage capacity. A growing independent power producer, TransCanada owns or has interests in over 11,800 megawatts of power generation in Canada and the United States. TransCanada is developing one of North America’s largest oil delivery systems. TransCanada’s common shares trade on the Toronto and New York stock exchanges under the symbol TRP. For more information visit: www.transcanada.com or check us out on Twitter @TransCanada or http://blog.transcanada.com.

About Canadian Solar

Founded in 2001 in Canada, Canadian Solar Inc. (NASDAQ: CSIQ) is one of the world’s largest and foremost solar power companies. As a leading vertically integrated provider of solar modules, specialized solar products and solar power plants with operations in North America, South America, Europe, Africa, the Middle East, Australia and Asia, Canadian Solar has delivered more than 6GW of premium quality solar modules to customers in over 70 countries. Canadian Solar is committed to improve the environment and dedicated to provide advanced solar energy products, solutions and services to enable sustainable development around the world. For more information, please visit www.canadiansolar.com.

Safe Harbor/Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially. These statements are made under the “Safe Harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by such terms as “believes,” “expects,” “anticipates,” “intends,” “estimates,” the negative of these terms, or other comparable terminology. Factors that could cause actual results to differ include the risks regarding general business and economic conditions and the state of the solar industry; governmental support for the deployment of solar power; future available supplies of high-purity silicon; demand for end-use products by consumers and inventory levels of such products in the supply chain; changes in demand from significant customers; changes in demand in our project markets, including Canada; changes in customer order patterns; capacity utilization; level of competition; pricing pressure and declines in average selling prices; delays in new product introduction; continued success in technological innovations and delivery of products with the features customers demand; utility-scale project approval process; delays in utility-scale project construction; shortage in supply of materials or capacity requirements; availability of financing; exchange rate fluctuations; litigation and other risks as described in the Company’s SEC filings, including its annual report on Form 20-F filed on April 26, 2013. Although the Company believes that the expectations reflected in the forward looking statements are reasonable, it cannot guarantee future results, level of activity, performance, or achievements. You should not place undue reliance on these forward-looking statements. All information provided in this press release is as of today’s date, unless otherwise stated, and Canadian Solar undertakes no duty to update such information, except as required under applicable law.

(ORMP) Receives Patent Allowance in Israel and Australia for Platform Technology

JERUSALEM, January 2, 2014 — Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has received Notices of Allowance from the Israel and Australian Patent Offices. The patent entitled, “Methods and Compositions for Oral Administrations of Proteins” covers a core concept of the company’s technology for the oral delivery of drugs and vaccines currently delivered via injection. The allowance in Israel marks the second from the Israel Patent Office in the past 30 days. Additionally, this is Oramed’s second Australian patent allowance, following the grant of a different patent in May 2012.  The patent has also been approved in Japan, China, Russia, and New Zealand.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD^[TM]) technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.

For more information, the content of which is not part of this press release, please visit http://www.oramed.com

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials or revolutionizing the treatment of diabetes with our products. These forward-looking statements and their implications are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.

Company Contact:
Oramed Pharmaceuticals
Aviva Sherman
Office: +972-2-566-0001
Email: aviva@oramed.com

(HSOL) to Supply 11.5 MW to Ikaros Solar

Leading Belgian solar company to install high-quality modules in UK

Hanwha SolarOne Co., Ltd. (the “Company”, or “Hanwha SolarOne”), a top-10 global photovoltaic manufacturer of high-quality, cost-competitive solar modules, today announced that it will supply 11.5 MW of high quality solar modules to Ikaros Solar Belgium NV (the “Ikaros Solar”). The modules are scheduled for delivery in January and February 2014. Ikaros intends to install the modules in a solar park in Norfolk County, United Kingdom. Hanwha SolarOne will supply its 72-cell module HSL-72, characterized by excellent real-life performance and extended durability.

Ikaros Solar operates as a project planner and wholesaler and is active in both large-scale and rooftop segments. Based in Belgium, Ikaros Solar has evolved into an international company with a global network of offices. Hanwha SolarOne has delivered high-quality PV modules to a number of solar projects constructed by Ikaros Solar.

“In Hanwha SolarOne, we have found a partner that can ensure both high quality and financial stability,” said Yves Devis, CEO at Ikaros Solar. “The PV modules from Hanwha SolarOne have demonstrated high performance and durability in our past projects. With the improved features of the new HSL-module series providing further benefits, Hanwha SolarOne was a natural choice for our latest large-scale project.”

“This project is the result of a strong, long-term collaboration with Ikaros Solar, a leading solar company in the Benelux region,” said Laurent Bodin, Director Sales France and Benelux at Hanwha SolarOne. “The partnership is based on mutual respect between two reliable companies that share the highest quality requirements. We look forward to contributing to more successful Ikaros projects in the future.”

Ikaros intends to start the construction of the new solar park in January 2014 and connect the new solar park to the grid by the end of March 2014. The solar park will include 38,334 modules supplied by Hanwha SolarOne.

About Hanwha SolarOne

Hanwha SolarOne Co., Ltd. (NASDAQ: HSOL) is one of the top 10 photovoltaic module manufacturers in the world, providing cost-competitive, high quality PV modules. It is a flagship company of Hanwha Group, one of the largest business enterprises in South Korea. Hanwha SolarOne serves the utility, commercial, government and residential markets through a growing network of third-party distributors, OEM manufacturers and system integrators. The company maintains a strong presence worldwide, with a global business network spanning Europe, North America, Asia, South America, Africa and the Middle East. As a responsible company committed to sustainability, Hanwha SolarOne is an active member of the PV Cycle take-back and recycling program. For more information, please visit: www.hanwha-solarone.com.

About Ikaros Solar

Ikaros Solar, headquartered in Schoten, is one of Belgium’s top companies operating in the PV market. It provides PV solutions for companies and the residential market. In addition, it is a wholesaler for certified installers. It offers its clients a total service during the selection and installation of solar energy and for maintenance and monitoring afterwards. Ikaros Solar was founded in 2006 and has evolved into an international company with offices in Belgium, Great Britain, Portugal, India, Mexico and Turkey. Ikaros Solar has installed more than 2,000 private PV systems and supplied installations to many public authorities and companies including IKEA, Carrefour, Philips, Janssen Pharmaceutica, DP World and Molenbergnatie. Furthermore, Ikaros Solar has partnerships with certified installers for the private sector. For more information, please visit: http://www.ikaros-solar.eu/

Safe-Harbor Statement

This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the quotations from management in this press release and the Company’s operations and business outlook, contain forward-looking statements. Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Further information regarding these and other risks is included in Hanwha SolarOne’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F. Except as required by law, the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Hanwha SolarOne has not independently verified any information in “About Ikaros Solar” or any other information regarding the market position of Ikaros Solar. Hanwha SolarOne makes no representations regarding the accuracy or completeness of any such information.

(PLUG) Meets Projected Order Targets for Fourth Quarter of 2013

$32 Million in Unit Orders, Service and Hydrogen Contracts; Company Signs First Large Turnkey GenDrive Solution Customer

LATHAM, N.Y., Jan. 2, 2014 — Plug Power Inc. (Nasdaq:PLUG), a leader in providing clean, reliable energy solutions, today announces it has met order targets set for the fourth quarter of 2013. Orders for the fourth quarter of 2013 totaled approximately $32 million, and includes contracts with Walmart, Kroger, Procter & Gamble, Bridgestone, BMW, Sysco, Ace Hardware, CVS, Mercedes Benz, Lowes, Stihl, and Coke.

Key highlights associated with Plug Power’s fourth quarter bookings include:

• A contract to deploy multiple sites with a single food distribution customer using Plug Power’s turnkey GenDrive solution which includes products, service, and hydrogen;
• Repeat business with key material handling giants like Walmart, Kroger, Mercedes Benz, and BMW, resulting in fleet expansion and follow-on orders. These orders include both products and recurring revenue for service;
• And, addition of new customers to Plug Power’s growing customer list.

“Plug Power has continued to deliver value to material handling customers through its GenDrive product suite,” said Andy Marsh, CEO at Plug Power. “Moving forward, as we significantly grow the business, Plug Power will increase its value-add for each customer through building our product base and establishing recurring revenue streams through hydrogen and service. Plug Power has seen significant traction closing out 2013, and we expect the first quarter of 2014 bookings to meet or exceed the fourth quarter of 2013.”

Actual financial results and further overview of customer success will be presented and reviewed on the Company’s fourth quarter and year-end conference call. The Company will be holding its next business update conference call on Tuesday, January 14 at 10:00 am ET. Details to access the conference call will be posted on the homepage of Plug Power’s web site, www.plugpower.com.

About Plug Power Inc.

The architects of modern fuel cell technology, Plug Power is revolutionizing the industry with cost-effective power solutions that increase productivity, lower operating costs and reduce carbon footprints. Long-standing relationships with industry leaders forged the path for Plug Power’s key accounts, including Walmart, Sysco, P&G and Mercedes. With more than 4,000 GenDrive units deployed to material handling customers, accumulating over 16 million hours of runtime, Plug Power manufactures tomorrow’s incumbent power solutions today. Additional information about Plug Power is available at www.plugpower.com.

Plug Power Inc. Safe Harbor Statement

This communication contains statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements contain projections of our future results of operations or of our financial position or state other forward-looking information. These forward-looking statements include, without limitation, statements regarding financial expectations for the fourth quarter of 2013 and the year 2014, growth prospects for future orders, bookings and revenues, EBITDA projections, reductions in material and service costs and alternative supply sources. We believe that it is important to communicate our future expectations to our investors. However, there may be events in the future that we are not able to accurately predict or control and that may cause our actual results to differ materially from the expectations we describe in our forward-looking statements. Investors are cautioned not to unduly rely on forward-looking statements because they involve risks and uncertainties, and actual results may differ materially from those discussed as a result of various factors, including, but not limited to: the risk that we continue to incur losses and might never achieve or maintain profitability, the risk that we expect we will need to raise additional capital to fund our operations and such capital may not be available to us; the risk that we do not have enough cash to fund our operations to profitability and if we are unable to secure additional capital, we may need to reduce and/or cease our operations; the risk that a “going concern” opinion from our auditors, KPMG LLP, could impair our ability to finance its operations through the sale of equity, incurring debt, or other financing alternatives; the recent restructuring plan we adopted may adversely impact management’s ability to meet financial reporting requirements; our lack of extensive experience in manufacturing and marketing products may impact our ability to manufacture and market products on a profitable and large-scale commercial basis; the risk that unit orders will not ship, be installed and/or converted to revenue; the risk that pending orders may not convert to purchase orders; the risk that our continued failure to comply with NASDAQ’s listing standards may result in our common stock being delisted from the NASDAQ stock market, which may severely limit our ability to raise additional capital; the cost and timing of developing, marketing and selling our products and our ability to raise the necessary capital to fund such costs; the ability to achieve the forecasted gross margin on the sale of our products; the actual net cash used for operating expenses may exceed the projected net cash for operating expenses; the cost and availability of fuel and fueling infrastructures for our products; market acceptance of our GenDrive systems; our ability to establish and maintain relationships with third parties with respect to product development, manufacturing, distribution and servicing and the supply of key product components; the cost and availability of components and parts for our products; our ability to develop commercially viable products; our ability to reduce product and manufacturing costs; our ability to successfully expand our product lines; our ability to improve system reliability for our GenDrive systems; competitive factors, such as price competition and competition from other traditional and alternative energy companies; our ability to protect our intellectual property; the cost of complying with current and future federal, state and international governmental regulations; and other risks and uncertainties discussed under “Item IA—Risk Factors” in Plug Power’s annual report on Form 10-K for the fiscal year ended December 31, 2012, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2013 and as amended on April 30, 2013 and the reports Plug Power filed from time to time with the SEC. These forward-looking statements speak only as of the date on which the statements were made and are not guarantees of future performance. Except as may be required by applicable law, we do not undertake or intend to update any forward-looking statements after the date of this communication.

CONTACT: Teal Vivacqua
         518.738.0269
         media@plugpower.com