Pixelworks (PXLW) to Unveil Tablet and Ultrabook Display Processor Technology

Pixelworks, Inc. (NASDAQ: PXLW) today announced that it is bringing its innovative video display processor technology to Tablets and Ultrabooks. At invitation-only meetings at this year’s COMPUTEX TAIPEI, the company will demonstrate its technology for the highest quality video on Windows 8™ Tablets and Ultrabooks based on Intel’s 4^th generation Core™ processors.

With the increase of media consumption across all screens, users are demanding the best picture quality for their movies, photos and video games. Traditionally this type of video display processing has only been available for large screens. Utilizing an innovative new approach, Pixelworks is able to bring the highest display quality to Tablets and Ultrabooks.

“Pixelworks has always been about video quality, and we believe that every screen, especially the highest resolution Tablets and Ultrabooks, are ideal platforms for the very best video processing technology,” said Graham Loveridge, Sr. Vice President of Marketing at Pixelworks.

To obtain an invitation to the Pixelworks suite at COMPUTEX, or for additional information about Pixelworks’ products, including the company’s newest video display processor solutions for Tablets and Ultrabooks, please contact your local Pixelworks office (http://www.pixelworks.com/locations.php).

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.

Flamel Technologies (FLML) Announces FDA Approval of Bloxiverz

LYON, FRANCE — (Marketwired) — 06/03/13 — Flamel Technologies (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for Bloxiverz™ (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Flamel expects to launch Bloxiverz™ in July 2013 in 0.5 and 1.0 mg/mL strengths.

“We are extremely excited and pleased to receive this FDA approval for Bloxiverz™, the first product from the portfolio of Éclat products acquired in March 2012,” said Mike Anderson, Chief Executive Officer of Flamel.

Bloxiverz™ is the first FDA-approved version of neostigmine, even though other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug and Cosmetic Act of 1938. Today, neostigmine is the most common agent used for the reversal of the effects of other agents used for neuromuscular blocks.

“Based on our marketing experience, we believe that hospitals will welcome the addition of Bloxiverz™ as an FDA-approved version of neostigmine,” continued Mr. Anderson. “In addition, unapproved versions of neostigmine have been in short supply for nearly a year, which may add to the need for a reliable source of FDA-approved product.”

Safety Information
The most common adverse reactions during treatment include bradycardia, nausea and vomiting. Atropine or glycopyrrolate should be administered prior to Bloxiverz to minimize the risk of bradycardia. Bloxiverz should be used with caution in patients with arrhythmias, recent acute coronary syndrome, vagotonia, hyperthyroidism, myasthenia gravis, epilepsy or peptic ulcer. Because of the possibility of hypersensitivity in an occasional patient, atropine and medications to treat anaphylaxis should always be readily available. Large doses of Bloxiverz administered when neuromuscular blockade is minimal can produce neuromuscular dysfunction. The dose of Bloxiverz should be reduced if recovery from neuromuscular blockade is nearly complete.

About Bloxiverz (neostigmine)
Bloxiverz (neostigmine) is a cholinesterase inhibitor that inhibits the hydrolysis of acetylcholine by competing with acetylcholine for attachment to acetylcholinesterase at sites of cholinergic transmission. It enhances cholinergic action by facilitating the transmission of impulses across neuromuscular junctions. Neostigmine’s ability to increase synaptic acetylcholine levels underlies its effectiveness in reversing neuromuscular blockade produced by neuromuscular blocking agents used during surgery. Neostigmine does not readily cross the blood-brain barrier and therefore does not significantly affect cholinergic function in the central nervous system.

About Flamel Technologies. Flamel Technologies SA’s (NASDAQ: FLML) business model is to blend high-value internally developed products with its leading drug delivery capabilities. The Company has a proprietary pipeline of niche specialty pharmaceutical products, while its drug delivery platforms are focused on the goal of developing safer, more efficacious formulations of drugs to address unmet medical needs. Its partnered pipeline includes biological and chemical drugs formulated with its Medusa® and Micropump® (and its applications to the development of liquid formulations, i.e. LiquiTime™ and of abuse-deterrent formulations Trigger Lock™) proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. The Company has developed products and manufactures Micropump-based microparticles under FDA-audited GMP guidelines. Flamel Technologies has collaborations with a number of leading pharmaceutical and biotechnology companies, including GlaxoSmithKline (Coreg CR®, carvedilol phosphate). The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and manufacturing facilities in Pessac, France. Additional information may be found at www.flamel.com.

Safe Harbor
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including certain plans, expectations, goals and projections regarding financial results, product developments and technology platforms. All statements that are not clearly historical in nature are forward-looking, and the words “anticipate,” “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and similar expressions are generally intended to identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond our control that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that the continued integration of Éclat Pharmaceuticals may not be successful or that certain payment acceleration events may be triggered; the reacquisition of the exclusive rights to develop and commercialize IFN-β XL worldwide and identification of an alternative strategic partner for the program may not be successful; the identified opportunities will not result in shorter-term, high value results; clinical trial results may not be positive or our partners may decide not to move forward; products in the development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements; products in development may not achieve market acceptance; competitive products and pricing may hinder our commercial opportunities; we may not be successful in identifying and pursuing opportunities to develop our own product portfolio using Flamel’s technology; and the risks associated with our reliance on outside parties and key strategic alliances. These and other risks are described more fully in Flamel’s Annual Report on Form 20-F for the year ended December 31, 2012 that has been filed with the Securities and Exchange Commission (SEC). All forward-looking statements included in this release are based on information available at the time of the release. We undertake no obligation to update or alter our forward-looking statements as a result of new information, future events or otherwise.

IBM and FalconStor (FALC) Team Up to Create Backup Appliance for the Midmarket

FalconStor VTL With Deduplication to be Integrated With IBM Servers and Storage for Midmarket IBM Customers

MELVILLE, N.Y., June 3, 2013 (GLOBE NEWSWIRE) — FalconStor Software, Inc. (Nasdaq:FALC), a market leader in disk-based data protection, today announced that it has entered into a partnership with IBM through IBM’s Indirect OEM (IOEM) program. Under the program, FalconStor^® Virtual Tape Library (VTL) with deduplication software will be integrated with IBM servers and storage to address the needs of IBM midmarket customers.

The new FalconStor VTL IBM Series appliance will be integrated by Avnet Embedded (see related press release, “FalconStor Teams with Avnet Embedded to Create Global Supply Chain“) and will be sold through FalconStor’s channel as well as through IBM business partners who sign up with FalconStor. The new product will be available in North America initially and then throughout the rest of the world early next year.

“In the six years we’ve been partners with FalconStor, our clients have had nothing but praise for the FalconStor VTL backup and deduplication solution. Many of them have been asking for an IBM-based appliance for some time,” said Ken Scott, director of storage sales for Cima Solutions Group. “The FalconStor VTL IBM Series appliance addresses the needs of small to medium-size businesses for which IBM’s ProtecTIER is much more than they need. With this new appliance, we can serve the IBM-based midmarket more effectively – shortening sales cycles and getting customers up and running faster.”

“ServIT has been selling FalconStor VTL software and appliances to meet the data protection needs of the midmarket with great success,” said Craig Jacquez, business development director for ServIT. “The FalconStor VTL solution helps our customers migrate to disk-based backup and recovery, dramatically reduce the backup window and optimize tape for archiving – or eliminate tape altogether. Delivered on the IBM hardware platform, the new system expands our product offering and enhances our ability to give IBM customers exactly what they need.”

“The partnership between FalconStor and IBM is a big win for both companies. IBM midmarket customers now have a comprehensive data protection solution specifically designed for them, and our channel partners gain access to a large new market,” said Gary Quinn, chief operating officer for FalconStor Software. “Enterprise-class data protection and optimization is not just for large enterprises. This joint offering provides the mid-size IBM data center with the same robust, reliable, award-winning technology that is enjoyed by so many of the largest IT operations in the world today.”

About the FalconStor VTL IBM Series appliance

The new FalconStor VTL IBM Series appliance consists of FalconStor VTL software integrated with IBM System x3650 M4 Express servers and IBM System Storage EXP2512 Express Storage enclosures, manufactured and quality-tested by Avnet Technology Solutions. The FalconStor VTL solution provides enterprise-class disk-based backup and deduplication to businesses of all sizes. It optimizes backup speed and performance, minimizes backup windows and makes data secure, available and easy to recover. FalconStor VTL solutions offer several deduplication methods so that customers can tailor to meet the needs of their business.

Pricing and availability

The FalconStor VTL IBM Series appliance and pricing will be available in North America at the end of August and will be rolled out to Europe and Asia-Pacific in Q1 2014.

About FalconStor Software

FalconStor Software, Inc. (Nasdaq:FALC) is a market leader in disk-based data protection. The company’s mission is to transform traditional backup and disaster recovery into next-generation service-oriented data protection. Built upon an award-winning platform, FalconStor solutions deliver disk-based backup, continuous data protection, WAN-optimized replication and disaster recovery automation. FalconStor solutions are available through a worldwide network of partners, including solution providers, top-tier strategic partners and major OEMs. Thousands of customers worldwide, from small businesses to Fortune 100 enterprises, entrust their data to FalconStor solutions. FalconStor maintains headquarters in Melville, N.Y., and offices throughout Europe and the Asia Pacific region. For more information, visit www.falconstor.com or call 1-866-NOW-FALC (866-669-3252).

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FalconStor and FalconStor Software are registered trademarks of FalconStor Software, Inc., in the U.S. and other countries. All other company and product names contained herein may be trademarks of their respective holders.

Links to websites or pages controlled by parties other than FalconStor are provided for the reader’s convenience and information only. FalconStor does not incorporate into this release the information found at those links nor does FalconStor represent or warrant that any information found at those links is complete or accurate. Use of information obtained by following these links is at the reader’s own risk.

CONTACT: Roman Kichorowsky
         FalconStor Software, Inc.
         631-773-4303
         roman.kichorowsky@falconstor.com

         Kathryn Ghita
         Metis Communications
         617-236-0500
         falconstor@metiscomm.com

TESARO (TSRO) and the ENGOT Developing Niraparib for Ovarian Cancer

CHICAGO, June 3, 2013 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, and the European Network of Gynecological Oncological Trial Groups (ENGOT), a network of national and regional clinical trial organizations, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor.

The collaboration between TESARO and ENGOT will facilitate and promote the Phase 3 clinical trial of niraparib in patients with ovarian cancer at leading European cancer centers. Major goals of this partnership include optimizing the scientific and clinical impact of the Phase 3 protocol design, accelerating and streamlining selection of investigators and clinical site management, and expediting patient enrollment and publication of data from this trial.

“As an organization dedicated to gynecological cancer research and treatment, we look forward to partnering with TESARO to accelerate the development of niraparib for patients with ovarian cancer,” said Dr. Mansoor Raza Mirza, Medical Director of the Nordic Society of Gynecologic Oncology Clinical Trial Unit. “We are pleased to support clinical research initiatives for this innovative and potentially new class of cancer therapeutics.”

“We are excited to be working with ENGOT to advance the treatment paradigm for patients with ovarian cancer, where significant unmet medical need still exists,” said Dr. Mary Lynne Hedley, President of TESARO. “We look forward to opening this global study to patients in mid-2013 and are pleased to have ENGOT supporting enrollment at key European trial sites.”

This double blind, placebo-controlled, international Phase 3 trial of niraparib is planned to enroll 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer. Patients will enroll into one of two independent cohorts based on germline BRCA mutation status. Within each cohort, patients will be randomized 2:1 to receive niraparib or placebo, and will be continuously treated with placebo or 300 milligrams of niraparib until progression. The primary endpoint of this study is progression free survival. Secondary endpoints include patient reported outcomes, chemotherapy free interval length, and overall survival.

About The European Network of Gynecological Oncological Trial Groups (ENGOT)

ENGOT is a pan-European Network of Gynecological Oncological Trial Groups supported by and part of the European Society of Gynecological Oncology (ESGO). ESGO is an independent not-for-profit scientific society which was founded as a forum for healthcare professionals dedicated to the care of women with gynecological cancer. The ultimate aim of ESGO is to improve the survival and quality of life of women by contributing to the prevention, treatment and study of gynecological cancer and education professionals worldwide. For more information, please visit www.engot.org and www.esgo.org.

About TESARO

TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.

To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO’s Form 10-K for the year ended December 31, 2012.

CONTACT: Investor/Media Contact:
         Jennifer Davis
         Sr. Director, Corporate Development & Investor Relations
         +1.781.325.1116 or jdavis@tesarobio.com

Clovis Oncology’s (CLVS) Rucaparib Encouraging Results in Solid Tumors

Clovis Oncology (NASDAQ:CLVS) today announced initial findings from an ongoing Phase I/II monotherapy study of rucaparib, the Company’s oral, potent, small molecule poly (ADP-ribose) polymerase (PARP) inhibitor being developed for the treatment of ovarian cancer. Initial results from the Phase I dose-escalation portion of this Phase I/II study are being presented for the first time today at a poster session during the American Society of Clinical Oncology (ASCO) Annual Meeting 2013 in Chicago.

“Oral rucaparib is a potent PARP inhibitor active in patients with ovarian, breast and pancreatic cancers. Clinically meaningful results have been seen in the rucaparib monotherapy Phase I trial; 89% of patients with ovarian cancer demonstrated a clinical benefit. Increasing evidence suggests that genetic analysis of ovarian tumors can help identify patients who derive benefit from PARP inhibitor therapy – best known predictors are mutations in BRCA genes, either at germline or somatic level, but there are likely other predictive mutations as well. The Clovis development program seeks to exploit these new insights and I am pleased to be jointly leading their larger-scale trials to assess the full clinical potential of this well-tolerated drug in ovarian cancer,” said Professor Jonathan Ledermann, Professor of Medical Oncology & Director, Cancer Research UK and UCL Cancer Trials Centre, UCL Cancer Institute.

“These initial results suggest that rucaparib is both well-tolerated and predictably absorbed, and provides meaningful clinical benefit to certain ovarian cancer patients,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Once we identify the recommended Phase II dose, we look forward to commencing the late-stage development program in platinum-sensitive ovarian cancer in 2H13. This comprises two trials – a biomarker study which will refine the definition of patients beyond those with mutant BRCA who may benefit from rucaparib, and a Phase III pivotal trial in all patients with a stratified efficacy analysis in genetically-defined groups, including somatic and germline BRCA mutations as well as a broader population with mutations beyond BRCA, utilizing insights from the biomarker study.”

The Phase I dose escalation portion of the study is open to patients with all solid tumors. Study objectives were typical for a Phase I trial, including determining safety and tolerability, evaluating the pharmacokinetic profile, identifying the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) as well as the preliminary efficacy signals in various solid tumors.

Thirty-seven patients have been treated with rucaparib monotherapy in this study as of May 2013, in once-daily (QD) and twice-daily (BID) dosing cohorts, up to 300 mg QD and 480 mg BID. Dose-escalation continues and the MTD has not yet been reached.

Patients have received a median of four previous anticancer regimens and over half have received three or more previous therapies. Twenty-one patients (57%) have breast tumors, 10 patients (27%) have ovarian/peritoneal tumors and six patients (16%) have other solid tumors.

Key data from the study presented at ASCO include:

Evidence of Activity

Objective responses have been observed in ovarian, breast and pancreatic cancer patients with germline BRCA mutations. Durable disease control has been observed in heavily pre-treated ovarian cancer patients across all dose levels, with a disease control rate of 89% (stable disease or better beyond 12 weeks after study initiation in 8 of 9 ovarian cancer patients). The disease control rate for germline BRCA mutant ovarian cancer patients was 100% (7 of 7). Measurable disease was not a requirement for entry into the dose escalation phase of the study, precluding systematic response analysis.

Safety and Tolerability

Safety data to date shows rucaparib to be well-tolerated, which is important for a drug intended to be used in a maintenance setting. There were 19 patients (54%) with treatment-related adverse events. The most common adverse events attributed to rucaparib therapy include fatigue (23%), nausea (14%) and decreased appetite (11%). No patient experienced a treatment-related adverse event that led to study drug discontinuation and no grade 3/4 myelosuppression has been observed in any patient. There have been two treatment related grade 3 toxicities: one patient with grade 3 nausea and one patient with grade 3 fatigue.

Pharmacokinetics

Oral rucaparib has attractive pharmacokinetic properties as a potential oral cancer therapeutic. Patients receiving BID doses above 240 mg experienced consistently high plasma drug concentrations throughout the 24-hour period, which is likely important for optimal activity. Intra- and inter-patient variability was also low, which is advantageous for uniform flat dosing strategies.

The poster, titled “A Phase I Dose Escalation and Pharmacokinetic Study of Continuous Oral Rucaparib in Patients with Advanced Solid Tumors,” is being presented on Monday, June 3, 8:00am – 11:45am CDT, in S Hall A2, Poster Board: 7E at McCormick Place in Chicago. The poster will also be available at www.clovisoncology.com.

About Rucaparib

Rucaparib is an oral, potent inhibitor of PARP1 and PARP2 in development for the treatment of ovarian cancer. Rucaparib is currently in two Company-sponsored Phase I clinical studies; one to determine the maximum tolerated dose (MTD) of oral rucaparib administered on a daily basis as monotherapy; and a second trial to determine the MTD of oral rucaparib that can be combined with intravenous platinum chemotherapy for the treatment of solid tumors. Once the optimal dose and schedule have been established in the Phase I portion of the monotherapy study, the Company will initiate a Phase II expansion cohort to assess efficacy in selected ovarian cancer patients. The Company expects to initiate a biomarker study in platinum-sensitive ovarian cancer patients in the third quarter of 2013, as well as the pivotal Phase III study in platinum-sensitive ovarian cancer patients in late 2013.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, and has additional offices in San Francisco, California and Cambridge, UK.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. Clovis Oncology undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Clovis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2012 and its other reports filed with the Securities and Exchange Commission.