Archive for July, 2015
(NETE) S&P Capital IQ Initiates Coverage in S&P Capital IQ Factual Stock Reports
NEW YORK, July 6, 2015 — S&P Capital IQ (MHFI) announced today that it has commenced Factual Stock Report coverage on Net Element Inc.
Net Element, Inc. (NETE) is a global technology-driven company specializing in mobile payments and value-added transactional services. It provides services in emerging countries, including the Russian Federation and the Commonwealth of Independent States, as well as the United States.
The company owns and operates a global mobile payments and transactional processing provider, TOT Group, Inc. TOT Group companies include Unified Payments, Aptito, a next generation cloud-based point-of-sale (POS) payments platform, and TOT Money, a provider of SMS messaging and mobile billing solutions.
TOT Group offers end-to-end payment solutions to enable commerce around the world with a focus on emerging markets. TOT Payments, which markets its services in the United States under the brand Unified Payments, is the company’s transactional processing group for small and medium-sized businesses, providing technology and services that businesses require to accept cashless transactions. TOT Payments processes cashless transactions for card-present (or “swipe”) or card-not-present transactions, including POS, mobile POS (mPOS), EMV, near field communication, Apple Pay, Internet businesses, service-oriented businesses and mail order/telephone order merchants. TOT Payments also processes other cashless transactions including checks and direct debits. TOT Payments services include merchant performance analytics and merchant back office reporting. TOT Payments services are distributed in most part through independent sales groups, value-added resellers, system integrators and affinity partners.
Aptito, an all-in-one digital solution for the food and beverage industry, helps restauranteurs to interact with customers and remotely manage operations. The cloud-based Software-as-a-Service (SaaS) restaurant management solution provides integrated functionality to drive consumer engagement via Apple iPad-based POS, kiosk and all other cloud-connected devices. Aptito’s Restaurant mPOS solution provides restaurants with tools designed to increase sales, productivity and customer loyalty. Aptito’s suite of integrated tools enables inventory management, complete payroll, staff scheduling, patron reservations and digital menus.
TOT Money, the company’s proprietary mobile payments and commerce platform, provides carrier-integrated mobile payments solutions, mobile campaign management and distribution. The TOT Money mobile platform provides carrier billing checkout and offers various mobile payment solutions for web services and mobile applications. Net Element provides mobile payment solutions to help digital merchants, such as social networks, games, online magazines and digital media, monetize their mobile clients and the subscription base.
Net Element believes that it provides users with a simple, secure and fast way to pay for purchases via mobile without a credit card or a bank account. Its mobile campaign tools allow for the delivery of scalable mobile campaigns on behalf of content partners. TOT Money’s relationships and integration with mobile operators gives Net Element substantial geographic coverage and the ability to offer its clients In-App payments, wireless access protocol (WAP) click, premium short message services (P-SMS), online and carrier billing.
The company enables mobile payment processing services for more than 390 million mobile users in Russia through strategic direct agreements and integrations with leading mobile operators such as Mobile TeleSystem, MegaFon and VimpelCom, Ltd. In January 2015, Net Element reached a company milestone by exceeding 1 million recurring mobile payment subscribers. As of December 31, 2014, Net Element’s mobile payments subscriber base consisted of 941,668 recurring mobile payments subscribers.
On May 27, 2015, Net Element announced the execution of definitive documentation to acquire PayOnline, an online payments company, for up to $8.4 million in total consideration. PayOnline processes online payments for over 10 million active consumers and thousands of merchants in the Russian Federation, Europe and Asia.
On June 4, 2015, Net Element launched its online payments processing business in Kazakhstan by securing a contract with Kassir.com, the country’s largest online events ticketing website and second largest online merchant serving the Kazakhstan market.
In June 2015, NETE announced it has secured a contract in Kazakhstan, with the country’s largest bank.
S&P Capital IQ’s Factual Stock Report coverage on Net Element Inc. will also be accessible on an ongoing basis to the investment community by scores of buy-side institutions and sell-side firms that utilize S&P Capital IQ research and information platforms daily. Millions of self-directed investors also have access to the report via their e-brokerage accounts. Please visit http://www.netelement.com/ for additional information.
About S&P Capital IQ’s Factual Stock Reports
Currently profiling approximately 400 issuers, S&P Capital IQ (MHFI) Factual Stock Reports increase market awareness of issuers in the investment community with insightful commentary, key statistics, and relevant corporate information. The Reports provide factual research coverage about company fundamentals and business prospects, thereby enabling information on the covered companies to reach a wide spectrum of Buy and Sell-side investors. Updated weekly with the latest pricing, trading volume, and other data, the Reports also capture recent company developments, a financial review, key operating information, industry and peer comparisons, Street Consensus, performance charts, business summary, fundamental data, and timely news stories. Coverage of these reports is underwritten by the issuer, therefore S&P Capital IQ does not offer investment opinions concerning the advisability of investing in these stocks.
S&P Capital IQ Factual Stock Reports are produced separately from any other analytic activity of S&P Capital IQ or related organizations. S&P Capital IQ does not trade on its own account.
About S&P Capital IQ
S&P Capital IQ, a part of McGraw Hill Financial (NYSE:MHFI), is a leading provider of multi-asset class and real time data, research and analytics to institutional investors, investment and commercial banks, investment advisors and wealth managers, corporations and universities around the world. S&P Capital IQ provides a broad suite of capabilities designed to help track performance, generate alpha, and identify new trading and investment ideas, and perform risk analysis and mitigation strategies. Through leading desktop solutions such as the S&P Capital IQ, Global Credit Portal and MarketScope Advisor desktops; enterprise solutions such as S&P Capital IQ Valuations; and research offerings, including Leveraged Commentary & Data, Global Markets Intelligence, and company and funds research, S&P Capital IQ sharpens financial intelligence into the wisdom today’s investors need. For more information, visit www.spcapitaliq.com.
In the United States, research reports are prepared by Standard & Poor’s Investment Advisory Services LLC, a part of S&P Capital IQ and a registered investment adviser with the U.S. Securities and Exchange Commission. S&P Capital IQ provides a broad suite of capabilities designed to help track performance, generate alpha, and identify new trading and investment ideas, and perform risk analysis and mitigation strategies.
(NVEE) Acquires Infrastructure Engineering Firm the RBA Group, Inc.
HOLLYWOOD, FL–(Jul 2, 2015) – NV5 Holdings, Inc. (the “Company” or “NV5”) (NASDAQ: NVEE), a provider of professional and technical engineering and consulting solutions, announced today that it has acquired the RBA Group, Inc., an infrastructure engineering firm focused on the provision of transportation engineering, planning, and construction inspection, environmental engineering, civil engineering, surveying, and architecture services to public and private clients throughout the East Coast. RBA has a very large presence in New York City and is headquartered in Parsippany, NJ, with other offices in Melville, LI, Trenton, NJ, Norwalk, CT, Philadelphia, PA and Silver Spring, MD. The Company has approximately 250 full-time employees and annualized revenues of $40 million.
The acquisition will be immediately accretive to NV5’s earnings and was primarily a cash transaction.
“RBA is our largest acquisition since 2010. With the acquisition of RBA we are significantly expanding the reach of our infrastructure vertical to capture key clients and markets in the Northeast,” said Dickerson Wright, PE, Chairman and CEO of NV5. “This is especially critical to our efforts to increase operating margins and profitability through cross-selling and synergies among our five service lines. While RBA has been a very successful and respected standalone business for more than 40 years, I am confident that the highly experienced infrastructure engineers at RBA will benefit greatly from the ability to collaborate with the construction quality assurance, program management, and environmental services groups that we have built up throughout the East Coast in the last year, and vice versa,” he added.
“The RBA team is extremely excited about joining the NV5 organization and looks forward to the opportunity to participate in projects geographically where NV5 already exists, and with the support of other areas of expertise existing in NV5, the team expects to provide additional services to our large existing client base,” said Neil Bernstein, PE, President and CEO of RBA.
About The RBA Group
The RBA Group has been providing professional engineering services to a diverse client base throughout the East Coast since 1968. RBA’s client base includes the New York City Department of Transportation, the New York City Department of Design and Construction, the New York Department of Transportation, the New Jersey Department of Transportation, the New Jersey Turnpike Authority, the U.S. Navy, and many other local, state, and federal agencies. The Company’s portfolio of services includes highway design, structural engineering, traffic engineering and transportation planning, construction management, environmental engineering, cultural resource management, site engineering, and surveying. RBA’s commitment to quality services and products and maintenance of a strict quality assurance program drives the Group’s central goal of project completion according to client satisfaction. For more detailed information on The RBA Group’s clients, projects and capabilities, please visit www.rbagroup.com.
About NV5
NV5 Holdings, Inc. (NASDAQ: NVEE) is a provider of professional and technical engineering and consulting solutions to public and private sector clients in the infrastructure, energy, construction, real estate and environmental markets. NV5 primarily focuses on five business verticals: construction quality assurance, infrastructure, engineering and support services, energy, program management, and environmental solutions. The Company operates 35 offices in Arizona, California, Colorado, Florida, Massachusetts, New Jersey, New Mexico, Ohio, Pennsylvania, Utah, Washington and Wyoming and is headquartered in Hollywood, Florida. For additional information, please visit the Company’s website at www.NV5.com. Also visit the Company on Twitter, LinkedIn, Facebook, and Vimeo.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that the acquisition will be immediately accretive to NV5’s earnings. The Company cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements contained in this press release. Such factors include: (a) changes in demand from the local and state government and private clients that we serve; (b) general economic conditions, nationally and globally, and their effect on the market for our services; (c) competitive pressures and trends in our industry and our ability to successfully compete with our competitors; (d) changes in laws, regulations, or policies; and (e) the “Risk Factors” set forth in the Company’s most recent SEC filings. All forward-looking statements are based on information available to the Company on the date hereof, and the Company assumes no obligation to update such statements, except as required by law.
Contact
NV5 Holdings, Inc.
Lauren Wright, Ph.D.
Director of Investor Relations
Tel: +1-408-392-7233
Email: ir@nv5.com
(NAVB) Clinical Data Demonstrating KS Lesion Localization For Manocept™
– Reinforces Therapeutic Potential of Targeting Activated Macrophages via the CD206 Receptor-
– Data also suggest a new origin of KS as a macrophage fusion tumor –
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) and its subsidiary, Macrophage Therapeutics, Inc., today announced that imaging results from the Manocept™ clinical trial in Kaposi’s Sarcoma (KS) and other preclinical studies were presented at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents in Hollywood, Florida. The clinical imaging study, using Tc 99m tilmanocept, a Manocept platform product, in both HIV+ and HIV- patients suggests that KS tumor lesions, both cutaneous and suspected extra-cutaneous sites, can be easily visualized and mapped, demonstrating that this technique may potentially provide a means for routine patient assessment. The results also show that use of Manocept represents a potential therapeutic pathway for targeting tumor associated macrophages (TAMs). Manocept agents are designed to target CD206, which is highly expressed on TAMs and the KS tumor itself. As a potential therapeutic, Manocept could be used as a precision vehicle to deliver payloads to tumor sites throughout the body.
“These pre-clinical and clinical studies support using Kaposi’s sarcoma as a model tumor system for evaluating therapeutic approaches for the Manocept platform in other forms of solid tumors,” commented Michael Tomblyn, M.D., Navidea’s Chief Medical Officer. “They provide evidence that Manocept agents can target CD206 and are internalized into tumor associated macrophages and tumor cells. This along with clinical observations that demonstrate tilmanocept can be used to image KS tumors both externally and internally indicates excellent potential for immunotherapeutic utility.”
“Using a targeted imaging agent like tilmanocept in this group of HHV8+patients represents an elegant approach to potentially detect internal KS lesions that would previously be difficult or impossible to non-invasively locate,” commented Toby Maurer, M.D., FAAD, Professor of Dermatology at the University of California, San Francisco (UCSF), and Chief of Dermatology at San Francisco General Hospital and Trauma Center, who co-led the clinical study at UCSF with Michael S. McGrath, M.D., PhD. “Further, the specificity and the ability to quantify tumor burden could enable regular patient evaluations and monitoring of therapeutic effectiveness addressing important unmet patient needs.”
Five Human Herpes Virus8 positive (HHV8+) patients (4 HIV+, 1HIV-) were enrolled in the NAV03-12 study. Patients received a single subcutaneous injection of Technetium Tc 99m tilmanocept in the region of a cutaneous KS lesion and imaging was performed at 1, 4 and 24-hours post-injection to visualize localization of tilmanocept. Results represented by whole body Single-Photon Emission Computed Tomography (SPECT/CT) imaging scans from study patients were presented. Collectively, the scans show localization of tilmanocept and detected multiple cutaneous lesions in the extremities, face and genitalia, as well as extra-cutaneous localization found in the nasopharynx, lymph nodes and brain. Results also indicate that KS lesions are anatomically linked in chains by and within the lymph ducts. The study concludes that both HIV+ and HIV- patients have pan-tumor expression of CD206, strongly suggests tilmanocept crosses the blood brain barrier and that a Manocept-drug conjugate may have the potential as a therapeutic with high target effect and low off-target concerns.
The data from these studies also suggest a novel theory on the genesis of KS in which KS arises from an HHV8 infected macrophage type cell and its interaction with the lymphatic system. This interaction provides the means for access of the KS through CD206 receptor for diagnosis, evaluation, and potential therapy using the Manocept platform.
Navidea and Macrophage Therapeutics plan a webcast to provide investors with a complete look at the data being presented at the International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents conference on July 7, 2015 at 1:00 pm EDT. Webcast details will be available on the Navidea website.
About the Manocept™ CD206-targeting platform
The Manocept™ platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on macrophages. Macrophages play important roles in many disease states and are an emerging target in many disorders. This flexible and versatile platform acts as an engine for purpose-built molecules that may enhance diagnostic accuracy, clinical decision-making, targeted treatments and ultimately patient care. As a diagnostic tool, the Manocept technology has the potential to utilize a breadth of imaging modalities, including SPECT, PET, intra-operative and/or optical-fluorescence detection. By adding a therapeutic agent on the Manocept molecular backbone, there is the potential to develop novel, targeted immunotherapies specifically designed to selectively deliver an agent that can kill or alter disease-associated macrophages. Navidea’s FDA-approved precision diagnostic imaging agent, Lymphoseek® (technetium 99m tilmanocept) injection, is representative of the platform’s ability to successfully exploit this mechanism and offer the potential for development of new CD206-targeted diagnostic agents and therapeutics.
About Kaposi’s Sarcoma
Kaposi sarcoma (KS) is a cancer that develops from the cells that line lymph nodes or blood vessels. It usually appears as tumors on the skin or on mucosal surfaces such as inside the mouth, but tumors can also develop in other parts of the body, such as in the lymph nodes (bean-sized collections of immune cells throughout the body), the lungs, or digestive tract. The abnormal cells of KS form purple, red, or brown blotches or tumors on the skin. These affected areas are called lesions. The skin lesions of KS most often appear on the extremities, trunk and face. AIDS-related KS is the most common type of KS in the United States which develops in people who are infected with HIV, the virus that causes AIDS. KS can also develop in people whose immune systems have been suppressed after an organ transplant and is called transplant-related KS.1
About Lymphoseek®
Lymphoseek® (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
- Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
- Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.
In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics, therapeutics and radiopharmaceutical agents. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and therapeutics, and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.
About Macrophage Therapeutics
Macrophage Therapeutics, a newly created subsidiary of Navidea Biopharmaceuticals, Inc. (NAVB), is developing therapeutics using the patented Manocept immunotherapy platform licensed from Navidea to target over-active macrophages implicated in cancer, cardiovascular, central nervous system, autoimmune, antiviral, and skin diseases. Manocept specifically targets CD206, or the mannose receptor prevalent on over-active macrophages. The technology enables highly specific targeted delivery of active (either existing or yet to be developed) agents that can modulate the activity of over-active macrophages that have been implicated in many diseases. Targeted delivery should significantly enhance a given compound’s efficacy and safety.
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
1 American Cancer Society web accessed 22May2015. http://www.cancer.org/cancer/kaposisarcoma/detailedguide/kaposi-sarcoma-what-is-kaposi-sarcoma
Navidea Biopharmaceuticals
Investors
Tom Baker, 617-532-0624
tbaker@navidea.com
or
Media
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications
(VRTX) FDA Approves Cystic Fibrosis Drug ORKAMBI™
-Approximately 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease-
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved ORKAMBI™ (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test.
Cystic fibrosis is a rare, life-threatening genetic disease. People with two copies of the F508del mutation represent the largest group of people with CF. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two copies of the F508del mutation. ORKAMBI will be available for shipment to specialty pharmacies in the United States within days.
“Today is a remarkable day for science, medicine and the CF community,” said Jeffrey Leiden, M.D., Ph.D., Vertex’s Chairman, President and Chief Executive Officer. “More than 15 years ago, our scientists set out to discover and develop medicines to treat the underlying cause of cystic fibrosis. Today, the approval of ORKAMBI represents a fundamental change in the treatment of the most common form of CF, marking significant progress for us and for the entire CF community. While we celebrate this important step forward, we also recognize that two out of three patients in the U.S. still do not have a medicine to treat the underlying cause of their disease. We share their urgency and are committed to continuing our significant investment in research and development to discover new medicines for them and to improve upon what we offer patients today.”
Vertex will host an investor conference call on Thursday, July 2, at 2:15 p.m. ET. to provide more information on the approval of ORKAMBI.
The approval of ORKAMBI was based on data from two Phase 3 studies (TRAFFIC and TRANSPORT) that enrolled more than 1,100 people with CF ages 12 and older with two copies of the F508del mutation. Patients treated with ORKAMBI experienced statistically significant improvements in lung function. Patients also experienced reductions in pulmonary exacerbations and improvements in body mass index (BMI). The most common adverse events included shortness of breath and/or chest tightness, upper respiratory tract infection (common cold) and gastrointestinal symptoms (including nausea, diarrhea, or gas).
Vertex continues to invest in CF research and development with the goal of treating the vast majority of people with the disease and enhancing the benefit for those we treat. Multiple Phase 2 and Phase 3 clinical studies are in progress and Vertex has an ongoing research program focused on discovering new CF medicines.
“In 1998, Vertex and the CF Foundation embarked on a scientific challenge that many believed would be impossible – to discover medicines that treat the cause of CF,” said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. “Today’s approval is a milestone for the CF community. We congratulate Vertex for their success in developing new CF medicines and are pleased with their continuing commitment to help all eligible patients get access to these medicines.”
Helping Patients Access ORKAMBI
The people who work at Vertex understand that medicines can only help patients who can get them. The Vertex Guidance & Patient Support (Vertex GPS™) program provides a dedicated team of Vertex employees who help eligible patients who have been prescribed our medicines within their labeled indications understand their insurance benefits and the resources that are available to help them.
Vertex also offers a co-pay assistance program for patients with commercial insurance coverage and a free medicine program for qualifying patients who are uninsured and who meet certain income and other eligibility criteria. More information is available by visiting www.VertexGPS.com or by calling 1-877-752-5933.
About CF and ORKAMBI
Cystic fibrosis is a rare genetic disease that is caused by defective or missing cystic fibrosis transmembrane conductance regulatory (CFTR) proteins resulting from mutations in the CFTR gene. The defective or missing proteins result in poor flow of salt and water into or out of the cell in a number of organs, including the lungs. In people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little to no CFTR protein at the cell surface. Patients with two copies of the F508del mutation are easily identified by a simple genetic test.
ORKAMBI is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface. ORKAMBI is taken every 12 hours – once in the morning and once in the evening.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR ORKAMBI™ (lumacaftor/ivacaftor) TABLETS
ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene. The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.
Worsening of liver function, including hepatic encephalopathy, in patients with advanced liver disease has been reported in some patients with CF while receiving ORKAMBI. ORKAMBI should be used with caution in patients with advanced liver disease and only if the benefits are expected to outweigh the risks. If ORKAMBI is used in these patients, the patients should be closely monitored and the dose reduced.
Serious adverse reactions related to elevated transaminases have been reported in patients with CF receiving ORKAMBI and, in some instances, associated with concomitant elevations in total serum bilirubin. It is recommended that ALT, AST, and bilirubin be assessed prior to initiating ORKAMBI, every 3 months during the first year of treatment, and annually thereafter. For patients with a history of ALT, AST, or bilirubin elevations, more frequent monitoring should be considered. Patients who develop increased ALT, AST, or bilirubin should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST greater than 5x upper limit of normal (ULN) when not associated with elevated bilirubin. Dosing should also be interrupted in patients with ALT or AST elevations greater than 3x ULN when associated with bilirubin elevations greater than 2x ULN. Following resolution of transaminase elevations, consider the benefits and risks of resuming dosing.
Respiratory events (e.g., chest discomfort, shortness of breath, and chest tightness) were observed more commonly in patients during initiation of ORKAMBI compared to those who received placebo. Clinical experience in patients with percent predicted FEV1 <40 is limited, and additional monitoring of these patients is recommended during initiation of therapy.
Co-administration of ORKAMBI with sensitive CYP3A substrates or CYP3A substrates with a narrow therapeutic index is not recommended as ORKAMBI may reduce their effectiveness.
ORKAMBI may substantially decrease hormonal contraceptive exposure, reducing their effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with ORKAMBI.
Co-administration with strong CYP3A inducers (e.g. rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John’s wort) is not recommended as they may reduce the therapeutic effectiveness of ORKAMBI.
ORKAMBI has the potential to affect other drugs. For additional information regarding drug interactions, see full Prescribing Information.
Abnormalities of the eye lens (cataracts) have been reported in pediatric patients treated with ivacaftor, a component of ORKAMBI. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating treatment with ORKAMBI.
Serious adverse reactions that occurred more frequently in patients treated with ORKAMBI included pneumonia, blood in sputum, cough, increased muscle enzyme levels, and liver enzyme elevations. The most common adverse reactions associated with ORKAMBI include shortness of breath, sore throat, nausea, diarrhea, upper respiratory tract infection, fatigue, chest tightness, increased blood creatinine phosphokinase, rash, flatulence, runny nose, and influenza.
Please see full prescribing information for ORKAMBI available at www.ORKAMBI.com.
Global Regulatory Submissions for ORKAMBI
Outside of the U.S., Vertex has submitted ORKAMBI for regulatory approval in the European Union, Australia and Canada. A decision by the European Medicines Agency (EMA) is anticipated by the end of 2015. Reviews by Health Canada and Australia’s Therapeutic Goods Administration (TGA) are also ongoing.
Investor Conference Call
Vertex will host an investor conference call and webcast on Thursday, July 2, at 2:15 p.m. ET. To listen to the live call on the telephone dial (866) 501-1537 (United States and Canada) or (720) 545-0001 (International). The conference ID number for the live call and replay is 76077705. In addition, the conference call will be webcast live, and a link to the webcast may be accessed through Vertex’s website at www.vrtx.com in the “Investors” section under the “Events & Presentations” page.
The call will be available for replay via telephone and webcast. The replay phone number in the United States and Canada is (855) 859-2056. The international replay number is (404) 537-3406. The archived webcast will be available at www.vrtx.com.
About Cystic Fibrosis
Cystic fibrosis is a rare, life-threatening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.
CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, lead to CF by creating defective or too few CFTR proteins at the cell surface. The defective or missing CFTR protein results in poor flow of salt and water into or out of the cell in a number of organs, including the lungs. This leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median predicted age of survival for a person with CF is 41 years, but the median age of death is 27 years.
Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)
Vertex initiated its CF research program in 1998 as part of a collaboration with CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. Both of our approved CF medicines were discovered by Vertex as part of this collaboration.
About Vertex
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.
Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For five years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, as amended, including the statements by Dr. Leiden in the third paragraph of this press release and statements regarding (i) the timing of the availability of ORKAMBI for shipment to specialty pharmacies in the United States; (ii) Vertex’s commitment to continuing its significant investment in research and development programs in cystic fibrosis; and (iii) the anticipated timing of the completion of regulatory reviews in international markets. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, risks related to commercializing ORKAMBI in the United States, obtaining approval and commercializing ORKAMBI in international markets, developing additional medicines to treat cystic fibrosis and the other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex’s website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.
(VRTX-GEN)
© 2015 Vertex Pharmaceuticals Incorporated I VRX-US-02-01002 I 07/2015
Vertex Pharmaceuticals Incorporated
Investors:
Michael Partridge, 617-341-6108
or
Eric Rojas, 617-961-7205
or
Kelly Lewis, 617-961-7530
or
Media: mediainfo@vrtx.com
US: 617-341-6992
Europe & Australia: +41 22 593 6066
(SAND) Provides Asset Update
VANCOUVER, July 2, 2015 – Sandstorm Gold Ltd. (“Sandstorm” or the “Company”) (NYSE MKT: SAND, TSX: SSL) is pleased to provide an update at various projects underlying the Company’s streams and royalties.
LUNA GOLD ANNOUNCES CLOSING OF RESTRUCTURING AND FINANCING
Luna Gold Corp. (“Luna”) has closed the previously announced $30 million financing with Pacific Road Resources Funds, as part of which Luna’s gold steam and debt facility with Sandstorm were restructured (“Luna Restructuring”).
Concurrently with closing of the Luna Restructuring, Luna repaid and settled its debt facility with Société Générale (Canada Branch) and Mizuho Corporate Bank. Luna expects to use the remainder of the proceeds from the Luna Restructuring to commence an infill drilling program, prepare engineering studies and submit updated permits at its Aurizona project in Brazil (“Aurizona”) and for general working capital and corporate purposes.
Sandstorm has a sliding scale net smelter returns royalty (“NSR”) on Aurizona based on the price of gold. At gold prices less than or equal to US$1,500 per ounce the royalty is a 3% NSR. Sandstorm also holds a 2% NSR on Luna’s 200,000 hectares of greenfields exploration ground.
For more information, visit the Luna website at www.lunagold.com and see the press release dated June 30, 2015.
METANOR RESOURCES ANNOUNCES POSITIVE DRILL RESULTS
Metanor Resources Inc. (“Metanor”) has released positive drill results from its exploration activities at the Bachelor Lake Mine in Quebec, Canada (“Bachelor Lake”). A diamond drilling program has been underway in the west sector of Bachelor Lake between underground levels 6 and 8. The assay results have included 22.85 grams per tonne (“g/t”) Au over 4.04 metres, 12.8 g/t Au over 10.8 metres as well as 6.82 g/t Au over 8.7 metres. In addition, Metanor recently intersected mineralization in an unknown sector on level 12. The assay results returned 18 g/t Au over 1.5 metres.
Sandstorm has a gold stream agreement with Metanor to purchase 20% of the gold produced from Bachelor Lake at a per ounce price of US$500 per ounce.
For more information, visit the Metanor website at www.metanor.ca and see the press releases dated June 22, 2015, June 25, 2015, June 30, 2015 and July 2, 2015.
CANADIAN ZINC DISCOVERS NEW VEIN SYSTEM DURING UNDERGROUND DRILL PROGRAM
Canadian Zinc Corporation (“Canadian Zinc”) recently provided assay results from five diamond drill holes from the ongoing underground exploration program at the Prairie Creek Mine in the Northwest Territories, Canada (“Prairie Creek”). Highlights included:
- Drill hole PCU-15-62 which intercepted a previously unknown quartz vein fault structure 75 metres into the footwall of the Main Quartz Vein (MQV) structure, and graded 8.3% Pb, 19.8% Zn and 150 g/t Ag across an estimated true width of 5.4 metres;
- PCU-15-65, drilled on the next section 50 metres north, 95 metres to the west of the MQV structure which graded 4.9% Pb, 22.7% Zn and 164 g/t Ag across 1.2 metres of estimated true width, also intercepted the second quartz vein structure and graded 4.6% Pb, 13.8% Zn, 92 g/t Ag across 2.9 metres of estimated true width;
- Diamond drilling of the lower portion of the MQV structure in hole PCU-15-64 intersected two veins side by side (separated by approximately 8 metres but both interpreted to be the MQV) grading 22.7% Pb, 9.7% Zn, 226 g/t Ag across 8.4 metres estimated true width and 14.0% Pb, 3.5% Zn 194 g/t Ag across 5.1 metres estimated true width, respectively;
- Multiple intercepts of stockwork mineralization were also returned in all stockwork targeted holes including hole PCU-15-65 which graded 24.7% Pb, 32.7% Zn, and 311 g/t Ag across an estimated true width of 2.4 metres and further down the hole 9.5% Pb, 38.1% Zn, 381 g/t Ag across an estimated true width of 1.5 metres.
Canadian Zinc has completed over 5,000 metres of exploration drilling since the beginning of 2015 from three drill stations. The drilling program was completed at the end of June and the geological data is being incorporated into a newly interpreted geological block model. This data will be further interpreted, modelled and incorporated into the future resource and reserve calculations and a revised mine plan.
Sandstorm holds a 1.2% NSR royalty on the Prairie Creek project.
For more information, visit the Canadian Zinc website at www.canadianzinc.com and see the press release dated June 23, 2015.
QUALIFIED PERSONS
Pascal Hamelin, P. Eng., is Metanor’s Vice President of Operations and a Qualified Person as defined by NI 43-101. Mr. Hamelin has reviewed and approved the technical information related to Bachelor Lake in this press release.
Alan Taylor, P. Geo., is Canadian Zinc’s Chief Operating Officer & Vice President Exploration and is a Qualified Person as defined by NI 43-101. Mr. Taylor has reviewed and approved the technical information related to Prairie Creek in this press release.
ABOUT SANDSTORM GOLD
Sandstorm Gold Ltd. is a gold streaming and royalty company. Sandstorm provides upfront financing to gold mining companies that are looking for capital and in return, receives the right to a percentage of the gold produced from a mine, for the life of the mine. Sandstorm has acquired a portfolio of 72 streams and royalties, of which 14 of the underlying mines are producing. Sandstorm plans to grow and diversify its low cost production profile through the acquisition of additional gold streams and royalties.
For more information visit: www.sandstormgold.com
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This press release contains “forward-looking statements”, within the meaning of the U.S. Securities Act of 1933, the U.S. Securities Exchange Act of 1934, the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation, concerning the business, operations and financial performance and condition of Sandstorm Gold Ltd. (“Sandstorm”). Forward-looking statements include, but are not limited to, statements with respect to the future price of gold, the estimation of mineral reserves and resources, realization of mineral reserve estimates, and the timing and amount of estimated future production. Forward-looking statements can generally be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “continue”, “plans”, or similar terminology.
Forward-looking statements are made based upon certain assumptions and other important factors that, if untrue, could cause the actual results, performances or achievements of Sandstorm to be materially different from future results, performances or achievements expressed or implied by such statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which Sandstorm will operate in the future, including the price of gold and anticipated costs. Certain important factors that could cause actual results, performances or achievements to differ materially from those in the forward-looking statements include, amongst others, gold price volatility, discrepancies between actual and estimated production, mineral reserves and resources and metallurgical recoveries, mining operational and development risks relating to the parties which produce the gold Sandstorm will purchase, regulatory restrictions, activities by governmental authorities (including changes in taxation), currency fluctuations, the global economic climate, dilution, share price volatility and competition.
Forward-looking statements are subject to known and unknown risks, uncertainties and other important factors that may cause the actual results, level of activity, performance or achievements of Sandstorm to be materially different from those expressed or implied by such forward-looking statements, including but not limited to: the impact of general business and economic conditions, the absence of control over mining operations from which Sandstorm will purchase gold and risks related to those mining operations, including risks related to international operations, government and environmental regulation, actual results of current exploration activities, conclusions of economic evaluations and changes in project parameters as plans continue to be refined, risks in the marketability of minerals, fluctuations in the price of gold, fluctuation in foreign exchange rates and interest rates, stock market volatility, as well as those factors discussed in the section entitled “Risks to Sandstorm” in Sandstorm’s annual report for the financial year ended December 31, 2014 available at www.sedar.com. Although Sandstorm has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sandstorm does not undertake to update any forward looking statements that are contained or incorporated by reference, except in accordance with applicable securities laws.
(AGTC) & (BIIB) Enter Collaboration to Develop Gene Therapies in Ophthalmology
Companies to advance a potentially transformative treatment approach for genetic diseases of the eye
AGTC to receive $124M upfront, with potential future milestone payments and royalties
AGTC to host conference call today at 8 a.m. EDT
Biogen (NASDAQ: BIIB) and AGTC (NASDAQ: AGTC) today announced a broad collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights.
“With this collaboration, we hope to advance gene therapies to open possibilities for patients who suffer from diseases that are well understood, but have no adequate treatment,” said Olivier Danos, Ph.D., senior vice president, cell & gene therapy at Biogen. “AGTC is an exceptional partner to help us advance our gene therapy capabilities by targeting diseases of the eye – an organ that provides an ideal setting for the localized, selective delivery of gene-based therapies.”
“We expect this collaboration will further validate our novel adeno-associated virus (AAV) gene therapy platform and support the development of new therapies that may allow for transformative treatments for these rare inherited eye diseases and other clinical indications,” added Sue Washer, president and CEO of AGTC. “Biogen’s significant commitment to advancing gene therapies and demonstrated success in developing innovative therapies to treat complex diseases, combined with our proprietary manufacturing technology and extensive gene therapy experience, makes this an ideal partnership.”
The lead development programs in the collaboration include a clinical candidate for X-linked Retinoschisis (XLRS) and a pre-clinical candidate for the treatment of X-Linked Retinitis Pigmentosa (XLRP). XLRS, a disease affecting young males beginning during the teenage years, can lead to serious complications such as vitreous hemorrhage or retinal detachment during adulthood. XLRP usually causes night blindness by the age of ten and progresses to legal blindness by an individual’s early forties. Both conditions represent significant unmet needs that may be addressed by replacing the single, faulty gene causing each disease.
Collaboration Overview
Biogen will make an upfront payment in the amount of $124 million to AGTC, which includes a $30 million equity investment in AGTC at a price equal to $20.63 per share and certain prepaid research and development expenditures. Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection.
Under the collaboration, AGTC is eligible to receive upfront and milestone payments exceeding $1 billion. This includes up to $472.5 million collectively for the two lead programs, which also will carry royalties in the high single digit to mid-teen percentages of annual net sales. In addition, Biogen will make payments up to $592.5 million across the discovery programs, along with royalties in the mid single digits to low teen percentages of annual net sales.
Biogen obtains worldwide commercialization rights for the XLRS and XLRP programs. AGTC has an option to share development costs and profits after the initial clinical trial data are available, and an option to co-promote the second of these products to be approved in the United States. AGTC will lead the clinical development programs of XLRS through product approval and of XLRP through the completion of first-in-human trials. Biogen will support the clinical development costs, subject to certain conditions, following the first-in-human study for XLRS and IND-enabling studies for XLRP. Under the manufacturing license, Biogen will receive an exclusive license to use AGTC’s proprietary technology platform to make AAV vectors for up to six genes, three of which are in AGTC’s discretion, in exchange for payment of milestones and royalties.
The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the third calendar quarter of 2015.
AGTC will host a live webcast presentation and conference call on July 2 at 8:00 a.m. EDT to discuss the collaboration. The webcast can be accessed at ir.agtc.com/events.cfm or by dialing (888) 427-9419 (US) or (719) 325-2491 (outside of the US) fifteen minutes prior to the start of the call. The passcode is 6785007. The webcast will be archived on the AGTC website.
About Gene Therapy
Gene therapy is an evolving field of medicine in which faulty genes are corrected in cells. Genes control heredity and provide the basic biological code for determining a cell’s specific functions. The most common form of gene therapy involves using DNA that encodes a functional, therapeutic gene to replace a defective gene. In gene therapy, the healthy copy of a defective gene is packaged within a vector, a biological delivery mechanism which is used to transport the genetic information into the diseased cells within the body. Once the gene is delivered into the correct cell, a therapeutic protein is naturally made by the cell from the therapeutic gene.
About Adeno-Associated Virus (AAV) Vectors
AAV vectors have emerged as an attractive approach for gene therapy since they can deliver the genes for therapeutic proteins to accessible tissues in the body. Several AAV gene therapy products are in late-stage clinical development, and one product is approved in the EU.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies, and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For product labeling, press releases and additional information about the company, please visit www.biogen.com.
About AGTC
AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases in ophthalmology. AGTC’s lead product candidates focus on X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa, which are inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC is also using its gene therapy expertise to expand into disease indications with large market opportunity such as wet AMD and other ophthalmology and orphan indications.
Biogen Safe Harbor
This press release contains forward-looking statements, including statements about the potential benefits and advancements that may be achieved through the collaboration with AGTC and the expected timing of the closing the transactions. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Biogen’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include, among others: uncertainty inherent in the regulatory review process and satisfaction of other closing conditions relating to the transactions; uncertainty regarding the ability to achieve the expected benefits from the proposed collaboration, including as a result of risks and uncertainties associated with drug development and commercialization, reliance on third parties over which Biogen may not always have full control and other risks associated with collaborations; and other risks and uncertainties that are described in the Risk Factors section of Biogen’s most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and Biogen assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
AGTC Safe Harbor
This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning the expected timing of the closing of the transactions contemplated by the proposed collaboration, possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: uncertainty inherent in the regulatory review process and satisfaction of other closing conditions relating to the transactions; uncertainty regarding the ability to achieve the expected benefits from the proposed collaboration, including as a result of risks and uncertainties associated with drug development and commercialization, reliance on third parties over which AGTC may not always have full control and other risks associated with collaborations; and other risks and uncertainties that are described under the heading “Risk Factors” in AGTC’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly 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.
MEDIA CONTACTS:
Biogen:
Todd Cooper, +1 781-464-3260
public.affairs@biogen.com
or
Lazar Partners Ltd. for AGTC
Danielle Lewis, 212-843-0211
dlewis@lazarpartners.com
or
INVESTOR CONTACTS:
Biogen
Carlo Tanzi, Ph.D., +1 781-464-2442
IR@biogen.com
or
Lazar Partners Ltd. for AGTC
David Carey, 212-867-1768
dcarey@lazarpartners.com
(RADA) Awarded UAV Avionic Unit Upgrade & Production Contract
NETANYA, Israel, July 1, 2015 — RADA Electronic Industries of Netanya, Israel (Nasdaq:RADA) announced today that it was awarded a contract from a leading Israeli defense contractor to upgrade a previously designed UAV (unmanned aerial vehicle) avionics unit and to supply additional production units. The total order value is $1.5 million with deliveries expected during the next 24 months.
During the last 10 years, UAV avionics have been one of the established areas of expertise at RADA, and the company is active in this market both in Israel and overseas.
For this new order, RADA will upgrade and modify the design of a previously developed unit, qualify the upgraded unit to the UAV environment and supply production units.
Zvi Alon, RADA’s CEO, commented: “This contract evidences the long-term recognition by a leading defense contractor of our avionics design and production capabilities, and we expect to maintain our presence in this advanced avionics market.”
About RADA
RADA Electronic Industries Ltd. is an Israel-based defense electronics contractor. The company specializes in the development, production, and sale of tactical land radar systems for force and border protection, inertial navigation systems for air and land applications, and avionics systems and upgrades.
CONTACT: RADA Dubi Sella (CBDO) Tel: +972-9-892-1111 mrkt@rada.com www.rada.com
(RCPI) Human Proof of Principle Study with Lead Compound in Anti-inflammatory Role
SARASOTA, Fla., July 1, 2015 — Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today the results of a human proof of principle study with anatabine citrate, the Company’s lead compound. Results from the study show that a single oral dose of anatabine citrate can significantly inhibit the activation of inflammatory proteins in the blood of human subjects. The Company is developing this compound in a Phase 1 clinical trial under a Medicines and Healthcare Products Regulatory Agency (MHRA) regulatory protocol in the United Kingdom.
New Zealand Study
In December of 2014, the Company received a New Zealand Ministry of Health Ethics Committee approval to conduct a single-site, single dose, open-label human study, entitled “Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal, Healthy Volunteers.”
The primary objective of the study was to determine whether a single dose of orally administered anatabine citrate could reduce the activation of inflammatory proteins in human white blood cells. Blood samples were taken from ten healthy human subjects, collected before and after oral administration of anatabine citrate. The blood samples were immediately challenged with lipopolysaccharide (LPS), a well-known potent stimulator of inflammation. The blood samples were then evaluated to measure the activation of two proteins, NF-kB and STAT3, which are known to be central to inflammation. The study compared the amount of LPS-induced activation of NF-kB and STAT3 in the white blood cells before and after the administration of anatabine citrate. Activated NF-kB and STAT3 protein levels were measured by two different, well-established molecular biology methods.
Data analysis showed that there were statistically significant (p<0.05) reductions in LPS stimulated levels of both NF-kB and STAT3 in human white blood cells after a single oral dose of anatabine citrate. These data are consistent with several peer reviewed scientific papers showing that anatabine can reduce NF-kB and STAT3 activation in animal models of inflammatory diseases, as well as in several human cell lines as shown by in vitro studies. Additionally, evaluation of safety data showed that anatabine citrate was well tolerated by the study participants and there were no safety concerns.
Ryan Lanier, PhD, Rock Creek Pharmaceuticals’ Chief Scientific Officer remarked, “This is the first time that anatabine citrate taken orally by human subjects has been shown to oppose the activation of these known inflammatory proteins in white blood cells. The data are entirely consistent with our proposed mechanism of action of anatabine citrate which forms the basis for our advancement of this compound into clinical trials for human inflammatory diseases.”
About Anatabine Citrate:
Rock Creek Pharmaceuticals’ Anatabine Citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer’s Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of Anatabine Citrate. In addition, the Company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies and post-marketing data collection of the previously marketed nutraceutical product, has provided important insights for clinical development.
About Rock Creek Pharmaceuticals, Inc.:
Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic inflammatory disease, neurologic disorders and behavioral health.
For more information, visit: http://www.rockcreekpharmaceuticals.com
Forward Looking Statements:
Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “targets,” “projects” and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, failure to obtain sufficient capital resources to fund our development program and operations, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our significant payables, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices, pending litigation matters, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2014 filed on March 12, 2015. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.
CONTACT:
Stephanie Carrington
Investors
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282
stephanie.carrington@icrinc.com
Ted Jenkins
Vice President, Corporate Strategy and Development,
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com
(LJPC) Lakhmir S. Chawla, M.D. Receives the International Vicenza Award
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that Lakhmir “Mink” S. Chawla, M.D., the Company’s Chief Medical Officer, received the International Vicenza Award for Critical Care Nephrology at the 33rd Course on Critical Care Nephrology in June 2015. This award recognizes individuals who have made seminal clinical research advancements that have significantly improved the care of critically ill patients with acute kidney injury (AKI) and have been adopted worldwide.
Dr. Chawla was selected as the recipient of the Vicenza Award for his contributions to the development of the renal angina model, the development and standardization of the furosemide stress test, the link between AKI and chronic kidney disease (CKD), and the use of angiotensin II in the treatment of high-output shock. Dr. Chawla is the tenth recipient to receive the Vicenza Award.
Prior to his appointment at La Jolla, Dr. Chawla was an Associate Professor of Medicine at the George Washington University, where he had dual appointments in the Department of Anesthesiology and Critical Care Medicine and in the Department of Medicine, Division of Renal Diseases and Hypertension. Dr. Chawla was also the Chief of the Division of Intensive Care Medicine at the Washington D.C. Veterans Affairs Medical Center.
Dr. Chawla has been an active investigator in the field of critical care nephrology since 2002. His research has focused on shock, inflammation, AKI epidemiology and outcomes, the link between AKI and CKD, and AKI risk assessment. He is also a leading researcher in the field of AKI biomarkers and functional kidney testing.
“On behalf of the entire La Jolla team, I would like to congratulate Mink on receiving this prestigious award,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “Mink has made many valuable contributions to the field of medicine, and we are honored to have him on our team.”
Professors Claudio Ronco, M.D. and Rinaldo Bellomo, MBBS, M.D., FRACP, FCICM, PGDipEcho presented the award. Professor Ronco founded the International Renal Research Institute of Vicenza that has hosted more than 100 fellows from all over the world and is renowned for the interdisciplinary nature of the research carried out in its many laboratories. Professor Bellomo is the Director of Intensive Care Research at the Austin Hospital in Melbourne, the Founding Chair of the Australian and New Zealand Intensive Care (ANZIC) Society Clinical Trials Group and the current Co-Director of the ANZIC Research Centre.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. LJPC-401 is La Jolla’s novel formulation of hepcidin for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis and beta thalassemia. LJPC-30Sa and LJPC-30Sb are La Jolla’s next-generation gentamicin derivatives for the potential treatment of serious bacterial infections and rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit www.ljpc.com.
La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
858-207-4264
gtidmarsh@ljpc.com
or
Dennis M. Mulroy
Chief Financial Officer
858-433-6839
dmulroy@ljpc.com
(WPCS) Suisun City Opens Fiscal 2016 by Signing $3.6 Million in New Contracts
SUISUN, CA–(Jul 1, 2015) – WPCS International Incorporated (NASDAQ: WPCS), which specializes in contracting services for communications infrastructure, today announced that it was awarded $3.6 million in new contracts during the first two months of fiscal year 2016.
According to Sebastian Giordano, Interim CEO of WPCS, “With Suisun City Operations having just completed a profitable fiscal year end 2015, this is a very good start to the new year.”
These new projects include a significant $2.4 million technology cabling and technology room build-out for all network cabling at the new California Pacific Medical Center, St. Luke’s Campus Hospital, located in the Mission District of San Francisco. The new hospital will be a 215,000 square foot acute health care facility providing 120 new patient beds.
About WPCS International Incorporated
WPCS provides contracting services to the public services, healthcare, energy and corporate enterprise markets in the United States. For more information, please visit www.wpcs.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements with respect to the Company’s future growth opportunities and strategic plan. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
INVESTOR CONTACT:
WPCS International Incorporated
David Allen
Chief Financial Officer
Phone: 707.759.6008
Email: Email Contact
(VSTA) FDA, NIH Clearance for NIH-Funded AV-101 Phase 2 Study in MDD
Phase 2 Clinical Study in Major Depressive Disorder Expected to Commence at NIH in 3Q 2015
SOUTH SAN FRANCISCO, CA–(Jul 1, 2015) – VistaGen Therapeutics, Inc. (OTCQB: VSTA), a clinical-stage biopharmaceutical company committed to developing and commercializing innovative product candidates for patients with depression, other diseases and various disorders related to the central nervous system as well as cancer, has received clearance from the U.S. Food and Drug Administration (FDA) and the U.S. National Institutes of Health (NIH) to initiate an NIH-funded Phase 2 clinical study of its orally active AV-101 in subjects with treatment-resistant Major Depressive Disorder (MDD) under protocol number 15-M-0151. The Principal Investigator of the study will be Dr. Carlos Zarate, Jr., Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the U.S. National Institute of Mental Health (NIMH), which is part of the NIH. The Phase 2 study will be a randomized, double-blind, placebo-controlled, crossover clinical trial conducted at the NIMH and designed to evaluate the efficacy and safety of a single oral dose of AV-101 administered once per day for 14 days to approximately 25 patients with MDD. VistaGen and the NIMH expect to initiate enrollment of subjects in the study in 3Q 2015.
AV-101 is an orally active, clinical-stage prodrug candidate that readily gains access to the central nervous system (CNS) after systemic administration and is rapidly converted in vivo to its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized, potent, and highly-selective antagonist of the glycine-binding co-agonist (GlyB) site of the N-methyl-D-aspartate receptor (NMDAR). Current evidence suggests that AV-101’s antagonism of NMDAR signaling may provide fast-acting antidepressant effects in the treatment of MDD. In addition, as confirmed in two Phase 1 clinical studies, using AV-101 to target the GlyB site of the NMDAR may bypass potential adverse effects that occur with ketamine, while activating similar pathways resulting in the “glutamate surge” that has been associated with increased neurogenesis and the rapid-acting antidepressant effects of ketamine observed in previous clinical studies.
“The NIMH and several key leaders in the field with clinical experience using ketamine to treat MDD provided valuable expert advice on the design of our Phase 2 MDD study. We are grateful for their assistance. With their help, we have now achieved an important regulatory milestone for our AV-101 clinical development program,” said H. Ralph Snodgrass, the Company’s President and Chief Scientific Officer. “The pharmacology and existing clinical safety data and preclinical efficacy data point to AV-101’s potential to provide a transformative advancement in the treatment of MDD, in a manner fundamentally different from all currently approved antidepressants.”
About MDD
While most people will experience episodic depressed mood at multiple points during their life, MDD is different. MDD is the chronic, pervasive feeling of utter unhappiness, hopelessness and suffering, which impairs daily functioning. Symptoms of MDD include diminished pleasure in activities, changes in appetite that result in weight changes, insomnia or oversleeping, psychomotor agitation, loss of energy or increased fatigue, feelings of worthlessness or inappropriate guilt, difficulty thinking, concentrating or making decisions, and thoughts of death and attempts at suicide. Suicide is estimated to be the cause of death in up to 15% of individuals with MDD. MDD is one of the most common mental disorders in the United States. According to the NIMH, about 6.7% of U.S. adults experience MDD each year.
About Current Antidepressants
Current medications available in the multi-billion dollar global antidepressant market, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), have limited effectiveness. Because of their mechanism of action, SSRIs and SNRIs must be taken for several weeks before patients experience significant therapeutic benefit. Approximately two-thirds of depression sufferers do not benefit from initial treatment with SSRIs and SNRIs. Although approximately two-thirds patients may find an antidepressant drug or drug combination that induces remission of their depressive symptoms after several different drug treatment attempts, this trial and error process and the systemic effects of the various antidepressant medications involved increases the risks of patient tolerability issues and serious side effects, including the potential of increased suicidal thoughts and behaviors during the time period before the therapeutic effects of the drugs are obtained.
About Ketamine for MDD
Ketamine hydrochloride (ketamine) is an FDA-approved, rapid-acting general anesthetic. The use of ketamine to treat MDD has been studied in several clinical trials conducted by depression experts, including Dr. Carlos Zarate and others at the NIMH. In randomized, placebo-controlled, double-blind clinical trials reported by Dr. Zarate and others at the NIMH, a single subanaesthetic intravenous dose of ketamine (0.5 mg/kg over 40 minutes) produced robust and rapid antidepressant effects in MDD patients who had not responded to currently-approved medications. These results were in contrast to the slow onset of currently FDA-approved antidepressant medications, which usually require many weeks or months of chronic usage to achieve similar antidepressant effects. The potential for widespread therapeutic use of ketamine is severely limited by its potential for abuse, dissociative and psychosis-like side effects, and by practical challenges associated with its intravenous administration in a medical center. Notwithstanding these limitations the discovery of ketamine’s fast-acting antidepressant effects revolutionized thinking about the MDD treatment paradigm. The discovery also increased interest in the development of a new generation of antidepressants with a fast-acting mechanism of action similar to ketamine’s.
About AV-101 for MDD
AV-101’s fundamentally novel mechanism of action places it among a new generation of glutamatergic antidepressants with potential to treat millions of MDD sufferers worldwide who are poorly served by SSRIs, SNRIs and other current depression therapies. Like ketamine, AV-101 modulates (down-regulates) NMDAR activity. However, unlike ketamine’s antagonistic activity, which results from its blocking the NMDAR ion channel, AV-101’s antagonistic activity results from its selective binding to, and blocking of, the functionally-required GlyB site of the NMDAR. In addition, AV-101 is orally available and has a much longer half-life than ketamine and mechanistically similar peptides currently under development for MDD.
About the U.S. National Institute of Mental Health
The U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH), is the largest scientific organization in the world dedicated to mental health research. NIMH is one of 27 Institutes and Centers of the NIH, the world’s leading biomedical research organization. The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit www.nimh.nih.gov.
About VistaGen Therapeutics
VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative product candidates for patients with depression, other diseases and various disorders related to the central nervous system as well as cancer. VistaGen’s AV-101 is a new generation orally-available NMDAR GlyB antagonist in Phase 2 clinical development for Major Depressive Disorder. Based on preclinical studies, AV-101 may also have potential as a treatment for other CNS-related conditions, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases such as Parkinson’s disease and Huntington’s disease. VistaGen is also developing and using pluripotent stem cell technology and clinically-predictive bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, for drug rescue applications focused on producing proprietary new chemical entities (NCEs) for its internal development pipeline.
Visit VistaGen at http://www.VistaGen.com
Follow VistaGen on Twitter at http://www.twitter.com/VistaGen
Connect to VistaGen’s Facebook page at http://www.facebook.com/VistaGen
Cautionary Statement Regarding Forward-Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the VistaGen’s and the NIH’s successful completion of the NIH-sponsored Phase 2 clinical study of AV-101 in MDD, its stem cell technology-based drug rescue activities, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the foregoing activities. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
For more information:
Shawn K. Singh, J.D.
Chief Executive Officer
VistaGen Therapeutics, Inc.
www.VistaGen.com
650-577-3613
Investor.Relations@VistaGen.com
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