Gilead Submits NDA to U.S. FDA for Fixed-Dose Combo of Emtricitabine/Tenofovir Alafenamide; Oncolytics Announces Filing for Gastric Cancer Print E-mail
By Josh Gee   
Tuesday, 07 April 2015 18:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 7, 2015.  
 
Gilead Sciences, Inc., (NASDAQ: GILD) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.
TAF is a novel nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy at a dose less than one-tenth that of Gilead's Viread® (tenofovir disoproxil fumarate, TDF), as well as improved renal and bone laboratory parameters as compared to TDF in clinical trials.
"Gilead has a long history of innovating HIV treatments, and with F/TAF we have the potential to further optimize therapies for HIV patients who face a lifetime of antiretroviral treatment," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "With its high antiviral efficacy and favorable safety profile, F/TAF may offer an improved backbone for a new generation of HIV regimens."
Today's filing is Gilead's second F/TAF-based NDA submitted to the FDA for review. In November 2014, Gilead filed an NDA for an investigational once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg (E/C/F/TAF). Under the Prescription Drug User Fee Act, the FDA has set a target action date of November 5, 2015. Additionally, a Marketing Authorization Application in the European Union for E/C/F/TAF was fully validated on December 23, 2014.
The F/TAF NDA is supported by data from Phase 3 clinical studies evaluating the safety and efficacy of E/C/F/TAF for the treatment of HIV-1 infection among treatment-naïve adults, in which the F/TAF-based regimen (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to F/TDF-based therapy (administered as E/C/F/TDF or Stribild®). The NDA is also supported by data from additional Phase 3 studies evaluating the F/TAF-based regimen (administered as E/C/F/TAF) among treatment-naïve adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of F/TAF achieved the same drug levels in the blood as in E/C/F/TAF.
The recommended dose of F/TAF is 200/25 mg; if it is used in combination with a protease inhibitor that is administered with either ritonavir or cobicistat, the recommended dose is 200/10 mg.  Additional F/TAF-based regimens for HIV treatment are currently in development. In December 2014, Gilead announced the expansion of its existing agreements with Janssen Sciences Ireland UC for the development and commercialization of two new investigational once-daily single tablet regimens containing F/TAF. One combines F/TAF with Janssen's rilpivirine. The other regimen contains F/TAF, cobicistat and Janssen's darunavir.  Gilead plans to submit a regulatory application for F/TAF in the European Union in the second quarter of 2015.  F/TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
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Oncolytics Biotech® Inc. (TSX:ONC, NASDAQ:ONCY) announced it has submitted an application for Orphan Drug Designation to the U.S. Food and Drug Administration ("FDA") for REOLYSIN® for the treatment of gastric cancer.
"Patients diagnosed with later stage gastric cancer generally have very poor prognoses," said Dr. Brad Thompson, President and CEO of Oncolytics. "As a result, gastric cancer is a serious issue both in the United States and other countries around the world including Japan and Korea where incidence rates are higher."
The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees. The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval. For more information, please visit:
Also Tuesday:
Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology, announced today that David Main, Aquinox's President & CEO, will present a corporate overview at the upcoming 14th Annual Needham Healthcare Conference on Tuesday, April 14th at 4:20 PM Eastern Time. 
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced its poster titled "Analysis of Specific Antibody Levels in PIDD Patients Enrolled in a Pivotal Trial with an IVIG Containing High Titer Neutralizing Antibody to RSV," will be presented at the upcoming Clinical Immunology Society 2015 Annual Meeting, being held April 9-12, 2015 in Houston, Texas.
 
Agile Therapeutics, Inc. (Nasdaq:AGRX) a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, announced today that Al Altomari, President and Chief Executive Officer will present at the 14th Annual Needham Healthcare Conference on April 15, 2015 at 4:20 PM Eastern Time.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer using its Arcelis® technology platform, today announced that Jeff Abbey, president and chief executive officer, will present at the 14th Annual Needham Healthcare Conference on Tuesday, April 14th, 2015, at 2:20 p.m. Eastern Time. 
Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Dr. Derek Chalmers, President and CEO, will present a company overview at the 14th Annual Needham Healthcare Conference on Tuesday, April 14, 2015, at 3:00 p.m. ET in New York City.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG), a biomedicine firm engaged in the development of effective treatments for degenerative and cancerous diseases, today announced the closing of a private placement transaction under which it sold an aggregate of 515,789 shares (the "Shares") of the Company's common stock, par value $0.001 per share (the "Common Stock"), to selected private investors (the "Investors") at $38.00 per share, for total gross proceeds of approximately $19.6 Million.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) announced today its scheduled presentation of the company's programs and outlook at the 14th Annual Needham Healthcare Conference on Wednesday, April 15, 2015, at 2:20 p.m. ET, in New York. 
Endocyte, Inc. (Nasdaq:ECYT) a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today announced that P. David Mozley, M.D. has been appointed as vice president of imaging. 
ExamWorks Group, Inc. (NYSE:EXAM) announced today that it intends to commence an offering of $500 million in aggregate principal of senior unsecured notes due 2023 pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (SEC). 
Geron Corporation (Nasdaq:GERN) today announced that John Scarlett, M.D., President and Chief Executive Officer, will present an overview of the company at the 14th Annual Needham Healthcare Conference in New York. 
Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX), a biopharmaceutical company focused on developing breakthrough treatments for human disease, will visit the Nasdaq MarketSite in Times Square.
Marrone Bio Innovations, Inc. (Nasdaq:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced the recent additions of several strategic hires to its sales team as regional territory managers.
Nanosphere, Inc. (Nasdaq:NSPH), a company enhancing medicine through targeted molecular diagnostics, announced today that a 20-to-1 reverse split of its common stock will be effective at 5:00 p.m. EDT on April 8, 2015, and commencing at the open of trading on Thursday, April 9, 2015, trading of the common stock will continue on the NASDAQ Capital Market on a reverse stock split-adjusted basis. 
Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the presentation of pre-clinical data of its leading proprietary compounds at the 2015 AACR Annual Meeting being held April 18-22, 2015 at the Pennsylvania Convention Center in Philadelphia, PA.
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) today announced that its partner, FUJIFILM RI Pharma Co. Ltd. (Fuji), has dosed the first patient in its early Phase 2 trial of 1404 in Japan in newly-diagnosed prostate cancer patients with lymph node and/or bone metastases or at high risk for metastatic disease. 
StemCells, Inc. (Nasdaq:STEM) announced today that Martin McGlynn, CEO of StemCells, Inc., will make a presentation on the Company's programs and operations at the 14th Annual Needham Healthcare Conference. Management is scheduled to speak at 3:40 p.m. Eastern Daylight Time on Wednesday, April 15, at The Westin NY Grand Central Hotel located at 212 E 42nd Street in NYC.
Summit Therapeutics plc (Nasdaq:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and C. difficile infection, announces that Mr. Glyn Edwards, Summit's Chief Executive Officer, is scheduled to present at Needham and Company's 14th Annual Healthcare Conference at 11:20am EDT (4:20pm BST) on 15th April 2015 in New York City.
Tetraphase Pharmaceuticals, Inc. (Nasdaq:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that Guy Macdonald, Tetraphase President and Chief Executive Officer, will present at the 14th Annual Needham Healthcare Conference on Tuesday, April 14th at 8:40 a.m. Eastern Time at The Westin Grand Central Hotel in New York City.
Trillium Therapeutics Inc. (Nasdaq:TRIL) (TSX:TR) an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that it has completed its previously announced underwritten public offering of common shares and non-voting convertible preferred shares. 
Wellness Center USA, Inc. (OTCQB:WCUI), today announced that its wholly owned subsidiary, Psoria-Shield, Inc., has been accepted into MATTER, the nation's newest healthcare technology incubator, focused on next-generation health IT, medical device, bio/pharma and diagnostic innovation.



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