Gilead Submits NDA to FDA for Single Tablet Regimen for HIV; CEL-SCI Reports June Patient Enrollment Print E-mail
By David Fowler   
Wednesday, 01 July 2015 20:02
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 1, 2015.
Gilead Sciences, Inc. (NASDAQ: GILD) announced it has submitted a New Drug Application to the U.S. Food and Drug Administration for an investigational, once-daily single tablet regimen that combines Gilead's emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with rilpivirine 25 mg (R/F/TAF) from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the treatment of HIV-1 infection in adult and pediatric patients 12 years of age and older. The data submitted in the NDA support the use of R/F/TAF among patients who are HIV treatment-naïve or who are virologically suppressed and want to replace their current antiretroviral treatment regimen.
A Priority Review voucher acquired from Knight Therapeutics in November 2014 was submitted to the FDA along with the R/F/TAF NDA. Under the Prescription Drug User Fee Act (PDUFA), the anticipated target action date for the R/F/TAF NDA is six months after the FDA's acceptance of the filing.
"R/F/TAF is Gilead's third TAF-based filing in less than a year, and we are looking forward to the potential to offer people living with HIV another effective treatment option with a favorable safety profile," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents Gilead's next collaboration with Janssen in our combined efforts to increase and potentially improve HIV treatments for a range of patients."
TAF is a novel, investigational 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 in combination with other antiretroviral agents.
In addition to R/F/TAF, two other TAF-based HIV treatments are also under FDA 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). Gilead filed another NDA in April 2015 for two doses of an investigational, fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for use in combination with other HIV antiretroviral agents. Under the PDUFA, the FDA has set a target action date of November 5, 2015, for E/C/F/TAF and April 7, 2016, for F/TAF.
Marketing Authorization Applications in the European Union were fully validated on December 23, 2014, and May 28, 2015, for E/C/F/TAF and F/TAF respectively. Gilead plans to submit a regulatory application for R/F/TAF in the European Union in the third quarter of 2015.
The current NDA is supported by a bioequivalence study demonstrating that R/F/TAF achieved the same drug levels of emtricitabine and TAF in the blood as E/C/F/TAF (10 mg TAF dosage) and the same drug levels of rilpivirine as a 25 mg dose of rilpivirine (Edurant®) alone. The safety and efficacy of TAF is supported by a number of clinical studies in a range of patients with HIV, including treatment-naïve adults and adolescents, virologically suppressed adults who switched regimens and adults with mild-to-moderate renal impairment. In studies, TAF-based treatment (administered as E/C/F/TAF) resulted in non-inferior efficacy and improved renal and bone laboratory parameters as compared to TDF-based therapy (administered as E/C/F/TDF or Stribild®).
The R/F/TAF filing is the latest step in an expanded development and commercialization agreement between Gilead and Janssen, first established in 2009. Under this agreement, and pending the product's approval, Gilead will be responsible for the manufacturing, registration, distribution and commercialization of the regimen in most countries, while Janssen will distribute it in approximately 17 markets and have co-detailing rights in several key markets, including the United States. The original agreement was established for the development and commercialization of Complera®, marketed as Eviplera® in the European Union.
A fourth investigational TAF-based regimen containing Gilead's TAF, emtricitabine and cobicistat, and Janssen's darunavir (D/C/F/TAF) also is under development under another licensing agreement. Under the agreement, Gilead is transferring to Janssen further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide.
TAF-based regimens are investigational products and have not been determined to be safe or efficacious.
CEL-SCI Corporation (NYSE MKT: CVM) announced in June it has enrolled 25 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in just diagnosed, not yet treated patients with head and neck cancer. Total patient enrollment is now 488 as of June 30, 2015 in the world's largest Phase 3 study in head and neck cancer.
A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in about 25 countries by the end of March 2016.
About the Multikine Phase 3 Study  --  The Multikine Phase 3 study is enrolling just diagnosed, not yet treated patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. Standard of Care for these patients consists of the surgical removal of the tumor and any locally involved lymph nodes, followed by radiotherapy or concurrent radiochemotherapy.
Also Wednesday:
Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced an update and clarification with respect to media reports regarding its inactive manufacturing joint venture with Usina São Martinho, SMA Indústria Química S.A, or SMA., noting that, at present, its existing Brotas facility is exceeding targets and provides adequate capacity to meet its near and mid-term business needs.
Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, today announced the appointments of Amit Agrawal as Chief Operating Officer, effective July 8, 2015, and Naseem Amin, M.D. as an Independent Director of the Company, effective June 29, 2015.
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced the promotion of Richard Wright, Ph.D. to Senior Vice President and the newly created position of Chief Commercial Officer. Dr. Wright was previously Vice President of Commercial Operations at Celldex and brings nearly 25 years of industry experience, including the commercialization of six successful drug therapies. 
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 the company's management team will present at the Cantor Fitzgerald Healthcare Conference on Wednesday, July 8, at 4:15 p.m. EDT. 
The Ensign Group, Inc. (NASDAQ:ENSG), the parent company of the Ensign™ group of skilled nursing, rehabilitative care services, home health care, hospice care, assisted living and urgent care companies, announced today that it has agreed to purchase ten skilled nursing and assisted living operations in Arizona.
Evoke Pharma, Inc. (Nasdaq:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, will host an investor presentation on Wednesday, July 8, 2015 at 10:15 AM ET at the Cantor Fitzgerald Inaugural Healthcare Conference. 
The Female Health Company (NASDAQ:FHCO) today announced that it expects to report unit sales for the third quarter of FY2015 totaling approximately 14.4 million units.
Heat Biologics, Inc. (Nasdaq:HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that Jeff Wolf, CEO, will present a corporate update at the Cantor Fitzgerald Healthcare Conference in New York City on July 8.
Inogen, Inc. (NASDAQ:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, announced today that Bob Fary, Inogen VP of Strategic Alliances, has been selected to join the American Association of Homecare Board of Directors.
Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that it has completed the previously announced tax-free spin-off of its orthobiologics and spinal fusion hardware business, now known as SeaSpine Holdings Corporation (NASDAQ:SPNE).
Kite Pharma, Inc., (Nasdaq:KITE) and The Leukemia & Lymphoma Society (LLS) announced today that they have entered into a partnership to enhance the development of Kite's lead product candidate, KTE-C19, for the treatment of patients with refractory aggressive non-Hodgkin lymphoma (NHL).
Medical Marijuana, Inc. (OTC Pink:MJNA), an industrial hemp industry innovator and investor, released a video statement from one of the cannabis industry's top product quality testing authorities: ProVerde Laboratories. Dorian A. Des Lauriers, Chief Executive Officer of ProVerde Laboratories, states that his company has tested MJNA brands including Real Scientific Hemp Oil™ (RSHO™) and others from HempMeds® for more than two years. In the video statement, Des Lauriers states these products are, "...perfectly clean for human consumption."
Medical Marijuana, Inc. (OTC Pink:MJNA), an industrial hemp industry innovator, is proud to announce that its portfolio company,
Onconova Therapeutics, Inc. (Nasdaq:ONTX) a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced that Ramesh Kumar, Ph.D., President and Chief Executive Officer, will present a company update, including details of a new global Phase 3 trial in higher-risk myelodysplastic syndromes at the Cantor Fitzgerald Healthcare Conference in New York, NY. 
Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that William Haskel joined the company as Senior Vice President, General Counsel and Corporate Secretary. He will be based out of the company's Boston office.
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that it has received two notices of allowance from the United States Patent and Trademark Office (USPTO) regarding its patent application numbers 13/722,395 and 14/271,758 covering RHB-104.
Relypsa, Inc. (Nasdaq:RLYP), today announced that John A. Orwin, president and chief executive officer, will present at the Cantor Fitzgerald Inaugural Healthcare Conference on July 8, 2015 at 11:45 a.m. ET.
StemCells, Inc. (Nasdaq:STEM) announced today that management will make a presentation on the Company's programs, pipeline and operations at Cantor Fitzgerald's Inaugural Healthcare Conference. Management is scheduled to speak at 11:45 a.m. Eastern Standard Time on Wednesday, July 8, at the Le Parker Meridian Hotel, located at 119 W. 56th Street in New York City.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that Daniel Swisher, Chief Executive Officer of Sunesis, will present at the Cantor Fitzgerald Inaugural Healthcare Conference on Wednesday, July 8th at 9:00 AM Eastern Time at Le Parker Meridien Hotel in New York City.
TRACON Pharmaceuticals (NASDAQ:TCON) today announced that its partner, Santen Pharmaceutical Co. Ltd. (Santen), filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for the initiation of clinical studies for DE-122 in patients with wet AMD. 
XBiotech (NASDAQ:XBIT), the developer of True Human™ therapeutic antibodies, announced today that it held an investigators meeting to update clinicians and support staff on the overall status of the Company's Phase III study in colorectal cancer. 

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