Bristol-Myers Squibb Submits NDA to FDA for Fixed-Dose Combo Tablet; pSivida Announces PDUFA Date for ILUVIEN Print E-mail
By Staff and Wire Reports   
Monday, 14 April 2014 19:58

Below is a look at some of the headlines for companies that made news in the healthcare sector on April 14, 2014. Bristol-Myers Squibb Company (NYSE: BMY) announced the submission of a new drug application (NDA) on April 4, 2014 to the U.S. Food and Drug Administration (FDA) for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences, Inc.

Approximately 245,000 patients in the U.S. have been treated with Reyataz since its launch in 2003, nearly twice that of any other protease inhibitor launched since that time. Reyataz is currently used in combination with other antiretroviral agents and is most commonly used with ritonavir, a pharmacokinetic enhancer. A once-daily therapy, Reyataz is indicated for the treatment of HIV-1 infection in treatment-naïve and treatment-experienced adult patients and pediatric patients six years of age or older.

“Bristol-Myers Squibb is committed to enhancing our existing regimens, as well as developing new therapies to make HIV treatment simpler for patients,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “The submission of this NDA represents an important step forward in our efforts to provide patients with new options for Reyataz treatment.”

Reyataz is the only protease inhibitor that has been evaluated with cobicistat in a prospective, randomized, Phase III double-blind clinical trial (Gilead's Study 114), which compared the efficacy and safety of cobicistat-boosted Reyataz (atazanavir sulfate) versus ritonavir-boosted Reyataz in treatment-naïve adult patients for 48 weeks. Study 114 may support the clinical use of atazanavir and cobicistat together.

“Adhering to HIV treatment regimens can be challenging for some patients, and if the prescribed medications are not taken properly, it could result in treatment failure,” said Calvin J. Cohen, M.D., MPH, director of research, Community Research Initiative of New England and internist, Harvard Vanguard Medical Associates. “If approved by the FDA, a once-daily, fixed-dose combination of atazanavir sulfate and cobicistat would offer patients living with HIV-1 another treatment option.”

In October 2011, Bristol-Myers Squibb announced a licensing agreement with Gilead for the development and commercialization of a once-daily, single tablet fixed-dose combination product of atazanavir sulfate and Gilead's cobicistat. Under the terms of the agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.


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pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has established a Prescription Drug User Fee Act (PDUFA) goal date of September 26, 2014 for ILUVIEN® following the recent resubmission of the New Drug Application (NDA) by pSivida's licensee, Alimera Sciences. The FDA acknowledged the resubmission as received as a complete class 2 response to the FDA's October 2013 complete response letter.

The resubmission responded to questions raised in the FDA's October 2013 letter and provided data from ILUVIEN patients and from physician experience with the applicator in the United Kingdom and Germany where ILUVIEN is currently commercially available.

“We are pleased to have the PDUFA goal date set for ILUVIEN and look forward to the FDA's action on the resubmitted NDA,” said Paul Ashton, pSivida's president and chief executive officer.


Also Monday: 

Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing the next generation of cancer immunotherapies, announced that the Japan Patent Office issued to Advaxis two notices of allowance for two patent applications (P-72863-JP, P-7924) with claims for each patent application related to the Company's proprietary cancer immunotherapy platform technology.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
, a global leader in the development and commercialization of therapies for rare genetic diseases, today announced that the Food and Drug Administration (FDA) granted KUVAN® (sapropterin dihydrochloride) Powder for Oral Solution and Tablets a six-month pediatric exclusivity extension.

Hemp, Inc. (OTC:HEMP)
announces sales for the first quarter of 2014, of $5,463,215, surpassing previous high marks for revenue, in any one quarter, since inception.

Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I),
a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the three months ended February 28, 2014.

Medical Marijuana Inc. (OTC Pink:MJNA)
is pleased to announce its newest subsidiary, aNew Chocolate, LLC ("aNew Chocolate"), that manufactures the world's first cannabidiol (CBD)-rich hemp oil-infused chocolate bars.

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, announced today that it has entered into a definitive agreement to acquire California Stem Cell, Inc. ("CSC"), an Irvine, California based stem cell biotechnology company.

Portola Pharmaceuticals (Nasdaq:PTLA)
today announced publication of the design and rationale of the Phase 3 APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study in the March 2014 issue of the American Heart Journal.i Betrixaban, the Company's wholly-owned, oral, once-daily Factor Xa anticoagulant, is being evaluated in the only ongoing global, pivotal study of in-hospital and post-discharge prevention of venous thromboembolism (VTE), or blood clots, in patients who have been hospitalized for medical conditions, such as heart failure, stroke, infection and pulmonary disease.

Protea Biosciences Group, Inc. (OTCQB:PRGB)
announced today that the company's shares of common stock have commenced trading on the OTCQB marketplace of the OTC Markets Group Inc. under the ticker symbol PRGB.

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced the appointment of Mary Lynne Hedley, Ph.D. as a director of Receptos.

Rich Pharmaceuticals, Inc. (OTCQB:RCHA)
, has been made aware of a recent spam stock promotion regarding shares of Rich. Rich has received complaints, and has been forwarded emails and links to social media sites, relating to unsolicited messages containing false and misleading information regarding Rich.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that three individual abstracts for Triferic™ have been selected by the National Kidney Foundation for presentation at their Spring Clinical Meetings, April 22-26, 2014 in Las Vegas, Nevada.




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