Merck, Pfizer Announce Worldwide Collaboration Deal for Ertugliflozin; Gilead Receives CRL from FDA for Elvitegravir, Cobicistat Print E-mail
By Mary Davila   
Monday, 29 April 2013 19:19
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 29, 2013.

Merck & Co., Inc. (NYSE: MRK)
, known as MSD outside the United States and Canada (“Merck”), and Pfizer Inc. (NYSE: PFE) announced they have entered into a worldwide (except Japan) collaboration agreement for the development and commercialization of Pfizer's ertugliflozin (PF-04971729), an investigational oral sodium glucose cotransporter (SGLT2) inhibitor being evaluated for the treatment of type 2 diabetes. Ertugliflozin is Phase III ready, with trials expected to begin later in 2013.

“We are pleased to join forces with Merck in the battle against type 2 diabetes and the burden that it poses on global health,” said John Young, president and general manager, Pfizer Primary Care. “Through this collaboration, we believe we can build on Merck's leadership position in diabetes care with the introduction of ertugliflozin, an innovative SGLT2 inhibitor discovered by Pfizer scientists.”

Under the terms of the agreement, Merck, through a subsidiary, and Pfizer will collaborate on the clinical development and commercialization of ertugliflozin and ertugliflozin-containing fixed-dose combinations with metformin and JANUVIA® (sitagliptin) tablets. Merck will continue to retain the rights to its existing portfolio of sitagliptin-containing products. Pfizer has received an upfront payment and milestones of $60 million and will be eligible for additional payments associated with the achievement of pre-specified future clinical, regulatory and commercial milestones. Merck and Pfizer will share potential revenues and certain costs on a 60/40 percent basis.

“Merck continues to build upon our leadership position in the oral treatment of type 2 diabetes through our own research and business development,” said Nancy Thornberry, senior vice president and Diabetes and Endocrinology franchise head, Merck Research Laboratories. “We believe ertugliflozin has the potential to complement our strong portfolio of investigational and marketed products, and we look forward to collaborating with Pfizer on its development.”


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Gilead Sciences, Inc. (Nasdaq: GILD) announced the company has received Complete Response Letters from the U.S. FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.

In its communications, FDA states that it cannot approve the applications in their current forms. The letters state that during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed. Gilead is working with FDA to address the questions raised in the Complete Response Letters and move the applications forward.

Elvitegravir and cobicistat are also components of Gilead's once-daily single tablet HIV-1 regimen Stribild^® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), which was approved by FDA in August 2012 for treatment-naïve adults. This regulatory action does not affect the marketing authorization or continued use of Stribild.

Gilead submitted its NDAs for elvitegravir and cobicistat in June 2012. Marketing applications are also pending in Europe.



Also Monday:



ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, announced that Carrie Daly, MS, RN, APN, AOCN of Rush University Medical Center presented data from a MuGard study, performed by the Institution, at last week's Oncology Nursing Society Annual Congress in Washington, DC.

Andain Inc. (OTCBB: ANDN)
("Andain" or the "Company"), a company engaged in commercializing novel technologies in biotech, medical and life sciences fields through its accelerating incubator program, announces today its innovative nano-particles drug delivery technology.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, will display its ForeCYTE Breast Health Test at the 61st Annual Clinical Meeting of the American Congress of Obstetrics and Gynecology in New Orleans from May 4 - 8, 2013.

BioDrain Medical, Inc. (OTCQB: BIOR)
(the "Company"), producer of the FDA approved STREAMWAY® System for automated, direct-to-drain surgical fluid disposal that reduces the risk of exposure to hazardous waste, announced today that the Company has installed its STREAMWAY® System at the Riva Road Surgical Center in Maryland.

Celgene Corporation (NASDAQ: CELG)
plans to present at four upcoming investor conferences in May. The conferences will be webcast live and the webcasts will be available in the Investor Relations section of the Company’s website at www.celgene.com.

Codexis, Inc. (NASDAQ: CDXS)
, a developer of engineered enzymes for pharmaceutical, biofuel and chemical production, today announced it will host a live conference call and audio webcast on Tuesday, May 7, 2013 at 4:30 p.m. Eastern Time to discuss its first quarter 2013 financial results for the period ended March 31, 2013.

Gilead Sciences, Inc. (Nasdaq: GILD)
today announced that the company has received Complete Response Letters from the U.S. Food and Drug Administration (FDA) for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced that it will showcase its Sensei® X Robotic Catheter System with the new Artisan Extend® Catheter at the Heart Rhythm Society's (HRS) 34th  Annual Scientific Sessions from May 8-11, 2013 in Denver, CO.

InSite Vision Incorporated (OTCBB: INSV) today announced that it has sponsored research being presented in five scientific posters at the 2013 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held from May 5-9, 2013, in Seattle, Washington.

Islet Sciences, Inc., (OTC.BB: ISLT) a biotechnology company engaged in the research, development and commercialization of patented technologies for people with diabetes, announced today the receipt of a Japanese Patent for allowed claims, Patent Application No. 2008-529208.

Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that Impax and GlaxoSmithKline (GSK) are terminating their collaboration for the development and commercialization of IPX066 outside the United States (U.S.) and Taiwan.

InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the first quarter ended March 31, 2013 on Tuesday, May 7, 2013.

Luminex Corporation (NASDAQ: LMNX) today announced financial results for the first quarter ended March 31, 2013.  

Medicure Inc. (TSX VENTURE:MPH) (PINKSHEETS:MCUJF), a specialty pharmaceutical company, today reported its results from operations for the quarter ended February 28, 2013.

Neuralstem, Inc. (NYSE MKT: CUR)
announced that final data on the intraspinal delivery method employed in its NSI-566 Phase I trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) was presented today at the American Association of Neurological Surgeons Annual Meeting.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of clinically-relevant fluorescence imaging solutions for use in surgical and outpatient wound care procedures, today announced financial results for its first quarter ended March 31, 2013.

While many biotech and pharmaceutical companies are designing one drug after another to address specific health problems, Nuvilex, Inc. (OTCQB: NVLX) is using its own living cell encapsulation as a "one size fits all" type solution.

Plandai Biotechnology, Inc. (OTCQB: PLPL)
, a producer of highly bioavailable plant extracts for industries including health, wellness, nutraceutical, and pharmaceutical, today announced an agreement for NutraGenesis, a diversified nutraceutical product marketing company, to sell and market Plandai's patented Phytofare™ extracts under a 3-year distribution agreement.

PLC Systems Inc. (OTCQB: PLCSF)
, a medical device company focused on innovative technologies for the cardiac and vascular markets, today announced the launch of a new corporate website including a suite of online digital corporate communication channels to maintain on-going direct communication with shareholders.

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced proposals for changes in the membership of the Supervisory Board that will be put forward for approval by shareholders at the next Annual General Meeting scheduled for June 26, 2013.

Levi & Korsinsky is investigating the Board of Directors of PROLOR Biotech, Inc. (NYSE MKT: PBTH) for possible breaches of fiduciary duty and other violations of state law in connection with the sale of the Company to OPKO Health, Inc. (NYSE: OPK).

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) announced results of operations for the first quarter of 2013, delivering innovation and growth in a challenging business environment.

SK3 Group, Inc. (OTC Pink: SKTO) announces today that it has signed a definitive agreement to acquire Berkeley Bio-Organic Research Laboratories, a firm devoted to developing the pure science of cannabis medicine.

Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH)
today announced that it has presented results from studies that demonstrate efficacy of two next-generation antibiotic candidates against community-acquired multi-drug resistant (MDR) infections.



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