Ambrx and Bristol-Myers Squibb Collaborate on Discovery; Bristol-Myers Squibb Receives US FDA sNDA Approval for SUSTIVA Print E-mail
By Staff and Wire Reports   
Friday, 03 May 2013 19:06
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 3, 2013.

Ambrx entered into a collaboration agreement with Bristol-Myers Squibb (NYSE: BMY) for the discovery and development of novel antibody drug conjugates using Ambrx's protein medicinal chemistry technology.

Under terms of the agreement, Ambrx will receive an upfront payment of $15 million, funding for discovery and research activities, and potential development, regulatory and sales based milestone payments of up to $97 million per product resulting from the collaboration. Bristol-Myers Squibb will receive worldwide rights to develop and commercialize products resulting from the collaboration, and Ambrx is eligible to receive royalties on net sales. Additional terms were not disclosed.

"Bristol-Myers Squibb is a global biopharmaceutical leader with expertise developing and commercializing novel medicines for the treatment of cancer and other diseases, and we are pleased to enter into a third collaboration with the company to include another aspect of our technology platform," said Lawson Macartney, Ph.D., chief executive officer of Ambrx. "We look forward to working together to further utilize Ambrx's technology to discover and advance these antibody drug conjugates for oncology indications."

Ambrx and Bristol-Myers Squibb entered into two separate agreements in September 2011 to research, develop and commercialize biologics created with Ambrx's protein medicinal chemistry technology. These therapeutic candidates, which target the Fibroblast Growth Factor 21 (FGF-21) protein for the potential treatment of type 2 diabetes, and the Relaxin hormone for the potential treatment of heart failure, are being developed by Bristol-Myers Squibb.


Bristol-Myers Squibb Company (NYSE: BMY)
announced the U.S. FDA has approved a supplemental new drug application (sNDA) for SUSTIVA® (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg. This approval offers a once-daily option as part of a regimen for this population and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets. Detailed information about the “capsule sprinkle” method is provided in the ‘Instructions for Use' at the end of the Patient Information section of the Package Insert.

SUSTIVA is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the U.S. in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kg. SUSTIVA is not to be taken by patients who are allergic to efavirenz, or to any of its ingredients.

“Bristol-Myers Squibb recognizes the importance of offering alternative methods of administration of HIV medicines, including for pediatric patients who cannot swallow tablets or capsules, and their caregivers who help manage their treatment,” said Brian Daniels, M.D., Senior Vice President, Global Development and Medical Affairs. “This approval is one example of our enduring commitment to the HIV patient community.”

This sNDA was based on results from three open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of SUSTIVA in combination with other antiretroviral agents in 182 antiretroviral-naïve and –experienced HIV-1 infected pediatric patients (three months to 21 years of age) for a median of 123 weeks. Virologic and immunologic response was observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell count.

The adverse reactions observed in the three pediatric trials were similar to those observed in clinical trials in adults, except that rash was more common in pediatric patients (32 percent for all grades regardless of causality) and more often of higher grade (i.e., more severe). Five pediatric patients (2.7 percent) discontinued from the study because of rash. Use of SUSTIVA (efavirenz) in patients younger than three months of age OR less than 3.5 kg body weight is not recommended because the safety, pharmacokinetics and antiretroviral activity of SUSTIVA have not been evaluated in this age group and there is a risk of developing HIV resistance if SUSTIVA is underdosed.

Bristol-Myers Squibb remains at the forefront of HIV/AIDS research and continues to pursue the development of treatment options for children and adults with HIV. Studies are ongoing for new treatments, including an NRTI (BMS-986001), an attachment inhibitor (BMS-663068) and a maturation inhibitor. Bristol-Myers Squibb is also developing a fixed-dose combination of atazanavir sulfate and Gilead's investigational drug cobicistat.

Also Friday:

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX)
, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today announced that it will release first quarter 2013 financial results after market close on Wednesday, May 8, 2013.  

Alimera Sciences, Inc. (NASDAQ: ALIM)
("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it will release its first quarter fiscal year 2013 financial results after the market close on Thursday, May 9, 2013.

Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH)
, a biopharmaceutical company focused on developing and commercializing products to treat autoimmune diseases, will release its first quarter 2013 financial report after market close on Monday, May 13th.

Boston Scientific Corporation (NYSE: BSX)
is scheduled to participate at Heart Rhythm 2013, the Heart Rhythm Society's 34th Annual Scientific Sessions May 8-11 in Denver.  

CEL-SCI Corporation (NYSE MKT: CVM)
announced today that it will deliver a presentation at the American Association of Immunologists 100th Annual Meeting at the Hawaii Convention Center in Honolulu, Hawaii. The Company will have a poster presentation at the event for attendee’s review and will deliver an oral presentation at the symposium “Therapeutic Approaches to Autoimmunity” on Saturday, May 4th, 2013, from 1:00 pm to 3:00 pm local time.

Corgenix Medical Corporation (OTC BB: CONX), a worldwide developer and marketer of diagnostic test kits, will host a conference call on Tuesday, May 14, 2013, at 4:00 p.m. EDT to discuss the Company’s financial and operating performance for its quarter ended March 31, 2013, and the status of the Company’s product development and marketing activities.

eHealth, Inc. (NASDAQ: EHTH)
, America's first and largest private health insurance exchange, will be participating in a panel on private-sector exchanges at the Health Insurance Exchange Summit today in Arlington, VA.

Emergent BioSolutions Inc. (NYSE: EBS)
today announced that it presented preclinical data on its lead bispecific ADAPTIRTM (Modular Protein Technology) molecule, ES414, at the 9th Annual Protein and Antibody Engineering Summit (PEGS), currently underway in Boston, MA. ES414 is being developed as a potential therapeutic for metastatic castration-resistant prostate cancer (mCRPC).

GTx, Inc. (Nasdaq: GTXI)
today provided a Company update and reported financial results for the first quarter of 2013.

today announced that its restatement of financial statements for the second quarter and third quarter of 2012 (the "Affected Statements") and filing of related amended periodic reports for the same fiscal quarters will be delayed due to unforeseen administrative delays.

iCAD, Inc. (Nasdaq: ICAD)
, a leading provider of advanced imaging and radiation therapy technologies for the detection and treatment of cancer, today announced that the Company’s Xoft® Axxent® Electronic Brachytherapy System® for Intraoperative Radiation Therapy (IORT) will be a featured subject of several scientific and training sessions at the American Society of Breast Surgeons’ 14th Annual Meeting taking place this week at the Sheraton Chicago Hotel & Towers.

ImmunoGen, Inc. (Nasdaq: IMGN)
, a biotechnology company that develops anticancer therapeutics using its Targeted Antibody Payload (TAP) antibody-drug conjugate (ADC) technology, today announced that Gregory Perry, Executive Vice President and Chief Financial Officer, will present at the upcoming Credit Suisse Antibody Day in New York.

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
, a biopharmaceutical company focused on discovering breakthrough treatments for human disease, will release its first quarter 2013 financial results on Friday, May 10, 2013 before the financial markets open.

Maxygen, Inc. (Nasdaq: MAXY)
, a biopharmaceutical company, today announced financial and business results for the quarter ended March 31, 2013.

Milestone Scientific Inc.(OTCQB: MLSS)
, the recognized leader in advanced, computer-controlled injection technologies, today announced that it will host a conference call at 8:30 A.M. Eastern Time, on Tuesday, May 7, 2013 to discuss the company's financial results for the first quarter ending March 31, 2013, as well as the Company's corporate progress and other meaningful developments.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that the Company will report its financial results for the first quarter of 2013, on Wednesday, May 8, 2013 before the market opens.

Northwest Biotherapeutics (NASDAQ: NWBO)
(NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today the availability on the web of several interviews of their CEO Linda Powers on the floor of the New York Stock Exchange on May 1, 2013 by FOX Business News (FOX), the Huffington Post, and the International Business Times, amongst others.

Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX)
, a specialty pharmaceutical company, today announced that it will release its first quarter 2013 financial results before the U.S. stock market opens on Friday, May 10, 2013 and has scheduled a conference call at 9:00 a.m. EST that day to discuss the financial results.

Positron Corporation (OTCBB: POSC), a nuclear medicine healthcare company specializing in the field of cardiac Positron Emission Tomography (PET) imaging and high tech pharmacy automation, today announced a co-marketing agreement with Biologics Modular.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced financial and operating results for the first quarter of 2013 and provided an update on development programs.

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 deficiency, secondary hyperparathyroidism and hemodialysis, announced today that it will hold its quarterly conference call to discuss first quarter results on Wednesday, May 8, 2013 at 4:30pm Eastern Time.

Soligenix, Inc. (OTCQB: SNGX)
(Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today its financial results for the quarter ended March 31, 2013.

Walgreens (NYSE: WAG) (Nasdaq: WAG)
had April sales of $5.98 billion, an increase of 3.8 percent from $5.76 billion for the same month in fiscal 2012.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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