FDA To Take Another 3 Month Review and Requested an REMS for Vivus's Qnexa Diet Pill Print E-mail
By Staff and Wire Reports   
Monday, 09 April 2012 19:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 9, 2012.

Drugmaker Vivus Inc. (NASDAQ: VVUS) said regulators will take a three month PDUFA extension to make a decision on its closely-watched obesity drug Qnexa, which could become the first new prescription weight loss pill to reach the market in more than a decade.

The FDA informed Vivus that it will decide whether to approve Qnexa by July 17 as it needs more time to review the company's risk evaluation plan for the drug. The previous FDA action date for Qnexa had been April 17.

Vivus's Qnexa is one of three experimental new weight loss drugs seeking FDA approval after initial rejections by the agency. Arena Pharmaceuticals Inc (NASDAQ:ARNA) and Orexigen Therapeutics (NASDAQ:OREX) are also hoping for better news from the FDA after rejections of their diet pills.

After an advisory panel to the FDA in February voted overwhelmingly to recommend approval of Qnexa, saying that its benefits outweighed the risks, hopes that the first new obesity treatment would be approved for sale in the United States in more than a decade soared -- along with Vivus's share price.

But the FDA requested a Risk Evaluation and Mitigation Strategy (REMS) plan from the company, which the agency considers a major amendment to the approval application requiring further review time.

"The Qnexa REMS submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," Vivus Chief Executive Leland Wilson said in a statement.

"We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans," Wilson added.

Qnexa, which combines the appetite suppressant phentermine and the anti-seizure drug topiramate, helped patients on average lose at least 10 percent of their weight after a year of treatment in pivotal clinical trials.

With about a third of Americans deemed obese and some two thirds classified as overweight, the FDA has been under mounting pressure to approve a new weight loss treatment. But high profile safety problems with past diet drugs and the knowledge that a huge portion of the population will be tempted to take any new diet pills has left the FDA reluctant to approve them.

The FDA could still require Vivus to conduct additional studies to rule out heart problems as it has done with Orexigen's Contrave, or could allow Vivus to conduct such studies after the drug is already on the market.

Vivus shares fell 6.4 percent after the delay was announced, slipping to $21.45 in extended trading from their Nasdaq close at $22.92.


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The U.S. FDA approved Eli Lilly's (NYSE:LLY) radioactive dye, called Amyvid, to help doctors rule out whether patients have Alzheimer's, the most common form of dementia.

The dye binds to clumps of a toxic protein called beta amyloid that accumulates in the brains of patients with Alzheimer's. Doctors can then see the plaque light up on a positron emission tomography, or PET, scan.

Patients with Alzheimer's always have some brain plaque, so its absence in the test would tell doctors to look for other causes of mental decline, such as depression or medications, Lilly has said.

But Lilly, which plans to sell the drug through its unit Avid Radiopharmaceuticals Inc, said the test should not be used to diagnose Alzheimer's, since brain plaque can also be tied to other neurologic conditions and may occur naturally in older people with normal mental states.

An FDA advisory panel recommended against approving the dye last year, saying doctors might have trouble interpreting scans of the plaque, and the FDA rejected Amyvid last March.

There is currently no cure for Alzheimer's, a mind-robbing disease that affects more than 35 million people worldwide and gets worse with age.

But an early hint that something is wrong might improve the success of drugs meant to prevent or delay disease progression, researchers believe.

Avid has been in the lead in the race for imaging agents for Alzheimer's, which are estimated to have a potential global market anywhere from $1 billion to $5 billion.

Lilly, as well as Pfizer Inc, are the farthest along in developing experimental medicines to treat Alzheimer's. Lilly expects to release final data for its contender, solanezumab, as soon as this summer.


Also Monday:


Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC)
, a leader in the field of regenerative medicine, announced that Michael T. Heffernan, R.Ph. has been appointed to the company’s board of directors, effective today.

Affymax, Inc. (Nasdaq: AFFY)
today announced that it has received a $50 million development milestone payment from Takeda Pharmaceutical Company as part of the companies' exclusive global agreement to develop and commercialize OMONTYS® (peginesatide) Injection.

BSD Medical Corporation (NASDAQ:BSDM)
(Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has sold an additional MicroThermX® Microwave Ablation System (MicroThermX®) to Synapse Medical Ltd. Synapse Medical is a premier specialty distributor of medical devices in Ireland and Northern Ireland, and is an exclusive distributor for a number of leading medical device companies, including BSD. Synapse is a subsidiary of SISK Healthcare, which is part of the SISK Group.

Biogen Idec Inc. (NASDAQ:BIIB)
today announced it will report first quarter 2012 financial results on Tuesday, May 1, 2012, before the financial markets open.

Dendreon Corporation (Nasdaq:DNDN)
today announced that management will host a conference call on Monday, May 7, 2012, at 4:30 p.m. EDT to review first quarter financial results.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that a U.S. Food and Drug Administration (FDA) Advisory Panel has proposed a review of the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on June 13, 2012.

HemaCare Corporation (OTCBB:HEMA)
announced today that it filed a Form 15 with the Securities and Exchange Commission (the “SEC”) to voluntarily deregister its shares of common stock under the Securities Exchange Act of 1934, as amended (the “Act”).

Illumina, Inc. (NASDAQ:ILMN)
, a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function, today is sending a letter from its Board of Directors highlighting supportive reports issued by two of the nation’s leading proxy advisor firms. Illumina’s Board recommends that stockholders reject Roche’s offer and vote for the election of Illumina’s highly qualified nominees at its 2012 Annual Meeting of Stockholders by completing the WHITE proxy card today.

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ)
, a developer of real-time medical imaging systems for use in the operating room, today announced the closing of its previously announced public offering of 6,100,000 common shares at a public offering price US$5.75 per share.

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX)
today announced the commercial launch of EXPAREL® (bupivacaine liposome injectable suspension) in the United States.

PharMerica Corporation (NYSE: PMC)
announced today that it will provide an online simulcast of its first quarter 2012 earnings conference call on Thursday, May 3, 2012.

PharMerica Corporation (NYSE: PMC)
, a national provider of institutional pharmacy and hospital pharmacy management services, today announced that the Company’s annual meeting of shareholders will be held on Tuesday, June 12, 2012, in Louisville, Kentucky.

Proteonomix, Inc. (OTCBB: PROT)
, a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, today provided updates on its progress.

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX)
(“the Company” or “RegeneRx”) announced today that the Company has received an issued patent in Mexico and allowances of three additional patent applications in Mexico and Israel.

Rodman & Renshaw, LLC, a wholly owned subsidiary of Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM) announced that it has acted as a Co-Manager for its client Galena Biopharma (NASDAQ: GALE), a biotechnology company focused on developing innovative, targeted oncology treatments addressing major unmet medical needs to advance cancer care, in its underwritten public offering of 8,500,000 shares of its common stock at a public offering price of $1.50 per share.

Simulations Plus, Inc. (Nasdaq: SLP)
, a leading provider of software and consulting services for pharmaceutical R&D and environmental toxicology, announced that it expects to file its quarterly report on Form 10-Q for the second quarter of its 2012 fiscal year, ended February 29, 2012, with the U.S. Securities and Exchange Commission today, Monday, April 9, 2012.

Sunshine Biopharma Inc. (OTCBB: SBFM)
is pleased to announce that it has recently received notification that the United States Patent and Trademark Office has issued a “Notice of Allowance” for the patent application covering its lead anti-tumor compound, Adva-27a.

TherapeuticsMD™, Inc. (OTCQB: TXMD)
, parent company of vitaMedMD®, LLC ("vitaMedMD"), a specialty pharmaceutical company ("TherapeuticsMD" or the "Company"), announced that on April 9, 2012 it launched its second prescription prenatal vitamin, vitaMedMD™ One Rx, following the successful launch of vitaMedMD™ Plus Rx last month.

Verastem, Inc. (NASDAQ: VSTM)
, a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced that the Company will be presenting at the 2012 BD Biotech Conference on Tuesday, April 17 and Wednesday April 18, 2012, at the Mandarin Oriental in Boston, MA.



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