Vivus Inc (NasdaqL VVUS) Gets FDA Approval on Weight Loss Drug

Atlanta, GA 7/18/12 (StreetBeat) – Vivus Inc (Nasdaq: VVUS) is trading up 13.6% or $3.60 at $30.06 following FDA approval of its one a day weight loss drug, Qsymia.

Vivus is a biopharmaceutical company focusing its studies in obesity, sleep apnea, diabetes, and sexual health. The Qsymia drug, with an expected fourth quarter 2012 release, is the first drug of its kind to be approved by the FDA.

"Qsymia is the first FDA-approved once daily combination treatment for patients struggling with obesity," said Peter Tam, president of Vivus in a prepared statement. "The degree and severity of obesity and the lack of effective pharmacological interventions that we face as a society were two primary reasons for the development of Qsymia. We are pleased with FDA's decision today because patients and physicians now have another treatment option available to them."

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Vivus (Nasdaq: VVUS), Arena (Nasdaq: ARNA) Unlikely to Be Affected by FDA Obesity Panel

Chicago, IL 3/30/12 (StreetBeat) – Arena Pharmaceuticals Inc. (Nasdaq: ARNA) and Vivus Inc. (Nasdaq: VVUS), competing to win U.S. regulatory approval for weight-loss treatments, probably won’t be affected by an advisory panel’s recommendation for heart-risk studies, a Food and Drug Administration spokeswoman said.

The panel voted 17-6 yesterday in Silver Spring, Maryland, to recommend that companies developing weight-loss therapies should conduct clinical trials to assess heart danger or review pre-approval human trial data on heart attacks and strokes. The panel’s goal was to help the agency update guidelines for bringing obesity treatments to market, Erica Jefferson, a spokeswoman for the FDA, said in an e-mail today.

“It’s unlikely that the discussions over the past couple days will impact any existing applications,” Jefferson said.

Vivus, Arena and a third California-based company, Orexigen Therapeutics Inc. (Nasdaq: OREX), are racing to bring the first weight-loss pill to market in 13 years. The fen-phen appetite-suppression drug combination was pulled from pharmacies 15 years ago when it was linked to heart-valve abnormalities.

Vivus rose 7.5 percent to $22.88 at 9:43 a.m. New York time. Arena increased 1.6 percent to $3.09 and Orexigen fell 3.5 percent to $4.38.

The FDA is set to make a decision on Mountain View, California-based Vivus’s drug Qnexa by April 17. San Diego-based Arena’s treatment lorcaserin faces an advisory panel May 10, with the agency expected to make a decision by June 27.

Orexigen agreed in September with the FDA to conduct a two- year study of heart risks for the drug Contrave. The La Jolla, California-based company is a partner with Takeda Pharmaceutical Co. (4502), based in Osaka, Japan.

Two-Tiered Studies

Panel members agreed studies should be two tiered: pre- and post-approval. Companies should rule out a certain degree of risk during pre-approval and further prove the drugs don’t cause excessive heart harm after the medicines are on the market, advisers said during discussion. The FDA isn’t required to follow the panel’s guidance.

The panel voted Feb. 22 that Qnexa’s benefits outweigh its risks. Sanjay Kaul, a professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member, said the treatment works the best to help patients lose weight, giving it a good chance of the FDA requiring post-approval studies on heart risk instead of additional ones before.

The last obesity drug the FDA approved was Roche Holding AG (Pinksheets: RHHBY)’s Xenical in 1999.Abbott Laboratories (NYSE: ABT) withdrew its obesity treatment Meridia in 2010 after a post-market trial revealed a 16 percent increase in risk of heart attack or stroke in those taking the product over those using a placebo and little difference in weight loss.

Arena is studying its compound lorcaserin to assess cancer risks. The company is in a partnership with Tokyo’s Eisai Co. (4523)

The FDA previously has rejected all three drugs, asking for more data on safety risks, including the likelihood of birth defects associated with Qnexa.

More than 78 million U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta. Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the CDC.

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Biotech Stocks Sector Snapshot and Podcast: VVUS, INFI, SNTS on the Move

Tallahassee, FL 2/24/12 (StreetBeat)- Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for notable sector gainers VIVUS, Inc. (NASDAQ: VVUS), Infinity Pharmaceuticals (Nasdaq:INFI) and Santarus, Inc. (NASDAQ:SNTS).

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VIVUS, Inc. (NASDAQ: VVUS) closed up with massive gains at $18.73, up $8.18(77.54%) with after hours trading moving it to $!8.95, up another 0.22 (1.17%).The day’s high on the stock was $21.44 on over 58 Million shares. The stock’s monster move was on news that the FDA Advisory Committee had recommended the approval of Qnexa for the treatment of obesity in adults

Infinity Pharmaceuticals (NASDAQ:INFI) closed up at $7.15, up 0.84 or (13.31%). The Company announced on Tuesday that they will be presenting at the Cowen and Company 32nd Annual Health Care Conference on Monday, March 5th

Santarus, Inc. (NASDAQ:SNTS) finished the day at $5.01 up 0.51(11.33%). The Company announced Wednesday that they have entered into a settlement agreement with Lupin to resolve pending patent litigation involving GLUMETZA

About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. www.vivus.com.

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Vivus' (Nasdaq: VVUS) shares soar on favorable view for obesity pill

Northern, WI 2/23/12 (StreetBeat) -- Shares of Vivus Inc (Nasdaq: VVUS) nearly doubled on Thursday as investors bet that its experimental weight-loss drug, Qnexa, would be approved by U.S. regulators.

On Wednesday, a U.S. Food and Drug Administration panel voted 20-to-2 in favor of approval, potentially bringing the first weight-loss pill to market in 13 years and raising hopes that two competing drugs would also be approved.

"In our view, the resounding vote of confidence from yesterday's FDA Advisory Committee meeting provides us with high confidence that Qnexa will be approved by the April 17th (review) date," JMP Securities' Jason Butler said in a research note, while raising his price target nearly three-fold to $45.

Vivus' Qnexa competes with Arena Pharmaceuticals Inc's lorcaserin and Orexigen Therapeutics Inc's Contrave.

But risks remain. The panel said Vivus should conduct a study on possible heart problems and supported the company's plan to limit its use to women who are not pregnant. One component of the drug, the anti-seizure drug topiramate, has been shown to raise the rate of birth defects.

"Qnexa's near-term approvability can still be derailed by a negative CV (cardiovascular) panel in late March or by just an independent FDA conclusion," Jonathan Aschoff, an analyst at Brean Murray Carret & Co, said in a research note.

While the FDA usually follows its advisory panel's recommendations it is not required to.

"Until then, Vivus is clearly safe and our conviction in an ultimately negative outcome was significantly reduced after yesterday," he said.

Shares of the Mountain View, California-based company were up nearly 100 percent at $21.08 in early trading on Nasdaq.

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