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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Diet Pill Maker Arena Pharmaceuticals (Nasdaq: ARNA) Wins Backing of FDA Advisers

Orlando, FL 5/11/12 (StreetBeat) -- In a stunning turn of events in less than two years, diet pill maker Arena Pharmaceuticals (Nasdaq: ARNA) won the backing of a panel of government advisers to sell what may be the first new weight-loss treatment in the US in more than a decade. The company’s shares rose 80% in early trading Friday after advisers voted 18-4 in favor of approving Arena’s drug, lorcaserin.

Arena is the second company to win such an endorsement for a diet drug this year after Vivus (Nasdaq: VVUS) was recommended by Food and Drug Administration advisers in February. The FDA delayed a decision on Vivus’ Qnexa, moving a potential approval date later than one set for Arena. If the FDA doesn’t adjust its dates, it will decide on Arena’s drug, lorcaserin, by June 27, and on Vivus’ Qnexa by July 17.

After a pair of overwhelmingly positive panel recommendations from advisers, it’s beginning to look like there may be two near-term approvals for diet drugs. That seemed unthinkable a little more than a year ago after Orexigen Therapeutics (Nasdaq: OREX) followed Arena and Vivus in being rejected by the US agency because of safety concerns.

Shares of Arena rose to $6.59 in morning trading. Vivus was up 4% to $23.57 and Orexigen, which is the farthest away from any potential approval, jumped 7% to $3.57.

Safety has been the killer for these new diet pills. The FDA is very cautious about approving another product that could pose health risks to people taking them. Abbott Laboratories (NYSE: ABT) withdrew its drug Meridia from the market in 2010 after fears of heart attack and stroke. The drug cocktail fen phen was withdrawn from the market in 1997 after evidence of heart valve damage. Those drugs were sold by American Home Products, which was later renamed Wyeth and is now part of Pfizer (NYSE: PFE).

In April, Vivus said the FDA was extending its deadline for an approval ruling on Qnexa because the agency needed more time to review a company plan on mitigating risks for patients. Arena, which is partnered with Japanese drug maker Eisai to sell lorcaserin, has responded to FDA worries about safety, including heart valve problems. However, Arena hasn’t yet discussed a risk plan -- a so-called a risk evaluation and mitigation strategy -- or a post-approval safety study with the FDA, company executives said on a conference call Friday. Eisai would pay 90% of any post-approval safety analysis. No decision has been made yet on a price for the pill.

Arena, Vivus and Orexigen argue that obesity is an epidemic in the US, leading to health problems such as heart disease, diabetes and other conditions.

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LargeCap Stocks to Watch Today

Tomahawk, WI 4/10/2012 (StreetBeat) -- Alcoa (AA) is expected to report first-quarter results after the markets close on Tuesday and analysts expect the aluminum maker to post a loss of 4 cents a share on revenue of $5.77 billion.

Alcoa is struggling with lower pricing and the impact of Europe's sovereign debt woes on demand, leading to cutbacks in production.

Sony (SNE), the Japanese electronics giant, said Tuesday it projects an annual loss of 520 billion yen ($6.4 billion), much wider that earlier predictions of a loss of 220 billion yen.

Sony is recording a charge of 300 billion yen from write-offs of deferred tax credits in the United States.

Sony forecast a return to profit in the year through March 2013.

On Monday, media reports said Sony, hurt by weakness at its LCD television unit. was preparing to cut 10,000 jobs, or 6% of its work force, by the end of the year.

Yahoo! (YHOO) CEO Scott Thompson holds an all-staff meeting Tuesday at 1 p.m. EDT to brief employees on the company's new management structure.

The Internet company said last week it would be slashing 2,000 jobs.

Vivus (VVUS) said the review date of its new drug application for Qnexa has been extended by three months.

The company said it has been informed that the Food and Drug Administration has moved the Prescription Drug User Fee Act date for its review of Qnexa's NDA to July 17 from April 17.

The stock fell more than 8%% in after-hours trading on Monday.

Fidelity, Federated Lead Charge Against Money Fund Reform

Supervalu (SVU), the grocery retailer, is expected by analysts Tuesday to post a profit of 35 cents a share in its fiscal fourth quarter.

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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.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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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).

Investorideas.com sector snapshot podcast for biotech stocks, for trading as of Thursday February 23rd:
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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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Vivus (Nasdaq: VVUS) Data Shows Weight Loss Drug Ingredient Associated with Oral Clefts

Orlando, FL 12/12/11 (StreetBeat) -- Vivus (Nasdaq: VVUS) said late yesterday there was an increased association between babies born with an oral cleft in mothers who took the drug in the company’s weight loss treatment while pregnant.

Mothers who had taken the antiepileptic drug topiramate in the first trimester of pregnancy showed prevalence rate of 0.29% of babies born with oral clefts, according to Vivus’ retrospective study of medical claims data, while mothers who took the drug prior to pregnancy but not during pregnancy has a 0.16% prevalence.

Women with similar medical profiles but no topiramate exposure had a prevalence of 0.07% babies born with oral clefts.

Vivus’ Qnexa weight loss drug is a combination of phentermine and topiramate, and has shown statistically significant weight loss, glycemic control and improvement in cardiovascular risk factors in studies thus far.

Vivus resubmitted its new drug application for Qnexa in October with a contraindication for women of childbearing age, and is studying the impact of the drug in pregnant women and babies.

The company has been in a race to develop an FDA-approved obesity drug, with rivals Arena Pharmaceuticals (ARNA) and Orexigen (OREX).

Vivus shares are taking a hit today on the news that the ingredient in Qnexa is associated with oral cleft defects.

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