FDA Approves Avanir and Forest Labs Treatments for PBA and Bacterial Infections

FDA Ends October With Drug Approvals

BOSTON (TheStreet) -- U.S. regulators ended October with two drug approvals, clearing an antibiotic from Forest Labs(FRX_) and a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals(AVNR).

Investors are still waiting on the fate of Biodel's (BIOD) fast-acting insulin Linjeta. The U.S. Food and Drug Administration was expected to issue an approval decision Friday, but the news could come Monday.

October was a busy but tough month for new drug approvals at the FDA. Regulators rejected seven new drugs, including a diabetes drug from Amylin Pharmaceuticals (AMLN) and weight-loss drugs from Arena Pharmaceuticals (ARNA) and Vivus (VVUS), respectively.

The FDA approved four drugs: the two mentioned above plus drugs from Questcor Pharmaceuticals(QCOR) and Alkermes (ALKS).

Bull or Bear? Vote in Our Poll

The Forest Labs (FRX) injectable antibiotic Teflaro approved Friday will be used to treat patients with pneumonia and bacterial skin infections, including methicillin-resistant Staphylococcus aureu, or MRSA.

Put Calls Anyone?

Image via Wikipedia Arena Pharmaceuticals is in a tough spot as the FDA rejects their weight loss drug lorcaserin, apparently one of the safer of the 3 up for approval.

Here is the link to investors. 

This decision was expected and predicted in my past articles on the Obesity Drug Market.  We all saw it coming.  I'm sorry if you didn't.  But expect loses for Orexigen, and Vivus with their upcoming FDA decisions.   I can only see gains made with shorting the stocks.  Those that had are sitting pretty right now.  It's a gamble but sometimes these gambles pay off.  I expect more loses to mount for these companies in the near future.  Arena Pharmaceuticals, Vivus Inc., and Orexigen Therapeutics.

What they chose to do next is anyones guess.  The technology could be sold off for further research.  And the company enters bankruptcy court.  Nonetheless just passing on the news.  I'm not always right but some are easier to pick than others.  Last weeks news of Amylin, Alkermes, and Eli Lilly and Company for their diabetes medicine was a heartbreaker for those who thought it would go the other way.  But there are always more to look at.  Keep looking forward and use it as a lesson.

Arena Pharmaceuticals Enters FDA Purgatory

Welcome to FDA purgatory, Arena Pharmaceuticals. It could be a long wait.

Why the FDA Won't Approve Lorcaserin and Qnexa (Yet)

Hot Air Images via WikipediaI don't see much hope for Arena Pharmaceuticals, Vivus, or Orexigen at gaining FDA approval at this time.  I see it as a bunch of hot air and will not be approved with this conservative FDA panel right now.  That's not to say a CRL is necessarily a bad thing but at what point does the funding run dry?  Shorting these stocks wouldn't be a bad idea.  Especially, Vivus and Orexigen.  At a lofty 5 and 6 points it won't take much time to take the plunge to 2.

Wikinvest--ARNA, VVUS, OREX

By Brian Orelli
More Articles

October 19, 2010
 
After months of speculation and a pair of Food and Drug Administration advisory panels, FDA decisions for Arena Pharmaceuticals' (Nasdaq: ARNA) lorcaserin and VIVUS' (Nasdaq: VVUS) Qnexa are finally upon us.

Arena's PDUFA date is Oct. 22, while VIVUS' date with destiny is six days later on the 28th. The Prescription Drug User Fee Act (PDUFA) sets the goal for the FDA to make a decision by then, but the FDA is free to make a decision at any point before or after that date. A decision on lorcaserin especially could be delayed since the FDA advisory panel met just last month.

What's the chance of lorcaserin and Qnexa gaining FDA approval? I'd put it somewhere between unlikely and nonexistent.

If you would like more Subscribe To BioPharma Investor for everyday stock news and up to date FDA decisions.  Biopharma Investor

Investor's Class Action Lawsuit For Arena Pharmaceuticals: ARNA

Image via Wikipedia

I received a Class Action Notice from William Pratt on Arena Pharmaceuticals.  Plaintiffs have until November 19, 2010 to move to court.  You must have been an investor from December 8, 2009 anytime until September 16, 2010.  I actually sold my shares before the decline so I didn't really lose that much money, but I realize that many people did lose a lot of money over this stock.  I advised people to sell when I didn't like what I saw. 

Numerous Law Firms are Filing Class Action Lawsuits against Arena Pharmaceuticals.  This cannot be good for the future of the company.  I personally did not lose a huge sum of money and warned people against the dangers of the FDA decisions being made or not being made by the FDA.  This actually came down because of an FDA panel lack of recommendation.

 

 

Arena Pharmaceuticals, Inc. Class Action Litigation.: Filed Case  

Spector Roseman Kodroff & Willis, P.C. Announces Class Action Lawsuits Against Arena Pharmaceuticals, Inc. -- ARNA

FDA rejects Arena's Lorcaserin, Stock Plunges

If you may have noticed, I haven't covered the weight loss drug companies since the panel rejected Vivus' Qnexa. Vivus (VVUS), Orexigen (OREX), and Arena (ARNA) are all horrible stock plays right now with the Ultra Conservative FDA board under the Obama administration right now. Sure the drugs might work., but the FDA isn't going to approve anything that might have any hint of a safety concern. Today is a good example of why that is true.

Savient Soars On Gout Treatment Approval While Arena Slumps On Weight Loss

Image via Wikipedia

Market Pulse
Sept. 15, 2010, 1:14 p.m. EDTSavient shares soar on FDA gout treatment approval

SAN FRANCISCO (MarketWatch) -- Shares of Savient Pharmaceuticals Inc. (SVNT 20.23, +0.25, +1.24%) jumped Wednesday after the biotech company said the Food and Drug Administration approved its gout treatment. Savient shares rose 29% to $19.09 in recent trading. The FDA approved Savient's Krystexxa for the treatment of hard-to-treat gout in adults. Gout is a type of arthritis where uric acid crystallizes in the joints causing inflammation and pain. Savient expects Krystexxa to be available on the U.S. market later in the year, and said the drug is protected by patents out to 2026

Biotech Stocks

Sept. 14, 2010, 1:11 p.m. EDT

Arena plunges on FDA news; drug indexes climb

Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

Image via CrunchBase Alexza Pharma Clears Hurdles Towards Approval for Agitation Drug

I have actually changed positions on this stock and do not think it will be approved based on a conservative FDA panel under the Obama Administration.  I might change that opinion but we will have to see on This Weeks FDA panel meeting.
About the author: Sheff Station Sheff is a trader and investor of big board, small cap, and biotech stocks.

Top BioPharma Pipeline Plays August 2010

Image via CrunchBase Stocks currently on my Watchlist for top BioPharma plays in the near future.

1. Valeant Pharmaceuticals (NYSE:VRX)

Biotechnology Research Report on Valeant's Potiga

On August 11, 2010, we expect the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee to review the marketing application of Valeant Pharmaceuticals International’s (VRX) Potiga (formerly known as Retigabine), designed for the treatment of partial-onset seizures in epilepsy patients who have become refractory (failing to show response to prior therapy) to anti-epilepsy drugs (AEDs).

Three Hot BioPharma Investment Plays: ARNA, JAZZ, and PRAN

 I have a few investment plays in the BioPharma field that I would like to share with everyone. These plays include Arena Pharmacueticals, Jazz Pharmaceuticals, and Prana Biotechnology. The first play is Arena Pharmaceuticals NASDAQ:ARNA. JP Morgan recently downgraded the stock Monday August 2 to Neutral, however Jim Cramer recommended the stock as a buy last Friday on his show MadMoney. Today's afterhours earnings estimate for Q2 was a better than expected loss and I see the stock rising heavily in the next month with the highly anticipated FDA panel review September 16th. ---I have since changed my outlook on all these stocks and actually recommend shorting them lately.

F.D.A. Panel Votes Against Obesity Drug

F.D.A. Panel Votes Against Obesity Drug
By ANDREW POLLACK
Published: July 15, 2010 From the NY Times

A federal advisory committee voted narrowly against endorsing a drug vying to become the first new prescription medicine for obesity in more than a decade, signaling heightened concerns for possible health risks associated with a new generation of diet pills.

The advisory committee to the Food and Drug Administration voted 10 to 6 that the safety concerns, like increased heart rate, possible birth defects and psychiatric problems, overrode the potential benefits of the drug, called Qnexa and developed by Vivus.

Vivus Inc.'s FDA Review Of Weight Loss Drug Qnexa could Hint At Future Approval For Arena And Orexigen

Tomorrow is a big day for Vivus, Inc. and stock VVUS. Vivus is preparing tomorrow for the FDA's Endocrinologic and Metabolic Drugs Advisory Committee review panel on the weight loss drug Qnexa. I wrote an article on this subject last year based on their Phase III clinical trial results titled Vivus's Qnexa Drug Approval Makes It a Nice Trade, and was impressed with the long-term growth potential in the $40B weight loss industry.

October Biotech Calendar: Key Dates and Events

Biotech Calendar: Key Dates and EventsA quick and dirty guide to important biotech events for October.
By Adam Feuerstein, TheStreet.com Senior Columnist

THESTREET.COM — 09/30/09
BOSTON (TheStreet) -- A calendar of important, potentially stock-moving biotech events for October:

Oct. 5-6
JMP Securities Healthcare Focus conference

Oct. 7-8
Cowen & Co. 12 th Annual Therapeutics Conference

Oct. 8
FDA approval decision date for Spectrum Pharmaceuticals' (Symbol: SPPI) colon cancer drug Fusilev.

Vivus' Qnexa Drug approved by FDA and Seeking a Partner to Sell Its Anti-Obesity Medication

Here are today's articles concerning Vivus Inc's FDA approval for Qnexa. I see this as a blockbuster drug candidate and good news for the nearly 40M Obese Americans. My only caution is later health problems as it uses some form of the fen-phen medication. This as a nice trade right now and in the future. Watch out Alli, Glaxo Consumer Health's obesity drug, here Vivus comes! Glaxo's alli just received health concerns recently over liver failure. In addition to Qnexa, Vivus also has various ongoing Phase III clinical trials for ED medication Avanafil due Oct 2009, with a long term safety study due Oct 2010.

This just in to the Wall Street Journal: Vivus CEO Ready To Roll Up Sleeves In Finding Qnexa Partner
As Vivus Inc. (VVUS) moves forward with developing its experimental weight-loss treatment Qnexa, Wall Street will be focused on the next step for the small drug developer: Finding a partner to sell the drug.

PR Newswire: VIVUS Announces Positive Results From Two Phase 3 Studies; Obese Patients on Qnexa Achieve Average Weight Loss up to 14.7% and Significant Improvements in Co-Morbidities

Results of EQUIP and CONQUER Phase 3 Studies Exceed FDA Benchmarks for Obesity Treatments, Demonstrate Positive Safety Profile

MOUNTAIN VIEW, Calif., Sept. 9 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of Qnexa(TM), an investigational drug, in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including blood pressure, lipid levels, and type 2 diabetes.


Vivus Soars After Drug Hits U.S. Weight-Loss Targets
Sept. 9 (Bloomberg) -- Vivus Inc. rose 71 percent, the most in about a decade, after the biotechnology company said its weight-loss drug met U.S. guidelines in two large human trials.

Vivus climbed $4.89 to $11.80 at 4 p.m. New York time in Nasdaq Stock Market composite trading, its biggest gain since Dec. 22, 1999, when the Mountain View, California-based company asked U.S. regulators to clear an erectile dysfunction drug.

Vivus is competing with Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc., both of San Diego, to introduce a new diet drug in the U.S., a market that might be worth $10 billion annually for a safe therapy that helps patients lose 10 percent of their weight in a year, said Needham & Co. analyst Mark Monane. Global obesity levels, linked to rising rates of diabetes and heart disease, will swell 75 percent to 700 million people by 2015, according to the World Health Organization.

“We would market this drug to people with significant obesity and co-morbidities,” such as diabetes, high cholesterol and high blood pressure, said Leland Wilson, Vivus’s president and chief executive, in a telephone interview today. “This is serious medicine for those with serious disease.”

The Vivus drug, Qnexa, could generate sales of $3 billion by 2016, said Michael King, a New York-based analyst for Merriman Curhan Ford & Co., in an Aug. 20 telephone interview.

“Obesity is one of the last true, broad-based consumer markets where you can get significant revenue,” King said.

Study Results

Two 56-week studies counted patients on Qnexa who lost at least 5 percent of their weight, compared with how many on a placebo pill did the same. In one study, 67 percent of people taking the drug achieved that goal, compared with 17 percent on placebo. In the other trial, it was 70 percent, compared with 21 percent.

The Vivus studies reported today are the final stage of clinical trials generally required to seek U.S. regulatory clearance. The company said it will seek permission to sell Qnexa by the end of the year.

Patients who finished both studies followed a low-calorie diet and lost an average of 6 pounds after a year with a placebo. In one of the two studies, called Equip, people on the highest dose of Qnexa lost an average of 18 pounds when they completed the trial. In the second study, called Conquer, average weight loss on the higher dose of Qnexa was 30 pounds.

Heart and Metabolism

The study also showed “significant improvements” in cardiovascular and metabolic risk factors, including blood pressure, cholesterol levels and type 2 diabetes, Vivus said in a statement.

“To get payers in the health care system to want to pay for these drugs you need to have real benefit in altering these co-morbidities,” Wilson said in the interview. “It puts obesity into a serious disease category that insurers, employers and government want to treat in order to save money, lives and improve quality of life.”

The trials “demonstrated remarkable safety,” Wilson said.

Qnexa combines a generic form of the appetite suppressant phentermine, a commonly prescribed obesity drug that was an ingredient in the recalled diet pill known as fen-phen, with the anticonvulsant drug topiramate, the generic form of Johnson & Johnson’s Co.’s Topamax, which is used to treat epilepsy and migraine headaches.

Greater Effect

While each of the ingredients in Qnexa has some weight-loss impact, the combination of the two “has a greater effect than either of the individual components,” King said.

The positive study data will allow Vivus to accelerate discussions with “major pharmaceutical partners,”, Wilson said in the interview. That partner needs to be in place about six months before the product launch, expected in early 2011, he said.

Arena Pharmaceuticals may be the first of the three companies to ask U.S. regulators to approve its obesity treatment, lorcaserin, when it files “late this year,” Chief Executive Officer Jack Lief told analysts during an Aug. 3 conference call. The company expects to release in September the results of the second of two pivotal, late-stage studies of lorcaserin that will be used to seek approval of the drug.

Lorcaserin is similar to, but chemically different from, fenfluramine, an ingredient in Wyeth’s combination diet-drug known as fen-phen, which was taken off the market in 1997 after being linked to heart and lung problems. Studies so far have demonstrated the Arena drug is well-tolerated by patients and shows no evidence of the heart-valve damage seen in fen-phen users, the company said.

Arena Data

Experimental data released by Arena in June showed lorcaserin met one of two benchmarks required by the U.S. Food and Drug Administration to show a drug’s effectiveness. The treatment helped 48 percent of patients -- or more than twice the comparable placebo result -- lose more than 5 percent of their total body weight, the study found.

The average weight loss after one year for lorcaserin was 3.6 percent more than that of patients on a placebo. The results failed to meet a second FDA standard that an obesity drug has at least a 5 percentage point difference in weight loss between the drug and a placebo.

About 32 percent of Americans adults are obese, according to data from the Centers for Disease Control and Prevention in Atlanta. Medical spending for obesity was $147 billion in 2008, an 87 percent increase over the past decade, according to a government study published July 27 in the journal Health Affairs.

Sanofi Drug

Paris-based drugmaker Sanofi-Aventis SA withdrew its weight loss drug Acomplia from the market in Europe last year after it was rejected by the U.S. Food and Drug Administration over reports of increased psychiatric disorders. New York-based Pfizer Inc. and Merck & Co. of Whitehouse Station, New Jersey halted development of similar drugs.

Amylin Pharmaceuticals Inc., of San Diego, is working on a drug that combines pramlintide, the active ingredient in its diabetes drug Symlin, with leptin, a hormone tied to hunger.


Merriman Curhan Sees Another 20% Upside In Vivus (VVUS)
September 9, 2009 2:51 PM EDT
Merriman Curhan issued some bullish comments on Vivus (Nasdaq: VVUS) which is up 70% todya following positive Phase III results of Qnexa in Obesity, saying the stock could push toward a $1 billion market cap.

Merriman analyst Michael G. King commented in a report this afternoon saying "Vivus, with the issuance of top-line data from its Phase III trials, Equip and Conquer, has shifted the landscape for the treatment of obesity to a new level. These results open the door to a new frontier in which safe and effective pharmacotherapy for obesity now becomes the new normal. On the basis of the anticipated continued positive news flow, we would expect the shares to push their way toward a $1B market cap.

Even with today's 70% surge the market capitlization of Vivus is about $825 milion, which leaves more room to continue to Buy the shares Merriman said.

A $1 billion market cap would push shares of VVUS to about $14.30 each, based on the current 70 million share outstanding at this point. That would suggest another 19% upside!