Re: FDA set to approve first weight loss drug

[Guest guest]

Interesting, I know doctors who have prescribed topamax (off the label use) to

assist patients with weight loss.  

Margie Hirsch,MFCS,RD,LD

Subject: FDA set to approve first weight loss drug

To: " theissn " <theissn >,

" ACSMNutrition " <ACSMNutrition >,

" nutritionnews " <nutritionnews >, "

(rd-usa ) " <rd-usa >

Cc: " Kalman "

Date: Thursday, February 23, 2012, 12:26 PM

 

Vivus Shares Surge After FDA Panel Backs Diet Drug

http://online.wsj.com/article/SB10001424052970203960804577241220152561402.html

By GEORGE

STAHL<http://online.wsj.com/search/term.html?KEYWORDS=GEORGE+STAHL & bylinesearch=\

true> And MATT

JARZEMSKY<http://online.wsj.com/search/term.html?KEYWORDS=MATT+JARZEMSKY & bylines\

earch=true>

Vivus<http://online.wsj.com/public/quotes/main.html?type=djn & symbol=VVUS> Inc.

shares doubled Thursday after a federal advisory panel overwhelmingly backed the

weight-loss drug Qnexa, clearing the way for U.S. approval of the first

prescription diet drug in more than a decade.

The drug still requires approval by the larger Food and Drug Administration,

which has rejected previous obesity drugs after panel support; however, the

panel's strong 20-2 vote Wednesday in favor of recommending Qnexa for sale has

eased concerns about a reversal by the FDA. The FDA is expected to make a final

decision by April 17.

" The resounding vote of confidence from yesterday's FDA Advisory Committee

meeting provides us with high confidence that Qnexa will be approved, " JMP

Securities analyst said.

Vivus said on a conference call Wednesday that assuming final approval in April,

it plans to launch the product itself in the U.S. in the third quarter. The

company provided no details on how much the drug would cost.

" Pricing will be one of the last things that we'll decide on in the launch

process, " Chief Executive Leland said, according to a transcript from

FactSet Research.

The company doesn't anticipate problems with producing the drug. " We've got, we

think, plenty of capacity by a manufacturer that hasn't been disclosed, but

they've been approved by the FDA several times, " Chief Financial Officer

said. " We're very comfortable with the manufacturing and the supply

chain. "

Vivus shares more than doubled to as much as $21.44, the first time the stock

was above $20 in more than 15 years. Shares recently traded at $19.67, up 86%.

JMP's raised his price target on Vivus to $45 from $16.

" We point to additional near-term catalysts, which we believe are not being

appreciated by investors, most importantly the potential for Qnexa approval in

Europe by mid-year " and a possible FDA OK in late April on avanafil, an

experimental erectile dysfunction treatment, said.

Shares of rival obesity drug makers also jumped on the news. Orexigen

Therapeutics<http://online.wsj.com/public/quotes/main.html?type=djn & symbol=OREX>\

Inc. gained 20% to $3.86, while Arena

Pharmaceuticals<http://online.wsj.com/public/quotes/main.html?type=djn & symbol=AR\

NA> Inc. added 7.2% to $1.94. These two companies, like Vivus, had their

respective obesity drugs rejected by the FDA in recent years but are working

with the agency to resubmit their applications.

Vivus' Qnexa is a controlled-release formulation that combines low doses of two

older generic drugs: the stimulant phentermine, which cuts appetite, and

topiramate, which increases the sense of feeling full. Topiramate is also sold

under the brand name Topamax by &

<http://online.wsj.com/public/quotes/main.html?type=djn & symbol=JNJ> to

treat migraines and seizures.

The FDA, in rejecting Qnexa in 2010, asked Vivus for an assessment of the drug's

potential to cause birth defects and for evidence Qnexa doesn't increase the

risk of major adverse cardiovascular events.

In response to the concerns, Vivus agreed to conduct additional analysis looking

at the drug's safety profile over a longer time frame. It also said it would

continue discussion with the FDA on its so-called risk evaluation and mitigation

strategies plan. Such plans open the door for long-term post-approval studies or

changes to a drug's label.

Vivus said the Qnexa patent goes through 2020 but that the company will file for

an extension after final FDA approval.

S. Kalman PhD, RD, FACN

Director, BD - Nutrition & Applied Clinical Trials

Miami Research Associates

6141 Sunset Drive - Suite 301

Miami, FL. 33143

Direct -

Office ext. 5109

Fax

Email: dkalman@...

Web: www.miamiresearch.com<www.mraclinicalresearch.com/>

Linked In: http://www.linkedin.com/in/douglaskalmanphdrd