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VVUS - Sector: Healthcare---Industry: Biotechnology & Drugs

Started by la-onda, April 09, 2007, 01:34:49 AM

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la-onda

fyi; nice chart & products/pipeline, will be on my watchlist
comments/feedback as always appreciated

1)
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually. VIVUS has three products that are positioned to enter Phase 3 clinical trials and one product currently under NDA review by the FDA. The investigational pipeline includes: Qnexa(tm), for which a Phase 2 study has been completed for the treatment of obesity; Testosterone MDTS®, for which a Phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); EvaMist(tm), for which a Phase 3 study has been completed and an NDA submitted for the treatment of menopausal symptoms; avanafil, for which a Phase 2 study has been completed for the treatment of erectile dysfunction (ED); and, MUSE®, which is approved and currently on the market for the treatment of ED.

2)
Latest news:
VIVUS Agrees to Sell EvaMist Rights to KV Pharmaceutical

VIVUS Eligible to Receive $150 Million in Cash Payments Through NDA Approval

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--March 30, 2007--VIVUS, Inc. (NASDAQ: VVUS) today announced that it had executed an agreement to transfer its exclusive rights and assets related to EvaMist(TM), an investigational metered dose transdermal estradiol spray for the treatment of menopause symptoms, to KV Pharmaceutical Company (the "Transaction"). The closing of the Transaction is expected to occur by mid 2007 following the satisfaction of various closing conditions as well as the completion of a review by the Federal Trade Commission under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Under the terms of the Transaction, VIVUS is eligible to receive an upfront payment of $10 million upon the closing and an additional $140 million upon the approval of the New Drug Application ("NDA") for EvaMist currently under review by the Food and Drug Administration. VIVUS may also receive milestone payments of up to $30 million based on sales of EvaMist through the term of the agreement.

Upon the closing of the Transaction, KV Pharmaceutical will be responsible for the manufacturing, selling, marketing and regulatory requirements once the product is approved. VIVUS previously submitted the NDA for EvaMist on September 29, 2006. The PDUFA date is July 29, 2007. KV Pharmaceutical will also assume all additional expenses and liabilities associated with EvaMist.

"KV, with its strong women's health franchise, is the ideal company to maximize EvaMist's potential in the US," said Leland F. Wilson, President and Chief Executive Officer for VIVUS. "If approved, EvaMist will provide an important new treatment option for women suffering with the symptoms of menopause, and we are pleased to be able to have a company such as KV, with an exceptional infrastructure already in place, including 285 sales representatives and sales management personnel in their Ther-Rx division, to quickly bring the benefits of EvaMist to patients."

Marc S. Hermelin, KV's Chairman of the Board and Chief Executive Officer stated, "EvaMist is a great strategic fit with our Ther-Rx women's health franchise, an area in which we are devoting significant R&D resources to expand our footprint. EvaMist targets a new and compelling market for Ther-Rx with great growth potential, menopause, with an innovatively delivered drug that is designed to promote patient compliance. Upon approval, we will be able to leverage the promotion of this product through our current branded sales force, focusing on the specific targets of OB/GYN and select primary care physicians that write for Estrogen Replacement Therapy. EvaMist has the potential to be one of Ther-Rx's largest products in terms of revenue." In clinical trials, EvaMist has been shown to reduce the number and severity of hot flashes in post-menopausal women. Once approved, KV will promote EvaMist to the OB/GYN community that currently treats postmenopausal women. In 2006, sales of all prescription estrogen products were approximately $1.5 billion, with the transdermal segment of the market approaching $300 million.
3)
Nice chart & slides

setravis

This is a resolving.......
There's little or no upside resistance as its getting ready to make new 3 yr. highs
on improving volume and is staying above its 30-day MA.


March 30 (Reuters) - KV Pharmaceutical Co. ((KVa.N)) said it agreed with California-based VIVUS Inc. (VVUS,Trade) to buy the U.S. marketing rights to EvaMist, a candidate for the treatment of menopause symptoms, in an all-cash deal. The drugmaker said it agreed to pay $10 million at the closing of the deal and to make an additional payment of about $140 million at the time of final approval of the New Drug Application for EvaMist from the U.S. regulators. (Reporting by Esha Dey in Bangalore)

Support @ $5.61...5.35...4.89
Resistance @ $5.91...6.19

52wk Range: 2.95 - 5.92
Volume: 518,834
Avg Vol (3m): 301,089

Technicals
Last Price Quote is:
3.88%above 13-day MA
16.86%above 50-day MA
RS Rating: 91 

Fundamentals
Key Data:
Market Cap (M): $334.90 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 07/26/2007
Last Analyst Rating: Average
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

8 Promising Biotech Buyout Targets if Their Products Can Deliver...

The following are a few biotechs with promising products in their pipelines that have made the big boys sit up and take notice. Without further ado, the 8 promising biotechs priced for a buyout if their products can deliver:

Vivus (VVUS): Vivus develops products targeted towards the treatment of obesity and erectile dysfunction. Vivus got some great news on Monday about its weight-loss drug Qnexa. Studies found that patients who took Qnexa over a two-year period experienced improved blood pressure, better lipid levels, and significant weight loss. Patients taking the drug also reduced the number of hypertensive medications they used by 19%. The positive news comes at a good time for Vivus, as the FDA declined approval for the drug in October citing cardiovascular health risks. The recent results should alleviate those worries, but regulators are still concerned about a link between one of the drug's ingredients and an increased risk for birth defects. If the drug does gain FDA approval, many experts tout Qnexa as "the most promising weight-loss drug in more than a decade." We'll see if it gets to that point.
Shares currently trade at $6.77

Technicals
Last Price Quote is:
2.44%above 13-day EMA
-2.44%below 50-day EMA
RS Rating: 7 
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Vivus's Qnexa And Its Potential Value

Vivus's (VVUS) chances of getting FDA approval for Qnexa, its investigational drug combination for obesity, have never looked better. To suggest that the process has been difficult would be to say that War and Peace is a little wordy or that Michael Jordan could play a little ball.

Nevertheless, a surprisingly positive panel vote has investors excited that the FDA very well may approve the first prescription drug for obesity in over a decade. The question investors may want to ask then, aside from what the chances are that the FDA goes along with its panel, is how much appreciation potential may be left in the shares.

"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis

setravis

Vivus Inc. rose 18.2 percent to $22.13 with 28,559,100 shares traded.

Day's Range: 18.76 - 22.19
52wk Range: 6.00 - 22.19
Volume: 29,144,445
Avg Vol (3m): 3,759,050
Market Cap: 1.97B
"Success loves to hide behind challenges.
Embrace the challenge, enjoy the journey."

Do your own DD and invest based on your DD, not mine !

Semper Fi
S.E.Travis