Sanofi-Pasteur and VaxGen's HIV Vaccine Discovery

News from the new Aids Vaccine. The study involved 16000 volunteers from Thailand shows promise with a 30% effective rate in preventing HIV. Sanofi-Aventis (SNY) and VaxGen (VXGN) were the stocks involved. Sanofi is approaching a 1 year high trading at 36.76 while VaxGen is experiencing a strong sell-off closing at 0.68 after reaching a high of 0.999 in OTC trading.

In 1995, Drs. Francis and Nowinski, a Seattle-based retrovirologist and entrepreneur, led the spin-off of the Genentech HIV vaccine effort, forming VaxGen to concentrate on further development of AIDSVAX.

The VaxGen team then developed the bivalent form of AIDSVAX to increase the vaccine's potential to protect against additional strains of HIV. Genentech, VaxGen's manufacturing and development partner for the vaccine, has manufactured large quantities of the bivalent AIDSVAX for the upcoming Phase III clinical trials.

"We are proud of the role Genentech played in the development of this vaccine. We congratulate VaxGen's team and support them as they continue this vital work," said William D. Young, Chief Operating Officer of Genentech and a member of VaxGen's board of directors.

VaxGen, based in South San Francisco, Calif., is a biotechnology company committed to making an HIV vaccine for worldwide use. Genentech, one of the world's leading pharmaceutical biotechnology companies, is also based in South San Francisco and is VaxGen's largest shareholder

This vaccine needs more devolopment, mostly with efficacy, but there are other stocks in search for a HIV vaccine.

Other companies searching for the HIV vaccine:

PRO542 Progenics Pharmaceuticals (PGNX) HIV
PRO 140 Progenics Pharmaceuticals (PGNX) HIV
HVTN 502 Merck (MRK)
HVTN 503 Merck (MRK)

Top Newswire Coverage from the HIV Vaccine Clinical Discovery.

CNN: Combo vaccine reduces risk of HIV infection, researchers say

Xcomony: The Quest for an HIV Vaccine

The Guardian: HIV breakthrough as scientists discover new vaccine to prevent infection

Reuter's: AIDS vaccine works, but back to the drawing board

Wikipedia HIV Vaccine

Wall St. Journal: Vaccine Shows Promise in Preventing HIV Infection

HIV vaccine: After 25 years of failure, an experimental drug offers hope

Nearly 30 years after its discovery, AIDS still has no known cure. Researchers almost gave up hope of ever finding a vaccine. However, hopes were rekindled when a Phase III clinical trial involving more than 16,000 adult volunteers in Thailand demonstrated that an experimental HIV vaccine was safe and modestly effective, preventing HIV infection in 31.2 percent of cases.

That's a step in the right direction, but those are modest results; for any other disease, preventing infection in fewer than a third of the tested cases wouldn't arouse much hype or hope. But with the HIV virus, after 25 years of attempts and failures, some fairly recent, it's no wonder everybody is excited for this potential breakthrough.

The experimental vaccine is a combination of ALVAC, from Sanofi Pasteur, the vaccine division of Sanofi-Aventis (SNY), and AIDSVAX, originally developed by VaxGen (VXGN) and now held by the nonprofit Global Solutions for Infectious Diseases. Neither vaccine worked individually in previous trials, but the combination, called RV144, showed modest results. (Neither vaccine causes HIV, separately or together.) The trial was a collaborative effort among the U.S. Army, the Thai Ministry of Public Health, the National Institute of Allergy and Infectious Diseases, the National Institutes of Health, Sanofi Pasteur, and GSID.

16,402 volunteers in Thailand participated in the trial, which opened in 2003. Half received the vaccine, and half placebos; all were counseled on HIV prevention. Of the 8,198 people injected with the placebo, 74 contracted HIV; of the 8,197 who got the vaccine, 51 got the virus -- a difference the collaborative effort calls statistically significant. More details will be given at the AIDS Vaccine Conference in Paris in October.

Researchers seemed surprised. "These results show that development of a safe and effective preventive HIV vaccine is possible," said Col. Nelson Michael, director of the U.S. Military HIV Research Program, in a statement. "While these results are very encouraging, we recognize that further study is required to build upon these findings."

The U.S. HIV/AIDS epidemic began in 1981, according to the NIAID; 565,927 people in the U.S. have died of AIDS. Globally, 33 million have lived with HIV/AIDS, and 2 million died of related illnesses in 2007.

But many challenges lie ahead. Different strains of HIV exist throughout the world; those common in Thailand unusual in the U.S., Africa, and elsewhere. Scientists will need to determine how long the protection lasts, whether booster shots will be needed, and so on. And some in the scientific community are skeptical; Jon Cohen at Science Insider explains that many AIDS vaccine researchers had predicted that the study would fail. They are now "dumbfounded -- and circumspect": concerned that the results came by chance.

This is the third big vaccine trial since 1983, when HIV was identified as the cause of AIDS, the AP reports. As recently as 2007, Merck & Co. (MRK) halted a study of its experimental vaccine after seeing that it actually increased the risk of infection. Before that, in 2003, AIDSVAX also failed in trials.

Vaccine makers might try to license the two-vaccine combo in Thailand. The U.S. Food and Drug Administration will need more studies before the vaccine can be considered for U.S. licensing, and its effectiveness will most likely need to be higher before it gets approval.

While Sanofi shares are down today, VXGN's are up over 10 percent.

Related articles

• Antibody Neutralizes 91% of HIV Strains, Strong Step Towards a Vaccine (singularityhub.com)
• HIV vax researchers ponder best R&D strategies in Atlanta (fiercebiotech.com)
• VaxGen and diaDexus Complete Merger (prnewswire.com)
• Push for HIV vaccine gets stronger (cbc.ca)
• Sanofi Pasteur buys VaxDesign for $60M - Bizjournals.com (news.google.com)
• HIV vaccine scientists vow to speed up search (cbc.ca)

Mylan Pharmaceuticals Stock Analysis

Mylan Pharmaceuticals (Nasdaq:MYL) keeps coming up on my radar so I would like to take the time to analyze the stock and give some recommendations on it. Mylan is approaching its 52 week high so is it a buy or not? In October 2008, they reached a 52 week low of 5.75 and today is trading at 14.88. So that old adage of Buy Low-Sell High is coming into play. In these economic times many rules of trading are finding exceptions to that rule. Mylan's Financial picture can be found on Google Finance here. I see a good exception to Mylan's future, and see the company's stock rising based on FDA approvals that have come in over the past few months.

I really like the generic market right now. With patents expiring you can literally gauge how much a generic will make based on the patents expiring in the next few months. These generics are the hyenas in a pack of lions that have a good way of scavenging for their food in the Serengeti. The hyena has a distinct relationship with the Lions. The lions kill much of the food the hyena scavenges. But then there are vultures too so we will end this charade and get to the point. They may not come up with the drugs but they are definitely going to make a nice profit from them. But the competition is fierce these days. Some competitors in the generic market include Watson (WPI), Teva (TEVA) , Dr Reddy's Labs (RDY), Hi-Tech Pharmacal (HITK), Par Pharmaceuticals (PRX), and Caraco (CPD).

Recent news has cleared Mylan's name from their Morgantown, WV 483 letter fiasco. Mylan's stock went from 13.85 to 12.10 based on the news on July 27th. The Post Gazette article can be found here titled Adverse reaction: The FDA probes quality control at Mylan. It is funny how quick we come to judgement over initial accusations. With that said, the Pittsburgh Post Gazette published allegations of profound quality control issues that got the attention of the FDA to investigate their plant. No 483 letter was issued and Mylan has since sued the Newspaper over the SOP deviation document stories. FDA cleared Mylan and Mylan Pharmaceuticals Receives Final FDA Report and Reaffirms Its 48-Year Exemplary Record of Quality on August 13th.

But to run a business in a lower economic area like West Virginia can be profitable, if they can handle their quality control issues. They can pay employees less based on the economic value of the area and can make more money. I have seen this first-hand by working outside of Raleigh in a rural area and finding out how much less we were making than those in the RTP area. Anyways, they choose these sites for a reason. I love West Virginia and have rafted the Upper and Lower Gauley myself. People in West Virginia definitely need the jobs.

Anyways, is this company going to make money or not? I say yes. Going through PR Newswire recently, Mylan continues gaining FDA approval for marketing for key generics. Here is a list compiled from the last few months for FDA approvals.

1. August 27, 2009 Mylan Begins Marketing First Generic Version of BenzaClin(R) Acne Treatment

2. August 18, 2009 Mylan's Matrix Receives First and Only Tentative FDA Approval Under PEPFAR for Generic Version of Atripla(R) HIV Treatment

3. August 10, 2009 Mylan Receives FDA Approval for Generic Version of Migraine Treatment Imitrex(R)

4. July 20, 2009 Mylan Receives FDA Approval for Additional Strengths of the Antipsychotic Haloperidol---> Key News from the article. Currently, Mylan has 119 ANDAs pending FDA approval representing $84.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $16.6 billion in annual brand sales, according to IMS Health.

5. July 16, 2009 Mylan Receives FDA Approval for Generic Version of Thyroid Deficiency Treatment Cytomel

6. July 7, 2009 Mylan Receives FDA Approval for Generic Version of Prostate Cancer Treatment Casodex

7. June 17, 2009 Mylan Receives FDA Approval for Additional Strength of Generic Restoril(R)

8. May 29, 2009 Mylan Receives Tentative FDA Approval for Generic Version of Singulair(R)

9. May 7, 2009 Mylan Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)

10. April 14, 2009 Mylan Confirms First-to-File Patent Challenge Relating to Xeloda(R) Cancer Treatment

But with the good I would like to investigate their financials a little closer. They have a Market Cap of 4.54 Billion. For the six months ended June 30, 2009, Mylan reported total revenues of $2.48 billion compared to $2.28 billion in the same prior year period. This represents an increase of $199.3 million or 8.8%. Net revenues increased $174.5 million, while other revenues increased $24.8 million. The increase in net revenues is due to higher third-party sales in all three of the Company's segments. The Generics Segment accounted for the majority of the increase ($131.3 million) followed by the Matrix Segment ($25.2 million) and the Specialty Segment ($18.0 million). On a constant currency basis, total revenues increased by approximately 17%. Their August 3rd quarterly report can be found here.

Revenue is up and gross profit is up too. However, so was their operating expenses. Earnings per share were 0.19, slightly down from Q1, but not a loss. That is good news. I see their generic market for HIV medications as their key growth. President Clinton and Mylan Chairman and CEO Robert J. Coury Announce New Agreement to Lower Price of Treatment for Patients with Drug-Resistant HIV in Developing Countries.