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Gilead Science, makers of Tamiflu, currently are in Phase III trials for the anti-HIV medicine Truvada. Gilead, the global leader in treatments for human immunodeficiency virus that causes AIDS, derives 80 percent of its $5 billion in annual sales from AIDS treatments. The company markets Atripla, a three-in-one daily pill containing its dual drug pill Truvada plus Bristol-Myers Squibb Co.’s Sustiva.

President and COO of Gilead Sciences Inc. (GILD) John F Milligan.
“The fixed dose Quad pill is the most exciting thing we’re working on,” Milligan said.
The Quad pill would be Gilead’s first to combine only its own AIDS drugs, Milligan said. It would contain the two-in-one HIV pill Truvada, plus Gilead’s new compound elvitegravir that blocks an enzyme called integrase that the virus needs to insert itself into its victim’s genes. The Quad also would include a booster medicine Gilead developed.

A main advantage of the new pill is that it would offer an alternative for those who can’t tolerate Sustiva’s central nervous system side effects, including bad dreams and hallucinations, Milligan said. In addition, birth defects seen in animal studies of Sustiva could also make some doctors reluctant to prescribe the drug for women who may have children.

The Quad pill would be especially important for persons of African descent who are hardest hit by the virus, because they metabolize Sustiva more slowly, making its side effects more pronounced, according to Milligan.

“If Sustiva isn’t useful, the Quad may be of more benefit,” Milligan said.


Recently another trial was started by the NIH called the Voice Study
VOICE study, a major HIV prevention trial for women, is launched in Zimbabwe

Microbicide trials
More than a dozen clinical trials are underway to determine whether various gels can prevent male-to-female or male-to-male transmission of HIV infection. These trials are part of a global effort to identify a safe, effective microbicide that could be applied topically to protect users against HIV and other sexually transmitted infections (STIs). There are no proven effective microbicides at this time; ongoing clinical trials, including efficacy trials of candidates using different strategies, will yield results in the coming years. As with any new experimental intervention, the first candidates are expected to be partially effective; however even a partially-effective microbicide could potentially be a powerful prevention tool when used alongside existing prevention strategies such as male and female condoms, risk reduction counselling, and diagnosis and treatment of sexually transmitted infections.

What is Truvada?
•Truvada is an HIV medication. It is in a category of HIV medicines called nucleoside reverse transcriptase inhibitors (NRTIs). Truvada prevents HIV from altering the genetic material of healthy CD4 cells. This prevents the cells from producing new virus and decreases the amount of virus in the body.

•Truvada is marketed by Gilead Sciences. It was approved by the U.S. Food and Drug Administration (FDA) for use by people living with HIV in August 2004.

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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.


Disclosure:  No Positions

Sequenom Inc(SQNM) has been a disaster of a trade today. Down huge. Today alone lost 39%, trading down to 3.46. A year ago Sequenom was trading at 21.41. They were recovering slightly from their FDA false data reports for their clinical studies on pre-natal testing for Down's Syndrome, or Trisomy 21.

Sequenom Inc (SQNM.O) shares plunged Tuesday, a day after the company removed almost its entire top management following an independent probe that found the company failed to prevent mishandling of data related to its prenatal Down Syndrome test.

In April, Sequenom had delayed the launch of the SEQureDx test, citing mishandling of research and development test data by employees and initiated an independent investigation into the matter. Earlier this month, the company launched its cystic fibrosis carrier screening test. It is also developing other prenatal tests, including one for gender determination.

"While considerable uncertainty remains regarding the timeline of the company's diagnostics pipeline, we continue to believe that the underlying science, which has been published in peer reviewed journals independent of the company, remains sound," said Barclays Capital analyst Anthony Butler.

Sequenom's SEQureDx technology, which isolates and analyzes circulating fetal nucleic acid from a maternal blood sample, is based on the work of Dennis Lo, a professor at the Chinese University of Hong Kong.

"While Sequenom maintains an extensive intellectual property portfolio in prenatal diagnosis, it is not clear if some of the patents may revert to their innovator, Dennis Lo, if adequate progress is not made," said Rodman & Renshaw analyst Elemer Piros.

JMP Securities analyst Charles Duncan said a potential equity financing will be an overhang until clarity can be provided on both the development timelines and budget for the development of the prenatal Down Syndrome test.

As of June 30, Sequenom had total cash and cash equivalents of $69.3 million. It is also facing a U.S. Securities and Exchange Commission investigation and a series of investor lawsuits over the publication of misleading data.


Sequenom's Tragic Downfall: Sequenom Bloodied and Unbowed


Here is news of the Sept 28, 2009 Sequenom Conference Call. It announces the firing of CEO Harry Stylli and Sr VP of R & D Elizabeth Dragon.

Just last week Sequenom annouced similar testing for Cystic Fybrosis: SEQUENOM Announces Launch of SensiGene Cystic Fibrosis Carrier Screening Test

Early this year the biotech firm Sequenom made waves by saying it could test a sample of a mother's blood to detect Down syndrome as early as eight weeks into pregnancy with nearly 100% accuracy.

The results of clinical studies conducted by the company fanned hopes for a noninvasive and highly accurate alternative to amniocentesis, which carries risks for mother and baby.

But in April, Sequenom disclosed that the launch of the new Down syndrome test, expected in June, would be delayed "due to the discovery of mishandling of research and development test data and results."

That bombshell slammed the company's stock and triggered an independent investigation by outside lawyers, shareholder lawsuits and an inquiry by the Securities and Exchange Commission. Now, five months later, Sequenom said the independent report is in and it has fired company president and CEO Harry Stylli and R&D chief Elizabeth Dragon. Several other employees were let go or resigned.

What went wrong?

The report, prepared with the help of more than 40 witnesses and 300,000 pages of documents and emails, wasn't released. But the company did say it had "failed to put in place adequate protocols and controls for the conduct of studies" for the Down syndrome test. The company will be sharing the details with the SEC soon, though.

Does the test work? In a Monday conference call, Interim CEO Harry Hixson said Sequenom had made "inadequately substantiated claims" about the Down syndrome test and that in several instances "flawed test data and results were reported to the public." The company said nobody should rely on the data it has publicly reported on the test either. That's something you don't hear every day.

One investor on the call accused the company of "dancing around what happened" and demanded to know when details would be revealed. Hixson said the shareholder suits and SEC investigation constrained what he and Sequenom could say.

Still, the company maintains confidence in its technology for using mass spectrometry to assay fetal genetic material circulating in maternal blood as a way to catch birth defects early and accurately. Sequenom recently launched this sort of test to detect cystic fibrosis.

Disclosure: No Positions