October Biotech Calendar: Key Dates and Events

Biotech Calendar: Key Dates and Events
A 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.

Oct. 13
Presentation at the American Neurological Association meeting of detailed data from the phase III study of Avanir Pharmaceuticals' (Symbol : AVNR) Zenvia, an experimental drug for the treatment of uncontrollable laughing and crying episodes a condition known medically as pseudobulbar affect. Avanir announced positive top-line results from this study in August.

Third-quarter earnings: Johnson & Johnson (Symbol : JNJ) (before market open) and Gilead Sciences (Symbol : GILD) (after market close.)

Oct. 14
The FDA'sPeripheral and Central Nervous System Drug Advisory Committee will convene to review Acorda Therapeutics' (Symbol : ACOR) fampridine (brand name Amaya). The proposed indication for Amaya is to improve the walking ability of patients with multiple sclerosis. Biogen Idec (Symbol : BIIB) is Acorda's marketing partner for Amaya.
Take note: The FDA's briefing documents for Amaya should be posted to the agency's web site on Oct. 12 or 13. When available, those documents can be found here.
Third-quarter earnings: Abbott Labs (Symbol : ABT) (before market open.)

Oct. 15
Third-quarter earnings: Cubist Pharmaceuticals (Symbol : CBST) (after market closes.)

Oct. 16-21
The American College of Rheumatology annual meeting in Philadelphia. Noteworthy clinical data expected for presentation includes Pfizer's CP-690550 in rheumatoid arthritis and Rigel Pharmaceuticals' (Symbol : RIGL) R788 in rheumatoid arthritis

Oct. 19
FDA approval decision date for Amgen's (Symbol : AMGN) osteoporosis drug denosumab. If approved, Amgen (Symbol : AMGN) will market the drug under the brand name Prolia.

Oct. 22
FDA's approval decision date for Acorda's drug Amaya.

Oct. 24-28
The Obesity Society annual meeting convenes in Washington, D.C. Detailed data from phase III studies of three closely watched weight-loss drugs will be presented at the meeting: Arena Pharmaceuticals' (Symbol : ARNA) lorcaserin, Vivus' (Symbol : VVUS) Qnexa and Orexigen Therapeutics' (Symbol : OREX) Contrave.

Oct. 30
FDA approval decision date for GTX's Acapodene for the reduction of bone fractures in prostate cancer patients undergoing androgen deprivation therapy.
FDA approval decision date for Transcept Pharmaceuticals' (Symbol : TSPT) Intermezzo for insomnia.

Oct. 30-Nov. 4
The American Association for the Study of Liver Disease convenes in Boston. This is the most important meeting for hepatitis C drug research held on the U.S. every year. Stocks to watch include Vertex Pharmaceuticals (Symbol : VRTX), InterMune (Symbol : ITMN), Pharmasset (Symbol : VRUS), Idenix Pharmaceuticals (Symbol : IDIX) and Anadys Pharmaceuticals (Symbol : ANDS).

Important clinical trials with potential data readouts or other biotech events expected in October:

Company: Protalix BioTherapeutics (Symbol : PLX)
Drug/indication: prGCD (Uplyso) in Gaucher's disease.

Company: Allos Therapeutics (Symbol : ALTH)
Commercial launch of Folotyn in peripheral T-cell lymphoma

and Anadys Pharmaceuticals (Symbol : ANDS).

Important clinical trials with potential data readouts or other biotech events expected in October:

Company: Protalix BioTherapeutics (Symbol : PLX)
Drug/indication: prGCD (Uplyso) in Gaucher's disease.

Company: Allos Therapeutics (Symbol : ALTH)
Commercial launch of Folotyn in peripheral T-cell lymphoma

Preventing HIV with Gilead Science's Truvada

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.

•Truvada is a combination of two drugs: 300mg of Viread (tenofovir DF) and 200mg of Emtriva (FTC). Truvada should be prescribed by a healthcare provider for patients who need both of these drugs. Both of these drugs can still be purchased individually for use in combination with other HIV drugs.

•Truvada must be combined with at least one other HIV drug, usually a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI).

•Atripla, a combination tablet containing the NNRTI Sustiva (efavirenz) and the tenofovir and emtricitabine in Truvada, was approved for use in the United States in July 2006. Truvada can still be purchased for use in combination with HIV drugs other than Sustiva.

•Both the Viread and the Emtriva in Truvada are active against the hepatitis B virus (HBV), the virus responsible for causing hepatitis B. Although Emtriva and Viread have not been approved by the FDA for the treatment of hepatitis B, some doctors may prescribe Truvada to treat both hepatitis B and HIV. See What about side effects? below for more important information regarding Viread, Emtriva, and hepatitis B.

•Gilead has established a patient assistance program (PAP) for people living with HIV who do not have private or public health insurance and are unable to afford Truvada. To learn more about the PAP for Truvada, call Gilead (800-226-2056). For those with private health insurance, Gilead has established a program to help cover up to $200 toward each monthly Truvada co-payment (people will be responsible for paying the first $50 of their monthly Truvada co-payment). To learn more about this co-pay program, call 866-784-3431.

Where can I learn more about clinical trials involving Truvada?
•If you would like to find out if you are eligible for any clinical trials that include Truvada, there is an interactive web site run by ACRIA, the AIDS Community Research Initiative of America.

•Another useful service for finding clinical trials is AIDSinfo.nih.gov, a site run by the US National Institutes of Health. They have "health information specialists" you can talk to at their toll-free number at 1-800-HIV-0440 (1-800-448-0440).

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.

Sequenom's Stock Falls, Clouded With Uncertainty

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.

You can listen to the Monday conference call between Sequenom and investors here. Zip ahead to around minute 32 to hear the angry shareholder press Hixson for details.

YouTube credit card rant gets results

I mostly write about BioPharma Stocks but this does deal with a prominent stock Bank of America (BAC), who's stock price has risen considerably from the bailout period a year ago. The Debtor's Rant/Revolt Youtube video sets up some interesting points that could possibly hurt a stock or our country, which could happen. Theoretically this could cause an uproar and maybe another state of depression that we are currently experiencing. But could it possibly happen?

Would enough people risk hurting their credit? What could happen to our country if there was another tax revolt? This country was founded on a tax revolt so it's not exactly hard to imagine if people would form a revolution against Big Business and Wall Street. I still make trades but I am somewhat cautious on my trades as anything and everything can happen.

Check out the video of the Debtor's Revolution Here

YouTube Credit Card Rant Gets Results

Ann Minch said Bank of America 'jacked up' the interest rate on her credit card to 30%. After her video went viral, the bank slashed her rate back down to 12.99%.

NEW YORK (CNNMoney.com) -- "You are evil, thieving bastards."

That's just one of the scathing comments from Ann Minch, a disgruntled Bank of America (BAC, Fortune 500) customer who says in a YouTube video that the bank "jacked up my interest rate to a whopping 30% APR."

Her rant went viral, and Minch says the bank scaled her rate back to its original 12.99%. Citing customer privacy, a Bank of America spokeswoman said she could not comment on individual accounts but confirmed "we did ... reach a mutually agreeable resolution based on additional information that we reviewed."

The video, titled "Debtor's Revolt Begins Now!," has been streamed about 350,000 times and earned a five-star user rating since it was posted on Sept. 8.

In the video, Minch claims she wasn't over her credit limit and hasn't been late with payments, despite the fact that she doesn't have a full-time job.

She says she tried to negotiate with Bank of America, where she has been a customer for 14 years, "but they weren't willing to negotiate anything."

"I could get a better rate from a loan shark," she adds.

Betty Riess, the Bank of America spokeswoman, said customers receive advance notice of rate hikes and can choose to pay off their balance at the current rate to close out the account.

True to her YouTube handle, Rockerchic4God, Minch sports fiery red hair and kohl-rimmed eyes that glare into the camera for the duration of the 4-1/2 minute video.

"You have reaped ungodly profits in your behemoth casino scams, then lost, only to turn around and usurp the wealth of this great nation by the outright rape and pillage of middle-class Americans whose sweat and toil built it," she says.

Calling the bailout "the biggest rip off in the history of the world," Minch lays out her terms: If Bank of America refuses to reinstate her previous, lower interest rate and monthly payments, she won't pay "one more red cent on your 30%."

Minch tells her viewers that she is "willing to sacrifice [my credit score] in order to take a stand for what's right," and she calls on them to join her in an "American debtors' revolution."

"Stick that in your bailout pipe and smoke it," she says, smirking.

A response

Minch attracted a lot of media attention, and word of her crusade apparently got through to one of Bank of America's top brass. In a follow-up video posted Sept. 19 Minch says Jeff Crawford, the bank's senior vice president of existing customer credit services, called her to discuss her concerns.

He told her that she had two late payments, which was why her rate was hiked, and he tried to convince her to agree on a 16.99% interest rate.

Minch replied that Bank of America is receiving "money from the Fed at 0% interest ... 12.99% is a more-than-generous profit margin." Crawford agreed to that original rate, although Minch says her most recent online statement shows a 23.99% APR.

Still, the credit-card crusader is significantly more subdued in her follow-up video, in which she updated viewers about her predicament and noted that Crawford "was very polite."

But Rockerchic4God isn't completely mollified. She's launching a Web site at DebtorsRevoltNow.com, and says her next project is "a tax revolt."

"That won't involve anybody having to go to jail for not paying their taxes," she says. "There's a way around that, so stay tuned."

Minch's original video has spawned more than 5,000 comments -- some praising her, others condemning her "revolt." One detractor, billb0313, writes: "Banks need a bailout b/c people like Ann defaulted on their unsecured loans left and right."

Other posters are in Minch's corner. "You're not alone," writes tommosm. "[My] Chase is at 33% ... I'm paying more in finance charges than the minimum payment."