Biotech/Pharma Stocks and Upcoming FDA Actions Dates

A few biotech stocks whose FDA approval/response dates are coming up are listed here without any analysis or predictions. Momentum traders could use these tickers, study the stock behavior and make appropriate trades. Or look at the drug/device's long term trial/data process and make bets on either side of the trade and hold steady. Good luck and don't be greedy. Stocks are listed from the nearest date of decision onward. Thanks for a diligent poster (sxyam) on the yahoo message board of HUN.
Chelsea Therapeutics(CHTP Quote)
Drug/indication: Droxidopa for neurogenic orthostatic hypotension
Outcome of FDA meeting to discuss changing primary endpoint of phase III study: December 2009.

Cephalon(CEPH Quote)
Drug/indication: Nuvigil for jet lag disorder
FDA approval decision date: Dec. 29

Arena Pharmaceuticals(ARNA Quote)
Drug/indication: lorcaserin for obesity
Filing for FDA approval: December 2009

Auxilium Pharmaceuticals(AUXL Quote)
Drug/indication: Xiaflex for Dupuytren's contracture
FDA approval decision date: December 2009

Biodel(BIOD Quote)
Drug/indication: Viaject for diabetes
Filing for FDA approval: December 2009

Novartis(NVS Quote)
Drug/indication: fingolomid for multiple sclerosis
Filing for FDA approval: December 2009

Novo Nordisk(NVO Quote)
Drug/indication: Victoza for diabetes
FDA approval decision date: December 2009

Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: Replagal for Fabry's disease
Filing for FDA approval: December 2009

Vivus(VVUS Quote)
Drug/indication: Qnexa for obesity
Filing for FDA approval: December 2009

Mannkind(MNKD Quote)
Drug/indication: Afresa for diabetes
FDA approval decision date: Jan. 16, 2010

Acorda Therapeutics(ACOR Quote)
Drug/indication: Amaya for multiple sclerosis
FDA approval decision date: Jan. 22, 2010

Spectrum Pharmaceuticals(SPPI Quote)
Drug/indication: Fusilev for colon cancer
Outcome of meeting with FDA to discuss complete response letter: January 2010

Labopharm(DDSS Quote)
Drug/indication: Trazodone Contramid for depression
FDA approval decision date: Feb. 11, 2010

Cadence Pharmaceuticals(CADX Quote)
Drug/indication: acetavance for pain
FDA approval decision date: Feb. 12, 2010

Gilead Sciences(GILD Quote)
Drug/indication: Cayston for cystic fibrosis
FDA approval decision date: Feb. 13, 2010

Salix Pharmaceuticals(SLXP Quote)
Drug/indication: Xifaxan for hepatic encephalopathy
FDA advisory committee meeting: February 2010
FDA approval decision date: March 24, 2010

Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: velaglucerase for Gaucher's disease
FDA approval decision date: Feb. 28, 2010

Amylin Pharmaceuticals(AMLN Quote)
Drug/indication: Exenatide LAR for diabetes
FDA approval decision date: March 5, 2010

Clinical Data(CLDA Quote)
Drug/indication: vilazodone for depression
Filing for FDA approval: First quarter 2010

Somaxon Pharmaceuticals(SOMX Quote)
Drug/indication: Silenor for insomnia
Outcome of FDA meeting to discuss complete response letter: First quarter 2010

Cell Therapeutics(CTIC Quote)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
FDA approval decision date: April 23, 2010

Eli Lilly(LLY Quote)
Drug/indication: Erbitux for first-line non-small cell lung cancer
Filing for FDA approval: First quarter 2010

Dendreon(DNDN Quote)
Drug/indication: Provenge for prostate cancer
FDA approval decision date: May 1, 2010

Avanir Pharmaceuticals(AVNR Quote)
Drug/indication: Zenvia for pseudobulbar effect
Filing for FDA approval: Second quarter 2010

Alkermes(ALKS Quote)
Drug/indication: Vivitrol for opioid addiction
Filing for FDA approval: First half 2010

InterMune(ITMN Quote)
Drug/indication: pirfenidone for idiopathic pulmonary fibrosis
FDA advisory committee meeting: First half 2010

FDA approval decision date: Second half 2010

Human Genome Sciences(HGSI Quote)
Drug/indication: Benlysta for lupus
Filing for FDA approval: First half 2010

Orexigen Therapeutics(OREX Quote)
Drug/indication: Contrave for obesity
Filing for FDA approval: First half 2010

CDC Update

The Center for Disease Control (CDC) analyzes influenza activity and publishes key findings each week.

Key Flu Indicators

FluView.*

During the week of November 1-7, 2009, a review of key indicators found that certain indicators declined, while others continued to rise. Overall, flu activity in the United Sates remained very high. Below is a summary of the most recent key indicators:

• Visits to doctors for influenza-like illness (ILI) nationally decreased this week over last week. This is the 2nd week of national decreases in ILI after four consecutive weeks of sharp increases. (Visits to doctors for ILI is still higher than what is seen during the peak of many regular flu seasons.
• Total influenza hospitalization rates for laboratory-confirmed flu continue to climb and remain higher than expected for this time of year.
  
• The proportion of deaths attributed to pneumonia and influenza (P&I) based on the 122 Cities Report continues to increase and has been higher than what is expected for six weeks now.
• Forty-six states are reporting widespread influenza activity at this time; This many reports of widespread activity at this time of year are unprecedented during seasonal flu.
• Almost all of the influenza viruses identified so far continue to be 2009 H1N1 influenza A viruses. These viruses remain similar to the virus chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.

Our inferences and predictions:
The rare exception as well as the cases of hospitalization both seem to be good candidates for increased use of peramivir (BCRX) or intravenous Relenza (GSK)/Tamiflu (RHHBY.PK).

NVAX Special Opinion

If any new investors to NVAX are panicking because of this article on Motley Fool, fear not. The Fool used to be a good source, but with their open source approach of letting anyone write articles, it has become a general bulletin board where everyone is free to dish their opinion. For instance, the author Tim Hanson has completely missed Novavax's long standing work in virus like particle (VLP) technology based vaccines for seasonal flu.
In fact NVAX is currently initiating phase II studies on comparing the dosing of its VLP based vaccine to existing flu vaccines (of other companies) {press release pdf}.

The problem with this approach is that there is no objective or comprehensive coverage of companies. Instead, we have a piecemeal approach picking on factors and comments on "absence of long term plans" -(paraphrased).

Tim Hanson says:
"I'm not here to be negative about either Novavax"

That was a funny circuitious route towards attacking a company which has very clear long term plans. Especially with long term manufacturing agreements with Cadila (india) and another company in Spain. They also have seasonal flu vaccines for long term (let me see) EVERY YEAR. Stop whining about sour grapes and actually make some real research. In addition, NVAX CEO has come to Novavax with 25 yrs big pharma experience because he saw big potential here.

Anyways, i am sitting in NVAX, long term with several long calls for next year. I am not concerned much. But what I am concerned is for small retail investors (who I was one of 3 years back) who would be misled by these opinions posing as research.

With today's search capabilities, it is quite easy to come up with a timeline of almost anything. In case of NVAX, you can check out their timeline with vaccine development and other progress here.

SVA NVAX BCRX APT

Expect moves in Sinovac (SVA), Novavax (NVAX), Biocryst (BCRX) and Alpha Protech (APT) this week and in early November. I expect most of these moves to be on the upside.

Biocryst Pharma recently received Emergency Use Authorization for Permamivir (it's IV administered antiviral for use in hospitals against H1N1 flu disease). Sinovac accounced additional orders on Tuesday morning. Novavax and Alpha Protech are solid bets, APT has true revenues from products and Novavax is producing vaccines for trials in Mexico, has joint agreements in India and other good prospects.

• Sinovac Biotech Ltd. (courtesyYahoo finance)
  

BEIJING, Oct. 27 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE: SVA - News), a leading provider of biopharmaceutical products in China, announced today that it has received its third purchase order for its H1N1 vaccine, PANFLU.1, from China's Ministry of Industry and Information Technology for the national stockpiling plan. Under this purchase order, Sinovac is required to produce an additional 5.19 million doses of PANFLU.1 (15ug/0.5ml) for the Chinese central government. Out of today's announced PANFLU.1 order, Sinovac is required to complete delivery of 2.89 million doses to the appointed provincial and municipal governments by the end of this year and supply the remaining 2.3 million doses for the central government stockpiling.

Symbol	Price	Change
SVA	8.06	0.00

The latest 5.19 million dose purchase order is in addition to an initial order for 3.3 million doses and second order for 3 million doses received by Sinovac from the Ministry of Industry and Information Technology of China on September 4, 2009 and September 30, 2009, respectively, for a total of 11.49 million doses.

Novavax, Biocryst to make big moves

Novavax and Avimex are initiating the blinded, placebo-controlled clinical trial in Mexico City to evaluate the safety, immunogenicity and efficacy of Novavax's 2009 H1N1 VLP vaccine in healthy adults. Biocryst Pharma is showing lot of promise with its antiviral drug Peramivir. (after the jump)

The first stage will evaluate the vaccine's safety, immunogenicity and efficacy among 1,000 subjects, including 750 VLP recipients and 250 placebo recipients. Pending favorable results from the first stage, the second stage of the study will be initiated to evaluate the safety of the vaccine in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The primary safety and immunogenicity results are expected within 3 months of the start of this study in January 2010. If the results are clinically acceptable, they will be used to seek registration of Novavax's 2009 H1N1 pandemic flu vaccine in Mexico. These data are also expected to support development of the company's pandemic and seasonal flu VLP vaccines in other countries, including the United States.
http://www.marketwatch.com/story/novavax-ge-avimex-set-mexico-h1n1-vaccine-trial-2009-10-20?siteid=yhoof2


Watch this video to find out more:
http://www.wral.com/business/story/6241972/DIRECT LINK TO VIDEO