Novartis Expands China Vaccine Investments (NVS)
Novartis AG (NYSE: NVS) wants to get larger in teh realm of vaccines. In China for that matter. The Swiss drug giant has announced plans to buy an 85% majority stake in a privately held Chinese vaccine maker called Zhejiang Tianyuan. The purchase price is roughly $125 million.
This is a tiny scratch on the surface for Novartis as far as its overall size, but this is a clear move further into China, which is now the world’s third-largest market for vaccines but has the world’s largest population. The deal is of curse subject to regulatory approval in China.
This week Novartis had already indicated that will invest up to $1 billion to make its Chinese R&D efforts a top target as the huge nation could easily become one of the Swiss drug maker’s top target markets.
Jon C. Ogg
Do Flu Vaccines Need to Worry About Pain Killers? (GSK, AZN, SNE, NVS)
There is an interesting release out today showing that research from the University of Rochester Medical Center shows an inverse relationship between some of the more common pain killers or relievers and the effectiveness of flu shots. While this does not impact the need for flu vaccines and while this probably won’t impact the sale of flu vaccines by any doses, it does highlight that flu vaccines might not be as effective under a very common circumstance. It also shows how these pain killers might inhibit some of the body’s defenses in general. The study shows that the use of common pain killers to the likes of Advil, Tylenol, and aspirin at the time of a flu shot injection may actually blunt the effect of the shot. It also noted a negative immune system response.
This has been studied for years by a Dr. Richard Phipps and the findings were presented at an international conference on inflammatory diseases. The study data also corresponds to a report in The Lancet from last month by researchers out of the Czech Republic.
The companies most tied to seasonal flu vaccines are large diversified international conglomerates GlaxoSmithKline Plc (NYSE:GSK), AstraZeneca Plc (NYSE: AZN) via MedImmune, and Sanofi-Aventis (NYSE: SNY). Novartis (NYSE: NVS) also recently said that the backlog Of Swine-Flu vaccine orders would be filled by January, but unfortunately that is after many flu contractions will have been seen. It is a flu vaccine supplier.
Again, this won’t likely have any impact on the sales of vaccines that are already in very short supply. But it is important to consider if you are taking a flu vaccine or if you are ill. Particularly so when you consider that many ill and not so ill people take these three pain relieves and pain killers routinely.
JON C. OGG
Biotech Short Sellers Changing Beat (AMGN, GILD, BIIB, CELG, GENZ, LIFE, DNDN, HGSI, AMLN, OSIP)
Over the weekend we got to see some of the short interest changes for the key biotech stocks. While these was no clear unified directional move, there were some interesting changes seen. Amgen Inc. (NASDAQ: AMGN), Gilead Sciences Inc. (NASDAQ: GILD), Biogen Idec Inc. (NASDAQ: BIIB), Celgene Corporation (NASDAQ: CELG), and Genzyme Corp. (NASDAQ: GENZ). Due to growing market caps in the sector, we have also included Life Technologies Corporation (NASDAQ: LIFE), Dendreon Corp. (NASDAQ: DNDN), Human Genome Sciences Inc. (NASDAQ: HGSI), Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN), and OSI Pharmaceuticals Inc. (NASDAQ: OSIP)in the run down this month.
Amgen Inc. (AMGN)
AS OF DATE Short Int. Change
9/30/2009 18,363,198.. 5% GAIN
9/15/2009 17,449,497
Gilead Sciences Inc. (NASDAQ: GILD)
AS OF DATE Short Int. Change
9/30/2009 16,015,311.. 3.8% GAIN
9/15/2009 15,466,285
Celgene Corporation (NASDAQ: CELG)
AS OF DATE Short Int. Change
9/30/2009 8,177,698.. 9% DROP
9/15/2009 8,935,957
Biogen Idec Inc. (NASDAQ: BIIB)
AS OF DATE Short Int. Change
9/30/2009 9,459,673.. 1% DROP
9/15/2009 9,565,418
Genzyme Corp. (NASDAQ: GENZ)
AS OF DATE Short Int. Change
9/30/2009 8,771,379.. 19% GAIN
9/15/2009 7,388,108
Life Technologies Corporation (NASDAQ: LIFE)
AS OF DATE Short Int. Change
9/30/2009 6,799,196.. 3% DROP
9/15/2009 7,033,841
Dendreon Corp. (NASDAQ: DNDN)
AS OF DATE Short Int. Change
9/30/2009 8,939,869.. 2% DROP
9/15/2009 9,146,253
Human Genome Sciences Inc. (NASDAQ: HGSI)
AS OF DATE Short Int. Change
9/30/2009 19,786,339.. 1% DROP
9/15/2009 19,867,823
Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN)
AS OF DATE Short Int. Change
9/30/2009 13,171,869.. 5.7% DROP
9/15/2009 13,928,154
OSI Pharmaceuticals Inc. (NASDAQ: OSIP)
AS OF DATE Short Int. Change
9/30/2009 5,444,450.. 5.8% GAIN
9/15/2009 5,137,212
JON C. OGG
Dynavax Technologies (DVAX) Up Sharply On Hepatitis News
Dynavax Technologies (DVAX) said that the U.S. Food and Drug Administration (FDA) has removed the clinical hold for the HEPLISAVTM Investigational New Drug (IND) application in individuals with chronic kidney disease. HEPLISAV is a Phase 3 investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.
Dynavax expects to initiate a Phase 3 trial in chronic kidney disease patients in the near-term. Dynavax also plans to initiate a Phase 3 lot-to-lot consistency trial in adults over 40 years of age in early 2010.
Shares are 86% higher at $3.18 and hit a 52-week high of $3.35, up from a period low of $.15.
DVAX revenue for the second quarter 2009 were $15.9 million, compared to $10.0 million reported for the second quarter in 2008. The net income of $4.1 million, or $0.10 per share, reported for the second quarter 2009 improved from the net loss of $6.1 million, or $0.15 per share, for the same period in 2008. At the end of the quarter, the company had $53 million in cash and has a market cap of $127 million.
Douglas A. McIntyre
Positive News On Sinovac (SVA) Fail To Move Shares
Sinovac (SVA) must be over-bought. It seems no amount of positive news will push the shares higher.
Today the company announced that the Ministry of Industry and Information Technology of the People’s Republic of China has issued the initial order to Sinovac to purchase H1N1 vaccine for the national stockpiling plan. According to the initial order, Sinovac is required to complete the production of 3.3 million doses of PANFLU.1 (15ug/0.5ml), the H1N1 vaccine manufactured by Sinovac, before September 15, 2009. Two doses of the vaccine are packaged in one vial. The news has been priced into the stock, obviously.
SVA is trading down almost 3% to $9.17
Douglas A. McIntyre
Sinovac (SVA) Still Most Volatile Biotech
Sinovac Biotech (SVA) is up 20% today to $10.30. It reported that today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac’s H1N1 vaccine, and has issued Sinovac a production license for this vaccine.
Yesterday, the shares dropped on what was considered poor news about its revenue potential in Korea
Sinovac is becoming a dangerous stock for everyone except the most skilled day-traders. In the course of a week of trading, share have moved from $5.78 to $12.11.
Sinovac is starting to become the Vonage (VG) of its industry.
Douglas A. McIntyre
Sinovac (SVA) Drops 15% On Poor Distribution Model
Investors assumes the Sinovac Biotech’s (SVA) new H1N1 virus would get substantial distribution around Asia and get it soon. Instead the company came up with a very small deal and the market was disappointed sending shares down 15% to $8.80.
Sinovac announced an agreement with Boryung Pharmaceutical Company Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible vaccine supply efforts to the government of South Korea for Sinovac’s H1N1 vaccine.
The agreement follows meetings between Sinovac and the Korean Food and Drug Administration (KFDA) and the Korean Center for Disease Control (KCDC) where Sinovac presented the scientific data of Sinovac’s H1N1 vaccine. The deal gives Boryung exclusive rights to represent Sinovac in discussions with the KFDA and KCDC in the development of business opportunities in South Korea surrounding Sinovac’s H1N1 vaccine. The price, volume, delivery schedule and other specific details about how Sinovac’s H1N1 vaccine might be marketed and supplied to the government of South Korea have not been determined.
In other words, it could be a very, very small deal.
Douglas A. McIntyre
Novavax (NVAX) Soars On Flu Vaccine Data
Vaccine maker Novavax (NVAX) traded up 27% to $7.73, a 52-week high.
The firm reported favorable results from a Phase II human clinical trial of its trivalent seasonal influenza virus-like particle (VLP) vaccine candidate. The vaccine was well tolerated and induced robust immune responses against all three influenza strains in the vaccine. These results continue to support the planned study in elderly adults scheduled for the fourth quarter this year and pave the way for Novavax to advance its seasonal influenza VLP vaccine into Phase III studies next year.
Novavax now has a market cap of $700 million.
The stock could give back all or most of its gains if the Phase III trails go poorly.
Douglas A. McIntyre
Cell Therapeutics (CITC), Novarax (NVAZ), Human Genome (HGSI) Move
Several biotechs are trading on huge volume early in the session:
Cell Therapeutics (CTIC) has traded almost four million shares, and is up 2% to $1.69. The Food and Drug Administration accepted its application for review of pixantrone for refractory aggressive non-Hodgkin’s lymphoma, a form of cancer, yesterday. Read more
Pandemic Flu and Swine Flu Study Launches Inovio (INO)
Inovio Biomedical Corporation (NYSE Amex: INO) is not just up big. It is up exponentially as traders are chasing the news reports this morning that its SynCon™ H1N1 influenza DNA vaccines achieved protection against current circulating swine origin influenza A/H1N1 viruses in animal studies. Inovio Biomedical is engaged in the design, development, and delivery of a new generation of DNA vaccines, focused on cancers and infectious diseases.
The company had previously reported some interim data from an ongoing study in a pig model where the SynCon™ based H1N1 vaccines achieved hemagglutination inhibition (HI) titers above the protection threshold in 100% of the vaccinated animals against the swine influenza virus.
Inovio investigators continued that study and tested the immune sera for responses against a virus isolated from the current circulating strain of swine origin influenza A/H1N1. All the animals immunized with the SynCon™ H1N1 vaccine developed HI titers exceeding the 1:40 level commonly associated with protective immunity.
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