Does Amgen Have a Genentech-Like Cancer Arsenal? (AMGN, MRK, RHBY, DNDN)

September 29, 2010 · Filed Under Anemia, Cancer, dendreon, fda, osteoporosis, R&D, vaccine · Comment 

Amgen Inc. (NASDAQ: AMGN) may have a recent trading history of being dead money.  There is at least a small chance that this could finally change through time.  If the implications end up coming to fruition, Amgen could be sitting on perhaps what could be the next Avastin-like franchise.

Two recent pre-clinical mice studies show that the osteoporosis drug Prolia from Amgen may actually treat breast cancer in a manner that is separate from its bone-related function.  While you will hear “may” and “could” a lot, this is something to watch for Amgen due to a long-standing range bound stock price.

Bisphosphonates as a class, from Merck & Co. (NYSE: MRK) with Fosamax and even from Roche Holding AG (RHHBY) with Boniva, could reduce the risk of breast cancer.

Prolia was approved in June as an osteoporosis treatment and it is expected to add to the growth of the biotech giant.  Amgen is seeking to expand its approval for the bones of cancer patients. Additional data is not expected until late in 2010.  Prolia is already approved to treat osteoporosis, but Amgen also has filed for FDA approval to help bone complications in cancer patients at much higher doses.

One study published by the journal Nature showed that RANK Ligand and its receptor seemingly play a key role in hormone-induced breast cancer and the study shows an indication so far that it decreased and delayed breast cancer onset.

Another Nature article may be a bit more pointed or less independent due to ties with Amgen.  That article follows the same lines and implies that the blocking RANK Ligand lowers or weakens breast tumor development.

The implication today is that the studies suggest that Prolia could actually help to delay or prevent cancer rather than just treating bone-related issues that come up in cancer treatment.

Whether Prolia is a Holy Grail treatment is not going to be known in the immediate future.  Maybe years.  Amgen is in a long-term clinical study aimed at testing Prolia’s efficacy in early stage breast cancer that has a higher risk of recurrence and the study will measure if Prolia extends the time period that women live before breast cancer returns and before it ultimately spreads into bones.

Why do we call this an Avastin-like ‘potential’ franchise?  Amgen is still studying whether or not the drug helps to prevent advanced prostate cancer (in men, obviously) from metastasizing and entering the bone structure.  That data is also due in the fourth quarter per our expectations.  Treating cancers in men and women can often be very different because of hormonal differences.  If Prolia is a success in one cancer, the theory would be that it has other cancer treatments in hiding.

Again, all of these points are highly dependent upon success from the start, and human data often is grossly different than in mice, monkeys, and in static environments.

Dendreon Corporation (NASDAQ: DNDN) and others have signaled multiple cancer treatments from the same process. Dendreon noted that other cancer cell antigens play a role in immune reactions that may help the body’s resistance against cancer and noted that CA9 is present on approximately 75% of cervical and colon cancers and 95% of renal cancers.  It also noted that the carcinoembryonic antigen is present on 70% of lung cancers, virtually all cases of colon cancer and about 65% of breast cancers. Does that mean a treatment for one is a treatment for another?  No, but it keeps the door open to endless treatment avenues.  Oncolgists have always said that each person’s cancer treatment will vary drastically from another’s.

IF… THEN… Amgen finds itself in a giant “IF THEN” scenario.  The good news is that these revenues are not apparently factored in for finite revenues in the years beyond 2011.  New potential uses can bring great expansion in revenues.  It has happened with Avastin, and ultimately Genentech was acquired.

Amgen may be too large to ever be acquired because its market cap is roughly $52.5 billion.  At $54.75, its 52-week trading range is $50.26 to $61.85.  Amgen peaked around $80 in 2005 to 2006 and the trading band since early 2007 has for all practical  purposes been $50 to $60 for most of the time.  There is also a value component here despite its market cap.   Thomson Reuters has estimates of $5.11 EPS and $15.02 billion in revenues for 2010 and $5.38 EPS and $15.43 billion in revenues for 2011.

How many biotech stocks trade at 10 to 11 times earnings?  Not many.  That is why we have called Amgen the biotech that trades like a stodgy Big Pharma company rather than a growth biotech stock.

Visit NATURE article #1
Visit NATURE article #2

JON C.  OGG

Novartis Expands China Vaccine Investments (NVS)

November 4, 2009 · Filed Under Financial, flu, M&A, vaccine · Comments Off 

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)

November 3, 2009 · Filed Under flu, vaccine · Comments Off 

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)

October 12, 2009 · Filed Under Cancer, dendreon, Financial, General, vaccine · Comments Off 

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

September 10, 2009 · Filed Under fda, vaccine · Comments Off 

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

September 4, 2009 · Filed Under flu, vaccine · Comments Off 

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

September 3, 2009 · Filed Under flu, vaccine · Comments Off 

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

September 2, 2009 · Filed Under flu, vaccine · Comments Off 

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

September 1, 2009 · Filed Under flu, vaccine · Comments Off 

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

August 25, 2009 · Filed Under flu, vaccine · Comments Off 

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

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