Big Gains For Pain Therapy Stocks Today: KG, PTIE, WPI, ENDP

So Pfizer is increasing their portfolio with King Pharmaceuticals, a maker of veterinary meds and pain therapies.  In addition to this news, another company came into the spotlight for pain management therapies.  This company is Pain Therapeutics (PTIE).  Pain Therapeutics is in clinical trials now in collaboration with King Pharmaceuticals so look for Pfizer to kick in some clinical trial expertise with Pain Therapeutics (PTIE).  Additional companies involved in pain therapies is Endo Pharmaceuticals.  I highly suggest buying Endo as a buy right now.  Since June 2010 Endo's stock has risen form 20.22 to its current trading at 34.99.  I suggest a limit order to buy at some discount.  Another Pain therapies stock is Watson Pharmaceuticals, a generic drug maker. 

My opinion on this is that Pain Therapeutics could be slightly overvalued on the hyped news, and although it may seem attractive to buy right now, I suggest waiting for the pullback as it will be years before these clinical trials are actually approved by the FDA.  Also, I am a little cautious placing a buy on Pfizer right now as they will be losing patents on Lipitor next year and other brand name drugs will become available as generics.  I might actually place Pfizer's stock right now on hold or sell, as earnings could be lower than expected.  Just because everyone is doing it does not make it a buy in my opinion. I actually do not necessarily see King Pharmaceuticals as such a hot buy with only 4.85% profit margin and 18M in profits on 380M in revenue.  But given that layoff will presume who knows. 

Stick to your guns and remain a cautious investor and good things will come.  I apply Warren Buffett's principles to the BioPharma Stock World and like purchasing stocks at a discount.  You should be searching for the next Pfizer and not chasing after something that is overly hyped.  Just my opinion.

Stocks mentioned in this article

Pfizer--(PFE)
King Pharmaceuticals --(KG)
Endo Pharmaceuticals --(ENDP)
Pain Therapeutics --(PTIE)  Up 18.56% today on the news
Watson Pharmaceuticals--(WPI)

Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

Stem Cell Focus from Geron Corporation( GERN) and International Stem Cells (ISCO)

July 06, 2009 07:30 AM Eastern Daylight Time
Geron Scientists and Collaborators Publish Data Showing Functional Dendritic Cells Can Be Derived from Human Embryonic Stem Cells Using Scalable Production Methods
Study Supports Potential for Off-the-Shelf Dendritic Cell Vaccine Development

MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq:GERN) today announced the publication of data demonstrating that dendritic cells (DCs) scalably manufactured from human embryonic stem cells (hESCs) exhibit the normal functions of naturally occurring human DCs found in the bloodstream. These findings support the use of hESC-derived DCs in therapeutic vaccine applications for cancer and other diseases. Substituting standardized, off-the-shelf hESC-derived DCs for current approaches using DCs obtained from individual patients may result in more cost effective and reliable approaches to cancer immunotherapy.

The study, authored by Geron scientists and collaborators Prof. Waldmann and Dr. Fairchild at the Sir William Dunn School of Pathology, University of Oxford, appears online in advance of print in the journal Regenerative Medicine. The abstract of the publication is available at: http://www.futuremedicine.com/doi/abs/10.2217/rme.09.25.

Dendritic cells (DCs) are immune cells that detect pathogens (e.g. viruses or bacteria) and activate other immune cells (called T-cells) to launch an immune attack against the pathogen. DCs reside in small numbers within most tissues, particularly where there is contact with the external environment, such as the skin or gut. DCs will engulf and digest a foreign pathogen and present pieces of pathogen proteins (known as antigens) on the cell surface. The presentation of antigen by DCs activates the T-cell immune response directed against that pathogen. In a similar manner, dendritic cells can also educate the immune system to initiate an immune response against aberrant cells in the body, such as tumor cells.

The data in the Regenerative Medicine publication show that immature hESC-derived DCs are able to take up, process and present antigens, and then, following maturation in the manufacturing process, are able to migrate, produce pro-inflammatory cytokines and induce specific immune responses to both tumor and viral antigens in vitro. These data show that hESC-derived DCs display the functions of human DCs taken from the bloodstream.

The potential for DCs to stimulate potent and specific immune responses is being explored in clinical trials of DC vaccination protocols for the treatment of malignant and infectious diseases. “We are using a DC platform with our cancer vaccine directed against telomerase, GRNVAC1, currently in Phase II studies in AML,” said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. “However, GRNVAC1 and other therapies currently in development, use DCs that are generated from individual patients. Autologous cell treatments are costly to manufacture and difficult to control. Variation between individuals and the effects of their disease and prior treatments can affect vaccine potency. We are therefore developing a second generation cancer vaccine, GRNVAC2, based on DCs derived from hESCs to generate a scalable, reliable, off-the-shelf product, free from individual patient variability.”

“The data in the current study demonstrate that DCs derived from hESCs are immunogenic and can be developed as a scalable and consistent source of DCs for immunotherapies,” said Jane S. Lebkowski, Geron’s senior vice president and chief scientific officer for regenerative medicine. “Importantly, the production protocol is defined, and does not use serum or feeder cells, an important condition for large scale production and therapeutic development.”

The defined protocol for generating hESC-derived DCs described in the current study is a stepwise process in which hESCs are first differentiated into monocytic cells, and then converted to immature DCs. Subsequent exposure to a cocktail of maturation factors generates mature hESC-derived DCs that express surface proteins and morphological characteristics typical of mature DCs derived from peripheral blood monocytes (PBM).

The data in this study show that mature hESC-derived DCs produce a number of cytokines important for T-cell stimulation, including IL-12p70, and stimulate allogeneic T-cell proliferation when co-cultured with peripheral blood mononuclear cells in a mixed leukocyte response (MLR) assay. Another key function of DCs is their ability to migrate from the site of antigen uptake to the lymph nodes in response to chemical signals. Migratory response of mature hESC-derived DCs was comparable to PBM-derived DCs in an in vitro chemotactic assay using the chemokine MIP3β.

When a dendritic cell presents an antigen to a T-cell in vivo, it stimulates the T-cell to produce inflammatory cytokines and causes antigen-specific T-cell proliferation. In the current study using mumps, cytomegalovirus, and telomerase antigens in three separate series of experiments, the hESC-derived DCs stimulated antigen-specific T-cell proliferation in each case, a prerequisite for effective in vivo immunotherapy.

“We are very enthusiastic about these data,” said Paul J. Fairchild, Ph.D., Co-Director of the Oxford Stem Cell Institute, within the James Martin 21st Century School, University of Oxford. “Allogeneic dendritic cells have great potential as a new vaccine and immunotherapy platform that could have therapeutic value across a range of infectious diseases as well as cancer.”

Geron holds a broad-ranging intellectual property portfolio relating to DC-based immunotherapies. The portfolio includes a worldwide exclusive license to patents owned by the University of Oxford covering the differentiation of DCs from hESCs, and Geron’s own patent filings for optimized and scalable production methods of hESC-derived DCs. It also includes co-exclusive rights to patents owned by the Rockefeller University covering methods relating to maturation of DCs in vitro as well as patents owned by Duke University covering the introduction of antigen encoding mRNA into dendritic cells for immunotherapeutic applications. These co-exclusive rights were conveyed to Geron in a 2004 license agreement with Argos Therapeutics (formerly Merix BioScience, Inc.). In addition, Geron owns intellectual property rights covering key aspects of scalable manufacturing of hESCs as well as a license to foundational hESC patents held by the Wisconsin Alumni Research Foundation.

About Geron GERN
Yahoo Finance Quote:
http://finance.yahoo.com/q?s=GERN

Geron is a biopharmaceutical company that is developing first-in-class therapeutic products for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The products are based on our core expertise in telomerase and human embryonic stem cells. For more information about Geron, visit www.geron.com.


On a side note here is another Stem Cell Focus with Stem Cells International

Stock Quote: ISCO

Here is their yahoo Finance page:
http://finance.yahoo.com/q?s=isco.ob&d=t

July 06, 2009 08:15 AM Eastern Daylight Time
International Stem Cell Corporation Secures $5 Million Financing Commitment
OCEANSIDE, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB:ISCO), has entered into a definitive agreement for a $5 million investment commitment (the “Investment”) with a biotechnology-focused fund (the “Investor”) that has offices in New York and California. The Investment will be used to fund operations and working capital needs of the company and expand its scientific research. Proceeds of the investment provide a valuable addition to the company’s capital structure. Together with the private capital already committed to the company and its internally generated revenue, these funds are expected to provide the capital needed by ISCO for the balance of 2009 and a significant amount of the capital expected to be needed in 2010.

The Company may draw down funds from the Investor as it finds a need, but is not obligated to do so. Funds will be drawn down through the issuance of Series E Preferred Stock (the “Preferred Stock”). The Preferred Stock will not be convertible into common stock and may be redeemed by the Company after one year. Each issue of Preferred Stock will be accompanied by the issuance of five-year warrants to purchase common stock at 100% of the closing price of the company’s common stock on the day prior to the date the company gives notice of its election to draw funds. The total exercise value of warrants issued will equal 135% of the drawdown amount. Dividends on the Preferred Stock are payable in additional shares of non-convertible Preferred Stock at the rate of 10% per annum. A commitment fee of $250,000, payable in shares of common stock, was made to the Investor.

“The flexibility of this financing will add greatly to our financial strength,” commented Kenneth Aldrich, CEO and Chairman of ISCO. “We are pleased that we have secured a financing source that will be available to us at the time of our own choosing over the next year.”

For more news and information on International Stem Cell Corporation please visit www.IRGnews.com/coi/ISCO where you can find the CEO’s video, a fact sheet on the company, investor presentations, and more.

ABOUT INTERNATIONAL STEM CELL CORPORATION (ISCO.OB):

International Stem Cell Corporation is a California biotechnology company focused on developing therapeutic and research products. ISCO’s technology, Parthenogenesis, results in the creation of pluripotent human stem cell lines from unfertilized human eggs. ISCO scientists have created the first Parthenogenetic homozygous stem cell line (phSC-Hhom-4) that can be a source of therapeutic cells that will minimize immune rejection after transplantation into hundreds of millions of individuals of differing sexes, ages and racial groups. These advancements offer the potential to create the first true “Stem Cell Bank” and address ethical issues by eliminating the need to use or destroy fertilized embryos. ISCO also produces and markets specialized cells and growth media worldwide for therapeutic research through its subsidiary Lifeline Cell Technology. For more information, visit the ISCO website at: www.internationalstemcell.com.

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