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Interesting Transaction

May 6, 2008

Analysis of:Esperion Therapeutics Completes $22.75 M Series A Financing | www.pipelinereview.com

Pfizer attempts to leverage their original purchase by a sale of assets and retention of portions of the Esperion assets.  They appear to be retaining a portion of the research of the company while divesting the remaining technology.  They are keeping a small equity position in Esperion which will allow them to recapture their investment and possibly make money.  They are keeping a select focus of research which may allow them to have a cardiovascular product in the future which fits their franchise. The funds which are part of this transaction are all highly experienced and first rate.  There is no way they would be part of such an arrangement unless they expect to make money!  The ability of Esperion to raise capital around the remaining technologies will allow for continued development of those technologies which Pfizer appears to not be willing to support.  This is not unexpected since Pfizer has their own financial issues to manage.  I makes a lot of sense.

It Remains to Be Seen

May 6, 2008

Analysis of:Can biologic drugs tackle antibiotic resistance? | www.pharmaceutical-business-review.com

Microbes have a remarkable ability to mutate to allow for their survival.  Biologics can introduce new means of treating invections, but are unlikely to overcome the ability of them to become resistant.  Several biological components have been studied by companies and claim lack of resistance. These were mostly designed to have a lack of specificity thus causing greater toxicity to the patient.  As soon as specificity for the microbe is introduced, the microbe will have an ability to mutate away from suchs specificity. While it is not possible to be absolutely certain, the short term treatments will likely work as they are new agents.  The long term view is the microbes will mutate to become resistant to the new agents.

Stem Cell Reseach - A step in the right direction

April 14, 2008

Analysis of:FDA to take key step in stem cell research | money.cnn.com

Stem cells have a great potential for a wide range of medical treatments.  Laying out the direction to allow for clinical studies is an important step. Cancer Stem cell research is a new area where modulation of stem cell activity may prevent metastatic events.  The FDA's concern for embryonic stem cells being a cause for cancer in some patients is a real concern.  On the other hand, finding a way to modulate the activity of stem cells can lead to a cancer treatment. While there are concerns about loss of life of unborn children, the ability to save lives is a trade off.  The FDA's steps are in the right direction and evaluating stem cell benefits is an important research area.

Galaxo's Win is a Win for The Industry

April 14, 2008

Analysis of:Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office | biz.yahoo.com

It often takes several attempts to finalize the Patent Claims and language to satify the examiner.  The limitation of such attempt would place an undue burden on companies and would certainly result in loss of coverage of Intellectual Property (IP). Loss of IP results in reduction of a company desire to commercialize a new pharmaceutical product.  The costs associated with such a launched product from New Chemical Entity to Final Product is so Great that the lack of exclusiveness will prevent some drugs from making it to market. The IP stable is absolutely critical to profits.  Generics will compete too soon when IP is not covering the products.  Why launch a product costing more than $500MM to develop when a Generic will cut into profits if IP does not prevent it. The Win by Glaxo is a Win for the industry.

Vytorin resolution not soon

April 8, 2008

Analysis of:The Vytorin Saga Continues: Krumholz Strikes Back | www.pharmalot.com

Development of plaque in arteries takes place over a lifetime.  There have been studies suggesting plaque removal can happen over shorter periods, but data demonstration that this solves medical problems is not available.  Complicatons like heart attacks come from the unstable plaque pealing off and resulting in a clot.  Reduction of cholesterol and LDL are indicators, but a definative study is needed to document that Vytorin decreases medical complications or death.  Such data would certainly be expected to lead to ehnance product use by physicians.  The problem is that such studies will take a few years to get data satisfactory to convince most physicians.

Bigger is not always better

April 8, 2008

Analysis of:Investor chief questions role of Big Pharma in development of medicines | business.timesonline.co.uk

Larger R&D is important to developing products which have large capital requirements and need for large groups.  Smaller groups can act much faster when developing products with managable resouce needs.  Smaller groups working independently from a large corporation have several means of rasing the required capital via independent funding mechanisms.  This can reduce capital risks of a larger corporation while increasing speed. It may require licensing technologies from these smaller groups but this means a larger company can have a proof of concept prior to taking the product through its final development stages.  When averaged out over the failures in large pharma, the costs of acqusition versus internal development is an important consideration.  I usually opt for smaller groups vs larger.

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