Biotech Values

[DewDiligence]

Torcetrapib R.I.P.—an unmitigated disaster for PFE.
The timing could not possibly have been worse, coming
a mere two days after PFE spent hours telling Wall
Street how confident they were in this program. Will
the Esperion program (#msg-15219428) now see a
sudden renaissance?

http://biz.yahoo.com/prnews/061202/nysa014.html?.v=51

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In Interests of Patient Safety, Pfizer Stops All Torcetrapib Clinical Trials; Company Has Notified FDA and is in the Process of Notifying All Clinical Investigators and Other Regulatory Authorities

Saturday December 2, 9:11 pm ET

Decision Based on Recommendation Received Today of Independent Data Safety Monitoring Board for ILLUMINATE Trial; Pfizer Will Discontinue Development of Compound

Pfizer Reaffirms Financial Guidance into 2009

Pfizer to Accelerate Timetable for Transformation of Operations; Will Invest in Diverse Range of Pipeline and External Opportunities

NEW YORK, Dec. 2 /PRNewswire-FirstCall/ -- Pfizer Inc said that in the interests of patient safety it is stopping all torcetrapib clinical trials and that it has informed the Food and Drug Administration. The Company is in the process of notifying all clinical investigators in the program as well as other regulatory authorities.

The Company was informed today that the independent Data Safety Monitoring Board (DSMB) monitoring the ILLUMINATE morbidity and mortality study for torcetrapib recommended terminating the study because of an imbalance of mortality and cardiovascular events.

The Company has terminated ILLUMINATE and is in the process of asking all clinical investigators conducting trials in this development program to inform patient participants to stop taking the study medication immediately. THE COMPANY HAS ALSO ENDED THE DEVELOPMENT PROGRAM FOR THIS COMPOUND [emphasis added].

Dr. Philip Barter, Director of the Heart Research Institute in Australia and Chairman of the Steering Committee overseeing the ILLUMINATE study, said, "Based on all the evidence we have seen regarding torcetrapib and in light of prior study results, we were very surprised by the information received from the DSMB, the only body with access to the unblinded safety data. We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug."

Pfizer's Chief Executive Officer Jeffrey B. Kindler said, "While the DSMB information we received today was both surprising and disappointing, our focus is on the best interests of patients and making sure all this information is communicated to appropriate medical and regulatory authorities as quickly as possible.

"With regard to our business, we understand the challenge that this represents and we will respond quickly and aggressively to it. It is important to put this information in the context of both our commitment to transform Pfizer and our overall product and financial strength," Mr. Kindler added.

He emphasized three key points:

* First, Pfizer has a broad and diverse in-line and new product portfolio, as well as substantial operating and financial strength.

Our financial guidance for 2006 is unchanged. As well, we continue to forecast revenues in 2007 and 2008 that are comparable to 2006, a return to revenue growth in 2009, and high single-digit average growth in adjusted diluted EPS(1) over the next two years. We will further enhance total returns to shareholders through dividends and share purchases.

* Second, Pfizer's previously announced plan for transforming the company will now be accelerated. Pfizer will focus on its core research and development, manufacturing and commercial operations, as well as procurement and other areas, to improve efficiency and lower its costs as expeditiously as possible.

* Notwithstanding the acceleration of the Company's transformation, Pfizer's substantial financial strength will enable it to continue to invest in a wide range of pipeline opportunities across a diverse range of therapeutic areas, capitalizing on the largest pipeline in its history. It will bring forward these major new product opportunities as aggressively as possible. In addition, Pfizer will bring increased focus and emphasis to its business development and licensing efforts in order to identify new products and technologies that will supplement its pipeline. As a result, Pfizer continues to target the introduction of about six new products a year starting in 2010.

It is important to note that in the ILLUMINATE trial, Lipitor was used as a comparator for safety and efficacy. It is the most studied statin in reducing cardiovascular outcomes. "The only reason the study was stopped early was due to the torcetrapib data. The ILLUMINATE Steering Committee wants to reassure physicians and patients that nothing in today's information has any impact on the safety or efficacy of Lipitor whatsoever," said Dr. Barter.
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