Isis to Receive Up to $14 Million from Pfizer for Its Acquisition of Excaliard Pharmaceuticals

Added Pfizer Resources to Support Clinical Progress of EXC 001 in Scarring

CARLSBAD, Calif., Nov. 22, 2011 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it will receive up to $14 million from Pfizer Inc. (NYSE: PFE) for its equity ownership of Excaliard Pharmaceuticals, Inc. from Pfizer's acquisition of Excaliard.  Upon closing of the acquisition, Isis will receive an initial $4.4 million.  Contingent payments of up to an additional $9.6 million could be paid to Isis upon achievement of various milestones associated with the clinical and commercial progress of EXC 001.  In addition, Isis will continue to be eligible for milestone and royalty payments under its licensing agreement with Excaliard for EXC 001.  The acquisition of Excaliard by Pfizer exemplifies the potential of Isis' strategy to partner antisense drugs in diseases that are outside of Isis' main therapeutic areas of focus and benefit financially from these partnerships.

"Our business strategy allows us to exploit our antisense drug discovery platform to create many opportunities outside of our core areas of therapeutic focus.  We have been extremely successful in implementing this unique strategy.  To date, we have generated more than $450 million from our satellite company partners.  Our partnership with Excaliard and their development of EXC 001 is the most recent example of the success of this strategy," said B. Lynne Parshall, J.D., Chief Operating Officer, Chief Financial Officer and Secretary at Isis.  "The local treatment of fibrosis for scarring is an area outside our key focus and, as such, is not one we would have pursued internally.  We chose instead to partner with Excaliard, a company with focused therapeutic expertise in this area.  Using its own resources and expertise, Excaliard has rapidly advanced EXC 001 to Phase 2, creating a strong clinical data package for this potentially breakthrough therapy.  Pfizer will provide additional drug development expertise and experience to support the continued advancement of EXC 001.  The market opportunity to treat disfiguring scars is very large, and we are pleased to have created an opportunity to participate in it through EXC 001 and Excaliard."

"CTGF has been an interesting target for fibrosis for years, and now we have the clinical data that Excaliard generated with EXC 001, which shows the importance of CTGF for the treatment of fibrotic disorders," said Brett Monia, Ph.D., Vice President, Drug Discovery and Corporate Development at Isis.  "We have been successfully pursuing systemic applications for CTGF, which differs from the local applications pursued by Excaliard, to treat a range of fibrotic diseases and look forward to advancing our program toward clinical development."

Isis and Excaliard entered into a collaboration in 2007 to discover and develop antisense drugs for the local treatment of fibrotic diseases, including scarring.  Excaliard is a private company funded by Rivervest Venture Partners, Alta Partners, Proquest Investments and Isis.  EXC 001 was co-discovered by Isis and Excaliard and developed by Excaliard for the treatment of skin scarring.  EXC 001 targets connective tissue growth factor, or CTGF, a growth factor that is over-expressed in damaged skin or tissue following a traumatic event.  In early 2011, Excaliard reported positive data from three Phase 2 studies demonstrating that EXC 001 significantly reduced scar severity in both hypertrophic and fine line scarring.  EXC 001 was safe and well tolerated in all subjects and is currently being evaluated in a Phase 2b study in patients following breast scar revision surgery.

ABOUT ISIS PHARMACEUTICALS, INC.

Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners.  Isis' broad pipeline consists of 25 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic and severe and rare/neurodegenerative diseases, and cancer.  Isis' partner, Genzyme, plans to commercialize Isis' lead product, mipomersen, following regulatory approval, which is expected in 2012.  Isis' patents provide strong and extensive protection for its drugs and technology.  Additional information about Isis is available at www.isispharm.com.

ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT

This press release includes forward-looking statements regarding Isis' collaboration with Excaliard, Inc., and its financial and business development activities, and the development, activity, therapeutic and commercial potential and safety of EXC 001.  Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs, including the planned commercialization of mipomersen, is a forward-looking statement and should be considered an at-risk statement.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs.  Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2010 and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.

In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries, including Regulus Therapeutics Inc., its jointly owned subsidiary.

Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc.

 

SOURCE Isis Pharmaceuticals, Inc.

Posted: November 2011


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