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ISIS > SEC Filings for ISIS > Form 8-K on 21-Aug-2014All Recent SEC Filings

Show all filings for ISIS PHARMACEUTICALS INC

Form 8-K for ISIS PHARMACEUTICALS INC


21-Aug-2014

Other Events


Item 8.01. Other Events.

On August 21, 2014, the first infant received their first dose of ISIS-SMNRx in the Isis Pharmaceuticals, Inc. ("Isis") Phase 3 study, ENDEAR, which is evaluating ISIS-SMNRx in infants with spinal muscular atrophy (SMA). Isis earned an $18 million milestone payment from its development partner, Biogen Idec International Holding Ltd as a result of Isis' achievement of this milestone event. The ENDEAR study, is the first Phase 3 clinical study for ISIS-SMNRx. Isis plans to initiate a second pivotal study in children with SMA later this year and additional studies are in the planning stages. Additional information regarding the ENDEAR study may be found at the following website:
http://clinicaltrials.gov/ct2/show/NCT02193074. Any information that is included on or linked to the foregoing website is not part of this current report or any registration statement or report that incorporates this current report by reference.

ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT

This current report includes forward-looking statements regarding Isis' alliance with Biogen Idec International Holding Ltd and the development of ISIS-SMNRx for the treatment of spinal muscular atrophy. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs 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, 2013, 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 Isis.


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