Health & Fitness
Wed, February 6, 2013
BENSALEM, Pa.--([ BUSINESS WIRE ])--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of all purchasers of the common stock of ISIS Pharmaceuticals, Inc. (aISISa or the aCompanya) (NASDAQ:ISIS) between March 29, 2012 and October 15, 2012, inclusive (the aClass Perioda).
"imbalance in neoplasms will need to be assessed further in on-going and future studies and post-marketing (if approved)"
ISIS engages in the discovery and development of drugs utilizing antisense technology, primarily to treat cardiovascular, metabolic, severe and rare diseases, as well as cancer. The Complaint alleges that throughout the Class Period the Company and certain of its executive officers issued materially false and misleading statements regarding the safety and efficacy of the Companyas flagship product, Kynamro (mipomersen sodium), for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Specifically, the Complaint alleges that defendants, through a series of materially false and misleading statements regarding the safety and efficacy of the product, and reportedly positive results from Kynamroas clinical trials, conditioned investors to believe that Kynamro would receive approval from the U.S. Food and Drug Administration (FDA).
On October 16, 2012 the FDA published a clinical briefing document raising concerns regarding the safety and efficacy of Kynamro, noting among other things, abnormal growths or neoplasms developed in 3.1% of patients treated with Kynamro, as compared to only 0.9% of patients who took a placebo; that the data submitted by the Company was limited by a small sample size and a short treatment time, and that during the clinical testing two patients treated with Kynamro died of heart attacks and another patient died of acute liver failure. The FDA report concluded that this aimbalance in neoplasms will need to be assessed further in on-going and future studies and post-marketing (if approved),a and that athe potential for a contributing effect of mipomersen cannot be ruled outa in the patient deaths. As a result of these disclosures, ISIS shares declined nearly 22%, to close at $10.27 on October 16, 2012.
No class has yet been certified in this action. Until a class is certified, you are not represented by counsel unless you retain one. If you purchased ISIS common stock during the Class Period, you have certain rights, and have until February 26, 2013 to move for lead plaintiff status. To be a member of the class you need not take any action at this time, and you may retain counsel of your choice. If you wish to discuss this action or have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, Toll Free at (888) 638-4847, or by email to [ howardsmith@howardsmithlaw.com ], or visit our website at [ http://www.howardsmithlaw.com ].
