Patient Recruitment for Desmoteplase Phase IIB/III Stroke Study DIAS-2 Placed on Hold
Public Company Information:
Forest Laboratories, Inc. (NYSE: FRX) and its development partner for desmoteplase, PAION AG (Aachen, Germany), today announced that the Steering Committee of the Phase IIB/III stroke study, DIAS-2, has decided in agreement with the Companies to place patient recruitment temporarily on hold until further data have been analyzed. The DIAS-2 study is evaluating PAION's drug candidate desmoteplase in patients with acute ischemic stroke.
The Steering Committee followed a recommendation by the independent Data Monitoring Committee (DMC). The DMC had requested additional data in order to facilitate the evaluation of a potential safety signal, which was not specified further by the DMC. The DMC had notified the Steering Committee in its statement that no conclusion on the safety or efficacy of desmoteplase should be drawn based upon this recommendation. The requested data has been processed and will be provided to the DMC within the next day.
Desmoteplase, the most specific plasminogen activator known today, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. Currently in Phase III, Desmoteplase has been successfully tested in two independent Phase II studies for the treatment of acute ischaemic stroke between 3 and 9 hours after onset of symptoms and has received fast-track designation from the U.S. Food and Drug Administration.
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical company dedicated to identifying, developing, and delivering products that make a positive difference in peoples' lives. Forest Laboratories' growing product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl- D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product, each indicated for the treatment of hypertension; and Campral(R)* (acamprosate calcium), indicated in combination with psychosocial support for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company's SEC reports, including the Forest Laboratories, Inc.'s Annual Report on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for the period ended June 30, 2006. and Replidyne, Inc.'s Prospectus on Form S-1 and on Form 10-Q for the period ended June 30, 2006.