Forest expects FDA approval of its ischemic stroke agent desmoteplase by 2009, Exec VP-Scientific Affairs Lawrence Olanoff said during SG Cowen's Annual Health Care Conference in Boston March 16.

The company recently commenced a Phase IIb/III dose-ranging study for the novel plasminogen activator (or "blood clot buster") in 150 patients. The study, DIAS2 (Desmoteplase in Acute Ischemic Stroke), is intended to confirm efficacy results seen in Phase II.

DIAS2, which could be a pivotal study from a filing standpoint, is expected to take one year to recruit, with top-line results out five months after recruitment is completed, Olanoff said.

Forest would then quickly move into Phase III. "We're already making arrangements so we can move right into a Phase III program within a few months of that time period," he said.

Forest expects to be in a position to file for approval in early 2009; the company previously had predicted a filing in 2007.

Earlier studies confirmed desmoteplase's nine-hour treatment window for acute ischemic stroke, which is three times longer than Genentech's Activase . The standard three-hour window means the majority of patients are not eligible for treatment, Forest said.

If approved, desmoteplase could greatly expand the market. "From our early experience, about 80% of patients that come through the door within that [nine-hour time] window will ultimately be treatable," Olanoff told investors.

The Phase II DEDAS study showed trends indicating that intravenous desmoteplase administered within nine hours of onset of a stroke improved blood flow in the damaged area of the brain and improved clinical outcome after 90 days versus placebo, the company said.

Forest in-licensed desmoteplase from Aachen, Germany-based PAION in July 2004 (¹ Also see "Forest Bites At Stroke Clot Dissolver; Desmoteplase Could Have Nine-Hour Treatment Window" - Pink Sheet, 6 July, 2004.). The biologic is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat.

Desmoteplase is one of a handful of late-stage pipeline products that could be filed later in the decade. Forest expects to be in a quiet period over the next couple of years, free from the "distractions" of product approvals, Olanoff said.

Forest is also developing the dual norepinephrine-serotonin reuptake inhibitor milancipran as a treatment for fibromyalgia; Phase III studies are underway. The company licenses the product from Cypress Bioscience.

In Alzheimer's disease, Forest is conducting two studies on neramexane , which is the follow-on agent to Namenda (memantine).

Forest will determine by mid-year whether to continue development of the drug; an earlier Phase III study of neramexane in combination with acetylcholinesterase inhibitors did not meet efficacy endpoints (² Also see "Forest To Test Alzheimer’s Drug Neramexane As Monotherapy in Phase II/III Trial" - Pink Sheet, 31 August, 2004.).

Information on Forest-sponsored clinical trials can be found at ³ www.forestclinicaltrials.com. The company launched the website in February pursuant to a consent decree with New York Attorney General Eliot Spitzer (⁴ Also see "Forest Clinical Trials Registry Launches With Antidepressant Data" - Pink Sheet, 8 February, 2005.).

- Kate Rawson

Desmoteplase Approval For Stroke Expected In 2009, Forest Says

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