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Biotech / Medical : Sepracor-Looks very promising -- Ignore unavailable to you. Want to Upgrade?


To: dfloydr who wrote (1292)10/14/1998 8:29:00 AM
From: BMcV  Read Replies (1) | Respond to of 10280
 
biz.yahoo.com

Sepracor Initiates (R)-Fluoxetine Clinical
Trials Phase I Studies Underway on
Single-Isomer Version of Prozac(R)

MARLBOROUGH, Mass., Oct. 14 /PRNewswire/ -- Sepracor Inc. (Nasdaq: SEPR - news) today announced that Phase I
clinical trials on (R)-fluoxetine, a single isomer of racemic fluoxetine, are underway. Racemic fluoxetine, marketed as
Prozac(R) by Eli Lilly and Company [NYSE:LLY - news], is the leading treatment for depression with worldwide sales of
$2.6 billion in 1997.

Fluoxetine is a racemic mixture, consisting of two isomers. Sepracor's single-isomer version, (R)-fluoxetine, has been
shown in preclinical studies to have the potential to treat depression while offering treatment flexibility due to a possible
shorter half-life, which may enable rapid switching of concomitant drug therapies and eliminate drug-drug interaction
problems. These potential benefits may offer greater suitability for treating the elderly, pediatric and adolescent patient
groups. Sepracor's (R)-fluoxetine may also be well suited for the treatment of new indications such as premenstrual
syndrome (PMS) and treatment of patients with eating disorders such as bulimia, anorexia nervosa and obesity.

''We are excited to begin clinical development of (R)-fluoxetine,'' said Dr. Paul D. Rubin, Senior Vice President, Drug
Development. ''(R)-fluoxetine has the potential to become a successful new option for treating depression, while also
offering the potential for additional indications. This compound is an important asset in Sepracor's portfolio of central
nervous system drug candidates.''

The Company will conduct a series of clinical pharmacology studies to evaluate the safety and efficacy of successively
ascending single doses of (R)-fluoxetine. In addition, Sepracor plans to conduct further tolerability, combination therapy,
special population and drug-drug interaction studies.

Selective serotonin reuptake inhibitors (SSRIs), which include Prozac (fluoxetine) and other compounds, are prescribed as
first-line therapy for the treatment of depression. In 1997, worldwide sales of SSRIs were approximately $6.5 billion.