KARO BIO ANNOUNCES THAT MERCK & CO., INC. PLANS TO PROCEED WITH PHASE II CLINICAL EVALUATION OF CANDIDATE COMPOUND
STOCKHOLM, SWEDEN, November 26, 2009. The Swedish biotech company Karo Bio (Reuters: KARO.ST) today announced that Merck & Co., Inc., through an affiliate, plans to enter a clinical phase IIa trial with the collaboration's lead investigational drug candidate, MK-6913, identified as part of their joint research collaboration. No milestone payment to Karo Bio is associated with the initiation of phase II clinical development.
The randomized, double-blind, placebo- and active-controlled study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes/hot flushes) in postmenopausal women. It is estimated that 300 patients will be enrolled in the study. ''We strongly believe that novel compounds targeting the estrogen receptor continue to hold great potential in the field of women's health”, commented Per Olof Wallström, President & CEO of Karo Bio. The collaboration with Merck targets estrogen receptors with the aim to develop novel treatments in the field of women’s health. The joint drug discovery phase of the collaboration with Merck was completed in 2002. MK-6913 is the first such estrogen receptor compound arising from the collaboration to enter Phase II. Under the terms of the collaboration agreement, Merck has the exclusive worldwide rights to all compounds identified during the collaboration and is responsible for their further preclinical and clinical development. Karo Bio has the rights to certain milestone payments from Merck based upon the further successful clinical development of the compound and final drug approval. Karo Bio also has the rights to royalties on future drug sales. The announcement today does not trigger a milestone payment to Karo Bio. For more information please contact: Per Olof Wallström, President Tel: +46 8 608 60 20 E-mail: p.o.wallstrom@karobio.se Erika Söderberg Johnson, CFO and responsible for Investor Relations Tel: +46 8 608 60 52 E-mail: erika.soderberg.johnson@karobio.se About Karo Bio Karo Bio is a drug discovery and development company specializing in endocrinology and targeting nuclear receptors as target proteins for the development of novel pharmaceuticals. The company has a project portfolio with innovative molecules that primarily target dyslipidemia, CNS-disorders, inflammation, and women’s health. In these areas, there are significant market opportunities and a clear need for pharmaceuticals with new mechanisms of action. Karo Bio develops compounds aimed at treating broad patient populations up to clinical proof of concept before out-licensing. In therapeutic niche areas, Karo Bio has the capacity to bring selected compounds into late stage clinical development and, potentially, to the market. In addition to the proprietary projects, Karo Bio has three strategic collaborations with international pharmaceutical companies for development of innovative therapies for the treatment of common diseases. Karo Bio is listed on NASDAQ OMX Stockholm since 1998 (Reuters: KARO.ST). This press release is also available online at: www.karobio.com and www.newsroom.cision.com