News

Basel, Switzerland, March 11, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that the Applicant Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, has submitted a request for re-examination of the negative opinion by the European Committee for Medicinal Products for Human Use (CHMP) on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).

Basel, Switzerland, February 24, 2010 - Basilea (SIX:BSLN) announced today that Basilea Pharmaceutica International Ltd. has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. (TSE:4503) for Basilea's azole antifungal agent isavuconazole in phase III clinical development for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan.

Basel, Switzerland, February 19, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that after the negative decision by the CHMP today, Cilag GmbH International, a Johnson & Johnson company, has given notice that it will return global rights of ceftobiprole to Basilea.

Basel, Switzerland, February 19, 2010 -  Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).

Basel, Switzerland, January 29, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that based on a futility analysis of the isavuconazole phase III trial for the treatment of invasive Aspergillus infections, the Independent Data Safety Monitoring Board (IDSMB) has recommended the continuation of the study.

Basilea Pharmaceutica Ltd. announces that the U.S. Food and Drug Administration (FDA) issued to the sponsor, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (Johnson & Johnson PRD), a Complete Response Letter on ceftobiprole for the treatment of complicated skin and skin structure infections (cSSSI).

Basilea Pharmaceutica Ltd. announces that Toctino^® (alitretinoin) was recommended for regulatory approval under the Repeat-use Procedure in 13 additional European Union (EU) Member States as well as in Norway and Iceland. Toctino^® is a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids.

Basilea Pharmaceutica Ltd. (SIX:BSLN) presents new research data on its innovative antitumor drug candidate BAL27862 at the international conference on Molecular Targets and Cancer Therapeutics in Boston (MA). BAL27862 is a novel, intravenous and orally bioavailable small molecule. It disrupts the microtubule network, a well established intracellular target in oncology, through a unique mechanism of action. The new data suggest that BAL27862 has the potential for a distinct anticancer profile in a wide range of cancer types, including those resistant to current treatment options.

Basel, Switzerland, November 18, 2009 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada.