Request for re-examination of ceftobiprole submitted to CHMP
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).
On February 18, 2010, the CHMP adopted a negative opinion on the MAA for ceftobiprole for the treatment of cSSTI. The Applicant Janssen-Cilag has given written notice to the Agency that it requests a re-examination of the negative opinion under standard procedures. According to current CHMP guidelines, a final opinion on the re-examination could be issued by the Agency within four to five months.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's integrated research and development operations are currently focused on new antibacterial, antifungal and oncology agents to fight drug resistance and on the development of dermatology drugs. Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting.
The company owns a diversified portfolio including two commercialized drugs (Toctino®, ZEFTERA(TM)/ Zevtera(TM)) and one investigational drug (isavuconazole) in phase III clinical development. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Toctino® (alitretinoin) is marketed in Denmark, France, Germany, Switzerland and the United Kingdom. It is approved in six additional European countries as well as in Canada and has been recommended for approval in 15 European countries. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S.
Ceftobiprole is marketed in Canada under the brand name ZEFTERA(TM) and in Switzerland under Zevtera(TM). Basilea has set up commercial organizations in Canada, France, Germany, the Nordics, Switzerland and the United Kingdom, while it is building sales and marketing organizations in other countries to commercialize alitretinoin.
This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For further information, please contact:
Head Public Relations &
+41 61 606 1460
Barbara Zink, Ph.D., MBA
Head Corporate Development
+41 61 606 1233
This press release can be downloaded from www.basilea.com
The press release can also be downloaded from the following link: