Basilea Pharmaceutica Ltd. (CH) - FDA Issues Warning Letter to Johnson & Johnson Related to Ceftobiprole
BASEL, Switzerland, August 18, 2009 - Basilea Pharmaceutica Ltd. announces that the company was notified today that the U.S. Food and Drug Administration (FDA) issued to Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) a Warning Letter related to clinical trials for ceftobiprole for the treatment of complicated skin and skin structure infections.
The Warning Letter to Johnson&Johnson PRD relates to observations from FDA sponsor and clinical site inspections conducted during the first part of 2008.
Consistent with Basilea's earlier press releases, the Warning Letter asserts that there was a failure to ensure proper monitoring of the studies as well as deficiencies in study conduct.
The FDA has posted the Warning Letter at www.fda.gov.
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic. It is marketed in Canada (ZEFTERA(TM)) for the treatment of complicated skin and skin structure infections (cSSSI), including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland (Zevtera(TM)) for the treatment of complicated skin and soft tissue infections (cSSTI) including diabetic foot infections without concomitant osteomyelitis.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International, a Johnson & Johnson company.
About Basilea 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 in phase III (isavuconazole).
Disclaimer 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: Media Relations
Jean-Christophe Britt, Ph.D. Corporate Communication & Public Relations +41 61 606 1354 media_relations@basilea.
Barbara Zink, Ph.D. Head Corporate Development +41 61 606 1233 investor_relations@basilea.
This press release can be downloaded from www.basilea.com
Posted: August 2009