SOURCE: Basilea Pharmaceutica AG

February 24, 2009 01:29 ET

Basilea Pharmaceutica files claims against Johnson&Johnson over its handling of ceftobiprole (ZEFTERA™/Zevtera™) clinical studies

BASEL, SWITZERLAND--(Marketwire - February 24, 2009) -


Basilea Pharmaceutica Ltd. announces that it has filed claims in arbitration against Johnson&Johnson, and affiliated companies related to delays in approval of ceftobiprole.

Basilea submitted a Request for Arbitration on February 24, 2009, to the Netherlands Arbitration Institute under the licensing agreement for ceftobiprole, naming Johnson&Johnson companies, Johnson&Johnson Pharmaceutical Research and Development, L.L.C. (Johnson&Johnson PRD) and CILAG GmbH International, a wholly owned Swiss subsidiary of Johnson&Johnson [collectively Johnson&Johnson] as respondents. The Request for Arbitration relates to damages suffered by Basilea that result from delay in the approval of ceftobiprole in the U.S. and EU as well as milestone payments.

Johnson&Johnson was granted an exclusive worldwide license to ceftobiprole in February 2005. A Marketing Authorization Application was filed with the European Medicines Agency (EMEA) for ceftobiprole for the treatment of complicated skin and soft tissue infections by the applicant Janssen-Cilag International NV, a Johnson&Johnson company in June 2007. In November 2008 ceftobiprole received a positive benefit-risk opinion and recommendation for approval from the EU Committee for Medicinal Products for Human Use (CHMP). The CHMP has now communicated that the EMEA will conduct Good Clinical Practice (GCP) inspections and that it has halted the EU commission decision process until review of the inspection outcome is completed. Basilea anticipates the CHMP GCP inspections to be completed in the second half of this year.

A New Drug Application for ceftobiprole was submitted to the FDA in the U.S. by Johnson&Johnson PRD in May, 2007. The FDA issued an Approvable Letter in March, 2008. Thereafter, the Agency conducted additional inspections of the investigator sites and an inspection of the sponsor Johnson&Johnson PRD and issued a sponsor 483 report. The FDA concluded from their inspections that Johnson&Johnson PRD failed to ensure proper monitoring of the studies. As already reported by Basilea in November 2008, the FDA indicated in its Complete Response Letter the existence of data integrity issues and that further resolution of specific deficiencies of study conduct is necessary. The Agency has also requested information on Johnson&Johnson PRD's clinical quality assurance programs. Furthermore, as a result of FDA inspections at investigator sites and of the sponsor, Johnson&Johnson PRD, the FDA suggested that Johnson&Johnson PRD have additional clinical site audits performed. These additional audits are anticipated to occur in the first half of 2009 with a Complete Response submission foreseen in the second half of this year.

Questions from the FDA regarding safety and efficacy of ceftobiprole received to date have been successfully answered.

Ceftobiprole is marketed in Canada under the brand name ZEFTERA™ and in Switzerland under Zevtera™.

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 (alitretinoin, ceftobiprole) and one investigational drug in phase III (isavuconazole). Toctino® (alitretinoin) is marketed in the United Kingdom, Denmark and Germany and is approved in Finland and France. Alitretinoin has been recommended for approval in six additional EU Member States and is under regulatory review in Canada and Switzerland. Furthermore a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Marketing applications for ceftobiprole (ZEFTERA™/Zevtera™) were submitted in the U.S., the EU and several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations in other countries to commercialize alitretinoin and to co-promote ceftobiprole, subject to approval.

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:

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| Media Relations                  | Investor Relations             |
|----------------------------------+--------------------------------|
| Jean-Christophe Britt, Ph.D.     | Barbara Zink, Ph.D., MBA       |
| Corporate Communication & Public | Head Corporate Development     |
| Relations                        | +41 61 606 1233                |
| +41 61 606 1354                  | investor_relations@basilea.com |
| media_relations@basilea.com      |                                |
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