European CHMP adopts negative opinion on ceftobiprole
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).
The sponsor Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, has been notified that the CHMP adopted a negative opinion on the MAA for ceftobiprole for the treatment of cSSTI.
The MAA for ceftobiprole for the treatment of cSSTI was filed by Janssen-Cilag in June 2007. After a positive opinion from the CHMP in November 2008, the European Medicines Agency took the unusual step of halting the European Commission authorization process on ceftobiprole pending completion and assessment of Good Clinical Practice (GCP) inspections.
The CHMP now stated that inspections showed that the phase III studies supporting the MAA had not been conducted in compliance with GCP in some sites. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about how reliable the results were. The Committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.
Janssen-Cilag aims to discuss with the CHMP as soon as possible the best path forward for ceftobiprole in Europe.
Basilea is committed to take those steps necessary to allow ceftobiprole to be more widely available to patients in need of new treatment options to fight potentially deadly resistant bacterial infections. The company is reviewing all strategic options to protect the interests of the company and its shareholders.
Due to the deficiencies identified by the U.S. Food and Drug Administration (FDA) in Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'s (Johnson & Johnson PRD) conduct of the clinical investigations and Basilea's claimed breaches of the License Agreement, Basilea submitted a Request for Arbitration under the License Agreement for ceftobiprole in February 2009. Basilea's claims under arbitration include that Johnson & Johnson PRD breached the License Agreement by, among other things, causing the delay in the approval of ceftobiprole in the U.S. and EU. Basilea's initial significant damage claims, including milestone payments and additional damages, in the arbitration will increase as a result of this further delay.
Basilea anticipates an arbitration decision prior to the end of 2010.
Regulatory key events
In December 2009, the FDA issued to the sponsor, Johnson & Johnson PRD, a Complete Response Letter on ceftobiprole for the treatment of complicated skin and skin structure infections (cSSSI), indicating that the Agency cannot approve the NDA in its present form. In order to address the deficiencies, the FDA recommended that two new, adequate, and well-controlled studies to evaluate the safety and efficacy of ceftobiprole for the treatment of cSSSI should be conducted. Johnson & Johnson PRD communicated that it intends to discuss the best path forward with the FDA as soon as possible.
In August 2009, the FDA issued to Johnson & Johnson PRD a Warning Letter on its role as a sponsor of clinical trials. The Agency noted that under the terms of the agreement between Basilea and Cilag GmbH International, a Johnson & Johnson company, all rights and responsibilities for ceftobiprole clinical trials were transferred to Johnson & Johnson PRD and the FDA concluded that Johnson & Johnson PRD did not adhere to the applicable statutory requirements or FDA regulations governing the conduct of clinical investigations. The FDA found numerous objectionable conditions during its investigation into Johnson & Johnson PRD's role as a sponsor of the two phase III trials of ceftobiprole for the treatment of cSSSI.
In February 2005, Basilea granted Cilag GmbH International an exclusive worldwide license to develop, manufacture and commercialize ceftobiprole.
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin antibiotic exhibiting activity against a wide spectrum of Gram-positive bacteria, including the 'superbug' methicillin-resistant Staphylococcus aureus (MRSA) and penicillin-resistant Streptococcus pneumonia as well as many clinically important Gram-negative bacteria, including Pseudomonas. Ceftobiprole is marketed in Canada (ZEFTERA(TM)) for the treatment of cSSSI, including non-limb threatening diabetic foot infections without concomitant osteomyelitis and in Switzerland (Zevtera(TM)) for the treatment of cSSTI including diabetic foot infections without concomitant osteomyelitis.
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Friday, February 19, 2010, 3:00 p.m (CET), during which the company will discuss today's press release.
Dial-in numbers are:
+41 (0) 91 610 56 00
(Europe and ROW)
+1 (1) 866 291 4166
+44 (0) 207 107 0611
A playback will be available 1 hour after the conference call until Tuesday, February 23, 2010, 6 p.m. (CET). Participants requesting a digital playback may dial:
+41 (0) 91 612 4330
+1 (1) 866 416 2558
+44 (0) 207 108 6233
and will be asked to enter the ID 14060 followed by the # sign.
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. Toctino® (alitretinoin) is marketed in Denmark, France, Germany, Switzerland and the United Kingdom and is approved in Austria, Belgium, Canada, Finland, Luxemburg, the Netherlands and Spain. Toctino® has been recommended for approval in 16 additional European countries. Furthermore, a phase III clinical program 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