FDA issues Complete Response Letter for ceftobiprole
Basel, Switzerland, November 26, 2008
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. (J&JPRD), a Complete Response Letter for ceftobiprole for the treatment of complicated skin and skin structure infections including diabetic foot infections.
Ceftobiprole showed in two large multinational, double-blind, randomized phase III clinical studies, that it was effective, as demonstrated by meeting the primary endpoint using a 10% non-inferiority margin. A safety profile consistent with the cephalosporin class of antibiotics was demonstrated. Ceftobiprole has been approved or recommended for approval in a number of territories including the European Union.
The FDA indicated in a Complete Response Letter to J&JPRD that further resolution of specific deficiencies of study conduct is necessary. As a result of FDA audits at investigator sites and of the sponsor J&JPRD, the Agency suggested that J&JPRD have additional clinical site audits performed.
The FDA indicated from their sponsor/monitor inspection that there was a failure to ensure proper monitoring of the studies. The Agency has requested information on J&JPRD's clinical quality assurance programs and also asked for a new audit plan that also addresses deficiencies in contract research organization monitoring. The FDA indicated to J&JPRD that they are unable to review the clinical data included in the submitted complete response until issues of data integrity have been resolved. The FDA has indicated to J&JPRD the need to fully respond to this action letter within one year.
"Ceftobiprole is a novel antibiotic addressing the very serious medical need related to resistant bacterial infections including MRSA. The drug met its primary clinical endpoint and was approved or recommended for approval in a number of countries including the EU based on two large independent and well designed trials. We are deeply disappointed with the further delay in the review of the U.S. NDA application. We will be working with J&JPRD and the FDA to address these outstanding issues as soon as possible. These events have not altered in any way our confidence in the efficacy and safety profile of ceftobiprole and its potential to satisfy a high medical need", said Dr. Anthony Man, Basilea's CEO.
The NDA submission of ceftobiprole for the treatment of complicated skin and skin structure infections includes the data from two pivotal phase III trials (STRAUSS 1 and STRAUSS 2). These trials comprise data from over 1600 patients including those with diabetic foot infections caused by Gram-negative and Gram-positive pathogens and with methicillin-resistant Staphylococcus aureus (MRSA) infections. In both of these large, multinational, double-blind, randomized phase III clinical studies, ceftobiprole was effective as demonstrated by achievement of the non-inferiority endpoint to single drug or two-drug combination comparators, respectively.
The New Drug Application (NDA) was submitted to the FDA by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. The FDA issued an Approvable Letter in March, 2008. The questions in the Approvable Letter were addressed in a complete response package that was filed and accepted by the FDA for review in September 2008.
Ceftobiprole is marketed in Canada and approved in Switzerland. Ceftobiprole received a positive opinion from the CHMP in the European Union in November 2008 and is under review in a number of other countries.
Conference Calls
Basilea Pharmaceutica Ltd. will hold two conference calls on November 26, 2008, one at 8:30 a.m. (CET) and one at 4 p.m. (CET) to discuss today's press release.
The Company invites you to participate in the conference call on November 26, 2008, 8:30 a.m. (CET).
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+44 (0) 207 107 0611 (UK)
+1 (1) 866 291 4166 (USA)
A second conference call is scheduled on November 26, 2008, 4 p.m. (CET).
Dial-in numbers are:
+41 (0) 91 610 56 00 (Europe and ROW)
+44 (0) 207 107 0611 (UK)
+1 (1) 866 291 4166 (USA)
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 and antifungal 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 (isavuconazole) in phase III. Alitretinoin (Toctino®) is marketed in the United Kingdom, in Denmark and in 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. Ceftobiprole is marketed in Canada and approved in Switzerland. Ceftobiprole received a positive opinion from the CHMP and is under review by regulatory authorities in several other countries. The company has set up commercial organizations in UK, Denmark and in Germany while it is building sales and marketing organizations 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.