Healthcare Industry News:  Janssen Pharmaceuticals 

Biopharmaceuticals Regulatory

 News Release - November 21, 2008

Zevtera(TM) (ceftobiprole medocaril), the novel anti-MRSA broad-spectrum antibiotic, receives a positive opinion from the CHMP

Basilea Pharmaceutica Ltd. announces that Zevtera(TM) (ceftobiprole medocaril), the first-in-class anti-MRSA broad-spectrum cephalosporin, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of complicated skin and soft tissue infections.

Basel, Switzerland, November 21, 2008 - (HSMN NewsFeed) - Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. said, "This positive opinion represents a transforming landmark for Basilea and a major validation for Zevtera(TM) in the treatment of severe skin infections. Zevtera(TM) is now a step closer to being available for healthcare professionals and patients in Europe to fight against potentially deadly infections, including methicillin-resistant Staphylococcus aureus (MRSA) infections. The announcement from the CHMP reflects our conviction that Zevtera(TM) is an innovative broad-spectrum antibiotic that can be used as first-line treatment for a wide range of serious skin infections before knowing the exact bacteria causing an infection."

As per the CHMP positive opinion, "Zevtera(TM) is indicated in adults for the treatment of complicated skin and soft tissue infections." The CHMP’s positive opinion is now referred for final action to the European Commission. Subject to approval by the European Commission, the positive CHMP opinion on Zevtera(TM) will apply in all 27 EU Member States plus Iceland and Norway.

Ceftobiprole is marketed in Canada under the trade name ZEFTERA(TM) through co-promotion with Janssen-Ortho Inc., a Johnson & Johnson company. Ceftobiprole is approved for the treatment of complicated skin and soft tissue infections including diabetic foot infections in Switzerland and currently under review for this indication by regulatory authorities in the U.S. and other countries.

Conference Call

Basilea Pharmaceutica Ltd. invites you to participate in a conference call on November 21, 2008, 4 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 (USA)
+44 (0) 207 107 0611 (UK)

The playback will be available 1 hour after the conference call for 48 hrs. Participants requesting a digital playback may dial:

+41 (0) 91 612 4330 (Europe)
+1 (1) 866 416 2558 (USA)
+44 (0) 207 108 6233 (UK)

and will be asked to enter the ID 10303 followed by the # sign.

About Zevtera(TM)

Zevtera(TM) (ceftobiprole medocaril for injection), Basilea’s lead antibacterial product, is the first approved broad-spectrum anti-MRSA antibiotic belonging to the cephalosporin class. Ceftobiprole as a single intravenous agent has demonstrated broad-spectrum activity against a wide range of difficult-to-treat Gram-positive and Gram-negative hospital- and community-acquired infections including methicillin-resistant Staphylococcus aureus (MRSA). In the trials, ceftobiprole was generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica International Ltd. and Cilag GmbH International. Basilea Pharmaceutica Ltd. has also exercised its option to co-promote ceftobiprole in the U.S. and in the major European markets together with Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. in the U.S. and the respective Janssen-Cilag companies in Europe. Basilea maintains an option to co-promote the drug in Japan and China.

About complicated skin infections

Complicated skin and soft tissue infections are among the most common infections in the hospital setting. Staphylococcus aureus, a Gram-positive microbe, is the predominant pathogen in skin infections. In recent years methicillin-resistant strains of S. aureus (MRSA) have become increasingly common and have been associated with increased morbidity and mortality. Patients with chronic wounds or those who have recently received antibiotics may also be infected by Gram-negative microbes. This is frequently the case for diabetic patients with foot infections. Treatment of diabetic foot infections requires broad-spectrum intravenous antibiotics and may include hospitalization and surgery. Broad-spectrum antibiotics that cover resistant bacteria are often needed for the treatment of more severe skin infections.

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 in phase III (isavuconazole). 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 the U.S. and in several other countries. The company has set up commercial organizations in UK, Denmark, Germany and Canada, while it is building sales and marketing organizations to commercialize alitretinoin and to co-promote ceftobiprole in the U.S. and in other European countries, subject to approval.


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.

Source: Basilea Pharmaceutica

Issuer of this News Release is solely responsible for its content.
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