European CHMP concludes re-examination of ceftobiprole
Basel, Switzerland, June 25, 2010 - Basilea Pharmaceutica Ltd. (SIX:BSLN) announces that following a request for re-examination from the Applicant Janssen-Cilag International NV (Janssen-Cilag), a Johnson & Johnson company, the European Committee for Medicinal Products for Human Use (CHMP) confirmed its previous negative opinion on the Marketing Authorization Application (MAA) for ceftobiprole for the treatment of complicated skin and soft tissue infections (cSSTI).
The CHMP has confirmed its previous negative opinion on the use of ceftobiprole for the treatment of cSSTI. The CHMP indicated that, although the study results suggested that the medicine was beneficial to patients, it was concerned about the reliability of the results. The Committee therefore recommended that, in light of the uncertainty surrounding the results, ceftobiprole should not be granted marketing authorization.
In February 2010, the CHMP issued a negative opinion on ceftobiprole in cSSTI stating that inspections had shown that the phase III studies supporting the MAA had not been conducted in compliance with good clinical practice in some sites. Following the Applicant Janssen-Cilag's request for a re-examination of the negative opinion under standard procedures, the Agency has reassessed the MAA.
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.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on the SIX Swiss Exchange (SIX:BSLN). Basilea's products are targeted to satisfy high medical and patient needs in the hospital and specialty care setting. Its integrated research and development operations are currently focused on antibiotics and antifungals, as well as on the development of dermatology and oncology drugs, all areas in which the medical challenge of rising resistance or non-response to current treatment options is commonly encountered.
The company owns a broad and diversified portfolio. Basilea is marketing Toctino® (alitretinoin), for the treatment of severe chronic hand eczema, in Denmark, France, Germany, Switzerland and the United Kingdom. The drug is approved in 15 additional European countries as well as in Canada and has been recommended for approval in seven further European countries. Basilea has appointed Almirall S.A. as its distributor for Toctino® in selected European markets and Mexico. Furthermore, a phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea has entered into a license, co-development and co-promotion agreement with Astellas Pharma Inc. for its phase III compound isavuconazole for the treatment of life-threatening invasive fungal infections on a worldwide basis, including an option for Japan. Full rights to a third late-stage product, ceftobiprole for the treatment of potentially life-threatening resistant bacterial infections, will be transferred from Cilag GmbH International, a Johnson & Johnson company, back to Basilea.
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.