BASEL, Switzerland, Dec. 7, 2006 (PRIME NEWSWIRE) -- Basilea Pharmaceutica Ltd. (SWX:BSLN) announced today that it has exercised its co-promotion option on ceftobiprole, its investigational anti-MRSA cephalosporin antibiotic, in North America and major European countries with Johnson & Johnson's affiliate Cilag GmbH International. Basilea will participate in the anticipated launch and promotion of ceftobiprole in these markets.
Basilea has three investigational drugs in late-stage clinical development for hospital and specialty care, and plans to fully integrate commercial operations into its organization. In addition to co-promoting ceftobiprole, Basilea anticipates that this organization will participate in the launch and the promotion of its specialty compound alitretinoin, following approval. The company expects first regulatory filing for alitretinoin next year followed by a potential launch in 2008.
The new commercial organization will have future additional synergies with Basilea's third late-stage compound isavuconazole. Isavuconazole is designed to treat invasive fungal infections and has significant overlap of patients and prescribers with ceftobiprole. Basilea will initiate phase III for isavuconazole this month.
Anthony Man, MD, Basilea's CEO said, "Through exercising our co-promotion option on ceftobiprole we are taking the next important step in building a sustainable hospital and specialty business. We will integrate commercialization where it optimizes product value. In the six years since founding we have brought three highly competitive investigational drugs into late-stage clinical development. Assuming successful phase III trial programs, we plan two registration filings in 2007 to bring these novel therapies to patients and prescribers as soon as possible."
Nicholas Benedict, responsible for Commercial Strategy and Operations at Basilea said, "This is an outstanding opportunity, which we will use to full effect. We intend to build a dynamic, effective sales and marketing organization to promote our three highly competitive compounds. We are currently evaluating the optimal organizational structures to support future activities across target markets in line with anticipated launch timelines."
Products in Late-stage Development
Ceftobiprole is an anti-MRSA broad-spectrum cephalosporin that has demonstrated positive phase III trial results in complicated skin and skin structure infections. Ceftobiprole has shown a low potential to select for resistance in-vitro and exhibits in-vitro activity against a wide spectrum of bacteria that cause many hospital and community-acquired infections including those due to resistant bacteria like methicillin-resistant Staphylococcus areus (MRSA). Top-line results of a second phase III study in skin infections are expected in the first half of 2007.
Ceftobiprole has received fast track status from the FDA and is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International, a Johnson & Johnson affiliate.
Alitretinoin is being developed by Basilea as a novel treatment for severe refractory chronic hand dermatitis, often a debilitating condition affecting over one million patients in developed countries. Severely affected patients may suffer for years from the disease without currently having an effective treatment option available. This lack of approved treatments contributes to the high socio-economic and individual patient burden. Following positive phase II results a phase III program had been designed meeting international regulatory requirements. The European and Canadian Phase III studies for alitretinoin are expected to deliver top-line data during the first quarter of 2007, with potential filing later in the year. A clinical program for the USA is planned to follow.
Isavuconazole, Basilea's novel antifungal drug addresses life-threatening fungal infections requiring hospitalization. Basilea plans to start phase III patient recruitment in studies for the treatment of candidemia and invasive aspergillosis this month. The FDA has granted fast track status to isavuconazole due to its potential to satisfy a high medical need.
About Basilea
Basilea Pharmaceutica Ltd. (SWX:BSLN) is an independent biopharmaceutical company headquartered in Basel, Switzerland, and listed on the SWX Swiss Exchange. Basilea's fully 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 setting. The company owns a diversified product portfolio including three products in late stages of clinical development for severe medical indications.
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.
Conference Call
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on Thursday, December 7, 2006, 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 und 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 391 followed by the # sign.
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