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Jun 15, 2010

Almirall to Pay Basilea Up To €27 for Approved Eczema Drug in Specific EU Territories and Mexico

  • Basilea Pharmaceutica could receive up to €27 million in up-front and milestone payments from Almirall as part of an exclusive licensing deal for the former’s oral eczema treatment Toctino® in selected European markets and Mexico. Under the terms of the deal, Basilea will receive up to €16 million in up-front payments and milestones related to the launch of Toctino in two key markets within its licensed territories.

    Toctino is a retinoid drug currently approved in a number of non-U.S. markets for the treatment of adults with severe chronic hand eczema that is unresponsive to topical corticosteroids.

    It is also already marketed in Denmark, France, Germany, Switzerland, and the U.K. It has been approved in Canada and 15 additional European countries and recommended for approval in seven European countries.

    Phase III trials in the U.S. are ongoing. Basilea claims the pivotal Handel trial is the first ever multicentered, controlled clinical study for patients with severe chronic hand eczema to be carried out in the U.S.

    Swiss firm Basilea is focused on the development of new antibacterial and antifungal agents as well as anticancer drugs and dermatology treatments. In February the company signed a license agreement with CHF 75 million (roughly $66.04 million) up front with Astellas Pharma covering co-development and co-promotion of Basilea's Phase III-stage isavuconazole antifungal agent on a worldwide basis, including an option for Japan.

    Full rights to Basilea’s broad-spectrum anti-MRSA cephalosporin antibiotic Zeftera™ are conversely in the process of being transferred back to Basilea from the Johnson & Johnson’s (JnJ) Janssen-Cilag subsidiary. JnJ licensed Zeftera from Basilea back in 2005, and in 2008 the firm achieved Canadian approval. However, since then both the U.S. and European regulatory authorities have recommended against approving the drug due to concerns regarding the conduct of clinical trials by JnJ. Following consultation with the Canadian health authorities, Janssen-Ortho has now also decided to discontinue sale of Zeftera in the country.

    In March Basilea reported that Janssen-Cilag, which submitted the original MAA to the EMEA, had submitted a request for re-examination of the negative opinion by the European Committee for Medicinal Products for Human Use.

    The approval process for Zeftera in the U.S. has been fraught with issues, leading FDA to rap JnJ on the knuckles for the inadequacies of its ceftobiprole clinical trials. The agency had issued JnJ with an Approvable Letter for the drug in March 2008. Thereafter, the agency conducted additional inspections of the investigator sites and an inspection of the sponsor, Johnson & Johnson PRD, and issued a Form FDA 483 concerning the latter’s failure to ensure proper monitoring of the ceftobiprole studies as well as deficiencies in study conduct. Since then a raft of correspondence between the agency and JnJ has finally led to FDA ruling in December 2009 that it could not approve the Zeftera application in its current form.

    To address the deficiencies FDA recommended that two new, adequate, and well-controlled studies be carried out to evaluate the safety and efficacy of ceftobiprole for the treatment of complicated skin and skin structure infections.

    Basilea submitted a request for arbitration under the license agreement for ceftobiprole in February 2009. The firm’s claims under arbitration include that JnJ breached the agreement by, among other things, causing the delay in the approval of ceftobiprole in the U.S. and EU. Basilea says that its initial damage claims in the arbitration, including milestone payments and additional damages, will increase as a result of this further delay. The firm anticipates an arbitration decision prior to the end of 2010.


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