GSK's Stiefel to pay $226M for global rights to Basilea's eczema drug Toctino
This article was originally published in Scrip
Skin care specialist Stiefel, a GlaxoSmithKline company, has obtained the exclusive worldwide rights for Basilea Pharmaceuticals' marketed hand eczema treatment, Toctino (alitretinoin), for £146 million ($226 million) in cash, with £50 million of cream on top if the US FDA approves the product. Basilea says it will now focus on anti-infectives and cancer.
Toctino is already commercially available in 14 countries, including Italy, Germany and France, and approved in another 15 countries. In the US, the retinoid product is in Phase III trials as an oral treatment for cases of severe refractory chronic hand eczema. Basilea will be eligible to receive double-digit royalties on US net sales, beginning three years after launch of the product in the US.
It is the only prescription drug specifically approved for treatment of severe chronic hand eczema that is refractory to treatment with potent topical corticosteroids. Under the deal, Stiefel gains access to the product's sales of £22 million last year.
Basilea recently told investors that it was moving towards a US NDA filing of Toctino following positive top-line results from the Phase III HANDEL study.
Jefferies analysts have expressed concern that the US Toctino safety database may be insufficient for a straightforward US approval given likely FDA safety concerns; it remains unclear at this time what kinds of stipulations the US regulator would put on a risk evaluation and mitigation strategy (REMS) (scripintelligence.com, 13 March 2012). The analysts foresee peak sales of Toctino at around $350 million, although this is several years off.
With the new deal in place with Stiefel, Jefferies analysts have been positive about the cash infusion for Basilea targeted for pipeline development. But there were some reservations about the fact that Basilea appeared to be handing over all Toctino rights with only limited future income post-US launch.
The US could be a major market for Toctino, depending upon whether or not US prescribing physicians would face burdensome restrictions. Obtaining reimbursement for products in new therapeutic areas has become more restrictive in the US.
As a derivative of vitamin A, Toctino is a teratogen and women of childbearing age must practice strict contraception and undertake regular pregnancy testing before, during and after treatment, which usually lasts 12-24 weeks.
Stiefel will assume responsibility for manufacturing and sales of Toctino, the companies said. Existing Toctino distribution agreements in Europe, Canada, Mexico, Israel, and the Republic of Korea will be assigned to Stiefel. About 90 Basilea employees who are involved in marketing the drug will have the option of transferring to Stiefel at the conclusion of the deal, Basilea chief executive Anthony Man said.
According to Dr Man, Basilea plans to use the cash infusion for two key projects: completing the regulatory filing of its antibiotic ceftobiprole for pneumonia in Europe this year (and subsequently in the US), and for finishing Phase III testing of its antifungal isavuconazole. Basilea also has in earlier stage compounds addressing resistant Gram-negative bacterial infections and drug resistance to current anti-tumour therapies.
The deal with Basilea comes just two weeks after Stiefel entered into an agreement with Canada's Welichem Biotech to acquire the latter's mid-stage investigational candidate, WBI-1001, for an upfront payment of $35 million; the candidate is a novel, non-steroidal topical anti-inflammatory agent to treat psoriasis and atopic dermatitis (scripintelligence.com, 1 June 2012).