Stiefel signs worldwide acquisition and license agreement for Toctino®

Stiefel, a GSK company, today announced that it has entered into a worldwide agreement to acquire Toctino (alitretinoin) from Basilea Pharmaceutica Ltd. (Basilea). Toctino is a once-daily oral retinoid and the only prescription medicine specifically approved for the treatment of severe chronic hand eczema unresponsive to potent topical steroids in adults. It is commercially available in 14 countries, approved in an additional 15 countries, and is in a Phase 3 trial in the US. In 2011, worldwide sales of Toctino were £22m.

Under the terms of the agreement, Stiefel will acquire all Toctino patent rights, trademarks and product registrations owned by Basilea and will license certain clinical information and product know-how from Basilea. Stiefel will be responsible for the product’s further development, manufacture and commercialisation worldwide. Basilea will receive an initial payment of £146m in cash from Stiefel and is eligible to receive further payments of up to £50m upon FDA approval of the product in the US and double-digit success payments on US net sales, beginning three years after launch of the product in the US. The transaction is subject to competition approval in Germany.

Simon Jose, President, Stiefel said: “Toctino is an important and growing product that complements the Stiefel portfolio and offers a proven therapy for patients with a significant unmet medical need. This acquisition gives us an immediate opportunity to develop and expand the availability of this new and innovative product of value and reinforces Stiefel and GSK’s commitment to dermatology.”

Hand eczema is a common recurring dermatological condition and leading cause of sick leave and disability.1 It is estimated to affect up to 10 percent of the general population. Approximately 5 – 7 percent of patients with hand eczema are estimated to suffer from severe chronic hand eczema and 2 – 4 percent of patients are unresponsive to topical treatment. Severe chronic hand eczema is usually characterised by a combination of signs and symptoms of thick scaly skin that gives rise to red patches, itching, and painful cracks and blisters.

References

1. Diepgen TL, Agner T, Aberer W, et al. Management of chronic hand eczema. Contact Dermatitis 2007: 57: 203-210.