Deal includes a further £50 million milestone fee upon FDA approval in another indication.
GlaxoSmithKline’s Stiefel Laboratories subsidiary bought eczema drug Toctino from Basilea Pharmaceutica for £146 million ($226.6 million) cash up front plus another £50 million ($77.6 million) tied to milestones. The deal marks GSK’s piecemeal approach to rebuilding its dermatology portfolio through acquisition of drugs showing growth in demand.
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 oversee the drug’s further development, manufacture, and commercialization worldwide. Existing Toctino distribution agreements in Europe, Canada, Mexico, Israel, and the Republic of Korea will be assigned to Stiefel.
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. Toctino is commercially available in 14 countries, approved in another 15 countries, and is in a Phase III trial in the U.S.
Upon FDA approval, Basilea will be eligible for between £30 million ($46.6 million) and £50 million in milestone payments plus double-digit success payments on U.S. net sales, beginning three years after U.S. launch of the product.
Worldwide sales of Toctino were CHF 31 million ($33.9 million) last year, 6% above the CHF 29.2 million ($30.3 million) reported for 2010 despite a 24% growth in volume sold, the disparity reflecting the Swiss Franc’s strength versus the Euro and other currencies. The Swiss Franc’s strength prompted Basilea last year to lower its guidance to investors on Toctino sales, from CHF 40 million ($41.5 million) to between CHF 32 million ($33.2 million) and CHF 34 million ($35.3 million). Basilea said it will issue later this year updated guidance to investors reflecting the Toctino transaction.
Sales of GSK’s dermatology products last year inched up 1% to £1.1 billion ($1.7 billion), as sales growth from Stiefel and other GSK acquisitions offset losses from the disposal of Zovirax in North America in Q1 2011 and as ongoing launches of Stiefel products in new markets offset the impact of price cuts in Europe and generic competition to the acne treatment Evoclin in the U.S.
“Through this transaction, we are immediately accessing the value of Toctino and we will be able to further focus our strategy on solving the massive healthcare threat of resistance in the areas of anti-infectives and oncology,” Anthony Man, M.D., Basilea’s CEO, said in a statement. The company linked its shift toward antibiotics to the expected passage in the U.S. of new legislation offering incentives for developers of new multidrug-resistant antibiotic drugs, including priority review and fast-track approval.
“We will use the proceeds from this transaction to support the regulatory filing of ceftobiprole for the treatment of pneumonia in the hospital in Europe this year and subsequently in the U.S. as well as completing the isavuconazole Phase III program to bring this important drug to the market,” Dr. Man stated. “Furthermore, we aim to advance our innovative Phase I compounds addressing resistant Gram-negative bacterial infections and drug resistance to current antitumor therapies.”