Type of information: Licensing agreement
Compound: Cresemba® (isavuconazole)
Company: Basilea Pharmaceutica (Switzerland) Pfizer (USA - NY)
Therapeutic area: Infectious diseases
Type agreement: licensing
- systemic antifungal agent. Isavuconazole is an intravenous and oral broad-spectrum antifungal. It has a fungicidal effect by blocking the synthesis of ergosterol, a key component of the fungal cell membrane, through the inhibition of the enzyme lanosterol 14 alpha demethylase. The drug demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as in-vitro activity against less prevalent but often fatal molds including those that cause mucormycosis. In clinical studies to date, isavuconazole achieved predictable drug levels supporting reliable dosing and a switch from intravenous administration to a once-daily oral dose. The intravenous formulation of isavuconazole, which is water-soluble, does not contain potentially kidney damaging solubilizers and has the potential to be given also to patients with pre-existing renal impairment.
Disease: life-threatening invasive mold infections
- • On June 14, 2017, Basilea Pharmaceutica International has entered into a license agreement with Pfizer for Cresemba (isavuconazole) for the treatment of life-threatening invasive mold infections. Pfizer will have the right to manufacture isavuconazole and to exclusively commercialize the drug in Europe (excluding the Nordics), Russia, Turkey and Israel.
- Under the terms of the agreement, Basilea will receive an upfront payment of CHF 70 million and will be eligible to receive up to USD 427 million in additional payments upon achievement of pre-specified regulatory and sales milestones. In addition, Basilea will also receive royalties in the mid-teen range on Pfizer's sales in the territory.
- The agreement is subject to customary regulatory approval. Subject to the transaction closing, Basilea anticipates its financial guidance for 2017 to improve with total operating expenses reduced to approximately CHF 9-10 million on average per month (net of anticipated BARDA reimbursements) and an operating loss of approximately CHF 2-3 million on average per month. Cresemba sales after closing will be booked by Pfizer. Considering the collaboration with Pfizer, Basilea's total product sales are expected at approximately CHF 11 million for the year. The contribution from the transaction in 2017 is estimated at approximately CHF 6 million through revenue recognition and royalty payments. Estimates are subject to adjustment depending on the timing of regulatory approval for the transaction.
- • On January 10, 2018, Basilea Pharmaceutica reported the completion of its extension of its license agreement with Pfizer for Cresemba® (isavuconazole) to include China (with Hong Kong and Macao) and sixteen countries in the Asia Pacific region, including Australia, India, South Korea, Singapore and Taiwan.
- Under the terms of the amendment, Basilea will receive an upfront payment of $ 3 million and is eligible to receive up to approximately $ 223 million additional payments upon achievement of pre-specified regulatory and commercial milestones related to China and the Asia Pacific region. In addition, Basilea will receive royalties in the mid-teen range on Pfizer's sales in the territory.
- • On December 1, 2017, Basilea Pharmaceutica International has amended its existing license agreement for Europe, Russia, Turkey and Israel with Pfizer for Cresemba® to include China (with Hong Kong and Macao) and sixteen countries in the Asia Pacific region.
- • On July 20, 2017, Basilea Pharmaceutica reported that its license agreement with Pfizer for Cresemba® which was announced on June 14, has completed and therefore will now be implemented.