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Agreements

Date: 2016-09-15

Type of information: Collaboration agreement

Compound: isavuconazole

Company: Basilea Pharmaceutica (Switzerland) Asahi Kasei Pharma (Japan)

Therapeutic area: Infectious diseases

Type agreement: collaboration

Action mechanism:

  • 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. In collaboration with Astellas Pharma, isavuconazole is being investigated in phase 3 clinical studies for the treatment of severe invasive fungal infections. 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: invasive aspergillosis, mucormycosis

Details:

  • • On September 15, 2016, Basilea Pharmaceutica announced that it has entered into a partnering agreement with Asahi Kasei Pharma for Basilea's antifungal drug isavuconazole in Japan. Asahi Kasei Pharma will be responsible for conducting clinical studies necessary to apply for Japanese marketing authorization for isavuconazole for the treatment of invasive aspergillosis and mucormycosis. It will purchase product for commercialization of isavuconazole from Basilea.
 

Financial terms:

  • Under the terms of the agreement, Asahi Kasei Pharma is granted an exclusive license to develop and commercialize isavuconazole in Japan. Basilea will receive an upfront payment of CHF 7 million and will be eligible to receive up to approximately CHF 60 million (at current exchange rate) of additional payments upon achievement of regulatory and commercial milestones. Basilea will also receive double-digit tiered royalties on product sales in Japan.

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