Basilea announces partnership for antifungal isavuconazole

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News Desk 2018

Sep 15, 2016 at 1:30 AM

Basilea announces partnership for antifungal isavuconazole in Japan with Asahi Kasei Pharma

Basilea grants Asahi Kasei Pharma exclusive license to develop and commercialize isavuconazole in Japan
Basilea eligible for upfront and milestone payments of up to CHF 67 million and double-digit royalties

BASEL, Switzerland, Sept. 15, 2016 (GLOBE NEWSWIRE) -- Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that Basilea Pharmaceutica International Ltd. (Basilea) has entered into a partnering agreement with Asahi Kasei Pharma Corporation (Asahi Kasei Pharma) for Basilea's antifungal drug isavuconazole in Japan.

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.

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.

Ronald Scott, Basilea's Chief Executive Officer, stated: "We are very pleased to partner with Asahi Kasei Pharma, which has a proven track record in the successful clinical development of innovative drugs and a strong commercial presence in the hospital area, including intensive care units and hematology. We look forward to making isavuconazole available to patients in this important market. Isavuconazole may provide a new treatment option for patients in Japan in this area of substantial unmet medical need."

About isavuconazole

Isavuconazole is an intravenous and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. Isavuconazole is approved in the United States for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.¹ In Europe, it received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.² Basilea has licensed the US rights to Astellas Pharma Inc. and the Japanese rights to Asahi Kasei Pharma Corporation. Basilea commercializes isavuconazole as CRESEMBA^® in Germany, Italy, the UK and Austria and is seeking national pricing and reimbursement in additional EU countries. The drug is commercialized in the US by Astellas Pharma US. Outside the US and the EU, isavuconazole is currently an investigational product and not approved for commercial use. The drug was co-developed by Basilea and Astellas.

About invasive aspergillosis and mucormycosis

Invasive aspergillosis and mucormycosis are life-threatening fungal infections that predominantly affect immunocompromised patients, such as patients with cancer. Invasive aspergillosis is known for high morbidity and mortality. Mucormycosis (also known as zygomycosis) is a rapidly progressing and life-threatening invasive fungal infection, known for high morbidity and mortality.

About Basilea

Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com .

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Basilea Pharmaceutica Ltd. and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

For further information, please contact:

Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations +41 61 606 1102 media_relations@basilea.com investor_relations@basilea.com

This press release can be downloaded from www.basilea.com .

References

CRESEMBA^® US prescribing information [Accessed: September 14, 2016]
European Public Assessment Report (EPAR) CRESEMBA^® : http://www.ema.europa.eu [Accessed: September 14, 2016]

Press release (PDF) http://hugin.info/134390/R/2042253/762235.pdf

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