Tag: CommunicableDiseases

Basilea Pharmaceutica AG /
Basilea announces completion of the license agreement extension with Pfizer for
antifungal Cresemba for China and Asia Pacific
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Basel, Switzerland, January 10, 2018 – Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today the completion of its extension of its license agreement with Pfizer Inc. (NYSE: PFE) for Basilea’s antifungal Cresemba (isavuconazole) to include China (with Hong Kong and Macao) and sixteen countries in the Asia Pacific region, execution of which was announced on December 1, 2017. The amendment was subject to customary regulatory review which has completed. Isavuconazole is an antifungal for the treatment of life-threatening invasive mold infections.

Under the terms of the amendment, Basilea will receive an upfront payment of USD 3 million and is eligible to receive up to approximately USD 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. Pfizer is granted an exclusive license to develop, manufacture and commercialize isavuconazole in China, including Hong Kong and Macao, and sixteen countries in the Asia Pacific region, including Australia, India, South Korea, Singapore and Taiwan.

In June 2017, Basilea signed a license agreement with Pfizer for Europe (excluding the Nordics), Russia, Turkey and Israel. Basilea received a CHF 70 million upfront payment and is eligible for additional milestone payments of up to USD 427 million and mid-teen royalties on sales.

About Cresemba (isavuconazole)

Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. Basilea has entered into several license and distribution agreements for isavuconazole covering the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel. 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 the 28 European Union member states, as well as in Iceland, Liechtenstein and Norway, isavuconazole is approved 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 In Switzerland, isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of mucormycosis in adult patients who are resistant to or intolerant of amphotericin B and in adult patients with moderate to severe renal impairment.³ Isavuconazole has U.S. and European orphan drug designation for its approved indications. Outside the U.S. and Europe, the drug is currently not approved for commercial use.

About Basilea

Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and 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 (http://www.basilea.com).

About Pfizer Anti-Infectives

Today, Pfizer is a leading global provider of anti-infective medicines, offering patients access to a diverse portfolio of more than 80 products. Since its pioneering work on penicillin in the 1940s, Pfizer has been actively engaged in the research and development of innovative medicines and creation of policies and educational programs to address the evolving needs of patients and physicians in the area of infectious diseases. In December 2016, Pfizer completed the acquisition of AstraZeneca PLC’s small molecule anti-infective business, which includes both marketed agents and clinical development assets primarily outside the United States. To learn more, please visit www.pfizer.com (http://www.pfizer.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:

This press release can be downloaded from www.basilea.com (http://www.basilea.com).

References
1 Cresemba US prescribing information (https://www.astellas.us/docs/cresemba.pdf) [Accessed: January 09, 2018]
2 European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu (http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002734/WC500196131.pdf)
[Accessed: January 09, 2018]
3 Full indication in: Swissmedic-approved information for healthcare professionals as of August 2017

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Basilea Pharmaceutica AG
Grenzacherstrasse 487 Basel Switzerland

Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;