December 01, 2017
Basilea extends existing license agreement with Pfizer for antifungal Cresemba® (isavuconazole) to China and Asia Pacific
- Basilea eligible to receive additional upfront and milestone payments of up to USD 226 million and mid-teen royalties on sales
- Basilea updates its financial guidance for 2017 - improved result expected
Basel, Switzerland, December 01, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that Basilea Pharmaceutica International Ltd. ("Basilea") has amended its existing license agreement for Europe, Russia, Turkey and Israel with Pfizer Inc. (NYSE: PFE, "Pfizer") for Basilea's Cresemba® (isavuconazole) to include China (with Hong Kong and Macao) and sixteen countries in the Asia Pacific region. Isavuconazole is an antifungal for the treatment of life-threatening invasive mold infections.
Ronald Scott, Chief Executive Officer of Basilea, said: "Cresemba is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections. We are very pleased to be expanding our partnership with Pfizer to China and Asia Pacific where it has a strong commercial presence and a proven track record of successfully developing and commercializing hospital antifungals. We have now established partnerships for isavuconazole with leading pharmaceutical companies in all major markets around the world."
"We are excited to extend our partnership with Basilea, a company that shares our passion and commitment to confronting the global challenges of infectious disease management," said Suneet Varma, Global President of Pfizer APAC, Greater China and Global Brands. "We believe our extensive geographic footprint in APAC and China together with our expertise in successfully commercializing innovative medicines will help enable us to continue to address the unmet medical needs of patients, especially in the area of anti-infectives."
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, Hong Kong and Macao, and sixteen countries in the Asia Pacific region, including Australia, India, South Korea, Singapore and Taiwan. The agreement is subject to customary regulatory approval.
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.
Considering the recent commercialization agreements, Basilea updates its financial guidance for 2017. Basilea expects a reduced operating loss of approximately CHF 1 million on average per month (previously: CHF 2 million on average per month) driven by higher product and contract revenues as well as lower operating expenses, partially resulting from accelerated transition of operational responsibilities to partners.
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 Unites 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 Europe (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.
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.
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.
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
This press release can be downloaded from www.basilea.com.
1 Cresemba US prescribing information [Accessed: November 30, 2017]
2 European Public Assessment Report (EPAR) Cresemba: www.ema.europa.eu
[Accessed: November 30, 2017]
3 Full indication in: Swissmedic-approved information for healthcare professionals as of August 2017