SBA Member, 02.11.2017
Cresemba launched by Pfizer in Spain and is now commercially available in all Top-5 EU markets
Marketing authorization received for Switzerland
Basel, Switzerland, November 2, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its licensing partner Pfizer recently launched the antifungal drug Cresemba® (isavuconazole) in Spain. Pfizer is now commercializing the product in the major EU markets and Austria. In addition, Swissmedic approved Cresemba for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.
David Veitch, Chief Commercial Officer of Basilea, said: "Cresemba's launch in Spain by our licensing partner Pfizer is an important step in expanding the availability of this important treatment option to even more patients across Europe who are suffering from invasive aspergillosis and mucormycosis. These are severe mold infections that predominantly affect immunocompromised patients, such as patients with cancer and after transplantation. In addition, we are very pleased with the progress we have made in transitioning Cresemba to our partner Pfizer. The two organizations have successfully completed the transition of commercialization responsibilities in the markets in Europe where Cresemba was previously marketed by Basilea."
In July, Basilea had completed an exclusive license agreement with Pfizer for Cresemba in Europe (excluding the Nordics), Russia, Turkey and Israel. Basilea received an upfront payment of CHF 70 million and is also 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.
Cresemba is currently being marketed in the U.S. by Basilea's licensing partner Astellas Pharma US; in Germany, Italy, the United Kingdom, France, Spain and Austria by Pfizer; and in the Nordic countries by Basilea's distribution partner Unimedic Pharma AB.
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 distributions agreements covering the Unites States, Europe, Japan, Latin America, 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, Cresemba 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 the 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.
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 1, 2017]
2 European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu
[Accessed: November 1, 2017]
3 Full indication: Swissmedic-approved information for healthcare professionals as of August 2017
Press release (PDF)