August 17, 2016
Basilea announces distribution agreement with Hikma for CRESEMBA® (isavuconazole) in the MENA region
- Basilea extending its agreement with Hikma to include antifungal CRESEMBA® in addition to antibiotic Zevtera®
Basel, Switzerland, August 17, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the company has extended its distribution and supply agreement for the Middle East and North Africa (MENA) region with Hikma Pharmaceuticals LLC (Hikma) to include the antifungal CRESEMBA® (isavuconazole) in addition to Zevtera® (ceftobiprole).
In October 2015, Basilea signed an exclusive distribution and supply agreement with Hikma for Basilea's broad-spectrum hospital antibiotic Zevtera® for the MENA region. Under the terms of the amended agreement, Hikma has the exclusive right to register, distribute and market isavuconazole across the region. Isavuconazole received European marketing authorization in October 2015 for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.1 The European regulatory dossier will be the basis for regulatory filings in MENA countries.
David Veitch, Basilea's Chief Commercial Officer, stated: "With this extension of our partnership with Hikma, a leading pharmaceutical company in the Middle East and North Africa region, we are building on a successful collaboration that was established last year which has already led to the first regulatory submissions for ceftobiprole in the MENA region. We look forward to our two anti-infective brands being available to physicians and patients in the MENA region for the treatment of severe and often life-threatening infections. Our partnership with Hikma is in line with our strategy to commercialize both CRESEMBA and Zevtera in as many regions as possible to maximize their global potential to benefit patients, physicians and Basilea."
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis.2 The European marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.1 Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea commercializes isavuconazole as CRESEMBA® in Germany, Italy, the UK and Austria. The drug is commercialized in the US by Basilea's license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use.
About invasive aspergillosis and mucormycosis
Invasive aspergillosis and mucormycosis are life-threatening fungal infections that predominantly affect immunocompromised patients, such as cancer patients. 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.
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.
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 Corporate Communications & Investor Relations
+41 61 606 1102
This press release can be downloaded from www.basilea.com.
|1|| European Public Assessment Report (EPAR) for CRESEMBA®: www.ema.europa.eu |
[Accessed: August 16, 2016]
|2||CRESEMBA® US prescribing information [Accessed: August 16, 2016]|