Basel, Switzerland, April 18, 2018 -
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that its license
partner Asahi Kasei Pharma Corporation ("Asahi Kasei Pharma") has
started enrollment in a clinical phase 3 study with the antifungal
isavuconazole for the treatment of deep-seated mycosis, comprised of
invasive aspergillosis, chronic pulmonary aspergillosis, mucormycosis
and cryptococcosis. The study is part of an abbreviated development
program. If the study is successfully completed, Asahi Kasei Pharma
plans to proceed with the submission of a marketing authorization
application for isavuconazole in Japan.
Ronald
Scott, Chief Executive Officer, said: "Invasive fungal infections can be
life-threatening and are an area of significant medical need worldwide.
Basilea is working together with its partners to bring isavuconazole to
patients around the world. We are pleased that Asahi Kasei Pharma has
enrolled the first patient in the phase 3 isavuconazole program in
deep-seated mycosis. This is an important milestone on the path toward
making this new antifungal available to patients in Japan."
The
randomized, open-label multicenter study aims to establish the safety
and efficacy of intravenously (i.v.) or orally administered
isavuconazole (as the prodrug isavuconazonium sulfate) versus i.v. or
oral voriconazole as active comparator in the treatment of Japanese
patients with deep-seated mycosis. The study is anticipated to enroll
approximately 100 adult patients.
About isavuconazole
Isavuconazole
is an intravenous (i.v.) and oral azole antifungal, commercialized
under the trade name Cresemba. Basilea has entered into license and
distribution agreements for isavuconazole covering the United States,
Europe, China, Japan, Latin America, Canada, Russia, Turkey, Israel and
the Asia-Pacific and Middle East and North Africa regions. Isavuconazole
is approved in the United States to treat patients 18 years of age and
older for 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.
With two commercialized drugs, 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.
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.
References
1 Cresemba US prescribing information [Accessed: April 17, 2018]
2 European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu
[Accessed: April 17, 2018]
3 Full indication in: Swissmedic-approved information for healthcare professionals as of August 2017
