CRESEMBA™ now available in Canada for the treatment of invasive aspergillosis and invasive mucormycosis
Blainville, Québec, May 2nd, 2019 – AVIR Pharma Inc. (AVIR), is pleased to announce that Cresemba™ (isavuconazole, as isavuconazonium sulfate), an antifungal approved for the treatment of adult patients with invasive aspergillosis or with invasive mucormycosis, is now available in Canada.1 Invasive aspergillosis and invasive mucormycosis are life-threatening fungal infections often occurring in patients with solid organ transplants, cancer and other immunocompromised patients.
“We are extremely proud to announce the availability of Cresemba™ and offer Canadian patients and healthcare professionals an important new therapeutic option for the treatment of invasive aspergillosis and invasive murcormycosis. Cresemba™ is a great addition to AVIR’s anti-infective portfolio of products and will provide potential commercial synergy with Zevtera® (ceftobiprole medocaril).” said Olivier St- Denis, President, AVIR Pharma.
In June 2017 AVIR Pharma Inc. and Basilea Pharmaceutica Ltd entered into a distribution and license agreement for Cresemba™ and Zevtera® in Canada. Cresemba is the only azole antifungal currently indicated for the treatment of both invasive aspergillosis and invasive mucormycosis.
“As a front-line Infectious Disease Physician, I see a great need for novel compounds that demonstrate both efficacy and tolerability to treat invasive fungal infections. Isavuconazole with expanded coverage that includes both Aspergillus spp and Mucorales spp, will be an important addition to the existing treatment options for managing Invasive Fungal Infections.” said Dr. Shariq Haider (Juravinski Cancer Centre - Hamilton Health Sciences)
About CRESEMBA™ (isavuconazole)
Isavuconazole is an intravenous (i.v.) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It is approved in Canada and in the United States 2 for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. In Europe, isavuconazole received marketing authorization for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.3 Isavuconazole has orphan drug designation for the approved indications in Europe and the US.
Health Canada’s approval of Cresemba™ was based on data from two Phase 3 clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, non-inferiority (versus active-control voriconazole) study of 516 adult patients with invasive aspergillosis; and VITAL, an open-label non-comparative study of Cresemba™ which included a subpopulation of 37 patients with invasive mucormycosis. In both studies, the primary endpoint was all-cause mortality at day 42.
About invasive aspergillosis and invasive mucormycosis
Invasive aspergillosis and invasive mucormycosis are life-threatening fungal infections that often affect immunocompromised patients, such as patients with cancer. Invasive aspergillosis is known for high morbidity and mortality. Invasive mucormycosis is a rapidly progressing and life-threatening invasive fungal infection, known for high morbidity and mortality.
About Avir Pharma Inc.AVIR Pharma Inc. is a wholly-owned, privately-held Canadian pharmaceutical company whose mission is to enhance the lives of Canadians through the acquisition, in-licensing and co-development of innovative, specialty pharmaceutical products. Located in Blainville, Quebec, AVIR Pharma Inc. is an affiliate of the Laboratoire Riva Group, an established company with over 40 years of experience in manufacturing, distributing and promoting pharmaceutical products in the Canadian marketplace. For more information, please visit the company’s web site at www.avirpharma.com.
About BasileaBasilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and anti-infectives. 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.
Noemi Soucy-Girard, NSG Public Relations
Marketing Director AVIR Pharma Inc.
1 CRESEMBA™ (isavuconazole) Product Monograph : AVIR Pharma Inc.; December 24, 2018 (http://avirpharma.com/pdf/Product-Monograph-Cresemba.pdf )
2 Cresemba® US prescribing information [Accessed: December 6, 2018] https://www.astellas.us/docs/cresemba.pdf
3 European Public Assessment Report (EPAR) Cresemba®: http://www.ema.europa.eu [Accessed: April 30, 2019]