New MA program with Basilea

09 June 2016

CLINIGEN GROUP PLC

Clinigen announces partnership with Basilea to initiate a Managed Access program for isavuconazole to treat patients with invasive fungal infectionsin Europe

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group') the global pharmaceutical and services company, and Basilea Pharmaceutica International Ltd ('Basilea'), a Swiss pharmaceutical company focused on providing innovative pharmaceutical hospital products, have initiated a Managed Access program for isavuconazole to treat patients with invasive fungal infections in those European countries where isavuconazole has been approved but is not yet commercially available.

Isavuconazole is an intravenous and oral triazole antifungal indicated for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is inappropriate.

Isavuconazole received US FDA approval in March 2015 and European Marketing Authorisation in October 2015, and is commercially available in the US and in certain key European Union (EU) countries, including Germany and the UK. Isavuconazole is not yet commercially available in all EU countries. Outside the US and EU, isavuconazole is an investigational product not approved for commercial use.

The access program will be run by Clinigen's Idis Managed Access (MA) division and will enable patients with serious fungal infections in those EU states where isavuconazole is not yet commercially available as well as Iceland, Liechtenstein and Norway, to access isavuconazole via their physician.

Access to isavuconazole will be provided by Idis MA following a physician request for individual patients who meet the established eligibility criteria.

Steve Glass, Group Managing Director of Clinigen said:

"Invasive fungal infections pose a fatal threat to immuno-compromised patients. It is therefore crucial that new treatment options like isavuconazole are made available and can be accessed by those who need it at the first possible opportunity. As partners to Basilea, Idis MA will leverage its European distribution network and regulatory expertise to deliver this important medicine to individual patients, wherever they are located in Europe."

Healthcare Professionals can obtain details about the isavuconazole Managed Access program by calling +44 (0) 1932 824 123 or emailing [email protected].

- Ends -

Contact Details

About invasive aspergillosis and invasive mucormycosis

Aspergillus is a fungus whose spores are present in the air we breathe, but do not normally cause illness. However, they can cause disease in those people with a weakened immune system, damaged lungs from conditions such as cystic fibrosis, or with allergies. Prospective surveillance among transplant recipients performed during 2001-2006 found that invasive aspergillosis was the most common type of fungal infection among stem cell transplant recipients and was the second-most common type of fungal infection among solid organ transplant recipients.1, 2

Mucormycosis is an increasingly emerging life-threatening infection caused by fungi in the order of Mucorales. Apart from immunocompromised patients, such as hematopoietic stem cell transplant recipients and patients with haematological malignancies, mucormycosis also may affect patients with diabetic ketoacidosis, those receiving deferoxamine therapy, injection drug users, and those with no apparent immune impairment. Severe infection of the sinuses, which may extend into the brain, is the most common presentation. Lungs, skin and gastrointestinal (GI) infections can also be seen. Mucormycosis can be fatal in up to 100% of patients, depending on its location, and although overall mortality improved from 84% in the 1950s to 47% in the 1990s, the high medical need for mucormycosis treatments has remained essentially unchanged.3 

About IsavuconazoleIsavuconazole is an intravenous and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. Isavuconazole 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. The European Commission granted marketing authorisation 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. Basilea has licensed the U.S. rights to Astellas Pharma Inc. Isavuconazole is commercialised under the trade name CRESEMBA® by Basilea in certain European countries and by Astellas in the U.S. Outside the U.S. the EU, Iceland, Liechtenstein and Norway, isavuconazole is currently an investigational product and not approved for commercial use. The drug was co-developed by Basilea and its U.S. licensee Astellas.

About Clinigen Group

Clinigen Group plc (AIM: CLIN) is a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines. Its mission is to deliver the right medicine to the right patient at the right time.

The Group consists of five synergistic businesses focused in three areas of global medicine supply; clinical trial, unlicensed and licensed medicines.

Clinigen Clinical Trial Services is the global market leader in the management and supply of commercial medicines for clinical trials.

The Group is also the trusted global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need, through three of its divisions: Idis Managed Access runs early access programs for innovative new medicines. Idis Global Access and Link Healthcare work directly with healthcare professionals to enable compliant access to unlicensed medicines on a global basis and niche essential licensed and generic medicines across Australasia, Africa and Asia (AAA region).

Clinigen Specialty Pharmaceuticals acquires global rights, revitalises and markets its own portfolio of niche hospital commercial products.

For more information, please visit www.clinigengroup.com

About Basilea

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 commercialise 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).

1Kontoyiannis DP, Marr KA, Park BJ, Alexander BD, Anaissie EJ, Walsh TJ, et al. Prospective surveillance for invasive fungal infections in hematopoietic stem cell transplant recipients, 2001-2006: overview of the Transplant-Associated Infection Surveillance Network (TRANSNET) Database. Clin Infect Dis. 2010 Apr 15;50(8):1091-100.

2Pappas PG, Alexander BD, Andes DR, Hadley S, Kauffman CA, Freifeld A, et al. Invasive fungal infections among organ transplant recipients: results of the Transplant-Associated Infection Surveillance Network (TRANSNET). Clin Infect Dis. 2010 Apr 15;50(8):1101-11.

3Roden MM, Zaoutis TE, Buchanan WL, Knudsen TA, Sarkisova TA, Schaufele RL, et al. Epidemiology and outcome of zygomycosis: a review of 929 reported cases. Clin Infect Dis. 2005 Sep 1;41(5):634-53