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European Commission publishes approval of Octapharma
Associated Press
2014-08-06 02:42 PM

LACHEN, Switzerland--(BUSINESS WIRE)--Aug 6, 2014--The European Commission has published approval of Octapharma's Nuwiq R (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with haemophilia A (congenital factor?VIII [FVIII] deficiency). Nuwiq R is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin. Nuwiq R is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor, both of which are potentially important properties in reducing FVIII inhibitor formation. The development of Nuwiq R aimed to address the challenges of inhibitor formation as well as the frequent infusions required for prophylaxis of bleeding.

"Nuwiq R represents a potential leap forward in dealing with the greatest clinical challenges in haemophilia?A ?V FVIII inhibitors and the frequent infusions needed for bleeding prophylaxis. In clinical trials, Nuwiq R demonstrated outstanding efficacy in preventing and treating bleeding in patients previously on FVIII (PTPs). No inhibitors in clinical trials in PTPs have been seen", says Olaf Walter, MD, PhD, MBA, Senior Vice President of International Business Units.

The benefit of Nuwiq R in terms of prevention and treatment of bleedings and haemostatic efficacy for surgical procedures was studied in three pivotal trials. In a study of 32 adults (GENA-08), overall prophylactic efficacy of Nuwiq R for spontaneous bleeds was rated as excellent in all (100%) patients. In a study of 59 children (GENA-03), prophylactic efficacy for spontaneous bleeds was rated as excellent or good in 96.6% of patients. Mean annualised bleeding rates for spontaneous bleeds during prophylaxis were approximately 1.5 in children and 1.2 in adults. Treatment of breakthrough bleeds during prophylaxis was rated as excellent or good for 28 of 28 (100%) bleeds in adults and for 89 of 108 (82.4%) bleeds in children. In on-demand treatment with Nuwiq R in 20 adults and 2 adolescents (GENA-01), efficacy for the treatment of bleeds was excellent or good in 931 of 986 (94.4%) bleeds. Overall efficacy across the GENA programme in surgical prophylaxis was rated excellent or good in 32 of 33 (97%) procedures.

The immunogenicity of Nuwiq R was evaluated in 135 PTPs (74 adults and 61 children). None of the patients developed inhibitors.

The next steps in Nuwiq R 's clinical programme include continued investigation of previously untreated patients (PUPs), with a target enrolment of 100 patients in the ongoing NuProtect study. PUPs are typically characterised by a higher risk of inhibitors. Octapharma is also committed to the ongoing NuPreviq study in PTPs, which is designed to test a robust programme of personalised prophylaxis, with a potential reduction in the number of FVIII infusions.

Regulatory data for Nuwiq R have been submitted to authorities in Canada, the US, and Australia, with further worldwide submissions planned.

About Haemophilia A

Haemophilia A is an X-linked hereditary disorder caused by FVIII deficiency which if left untreated leads to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. FVIII replacement prophylactic treatment reduces the number of bleeding episodes and the risk of permanent joint damage. This disorder affects one in every 5,000 to 10,000 men worldwide. Globally, 75% of haemophilia cases are left undiagnosed or untreated. The development of neutralising FVIII antibodies (FVIII inhibitors) against infused FVIII represents the most serious treatment complication. The cumulative risk of FVIII inhibitor development is reported to be currently up to 39%.

About Octapharma AG

Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation for more than 30 years. Its core business is the development, production and sale of human proteins from human plasma and human cell-lines. Patients in more than 100 countries are treated with products in the following therapeutic areas:

Haematology (coagulation disorders)

Immunotherapy (immune disorders)

Critical Care

Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.

CONTACT: Octapharma AG

Corporate Communications

Claudie Qumsieh

Tel.: +(41)-55-451-21-78

claudie.qumsieh@octapharma.com

KEYWORD: EUROPE NORTH AMERICA CANADA SWITZERLAND

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS PHARMACEUTICAL

SOURCE: Octapharma

Copyright Business Wire 2014

PUB: 08/06/2014 02:28 AM/DISC: 08/06/2014 02:28 AM

http://www.businesswire.com/news/home/20140805006847/en

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