Octapharma Canada

Octapharma Canada

November 10, 2014 14:00 ET

Health Canada Approves Octapharma's New Generation Recombinant FVIII (Nuwiq®) for All Age Groups in Hemophilia A

TORONTO, CANADA--(Marketwired - Nov. 10, 2014) - Octapharma Canada announced that Health Canada has approved Nuwiq® (recombinant FVIII) for treatment and prophylaxis of bleeding in patients of all ages suffering with hemophilia A (congenital factor VIII deficiency). Nuwiq® is a novel recombinant FVIII, produced in a human cell line cultured without additives of human or animal origin or any exposure to human blood or plasma, making it inherently free from blood-borne pathogens. In addition, Nuwiq® is also devoid of antigenic non-human protein epitopes, similar to FVIII produced in healthy humans. It has a high affinity for the von Willebrand coagulation factor.1

Nuwiq® was approved in the European Union and Australia and is under review by regulatory authorities in the US, with further worldwide submissions planned.

"The way Nuwiq® is produced is exciting as it allows the molecule to closely resemble the naturally occurring FVIII. Health Canada's approval of Nuwiq® provides patients with hemophilia A a new recombinant product option that will allow further customisation of hemophilia treatment on an individual basis ", says Dr. Anthony Chan, Professor, Pediatrics, Director of the Hemophilia Program at McMaster Children's Hospital.

The benefit of Nuwiq® in terms of prevention and treatment of bleedings and haemostatic efficacy for surgical procedures was studied in three pivotal trials.1 In studies of 32 adults (GENA-08) and 59 children (GENA-03), median annualised bleeding rates for spontaneous bleeds during prophylaxis were 'zero' for both patient groups. In 'on-demand' treatment with Nuwiq® 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 in surgical prophylaxis was rated excellent in all but one of the seven surgical procedures.

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

"The Canadian Hemophilia Society (CHS) is pleased to see Health Canada's approval of Nuwiq® for the treatment of hemophilia A," said Craig Upshaw, CHS President. "Nuwiq® has shown promising results in clinical trials and offers physicians and patients a new option in care. We hope it will be available to Canadian patients in the very near future."

Octapharma's clinical R&D efforts in hemophilia are dedicated to addressing the most important needs in hemophilia care: improving inhibitor safety and customising hemophilia management. The personalised medicine approach allows the control of bleeding with fewer infusions and is based on each individual patient's own physiology and lifestyle. Personalisation is aligned with the idea that prevention of bleeding is better than treating bleeds after the fact.

Nuwiq®'s ongoing clinical program includes a Phase III study in previously untreated patients (PUPs). The ongoing NuProtect study will enrol 100 PUPs including Canadian patients.2 PUPs are typically characterised by a higher risk of inhibitor development. The study will investigate whether the molecular properties of Nuwiq® will result in lower inhibitor development.
Two additional Phase III studies in previously treated patients are ongoing. The NuPreviq study and the Canadian Gena-21b study in previously treated patients are designed to assess the efficacy and safety of individually tailored prophylaxis.2 The goal of these studies is to provide optimal treatment for each patient based on their own pharmacokinetic properties with a potential reduction in the frequency of FVIII infusions.

About Hemophilia A

Hemophilia A is a rare, chronic, inherited disorder in which the ability of a person's blood to clot is impaired, which can lead to recurrent bleeding episodes. It is due to reduced factor VIII activity, which is needed for normal blood clotting. People with hemophilia A experience bleeding episodes that can cause pain and irreversible joint damage. Prophylactic treatment with factor VIII reduces the number of bleeding episodes and the risk of permanent joint damage. The most serious treatment complication is the development of antibodies (inhibitors) directed against infused FVIII. The risk of FVIII inhibitor can be as high as 38%.3

About Octapharma in Hemophilia

Octapharma has been dedicated to improving hemophilia care for over 30 years. Addressing the challenge of inhibitor formation in hemophilia A has been the focus of our hemophilia product development as well as our research efforts. For over a decade Octapharma has invested in inhibitor management registry studies, and in the development of recombinant VIII. Our understanding of bleeding disorders is reflected not only in our products for the treatment of hemophilia A, hemophilia B and von Willebrand disease, but also in the development of personalized treatment options. In Canada Octapharma is committed to providing new innovative treatment options and improving care for hemophilia and other bleeding disorders.

About Octapharma

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 since 1983. 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) and Critical Care.

Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. For additional information about the company, please visit www.octapharma.ca

(1) Nuwiq® Product Monograph. October 23, 2014. Octapharma Canada Inc.
(2) http://www.clinicaltrials.gov/
(3) Gouw SC, et al; PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.

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