Biotechnology Events

Home

Biogen Idec, Inc.

Partner : Sobi

.

PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

.

Biogen and Sobi Announce European Medicines Agency Validates ALPROLIX® (rFIXFc) Marketing Authorization Application
Category:
Corporate, Hematology, Investor Relations
Friday, June 26, 2015 2:00 am EDT

"The validation of the ALPROLIX MAA marks a critical regulatory milestone in our continued, collaborative global efforts."
CAMBRIDGE, Mass. & STOCKHOLM--(BUSINESS WIRE)--Biogen (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) of ALPROLIX® (rFIXFc), a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. This validation signifies the initiation of the EMA’s review process.

The MAA includes results from two global, Phase 3 clinical trials examining the efficacy, safety and pharmacokinetics (a measure of the presence of the therapy in a person’s body over time) of ALPROLIX for hemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12.

ALPROLIX is a recombinant, clotting factor IX therapy and is currently approved for the treatment of hemophilia B in the U.S., Canada, Japan and Australia. It is the only approved hemophilia B therapy to demonstrate prolonged clotting factor circulation in the body.

“The acceptance of this MAA is an important milestone in our goal to bring this innovative therapy to the European hemophilia community,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen. “We look forward to working with European regulators to help people with hemophilia B in Europe realize the benefits that treatment with ALPROLIX may offer.”

Biogen and Sobi are collaborators in the development and commercialization of ALPROLIX for hemophilia B. Sobi has an opt-in right to assume final development and commercialization of ALPROLIX for the Sobi territories (essentially, Europe, North Africa, Russia and certain Middle Eastern markets). Biogen leads development for ALPROLIX, has manufacturing rights, and has commercialization rights in North America and all other regions in the world excluding the Sobi territories.

“Our collaboration with Biogen remains focused on the goal of transforming the care of people living with hemophilia,” said Birgitte Volck, M.D., Ph.D., senior vice president of Development and chief medical officer of Sobi. “The validation of the ALPROLIX MAA marks a critical regulatory milestone in our continued, collaborative global efforts.”
More
Source: press release, 6/26/15. http://media.biogen.com/press-release/investor-relations/biogen-and-sobi...

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Alprolixt (Factor IX)HematologyHemophilia BCoagulation factor replacement therapeuticCoagulation cascade

Mechanism of action: Alprolixt (Factor IX), a fusion protein, Improves coagulation by replacing the defective factor IX clotting factor with an active factor IX fusion protein.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-05-27

Results:

.

Alprolix® (rFIXFc) Approved in the EU for the Treatment of Haemophilia B
First Fc Fusion Therapy Approved for haemophilia B in the EU to Provide Extended Protection Against Bleeds

Category: Rare and Genetic diseases

Friday, May 13, 2016 2:47 am EDT

"We’re proud to bring the European haemophilia community one of the first treatment advances in nearly 20 years, and believe the availability of extended half-life therapies in Europe will change the way that many approach treatment."
STOCKHOLM & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) and Biogen (NASDAQ:BIIB) today announced that the European Commission (EC) has approved Alprolix® (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) member states and maintained its orphan designation. Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic injections.

Alprolix is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages. Prophylactically, it can be administered with an initial dose every seven days or every 10 days with the ability to adjust the dosing interval based on individual response.

“With the approval of Alprolix, people with haemophilia B in Europe now have the potential to experience prolonged protection from bleeds with fewer injections,” said Krassimir Mitchev, M.D., Ph.D., vice president and medical therapeutic area head of Haemophilia at Sobi. “We are working to make Alprolix available in Europe as quickly as possible. Along with Biogen, we’re excited to continue offering innovative therapies to people with haemophilia around the world.”

The EC’s approval of Alprolix was based on results from two global Phase 3 clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for haemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12. The adverse drug reactions with an incidence of ≥ 0.5 percent for Alprolix were nasopharyngitis (common cold), influenza, arthralgia (joint pain), upper respiratory tract infection, headache, and hypertension. The majority of these events were judged as not related or likely not related to study drug.

“Alprolix has become a meaningful treatment advance for people living with haemophilia B in countries where it is approved and is backed by robust clinical data and the longest real-world experience of any prolonged circulation factor IX therapy to date.” said Gilmore O’Neill, M.D., senior vice president Drug Innovation Units at Biogen. “We’re proud to bring the European haemophilia community one of the first treatment advances in nearly 20 years, and believe the availability of extended half-life therapies in Europe will change the way that many approach treatment.”

Sobi and Biogen collaborate on the development and commercialisation of Alprolix for haemophilia B. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Alprolix and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.
More
Source: press release, 5/13/16. http://media.biogen.com/press-release/rare-and-genetic-diseases/alprolix...

.

Sobi and Biogen Receive Positive Opinion from CHMP for Alprolix® (rFIXFc) for the Treatment of Hemophilia B

Friday, February 26, 2016 7:11 am EST

"We are proud to work with Sobi to continue bringing to Europe these innovative Fc fusion therapies, which are grounded in the most robust real-world experience of any prolonged circulation factor therapies to date."
STOCKHOLM & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO: SOBI) and Biogen (NASDAQ: BIIB) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted for Alprolix® (rFIXFc), a recombinant factor IX Fc fusion protein therapy for the treatment of hemophilia B. If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals.

“This positive opinion marks an important step in our efforts to bring treatment innovation to people with hemophilia in Europe and around the world,” said Krassimir Mitchev, M.D., Ph.D., vice president and medical therapeutic area head of Haemophilia at Sobi. “We are already seeing the benefits that Fc fusion technology can offer through our recent EU launch of Elocta® for people with hemophilia A. We are excited at the prospect of also offering the possibility for prolonged protection and reduced treatment burden to the hemophilia B community with Alprolix.”

The positive opinion was based on results from two global, Phase 3 clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for hemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12. The CHMP's recommendation is now referred to the European Commission (EC), which grants marketing authorisation for medicines in the EU.

“Therapies that offer prolonged protection from bleeds are changing the way many approach treatment of hemophilia,” said Gilmore O’Neill, M.D., senior vice president, Drug Innovation Units at Biogen. “We are proud to work with Sobi to continue bringing to Europe these innovative Fc fusion therapies, which are grounded in the most robust real-world experience of any prolonged circulation factor therapies to date.”

Sobi and Biogen are collaborators in the development and commercialisation of Alprolix for hemophilia B. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Alprolix and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.
more
Source: press release, 2/26/16. http://media.biogen.com/press-release/biosimilars/sobi-and-biogen-receiv...

.