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New data presented at ASH show Elocta® and Alprolix® may help control target joint bleeds in people with haemophilia A and B


December 8, 2015 - London

Orlando, Florida, USA, 8 December 2015

New data demonstrate Elocta® (efmoroctocog alfa) [recombinant human coagulation factor VIII, Fc fusion protein]) (marketed as Eloctate® in the USA) and Alprolix® (rFIXFc) may effectively manage target joint bleeding and maintain low annualised bleeding rates (ABRs) in people with severe haemophilia A and B. The data, which were presented by Biogen (NASDAQ:BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla..

"As the first therapies to offer prolonged protection from bleeds, Elocta and Alprolix continue to show low rates in both joint bleeding and overall annualised bleeding episodes," said Kate Dawson, M.D., vice president, U.S. Medical at Biogen. "Their ability to reduce bleed rates, which may translate into the potential for reducing some joint disease, continues to reaffirm their clinical value for people living with haemophilia A and B."

For people with severe haemophilia A and B, most bleeding events occur in joints. When bleeding events occur repeatedly in the same joint (known as a target joint), it is often a precursor to chronic joint disease, marked by progressive deterioration of the joint.[1] These post-hoc analyses aimed to assess the frequency of bleeding events and the dosing of Elocta and Alprolix in study participants who had one or more target joint bleeds [major joint (e.g., knee, elbow, ankle) with three or more bleeding episodes in a three-month (haemophilia B) or six-month (haemophilia A) period].[2], [3]

"Understanding the impact of Elocta and Alprolix on people with target joint bleeds provides further insight into their value in a real-world setting," said Birgitte Volck, M.D., Ph.D., senior vice president of Development and Chief Medical Officer of Sobi. "These new results from the post hoc analyses highlight the value of extended half-life therapy in managing and controlling bleeds, adding to the body of robust clinical data and the longest real-world experience of any extended half-life therapy to date."

Results highlight therapies' potential for reducing bleed rates in target joints
In this ASPIRE (an ongoing extension of phase 3 pivotal trials A-LONG and Kids A-LONG) post-hoc analysis, for people with haemophilia A taking Elocta prophylactically, on-study ABRs overall and in target joints were lower than pre-study bleeding rates. Data from ASPIRE showed that nearly half of the adult and adolescent participants in the weekly prophylaxis, individualised prophylaxis and modified prophylaxis arms (n=26, n=82, n=12, respectively) did not have any target joint bleeds. For children, 53.8 per cent of participants in the individualised prophylaxis group (n=13) did not have any target joint bleeding episodes (42.3, 47.6 and 41.7 per cent, respectively). In addition, nearly all (97.4 per cent) target joints in adult and adolescent participants taking Elocta were resolved during the follow-up period, suggesting that the therapy may be equally effective for preventing target joint bleeding episodes in weight-bearing and non weight-bearing joints. The median dosing intervals for ASPIRE participants with target joints at baseline were similar to those for the A-LONG and Kids A-LONG overall population.2

In the B-LONG (the pivotal phase 3 study) post-hoc analysis, for people with haemophilia B taking Alprolix prophylactically, the therapy was shown effective for reducing the frequency of bleeding episodes overall and in target joints. The analysis found that 48.6 per cent of participants receiving weekly prophylaxis (n=35) and 37.5 per cent of participants on individualised interval prophylaxis (n=8) did not have any target joint bleeds at the end of B-LONG. Overall, participants' target joint, spontaneous target joint and traumatic target joint median ABRs were low for participants in the weekly prophylaxis arm (1.03, 0.00 and 0.00 respectively) and the individualised interval prophylaxis arm (2.20, 2.20 and 0.00 respectively). Additionally, among B-LONG participants entering the trial with target joints (n=43), the on-study median dosing intervals were longer (6.98 days in the weekly prophylaxis arm and 10.25 in the individualised interval prophylaxis arm) than the pre-study dosing interval with a traditional factor therapy, suggesting that target joint bleeds may be effectively managed and controlled with an extended prophylactic dosing regimen of every one to two weeks.3 

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About haemophilia A and B
Haemophilia is a rare, genetic disorder in which the ability of a person's blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male births annually, and more rarely in females. Haemophilia B occurs in about one in 25,000 male births annually, and more rarely in females. Worldwide, it is estimated that more than 400,000 people are living with haemophilia. Haemophilia A is caused by having substantially reduced or no factor VIII activity, while haemophilia B is caused by having substantially reduced or no factor IX activity; factor VIII and factor IX are needed for normal blood clotting.

People with haemophilia A or B experience prolonged bleeding episodes that can cause pain, irreversible joint damage and life-threatening haemorrhages. Prophylactic infusions of factor VIII or IX can temporarily replace the missing clotting factors that are needed to control bleeding and prevent new bleeding episodes.[4] The World Federation of Hemophilia recommends that prophylaxis be the goal of therapy because it may prevent bleeding and joint destruction. As a result, regular prophylactic treatment may slow progression of joint disease and may improve quality of life.[5]

About Elocta®/Eloctate®
Elocta [efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein)] is the first recombinant clotting factor VIII therapy that offers an extended half-life in the body. In Europe, it is indicated for the treatment and prophylaxis of bleeding episodes in patients with haemophilia A (factor VIII deficiency) and can be used by people of all ages. The safety and efficacy of Elocta in previously untreated patients has not yet been established. It is also approved in the United States, Canada, Australia and Japan under the trade name Eloctate® [Antihemophilic Factor (Recombinant), Fc Fusion Protein]. Elocta was developed by fusing B-domain deleted factor VIII to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). It is believed that this enables Elocta to utilise a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion technology has been used in other therapies for more than 15 years, Sobi and Biogen are the first companies to utilise it in the treatment of haemophilia. Allergic type hypersensitivity reactions and development of Factor VIII neutralising antibodies (inhibitors) may occur following administration of Elocta.

Common adverse reactions (incidence of greater than or equal to 1 per cent) reported in the registrational A-LONG study were arthralgia (joint pain) and malaise (general discomfort).

About Alprolix®
Alprolix (rFIXFc) is a long-acting recombinant factor IX Fc fusion protein product candidate for people with haemophilia B. Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], is the first recombinant, clotting factor therapy with prolonged circulation in the body for adults and children with haemophilia B, approved in the United States, Canada, Australia and Japan. Alprolix was submitted to the European Medicines Agency (EMA) for regulatory approval in Europe in June 2015. Alprolix was developed by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body). This enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body.

Common adverse reactions (incidence of greater than or equal to 1 percent) from the registrational B-LONG study were headache and oral paraesthesia (an abnormal sensation in the mouth). For additional important safety information, and the United States full prescribing information, please visit www.alprolix.com.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world's oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.

About Sobi
Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi's mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products for partner companies across Europe, the Middle East, North Africa and Russia. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2014, Sobi had total revenues of SEK 2.6 billion (USD 380 M) and about 600 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.

For more information please contact

Sobi
Media relations Investor relations
Oskar Bosson, Head of Communications Jörgen Winroth, Vice President, Head of Investor Relations
+46 70 410 71 80 +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
oskar.bosson@sobi.com jorgen.winroth@sobi.com
Biogen
Media relations Investor relations
Hayley Soffer Ben Strain
+1-781-464-3260 1-781-464-2442
publicaffairs.eu@biogen.com IR@biogen.com

 


[1]Hemophilia Federation of America. Joint Damage. Available at: http://www.hemophiliafed.org/bleeding-disorders/complications/joint-damage/. Accessed: November 2015.

[2] Kerlin, BA, et al. (December 2015). Long-term Efficacy of rFVIIIFc Prophylaxis in Pediatric, Adolescent, and Adult Subjects With Target Joints and Severe Hemophilia A. Poster session presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla.

[3] Shapiro, AD, et al. (December 2015). Analysis of Target Joint Bleeding With Prophylactic Use of Recombinant Factor IX Fc Fusion Protein in Patients With Severe Hemophilia B. Poster session presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla.

[4] Hemophilia Federation of America. What is Hemophilia? Available at: http://www.hemophiliafed.org/bleeding-disorders/hemophilia/treatment/. Accessed: November 15

[5] Guideline for the management of hemophilia, World Federation of Hemophilia, 2nd edition, http://www1.wfh.org/publication/files/pdf-1472.pdf. Accessed: December 2015

 


 
 
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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Swedish Orphan Biovitrum AB (publ) via Globenewswire

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