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Sobi™ signs manufacturing agreements with Pfizer

Press Releases   •   Apr 29, 2016 06:05 GMT

Sobi has extended the existing manufacturing agreement with Pfizer for the drug substance for ReFacto AF®/XYNTHA® until December 31, 2023. In addition, Sobi has decided to move production of Kineret® drug substance to Pfizer’s manufacturing site in Strängnäs, Sweden.

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Sobi™ publishes its report for the first quarter 2016

Press Releases   •   Apr 27, 2016 06:00 GMT

Sobi™ today announced its results for the first quarter 2016. Revenue for the quarter totalled SEK 1,273 M (865), an increase of 47 per cent compared to previous year. All parts of the business contributed to the result with Orfadin® and Kineret® delivering strong performance.

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Sobi publishes 2015 Annual Report

Press Releases   •   Apr 27, 2016 05:45 GMT

Sobi today published its 2015 Annual Report, themed “A new chapter of our story”. The integrated report summarises the business as well as financial highlights for 2015, and gives a deeper insight into the company’s strategic agenda and its patient-centric innovation model.

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Bo Jesper Hansen to step down as Chairman of Sobi™ – Håkan Björklund to be nominated as new Chairman of the Board

Press Releases   •   Feb 26, 2016 07:15 GMT

Sobi Chairman of the Board, Bo Jesper Hansen, MD, PhD, has informed the Sobi’s nomination committee that he will not stand for re-election at the 2016 annual general meeting of shareholders (AGM). The Nomination Committee will propose that the shareholders elect Håkan Björklund, PhD, as the new Chairman of the Board for Sobi.

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Sobi™ publishes its report for the fourth quarter and full year 2015

Press Releases   •   Feb 26, 2016 07:10 GMT

Sobi today announced its results for the fourth quarter and full year 2015. Revenues for the full year totalled SEK 3,228 M (2,607), an increase of 24 per cent compared to previous year. Revenues for the fourth quarter were 15 per cent higher year-on-year and the product revenues grew 21 per cent, with Orfadin® (nitisinone) and Kineret® (anakinra) delivering strong performance.

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Sobi announces commercial launch of Elocta® in first countries in Europe

Press Releases   •   Jan 11, 2016 07:00 GMT

Sobi today announced the commercial launch of Elocta® (efmoroctocog alfa) in first countries in Europe. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

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Sobi gains commercial rights for Relistor®, Deflux® and Solesta® from PharmaSwiss

Press Releases   •   Jan 07, 2016 07:00 GMT

Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today announced that the company has gained commercial rights from the Swiss based company PharmaSwiss SA, to distribute Relistor®, Deflux® and Solesta® in a territory including Western Europe, Czech Republic, Slovakia, Hungary and also for Relistor in Russia.

“I am delighted that we have expanded our successful partnership with PharmaSwiss and provide patients and physicians with additional treatment options that address unmet medical needs in each specific therapeutic category”, said Alan Raffensperger, senior vice president and Chief Operating Officer at Sobi.

Sobi will handle all commercial activities in the territory including launch, market and patient access and promotion activities, while PharmaSwiss will be responsible for manufacturing, providing the finished products and products’ information.

The three new products that Sobi will distribute, one pharmaceutical and two medical devices, are all approved for specialty care indications:

  • Relistor (methylnaltrexone bromide) is indicated for treatment of opioid-induced constipation when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older
  • Deflux is indicated for treatment of children with vesicoureteral reflux
  • Solesta is indicated for the treatment of faecal incontinence in patients 18 years and older who have failed conservative therapy

In June 2013, Sobi announced its first distribution agreement with PharmaSwiss to market the products Megace®, Monopril®, Cefzil® and Duricef® approved for the treatment of indications within the oncology, cardio-vascular and anti-infective therapy areas.

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About Sobi Partner ProductsSobi Partner Products (SPP) is a business unit within Sobi that offers a unique commercial platform for partners with niche and specialty products. SPP provides extensive knowledge and local experience through our direct presence across EU, Eastern Europe, Russia, Middle East and North Africa. We apply an integrated commercial, medical and market access approach to products that address important unmet needs, spanning from named patient use (NPU) programmes, through to reimbursement and full commercialisation, primarily in the Centre of Expertise setting.

About Sobi

Sobi is an international specialty healthcare company dedicated to rare diseases. Our 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. We also market 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 
Media relations 
Oskar Bosson, Head of Communications 
T: +46 70 410 71 80
oskar.bosson@sobi.com

 Investor relations
Jörgen Winroth, Vice President, Head of Investor Relations 
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135  
jorgen.winroth@sobi.com

Sobi today announced that the company has gained commercial rights from the Swiss based company PharmaSwiss SA, to distribute Relistor®, Deflux® and Solesta® in a territory including Western Europe, Czech Republic, Slovakia, Hungary and also for Relistor in Russia.

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Sobi and Biogen’s Elocta® (rFVIIIFc) approved in Europe for the treatment of haemophilia A

Press Releases   •   Nov 24, 2015 07:47 GMT

– First therapy to provide prolonged bleeding protection with prophylactic injections every three to five days –

– Product to launch in initial EU countries in early 2016 –

Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) and Biogen (NASDAQ: BIIB) today announced that the European Commission (EC) has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. Elocta, a recombinant factor VIII Fc fusion protein with an extended half-life, will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

“The EC’s approval of Elocta is an important milestone for the global haemophilia A community, offering the potential to improve the care of haemophilia A across the EU,” said Birgitte Volck, M.D., Ph.D., senior vice president of Development and chief medical officer of Sobi. “Our focus is now to ensure timely and sustainable access to Elocta for people living with haemophilia A throughout Europe.”

Elocta is indicated for both on-demand and prophylaxis treatment of people with haemophilia A of all ages. The EC approval was based on data from Elocta’s pivotal, phase 3 A-LONG clinical study, which demonstrated the efficacy, safety and pharmacokinetics of rFVIIIFc in previously treated males 12 years of age and older with severe haemophilia A, and from the phase 3 Kids A-LONG clinical study, which demonstrated the efficacy and safety of rFVIIIFc in previously treated male children with haemophilia A under 12 years of age. The adverse drug reactions with an incidence of ≥ 0.5 per cent for Elocta were arthralgia, malaise, myalgia, headache and rash.

“Elocta is the first meaningful treatment advance in haemophilia A in nearly 20 years and reinforces our commitment to improving the care of people with this disease around the world,” said Gilmore O’Neill, M.D., senior vice president Drug Innovation Units at Biogen. “Since the therapy’s approval in the United States last year, we have seen the benefits that extended protection against bleeds can offer people with haemophilia A, and we are excited to work with Sobi to make this innovative therapy available to people in Europe.”

Sobi and Biogen are collaboration partners in the development and commercialisation of rFVIIIFc for haemophilia A. Last year, Sobi exercised its opt-in right to assume rFVIIIFc’s final development and commercialisation in pre-specified territories, which essentially include Europe, North Africa, Russia and certain countries in the Middle East. Biogen leads development and manufacturing of the product and holds commercialisation rights in North America and all other regions in the world outside of the Sobi territory.

Elocta is the trade name for rFVIIIFc in Sobi’s territory, which is also approved under the name Eloctate® [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the treatment of haemophilia A in the U.S., Canada, Australia, New Zealand and Japan.

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About Elocta®

Elocta (rFVIIIFc) is the first recombinant clotting factor VIII therapy that offers an extended half-life in the body. 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. 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.

About haemophilia A

Haemophilia A is a rare, chronic, genetic disorder in which the ability of a person’s blood to clot is impaired due to missing or reduced levels of a protein known as factor VIII. People with haemophilia A experience bleeding episodes that may cause pain, irreversible joint damage and life-threatening haemorrhages. According to the World Federation of Haemophilia, an estimated 140,000 people worldwide are identified as living with haemophilia A.

Therapies for haemophilia A, the most common form of haemophilia, can be administered either on a schedule to help prevent or reduce bleeding episodes (prophylaxis) or to control bleeding when it occurs (on-demand). 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.

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.

About Biogen

Through cutting-edge science and medicine, Biogen discovers, develops and delivers to patients 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 product labeling, press releases and additional information about the Company, please visit www.biogen.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
Benjamin Russell Ben Strain
+41 41 392 1702 1-781-464-2442
publicaffairs.eu@biogen.com IR@biogen.com
Kate Niazi-Sai
+1-781-464-3260
public.affairs@biogen.com

Sobi and Biogen today announced that the European Commission (EC) has approved Elocta® (rFVIIIFc) for the treatment of haemophilia A in all 28 European Union (EU) member states, as well as Iceland, Liechtenstein and Norway. Elocta will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

Read more »
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Haemophilia therapy from largest multi-year donation now available to patients in developing world

Press Releases   •   Oct 12, 2015 11:37 GMT

World Federation of Hemophilia announces expansion of humanitarian aid programme. Biogen, Sobi and the World Federation of Hemophilia collaboration to enable a sustained humanitarian supply of haemophilia treatment with the potential to change treatment paradigm in developing countries.

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Kineret® receives Australian regulatory approval for use in Systemic Juvenile Idiopathic Arthritis

Press Releases   •   Aug 19, 2015 08:33 GMT

Swedish Orphan Biovitrum AB (publ) (Sobi) together with its Australian partner, A. Menarini Australia Pty Ltd received marketing authorisation in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a rare form of juvenile chronic arthritis.

“We are pleased and encouraged by this approval which was achieved through a fruitful collaboration between physicians, regulators, and our development team including Menarini,” says Kristina Timdahl, Medical Therapeutic Area Head for the business area Inflammation at Sobi, “We are looking forward to serving a wider group of patients in Australia going forward.”

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About SJIA

Systemic juvenile idiopathic arthritis (SJIA) is a rare form of chronic arthritis in children up to 16 years of age. About 100 of 100,000 children are affected by child arthritis, and of these 10-20 percent have the sJIA form, today classified as an autoinflammatory disease. The disease does not only cause inflammation of the joints but also fever spikes, rash, anaemia, and enlargement and inflammation of major organs. Despite treatment, many children suffer life-long and serious complications such as osteoporosis and stunted growth.

About Kineret

Kineret (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1α and IL -1ß by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and a significant contributor to autoinflammatory diseases.

About A.Menarini Australia

A member of the Menarini Group, a leading European biopharmaceutical company, Menarini Australia is focused on delivering differentiated ethical and consumer healthcare brands to Australians. With an extensive brand portfolio, Menarini Australia markets a wide range of pharmaceutical, biotechnology and consumer health brands. Building on our strengths in dermatology, primary care, consumer health and specialty care, Menarini Australia is now introducing new products in men’s sexual health, cardiovascular and allergy/respiratory therapeutic areas. For further information please visit www.menarini.com.au

About Sobi

Sobi is an international specialty healthcare company dedicated to rare diseases. Our 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. We also market 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 
Media relations 
Oskar Bosson, Head of Communications 
T: +46 70 410 71 80
oskar.bosson@sobi.com

 Investor relations
Jörgen Winroth, Vice President, Head of Investor Relations 
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135  
jorgen.winroth@sobi.com

Sobi together with its Australian partner, A. Menarini Australia Pty Ltd received marketing authorisation in Australia for Kineret (anakinra) for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a rare form of juvenile chronic arthritis.

Read more »

Contacts 1 contact

  • Press Contact
  • Senior Communications Manager
  • wpChflarpepjlojntte.afkltterckwuxcfcgzerarxk@szqobi.colym
  • 0707-297327

About Sobi

Pioneer in Rare Diseases

Sobi is an international speciality healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primary focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of speciality 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 2015, Sobi had total revenues of SEK 3.2 billion (USD 385 M) and approximately 700 employees. The share (STO:SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.

Address

  • Sobi
  • Tomtebodavägen 23 A
  • 112 76 Stockholm
  • Sweden