Sobi(TM) announces commercial launch of Elocta® in first countries in Europe
Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) 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.
Elocta is indicated for both prophylaxis and on-demand treatment of bleeding in people with haemophilia A and can be used for all age groups. The SmPC recommended prophylactic dose of Elocta is 50 IU/kg every three to five days. The dose may be personalised by the treating physician in the range of 25 to 65 IU/kg depending on the severity of the factor VIII deficiency, the location and frequency of bleeding, and the patient's activity level and clinical condition.
"The launch of Elocta is an important milestone for the haemophilia community, offering people with haemophilia A in the EU a treatment option that provides extended protection against bleeds", said Geoffrey McDonough, CEO and President at Sobi. "Since the approval of Elocta in the EU, our focus has been to ensure timely and sustainable access to Elocta for people living with haemophilia A. We are delighted to be able to announce that Elocta is now available."
Elocta is a fully recombinant fusion protein produced from a human cell line without the addition of human- or animal-derived protein. The European Commission's approval of Elocta was based on data from the pivotal phase 3 A-LONG clinical study which demonstrated the efficacy, safety and pharmacokinetics of Elocta 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 Elocta in previously treated boys under 12 years of age with haemophilia A.
"Low annualised bleeding rates, comparable with those seen in the pivotal A-LONG and Kids A-LONG trials, have been observed during the ongoing open label, long term follow-up ASPIRE study, with most participants receiving prophylactic treatment with similar weekly Elocta consumption as in the pivotal phase 3 studies", said Birgitte Volck, Senior Vice President, Chief Medical Officer at Sobi. "For long term prophylaxis Elocta offers a dosing regimen that can be personalised to meet the needs of each individual patient."
Sobi and Biogen are collaboration partners in the development and commercialisation of Elocta for haemophilia A, which is also known as Eloctate® (Antihemophilic Factor (Recombinant), Fc Fusion Protein) in Australia, Canada, Japan, New Zealand and the U.S., where it is approved for the treatment of haemophilia A. Sobi holds final development and commercialisation rights in pre-specified territories, which 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 (efmoroctocog alfa) is the first recombinant clotting factor VIII therapy in the EU 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). 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. As with any infused protein, allergic type hypersensitivity reactions and development of inhibitors may occur following administration of Elocta. For full prescribing information visit www.elocta.com.
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 Hemophilia, 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.
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
|Media relations||Investor relations|
|Oskar Bosson, Head of Communications||Jörgen Winroth, Vice President, Head of Investor Relations|
|T: +46 70 410 71 80||T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135|
 World Federation of Hemophilia. Annual Global Survey 2012. http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed July 2015.
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
Följ NASDAQ OMX
Skriv in din e-postadress så får du ett mejl när vi har något nytt att berätta.
Senaste pressmeddelandena från NASDAQ OMX
World Conference on Lung Cancer Tuesday Press Conference: Evidence to Support Innovative Lung Cancer Interventions17.10.2017 08:16 | Pressmeddelande
YOKOHAMA, Japan, Oct. 17, 2017 (GLOBE NEWSWIRE) -- Today's press conference at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) featured groundbreaking findings in the study of both small cell and non-small cell lung cancer. The studies presented covered broad research areas, from confirmation of existing classification criteria to ensuring viability of evidence to supporting the use of specific interventions. Biopsy specimen found to be reliable for evaluating DLL3 expression in small cell lung cancer Small cell lung cancer (SCLC) biopsy specimen was found to be reliable material for evaluating DLL3 expression; high levels of DLL3 in SCLC are correlated with poor survival trends. These results may lead to further evaluation of the scoring system for predicting DLL3-targeted therapeutic efficacy and clinical significance of DLL3 expression in high-grade pulmonary neuroendocrine carcinomas.
New Era Launches Direct-to-Consumer eCommerce Site Built by EPAM and Powered with SAP Hybris17.10.2017 06:01 | Pressmeddelande
New Site Expands Headwear and Apparel Offering with Immersive, Omnichannel Experience NEWTOWN, Pa., Oct. 17, 2017 (GLOBE NEWSWIRE) -- EPAM Systems, Inc. (NYSE:EPAM), a leading global provider of digital platform engineering and software development services, and New Era, a global headwear brand rooted in sports, today announced the launch of New Era's first direct-to-consumer website, neweracap.com. New Era's B2B business remains strong, and the company is now putting an emphasis on selling its products directly to customers and expanding its offering into the lifestyle market. The new site offers products for seasoned athletes and sports fans, as well as street and lifestyle consumers. "In an age where businesses cannot tolerate lengthy, scope changing technology projects, EPAM quickly established themselves as the standout partner for us to tackle this ambitious initiative," said Lorenz Gan, Global Vice President, Information Technology, New Era. "Whilst this p
LogicBio Therapeutics to Present Preclinical Data at European Society of Gene & Cell Therapy 25th Anniversary Congress in Berlin16.10.2017 15:00 | Pressmeddelande
· Company co-founder Professor Adi Barzel, Ph.D., to present new proof-of-concept efficacy data CAMBRIDGE, Massachusetts, Oct. 16, 2017 (GLOBE NEWSWIRE) -- LogicBio Therapeutics, Inc., a gene-therapy company with a mission to develop cures for early-onset life-threatening diseases, announced today that its company co-founder, Dr. Adi Barzel, will present new data from its genome-editing platform during the 25th Annual European Society of Gene & Cell Therapy (ESGCT) Congress in two presentations this Wednesday in Berlin, Germany. The ESGCT will be held from October 17-20, 2017, at the bcc Berlin. Dr. Barzel will present data in multiple animal models of disease demonstrating the extended therapeutic potential of LogicBio's proprietary GeneRide(TM) platform technology. The GeneRide technology harnesses the natural power of homologous recombination to enable precise, site-specific in vivo genome editing to deliver therapeutic genetic material without th
CP Kelco Appoints Didier Viala as New President16.10.2017 15:00 | Pressmeddelande
ATLANTA, Oct. 16, 2017 (GLOBE NEWSWIRE) -- CP Kelco, a leading global producer of specialty hydrocolloid solutions, announced today that Didier Viala has been appointed President, effective October 1, 2017. Viala replaces Donald Rubright, who served as CP Kelco President since 2006 and will retire at the end of 2017. Viala has also joined the CP Kelco Board of Directors. "As a market leader supplying high-quality hydrocolloid products for a range of foods and beverages, consumer products and industrial applications, CP Kelco will continue to invest in capacity additions, new product and applications development, strategic raw material sourcing, quality and safety management, and sustainability initiatives to support our customers' innovation efforts and growth strategies," Viala said. Over the course of more than 25 years with CP Kelco and its predecessor companies, Viala held leadership roles across a broad spectrum of critical areas, including innovat
Invitation to presentation of LeoVegas third quarter 201716.10.2017 14:35 | Pressmeddelande
LeoVegas interim report for the third quarter 2017 will be published at 08:00 CET on October 25, 2017. A webcast telephone conference will be held at 09:00 CET the same day, where Gustaf Hagman, CEO and President, and Viktor Fritzén, CFO, will present the results for the third quarter 2017. A possibility will be given to ask questions via the webcast and follow the presentation live. The webcast will be accessible at: https://edge.media-server.com/m6/p/4pk3b55e To participate in the conference call by phone, please call one of the following numbers: SE: +46 (0) 8 5352 6408 UK: +44 (0) 20 3427 1914 US: + 1646 254 3364 Confirmation code: 35 35 667 The webcast, which afterwards also will be
Inbjudan till presentation av LeoVegas kvartalsrapport för tredje kvartalet 201716.10.2017 14:35 | Pressmeddelande
LeoVegas kvartalsrapport för det tredje kvartalet 2017 kommer att publiceras klockan 08:00 den 25 oktober 2017. En webbsänd telefonkonferens kommer att hållas klockan 09:00 samma dag där Gustaf Hagman, VD och koncernchef samt Viktor Fritzén, CFO, presenterar resultatet för det tredje kvartalet 2017. Det kommer att finnas möjlighet att ställa frågor via webbsändningen där även presentationsmaterialet går att följa. Webbsändningen nås på adressen: https://edge.media-server.com/m6/p/4pk3b55e För att delta i telefonkonferensen via telefon, vänligen ring in på något av följande nummer: SE: +46 (0) 8 5352 6408 UK: +44 (0) 20 3427 1914 US: + 1646 254 3364 Bekräftelsekod: 35 35 667 Webbsändningen, som även kan ses i efterhand, och pres
I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.Besök vårt pressrum