STOCKHOLM, Sweden, Nov. 5, 2013 (GLOBE NEWSWIRE) --
Swedish Orphan Biovitrum AB (publ) (Sobi) announced its intention to bring a novel investigational biopharmaceutical drug candidate, SOBI002, into a phase I trial. The company also shared information regarding phase III data for Kepivance® recently acquired from Amgen. These updates as well as expectations for top line data for Kiobrina early next year were provided today at the company's Capital Markets Event in Stockholm. SOBI002 is a small biologic molecule based on the Affibody® platform that works as a potent and selective inhibitor of complement protein C5, a key protein in human immunological and inflammatory processes and central to a number of important diseases. "The advancement of SOBI002 into a phase I clinical trial marks an important milestone for Sobi", said Geoffrey McDonough, CEO and President at Sobi. "It is a solid validation of our partnership-oriented biologics innovation model and could address a wide set of rare disease indications where C5 plays a role." "We believe that the Affibody technology may offer a differentiated way to treat complement driven diseases, due to the small size, high solubility and stability of the molecule", said David Bejker, CEO at Affibody. "Sobi is well positioned to take advantage of the potentially unique features of SOBI002 as they have an excellent skill-set to develop and commercialize biologics for rare diseases." The study will evaluate single and repeated doses of SOBI002 administered subcutaneously and intravenously in healthy volunteers. Sobi expects to be able to commence the clinical trial during the first quarter 2014. Sobi also highlighted data from two phase III clinical trials concerning Kepivance. The trials demonstrate the potential for Kepivance to reduce the incidence and duration of severe oral mucositis, a complication of chemotherapy and radiotherapy regimens for Head and Neck cancers. The company is preparing to discuss the potential for a supplemental Biologics License Application (sBLA) filing to support a label expansion for Kepivance with the US Food and Drug Administration (FDA). Regarding the Kiobrina phase III study, Sobi explained that the top line data will initially include the primary endpoint of growth velocity at four weeks as well as some secondary endpoints from the period of the preterm infants' hospitalization. The company reiterated its expectation that the top line data for the study will be available in the first quarter in 2014. - - - 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 inflammation and genetic diseases, with three late stage biological development projects within haemophilia and neonatology. We also market a portfolio of specialty and rare disease products for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2012, Sobi had total revenues of SEK 1.9 billion (€ 215 M) and about 500 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com . About Affibody Affibody is a biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod(TM). Affibody is developing a portfolio of innovative drug projects and, in addition, offers the half-life extension technology, Albumod(TM), for outlicensing. Affibody has ongoing commercial relationships with several companies including Algeta, Amylin, Sobi, Daiichi- Sankyo, Daewoong, GE, and Thermo Fisher. Affibody was founded in 1998 by researchers from the Royal Institute of Technology and the Karolinska Institute and is based in Stockholm, Sweden. Major shareholders in the Company include HealthCap and Investor AB. More information is available at www.affibody.com . For more information - not for publication Sobi: Media relations Investor relations Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor Communications Relations T: +46 70 410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135 E: oskar.bosson@sobi.com E: jorgen.winroth@sobi.com Sobi hosts Capital Market Day event: http://hugin.info/134557/R/1740480/584533.pdf [HUG#1740480]
