Biotech Values

[DewDiligence]

Symphogen and Biovitrum Initiate Phase-1
Trial of First Recombinant Polyclonal Antibody
to Enter Clinical Evaluation

[The product to be tested consists of 25 distinct antibodies.]

http://biz.yahoo.com/bw/070312/20070312005494.html?.v=1

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Monday March 12, 3:11 am ET

Sym001 to be evaluated for Rare Blood Diseases and Anti-RhD Prophylaxis

Symphogen and Biovitrum are developing a recombinant, polyclonal antibody for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and anti RhD prophylaxis of Hemolytic Disease of the Newborn (HDN). The product, Sym001, consists of 25 different recombinant anti-Rhesus D antibodies.

COPENHAGEN, Denmark & STOCKHOLM, Sweden--(BUSINESS WIRE)--Symphogen and Biovitrum today announced the initiation of a Phase 1 clinical trial to test the safety, pharmacokinetics and pharmacodynamics of Sym001 (Anti-RhD) in healthy volunteers. Sym001 is a recombinant, polyclonal antibody product candidate, comprised of 25 different anti-Rhesus D antibodies. Sym001 is in development for the treatment of Idiopathic Thrombocytopenic Purpura (ITP) and for the prevention of Hemolytic Disease of the Newborn (HDN). Symphogen and Biovitrum are jointly developing Sym001 under a co-development and commercialization agreement announced in February 2006.

"Sym001 is the first ever recombinant polyclonal antibody to enter human clinical trials. The approval from the FDA to enter Phase 1 and the dosing of our first subjects are very significant milestones for Symphogen, and they serve as a demonstration of our successful partnership with Biovitrum," said Kirsten Drejer, Ph.D., CEO of Symphogen. "This landmark achievement for us is a clear validation that our platform technologies are able to generate consistent batches of important products which can progress now into clinical evaluation."

Mats Pettersson, CEO of Biovitrum, said, "We are very happy that we now have six projects in the clinic. We are gearing up for an intense year with a very strong news flow from our pipeline both in terms of results from ongoing trials and initiation of new trials especially within our protein-based specialist programs. Our partnership with Symphogen is of great strategic value and fits well with Biovitrum's long experience and broad knowledge within the area of protein therapeutics. Symphogen's technology platform with a recombinant polyclonal antibody product enables us to focus on diseases currently treated by traditionally produced immunoglobulins. This new approach has a broader therapeutic potential and the concept is well showcased in our partnership"

About the Sym001 Phase 1 Trial

Up to 39 RhD positive and 18 RhD negative healthy volunteers will be enrolled in the double-blind, randomized, placebo-controlled, dose escalation Phase 1 trial. The primary study objective is to assess the safety and tolerability of Sym001 following a single intravenous infusion. Secondary trial objectives are to evaluate the pharmacokinetic profile (binding, distribution, excretion), the pharmacodynamic profile (clinical activity) and any potential immunogenicity (immune system reaction) of Sym001. The trial is being conducted at a clinic in the United States and the study is expected to be completed with results at the end of 2007.

Conventional immunoglobulin products are isolated from the blood of donors, and therefore are subject to potential safety issues due to the risk of disease transmission, as well as to supply shortages caused by dependence on donor blood availability. Symphogen's and Biovitrum's recombinant polyclonal antibodies can be produced in unlimited supply, and they carry decreased risk of viral or prion transmission, qualities that the Companies believe make them a more attractive therapeutic option for both ITP and anti-RhD prophylaxis of HDN.

Symphogen's technology can also address the large markets currently targeted by monoclonal antibody therapies, and Symphogen's preclinical pipeline includes products targeting infectious diseases and cancer.

About Sym001

Sym001 consists of 25 different recombinant polyclonal anti-Rhesus D antibodies for the treatment of Idiopathic Thrombocytopenic Purpura and for the prevention of Hemolytic Disease of the Newborn. Preclinical studies of Sym001 demonstrated its binding potency and biological function similar to existing plasma-derived anti-RhD products. Symphogen has a co-development and commercialization agreement with Biovitrum AB for Sym001.

Idiopathic Thrombocytopenic Purpura is an autoimmune bleeding disorder characterized by abnormally low platelet levels, making it difficult for the blood to clot normally. Hemolytic Disease of the Newborn may result when a RhD-negative woman becomes sensitized to RhD while carrying a RhD-positive child. This immune reaction can trigger a maternal antibody response in subsequent RhD-positive pregnancies, causing the breakdown of fetal red blood cells.

About Biovitrum

Biovitrum is one of the largest biopharma companies in Europe. With operations in Sweden and in the UK Biovitrum conducts research and develops pharmaceuticals for unmet medical needs both for common diseases and conditions that affect smaller patient populations. Biovitrum has a broad and balanced R&D portfolio with several projects in clinical and preclinical phases for the treatment of obesity, diabetes, inflammation and eye and blood diseases as well as a number of well defined niche indications. Biovitrum develops and produces protein-based drugs on a contractual basis and markets a range of specialist pharmaceuticals primarily in the Nordic countries. Biovitrum has revenues of approximately SEK 1.2 billion and 550 employees. Biovitrum is listed on the Stockholm Stock Exchange since September 15, 2006. For more information see www.biovitrum.com.

About Symphogen

Symphogen is the leader in developing recombinant polyclonal antibodies (pAb), a new class of biopharmaceuticals for the treatment of serious human diseases. By employing its pioneering antibody discovery and manufacturing technologies, Symphogen generates recombinant antibody compositions that capture the diversity and effectiveness of the natural immune system. Symphogen is building a proprietary product pipeline within several disease areas, including infectious diseases and cancer. Symphogen has established collaborations with international pharmaceutical companies. Symphogen is a private biopharmaceutical company with over 75 employees, based in Copenhagen, Denmark. Refer to www.symphogen.com for further information on Symphogen.
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