News: Biotest AG: Biotest regains rights to Tregalizumab (BT-061)

Dreieich, June 24, 2015. Biotest AG today announced that AbbVie and Biotest will end their collaboration on the development and commercialisation of Tregalizumab (BT-061). AbbVie has exercised its rights to opt-out of the worldwide license, development and commercialisation agreement signed in June 2011. Upon the effective date of termination, AbbVie will return all rights granted under the agreement at no cost to Biotest.

Tregalizumab is an investigational humanised anti-CD4 monoclonal antibody, inducing selective activation of regulatory T-cells. As announced on April 24, 2015, the phase IIb study (TREAT 2b) of Tregalizumab (BT-061) in patients with moderate to severe rheumatoid arthritis (RA) did not meet its primary endpoint. Results of this trial are planned to be presented to the medical community at the conference of the American College of Rheumatology in November 2015.

"We thank AbbVie for their collaboration to advance the clinical development of Tregalizumab", commented Dr. Bernhard Ehmer, CEO of Biotest. "We evaluate the data from the ongoing study also in the context of previous study results in RA and other indications. The decision how to proceed with the further development will be taken within the next two months."

As already communicated a decision to discontinue the development of Tregalizumab (BT-061), would reduce this year's earnings by EUR 25-30 million.

About Treat 2b The Phase IIb study also known as TREAT 2b (T cell REgulating Arthritis Trial 2b) is a double blind, randomised and placebo-controlled trial with four treatment groups, evaluating the efficacy and safety of Tregalizumab (BT-061) in patients with rheumatoid arthritis. In the active treatment groups and the main part of the study Tregalizumab (BT-061) is administered at doses of 25, 100 and 200 mg subcutaneously once-weekly for a treatment duration of 24 weeks given in combination with methotrexate. Patients in the control arm receive methotrexate only. In patients who respond to treatment, the therapy can be extended for further six months in an 'extension phase'. More information can be found on clinicaltrials.gov (identifier NCT 01999192).

About Tregalizumab (BT-061)
Tregalizumab (BT-061) is a humanized monoclonal anti-CD4 antibody, which selectively activates regulatory T cells (Tregs). Tregalizumab (BT-061) thereby strengthens a natural function of the body that prevents excessive immune reactions. The antibody is being developed to treat diseases due to an overreaction of the immune system such as autoimmune diseases. Tregalizumab (BT-061) is currently in Phase IIb clinical development for rheumatoid arthritis.

About Biotest

Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2,100 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

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