UCB and Amgen Initiate Sclerostin Antibody Phase 3 program in patients with postmenopausal osteoporosis

First Patient Randomized Marks Start of Phase 3 Program to Evaluate Safety and Efficacy of CDP7851/AMG 785 in Women With Postmenopausal Osteoporosis

Brussels, Belgium & Thousand Oaks, Calif., (April 4, 2012) UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) – regulated information – announced today the start of their sclerostin antibody (CDP7851/AMG 785) Phase 3 clinical trial program for the treatment of postmenopausal osteoporosis.

“We look forward to working with UCB on the CDP7851/AMG 785 Phase 3 program,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis.”

“Our sclerostin antibody project with Amgen is one of the most exciting pipeline programs in UCB’s portfolio. Data collected so far indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis”, said Prof. Dr. med. Iris Loew-Friedrich, Chief Medical Officer of UCB and Executive Vice-President Global Projects and Development. “We are delighted about the start of the Phase 3 program. The progress made to date encourages and motivates us as we work toward providing a new treatment option for women living with postmenopausal osteoporosis.”

The Phase 3 program includes a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group, two-year study in more than 5,000 postmenopausal women with osteoporosis. The primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. Initial results from the Phase 3 program are expected by the end of 2015.

CDP7851/AMG 785 is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, CDP7851/AMG 785 is designed to increase the amount of bone in the skeleton. With more than 75 million people worldwide suffering from osteoporosis, there is a serious patient need for therapeutics that help build bone. Amgen and UCB are collaborating on the development of CDP7851/AMG 785 for the treatment of bone-related conditions, including postmenopausal osteoporosis and fracture healing.

Sources:

www.ucb.com

http://www.ucb.presscentre.com/News/UCB-and-Amgen-Initiate-Sclerostin-Antibody-Phase-3-program-in-patients-with-postmenopausal-osteoporosis-2d7.aspx

www.amgen.com

Follow us on www.twitter.com/amgen

Contacts:

UCB, Brussels

Antje Witte, Investor Relations UCB
, T +32.2.559.9414

antje.witte@ucb.com

France Nivelle, Global Communications, UCB, T +32 (2) 559 9178

france.nivelle@ucb.com

Laurent Schots, Media Relations, UCB
   T: +32 2 559 9264

laurent.schots@ucb.com

 

Amgen, Thousand Oaks


Christine Regan

T: 805-447-5476 (Media)

 

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