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Amgen buys KAI Pharma and its SHPT drug for $315 million
  World News | April 10, 2012

Amgen has hit the acquisition trail again and is buying privately-owned KAI Pharmaceuticals for $315 million in cash.

For its money, the world's largest biotech is getting access to the South San Francisco-based firm's KAI-4169, a novel peptide agonist of the calcium sensing receptor which affects calcium homeostasis by modulating the release of parathyroid hormone. The drug is in Phase II and is being initially studied for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) who are on dialysis.

SHPT, a component of CKD mineral and bone disorder, is a common and serious complication for patients with CKD who are on dialysis, noted Amgen, which will acquire worldwide rights to KAI-4169, excluding Japan. The rights in the latter country are held by Ono Pharmaceutical Co.

Amgen has provided a loan to enable Phase III development planning for KAI-4169 prior to closing. Sean Harper, Amgen's head of R&D, said "we are excited about acquiring KAI, as well as the opportunity to potentially deliver a novel therapy for CKD patients on dialysis suffering from SHPT".

Steve James, KAI's chief executive, added that his firm "and the nephrology community are excited by the additional clinical data we've generated for KAI-4169, and we are thrilled that Amgen shares our perspective on the differentiated profile and potential of this product candidate".

Amgen currently markets another drug for SHPT, namely Sensipar (cinacalcet), which is sold as Mimpara in Europe and had sales of $808 million last year. However the latter is an oral treatment, while KAI-4169 is administered intravenously.

At the end of January, Amgen announced it is buying Micromet, a biotech with its R&D centre in Munich and headquarters in Rockville, USA, for $1.16 billion.

UCB and Amgen bone-building drug goes into Phase III

World News | April 04, 2012

UCB and Amgen have announced the start of a Phase III clinical trial programme for their sclerostin antibody for the treatment of postmenopausal osteoporosis.

The programme includes a two-year study in more than 5,000 postmenopausal women with osteoporosis and its primary endpoint will evaluate the incidence of new vertebral fractures at 12 months. Initial results are expected by the end of 2015.

The investigational monoclonal antibody binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. As such, the drug, known as CDP7851/AMG 785 is designed to increase the amount of bone in the skeleton.

Iris Loew-Friedrich, R&D chief at the Belgian drugmaker, said that "our sclerostin antibody project with Amgen is one of the most exciting pipeline programmes in UCB's portfolio". She added that data collected so far "indicate the potential for a change of treatment paradigms in postmenopausal osteoporosis".

Sean Harper, head of R&D at Amgen, added that "despite available osteoporosis therapies, there remains a significant need for additional treatment options that form new bone in women diagnosed with postmenopausal osteoporosis."

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