Amgen Reclaims Drug Rights from GlaxoSmithKline in Plan to Grow Internationally

December 15, 2015
By Alex Keown, BioSpace.com Breaking News Staff

THOUSAND OAKS, Calif. – Amgen struck a deal with England-based GlaxoSmithKline to reacquire three drug therapies, Prolia (denosumab), Xgeva and Vectibix (panitumumab), to bolster its international pipeline offerings in oncology and bone health, the company announced this morning.

The deal, for an undisclosed amount of milestone payments, will bring the treatments back under Amgen’s umbrella in 48 different companies in Europe, Asia and Australia, the company said. The agreement with Glaxo involves key expansion markets for Amgen including Brazil, China, Colombia, Hong Kong, Israel, Singapore, South Korea, Taiwan and Thailand, Amgen said. GlaxoSmithKline has held rights to Prolia and Xgeva since 2009 and to Vectibix since 2010. Combined revenue from the drugs was $111 million in 2014. Amgen and GlaxoSmithKline originally partnered on these drugs so Amgen could take advantage of GSK’s “established presence in these markets,” a GlaxoSmithKline spokesperson told Bloomberg Business.

"This unique agreement with GSK allows Amgen to regain rights to three important growth products, and to directly serve more patients in key expansion markets," Robert Bradway, chairman and chief executive officer of Amgen, said in a statement. "The agreement also allows Amgen to build additional commercial infrastructure in oncology and bone health, two strategically important therapeutic areas for Amgen with emerging late-stage pipeline assets."

Prolia, XGEVA and Vectibix will bolster other oncological treatments in Amgen’s pipeline, including Blincyto, a drug designed to treat a rare form of acute lymphoblastic leukemia. Blincyto was approved by the FDA in December 2014. Analysts predict Blincyto could generate about $400 million in annual sales, investopedia.com reported. However, the expected $178,000 price tag on the drug was worrying to some in the medical community. Amgen also has an additional osteoporosis drug, romosozumab, in late stage clinical trials.

Prolia, an injectable, is approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Prolia is also approved for treatment to increase bone mass in men with osteoporosis at high risk for fracture.

Xgeva was approved by the FDA in 2010 for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. In 2013, Xgeva was approved by the FDA as the first treatment for adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Vectibix was approved in the U.S. in 2006 for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-and irinotecan-containing chemotherapy.

Amgen said it will work closely with GlaxoSmithKline to “enable a seamless transition for customers and patients.” The majority of markets are planned to be transitioned back to Amgen within a 12-month period. Amgen said it anticipated the transaction to be accretive to adjusted earnings in 2017.

Since last year, Amgen has freed up capital from laying off about 20 percent of its workforce, part of an effort to slash $15 billion in expenses by 2018. The company has eliminated more than 4,000 global jobs from its payroll. The freed capital is expected to be used to drive additional clinical trials in an effort to get more drugs to market.

Amgen’s stock is up more than 3 percent this morning, trading at $162.92 per share.