Amgen biosimilar push takes aim at blockbusters

NEW YORK Thu Feb 7, 2013 11:23am EST

NEW YORK (Reuters) - Amgen Inc (AMGN.O) said on Thursday that between this year and 2016 it will have key late-stage data from eight experimental medicines, and that it expects generic versions of biotech drugs, known as biosimilars, to be a multibillion-dollar opportunity for the company.

Amgen Chief Executive Robert Bradway, at a meeting in New York to update analysts and investors on business strategy, said the company plans to launch six biosimilars beginning in 2017 - four cancer drugs and two for inflammatory diseases.

Amgen has targeted biosimilar versions of some of the world's top-selling medicines, including the chief rivals for Enbrel, its own blockbuster rheumatoid arthritis drug - Abbvie's (ABBV.N) Humira and Remicade, which is sold by Johnson & Johnson (JNJ.N) and Merck & Co Inc (MRK.N).

It also plans to launch biosimilar versions of Roche Holding AG's (ROG.VX) multibillion-dollar cancer drugs Avastin, Herceptin and Rituxan, as well as Eli Lilly and Co's (LLY.N) Erbitux.

The world's largest biotechnology company believes it has a unique capability to become a major player in biosimilars once U.S. health regulators finalize the approval pathway for such drugs, which are not identical matches of the branded medicines in the manner of traditional generic versions of pills.

It also sees its still-growing Enbrel becoming more profitable at the end of this year, when a profit sharing arrangement with Pfizer Inc (PFE.N) ends and becomes a royalty payment for the next three years. The change will result in an operating profit of about $800 million in 2014, the company said.

Amgen raised its 2013 earnings forecast to account for a tax credit due to federal settlements for prior years.

Amgen said that it now expects adjusted 2013 earnings of $7.05 to $7.35 per share, and that it would record the credit in the first quarter. The company last month had forecast earnings per share of $6.85 to $7.15.

The 2013 revenue forecast remains unchanged at $17.8 billion to $18.2 billion.

Chief Financial Officer Jonathan Peacock said Amgen will continue to return more than 60 percent of adjusted net profit to shareholders through dividend increases and some share buybacks.

The company also said it plans to continue to pursue strategic acquisitions, and that it expects to expand significantly its business into Japan and China after 2016 and to begin selling its first drug in China in 2015.

Research chief Sean Harper provided an update of the company's drugs in development in several therapeutic categories, including medicines for a variety of cancers, heart disease, osteoporosis and psoriasis.

The cancer drugs include trebananib for ovarian cancer with key late-stage data expected in mid-2013, and rilotumumab for advanced gastric cancer, a huge unmet need in China and emerging markets. Late stage data on that drug is due in 2016, just about the time the company sees making a move into China.

Amgen's highest-profile drug in development is AMG-145, its cholesterol fighter from a closely watched new class of medicines called PCSK9 inhibitors meant to be taken by patients unable to tolerate statins, like Lipitor and Zocor, or those who fail to reach LDL goals with statins. In earlier clinical trials, PCSK9 inhibitors have dramatically reduced bad LDL cholesterol.

The class, which blocks a protein that prevents the body from removing artery-clogging LDL cholesterol from the bloodstream, is a hot area of research being pursued by several companies, including Regeneron Pharmaceuticals Inc (REGN.O) in partnership with Sanofi SA (SASY.PA), and Pfizer.

Amgen has begun a Phase III AMG-145 program with more than 26,000 patients over seven studies. It expects to have initial Phase III data in early 2014, and estimates having results in 2018 from a large so-called outcomes study to demonstrate that it can reduce heart attacks and strokes.

Harper said he was confident that AMG-145 would show "a decrease in cardiovascular outcomes." He added: "This will be the biggest study Amgen has ever done."

He expressed similar confidence that romosozumab for post-menopausal osteoporosis would prevent fractures in a pair of late stage trials of about 6,000 women, with data expected in 2015.

Tony Hooper, Amgen's head of global commercial operations, said AMG-145 would compete in a market estimated to be about 17 million high-risk patients.

Amgen shares were down 0.7 percent at $85.98 on Thursday morning on the Nasdaq.

(Editing by Gerald E. McCormick, Chizu Nomiyama and Matthew Lewis)

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