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Amgen readies migraine drug launch ahead of copycat competition for Neulasta

Amgen Inc. is offering free trials to provide a strong launch pad for its new migraine drug Aimovig as it prepares to compete with a copy of its blockbuster drug Neulasta.

The company recently received the U.S. approval for Aimovig, which will be the first drug of its class to hit the market ahead of rivals being developed by Teva Pharmaceutical Industries Ltd. and Eli Lilly and Co.

Thousand Oaks, Calif.-based Amgen has launched a free two-month trial to drum up support for Aimovig while it completes negotiations with payers.

"Right now, the majority of our business is in free drug but we are rapidly converting that business to paid prescriptions," Anthony Hooper, Amgen's executive vice president for global commercial operations, told analysts on an earnings call.

For its cholesterol-lowering drug Repatha, Amgen locked in new payers and has offered them higher rebates in exchange for allowing patients to switch to its drug with less documentation.

Repatha, which has been criticized for its more-than-$14,000-a-year tag, is locked in competition with Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent, which also belongs to a class of cholesterol therapies known as PCSK9 inhibitors.

Aimovig and Repatha's sales are expected to help Amgen add to the revenue from other new drugs such as multiple myeloma treatment Kyprolis and osteoporosis medicine Prolia as well as fill the gap expected from generic competition.

Biosimilar competition

Mylan NV recently gained the U.S. approval to market the first biosimilar of Amgen's blockbuster blood cancer therapy Neulasta, its second-biggest selling drug with 2017 sales of $4.53 billion.

While Neulasta's second-quarter sales increased 1% year over year to $1.10 billion, the company said it registered a slight reduction in the overall market segment.

To dent the blow from Mylan's cheaper Neulasta copy, Amgen has been working to push patients on using its on-body Neulasta injector, Onpro, in the U.S.

"We continue to drive the adoption of Onpro in the U.S. and exited quarter two at 63% share of Neulasta unit sales," Hooper said, adding that the company expects to see higher use of Onpro outside the U.S. in 2018, with recent launches in Germany, the U.K., the Netherlands, Poland, Ireland and Australia.

"So as regards to the Neulasta biosimilar, I mean, clearly, we've been competing in the marketplace with Neupogen and biosimilars for a number of years now. The team stands ready and able to compete," Hooper told analysts.

Amgen is developing its own biosimilar portfolio and recently launched its first biosimilar Kanjinti, which is a copy of Roche Holding AG's blockbuster cancer drug Herceptin in Europe.

The company also plans to launch Amgevita, a biosimilar to AbbVie Inc.'s Humira, on an international level later in 2018, Amgen CEO Robert Bradway said on the call, adding that the company is looking forward to launching a "steady stream of biosimilars in the years to come."

New products and M&A

With several companies presenting their data at a conference on Alzheimer's disease, Amgen also highlighted its experimental therapy AMG 520 that is being developed through two phase 3 studies.

To reduce the length of its trials, the company is enrolling patients with APOE4 gene variants, which puts patients at a higher risk of developing Alzheimer's disease.

"So what we decided to do is basically enriched for people who have both a certain age and the APOE status that we're likely to have enough of them so people going from cognitively normal to cognitively impaired during the course of the trial that won't take forever," said Sean Harper, Amgen's executive vice president of research and development.

The company also re-affirmed its appetite for merger and acquisitions despite having shown a greater tendency of returning its capital to shareholders.

Amgen recently completed a tender offer to repurchase about $10 billion worth of its common shares, representing 7.2% of its outstanding shares.

"What's also true is I think we all know that we have a tremendous capability for cash generation and we have a large amount of excess cash following tax reform and we are committed to return excess cash through time to shareholders. So I wouldn't read our ongoing repurchase activities to be anything other than following on that commitment and I would definitely not read that we're backing off from our commitment to continue to add to our pipeline and our portfolio," said Amgen CFO David Meline.