Thousand Oaks, Calif.-based Amgen (AMGN) announced stellar first quarter revenues yesterday, deflecting a failed asthma clinical trial.

The company announced a total revenue increase of 11 percent for the first quarter of 2015 compared to the same period last year, rising from $4.521 billion to $5.033 billion. Revenues were driven by sales of Enrel, Prolia, Epogen, Sensipar and Xgeva. Net earnings per share gained a whopping 51 percent. Enbrel is used to treat arthritis. Prolia is used to treat osteoporosis, and Epogen is used to treat anemia.

“Epogen and Sensipar beat consensus by the widest margin,” said Yaron Werber, analyst with Citi Research in a note, “making up for lower than expected Neulasta/Neupogen sales.”

On the downside, in a single line item on the quarterly press release, Amgen indicated that it had terminated a Phase II asthma study for brodalumab “due to futility.”

On Nov. 25, 2014, Amgen and AstraZeneca (AZN) announced that a pivotal, multi-arm Phase III trial for brodalumab for the treatment of moderate-to-severe plaque psoriasis had met its primary endpoints in comparison to Stelara (ustekinumab) and placebo. The drug is also being tested for psoriatic arthritis.

“Based on the recommendation of an independent data monitoring committee, Amgen stopped the brodalumab Phase IIb asthma study due to lack of observed efficacy in a planned interim analysis,” Kristen Davis, company spokeswoman, told BioSpace in an email. “The decision to stop the study was based on a lack of efficacy and was not based on safety findings. Amgen remains committed to developing brodalumab for patients with psoriasis and psoriatic arthritis, for which positive efficacy has been previously shown.”

The company also indicates it does not have additional asthma studies ongoing with brodalumab. Brodalumab is a human anti-IL17RA monoclonal antibody. It inhibits the activity of interleukin-17A, -17F, -17A/F and interleukin-17E, sometimes called interleukin-25. Interleukin-17 signaling has been associated with psoriatic arthritis and a number of diseases associated with inflammation.

Despite the problems with brodalumab for asthma, the company reported a number of other products and pipeline programs, including progress with Corlanor, for cardiac problems, Repatha, for cholesterol, Kyprolis for multiple myeloma, and several other compounds. Amgen is aggressively working to develop biosimilars, which are drugs that mimic other biologic medicines. The company has announced plans to have as many as five biosimilar products on the market by 2019. Neupogen, a biosimilar developed by Novartis, is the first such therapeutic to be approved in March in the U.S.

Analysts have noted that Amgen’s pipeline for biosimilars is one of the most ambitious in the field. “There’s already lots of competition, and we’re used to having to compete on value,” said Geoff Eich, executive director of Amgen’s biosimilars division in a statement. “This is the natural evolution.”

“For 2017-’19, we anticipate that Amgen will emerge as one of the top three global biosimilars players driven by five new product launches that will account for 9 percent of revenues over time,” said Werber.

Meanwhile, Amgen garners impressive revenue growth while simultaneously cutting its research and development expenses by 14 percent in the first quarter. Amgen also updated its 2015 Guidance, predicting total revenues to range from $20.9 billion to $21.3 billion and an adjusted earnings per share (EPS) of $9.35 to $9.65, up from the original projection of $9.05 to $9.40.

“Overall,” said Werber, “the first quarter was better than expected due to revenue growth and cuts to operational expenses. While the operational expense cuts were larger than expected this quarter, these expenses are expected to grow over the course of the year, in large part due to investment in product launches, including Repatha.”


4/22/2015 6:18:15 AM

By Mark Terry, Breaking News Staff