Amgen Goes on the Defensive When Critics Call Its Pipeline a Dud

Amgen Goes on the Defensive When Critics Call Its Pipeline a Dud June 22, 2017
By Alex Keown, BioSpace.com Breaking News Staff

THOUSAND OAKS, Calif. – Despite a clinical setback and some criticism over its potential revenue streams, Amgen is playing the long-game when it comes to its pipeline.

That’s the message that Sean Harper, Amgen’s head of research and development told Leerink analyst Geoffrey Porges. In a recent note, Porges described Amgen as a “defensive stock,” which sounds good. However, in the same breath Porges said Amgen lacks “the explosive upside potential typically associated with breakthrough or rapidly growing biotherapeutics stocks.”

That’s a criticism that some investors have taken to heart. Investors have been concerned over slowing sales of cholesterol drug Repatha, as well as safety concerns over Amgen’s late-stage osteoporosis treatment.

But those criticisms are something that Harper has sought to quell by pointing out the long-term growth opportunities from the company’s pipeline. He called Porges and shared his thoughts on the company’s pipeline with Porges, Barron’s reported.

In that conversation, the two men touched on Amgen’s recent problems surrounding its experimental osteoporosis drug Evenity and the anticipated delay in regulatory approval.

In May, the company reported that the Phase III Evenity met primary and secondary endpoints in reducing the incidence of new vertebral, clinical and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture. However, the data also showed the drug was causing cardiac issues with some of the patients. At the time Harper said the efficacy results were robust, but he said the company will have to take time in researching the cardiovascular problems.

Evenity is an investigational bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin and has a dual effect on bone, increasing bone formation and decreasing bone resorption.

In his conversation with Porges, Harper said “romosozumab’s adverse event liabilities emerged from insights beyond the reach of its preclinical and genetic validation approaches,” Barron’s reported, citing Porges note.

But the company continues to investigate, but that does move the regulatory approval timeline.

Harper also pointed to Amgen’s oncology pipeline, which could yield significant returns on investment for investors over the long run.

“Dr. Harper explained the potentially broadened scope for the company’s emerging oncology platforms and approaches, particularly those building on the company’s BiTE (Bispecific T cell Engager) antibodies, oncolytic viruses (Imlygic - herpes oncolytic virus). He believes that these programs are likely to offer significant incremental value for investors over the long run, given the breadth of the potential applications beyond the first generation of indications and applications,” Porges said in his note.

Amgen is also looking for a new revenue driver from its experimental migraine drug, Erenumab. In May, Amgen submitted a Biologics License Application to the U.S. Food and Drug Administration for the drug. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor.

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