Amgen: Neulasta Safe for Now; Dose Accuracy of Erenumab a New Focus

July 28, 2016

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

Amgen executives don’t seem too concerned that a viable competitor to the company’s Neulasta (pegfilgrastim) franchise will threaten its No. 2 seller, the company revealed in a second-quarter investor call on July 27, 2016. The company attributes some of the continued success of Neulasta to its unique drug-delivery system-the pre-timed, worn-on-body injector called Onpro. The adoption of the Onpro system “is growing due to its ability to ensure maximum benefit of Neulasta while improving the patient experience versus the traditional prefilled syringe. We exited the second quarter with Onpro representing about 40% of Neulasta units and still growing,” said Anthony C. Hooper, executive vice-president of global commercial operations. “We do not expect long-acting filgrastim biosimilar competition this year, so there remains a significant opportunity to further increase the adoption of Onpro,” Cooper added.

Neulasta is a granulocyte colony-stimulating factor that is used to treat neutropenia in patients receiving chemotherapy. Although Sandoz submitted a biosimilar application to FDA in November 2015 for Neulasta, the company recently said in a second-quarter media release that it received a complete response letter from FDA rejecting the application. Meanwhile, the European Medicines Agency agreed to review Mylan/Biocon's biosimilar to pegfilgrastim on July 22, 2016.

Dose accuracy key to chronic migraine medications
Amgen may rely on an innovative drug-delivery system to eventually market its investigational treatment for chronic migraines as well. It is co-developing erenumab (AMG 334) with Novartis, which targets the calcitonin-gene-related-peptide (CGRP) receptor, which is thought to be involved in the transmission of pain. In Phase II clinical trials, erenumab was shown to significantly reduce migraine pain in both the 70 mg- and 140 mg-dose cohorts.

Sean Harper, executive vice-president of R&D, said that he has not seen “any data to suggest that [currently available CGRP inhibitors] are different from one another with respect to what they can achieve when they are dosed and saturating quantity.” Thus, he says, a competitive advantage could lie with how easily administered the antibody is and what would be the minimal dose that would still be effective. Harper concluded, “Let's say we believe a monthly subcutaneous disposable auto-injector would be a very nice solution to this otherwise healthy active type of population.”

Source: Seeking Alpha