We issued an updated research report on Alkermes plc ALKS on Mar 19.
The company has a diversified product portfolio and a promising pipeline of candidates targeting major central nervous system (CNS) disorders, including schizophrenia, depression, addiction and multiple sclerosis.
Alkermes’ revenues are being driven by its proprietary products, Vivitrol and Aristada, and the five partnered products — Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza/Trevicta, Ampyra/Fampyra and Bydureon. We expect these products to continue contributing to the company’s top line in the coming quarters.
The company’s progress with pipeline candidates this year has been impressive. In November 2018, Alkermes released positive results from the ENLIGHTEN-2 pivotal study of pipeline candidate, ALKS 3831, which was compared to Lilly’s LLY Zyprexa (olanzapine) in patients with stable schizophrenia. The company expects to submit the new drug application (NDA) mid 2019.
Diroximel fumarate/BIIB098 (initially known as ALKS 8700) is being developed in collaboration with Biogen BIIB to treat relapsing forms of multiple sclerosis (MS). The company’s NDA for the candidate was accepted by the FDA in February 2019. The FDA has set an action date in the fourth quarter of 2019. If approved, Biogen plans to market the candidate under the brand name Vumerity.
Alkermes announced the initiation of ARTISTRY-2, a phase I/II study of ALKS 4230 administered subcutaneously as monotherapy and in combination with Merck’s (MRK) PD-1 inhibitor, Keytruda (pembrolizumab) in patients with advanced solid tumors. ARTISTRY-2 will be conducted in two stages — dose-escalation followed by dose-expansion.
Another pipeline candidate is ALKS 5461, being developed for the treatment of major depressive disorder (MDD). However, in February 2019, Alkermes received a complete response letter (CRL) from the FDA regarding the NDA for the candidate. The CRL states that the FDA is unable to approve the NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of the candidate for the adjunctive treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the agency will decide whether there is a viable path forward for the ALKS 5461 program.
With all these candidates in its pipeline, 2019 is an important year for Alkermes. However, the company is highly dependent on manufacturing and/or royalty revenues on sales of products that are commercialized by the partners. For instance, Johnson and Johnson’s JNJ Janssen is responsible for the commercialization of Risperdal Consta, Invega Sustenna/Xeplion, Invega Trinza and Vivitrol in Russia and certain Commonwealth of Independent States countries.
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