Celgene Plans To File Second NDA for Ozanimod in 2019 Following FDA Rejection in February


Celgene is eying the first quarter of 2019 to submit a second New Drug Application (NDA) for multiple sclerosis treatment ozanimod.

In February the company was stunned when the FDA issued a Refusal to File letter regarding some insufficient data. Celgene said it would seek guidance from the FDA and this morning the company confirmed that it had met with the regulatory agency in April, greenlighting its 2019 plan.

Celgene made the announcement about ozanimod in its first quarter 2018 report, which was released this morning. During a call with investors and analysts this morning, Celgene expressed confidence in the efficacy of ozanimod and its path to approval

Jay Beckstrom, Celgene’s chief medical officer, said following the Type A meeting with the FDA last month the company has a path forward in “what needs to be done” in order to grab approval.

“We’re confident in the regulatory path for ozanimod,” Beckstrom said.

This morning Celgene confirmed that the FDA will not require any additional human studies, which would likely set the potential approval back years. From the Type A meeting in April with the FDA, Celgene said there will be some necessary non-clinical bridging studies, which would allow a delay of only a year.

“The path forward is very well understood,” Beckstrom said.

Celgene had been seeking approval of ozanimod as a treatment for relapsing multiple sclerosis. The NDA was based on positive Phase III results that showed ozanimod demonstrated superiority versus Biogen’s Avonex (interferon beta-1a) in reducing annualized relapse rates and MRI brain lesions. Celgene gained ozanimod in the 2015 $7.2 billion acquisition of Receptos Inc.

While the company is preparing for a new NDA with the FDA next year, Celgene said it also intends to submit a Marketing Authorization Application for ozanimod in RMS in the first quarter of 2019.

Since the initial Refusal to File letter issued by the FDA, Celgene released additional ozanimod data from new analyses of the SUNBEAM and RADIANCE Part B trials. The new analyses show dose-dependent effects of ozanimod on annualized relapse rate (ARR) versus Avonex, an interferon beta-1a, that were consistent with the overall ARR primary endpoint. Celgene said data presentations of exploratory endpoints showed reductions in cortical grey matter and thalamic volume loss consistent with the reductions in whole brain volume loss in previous reports. Celgene noted that the clinical efficacy and safety data from these trials should support its efforts in gaining approval.

During the first quarter, Celgene reported total net product sales of $3.5 billion, an increase of 20 percent from the first quarter of 2017. Revenues were primarily driven by sales of Revlimid, which saw a 21 percent increase in the United States. Other strong drivers were Pomalyst, Otezla and Abraxane.

In addition to Celgene’s plans for ozanimod, the company said it completed its $9 billion acquisition of Juno Therapeutics in March. That deal positions the company as a key player in cellular immunotherapy. The company also completed its acquisition of Impact Biomedicines. The company snapped up the San Diego-based Impact for its Janus kinase 2 inhibitor for the treatment of myelofibrosis.

Celgene also used the quarter to strike several deals, including a collaboration with Prothena Corporation to develop new therapies for a broad range of neurodegenerative diseases, including Alzheimer’s and ALS. The partnership will focus on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, one of the key proteins implicated in Alzheimer’s disease

Also in March Celgene and Vividion Therapeutics forged a deal to develop small molecule therapies for oncology, inflammatory and neurodegenerative diseases.

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