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Glenmark to spin off originator drugs business

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An Indian drugmaker usually associated with generics is investing more in innovation and planning to bring its business to the US.

Mumbai-based Glenmark Pharmaceuticals said Thursday that it would spin off its business developing new drugs into a US-based company that will function as a wholly owned subsidiary with an independent board of directors and new CEO. The new company will include all of Glenmark’s new molecular entities, along with its biologics manufacturing center in Switzerland and its research and development centers in Switzerland, Paramus, New Jersey, and Mumbai.

In a phone interview, a spokesperson for Glenmark said the company had not yet announced the new subsidiary’s name, the amount of money it is investing or who the CEO will be. However, Glenmark will be at the American Society of Clinical Oncology’s annual meeting in Chicago in June, with a focus on assets from its oncology pipeline, he said.

The new company will develop eight new products in development, including five clinical assets and three that are preclinical.

In oncology, it has two drugs in Phase I development, namely GBR 1302, a bispecific antibody that targets HER2 and CD3. Another bispecific antibody, GBR 1342, targets CD38 and CD3 and is being developed for multiple myeloma. According to ClinicalTrials.gov, the GBR 1302 study started in May 2016 and is scheduled to finish in November of this year. Other bispecific antibodies targeting HER2 include Pieris Pharmaceuticals’ PRS-343, which targets that antigen and 4-1BB, and Merus’s MCLA-128, targeting HER2 and HER3. Janssen’s Darzalex (daratumumab) is a CD38-targeting monoclonal antibody, and Amgen is developing AMG 420, a bispecific antibody for multiple myeloma that targets BCMA and CD3.

In immunology, Glenmark is testing GBR 830, an OX40R-targeting monoclonal antibody, which is in Phase IIb development for moderate-to-severe atopic dermatitis. And in pain, GRC 27864 is a non-opioid drug for osteoarthritic pain in Phase IIb testing, while GRC 17536 has completed a Phase IIa proof-of-concept study in patients with diabetic neuropathy.

Preclinical assets include the EGFR/CD3 bispecific antibody GBR 1372, for colorectal cancer; an unnamed small-molecule drug; and the inhaled immunology drug GRC 39815.

Photo: Stas_V, Getty Images

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