India’s Glenmark spins out NMEs into U.S. company

India’s Glenmark is rolling all of the new molecular entities (NMEs) in its pipeline into a separate U.S. company in an effort to speed the programs to market.

Glenmark says all its preclinical and clinical projects in cancer, immunology and pain will transfer to the new company, which will remain a wholly owned subsidiary but have an independent board and a new CEO. The move draws a clear line between its specialty and generic medicine and innovative drug businesses.

In practical terms, the as-yet unnamed new company will have five clinical and three preclinical projects and take over the operation of Glenmark’s R&D units in Switzerland, Paramus in the U.S., and Navi Mumbai in India. A Swiss biologics manufacturing facility also comes with the package, and more than 400 Glenmark workers will make the swap to the new organization when the spinoff is complete in the next six to nine months.

Glenmark’s managing director Glenn Saldanha describes the rationale for the split as follows: "With the pipeline at an advanced stage, we believe it's the right time for the innovation business to be an independent entity and charter its own journey towards becoming a leading biotech organization globally."

When the transaction goes through, the U.S. subsidiary’s most advanced candidates will be GBR 830, an anti-OX40R antibody for moderate-to-severe atopic dermatitis, and GRC 27864, an oral microsomal prostaglandin E synthase-1 (mPGES-1) inhibitor being developed a non-opioid painkiller for osteoarthritic pain. Both of those are in phase 2b testing.

Following after is another drug in phase 2a—the TRPA1 antagonist GRC 17536 for pain associated with diabetic neuropathy—and two immuno-oncology candidates in early-stage clinical trials.

The cancer drugs are GBR 1302, a HER2xCD3 bispecific antibody in testing for HER2-positive cancers, and another bispecific targeting CD38 and CD3 antigens called GBR 1342 that is being studied for multiple myeloma and other blood cancers as well as solid tumors.

The three preclinical candidates are GBR 1372, an EGFR/CD3 bispecific intended for colorectal cancer, an inhaled RORγt inhibitor for chronic obstructive pulmonary disease (COPD) codenamed GRC 39815, and a small molecule oncology program based on tumor antigen presenting biology.

"The cutting-edge work that the innovation team has delivered over the years has resulted in numerous achievements, most notably among them being the fact that we have out-licensed our novel molecules to big pharmaceutical organizations consistently," says Saldanha.

Those deals—from the likes of Merck, Eli Lilly, Sanofi and Forest Labs—have garnered upwards of $250 million in licensing fees for Glenmark over the years, but not all have ended well. In 2015, Sanofi backed away from a $663 million multiple sclerosis deal with the Indian company after the main asset came up short in a mid-stage trial.

Shares in Glenmark fell after the spinout was announced but seem to have been dragged down mainly by a profit miss in its fiscal third-quarter results, which were also announced Friday.

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