India’s generic drug maker Glenmark draws up a US-based branded drugs unit

Israel’s Teva — the world’s largest generic drugmaker — isn’t the only one looking to capitalize on branded drugs. Indian generic drug manufacturer Glenmark is making innovative drugs a priority too, by spinning off its roster of new chemical and biological entities into a US-based unit.

The bulk of Glenmark’s business is generics, but it has started adding some specialty treatments to the mix – in its last reported quarter, Glenmark made a foray into the dermatology drugs business in the United States by acquiring the rights to seven branded products from Exeltis USA.

Meanwhile, the company has been building up infrastructure to develop its own branded drugs: it has R&D centres in Switzerland, US and Navi Mumbai, as well as a biologics manufacturing facility in Switzerland. To date, the company has also generated $250 million having facilitated eight out-licensing deals for new molecules to large pharmaceutical companies including Merck $MRK, Eli Lilly $LLY and Sanofi $SNY.
The new branded drug company will be based in Paramus, New Jersey, have an independent board, a new chief and 400 employees that will come from Glenmark’s various R&D facilities and biologics plant. The transfer of assets and personnel will be completed in the next 6 to 9 months, the company said on Thursday.

The name of the subsidiary has not yet been finalized, and a new CEO has not yet been appointed yet, although it will not be a member from the existing Glenmark team, a spokesperson from Glenmark told Endpoints News.

The unit, via its parent Glenmark, has eight new chemical and biologic entities in development for use in the field of immunology, oncology and pain management, including three immuno-oncology bispecific antibodies.

There are 4 oncology assets in Glenmark’s basket of new drugs in development. In phase I studies, the company has GBR 1302, a bispecific antibody being evaluated for HER2-positive cancers and GBR 1342, another bispecific for multiple myeloma as well as a variety of solid tumors. In preclinical development, the company has GBR 1372, a bispecific for colorectal cancer and a small molecule oncology program.

Within immunology, the company has two assets: GBR 830, an anti-OX40R monoclonal antibody, which is mid-stage development for atopic dermatitis as well as GRC 39815, an inhibitor of the Retinoid-related Orphan Receptor gamma t (RORγt), which is preclinical development for COPD.

In terms of pain management, Glenmark has a non-opioid painkiller — GRC 27864 — in phase II development for osteoarthritic pain, as well as a TRPA1 antagonist — GRC 17536 — which has completed a Phase IIa proof-of-concept study in patients with painful diabetic neuropathy.

https://endpts.com/indias-generic-drug-maker-glenmark-draws-up-a-us-based-branded-drugs-unit/