Booming Glenmark Pharma Could File One NDA Each Year For 10 Years

Booming Glenmark Pharma Could File One NDA Each Year for 10 Years June 8, 2017
(Last Updated: June 9, 2017 at 12:10pm PT)

By Alex Keown, Breaking News Staff

MAHWAH, N.J. – Glenmark Pharmaceuticals is in the middle of a strategic transformation that company officials believe will build off its revenues from a proven generics business to fund a pipeline of homegrown branded medicines.

“This is a very unique company. In all my years in the business, I’ve not seen a company that has the current business plan we have,” Fred Grossman, president and chief medical officer of Glenmark Pharmaceuticals, said in an exclusive interview with BioSpace.

In a preview for BioSpace, Grossman laid out some of the growth strategies the company will present at BIO 2017 in San Diego on June 20. Those plans include therapies in multiple phases of development across three treatment areas – respiratory, dermatology and oncology.

Glenmark has enough drugs in various stages of development that the company could conceivably file one New Drug Application with the U.S. Food and Drug Administration every year for the next 10 years starting in 2019 from each of its pipeline focuses. Glenmark currently has seven investigational treatments in clinical trials with another three expected to receive FDA clearance to begin clinical trials on the horizon.

“We have a lot going on,” Grossman chuckled. “We feel like a biotech with an exciting innovation. The atmosphere around here is like a startup that doesn’t have to worry about venture capital.”

In fact, the company has so much going on that it has seen some explosive growth in hiring over the past year or so in preparation for the company’s pipeline growth. Glenmark currently has about 12,000 employees in more than 50 companies. Grossman said many of its U.S. team has only joined the company in the past few years.

Because of the growth the company has seen and expects, Grossman predicted Glenmark will be considered a “major player” in the pharma industry within the next 10 years.

Glenmark’s 10-year-plan was set in motion by Glenn Saldanha, Glenmark’s chief executive officer. When Saldanha took over the reins of the company in 2000, Grossman said annual revenues were in “the mid-$30 millions.” Now, the company reports revenue of about $1.4 billion with a $4 billion market cap, he said. Grossman said Saldanha’s vision to move up the value chain, from generics to complex generics to innovation and branded products, is coming to fruition and providing the company with a transformative and possibly explosive future.

“This is not a fly-by-night company that moved into innovation because of the downward trend of generics,” Grossman said. “We have full capacity at this point to advance our pipeline completely.”

Glenmark’s respiratory pipeline includes combination therapies for chronic obstructive pulmonary disease, such as the nebulized Phase II GSP-304 (tiotropium bromide), as well as a biosimilar of Genentech ’s Xolair for the treatment of allergic asthma and chronic idiopathic urticaria. The company is also developing a therapy to address pulmonary fibrosis as well.

In March, the company reported positive Phase III results for GSP-301, an investigational fixed-dose combination of mometasone furoate and olopatadine hydrochloride for the treatment of seasonal allergic rhinitis. Grossman said the company intends to release full data from this trial later this year. While he would not reveal anything about the trial, he said they are “optimistic” about the future of that nasal spray.

In dermatology, Glenmark is developing an OX40 antagonist for the treatment of atopic dermatitis and other inflammatory diseases, Grossman said.

In oncology, the company is advancing a Phase I candidate GBR 1302-BEAT in patients with HER2+ cancers. Glenmark’s bi-specific antibody therapy is a technology platform that targets HER2 and CD3, based on the BEAT (Bi-specific Engagement of Antibodies based on the T cell receptor). In January, the FDA gave Glenmark clearance for a Phase I trial to begin. Preclinical studies suggest GBR-1302 may be effective against a range of HER2-expressing tumor types, including breast, gastric and other cancers.

Additionally, Glenmark is advancing a colon cancer therapy (GBR-1372) that targets the kras mutation as well as GBR-1342, a multiple myeloma therapy. In May, the company announced plans to initiate a Phase I study of GBR 1342 for patients with multiple myeloma who have exhausted available therapies.

“We have many shots on goal here. When you think about a company of our size… all we really need is one biologic to hit and that will transform the company,” Grossman said.

As the company moves forward past the BIO annual meeting and throughout the remainder of 2017, Grossman said Glenmark will be looking to advance its pipeline as well as seek strategic partnerships.

“We’re the most innovative company that you’ve never heard of, but soon will,” Grossman predicted. “I’ve never seen an opportunity like this. We’re taking advantage of the expertise that’s built up over the years.”

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