Mumbai: Glenmark Pharmaceuticals Ltd has received an approval from the US Food and Drug Administration (USFDA) to begin phase-II clinical trials for the administration of respiratory drug tiotropium bromide through a nebuliser to patients with chronic obstructive pulmonary disease (COPD), the company said in a press release on Wednesday.
The efficacy, pharmacokinetics and safety profiles of the currently available formulations of tiotropium bromide are well established, Glenmark said. As of now, tiotropium bromide is available in the US in powder and spray form, marketed by Boehringer Ingelheim under the brand names of Spiriva and Spiriva Respimat, respectively.
Glenmark plans to initiate a randomized, placebo-controlled, double-blind, dose-ranging phase-II study in the US for its molecule named GSP 304 with an active open-label comparator, Spiriva Respimat.
“Approximately 155 subjects will be randomized and treated for three weeks in order to inform the dose selection for phase-III (clinical trial) using pharmacokinetic and pharmacodynamic parameters,” the company said.
“Respiratory is a core area of focus for Glenmark as we continue to harness our heritage in generics and evolve into a specialty, innovation-focused company,” said Fred Grossman, president and chief medical officer at Glenmark. “Moving GSP 304 into phase- II is a great example of that focus and, if approved, it will be the first nebulized form of tiotropium bromide.”
Glenmark is relying on its specialty and innovative drugs pipeline, focused mainly on three therapeutic areas—oncology, dermatology and respiratory—to play out in the coming years to counter the challenging environment for generic drugs and expects to launch specialty products in the US by 2020 and innovative drugs by 2025.
The company, which is among the few early movers in India to invest in research and development of novel drugs, currently has 13 new drugs under development at various stages. By 2025, the company expects its specialty and innovative drugs portfolio to contribute 30% to total sales.
In December, Glenn Saldanha, chairman and managing director of the company, said that about 11% of its revenue will be spent on research and development annually over the next few years and the drug maker is open to out-licence all its new drugs.
Among the new molecules, respiratory drugs are likely to be the first ones to be filed for regulatory approvals in the US. The company expects to file two respiratory products in 2019 and one in 2020.
At 11.50am, shares of Glenmark were trading down 1% at Rs892.75 on the BSE, while the benchmark Sensex index was down 0.5% at 28,841.41 points.
