Glenmark to file first specialty product with US FDA in March quarter
Mumbai: Glenmark Pharmaceuticals Ltd said on Thursday that it will file a new drug application for its first specialty product, a nasal spray to treat seasonal allergic rhinitis, with the US Food and Drug Administration (FDA) in the quarter ending March.
The company has completed phase-III clinical trials in the US for the nasal spray, containing a fixed-dose combination of 25 mcg mometasone furoate and 665 mcg olopatadine hydrochloride.
The company said in a release that it had positive results from the 52-week trial on 601 adults and adolescents above 12 years of age with at least a two-year history of perennial allergic rhinitis to evaluate the product’s safety and efficacy.
In March, positive results of a shorter phase-III trial for the product were announced. This trial was conducted over 14 days on 1,176 adults and adolescents, who were given the medicine twice a day.
The US FDA has conditionally accepted Ryaltris as the brand name for this nasal spray, Glenmark said.
“Ryaltris has been extensively studied in three phase-3 trials for seasonal allergic rhinitis, and we are pleased that the addition of this long-term study in patients suffering with perennial allergic rhinitis met the primary safety and secondary efficacy endpoints. Collectively, these data suggest that Ryaltris is effective and well-tolerated,” Fred Grossman, president and chief medical officer at Glenmark, said in the release.
“We have worked closely with the FDA on the clinical development programme for Ryaltris, and look forward to providing robust data to support its potential approval,” he added.
Glenmark has identified respiratory, dermatology and oncology as the key focus areas. It has three specialty drugs in its pipeline currently, all of them in the respiratory segment, including the nasal spray.
The other two products are: Tiotropium bromide to be administered through a nebuliser to patients with chronic obstructive pulmonary disease (COPD), which is currently in phase-II clinical trials, and omalizumab, a proposed biosimilar for treating allergic asthma and chronic idiopathic urticarial.
Apart from these specialty products, the company has seven innovative products in its pipeline for the US market.
“Glenmark has rapidly evolved from a company with a thriving generic pharmaceutical business to one that is also discovering new treatments, and researching devices that deliver these treatments in new ways. Ryaltris is an important first step in this evolution, and the realization of the potential in the pipeline has only just begun,” Robert Matsuk, president, North America and global active pharmaceutical ingredient (API) at Glenmark, said.
The company is relying on its specialty and innovative drugs pipeline to play out in the coming years to counter the challenging environment for generic drugs. By 2025, Glenmark expects its specialty and innovative drugs portfolio to contribute 30% to total sales.
In the financial year ended March 2017, the drug maker had consolidated sales of Rs9,185.7 crore, up 20.1% from a year ago.
On Thursday, shares of Glenmark ended up 0.25% at Rs533.40 on the BSE, while the benchmark Sensex index was up 0.59% at 33,246.70 points.