Glenmark set to seek FDA nod for new nasal spray in FY18
Glenmark Pharmaceuticals announces positive results from phase-III clinical trials conducted in the US for the nasal spray
Mumbai: Glenmark Pharmaceuticals Ltd will file a new drug application with the US drugs regulator for its nasal spray to treat seasonal allergic rhinitis—commonly known as hay fever—in the year starting 1 April, chairman and managing director Glenn Saldanha said.
The Mumbai-based pharma major on Thursday announced positive results from phase-III clinical trials conducted in the US for the nasal spray containing a fixed-dose combination of 25 mcg mometasone furoate and 665 mcg olopatadine hydrochloride.
“The regulatory filing for this specialty product will be done during FY18 and it typically takes about 9-11 months to get approval,” Saldanha said.
The phase-III trial for the product, named GSP 301, was conducted over 14 days on 1,176 adults and adolescents, who were given the medicine twice a day, the company said in a press release.
Saldanha said the company does not plan to out-licence the product.
Over 17 million adults and 6 million children in US are affected by seasonal allergic rhinitis. As of January 2017, the annual value of the total US nasal spray market was $1.3 billion, according to the release.
Glenmark has three specialty drugs in its pipeline currently, including the nasal spray, and all are in the respiratory segment.
On 8 March, the company received approval from the US Food and Drug Administration 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 third specialty product is a biosimilar for treatment of asthma, which is currently in pre-clinical studies stage.
Saldanha said the market opportunity for the three specialty products put together is around $300 million.
Apart from these specialty products, the company has seven innovative products in its pipeline for the US market.
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. By 2025, the company expects its specialty and innovative drugs portfolio to contribute 30% to total sales.
In December, Saldanha had said that about 11% of the company’s revenue will be spent on research and development annually over the next few years and the drug maker is open to out-licencing all its innovative drugs.
In the next one year, Saldanha expects new generic drug launches, especially in the dermatology and oral contraceptives segments to drive growth in the US.
“It has become inevitable for Indian pharma companies to build a pipeline of specialty products in the US. Glenmark has a good portfolio of both specialty and innovative products. The risk is high but even if one innovative product goes through, there is a significant upside potential for the stock. It is a long-term play,” Vishal Manchanda, an analyst at Nirmal Bang Securities, said.
On Thursday, shares of Glenmark fell 0.85% to Rs864 on BSE, while the benchmark Sensex gained 0.4% to 29,647.42 points.