Glenmark expands specialty portfolio with OTIPRIO co-promotion agreement with Otonomy

Mumbai: Glenmark Therapeutics Inc., USA, a wholly-owned subsidiary of Glenmark Holding SA., today announced a co-promotion agreement with Otonomy, Inc., a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology.

This agreement provides Glenmark Therapeutics with an exclusive right to promote OTIPRIO (ciprofloxacin otic suspension) for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonasaeruginosa and Staphylococcus aureus in ear, nose and throat specialist offices in the United States and its territories.

Financial terms for the multi-year agreement were not disclosed; however, Glenmark Therapeutics will provide Otonomy with an annual co-promotion fee and provide reimbursement of a proportion of product support expenses. In addition, Otonomy will retain a share of the adjusted gross profits from the sale of OTIPRIO to Glenmark's accounts.

Commercial rights for use of OTIPRIO in other indications, including treatment of bilateral otitis media with effusion in patients 6 months and older who need ear tubes, will remain with Otonomy.

OTIPRIO is a sterile, preservative-free, otic suspension of 6% ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.

OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients 6 months of age and older with bilateral otitis media with effusion undergoing tympanostomy tube placement and the treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonasaeruginosa and Staphylococcus aureus.

Commenting on the agreement, Robert Matsuk, President North America for Glenmark Therapeutics said, “We are pleased to collaborate with Otonomy on this agreement which represents an excellent opportunity to fit within our respiratory franchise and supports our strategy of maintaining a commercial emphasis on specialists.”

“With FDA review of our first New Drug Application for Ryaltris well underway, we remain focused on developing new partnerships that bolster our specialty portfolio and commercial footprint in the U.S. This agreement is a clear example of Glenmark Therapeutics’ efforts to maximize and grow our presence by pursuing opportunities both through external partnerships and our internal R&D pipeline,” he added.

Glenmark Therapeutics is dedicated to developing and commercializing a franchise of branded
products for Glenmark Pharmaceuticals and is focused in the areas of respiratory and dermatology.

Glenmark Therapeutics Inc., USA is a wholly-owned subsidiary of Glenmark Holding SA. The company is dedicated to building a franchise of branded products for Glenmark Pharmaceuticals, a global, integrated pharmaceutical company with operations in more than 80 countries.

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