Cosette Pharmaceuticals Inc., a Bridgewater company that focuses on women’s health and cardiovascular medicines, announced June 8 it completed the acquisition of the global rights to Intrarosa from Endoceutics Inc., a subsidiary of Quebec-based Endorecherche Inc.
The deal – terms of which were not disclosed – includes 108 issued and pending patents, including Orange Book listed patents, which are those the U.S. Food and Drug Administration has “approved on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).”
Intrarosa is the only prescription drug providing both estrogen and androgen for the treatment of moderate-to-severe dyspareunia (a common symptom of vulvar and vaginal atrophy [VVA] due to menopause), according to Cosette. The drug is available in almost all major markets, including the U.S., U.K., European Union, Canada and Israel.
Cosette said the launch in the Asian market is set for 2025.
According to the company, Intrarosa differentiates itself from other pharmacological estrogen-containing medications because it does not carry a boxed safety warning on its label. These warnings, according to the National Institute of Health’s National Library of Medicine, “are the highest safety-related warning that medications can have assigned by the [FDA]. These warnings are intended to bring the consumer’s attention to the major risks of the drug.”
The site also noted these medications “can affect the marketability of the drug and generate negative news reports.”
In a statement, Cosette President and CEO Apurva Saraf said, “In partnership with MSH Pharma Inc., Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa. We look forward to expanding Cosette’s global footprint in new territories and with our existing distribution partners.”
Cosette estimated that there are about 32 million women in the U.S. alone who suffer from VVA symptoms, with 44% to 78% experiencing dyspareunia.
The global menopause drug market was valued at $15.8 billion in 2022 and is expected to expand to $24.1 billion by 2030, according to the Research and Markets site.
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