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In separate actions, two pharmaceutical makers have acquired the rights to a novel testosterone agent and a patented formulation for interstitial cystitis/painful bladder syndrome.
In separate actions, two pharmaceutical makers have acquired the rights to a novel testosterone agent and a patented formulation for interstitial cystitis/painful bladder syndrome (IC/PBS).
Endo International plc announced acquisition rights to testosterone nasal gel (Natesto) from Trimel BioPharma SRL. The drug was approved by the FDA in May 2014.
Endo said it expects the transaction to close in early 2015.
"We are pleased to acquire the rights to Natesto to further enhance our branded pharmaceutical portfolio and look forward to leveraging our commercial expertise in the areas of men's health and urology to support this highly differentiated product," Rajiv De Silva, president and CEO of Endo, said in a news release.
Natesto offers a unique intranasal delivery system. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).
Separately, Imprimis Pharmaceuticals, Inc. has entered into a license agreement, under which Imprimis acquired the U.S. rights to commercially compound a patented combination of alkalized lidocaine and heparin from Urigen Pharmaceuticals, Inc.
Physicians have been prescribing and instilling this compounded drug formulation in different dosages to treat individual patients suffering from IC/PBS, Imprimis said in a press release. Compounded alkalized lidocaine and heparin instillation procedures have been reimbursable by private health care providers and to Medicare beneficiaries under CPT Code 51700.
The license is for the U.S. market only and covers certain U.S. patent rights that extend through 2026. The agreement contains provisions for the parties to remain long-term partners throughout the product lifecycle.
"The acquisition of the license to compound Urigen's alkalized lidocaine and heparin formulation is an important milestone for our company and a win for the millions of women and men in the U.S. suffering from IC/PBS, a chronic and debilitating disease," said Mark L. Baum, CEO of Imprimis. "We intend to create national awareness for this urology formulation through a Defeat IC campaign, which we expect to begin in early 2015.”
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