MALVERN, Pennsylvania & KING OF PRUSSIA, Pennsylvania--Marillion Pharmaceuticals Inc and Cytokine PharmaSciences Inc has announced that the two companies have entered into a license agreement granting Marillion exclusive worldwide rights to develop and commercialize CPSI's Pilobuc buccal insert for the treatment of xerostomia.
Xerostomia, meaning dry mouth, is characterized by the chronic loss of salivary gland function and has been associated with various autoimmune diseases (e.g. Sjögren's syndrome), treatment with numerous medications and radiotherapy for head and neck cancers.
Xerostomia is a debilitating condition that may lead to difficulty speaking, swallowing and alteration in taste and is accompanied by halitosis and a significant increase in the incidence of oral infections, including candida and severe dental caries.
"The most common therapy for xerostomia is a tablet form of pilocarpine, which requires frequent oral dosing due to the short serum half-life of the active drug and causes dose limiting side effects in many patients," said Dr. Zahed Subhan, chief executive officer, Marillion Pharmaceuticals. "Pilobuc is a novel, proprietary, buccal formulation of pilocarpine shown in clinical trials to effectively and conveniently deliver the drug with reduced side effects compared to other routes of administration. Pilobuc has the potential to be a significant product in the xerostomia market, currently estimated to be worth more than $350 million worldwide."
CPSI's Pilobuc insert is based on a hydrogel polymer technology that delivers drugs to the buccal mucosa. The buccal insert allows controlled and sustained release over a period of several hours, relieving some of the problems associated with short term activities of many drugs.
Also, absorption through the oral mucosa minimizes swallowing of the drug and thereby avoids many unpleasant side effects associated with absorption in the gut. Pilobuc allows for the sustained buccal delivery of pilocarpine while reducing the side effects associated with oral systemic treatments.
"We believe Marillion is a strong partner for Pilobuc based on the company's extensive background and focus on oncology drug development," said Vidal de la Cruz, Ph.D, vice president for business development, CPSI. "As Cytokine PharmaSciences continues to progress its pipeline of products in women's health, inflammation and cancer, we will look for key strategic alliances, such as this licensing agreement with Marillion, to maximize the value of our clinical and preclinical stage assets."
To read more about xerostomia, go to xerostomia.