01.30.19
Contract development and manufacturing organization (CDMO), Particle Sciences, a Lubrizol LifeSciences company, has formed a partnership with Indian contract manufacturing organization (CMO), Encube Ethicals.
The two companies will develop innovative intravaginal rings with the intent to out-license to biopharmaceutical marketing partners. The partnership will focus on rings for the administration of existing approved drugs, improving drug effectiveness and patient compliance. The use of drug-eluting devices to provide sustained-release dosage forms has seen continued growth due to the ability to provide constant, localized, site-specific drug delivery. The market continues to be of interest as these devices can improve patient compliance, one of the greatest challenges in healthcare today.
Both parties will leverage each other’s drug development and manufacturing strengths: Particle Sciences has a proven track record and extensive expertise in the development and manufacturing of intravaginal ring devices and complex formulations, while Encube Ethicals has strong capabilities in developing complex topical and transdermal delivery systems, with two decades of experience in commercial manufacturing of topical products for a variety of markets, including women’s health for multiple countries.
The project is Particle Sciences’ latest in the complex generics space using the 505(b)(2) US Food and Drug Administration (FDA) regulatory pathway to develop new drugs that better meet the requirements of patients and physicians.
“Our collaboration with Encube Ethicals is an important step in our work on complex pharmaceuticals and particularly toward our efforts to accelerate improved therapeutics through the use of the 505(b)(2) pathway,” said Dr. Barbara Morgan, general manager, Particle Sciences.
Mehul Shah, founder and managing director, Encube Ethicals, said, “We are deeply invested in finding innovative ways to deliver drugs that make the patient’s experience significantly better and safer. We hope to leverage Encube’s experience in Topical products development and manufacturing to bring impactful breakthrough innovations to the market.”
The two companies will develop innovative intravaginal rings with the intent to out-license to biopharmaceutical marketing partners. The partnership will focus on rings for the administration of existing approved drugs, improving drug effectiveness and patient compliance. The use of drug-eluting devices to provide sustained-release dosage forms has seen continued growth due to the ability to provide constant, localized, site-specific drug delivery. The market continues to be of interest as these devices can improve patient compliance, one of the greatest challenges in healthcare today.
Both parties will leverage each other’s drug development and manufacturing strengths: Particle Sciences has a proven track record and extensive expertise in the development and manufacturing of intravaginal ring devices and complex formulations, while Encube Ethicals has strong capabilities in developing complex topical and transdermal delivery systems, with two decades of experience in commercial manufacturing of topical products for a variety of markets, including women’s health for multiple countries.
The project is Particle Sciences’ latest in the complex generics space using the 505(b)(2) US Food and Drug Administration (FDA) regulatory pathway to develop new drugs that better meet the requirements of patients and physicians.
“Our collaboration with Encube Ethicals is an important step in our work on complex pharmaceuticals and particularly toward our efforts to accelerate improved therapeutics through the use of the 505(b)(2) pathway,” said Dr. Barbara Morgan, general manager, Particle Sciences.
Mehul Shah, founder and managing director, Encube Ethicals, said, “We are deeply invested in finding innovative ways to deliver drugs that make the patient’s experience significantly better and safer. We hope to leverage Encube’s experience in Topical products development and manufacturing to bring impactful breakthrough innovations to the market.”
