ORGANOGENESIS/BIOMET COLLABORATIVE AGREEMENT FOR ORTHOPEDIC IMPLANTS
This article was originally published in The Gray Sheet
Executive Summary
ORGANOGENESIS/BIOMET COLLABORATIVE AGREEMENT FOR ORTHOPEDIC IMPLANTS is likely to result in the first product entering clinicals in 1995, Organogenesis projects. Under the agreement, signed July 27, the firms will develop orthopedic implants that utilize Organogenesis' proprietary Dense Fibrillar Collagen (DFC). Biomet has agreed to fund the preclinical and clinical development of the products, which will be manufactured by Organogenesis. Upon completion of development, Organogenesis will receive a milestone payment, while Biomet will have exclusive worldwide marketing rights to the devices. Preclinical studies of DFC are currently under way at the Memorial Medical Center in Long Beach, California. Organogenesis simultaneously announced that talks with Lilly to resume funding of Organogenesis' Graftartery device have ended. Lilly ceased funding for development of the small diameter arterial replacement product in November 1992, claiming the firm "failed to meet certain development milestones," according to Organogenesis ("The Gray Sheet" Nov. 9, 1992, In Brief). At issue was whether or not the device demonstrated extended graft patency in animals. While talks with Lilly continued, Organogenesis funded the project on its own and continued to "work with the Lilly project team," according to the firm. Since the project began in 1987, Lilly has provided approximately $16.2 mil. in funding; it would have had to pay an additional $2.1 mil. if the milestones were reached. Organogenesis says Lilly proposed modified terms for the continued collaboration that were unacceptable to the company. The Canton, Massachusetts firm will continue the development with its own funds while seeking a collaboration with another firm.
You may also be interested in...
Partisan Politics Returns To US FDA Congressional Oversight
The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Roche Gets Adjuvant ALK+ Lung Cancer To Itself With Alecensa Approval
The US FDA cleared Roche’s supplemental approval request for ALK inhibitor Alecensa in ALK-positive non-small cell lung cancer following tumor resection.