Roche announces strategic collaboration, license agreement

Under this agreement, Roche will acquire a majority interest in FMI of up to 56.3 percent on a fully diluted basis through a tender and acquisition of newly issued shares. Roche will tender for roughly 15.6 million shares of FMI at $50 per share, with an aggregate tender value of approximately $780 million. In addition, Roche will invest $250 million in FMI with the acquisition of five million newly issued shares at $50 per share. While FMI will continue to maintain operational independence following this move, Roche will gain minority representation on FMI's expanded board of directors. The boards of both companies have unanimously approved this deal.

Per the terms of the R&D collaboration agreement, Roche has committed to R&D funding that could reach more than $150 million for a minimum of five years, and will also contribute its oncology expertise, while FMI will contribute its expertise in developing comprehensive genomic profiling tests for oncology. The collaboration's initial focus will be on the development of genomic profile tests for cancer immunotherapies and continuous blood-based monitoring.

The companies have also agreed to a commercial collaboration agreement that is meant to expand FMI's position in the clinical and molecular information markets, in which Roche will obtain ex-U.S. rights under FMI's brand to existing FMI products, as well as to future co-developed products. In the U.S., Roche's U.S. medical education team will provide medical information to pathologists.

The collaboration agreements will become effective upon the completion of Roche's direct investment and tender offer. The transaction is expected to close in the second quarter of this year.

“We are very pleased to enter into this collaboration with FMI, which has the potential to improve both the development of medicines and patient care,” Daniel O’Day, chief operational officer of Roche Pharma, said with regards to the agreement. “By combining FMI’s pioneering approach to genomics and molecular information with Roche’s expertise in the field of oncology, we can bring personalized healthcare in oncology to the next level.”

“We are excited to announce this strategic collaboration with Roche, which will help accelerate our business, and importantly, represents significant potential for individuals with cancer around the world. We believe that putting molecular information at the center of cancer care will help transform the delivery of care for patients and speed the pace of drug discovery and development,” Dr. Michael J. Pellini, president and CEO of Foundation Medicine, commented in a statement. “The structure of our agreement with Roche also allows us to maintain the entrepreneurial spirit at Foundation Medicine and ensures that our business model, network of partnerships and objectives are not altered.”

Roche's second agreement was announced together with Meiji Seika Pharma and Fedora Pharmaceuticals, with the goal of targeting bacterial resistance to antibiotics. The three companies have struck a license agreement to develop and commercialize OP0595, a beta-lactamase inhibitor currently in Phase I clinical development. Per the agreement, Roche will gain worldwide rights from both companies for development and commercialization with the exception of Japan, where Meiji retains sole commercialization rights. In return, Meiji and Fedora will receive upfront payments and development, regulatory and sales event milestone payments that could potentially total up to $750 million. The two companies also stand to receive tiered royalties on sales of products that result from this agreement.

Beta-lactamase inhibitors restore or potentiate the activity of beta-lactam antibiotics, and the combination of OP0595 with a beta-lactam antibiotic can target severe infections cause by Enterobacteriaceae, including multi-drug-resistant strains.

“We have seen truly impressive bacterial eradication in highly resistant strains generated by combination of this beta-lactamase inhibitor with existing beta-lactam antibiotics,” said Christopher G. Micetich, founder and CEO of Fedora Pharmaceuticals. “The properties of OP0595 and its ability to be combined with new or existing beta-lactam antibiotics promise a significant advance in the battle against increasing multi-drug-resistant bacteria.”