Roche and Toyama Chemical Co. have entered into a licensing agreement for the research, development and commercialization of Toyama's oral rheumatoid arthritis agent T-5224. By inhibiting a specific inflammatory process, T-5224 has the potential to block signs and symptoms of rheumatoid arthritis and the progressive destruction of joint and bone. The compound is currently in Phase I.

Under the terms of the agreement, Roche has been granted exclusive rights to research, develop, and market T-5224 worldwide excluding Japan where Toyama Chemical will retain exclusive rights. The agreement also includes the joint R&D of back-up candidates to T-5224. Toyama Chemical will receive upfront payments and milestone payments totaling as much as $370 million, based on certain development and commercial milestones. If approved, Toyama Chemical will receive royalties on sales of T-5224.

"This novel oral compound complements Roche's developing portfolio of drug candidates in inflammation and rheumatoid arthritis. The agent T-5224 has the potential to inhibit a key trigger of rheumatoid arthritis and has already shown promising pharmacological efficacy and safety in early clinical studies," said Jean-Jacques Garaud, head of Roche Pharma Development. "Our new collaboration is good news for all patients with rheumatoid arthritis as well as for our two companies. We are looking forward to collaborating with our new colleagues in Japan to develop T-5224."

"By entering into a R&D collaboration with Roche, one of the world's leading R&D companies, we are able to increase Toyama's potential for novel drug development in the anti-inflammatory field, which is a field of concentration for Toyama Chemical," said Masuji Sugata, president of Toyama Chemical.

Under legislation to be introduced in the U.S. Senate, makers of generic drugs would gain the right to market generic versions of biopharmaceutical medicines. The legislation would create a pathway for the FDA to approve generic treatments made through biotechnology.

According to analysts, competition from lower-cost generics may cut biopharmaceutical drug prices by a third. Generic companies are targeting drugs whose patents have already expired or are set to expire. Companies such as Barr Pharmaceuticals and Teva Pharmaceutical Industries have already made significant investments in acquisitions and facilities outside the U.S. for the technology to make generic versions of biopharmaceuticals.

The Senate proposal would require generic companies to conduct animal studies and at least one clinical trial in humans unless the FDA determines that these steps aren't necessary. The FDA also would have leeway to decide if a generic product could be substituted by a pharmacist for a prescribed brand-name drug.

European regulators allow approval of generic versions they refer to as biosimilars, however, these products are not recognized as identical to the original drugs. Novartis AG recently received support from a European panel to sell biogeneric versions of Johnson & Johnson's Eprex, an anemia drug sold in the U.S. as Procrit and as Amgen's Epogen.

The Senate health committee is expected to address the legislation on June 27.

James M. Saponaro has joined BioStorage Technologies, Inc. (BST) as executive vice president. In this new role, Mr. Saponaro will oversee the company’s sales and marketing, operations, information technology and business development functions.

Mr. Saponaro has more than 20 years of executive experience driving the operations of businesses within healthcare markets including pharmaceutical distribution, retail pharmacy franchising, capital equipment, surgical instruments, surgical implants, pharmaceuticals and nutritionals. He spent the last 14 years in multiple executive positions in pharmacy distribution and retail pharmacy franchising and services for Cardinal Health, where he most recently served as chief operating officer of its retail franchise pharmacy division.

“Jim’s experience in delivering on aggressive strategic plans and leading profitable, high-growth operations for various healthcare and life science organizations is a tremendous addition to the strong BioStorage Technologies team,” said F. John Mills, M.D., Ph.D., BST’s chairman and chief executive officer. “In addition, his entrepreneurial background and metrics-based methodologies uniquely positions him to help us maximize our global reach while ensuring we remain nimble enough to react to the ever-changing pharmaceutical and biotech marketplace.”

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