Is the Transplant Drug Glass Half Empty or Half Full?
There is optimism (and concern) regarding pharma's commitment to new transplant drugs
Although many transplant professionals worry that big pharma may be less committed to the development of new immunosuppressant drugs than in the past, some are optimistic, especially in light of new genetic findings and investigations of agents that target relevant cell surface molecules and intracellular pathways.
John Neylan, MD, senior vice president, Clinical Research, at Genzyme Corporation, understands the concern that fewer drugs are in development; however, he says, “I think it oversimplifies the situation. Clearly transplantation is still in evolution and I suggest that we are in one of the most exciting times in its entire history. The science has never been stronger. I think it all speaks to a very strong commitment to develop new therapeutics.”
Dr. Neylan and others agree that challenges persist, such as the very real difficulties of conducting meaningful clinical trials under the current regulatory constraints, mandating problematic comparators and study design endpoints of diminishing relevance.
Additionally, Randall Morris, MD, head of Therapeutic Sciences for Transplantation and Immunology at Novartis Pharma AG, notes that, “given the complexity, risk and costs of developing a new immunosuppressant, a significant barrier remains for companies that are first entering the field.
“The cost of necessarily complex trials and increasing emphasis on benefits versus risks by regulatory agencies are all barriers to entry,” continued Dr. Morris. “However, the quality and novelty of most of the immunosuppressants now in trials are greater than many of the drugs studied in the 1990s and first years of the 21st century. One would hope, therefore, that the attrition rate for immunosuppressants now in trials will be lower and that their potential will be greater.”
Clearly transplantation is still in evolution and I suggest that we are in one of the most exciting times in its entire history. The science has never been stronger. I think it all speaks to a very strong commitment to develop new therapeutics.—John Neylan, MD
Meanwhile, some of the former players in transplant drug develdevelopment may have changed their business focus. For example, while noting a continuing commitment to transplantation—including further studies with their product CellCept and investment in the Roche Organ Transplant Research Foundation (ROTRF)—Urs Schleuniger, vice president for Strategic Marketing, Inflammation, at Roche, says the company has decided to discontinue its investment in basic transplantation research. However, Roche “is still committed to evaluating potential new medicine for transplantation from biotech or other sources,” he notes.