Heightened concern over the safety of new diabetes treatments is throwing significant roadblocks in front of their use and threatening to discourage development of drugs for the disease.
Diabetes is reaching epidemic levels, an estimated 180 million people have it, and so novel treatments are high on the wish-list of most pharmaceutical companies.
But getting new products through clinical trials, past regulators and widely used in clinical practice is proving to be a tough fight.
"There is great potential, but it's getting increasingly harder to tap into that potential," said Christine Helliwell, an analyst with market research firm Decision Resources.
The diabetes field suffered possibly a major blow earlier this week when studies suggested Sanofi-Aventis' widely used drug Lantus may increase the risk of cancer.
Sanofi disputed the quality of the studies, and the fallout on prescriptions remains to be seen, but the drugmaker's shares have already taken a hit. The U.S. Food and Drug Administration cast doubt on the cancer link on Wednesday, questioning whether the studies were long enough to assess such risk.
Safety concerns also undermined another promising drug class called GLP-1s recently. As worries over pancreatic inflammations slowed sales of Eli Lilly and Amylin Pharmaceuticals' Byetta, concerns over possible thyroid cancer side-effects are clouding prospects for improved, longer-lasting GLP-1 drugs being developed by Lilly and competitor Novo Nordisk.
The Lantus concerns echo the 2007 scare over heart problems with GlaxoSmithKline's Avandia, which halved its sales and badly hurt the British drugmaker's shares.
Vigilance over the safety of diabetes medicines is on the rise, said Dr. Richard Bergenstal, president-elect of medicine and science for the American Diabetes Association.
"For a long time, it was about achieving goals of efficacy parameters and now safety has entered the discussion and we're finding the right balance," said Bergenstal.
Safety filtered into the approval process this week when Takeda Pharmaceutical Co's revealed it faced a lengthy U.S. delay for experimental product alogliptin and its shares slumped.
The chronic nature of diabetes and the fact that it does not cause mortality directly make it hard to prove the value of medicines unequivocally. Taking drugs for a long time also increases the likelihood that relatively rare side effects will emerge.
Although drugs from several innovative classes of treatments have reached the market in recent years, the climate appears to be more challenging for new medicines to win approval.
In the United States, the largest pharmaceutical market, regulators now demand evidence of cardiovascular safety before clearing new diabetes treatments.
"I think the evolution of new agents has been fairly clear over the last decade, but the bar going forward is a pole vault," Barclays Capital analyst Tony Butler said.
The more stringent regulatory climate is one factor that may dissuade industry investment in diabetes research. Another is that doctors may be reluctant to try new medicines when they can bank on the safety of older drugs.
"We expect to see a lot of attrition in the pipeline," Helliwell said. "Companies may be in the long-term discouraged from investing in diabetes drugs."
Even with current therapies, diabetics frequently fail to stay compliant or keep their blood sugar at appropriate levels. The disease, in which the body fails to properly produce or use insulin, can lead to damage of the heart, eyes and kidneys if left uncontrolled.
"There are good medicines out there, but I think it's become pretty clear in looking across the landscape that there's still room for improvements," Bergenstal said.
The growing prevalence of diabetes is linked to rising levels of obesity, but tackling that issue has proved even harder for the pharmaceutical industry.
Mental health concerns doomed Sanofi's highly touted obesity drug rimonabant, which never made it to the U.S. market, and led to several drugmakers abandoning drugs in the same class. Safety problems led to the market withdrawal of the fen-phen diet drug combination in the 1990s.
Some of the new diabetes drugs that have been flagged for safety issues have demonstrated an attractive added benefit of causing weight loss.
The safety questions have hit diabetes drugs that already face rivals that work similarly. Avandia, Lantus and alogliptin all have competing products in their respective classes.
"For newer agents that are going to come to market...I think you have to be better than a similar agent in the class, or have something unique," Butler said.
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