BioMimetic Disputes Study on Cancer Risk

BioMimetic said it does not believe that an increased risk for cancer or cancer deaths has been demonstrated by the study.

BioMimetic shares spiked $2.30, or 35.4 percent, to $8.80 in pre-market trading. The stock, which plunged 56 percent on Thursday, has traded between $6.35 and $19.51 during the past 52 weeks.

Regranex, a Johnson & Johnson product, has been approved since 1997 to treat chronic diabetic foot ulcers. The treatment is made of a recombinant form of human platelet-derived growth factor, which causes cells to divide more rapidly.

On Thursday, the FDA posted a notice online about a study that investigated if patients with diabetes who apply Regranex ointment directly to skin ulcers on a daily basis have an increased risk of cancer.

"At this time, FDA believes that there may be some evidence for an increased risk of death from cancer in patients who had repeated treatments with Regranex," the agency said. The agency noted that it is not urging health care professionals to stop prescribing the treatment.

The FDA noted that a long-term safety study completed in 2001 indicated there were more cancers in people who used Regranex than in those who did not use it.

BioMimetic said the most recent study includes inconsistencies. According to the company, one analysis indicated no increased risk of cancer, while another analysis suggested an increase in the number of patients who died from cancer among those who were prescribed Regranex three or more times. BioMimetic noted that the incidence of increased mortality was based on a small number of cases.

The company said it has not received any communications from the FDA related to its online posting about Regranex.