DOV Pharmaceutical CEO resigns, senior management team reorganized

By Lisa Kerner and Jennifer Lanning Drey

Charlotte, N.C., July 5 - DOV Pharmaceutical, Inc. chief executive officer, president and board member Leslie Hudson has resigned, the company said in a news release Wednesday.

As part of the company's management reorganization, current chief financial officer Barbara Duncan has replaced Hudson in all three capacities.

Chief scientific officer Phil Skolnick was named executive vice president and chief scientific officer.

DOV chairman Arnold Lippa is now executive chairman of the board.

Remaining in their current roles are Warren Stern and Scott Myers, senior vice president of drug development and senior vice president of commercialization and strategic marketing, respectively.

The management changes are effective immediately.

"We have reorganized our senior management team to focus on our most near-term decisions and activities. With this new structure, we will address our financing challenges," said Lippa, during a company conference call on Wednesday.

The company plans to focus on its core scientific pipeline, which includes the painkiller bicifadine, and on potential preclinical candidates, Lippa said during the call.

DOV also said it has amended its ongoing 021 phase 3 study of bicifadine to enroll only patients identified by its previous 020 study to meet the subgroup criteria of severe pain or sciatica, Duncan said, during Wednesday's call.

In addition, the company decided to stop the 800 mg dosing arm before the 021 study because it had a high drop out rate in 020, she said.

"We believe these actions will provide us with the best overall risk-reward profile for study 021, and we are actively exploring our options with potential partners as we continue to work toward an NDA [New Drug Application] filing for chronic pain," said Duncan.

The company previously announced that the 020 study did not achieve a statistically significant effect compared to a placebo on the primarily endpoint of the study at any of the doses tested.

It subsequently announced job cuts.

Further analysis of the results indicated that "an unusually high placebo response rate was the single major contributory factor to the failure" of the trial.

The company also said when it announced the additional analysis that it had identified disease severity, as defined by either the degree of functional disability or the associated presence of pain radiating down the leg (sciatica), as the major factor controlling the difference between patients' response to the placebo and their response to bicifadine.

The analysis shows that as disease severity worsened, placebo response decreased and the relative effect of bicifadine increased, the company explained.

DOV is also continuing to enroll patients in a phase 2 clinical trial of bicifadine to test the drug's effectiveness for osteoarthritis patients, Duncan said.

"We believe a positive outcome in this trial would provide information regarding additional market opportunities for bicifadine," she said.

In its preclinical pipeline, DOV said it will focus on developing compounds in its follow-on analgesics program and plans to have another compound ready for the clinic within 18 months.

Located in Somerset, N.J., DOV discovers, acquires, develops and commercializes novel drug candidates for central nervous system disorders.

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