Tuesday, February 21, 2012

Repligen wins priority FDA review for pancreatic imaging agent

By Lori Valigra

Repligen Corp. of Waltham said this morning that it has been granted priority review by the U.S. Food and Drug Administration (FDA) for its SecreFlo pancreatic imaging agent, for which the company is moving cautiously to build a marketing and sales infrastructure, President and CEO Walter Herlihy told analysts on a conference call this morning.

“We have plans to commercialize SecreFlo in the United States with a lean infrastructure,” he said. “But we do not intend to commit to the expense of a sales force until we have a commitment from the FDA.” He said the company also plans to file a marketing application this quarter in Europe and is seeking partners there to distribute the product. Priority review designation is given to product candidates that offer a significant improvement in the treatment, diagnosis or prevention of a disease or that address an unmet medical need.

Herlihy said sales plans are not finalized yet, but the company could hire 10 to 15 sales representatives, or it may join with another company to amplify its sales efforts. “We are looking for opportunities to spread out the cost of marketing,” he said.

Repligen (Nasdaq: RGEN) plans to target SecreFlo at 600 high-volume patient hospitals. The product aims to improve a magnetic resonance image of the pancreas so a patient can avoid an invasive endoscopy procedure.

Under the accelerated scheme, the FDA will review Repligen’s new drug application for SecreFlo and give an opinion on June 21, Herlihy said. He added that one month before that deadline, the FDA also may ask for a review process by other parties, which he said is not unusual.

The company is being cautious about moving ahead with hiring salespeople until the FDA makes a decision, he said.

Repligen aims to be cash-flow positive in 2012. Also this morning Repligen announced preliminary results for the first quarter and nine-month fiscal period ended Dec. 31, 2011. During that period, the company completed its $23 million acquisition of Novozymes Biopharma Sweden AB and filed its first new drug application for SecreFlo.

Total revenue for the quarter ended Dec. 31 is expected to be $7.2 million compared to $7.1 million for the same quarter the prior year. The loss is expected to be $2 million to $2.5 million, the result of expenses related to buying Novozyme and filing the drug application. The company ended 2011 with $36 million in cash and no debt.

Repligen’s stock was up more than 2 percent in mid-morning trading to $4.30 per share.