Associate

Repligen Corp. raised $12.5 million through a private placement and will use the funds in part for its Phase III product, secretin, also called RG1068.

Repligen, of Waltham, Mass., sold 2.5 million shares at $5 each to The Riverview Group, an investment arm of Millennium Partners LP, of New York. Rodman & Renshaw Inc., also of New York, served as placement agent. Given the financial difficulties in the biotechnology industry, Repligen CEO and President Walter Herlihy said he was "very pleased."

Repligen's stock (NASDAQ:RGEN) fell 7 cents Friday to close at $6.22.

Herlihy said the company would use the funds to "expand our secretin development program. We are in Phase III trials in autism now and we're looking for additional indications."

Secretin is produced by the duodenum. RG1068 is Repligen's synthetic human secretin. In the past, a few autistic children with gastrointestinal dysfunction received secretin during a gastrointestinal examination and secretin seemed to have a positive effect on their autism symptoms. The Phase III trials have endpoints of improvements in reciprocal social interaction as measured by the Autism Diagnostic Observation Schedule and the Clinical Global Impression of Change. Secondary endpoints are improvements in language and behavior. (See BioWorld Today, Feb. 19, 2002.)

Herlihy said Repligen expects to close enrollment in the first of the trials later this month, with data expected at the end of 2003. The second trial is expected to trail by about six months.

The product failed in a Phase II trial in 2001, missing the primary endpoint of an improvement in symptoms measured by a psychologist's evaluation using the Childhood Autism Rating Scale. But Repligen saw a statistically significant symptomatic improvement in the secretin-treated group vs. placebo according to parental assessment, which led the company to move to a focused Phase III program. (See BioWorld Today, April 5, 2001.)

Repligen also will spend to expand its CTLA4-Ig program, which has the compound in a Phase I/II trial in the UK in autoimmune thrombocytopenic purpura, as well as other clinical work. The problem, however, is the product is caught in litigation with Bristol-Myers Squibb Co., of New York.

Repligen licensed rights to CTLA4-Ig from the University of Michigan. The university and Repligen are plaintiffs in a trial under way in Detroit, seeking "to correct inventorship on Bristol's patents," Herlihy said.

"The allegation is that the University of Michigan was left off the patents," he told BioWorld Today.

CTLA4 is a T-cell regulatory protein. CTLA4-Ig is a soluble form that is thought to have immunosuppressive activity. Bristol-Myers, Herlihy said, has it in Phase III trials for rheumatoid arthritis and also multiple sclerosis.

"Based on what Merrill Lynch analysts are saying, it could launch in the first quarter of 2005," Herlihy said, adding that if the trial ends in Repligen's favor, "[BMS] could practice without obligation to us and vice versa," and Repligen would move forward.

Repligen markets two products: Protein A and SecreFlo. Protein A is a consumable reagent used to produce monoclonal antibodies, and SecreFlo, secretin for injection, is marketed to gastroenterologists for pancreatic assessment. Although Repligen's fiscal year ended March 31 and it won't release year-end figures until June 5, it is expected the products together will have brought in between $7.5 million and $8 million for the year. The previous year, Repligen had just Protein A, which brought in $4.3 million.

The company expects its net loss for the year ended March 31 to be $4 million to $5 million. As of Dec. 31, it had $20.1 million in cash and investments. It posted a net loss of $2.8 million for the three months ended Dec. 31.

Herlihy said the company would "be opportunistic about any product opportunities we can find," and also said the money permits for an assertive demeanor.

"It allows us to aggressively develop our two lead products," he said. "Rather than staying in a single application or restricting our scale-up until we know the outcome of the trial," the company can push ahead on both fronts.