LONDON - Pharming Group NV, which specializes in production of pharmaceutical proteins in the milk of transgenic animals, is to float on the pan-European exchange Easdaq.

Based in Leiden, the Netherlands, Pharming aims to raise between US$50 million and US$60 million.

George Hersbach, president and CEO of Pharming, told BioWorld International the company chose to float on Easdaq “because it is a pan-European company with operations in Belgium, the Netherlands, Finland and the U.S. We concluded that Easdaq fits best with that.“

Hersbach said the performance to date of Easdaq, which was launched 18 months ago as a European version of Nasdaq, is “quite encouraging.“

Innogenetics NV, the Belgian firm which was the first biotechnology company to list on Easdaq, “has done remarkably well on it,“ he added. “We don't rule out a co-listing. We are geared to further expansion of the U.S. operation and could consider Nasdaq.“

The listing of Pharming brings the number of companies quoted on Easdaq to 28.

The merchant bank Mees Pierson, of Amsterdam, the Netherlands, is acting as lead manager of the issue of 4.1 million new shares. Hersbach said he expects the shares will be bought by investors all around Europe. There also will be a private placement in the U.S. with qualified institutional buyers.

Pharming will use the funds to progress clinical trials and to expand its facility in Belgium. Hersbach noted there are nine products in development, with two compounds in Phase I.

Phase III For Pompe's Disease Anticipated

The company has received “encouraging results“ in the Phase I trial of its lead compound, human alpha-glucosidase, for the treatment of the inherited muscle wasting disorder Pompe's disease (acid maltase deficiency).

“We are still doing some data analysis, but there were no adverse effects, and we plan to move on to a combined Phase II/III pivotal trial this year,“ Hersbach said. “We have had discussions with the FDA about the trial design and expect to conduct a nine to 12 month study, with the first approval in infantile indications.“

Pharming has been granted orphan drug status by the FDA. Hersbach said the drug will be a commercially significant development for the company. “We estimate the market is between 5,000 and 10,000 patients. The best comparison is with another glycolipid storage disorder, Gaucher's disease, where the treatment market is worth $350 million. The incidence of Gaucher's is lower than Pompe's disease.“

A full-scale production plant for human alpha-glucosidase produced in the milk of transgenic rabbits will be constructed in Geel, Belgium.

The other compound in Phase I is human lactoferrin, a natural antibiotic that is orally available, for the treatment of immunocompromised patients such as premature babies and those with cancer.

Collaborations Include Red Cross

Pharming also has a deal with the American Red Cross to produce the blood products Factor VIII, Factor IX and fibrinogen in the milk of transgenic animals. The development will combine Red Cross patents and research with Pharming's transgenic know-how.

In February Pharming was banned by the Dutch government from cloning animals by nuclear transfer. The ban coincided with the birth in the Netherlands of Holly and Belle, calves cloned through nuclear transfer of embryonic cells produced in vitro.

As a result the company was forced to move its nuclear cloning activities to its U.S. collaborator, Infigen Inc., of DeForest, Wis., a subsidiary of ABS Global Inc.

Hersbach said the ban is not hampering the company's commercial development. He noted, “The Netherlands is the only country to ban cloning by nuclear transfer, and this is more associated with worries about human cloning than transgenic animals. We have all the freedom we need [in the Netherlands], apart from animal cloning and nuclear transfer.

“We have not transferred existing activities to the U.S.; rather, we have added new activities there,“ he said.

The $50 million to $60 million raised by the flotation will last until 2002. “We will do deals in the meantime and will look for new collaborations,“ Hersbach concluded. *