BioWorld International Correspondent

MUNICH, Germany - Paion GmbH completed a multinational fourth round of private financing that brought the company €9.8 million in fresh capital.

Paion, of Aachen, Germany, will use the investment to initiate pivotal trials of Desmoteplase, its lead product. The compound is intended to treat acute stroke, and it can be administered up to nine hours after stroke onset with a superior safety margin, compared with current treatments that must be administered within three hours, the company said.

Paion said Desmoteplase is the first in a new class of neuroprotective plasminogen activators. The company completed a Phase II trial with the drug at the end of 2003, and the results beat Paion's expectations in both safety and efficacy.

Wolfgang Soehngen, Paion's CEO, told BioWorld International that the trial data played a key role in helping the company secure the new investment.

"The difference is that we have superb data in an area that people regarded for a long time as a disaster," he said. "The positive response that we have received from the stroke community was also important."

Soehngen added that the company expects to find a partner for Desmoteplase in the next few months. "We have good feedback from potential corporate partners," he said. "We are looking for co-development and co-commercialization on the lead compound for both stroke and pulmonary embolism. The lead compound is good for several indications. It is far from a one-trick pony."

Paion would combine money from a partnership with the capital just raised to undertake Phase III trials with Desmoteplase.

Future developments in the company's pipeline will extend its concentration on stroke, which is a leading killer in both Europe and the U.S. "After the lead compound," Soehngen said, "we are in discussions about in-licensing a neuroprotective compound, and we have several candidates. For treating strokes, the next phase after opening the artery [which Desmoteplase does] is combination with a neuroprotective."

Paion has a second Phase II trial of Desmoteplase under way, with results expected in the second half of 2004. The study has the same design as the first Phase II trial, but it concentrates on the dosages that showed good results in the previous trial, because "we want more data points," Soehngen said.

The company likely will pursue simultaneous registration in Europe and the U.S. Soehngen views trans-Atlantic expansion carefully, though.

"Many European companies have been rushed in their approach to the American market," he said. "We don't want to do it hastily; we want to do it with a solid basis."

Over the long term, he would like to see Paion become a drug development and marketing company. "The world has enough targets," he said. "What is needed is intelligent development, and we want to head in that direction.

"Like Novartis," he added, "Paion is run by physicians. We think about development back from the patient and the market. Plus we have been in difficult areas of research for all of our careers, and we have learned about difficult indications."

Innoven Partenaires, of Paris, led the round, which was joined by new investors OTC Asset Management, also of Paris. Existing investors that renewed their commitment included 3i Group, of Duesseldorf, Germany; Genevest SA, of Geneva; Neomed Innovation of Oslo, Norway; and S-VC, of Aachen.