BioWorld International Correspondent
Shares in Jerini AG gained slightly Tuesday on news that Baxter International Inc. had extended an existing agreement in hemophilia to include two new drug development programs involving two new targets.
Although details of the new agreement were sparse, the news caused a modest increase in the stock from €4.07 to €4.15 on the Xetra electronic trading platform in Frankfurt, Germany.
The new deal further augments an existing pact that was first signed in 2001 and then extended in 2004.
Berlin-based Jerini is receiving an undisclosed up-front payment and research funding for each of the new programs. The company also stands to gain additional payments based on discovery, preclinical and clinical milestones, plus royalties on eventual product sales.
"This shows that the current collaboration has been successful and that the program is being expanded due to positive results," Stacy Wiedenmann, Jerini's director of investor relations and corporate communications, told BioWorld International.
The two companies disclosed last year that they had identified several synthetic lead molecules that exhibited promising in vitro and in vivo activity as non-intravenous therapies for hemophilia. The companies have not disclosed the targets that are the focus of the collaboration.
Jerini declined to comment on whether the deal would alter its financial outlook for the year, but it is not expected to have a major effect on its balance sheet. The company reported a net loss of €16.7 million (US$21.6 million) for the nine-month period ending Sept. 30, and cash holdings of €74.5 million.
"The financial impact is limited, I would say," said Daniel Wendorff, analyst at Dusseldorf-based West LB. "At least it validates Jerini's peptidomimetic platform," he added.
The technology is designed to aid the discovery of small-molecule drugs and peptide mimics that act on protein targets that are regarded as being difficult to access by conventional methods.
Although the programs have long-term potential, they remain early stage and therefore will have little immediate impact on Jerini's share price.
The main driver of the stock remains Icatibant, a synthetic peptide antagonist of the bradykinin B2 receptor, which completed two Phase III clinical trials in hereditary angioedema last fall. (See BioWorld International, Sept. 27, 2006.)
The company said then that it has sufficient data to file a marketing authorization application with the London-based European Medicines Agency, but it is not yet clear whether the FDA will accept a new drug application at this point, since one of the two studies failed to attain statistical significance.
Jerini had a pre-NDA meeting with the FDA at the end of January and it will provide a further update on the situation in the coming weeks, once it receives the minutes of that meeting, Wiedenmann said.
"The market expectations are split, I would say," Wendorff said. "I believe they can file on the basis of the package they have."
Since hereditary angioedema is a condition for which there no approved therapy in the U.S., they may gain conditional approval, he said, which would require the company to conduct an additional trial once the drug was on the market.