By Matthew Willett
Trimeris Inc. entered purchase agreements to sell about 1.4 million shares to new and current shareholders in a private placement that will net $43.4 million for the company.
Proceeds from the financing will be used to develop the Durham, N.C.-based company¿s product candidates, T-20 and T-1249, antiviral candidates designed to block viral fusion ¿ the attachment and penetration of viruses to host cells.
Trimeris Chief Financial Officer Robert Bonczek said he¿s confident the financing will get his company where it needs to be.
¿It was an opportunity for us to satisfy some demands on the part of our current shareholders,¿ he told BioWorld Today, ¿and to take some of the financial risk off the table, as we were mindful that we don¿t want to dilute excessively in this kind of market. We¿re satisfied with our balance sheet right now, and it puts us in the position that even though the market climate seems uncertain we can operate with a higher degree of comfort than before, and we¿re comfortable and confident about the milestones we¿ll knock down in the near term.¿
Bonczek added that the financing will bring the company to the verge of seeking approval for T-20.
¿We¿ll surely have Phase III data in hand, and that¿s important to us,¿ he said. ¿Most of the money we spend is on clinical trials and manufacturing clinical material, but our partner Roche has been mindful of our spending, and that will be our target. Given where we are now and what we have and what we know, I feel comfortable.¿
T-20 showed efficacy in a 1997 Phase I/II trial, reducing the viral load of HIV in patients¿ blood by 98 percent in the highest dosage group. A 1999 Phase II trial in 75 adults whose HIV viral loads were no longer suppressed by approved anti-HIV drugs produced a median viral load reduction ranging from 69 percent to 97 percent.
T-20 is currently in two Phase III trials, and the company said it expects T-20 to be ready for launch by the end of 2002. (See BioWorld Today, Oct. 4, 2000.)
T-1249, another HIV fusion inhibitor, demonstrated HIV suppression in animal models, and a Phase I/II trial in 60 adults is under way. Both drugs were granted fast-track status by the FDA.
¿We¿re fortunate in that we¿re first in class with something that I think has a high level of attractiveness for a lot of reasons,¿ Bonczek said. ¿First, it works. Second, the toxicity, given the fact that it works outside of the cells, seems to be lower than that of other drugs, and the resistance profile seems different than some other ones.¿
The peptide T-20 works by binding to the virus¿ gp41 protein structure, thus blocking fusion with the cell, and consequently, viral replication within the cell.
Both compounds fall under a development and marketing agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The companies share development expenses and profits for the compounds in the U.S. and Canada. In other areas Roche will fund all development and pay royalties on sales. Roche made a $10 million up-front payment in the deal and is committed to an additional $58 million in milestone payments. (See BioWorld Today, July 13, 1999.)
Trimeris¿ stock (NASDAQ:TRMS) dropped 83 cents Tuesday, closing at $36.80.