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PRNewswire - November 8, 2004
Under the terms of the amended agreement, Vitex will issue approximately 54 million shares at closing to complete the merger and acquire all Panacos outstanding shares. Panacos will have the opportunity to receive approximately 31 million additional Vitex shares, for a total of 85 million shares, if it successfully achieves the defined endpoints of a Phase IIa study of its lead compound, PA-457, in HIV-infected patients. The number of shares is fixed and not subject to adjustment based on the market price of Vitex stock. A financing commitment of at least $25 million to fund the merged company is a condition of closing the merger.
Since the merger agreement was announced on June 3, the pace of the PA-457 clinical trial program has accelerated. PA-457 is the first in a new class of oral HIV drugs discovered by Panacos scientists that inhibit virus maturation, the last stage of the virus life cycle. It is designed to combat drug resistance, which occurs in most HIV patients treated with currently available drugs. Resistance to existing drugs is the most pressing problem in HIV therapy and the leading cause of treatment failure. PA-457 works by a mechanism completely different from approved drugs or other drugs in development by blocking a late step in processing of the viral Gag protein.
Following PA-457 treatment, virus particles released from HIV-infected cells are non-infectious and virus replication is terminated. Preclinical studies have shown that PA-457 retains full activity against drug-resistant virus, is effective in an animal model of HIV infection and should be suitable for use in combination therapy with other drugs.
PA-457 is currently completing Phase I testing in uninfected volunteers, where single dose and multiple dose studies have been performed. In July, 2004 at the XV International AIDS Conference in Bangkok, Thailand, Panacos scientists reported that PA-457 was well tolerated, with good oral bioavailability and favorable pharmacokinetics that support a once-a-day dosing regimen. Plasma concentrations of the drug were well above those predicted to provide therapeutic benefit in HIV-infected patients.
Based on the positive Phase 1 data, Panacos has initiated a Phase I/II study in HIV-infected patients to analyze pharmacokinetics and to determine the antiviral effect of a single dose of PA-457. Dosing of all 24 subjects in the Phase I/II study is complete and initial results are expected in the near term. Panacos is about to initiate a key multiple dose Phase IIa study in HIV-infected patients later this quarter with results expected in H1, 2005.
This study is designed to determine the antiviral effect of multiple once- daily doses of PA-457 in patients who are not on other antiretroviral therapy. "We are very excited about the rapid progress in developing PA-457," said Dr. Graham P. Allaway, COO of Panacos. "Positive results of the Phase I/II and Phase IIa studies would validate the clinical antiviral activity of PA-457 and pave the way for late-stage clinical development. PA-457's profile suggests it may have utility not only in patients failing current therapies due to drug resistance, but also as a first line therapy. If successfully brought to market, we believe it could make a major positive impact on HIV treatment, a $6 billion worldwide market." Dr. Allaway, a founder of Panacos, will continue as COO of Vitex with responsibility for Panacos operations.
Dr. Samuel K. Ackerman, currently Chairman and CEO of Panacos, and Chairman of Vitex, will be Chairman and CEO of the combined company. Dr. Ackerman commented, "We believe that the merger with Vitex will further accelerate the development of PA-457 and other exciting Panacos antiviral drug candidates including oral HIV fusion inhibitors. These products address major unmet needs and have rapid development potential as well as a clear path to market and great commercial promise. They will play a key role in Vitex's future growth and success. We are looking forward to completing the merger and creating a leading anti-infectives company."
The Board of Directors of Vitex and Panacos have approved the amendment to the merger agreement. The transaction is expected to close in January 2005 and is subject to approval by the shareholders of both companies and other customary closing conditions.
Drs. Ackerman and Allaway will participate in a live webcast with a slide presentation and conference call, hosted by Vitex today Monday, November 8 at 8:30 AM Eastern time to discuss the transaction. The webcast may be accessed via Vitex's web site at http://www.vitechnologies.com. A replay of the webcast will be available via a link from the Company's web site immediately after completion of the call, and will be archived for on-demand replay for 60 days.
The conference call may be accessed by dialing 800-795-1259, for domestic callers, and 785-832-1508, for international callers. A replay of the conference call will be archived for 60 days and may be accessed by dialing 800-934-8367 for domestic callers and 402-220-6994 for international callers.
About Vitex
Vitex is developing products designed to improve the safety of the world's blood supply. The Company's proprietary INACTINE(TM) technology, currently in a Phase III clinical trial, is designed to inactivate a wide range of viruses, bacteria and parasites, and has demonstrated its ability to remove prion proteins. Over 40 million red cell units are transfused annually in the U.S., Europe and Japan. More information on Vitex is available at http://www.vitechnologies.com.
About Panacos
Panacos Pharmaceuticals is engaged in the discovery and development of small molecule oral drugs for the treatment of HIV and other major human viral diseases. Panacos' proprietary discovery technologies focus on novel targets in the virus life cycle, including virus fusion and virus maturation, the first and last steps of viral infection. More information on Panacos is available at http://www.Panacos.com.
SOURCE Panacos Pharmaceuticals, Inc.
Web Site: http://www.panacos.com
http://www.vitechnologies.com
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PR041111
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