NEWS 2004
[11/29/2004]
Panacos Pharmaceuticals Reports Progress on Merger Agreement with V. I. Technologies
GAITHERSBURG, MD, November 29, 2004 /PRNewswire/ -- Panacos Pharmaceuticals, Inc. today announced that the terms of its proposed merger agreement with V. I. Technologies (Nasdaq: VITX), ("Bitex"), have been modified, following recent changes in the development status of key technologies at Panacos and Vitex. These changes impact the relative value of each company.
Under the terms of the amendment, Vitex will issue approximately 227 million shares shares to acquire all Panacos outstanding shares. Following the merger closing, the shareholders of Panacos will own slightly over 80% of the outstanding shares of the combined company. The new agreement has no milestones because Panacos has achieved the milestones of the original agreement, by demonstrating that PA-457 is safe and well tolerated with promising pharmacokinetics in uninfected volunteers and that it has a significant antiviral effect in HIV-infected patients. The number of shares is fixed and not subject to adjustment based on the market price of Vitex stock. The financing commitment, which is a necessary condition of the merger, has been revised to $20 million. Vitex recently reported signing a term sheet with a group of investors to invest $20 million in the merged company.
The amended terms represent a significant adjustment to the merger agreement and to the share exchange ratio between the companies, reflecting recent announcements on the development status of Panacos' HIV drug candidate, PA-457 and Vitex's INACTINE red cell pathogen inactivation system. On November 23rd Panacos announced positive preliminary results from a proof-of-principle Phase I/II clinical trial of the Company's lead HIV drug candidate, PA-457. In that study, PA-457 was administered as a single oral dose to HIV-infected patients who were not on other therapy, in order to determine the pharmacokinetics and antiviral effect of the compound. A significant reduction in viral load, of up to approximately 0.7 log10, was seen in patients receiving the higher dose levels. The study has been selected for oral presentation at the 12th Conference on Retroviruses and Opportunistic Infections to be held in Boston, MA during February, 2005, at which time a detailed description of the clinical trial and results will be provided.
Also on November 23rd, Vitex announced that it had temporarily suspended enrollment in the ongoing Phase III surgical study for the INACTINE pathogen inactivation system for red blood cells. The decision to suspend enrollment was made following identification of an immune response to INACTINE-treated red cells in one patient in the study. As a result of this finding and previous discussions with FDA, the overall timing and investment required to license Vitex's current INACTINE system for red blood cells and its commercial success cannot be predicted at this time. The INACTINE red cell system is Vitex's principal product development effort.
Dr. Graham Allaway, COO at Panacos commented: "PS-457 and Panacos' other programs will play a central role in the merged company. We recently passed a major milestone, demonstrating that PA-457 exhibits potent antiviral activity following a single dose in HIV-infected patients. This result provides strong validation for PA-457, which offers a powerful and innovative approach to address the huge demand for new treatment options effective against HIV/AIDS". Dr. Allaway will continue as COO in the combined company, with responsibility for Panacos operations.
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 that of any approved drug or other drug in development, by blocking a key step in the processing of a viral core protein called capsid. 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 recently completed Phase I testing in uninfected volunteers, where single dose and multiple dose studies have been performed. PA-457 was well tolerated in these studies, 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. Following demonstration of antiviral potency in the single dose, Phase I/II study in HIV-infected patients, 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 estimate the antiviral effect of multiple once-daily doses of PA-457 in patients who are not on other antiretroviral therapy.
In June, 2004, Panacos Pharmaceuticals entered into a definitive merger agreement with Vitex. The terms of the merger were first amended on November 5, 2004. The transaction is expected to close in the first quarter of 2005 and is subject to the approval by shareholders of both companies and other customary closing conditions
About Vitex
Vitex is developing products designed to improve the safety of the world's blood supply. The Company's proprietary INACTINE? technology 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 www.vitechnologies.com
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.
On June 2, 2004, Panacos Pharmaceuticals entered into a definitive merger agreement with V.I. Technologies, Inc. (Nasdaq: VITX), a biotechnology company dedicated to developing novel anti-infective technologies. The terms of the merger were amended on November 5, 2004, November 29, 2004 and December 8, 2004. The transaction is expected to close in the first quarter of 2005 and is subject to the approval by shareholders of both companies and other customary closing conditions.
More information on Panacos is available at www.Panacos.com.
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