MESSAGE FROM AVANT'S CEO
To Our Investors:
As 2003 comes to an end, I wanted to reflect on the key events of the last several months and what they mean for our company. AVANT has clearly advanced to the next level in its efforts to build a successful immunology based company with innovative, high value vaccines and human therapeutics addressed to large market opportunities and unmet medical needs.
Rotarix®
In particular, GlaxoSmithKline (GSK) has confirmed that Phase III trials of Rotarix®, our two-dose oral rotavirus vaccine, are well underway - officially giving AVANT its first Phase III product. GSK made Rotarix® a key feature of its R&D Day Meeting in London on December 3, where they released more details of the trial and their commercialization plans. The R&D Day presentation can be viewed on the investor section of GSK's website at www.gsk.com. This study, conducted in Latin America and South East Asia, will enroll up to 60,000 infants in the largest clinical trial ever conducted. Results from this trial - as well as from more than 30,000 previously vaccinated children - will support initial regulatory filings in the European Union and other international markets. GSK's product development pipeline reflects an estimated filing date for Rotarix® of 2004. Rotavirus infection is a deadly problem in much of the world, where it kills a child every minute and results in 2 million hospitalizations globally. GSK estimates the market for Rotarix® at more than $800 million in the EU and other non-U.S. countries, with a similarly sized market in the United States.
Manufacturing
With respect to AVANT's bacterial vaccines, we also took an important step towards changing the landscape for vaccine development by making vaccines that are fast acting, single-dose, oral and stable without refrigeration. In August, we announced plans to build a process development and pilot manufacturing plant in Fall River, Massachusetts, with assistance from MassDevelopment. Construction of that plant is now slated to begin in early 2004. Having our own manufacturing facility is important, as it lets us implement the VitriLife® technology that will enable AVANT's vaccines to be distributed and stored without the need for cold-chain refrigeration. Moreover, it will enable us to leverage that technology through partnerships and contract manufacturing arrangements that let us apply VitriLife® to other companies' products. Finally, having our own manufacturing capabilities should facilitate AVANT's ability to win additional biodefense contracts for the supply of its vaccines for clinical trials and potentially beyond.
TP10
Finally, in November, the clinical investigators for the Phase II study of TP10, AVANT's novel complement inhibitor, presented the detailed results of that trial to the American Heart Association. Data from the trial showed that TP10 effectively inhibited harmful complement-mediated inflammation in men undergoing cardiac surgery involving cardiopulmonary by-pass (open heart surgery), leading to a significant reduction in post-surgical deaths and heart attacks. As we did not see the same benefit in the relatively small number of women participating in the trial, AVANT is now about to begin a double-blind, placebo-controlled Phase II study in 200 - 300 women. The aim of that study will be to augment the safety data and further clarify TP10's effect in women, before advancing to a Phase III clinical study aimed at achieving product registration.
Clearly, this has been an important year for AVANT, and we look forward to moving ahead in 2004 at this new stage in our development. I will promptly communicate our progress to you as the New Year progresses.
Sincerely yours,
Una S. Ryan, Ph.D. |
