BIOM AGM Transcript, Part 2 of 2:
Now, why Merck? Why Merck KgaA? We, certainly as many of you very patient investors in Biomira have been aware that we have been talking to a variety of big pharma, big biotech and bio-pharma, for really quite some period of time and we have been able to narrow it down over the course of the last year to the point that we came to the conclusion that this company and its affiliate, EMD, have the right culture for Biomira and they have set themselves a very aggressive path to become leaders in the area of biological cancer therapy aiming to introduce to patients one new therapeutic option to treat cancer every year starting in 2002.
Merck KGaA is represented today by almost 200 operating companies in 52 countries employing 33,500 people. It has worldwide revenues, in 2000, of EUR 6.7 billion. This is not a small player; it's a critically important player for us because it has every expectation of moving the products that we're talking about jointly forward in a timely way. This is important to their portfolio and it's important to our portfolio. It's critical that these products not be allowed to sit on the backbench or on the shelf somewhere while some other individual's products are moving forward. And we have mechanisms for ensuring that a timely approach to moving these products forward is in place.
Now, what is our vision? What are we, as a biotech company based in Edmonton, Alberta, Canada? Well, we want to move forward from where we are now, which is a world class research and development organization, with a substantial experience in clinical and regulatory development in a wide variety of jurisdictions. We want to move towards forward integration so that our company through this particular partnership or collaboration, as well as internal and external identification of potential portfolio products can in fact become a fully integrated bio-pharmaceutical company.
Our Theratope vaccine has in fact completed enrollment, under FDA fast track designation, in 120 trial sites in 11 countries with over, with 1030 patients enrolled as of the end of March. The largest immunotherapeutic cancer trial, in breast cancer ever held, period. As I'm wont to say, to the people at Biomira, this trial is so elegantly designed and has been so rigorously and thoroughly reviewed that if this product works, this trial will allow it to be seen to work. That's critical. You can have a good product, which put in a poorly designed trial, will not achieve the statistical significance that's necessary to allow you to get an approval or on the other hand you might have a poor product, which no matter how many patients you subject to this product you won't get an approval. Now, on the basis of our phase II data and our work with a variety of focus groups including the NCI US and the FDA in the United States, we feel comfortable that this particular trial, which fulfills all the really important requirements of a phase III trial, it's blinded, it's randomized, it's treating patients with minimal tumor burden because they have been treated previously with combination chemotherapy and seen some evidence of a good response, either stable disease or partial or a complete response. They are then stratified into receiving the Theratope product or they receive non-specific immunotherapy. It's impossible for the patient and it's impossible for the physician to know which the patient is receiving. It's also a community based trial, this isn't an institutional trial, we're not going to have the problem that this trial was run at the NCI US or at Memorial Sloan-Kettering or at MD Anderson only and then transferred to Red Deer, Alberta and nobody in Red Deer, Alberta can get the same results. This trial has been studied in 120 centers in 11 countries, this is critically important from the perspective of the FDA.
It has two study endpoints, the first study endpoint is time to disease progression, patients have shown evidence of response to chemotherapy, they are put onto either Theratope or non-specific immunotherapy and are followed for evidence of progression. That's a critically important endpoint in relation to the first interim analysis. The second critical and even more important primary endpoint is do the patients live longer? What is the survival? And that's becoming critical at the level of the FDA. Now our Data Safety Monitoring Board, which is an external group of four experts, review our data generally to see whether or not the product appears safe and whether or not events, which is code for progression or death, whether the number of events are occurring at approximately the rate that we presumed they would when we developed the protocol. If they're not, then we need more patients or we need more time because we won't achieve, we won't have the possibility of achieving, what we have presented as assumptions in our protocol. And, of course, if the safety data indicates that the treatment group is being disadvantaged and it's clear, then the Data Safety Monitoring Board has to recommend that the trial be halted. Now, we've had a 300, 600 and 800 patient review, all three of which have come forward with the same comment, this product appears safe, the number of events occurring is according to what you've suggested, continue the trial as proposed. With respect to potential timelines, the trial has completed enrollment as of the third quarter of 2001. The final survival analysis, which has to be done, is a survival analysis comparing the two groups and that should begin in the third quarter of 2003. And if that is successful, then product launch should occur sometime in the third or fourth quarter of 2004. In order to take advantage of potentially exciting, even more exciting, results than we might have anticipated that would occur in the final analysis we have a second interim analysis, which looks at survival and looks at the third quarter of 2002, with a potential market launch of something in the third quarter of 2003. And a first interim analysis, which will look primarily at time to progression, because it's a relatively early trial now, all patients will have only been followed for six months, at this point in time, the trial having closed the end of March, we're looking at the data as of the third quarter of 2001, we'll also look for survival trends. If we demonstrate statistically significant, approvable survival benefit the FDA will provide us with an approval.
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