The CEO’s Blog — Garo H. Armen

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Oncophage receives its first regulatory approval

This morning we announced that Oncophage is registered in Russia for patients with intermediate-risk kidney cancer – representing an important therapeutic advancement for patients at risk for disease recurrence. The Russian medical system is advancing at an incredible rate, with a number of state-of-the-art facilities and skilled medical professionals already in place.

A number of key questions about how we anticipate commercializing Oncophage in Russia come to mind, but before addressing them, let me comment on what we have accomplished. Ever since we announced our Russian filing we have been reminded about the fact that there has been little or no precedent for such approval on a number of grounds: (1) first approval of a novel therapeutic in Russia which has not yet been approved elsewhere; (2) first approval of a personalized cancer vaccine anywhere in the world; and (3) acceptability of data from a subset analysis. While these are all valid points, what is fundamental is that there could be no innovation in any field if one only pursued that for which there is precedence.

Lately I have been traveling to Russia every month to make sure that we are optimally prepared for the launch of our product. With each visit, my respect for the rapid pace of progress and the quality of the level of professionalism in Russia grows. Clearly, we have much work to do before we can declare success in the Russian market. But with hard and intelligent work by our dedicated and growing team, I’m confident success is well within our reach.

I have explained the rationale of our convictions in some detail in my previous blog entries. In summary, our journey began after analyzing the results from the largest study conducted to date in the adjuvant setting in March 2006. We identified a substantial and clinically relevant subset of patients who demonstrated a significant extension in recurrence-free survival. Following an additional 17 months of data collection results continued to confirm our initial findings showing that Oncophage was demonstrating durable improvement in patients with earlier-stage disease. These results laid the foundation for Oncophage’s registration in Russia and potential submission to the European regulatory authorities by year-end. We also presented these findings in May 2007 at AUA and more recently at EAU in March 2008.

Now that Antigenics has obtained Russian approval, we can address questions posed from a range of constituencies, including what the next steps will be, how we will prepare the Russian marketplace, and what our anticipated revenues are. Our first step will be to obtain an export license from the FDA, and a decision by the agency is expected in approximately 60 days from the date of submission. During this intervening period, we are focusing our efforts on developing the commercial infrastructure for launch, including distribution and logistics for tumor procurement, vaccine delivery and storage – procedures in which Antigenics already has vast experience given that more than 800 patients worldwide have received Oncophage to date in clinical trials.

With these timelines in mind, we are working towards making Oncophage commercially available in Russia by mid 2008. The initial launch will focus on approximately 10 hospitals, classified as “centers of excellence” and located in Moscow and St. Petersburg. These hospitals attract both private patients as well as patients whose drugs are paid for by governmental reimbursement programs. The majority of our marketing efforts will concentrate on adding to these influential hospitals by targeting more centers across Russia throughout 2008 and beyond.

We are also embarking on an extensive outreach program to educate the prescribing community in Russia. We are developing a comprehensive range of materials and establishing a call center to service key decision makers from each of these targeted hospitals, which typically includes physicians, pathologists and pharmacists.

Given that this is a new market for us, we expect a modest ramp-up initially. However, we are excited with the prospect that Oncophage offers a treatment with the potential of preventing or delaying the cancer from returning. This is critical because even with the most novel drugs introduced in recent years, once the patient relapses with cancer, there is not much we can do to save their lives. We of course aspire to be able to register Oncophage in other countries and develop it for many other indications.

In closing, this registration denotes a key milestone in the developmental history of Oncophage allowing our product to become the first approved personalized cancer vaccine anywhere in the world. But more importantly, in allowing at-risk patients to be treated to prevent progression to metastatic disease, Oncophage is a true breakthrough in the treatment of kidney cancer.

This communication contains forward-looking statements, including statements regarding the advancement of the Russian medical system; the impact of Oncophage registration on patients with intermediate risk kidney cancer; the potential timing for an FDA decision with respect to an export license; our potential efforts and ability to make Oncophage available in other geographies and indications; the intention and timing for filing for conditional approval of Oncophage in Europe; and the success, scope and timing of the launch of Oncophage in Russia and related activities. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, decisions by regulatory agencies, physicians and patients; the possibility that results from future treatments with Oncophage will not be as favorable as the results from our subset analysis; our limited resources; and the factors described under the Risk Factors Section of our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the period ended December 31, 2007. Antigenics cautions investors that we do not expect to generate significant revenue from sales of Oncophage in Russia for several months, if ever. The amount of revenue we generate will depend on, among other things, securing reimbursement mechanisms and physician and patient assessment of the benefits and cost-effectiveness of Oncophage. Antigenics also cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this document, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics’ business and securities, investors should give careful consideration to these risks and uncertainties.

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