The CEO's Blog — Garo H. Armen
 SUBMIT A COMMENT
Antigenics files for Oncophage® approval in Russia
Why did Antigenics decide to first file Oncophage for registration in Russia?
I have carefully considered this question over the last 12 months. When we first discussed this idea with several individuals, whose opinions I trust implicitly, their first reaction was also “Why Russia?” They made me feel somewhat unpatriotic! The issue was how could a product that has been developed by a US company at a cost of nearly $500 million be first introduced in Russia?
The simple answer is that Russia currently offers a more promising commercial pathway for patients to have access to Oncophage than the US. Clearly we are driven by our conviction that our vaccine, Oncophage, provides significant and meaningful improvement in an important subset of kidney cancer patients. This subset is believed to be the logical target for cancer vaccines – a conclusion shared by key experts around the world. In spite of this, however – and this is a big “however” – subset analysis does not conform to the strict statistical standards as currently applied to the drug approval process in the US, irrespective of how logical the subset and how significant the benefit to the patients may be.
Therefore it is unlikely that the US regulatory system will deviate from this convention that has been created by the system. When I asked one of the most notable statisticians from the US once what defined the statistical guidelines used for drug approvals, he replied that “they were arbitrarily set and they seemed to work, so we made them the rule.” These rules were originally created a long time ago and not by physicians who treat patients. We need to be clear, however, that neither the FDA nor any individual expert or person in particular is to be faulted for this, and I have faith that continued education regarding the unique attributes of cancer vaccines can ultimately effect the needed evolution in FDA regulatory guidance to accommodate this novel and important approach to cancer treatment in the future.
So, if such is the case, what do we do now to bring this product to patients as quickly as possible? This is a novel product, which we and the substantial number of world-class experts believe has a much higher probability of helping patients than not, and is also essentially free of any of the side effects of typical cancer drugs. I feel, given the clinical data we have seen and the advice we have received from key experts, that the only ethical choice is to aggressively pursue the commercialization of Oncophage.
Another question that has been raised is why not do another trial in this specific patient group? The answer is that such a trial would take an additional six to eight years to conduct, be at an egregious cost and, according to a number of experts, would be impossible to execute due to the evolving treatment landscape. What’s more, such a trial would translate into a 12- to 14-year Phase 3 development program – unfeasible for most biotech and pharmaceutical companies. Given all this, we need to responsibly explore means of bringing Oncophage to patients based on data from the current trial elsewhere in the world where a viable business model can be practiced.
I just returned from a trip to Europe and Russia, my third trip to Russia since November 2006. While there are no guarantees in life, I was encouraged by the realistic possibility of getting Oncophage registered in Russia in a timely manner and also of getting Oncophage reimbursed by the rapidly expanding health care system there. I was encouraged that there may also be a way of getting conditional approval in Europe – although not a slam dunk – but a real possibility based on a well designed trial that would be run concurrently while Oncophage is made available commercially.
While we all know how to interpret the significance of a European approval, the same is not universally known for Russia. But here are some facts:
- The Russian pharmaceutical market is forecasted to be one of the fastest growing in the world (recent report by PricewaterhouseCoopers).
- Russia has been reimbursing for novel cancer drugs at or above US reimbursement rates for the past two years.
- The oncology market for drugs in Russia has more than tripled from 2005 to 2006 and is likely to grow by another 60 percent to 80 percent this year.
Although medical care is not widely available to all living in Russia, there has been a dramatic improvement in the last two years, as evidenced by significant growth in the use of novel medicines. Russian doctors are well trained professionals who have not historically had access to the sophisticated tools available in the west. But now all that is changing.
Another question that pops up is: “Are you going to Russia because their standards are lower?” The answer is a resounding no. On the contrary, the Russian system has rigorous scientific and medical standards. We are going to Russia first because I believe the Russian regulatory system may be more amenable to approving this product on the basis of the available scientific and medical evidence supporting Oncophage. We are also going to Russia because 25 percent of the 604 enrolled eligible patients in our kidney cancer trial came from Russia, and patient selection and adherence to the protocol was excellent.
When we had our first investigator meeting in St. Petersburg after the analysis of our results, it was the unanimous opinion of these physicians that Oncophage provided significant improvement to a clearly defined subset of patients; that this effect of Oncophage was consistent with their experience; and that the subset was the logical subset in which they would expect to see a greater effect. These doctors also unanimously expressed that based on the data, they would want Oncophage to be made available to their patients.
That pretty much sums up our decision on what the first steps should be for the commercialization of our Oncophage – a vaccine that key experts agree has a high probability of helping prevent relapse in a clearly defined subgroup of earlier-stage of kidney cancer patients for whom there are no approved medicines available.
This communication contains forward-looking statements, including statements regarding the clinical benefit of Oncophage in kidney cancer based on a subgroup analysis; the potential regulatory approval of Oncophage in Russia and other jurisdictions; the potential for the US regulatory process to accommodate the approval of Oncophage based on a subset analysis; the potential growth and opportunities in the Russian oncology market; and future activities that may be necessary to obtain regulatory approval for Oncophage, including, for example, further clinical trials in the US. 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, actions and decisions by regulatory agencies, including the Russian Ministry of Public Health and the US FDA; that efforts in Russia may not impact our efforts in other territories; the uncertainty of the Russian economic, reimbursement and regulatory systems; the ability to raise capital and finance future activities for the development and registration of Oncophage; and the factors described under Factors That May Impact Future Results in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of Antigenics’ Form 10-Q as filed with the Securities and Exchange Commission on May 10, 2007. Antigenics cautions investors not to place considerable reliance on the forward-looking statements contained in this communication. 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.
Comments
There are no comments posted at this time
SUBMIT A COMMENT
| 
