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Russian anticancer drug granted special status in US

Interview with Dmitry Genkin, the Chairman of the Board at the Russian Pharmaceutical Company Pharmsynthes.

Dmitry, Pharmsynthes has announced that its anticancer drug Virexxa has been granted the orphan drug status by the FDA. What is the importance of this development for your company?

This is very important both from regulatory, and strategic, and financial view for the company.  The orphan drug status designated drug has less strict regulatory requirements. You are entitled to reimburse your clinical expenses, for certain amount. It also gives us sort of inclusivity in the United States. If the drug is included in the orphan drug list, usually the state pays for the patients, which guarantees the market. So both from the economical and regulatory, and marketing view it is very important for us.

Virexxa is also the first Russian pharmaceutical that has been granted orphan drug status. Can this be considered a breakthrough that will change the way the Russian pharmaceuticals and their manufacturers will be viewed in the United States and worldwide?

 There are quite a lot of interesting developments here. An orphan drug regulatory is a very promising tool for them, not only for Russian companies. I think in future there will be more Russian drugs in the US market.

Dmitry, were there a lot of attempts prior to this successful one to receive orphan drug status or just generally to receive the FDA approval?

First of all you need to develop the drug, to prove that the drug is useful for this specific kind of patients, and provide clear evidence that the new drug can be useful, if it complies with the orphan drug regulations, then you need to submit an application, pass an application process, and if a special committee decides that it complies and that the drug can be beneficial for patients, it will be given this status.

Are there many Russian pharmaceuticals that have been granted the FDA approval, not just the orphan drug status, but maybe those that just were approved for general use and sale in the US?

No one.

So you are the only one? That really makes it quite a breakthrough!

Hopefully it will be the case. I think it will be the first Russian drug on the US market.

We have heard a lot of talk about modernization recently, have you seen this tendency spreading to your business? Can it help that the Russian pharmaceuticals may soon be able to compete on the worldwide market?

I think there are huge efforts from the State to modernize and to build up a new pharmaceutical industry here. I think if this trend survives over next few years, Russia will increase the presence in the sector of new drugs development.

How would you assess the potential of the Russian pharmaceutical industry? Are there Russian companies that could potentially become key players on the world market?

Not a key player, but a significant player.

So is your company currently working on any new products that can potentially join Virexxa in receiving a special status by the FDA or in any case being approved?

Yes, we have two other developments, two drugs in our portfolio. The first one is for treating multiple sclerosis, there are not so many effective drugs to fight multiple sclerosis on the market; the other one for specific sclerosis.

What can be said about the time before Pharmasynthes’ breakthrough to the world market? What has been accomplished to enable your company to finally make this breakthrough?

 Technologies, expertise and infrastructure. We are the first now, we started to do it in the early 1990s, so we have a history of 16-17 years building this expertise, that’s why we are first now. I think in next 3 or 5 years there will be no companies going in that direction, they just need time to collect expertise.

So you feel that the presence of qualified specialists and researchers in Russia is sufficient. What exactly needs to be done to raise the level of the industry as a whole so that Russia becomes compatible on the world market? Is there perhaps a need for additional government funding or something else?

There is need to increase the performance of R&D, research, just need time and money for this.

Thank you so much for your commentary! We wish your company luck in advancing your products, and we hope this will positively affect the Russian pharma industry as a whole!


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