Mylan Chairman Robert Coury On Lipitor's Future and India/Japan Expansion: An Interview With PharmAsia News

Mylan Inc. CEO Robert J. Coury demonstrated his ability to be a trendsetter when Mylan acquired Matrix Laboratories in 2007 at the highest value - at the time - for an India pharmaceutical company. Though doubted for that move and the next - of buying Merck KGaA's generics business for $6.8 billion, Coury now boasts of establishing a global generics footprint with a one-of-a-kind vertically integrated platform to build maximum operational efficiencies.

Coury announced a plan last week for a commercial entry into the Indian market. "A Big bang or a phased launch" will be clear in a few months, but Coury says Mylan does not do anything small, which suggests the potential of some dramatic moves in the company's nascent emerging markets strategy. Coury spoke to PharmAsia News' India Bureau and opened up on a range of issues starting from the controversial ANDA filings of Ranbaxy's Lipitor to the future of the global generics landscape.

PharmAsia News: You recently took U.S. FDA to court over the status of Ranbaxy's atorvastatin ANDA, but eventually that petition was dismissed. Was it primarily a legal play, or were you also looking to highlight the issue of the cost of healthcare and the importance of approving a Lipitor generic in a timely manner [ (Also see "Lipitor Generics: Ranbaxy Still In The Driver's Seat As Court Dismisses Mylan Lawsuit Against U.S. FDA" - Scrip, 4 May, 2011.) ]?

Robert Coury: You have the legislatures that legislate. When that is done, statutory language is written and when laws are put in place, we have the regulators that are put into place to administrate the statutory language that's been written. And when the administration or the system breaks down, the only thing that we are left with in the United States is the judicial process and that's exactly what we have done.

All we did was to work the system as it is set up to work. When you feel there is an imbalance, you try to get relief and bring a balance and we think that, in this particular case, there is a major imbalance.

PharmAsia News: You had hinted recently that you may be looking to appeal the decision by the U.S. District Court. Is that decision coming soon?

Coury: We have addressed the courts with everything that they had asked for. I don't want to make predictions about the courts and what we will do next. I think we are just going to let this play out.

PharmAsia News: Speculations about a faster FDA review for atorvastation were triggered again after the import alerts for Apotex's Canadian sites were lifted. How do you see this development?

[Apotex announced FDA had lifted an import alert on two Canadian facilities, which could be a positive step for later-field atorvastatin ANDAs if the agency is trying to line up alternatives to first-filer Ranbaxy. FDA and Ranbaxy have yet to resolve an import alert surrounding falsified data at Ranbaxy's Paonta Sahib facility, which could prevent or delay approval of Ranbaxy's atorvastatin (Also see "FDA Import Alert Lifted, Apotex Says; Will Lipitor ANDA Approvals Be Far Behind?" - Pink Sheet, 16 May, 2011.).]

Coury: Our biggest interest is in knowing if there is a wrong or if there is fraud, how do you right a wrong or how do you right a fraud? We are looking for an answer. We think that answer really resides between FDA and Ranbaxy and all we want to know is their answer.

PharmAsia News: How do you see the Biocon deal for high-end MAb biosimilars playing out? [Mylan signed a biologics deal with Biocon in 2009 that gives Mylan exclusive commercialization rights in the U.S., Japan, Canada, Australia and New Zealand, while the two companies share profits in Europe (Also see "Biologics Beckon: Biocon, Mylan Strike Deal; Combine To Take Teva, Sandoz Head-on" - Scrip, 29 Jun, 2009.)].

Are there no conflicts of interest with Biocon's deal with Pfizer Inc. for supplies of insulin? [ (Also see "With Biocon Deal, Pfizer Expects To Gain First Mover Advantage In Global Biosimilar Insulin Market" - Scrip, 18 Oct, 2010.).]

Coury: We saw Biocon's potential of doing collaborations. We were extraordinarily sensitive on exactly how we wanted to do our collaboration. We actually structured a very powerful and unique collaboration by actually carving out very specific assets for our project, even all the way down to select employees who are working on our project.

So, I certainly do not have a concern about any conflict because - starting with the relationship that I have with [Biocon Managing Director Kiran Mazumdar-Shaw] - all the way down to the operators, I think there is an unbelievable relationship and I would say that we have very strong discipline not to allow any problems to occur.

PharmAsia News: Biocon has spoken very clearly about preparing biosimilars products first for the developed, highly regulated markets before targeting the emerging markets, unlike others who are launching biosimilars products first in developing nations. Will you first go to the developed markets and then take a look at the emerging markets?

Coury: We have a plan which will consider all the opportunities. So if we have an opportunity in the emerging markets and if we are ahead of the developed markets in terms of the patent or the science issues, then yes, we will also be looking at using the same standards based on the regulatory needs of the emerging markets.

PharmAsia News: Close rival Dr. Reddy's Laboratories launched its fourth biosimilar recently. When do you think you can start marketing your products?

Coury: We are looking at the 2014-15 range for an apt time for launch in U.S. and Europe, but for the emerging markets, if things move well, it may be even faster than that.

PharmAsia News: Teva is consolidating fast in the Japanese market - the latest being its Taiyo acquisition. How do you see things moving there for Mylan? Will you also look at potential acquisitions [ (Also see "Teva Buys Japanese Generics Company For $460 Mil." - Scrip, 16 May, 2011.) ]?

Coury: We see it's evolving, and as you know nothing happens fast in Japan. We have a position there and I have said before that external activity is a potential option there. I feel the Japanese companies are very similar to the Indian companies promoted by families. They don't let go so easily, so we have to find the right match and we have to see the right strategic fit. We will do things at the right time.

PharmAsia News: On scaling higher numbers in Japan, will you be looking at potential Indian suppliers for such a large market or do you think Matrix is sufficient in capacity?

Coury: There is nothing excluded. When we sense an opportunity, we step back and see what we have across the globe, what makes sense and if we believe that an external option can bring us faster benefits, we act. So there are no options excluded.

PharmAsia News: Consultants are talking about a $20 billion Indian market by the end of the decade, but there is a huge scramble for market share at the bottom end. Do you believe you can make an impact alone by organic growth plans or collaborations or do you feel a buyout will be necessary?

Coury: When you have global scale, which is what we have, it is not as difficult for a company. So it is a natural question to ask but it is really for us to ramp up or turn the knob as fast as we would want to turn. So to do a launch in a measured way is what we would always want to do.

PharmAsia News: So is it correct to read that you will have a stronger preference to push your own products as opposed to an outright bid [ (Also see "Mylan Weighs "Big Bang Or Phased" Products Rollout In India; Significant Workforce Additions Planned" - Scrip, 27 May, 2011.) ]?

Coury: I don't think I should limit myself, and you should not think that either because I would absolutely look for opportunities. When we do it ourselves, there is more of a natural build up, but we will not hesitate to strike if that can accelerate the process with the right opportunity.

PharmAsia News: So you would not mind taking a call on an auction that has a multiple of ten-times sales? Is the market not overheated in India?

Coury: I don't really want to get into multiples and rather stick to the fundamentals. I don't want to approach the market from the outside in. I would approach from the inside out. We have spent a lot of time studying what is needed in the market landscape here. I have to tell you that we are very excited the way we are going to play here.

PharmAsia News: Any numbers that you would want to share in terms of reaching a target?

Coury: There is nothing that we do that we do not do in a big way. And I fully intend and clearly I want to be a major player down here.

PharmAsia News: And China comes next in your plans?

Coury: I think China still has some distance in my eyes, and right now I want to focus on India. I think there is a lot of preparation that is needed in China as we are still in the beginning phases of trying to understand that market as we watch it evolve.

PharmAsia News: Which other emerging markets would you identify for the next push?

Coury: I really like Brazil. I think that is a country ripe with opportunities.

PharmAsia News: Finally, how do you look at the global generics business, will it get stronger?

Coury: At last count, out of the nearly seven billion people on the planet we had four billion who had access to medicines. The rest is our opportunity. I don't have more than that to tell you. We are very institutional; we are a very industrial player from the long-term view. We have truly built a one-of-a-kind high quality and sustainable platform to compete in any type of market, whether it is hyper-competitive or otherwise. We will go with our mission to serve patients with high-quality, low-cost pharmaceuticals.

- Vikas Dandekar ([email protected])