Chairman and managing director of Glenmark Pharmaceuticals Glenn Saldanha outlines his US generic and emerging market strategy in an interview with Ujjval Jauhari and Ram Prasad Sahu. Edited excerpts:
What steps are you taking to ensure stable revenues after the patent cliff in 2015?
We have a multi-pronged strategy focused on drug discovery, branded generics and pure generics. Our strategy has never focused on the patent cliff.
Being a relatively late entrant (among Indian players) in the US (pure generics) market, we consciously stayed away from multi-billion dollar generics opportunities, which are marked by cut throat competition and eroding margins. We followed a strategy to capture niche and limited competition segments like dermatology, hormones (oral contraceptives) and oncology. Similarly, our strategy for Para IVs has been to focus on niche Para IVs where we will be the sole first-to-file player. The strategy has been successful and we have been able to build substantial scale for our US business in a relatively short span of time.
Glenmark is a leader among emerging market companies in the discovery of new molecules both NCEs (new chemical entities) and NBEs (new biological entities). The company has a pipeline of seven molecules – five NCEs and two NBEs in various stages of preclinical and clinical development. Moreover, most of these molecules are either best-in-class or first-in-class, with each molecule having potential peak sales opportunity of $1-3 billion.
In the branded generics space, apart from India, we have built a stronghold in emerging markets like Russia and Brazil. These markets are likely to witness healthy growth rates in the years to come and are independent of the patent cliff.
What is the pipeline for launches in the US? Could you highlight the same, given that you intend to double sales in three years in this geography?
Glenmark’s current portfolio consists of 80 products authorised for distribution in the US and 38 ANDAs pending approval with the US FDA. The portfolio consists of focused presence in niche and high entry barrier segments like dermatology, hormones, controlled substances and modified release categories. We expect to launch around 10 products in the US in FY13. We have already received approvals for five oral contraceptives (hormones), which we will be launching in the next three months or so; thus, making us the largest player in the US oral contraceptives market after Teva and Watson. Besides, we have also received an approval for Imiquimod, which is a $220-million product, which we will be launching in the next three months. In the derma space, we now have a portfolio of 19 products with around five to six additional products pending for approval with the US FDA. Besides these, we expect to launch another four to six products in other niche segments.
Among the first to file (FTF) opportunities, we launched Atovaquone & Proguanil HCl (Malarone) in September 2012 and Fluticasone lotion (Cutivate) in March 2012, which boosted our US sales in Q4-FY 12. In fact, we just had one week of sales of Cutivate in Q4-FY12, so it’s just the start. Malarone’s exclusivity is expected to run throughout the year, while in case of Cutivate, we will have six months exclusivity in the current financial year.
We are pretty confident of doubling our US business sales (from $250 million in FY12) in a three- to five-year horizon.
Is there a target for the growth of the emerging market generic business, given traction in countries such as Brazil? Which geography holds the most potential for you?
Brazil remains a key market for Glenmark. The Brazilian subsidiary has seen strong growth in FY12 (grown by around 30 per cent, while sales from the Latam region as a whole increased by 50 per cent). Besides, Russia is a key market for Glenmark (apart from the US and India). Glenmark is the fastest growing Indian company in Russia and among the top 20 pharma companies in the dermatology segment of the country.