Mylan Inc. is one of the world’s leading global generics and specialty pharmaceutical companies. Through its subsidiary Mylan India at Hyderabad, it has direct access to active pharmaceutical ingredients (APIs) and generic antiretroviral (ARV) therapies for HIV/AIDS. “India serves as a vital global hub for Mylan across manufacturing, R&D, regulatory and operations. The country will play a critical role to achieve our strategic objectives. We anticipate that we will continue to expand our operations here, as evidenced by the transactions and partnerships we have announced over the last several months. On the commercial side, we would like to be among the top 10 players in the Indian pharma sector”, said Rajiv Malik, president, Mylan Inc. Following are the excerpts of the interaction with Nandita Vijay.

Worldwide, there is a feeling that with patent expiries of many blockbusters and lack of new molecules over the next few years, generics biz will take a big leap forward. What’s your view on the outlook of generics biz?
Global macroeconomic trends will support continued growth of the generics industry. The world’s population is growing and aging. By 2015, those in the 60+ category are growing 3.5 times rapidly of the total population. The higher life expectancy is seen with greater incidence of chronic disease. It is seen 75% over the age of 50 have a chronic disease and 50% have two or more. But with a  growing global middle class, particularly in India and China, more people would have access to healthcare. Rise in global healthcare spending is unsustainable with expenditures expected to increase to $10 trillion in 2020. This is forcing governments to consider smarter healthcare policies, including those that drive increased generic utilization. All of this represents an opportunity for the generics industry. However, not all generics companies are the same and these macro trends and the impact of industry dynamics such as patent cliff will impact different companies differently. We believe Mylan is very well positioned for continued growth given our vertically and horizontally integrated, global, diversified platform and the broad set of opportunities we have identified and are prepared to execute.

How do you view the drug regulations in India as an MNC?
The Indian pharma industry has focused on manufacturing and has been regulated by policies which aim to offer medicines at affordable prices. Increased expenditure on healthcare by both Central and State governments as recommended by the 12th five year Plan, and pricing and reimbursement policies are the keys to drive growth. Strengthening regulatory systems that emphasize affordable quality drugs are also fundamental for the growth in exports as well as in the domestic market.

You are now appointed director on the board of Mylan Inc, what is your action plan on branded and generics biz?
Mylan’s task is to set new standards in healthcare and provide the world’s 7 billion people with access to high quality medicine. The company’s leadership team has outlined a strategic path through 2018 and beyond. In May of 2012, we communicated to our investors on our goal to double the company size in terms of manufacturing capacity and product portfolio by 2018 and target adjusted diluted earnings per share of $6.00. We laid out several strategic growth drivers, including geographic and portfolio expansion, continued expansion of ARV (anti retroviral) business, build specialty business, particularly EpiPen Auto-Injector franchise, enter bio-generics and expand institutional business – which includes injectables, among others. We expect this strategic growth to be supported by the powerful existing global platform that we have assembled and which we continue to invest in through R&D and capital expenditures.

What according to you are the key success factors of Mylan?
Mylan’s assignment is to provide the world’s 7 billion people with high quality medicines and our 20,000 workforce are focused in doing what is right, not just what is easy. Today, we are one of the world’s leading generics and specialty pharmaceutical companies with a global manufacturing presence with a capacity of over 45 billion doses, world-class R&D capabilities, and a portfolio over 1,100 products marketed in 140 countries.

Could you provide a snap shot on Mylan’s global strategy for next 5 years?
We have anticipated 13% compound annual growth from our ARV business between 2011 and 2016. Institutional business could become a $1billion franchise, which is now accelerated by the pending Agila acquisition. We see significant opportunities in Europe and Japan where generic utilization rates are still low and this would translate into opportunity for Mylan as governments are keen on generics. This is where some of the generic versions of difficult-to-manufacture products like Advair for respiratory disease, targeted for launch in 2015/2016 and Copaxone for Multiple Sclerosis, are seen to be as meaningful opportunities for Mylan. Bio-generics represents another important bolus of future growth for our industry and Mylan is well-positioned to succeed in this space through its partnership with Biocon.

In fact, over the last few months, Mylan has done some investments in India like partnerships with Biocon, Strides acquisition etc, what is the status of the collaborations with other Indian cos?
Each of these partnerships and investments bring together complementary capabilities to enable us further achieve our strategic objectives. The addition of Agila to Mylan’s existing injectibles platform will help accelerate faster growth.  The recent Biocon collaboration gives us a portfolio of high value insulin analog products. We are also pleased with the progress of the collaboration with Natco for Copaxone product and with Famy Care for oral contraceptives.  

Strides acquisition is a big story, now how would this integrate into Mylan’s overall biz of injectables?
By combining Agila’s strong injectables capabilities with Mylan’s powerful global engine, we will catapult our injectables business to a new level. It would help us become a top three global player in injectables space. Together we would have over 700 injectables and a global pipeline of more than 350 injectables in development. Further, the acquisition would help to leverage future generic biologics portfolio. Importantly, Agila will bring in state-of-the-art injectables manufacturing platforms and allow entry into key growth markets, such as Brazil. The transaction would help achieve Mylan’s $1 billion revenue target from institutional business.

We do not hear Mylan that frequently in branded formulations biz. Are you present in India and which products are marketing in India?
We entered the Indian commercial market with the launch of our first division last year with a comprehensive portfolio of ARVs for  HIV/AIDS. In the coming years, we intend to launch products for women’s healthcare other therapeutic categories.

Could you highlight on Mylan India’s manufacturing facilities and the team strength?
Today, India team strength is over 10,000 people. The pending acquisition of Agila will bring in another 1,700 employees. The India operations includes 8 API manufacturing units, 2 finished dose manufacturing units, an R&D facility and a clinical research center. We are headquartered at Hyderabad with commercial operations in Mumbai. Mylan recently agreed to purchase an oncology manufacturing facility from SMS and a solid orals manufacturing facility from Unichem. Further, the pending acquisition of Agila will bring us an additional 6 manufacturing facilities in India.