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Drug firm Alembic Pharmaceuticals, which is over 100-year-old, started focusing on the US market a bit late. In the past three years, the company has not only increased its research and development (R&D) efforts for the US market but has acquired Orit, an oral solids and liquids manufacturing firm. Alembic has a 200-product grid for the US market, up from 40 in three years and expects to launch 10-12 products for the US market every year.
Having popular brands like Glycodin (cough syrup) in its kitty, Vadodara-headquartered Alembic had a domestic focus until a few years ago. Its first abbreviated new drug application (ANDA) for the US market was filed in 2008-09; at a time when most of its peers were at least a decade into the North American market.
Alembic’s international business accounted for a 15.3 per cent share of its revenues in 2010-11. By 2015-16, this had risen sharply to around 50 per cent of the firm's overall business. Of the Rs 31.35 billion revenues in 2016-17, 59 per cent came from exports while 41 per cent was from domestic sales.
The company allocated a significant share of revenues to R&D to create a product pipeline for the US. Alembic’s research spend increased from Rs 1.48 billion in 2014-15 to Rs 3.5 billion in 2015-16, and Rs 4.7 billion in 2016-17. The R&D spend in the current year is expected to be around Rs 5 billion.
Analysts said Alembic made a ‘smart move’. It pumped funds generated from its two blockbuster drugs in the US (generic Cymbalta and generic Abilify) into capital expenditure and R&D. The company is implementing a Rs 10 billion capex plan. It has spent around Rs 3 billion in 2016-17 and will end 2017-18 with a Rs 5.5 billion capex.
Alembic’s capacity expansion projects include a Rs 4-billion injectables plant, Rs 2.5-billion oncology injectables and oral solids plant, along with a new Rs 2 billion oral solids plant at Jarod, and a Rs 1.7-billion dermatology plant. The oncology oral solids plant came on stream in July 2017.
The US Food and Drug Administration (FDA) approvals for the oncology oral solids are expected to arrive in 2019 while for the injectables they will take another nine months.
After growing organically for the most part of its history, Alembic acquired US-based generic drug-maker Orit Laboratories LLC in November last year. Orit has seven approved and four pending ANDAs, along with a manufacturing facility.
R K Baheti, director, finance, said Alembic had already launched one product from the Orit stable. "The process of transferring rights of certain products from Orit's partners to Alembic is on and we expect to launch four to five products in 2018-19," he said.
On top of this, Alembic aims to launch 10-12 products in the US market next financial year and continue the momentum for the next few years. The US market contributed around 28 per cent of Alembic’s sales in 2016-17.
Pranav Amin, joint managing director, said the company expected 50 per cent of its revenues to come from the US market by 2019-20.
As of January 2018, the firm has cumulatively filed 119 ANDAs for the US, received 70 approvals and 49 are pending. The filing rate has picked up in the last two years. It filed 20 ANDAs in 2016-17 and aims to end 2017-18 with 25 ANDA filings.
Meanwhile, the Aleor joint venture (JV) facility is ready and it has filed an ANDA in the third quarter of 2017-18. In 2016, Alembic had formed a 60:40 JV (Aleor Dermaceuticals) with Orbicular Pharmaceutical Technologies to develop, manufacture, and commercialise dermatology products for the global markets.
Amin said Alembic would continue to focus on the regulated markets for the time being. “India is a big market, and so is the US. We are focusing on the regulated markets and so far, we are comfortable with that strategy for the exports business. There is no immediate plan to focus on emerging markets,” he added.