US generic product launches boost revenue at Alembic Pharmaceuticals in Q2
Consolidated net profit up nearly 40% year-on-year to US$10.57m
Alembic Pharmaceuticals, based in Gujarat, India, has seen its US revenues grow at a compounded annual growth rate (CAGR) of 37% from 2008 to 2013.
The increase was mainly driven by consistent product launches in the highly competitive generic space. The drug firm markets 19 products in the US.
Although the company's US revenues are at only US$50m as of FY 2014, its research and development capability has been far better than its peers. It was the first company to launch Desvenlafaxine (Pfizer’s Pristiq for treating major depressive disorder, which has a market size of $550m) through the NDA route in March 2013, way ahead of its patent expiry in July 2022.
The company has since been working on a few more 505(b)(2) products, of which Warfarin is one.
Alembic entered into a development and licensing agreement with Florida based Accu-Break Pharmaceuticals in 2012 to develop products that would use ABP’s innovative Accu-Break tablet technologies.
ABP’s patented Accu-Break tablets can be split easily by hand into exact smaller doses to provide maximum flexibility, and to make it easier and safer for patients and caregivers to adjust their dosage.
The first product for which ABP will seek US Food and Drug Administration marketing approval is an Accu-Break-formatted version of the anticoagulant Warfarin.
The US company said it is looking forward to filing the first of many New Drug Applications for products using its patented Accu-Break technologies, in combination with Alembic’s broad base of active pharmaceutical ingredients and formulations.
Although Warfarin tablets have been available as generics since 1997, with Barr the first company to introduce generic Coumadin, the market size has remained steady at $150m.
Alembic Pharmaceuticals has developed from an anti-infectives player in 2007 to a focused speciality company in 2014.
The company reported healthy growth in the April to June quarter of 2014 with consolidated net profit growing 38.8% year-on-year to $10.57m as a result of strong growth in its international generic business and operating performance.
Its speciality and acute segments grew by 25% and 4%, respectively, while operating profit (EBITDA) jumped 33.75%.
Alembic filed three abbreviated new drug application (ANDA) applications in Q2, taking its cumulative ANDA filings to 64.
The company is expected to launch three generics versions of Toprol, Sular and Elmiron during 2015-2016. Its DMFs (drug master filings) also indicate further interesting opportunities, such as generic Tracleer and Multaq, which could translate into high margin opportunities over the next 2–3 years. The company's recent DMF filing of Asenapine (brand: Saphris, sublingual tablet) also highlights an increasing focus on complex drug deliveries.
