Centaur readies US plan to boost exports
30 July 2010, Anju Ghangurde, email@example.com
Centaur Pharmaceuticals of India expects exports to emerge as a significant contributor to revenues in the next few years, as it readies to tap the US market.
Centaur's managing director, S D Sawant, told Scrip that the company expected to submit its own drug master files (DMFs) in the US, although the process could take a year or so.
"We are now 'infrastructure-ready' to take a jump forward beyond the domestic market. Maybe the next step is to have our own dossiers based on our own active pharmaceutical ingredients (APIs)," Mr Sawant said ahead of announcing Centaur's in-licensing deal with aRigen of Japan for the latter's sorivudine cream, an antiviral for herpes zoster (shingles).
Centaur is a manufacturer and exporter of psychotropic APIs and has a US FDA-approved facility near Mumbai. It has also entered the contract manufacturing space and received UK MHRA and Australian TGA approvals for its formulations plant in Pune.
Exports currently account for about 20% of Centaur's business, with the domestic business accounting for 80%. However, the company expects around 50% of its sales to come from exports in the next three years. "DMFs would be started soon, but contract manufacturing and APIs would be major export revenue streams in the near future," a Centaur official said. The company reported sales of about $40 million in 2009-10.
Centaur has in-licensed from aRigen development and distribution rights to sorivudine in India and certain neighbouring nations, and hopes to introduce the product in India by 2013.
It will approach the Drugs Controller General of India for permission for Phase II and III trials and marketing rights in India. Scrip had earlier reported that 350-400 patients would take part in the Indian trials for sorivudine, which would be carried out in hospitals across four or five centres in the country (scripintelligence.com, 21 July 2010). The trials are expected to be conducted by Centaur's CRO, Lifesan Clinical Research.
Sorivudine is highly and selectively active against a number of herpes viruses, such as herpes simplex virus type 1 and varicella zoster virus, compared with existing anti-herpes agents.
The development of sorivudine cream had been put on hold in the US, after aRigen's partner, Janus Pharmaceuticals, decided to put more emphasis on a nail antifungal product which is seen as a potential competitor to Novartis's Lamisil (terbinafine). aRigen's president and CEO, Dr Gensuke Tokoro, said that it was only "financial reasons" that had led to the Phase II/III trials being put on hold in the US. "We have been looking for a partner who can leverage it for us," he said. aRigen holds a 10% stake in Janus.
© Informa UK, 2010
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