Baclofen Setback Forces Sun R&D Arm Towards Difficult Choices
Sun Pharma Advanced Research Company’s baclofen GRS has failed to meet its primary endpoint in a US Phase III study, posing several tough questions for the firm. It may have to advance partnering plans for some assets and also review its cash flow situation closely.
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Sun's Halol manufacturing facility is over the compliance hump, receiving an EIR [Establishment Inspection Report] from the US FDA. The site, seen as core to India's top ranked firm's promising filings, including injectables, is also expected to lift the prospects of Sun's spin-off R&D arm, SPARC.
Sun Pharma’s research arm SPARC says it’s still convinced its Indian parent’s troubled Halol plant offers the shortest route to US regulatory approval for its epilepsy drug Elepsia and its glaucoma medicine Xelpros. US FDA clearances of both drugs have been stalled by manufacturing lapses at Sun Pharma’s factory. But SPARC says it has a manufacturing 'plan B' if necessary.
Shares of Sun Pharmaceutical Industries Ltd and Sun Pharma Advanced Research Company Ltd (SPARC) were pounded in early trade Dec. 21 on Indian bourses after the weekend announcement of an FDA warning letter for Sun's Halol site, though analysts appeared cautiously optimistic about the firm's bounce-back prospects despite the short-term pain.