Celgene pulls EU Revlimid application as CHMP seeks follow-up cancer data
This article was originally published in Scrip
Celgene has withdrawn its European application to have its blood cancer drug Revlimid (lenalidomide) approved for maintenance use in newly diagnosed patients with multiple myeloma – an expanded use - after EU regulators made it clear that additional follow-up was needed from three ongoing studies in the submission with respect to the treatment's links to second primary malignancies. They claim they need this mature data to make a clear benefit-risk decision.
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Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.
ChemoCentryx has successfully completed its initial public offering on Nasdaq, raising $45 million to help support its multiple R&D programmes. It sold 4.5 million shares at $10, a somewhat less ambitious debut than it had originally planned in January when it wanted to sell four million shares at $14-$16. The reduced offer is a sign of the challenging nature of the IPO market, but ChemoCentryx's assessment of its own worth was at least closer to the market’s assessment that Cempra which got its IPO away on 6 February at valuation that was less than two-thirds of that implied by its initial prospectus (scripintelligence.com, 7 February 2012).
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