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Vernalis cough and cold drug knocked-back by FDA

Published on 07/08/17 at 10:13am

Vernalis has been given a second CRL for a cough and cold treatment by the FDA this year. The therapy, known as CCP-08, has fallen foul of the issues that led to CCP-07 being rejected earlier this year, in April.

Both drugs had been licensed from Tris Pharma and means that both treatments will now miss this year’s winter, where it would have expected to experience significant sales. Vernalis had expected the two therapies to achieve peak sales of between $150 million to $500 million but it will now face an extended wait to see if it can ease their way through to market.

The company had achieved success bringing another cough and cold drug, Tuzistra, licensed through the same partnership, to the market, in 2015. In financials released last month, it revealed that this drug had grown sales three-fold leading up to 30 June.

Despite this, the company made an operational loss and announced its cash reserves had fallen to £61 million.

It is not an unusual position for a biotech to be in, relying on investors, such as Neil Woodford, to back the company before it achieves commercial success. However, the latest failure to have CCP-08 accepted by the FDA is a blow the UK biotech.

“Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08. The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris and the FDA to resubmit both NDAs as quickly as possible," said Ian Garland, CEO of Vernalis plc. "We look forward to providing additional updates on our progress with this in the coming months.”

The updates will presumably be the re-submission of NDAs for its two treatments, once it has worked through the reasons for receiving the CRLs from the FDA. The company has not revealed why it received the CRLs but pointed out that no concerns were raised about the formulation or pharmacokinetic profile of the therapies.

Ben Hargreaves

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