Vernalis acknowledged today that its New Drug Application (NDA) for CCP-08 has been rejected by the FDA—the second time in four months that the agency has turned down applications by the company for its cough cold treatment candidates.
The company said it has received a Complete Response Letter (CRL) asking it to address similar issues to those that precluded the agency from approving another Vernalis cough cold treatment candidate, CCP-07—without disclosing those issues.
“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,” Vernalis CEO Ian Garland said in a statement. “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 Pharma and the FDA to resubmit both NDAs as quickly as possible,” Garland added. “We look forward to providing additional updates on our progress with this in the coming months.”
Vernalis disclosed the FDA CRL on CCP-07 on April 21, but has since offered no update—except for saying last month that it had nothing new to say: “There is no further information to announce on the resubmission of CCP-07 to the FDA or the wider cough cold development pipeline, but the Company will provide an update as soon as we are able,” Vernalis said July 18 in a statement summarizing company operations for the financial year ended June 30.
Both CCP-07 and CCP-08 use extended-release technology licensed by Vernalis from Tris Pharma through a 2012 agreement whose value has not been disclosed—namely Tris’ OralXR+™-based extended-release liquid suspension, designed to be equivalent to existing immediate-release prescription cough/cold treatments.
OralXR+ is designed to provide sustained-release dosage in forms that do not require patients to swallow pills. The technology relies on millions of small (about 100 microns) particles to deliver the drug over time, with the sustained-release coating masking the unpleasant-tasting drug particles, facilitating great-tasting dosage formulations.
Through their agreement, the companies developed the marketed 12-hour codeine-based cough syrup Tuzistra XR (codeine polistirex and chlorpheniramine polistirex), a Schedule III controlled prescription product that won FDA approval in April 2015 and was launched by Vernalis in September of that year.
According to Vernalis, Tuzistra generated £800,000 ($1.04 million) in revenues during July–December 2016, with January–June 2017 figures to be reported September 12.
More encouraging for Vernalis, the number of Tuzistra prescriptions tripled in January–June 2017 to approximately 35,000, compared with about 11,000 a year earlier, and is on pace for approximately 55,000 prescriptions this year.
The companies ultimately agreed to develop six prescription cough cold treatments for the U.S. market. CCP-07 was the second product, and CCO-08 the third, that Vernalis and Tris had advanced to NDAs under their collaboration—triggering undisclosed milestone payments from Versalis to Tris in each instance.
Shares of Vernalis sunk 10.53% to £17 ($22) a share, down £2 ($2.60) from Friday's closing price, and down more than 80% more than £88 ($114.60) two years ago.