FDA Extends Camizestrant Review, Issues CRL for PT010, and Adopts Single-Trial Approval Policy

The U.S. Food and Drug Administration has extended the review deadline for AstraZeneca's camizestrant breast cancer drug application and issued a complete response letter for the company's COPD drug PT010. The agency also implemented a revised approval process that allows a single comprehensive pivotal trial with confirmatory evidence, replacing the previous requirement of two trials. AstraZeneca, meanwhile, agreed to sell commercial rights for stomach treatment Losec to Cheplapharm Arzneimittel GmbH.

Camizestrant is being reviewed for use in combination with a cyclin-dependent kinase 4/6 inhibitor as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation. The extension follows an advisory committee meeting in April, where the FDA's Oncologic Drugs Advisory Committee did not reach a majority vote in favor of the benefit of switching to camizestrant in combination with a CDK4/6 inhibitor. The committee's assessment was based on data from the SERENA-6 Phase III trial, and the vote concerned switching patients to camizestrant after detection of an ESR1 mutation in circulating tumor DNA prior to radiographic progression. Following the advisory committee outcome, AstraZeneca provided additional analyses to the FDA in support of the application, which the agency requested before continuing its review.

For PT010, a possible new treatment for chronic obstructive pulmonary disease, AstraZeneca received a complete response letter from the FDA, which indicates the agency will not approve the application in its current form. The company submitted a new drug application including data from a phase 2 Kronos trial and will now work closely with the FDA regarding next steps, including submitting a review of results from its Ethos phase 3 trial, which was incomplete at the time of the first application submission.

In a separate corporate action, AstraZeneca agreed to sell commercial rights for Losec to Cheplapharm Arzneimittel GmbH for around USD243 million on completion plus milestones of up to USD33 million in 2021 and 2022. The sale excludes China, Japan, the US and Mexico, and includes drugs containing Losec's active ingredient, omeprazole, marketed under the names Acimax, Antra, Mepral, Mopral, Omepral and Zoltum. AstraZeneca will continue to manufacture and supply Losec and associated medicines. The executive vice president of BioPharmaceuticals said the agreement forms part of the company's strategy of reducing the portfolio of mature medicines to enable reinvestment in its main therapy areas.

The FDA's revised approval process, discussed in The New England Journal of Medicine, is expected to affect pharmaceutical companies including AstraZeneca. AstraZeneca, formed from the merger of Astra of Sweden and Zeneca of the United Kingdom in 1999, has a market capitalization of approximately $326.41 billion. The United States accounts for nearly one-third of its sales. The company reported revenue of $58.74 billion, a three-year revenue growth rate of 6.4%, a net margin of 17.45%, an operating margin of 23.42%, and a gross margin of 81.91%. Its debt-to-equity ratio is 0.61, current ratio 0.94, quick ratio 0.72, and cash ratio 0.19. The stock's P/E ratio is 31.86, P/S ratio 5.48, and P/B ratio 6.59, with an RSI of 68.38. Its Piotroski F-Score is 8 and Beneish M-Score is -2.36, with a beta of 0.13. At its last close, shares of AstraZeneca were trading at 13,960.0 pence, up 0.32%.