AstraZeneca gets positive breast cancer trial results; potassium drug suffers setback

Phamaceuticals giant AstraZeneca announced positive results for its Faslodex drug for the treatment of metastatic breast cancer, but also said US regulators will not currently approve its new drug for high potassium levels because of a manufacturing issue.

The company said on Friday that Faslodex met its primary endpoint of extended progression-free survival in post-menopausal women who have not had prior hormonal treatment for home-receptor-positive breast cancer.

Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at AstraZeneca, said: "The FALCON results bring us closer to offering more and earlier treatment options to postmenopausal women with HR+ locally-advanced or metastatic breast cancer; the potential to delay disease progression is important for these patients as there is currently no cure.

“Faslodex has over 10 years of clinical evidence and we are committed to exploring its potential along with the rest of our outstanding oncology portfolio"

Also on Friday, AZN said the US Food & Drug Administration would not approve one of its new drugs because of a manufacturing problem.

It said the FDA has issued a complete response letter (CRL) on the new drug application made for sodium zirconium cyclosilicate, the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by wholly-owned subsidiary ZS Pharma.

The CRL refers to observations arising from a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it has yet to review and said it does not require the generation of new clinical data.

“AstraZeneca and ZS Pharma are evaluating the content of the CRL and will work closely with the FDA to determine the appropriate next steps for the NDA.”

Societe Generale said the response from the FDA will probably delay launch by around six months to the second half of 2017.

“We spoke to AZN LN this morning. The group appears confident it can resolve these issues smoothly and swiftly. Our impression is that the FDA may be being overly vigilant. Nonetheless this news is unhelpful as ZS9 only entered AZN LN's pipeline in Q4 16 via the $3bn acquisition of ZS Pharma.”

Still, the bank said the news does not change its medium-term positive investment case on the stock, which it rates at ‘buy’.

At 0930 BST, AZN shares were down 0.3% to 3,998.50p.