Lambasted by AIDS activists about Truvada pricing, Gilead offers CDC drug supply deal; FibroGen MACE miscommunication leaves investors disoriented

→ Chastised by AIDS activists for its pricing policy on Truvada , Gilead $GILD has agreed to provide to CDC with up to 2.4 million bottles of the HIV-prevention pill annually for uninsured Americans at risk for HIV. The donation, which extends up to 2030, will transition to Descovy if it is approved for use as a preventative treatment or PrEP (pre-exposure prophylaxis), in which individuals at high risk for HIV take medicines daily to lower their chances of contracting the infection. I’m pleased to announce that as a result of discussions between the Trump Administration and Gilead Sciences, Inc., Gilead has agreed to make a historic donation of #HIV prevention medication for up to 200,000 individuals each year for up to 11 years. — Secretary Alex Azar (@SecAzar) May 9, 2019 About 200,000 of the estimated 1.1 million Americans at risk for HIV currently receive Truvada for PrEP, Gilead said .

→ On Thursday, FibroGen reported its first-quarter results and disclosed the keenly-anticipated MACE (major adverse cardiovascular events) integrated-safety analysis for its AstraZeneca $AZN -partnered potential blockbuster treatment, roxadustat . The anemia drug for chronic kidney disease — designed to stimulate the production of red blood cells by mimicking the effect of high altitude — is being developed as a safer alternative to the current standard-of-care: erythropoiesis-stimulating agents, which are associated with CV issues. But the MACE disclosure, stemming from the analysis of seven late-stage trials, encompassing more than 8,000 patients, left investors dazed and confused. The stock $FGEN tumbled after-market and was down nearly 24% at 34.76 in Friday morning trading.

For starters, the company did not disclose the actual data. For one 4,300 patient-trial, which included the significant population of dialysis-independent kidney disease patients, FibroGen vaguely said it believed there was no clinically meaningful difference in risk of MACE between roxadustat and placebo.”Investors interpreted this to mean that the trial had failed on the MACE non-inferiority statistical analysis, since otherwise why wouldn’t the company have disclosed that it had met that standard,” SVB’s Leerink’s Geoffrey Porges acknowledged in a note. Geoffrey Porges In Europe, where roxadustat is partnered with Astellas , the companies are held to a different endpoint called MACE+, which FibroGen was more forthcoming and conclusively positive about hitting, during the course of the call. “The reality is that the MACE outcomes appear to have trended similarly to the positive MACE+ outcomes, and roxa’s performance was not materially worse in MACE. The different disclosure appears to primarily relate to the caution of FibroGen’s partner AstraZeneca about declaring such an outcome, in the absence of agreement with the FDA about the boundaries for declaring the two populations non-inferior,” Porges said.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 50,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Tags:

Click Here to Continue!