It may be the first time a multinational pharmaceutical company AstraZeneca $AZN could begin selling a potential blockbuster medicine in China, before the United States or Europe. FibroGen $FGEN and the British drugmaker have secured China approval for their oral drug, roxadustat, for anemic patients with chronic kidney disease who are dependent on dialysis.
The drug, which stimulates the production of red blood cells by mimicking the effect of high altitude in humans, will be launched in the second half of next year under the Chinese brand name: ài ruì zhuó 爱瑞卓. While FibroGen will take care of manufacturing, AstraZeneca is in charge of commercialization. Approval for a larger pool of patients — who are not dependent on dialysis — is expected sometime in 2019, after Chinese regulators complete an inspection of trial sites, the San Francisco-based company said on Monday.
The approval could open up an estimated $300-500 million sales opportunity, noted Jefferies’ Michael Yee. “For China, FGEN has received $43 million from AZN already and is entitled to up to $334 million of additional payments, much of which could be paid to FGEN this quarter,” he wrote. Overall, FibroGen has roughly $900 million in global regulatory milestones outstanding, the majority of which should be realized over the next 12-18 months, noted Leerink’s Geoffrey Porges.
Over the past few years, China’s version of the FDA introduced a slate of reforms to entice drug developers, including overturning a rule that required drugmakers to conduct separate trials in China before approvals were sanctioned. However, Roxadustat — which could eventually be used to treat millions afflicted with CKD in China — was given priority review by Chinese health regulators, who agreed to evaluate the marketing application on a rolling basis, after the drug performed well in two pivotal studies in China.
Porges estimated roxadusat will generate sales of $9 million in China next year – but expects that number will climb to a hefty $1 billion by 2025.
In the United States, the drug is expected to be submitted for review in the first half of next year, after pivotal trials are completed. Top-line efficacy data from a US trial are expected in the coming weeks, followed by key MACE safety data in March/April 2019, Yee noted.
FibroGen, which originally developed the drug, has partnered with AstraZeneca since 2013 to develop and sell the treatment in regions including the United States, China, Australia, New Zealand and Southeast Asia. Astellas is working with FibroGen to do the same in areas such as Japan, Europe, the Middle East and South Africa. An application to market roxadustat in Japan was submitted in October.
FibroGen and AstraZeneca are locked in a race with Akebia $AKBA, whose experimental drug vadadustat has a similar mechanism of action. But pivotal vadadustat data are not expected until 2020. The dominant drugs for anaemia in the United States are red-blood-cell boosting erythropoiesis-stimulating agents (ESA) from Amgen $AMGN.
Healthy kidneys produce a hormone called erythropoietin (EPO), which prompts the bone marrow to make red blood cells that carry oxygen throughout the body. If diseased or damaged, kidneys are unable to make enough EPO, resulting in fewer blood cells, and eventually anaemia.
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