Protocols

Mary Szela resigns as CEO of Novelion; China is proving to be a rewarding market for AstraZeneca

→ After reorganizing Aegerion and leading the company through the merger with QLT that turned it into Novelion, CEO Mary Szela is leaving her position for personal reasons. Her resignation is effective immediately, and while the rare disease biotech $NVLN searches for a new CEO, a team of three execs will fill the office. Later this month, Murray Stewart will join as EVP and head of R&D, as the company prepares to launch Juxtapid in Japan and anticipates an EMA approval for metreleptin (Myalept) early next year.

→ Promising data is building behind Takeda and Myovant’s hormonal therapy relugolix, with the latest Phase III trial results proving good news for the drug. Takeda’s data showed relugolix, a once-daily oral drug, is alleviating symptoms for pain associated with uterine fibroids. The trial met its primary endpoint, with 57.6% of women treated with relugolix showing a significant improvement in pain compared to those treated with the placebo. This is particularly good news for Myovant $MYOV, which licensed rights to the drug from Takeda outside certain Asian markets. Myovant is currently doing two trials for a Phase III program testing relugolix in women with heavy menstrual bleeding associated with uterine fibroids. This program’s primary endpoint is to cut down on the patients’ menstrual blood loss. Secondary endpoints include reduction in pain, among other measures. Myovant will use Takeda’s new data in its NDA for US approval.

→ With recent regulatory reforms, China is proving to be a rewarding market for AstraZeneca $AZN — but not much for its rival GSK, Reuters reports. Revenue from the country, which makes up 15% of AstraZeneca’s global sales, increased by 12% in the Q3. The big pharma notes its lung cancer drug Tagrisso was approved at record speed, and it’s expanded its sales force in China. Meanwhile, GSK $GSK, still recovering from a 2014 bribery scandal, has seen China sales decline by a “mid-teens” percentage rate in the same period.

AstraZeneca noted in its Q3 report today that its star asthma drug tezepelumab failed in a Phase II study for eczema, or atopic dermatitis. Amgen, its partner, had earlier noted the setback for this drug, which represents a major program for the UK pharma giant. Analysts had considered this therapy a potential rival to Dupixent from Sanofi and Regeneron, but they may have to recalibrate their old projections based on the trial failure.


With additional reporting from Brittany Meiling and John Carroll



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