Eisai and Merck & Co.'s Keytruda-Lenvima combo won simultaneous approvals in the U.S., Canada and Australia in the first case of an FDA-initiated oncology drug review collaboration. But the Japanese drugmaker's Biogen-partnered BACE inhibitor Alzheimer's disease program basically died after a phase 3 trial on elenbecestat was terminated due to safety concerns. Sanofi is reportedly exiting Bangladesh, leaving behind more than 1,000 jobs. Fosun-backed Henlius Biotech raised $410 million in Hong Kong IPO as the city's financial function comes under pressure amid unrest. And more.
Drug regulators from the U.S., Canada and Australia concurrently approved Merck & Co. and Eisai’s Keytruda-Lenvima combo for women with certain advanced endometrial carcinoma. The simultaneous decisions were the first made under Project Orbis, an oncology drug review collaboration among the agencies. SVB Leerink analysts estimated U.S. sales for the combo’s indication between $86 million and $240 million by 2022.
Meanwhile, Eisai and partner Biogen’s Alzheimer’s disease BACE inhibitor program has finally hit the end. Despite the hype, the pair’s aducanumab failed a closely watched phase 3 earlier this year. Now, their second BACE candidate, elenbecestat, has been thrown out “due to unfavorable risk-benefit ratio,” the two said. Eisai still has an anti-amyloid beta antibody, BAN2401, which it pushed into phase 3 right after the aducanumab flop.
After more than 60 years, Sanofi is planning to leave Bangladesh, local media reports. The Bangladesh Chemical Industries Corporation, which owns part of the company’s local operation, pressed Sanofi to stay, but the company has reportedly made up its mind for strategic reasons. As of 2016, Sanofi was the largest pharma company in Bangladesh with more than 1,200 employees there.
Fosun-backed Shanghai Henlius Biotech is raising $410 million in its Hong Kong IPO after pricing the offering at the bottom of its range, or HK$49.60 per share. The company earmarked 40% of the proceeds for clinical development, regulatory filing and registration of its “core” cancer therapies, including several biosimilars. The firm in February earned China’s first biosim nod in a Rituxan copy.
The FDA’s orphan drug program has spurred development of drugs for small patient groups, but when manufacturing goes awry, the consequences for patients can be devastating. That’s a scenario Takeda’s recent recall of Natpara created. “Natpara is a medication we in the hypoparathyroid community rely on to have a productive and full life,” patient Lindsey Cowles said. “There are no other options that leave us feeling like a semi-normal human being. This recall has left many of us in a panic about our future!”
AstraZeneca revamped its 2012 pact with Ironwood Pharmaceuticals, gaining full Chinese rights to the latter’s irritable bowel syndrome (IBS) treatment Linzess. The drug, approved by Chinese regulators in January, is expected to be launched this year, targeting an estimated 14 million IBS with constipation patients in China. Ironwood CEO Mark Mallon was previously AZ’s China president.
After a damning Form 483 that laid out several manufacturing and data integrity concerns, Lupin’s Mandideep, India, finished-dose plant was hit with an FDA warning letter. The drugmaker said the facility had no outstanding drug applications, and it does not expect the warning to “have an impact on disruption of supplies or the existing revenues from operations of this facility.”
Astellas formed an R&D agreement with Iota Biosciences, hoping to use the latter’s ultrasmall implants to design new diagnostics and therapies that could work in concert with traditional treatments, or even replace them.
Glenmark Pharmaceuticals’ innovative drug-focused U.S. spinoff, led by Alessandro Riva, racked up one of its first major pipeline milestones. Its bispecific antibody candidate GBR 1342 being investigated for multiple myeloma secured an FDA orphan drug designation, the first time this label has been won by an Indian firm, according to Glenmark.