Biogen and Eisai hope to follow up on Aduhelm’s approval by seeking an accelerated nod from the FDA for another anti-amyloid Alzheimer’s disease candidate. Samsung Biologics has seen its long-term contract manufacturing partnership with Roche swell in value in the past eight years. Otsuka is licensing four clinical candidates for neuropsychiatric disorders from Sumitomo Dainippon Pharma’s Sunovion. And more.
Biogen and partner Eisai are still embroiled in Aduhelm’s controversial rollout, but they are once again seeking accelerated FDA approval for an Alzheimer’s disease candidate. The drug, lecanemab, reduced amyloid plaques and slowed down cognitive decline in a dose-dependent manner in a phase 2 trial, they reported. The two firms have brought the midphase data to the FDA, while a phase 3 trial is ongoing.
Samsung Biologics first signed a long-term collaboration with Roche in 2013. The two inked a contract manufacturing deal in January amid rising demand for COVID-19 meds. Now, the South Korean CDMO said the two parties’ contract value has reached $212.85 million.
Otsuka is paying $270 million upfront with $620 million in biobucks for four compounds at Sunovion, which is owned by Japan’s Sumitomo Dainippon Pharma. The four clinical-stage assets target serious neuropsychiatric disorders, Otsuka said. The most advanced candidate, ulotaront, has an FDA breakthrough designation and is in a phase 3 trial for schizophrenia.
Takeda has picked up commercial rights to JCR Pharmaceuticals’ Hunter syndrome treatment Izcargo in markets outside the U.S., except Japan and a few other Asia-Pacific countries. Takeda also holds an option to license the drug in the U.S. after data are available from a global phase 3 trial, expected in 2024. The drug won an approval in Japan in March based on data from a local trial.
Biocon’s insulin facility in Malaysia once again landed in the FDA’s crosshairs. The agency slapped the factory with a Form 483, citing six observations related to “drug substance, drug product and devices facilities,” the Indian company said. It doesn’t expect the citation will hurt the launch of Viatris-partnered Semglee, an interchangeable insulin biosimilar.
Shionogi has out-licensed a long-acting HIV candidate, known as S-365598, to ViiV Health, a joint venture it has with GSK and Pfizer. The third-generation integrase inhibitor looks to extend the dosing interval to three months or longer. A first-in-human study is expected to start in 2023.
After a $180 million upfront deal with AbbVie on an anti-CD47 drug, China’s I-Mab is reportedly talking to other global biopharma companies about partnerships and investments. The news follows earlier reports that the biotech is looking to partner on its anti-CD73 antibody uliledlimab.
A phase 3 trial in Asia found that Keytruda helped liver cancer patients previously treated with Bayer’s Nexavar live significantly longer than placebo did. The trial could save Keytruda’s conditional nod in second-line liver cancer, which came under FDA scrutiny after a confirmatory phase 3 flop.
In addition to reviewing immuno-oncology drugs like Keytruda, the FDA is now targeting two blood cancer meds from Secura Bio and Aurobindo Pharma. The two drugs haven’t succeeded in confirmatory trials since they were approved on an accelerated basis, and an FDA advisory committee will meet in December to discuss next steps.
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