Chinese firm Hutchmed Ltd. has out licensed its targeted colorectal cancer drug fruquintinib to Takeda Pharmaceutical Co. Ltd. as it eyes growth opportunities in the U.S., Europe and Japan in a deal totaling up to $1.13 billion. Under the terms of the agreement, Tokyo, Japan-based Takeda will gain an exclusive worldwide license to develop and commercialize the drug in all indications and territories outside of mainland China, Hong Kong and Macau. Takeda will bag $400 million up front and as much as $730 million in additional potential regulatory, development and commercial sales milestone payments, plus tiered royalties based on annual net sales.
Pliant posts positive phase IIa data in IPF
A lack of available options for treating idiopathic pulmonary fibrosis (IPF) is driving plenty of development into the indication. The latest data come from Pliant Therapeutics Inc., which posted positive 12-week interim data from the 320-mg dose group in its phase IIa study of PLN-74809 (bexotegrast). The oral, once-daily, dual-selective αvß6/αvß1 integrin inhibitor met its primary and secondary endpoints, with the 320-mg group showing a mean forced vital capacity increase of +29.5 mL relative to baseline at 12 weeks vs. a decline of 110.7 mL in the placebo group, resulting in a 140 mL increase compared to placebo. FVC is a measure of air a patient can exhale after inhaling. The company’s stock (NASDAQ:PLRX) reacted strongly to the data, with shares trading 44% higher at midday. The study’s final data are expected in the second quarter of 2023.
US FDA holding its position on orphan drug exclusivity
Although the U.S. FDA is complying with an appellate court order to set aside its pediatric approval of Jacobus Pharmaceutical Co. Inc.’s Ruzurgi, it’s not backing down from its interpretation of the seven-year orphan drug exclusivity provided by the Orphan Drug Act. Going forward, the agency intends “to continue to apply its existing regulations tying orphan-drug exclusivity to the uses or indications for which the orphan drug was approved,” according to a notice to be published in tomorrow’s Federal Register. That’s despite the 2021 ruling in Catalyst Pharmaceuticals Inc. vs. Becerra in which the U.S. Court of Appeals for the 11th Circuit stipulated that the orphan-drug exclusivity granted to Catalyst’s Firdapse blocked FDA approval of other versions of the drug for all uses or indications within the designated disease – in this case, Lambert-Eaton myasthenic syndrome.
CEPI partners with Vaxxas to advance development of needle-free COVID-19 vaccines
Vaxxas Pty. Ltd. and the Coalition for Epidemic Preparedness Innovations (CEPI) signed a partnership agreement to develop Vaxxas’ needle-free vaccine-patch delivery technology in a project that could end the need for frozen storage of mRNA vaccines. Under the terms of the agreement, CEPI will provide up to AU$6.4 million (US$4.3 million) for preclinical testing of Vaxxas’ platform – a needle-free, high-density microarray patch (HD-MAP) to assess its stability, safety and immunogenicity and to evaluate its potential as a rapid-response technology for heat-stable, dried-formulation mRNA vaccines. In exchange, Brisbane, Australia-based Vaxxas has committed to providing equitable access to the vaccine, including prioritizing supply for low-income and middle-income countries, producing vaccine volumes required to meet public health needs (at affordable pricing), as well as potential technology transfer.
Microsampling plus multiomics enables mail-order metabolism
Researchers at Stanford University School of Medicine have developed a method to measure several thousand metabolites, including proteins, metabolites, inflammatory markers such as cytokines and, to a degree, lipids. “It’s like Theranos, except it works,” corresponding author Michael Snyder, director of the Center for Genomics and Personalized Medicine at Stanford Medicine, told BioWorld.
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