In what it says could be the largest disclosed patent settlement in the pharmaceutical industry, Roivant Sciences Ltd. has reached a potential $2.25 billion settlement with Moderna Inc. over the use of its lipid nanoparticle (LNP) delivery technology in the Spikevax COVID-19 vaccine. Of this, $950 million will be paid up front by Moderna in July. But the $1.3 billion balance is contingent upon an appeal – which both parties have agreed Moderna will bring to the Federal Circuit – to put forward the government-contractor immunity defense, under 28 U.S. Code C Section 1498. That will argue Moderna’s use of the LNP patents was not unauthorized, because sales of Spikevax were made under a government contract, as part of the emergency response to the pandemic. This will be “a narrow legal appeal with one specific question: the applicability of Section 1498,” said Matt Gline, CEO of Roivant.

China approves first noninvasive therapy for cervical precancer

China’s National Medical Products Administration has approved Asieris Pharmaceuticals Co. Ltd.’s cold light photodynamic drug-device combination product, Cevira (APL-1702, hexaminolevulinate hydrochloride), which is used as a nonsurgical therapy for treating patients with cervical intraepithelial neoplasia grade 2 (CIN2). The approval marks the first nonsurgical therapy for CIN2 and could represent a turning point in treating cervical precancer with a potential new category of outpatient therapies designed to intervene earlier in the disease pathway. CIN2 is a precancerous condition caused primarily by persistent infection with high-risk human papillomavirus. While some lesions regress naturally, others progress toward cervical cancer.

UCB inks $1.1B deal for Antengene’s autoimmune bispecific TCE

Belgian pharma giant UCB SA is putting skin in the bispecific T-cell engager (TCE) game, announcing a potential $1.1 billion deal to license Antengene Corp.’s ATG-201. ATG-201 is a CD19/CD3 bispecific TCE antibody aimed at autoimmune disorders, though specific indications were not disclosed. The deal gives Brussels-based UCB exclusive rights to develop, manufacture and commercialize ATG-201 worldwide, as well as access to its manufacturing technology. Announced after U.S. market hours March 3, the agreement includes $80 million in up-front and near-term milestone payments, plus more than $1.1 billion tied to development, regulatory and sales milestones. Antengene is also eligible to receive tiered royalties on future net sales.

Can-Fite’s namodenoson shows promise in early pancreatic cancer trial

Can-Fite Biopharma Ltd.’s namodenoson met the safety endpoint in a phase II open-label study in advanced pancreatic ductal adenocarcinoma (PDAC) patients, news that sent shares (NYSE:CANF) up more than 100% in earning trading, though the stock had come back to Earth by midday, trading up a more modest 25%. While the safety findings are good news, it was the report that one-third of the patients in the study remain alive as of data cutoff that may have triggered the initial rise, with investors looking ahead to overall survival and progression-free survival data, expected to read out later. PDAC, an aggressive form of pancreatic cancer, currently has a five-year survival rate ranging from 8% to 14% and limited treatment options. Shortly after disclosing the latest data, Can-Fite also entered an agreement to exercise outstanding warrants to add $4 million to its balance sheet.

FDA’s rare disease toolbox not fully used

At the current pace of innovation in the U.S. rare disease space, developing and approving therapies for just half of the 10,000-plus known rare diseases would take more than 160 years, Bradley Campbell, president and CEO of Amicus Therapeutics Inc., told the Senate Committee on Aging last week. That’s based on an average of 31 orphan-designated novel approvals per year across CBER and CDER over the past five years, he said. But last year, the centers approved just 28 rare disease drugs – 23 at CDER and five at CBER. At the same time, the FDA issued more than 20 complete response letters for rare disease therapies. While the agency is proposing new initiatives to encourage regulatory flexibility in approving such treatments, several experts told the committee the FDA isn’t using the tools it already has.

Sanofi licenses Sino Biopharm’s JAK/ROCK drug for $1.4B

On the heels of China’s approval of Sino Biopharmaceutical Ltd.’s rovadicitinib, Sanofi SA is now inlicensing the first-in-class dual JAK/ROCK inhibitor in a deal worth more than $1.4 billion. As previously reported by BioWorld, China’s National Medical Products Administration approved rovadicitinib, branded as Anxu, for first-line treatment of adults with intermediate- or high-risk primary myelofibrosis, as well as post polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Sino Biopharm subsidiary Chia Tai Tianqing Pharmaceutical Group Co. Ltd. signed the global deal and is eligible to receive an up-front payment of $135 million, potential development, regulatory and sales milestone payments of up to $1.395 billion, and sales-based royalties.

Polares raises $50M for mitral valve system

Polares Medical SA raised $50 million in a series C financing round for MRace, its Posterior Leaflet Replacement system, designed to treat mitral regurgitation. The funds will be used to advance clinical studies in the U.S., Europe and Australia as the company looks to bring a much needed treatment option to patients with the structural heart condition.

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