Little more than a month after selling a narcolepsy drug from its portfolio, Jazz Pharmaceuticals plc has replaced it with another. The company entered an exclusive development and commercialization rights agreement for Sumitomo Pharma Co. Ltd.’s candidate for treating narcolepsy along with idiopathic hypersomnia and other sleep disorders. The selective oral orexin-2 receptor agonist is in a phase I study in Japan. Sumitomo is getting $50 million up front but could bring in $1.09 billion in development, regulatory and commercial milestone payments. In late March, Jazz sold Sunosi (solriamfetol) for treating narcolepsy or obstructive sleep apnea to Axsome Therapeutics Inc., of New York, for an up-front $53 million.

Intercept finds cash, optionality in sale of ex-US business to Advanz

Intent on expanding both the reach and approved uses of its farnesoid X receptor agonist, obeticholic acid (OCA), Intercept Pharmaceuticals Inc. is selling both its ex-U.S. operations and rights to the primary biliary cholangitis drug to U.K.-based Advanz Pharma Corp. Ltd. for $405 million up front. The deal, including an additional $45 million earnout tied to EU regulatory advances, represents an important step toward strengthening Intercept's balance sheet and options, said CEO and President Jerry Durso. Following a complete response letter in June 2020, Intercept is pursuing plans in the U.S. to refile OCA for the treatment of liver fibrosis due to nonalcoholic steatohepatitis. Company shares (NASDAQ:ICPT) rose 16% by midday, just ahead of its first-quarter earnings announcement May 6.

Hansoh wins greater China rights to oncology drug from Nikang in $218M deal

Hansoh Pharmaceutical Group Co. Ltd. has acquired greater China rights to oncology candidate NKT-2152 from Nikang Therapeutics Inc. in a deal worth up to $218 million. The orally administered small molecule, designed to inhibit hypoxia-inducible factor-2 alpha, is in a phase I/II trial to treat patients with advanced clear cell renal cell carcinoma. This deal marks the second collaboration between Nikang and Hansoh Pharma, which partnered in a $100 million April 2020 deal in which Hansoh Pharma in-licensed greater China rights to small-molecule antiviral candidate NKT-1992.

Senators: More light needed on PBM practices

Pharmacy benefit managers (PBMs) were in the spotlight today at a U.S. Senate subcommittee hearing on fairness and transparency in the prescription drug market, but lawmakers indicated they may need to turn up the klieg lights of the FTC to penetrate the black box of PBM operations. Sen. Richard Blumenthal (D-Conn.), chair of the Subcommittee on Consumer Protection, Product Safety, and Data Security, said he convened the hearing to “examine steps Congress can take to increase transparency in drug prices, require PBMs to operate fairly and ensure the Federal Trade Commission has the authority it needs to stop unfair practices in the prescription drug market.”

House user fee bill omits action on lab-developed tests, SaMD

The legislation that would reauthorize the U.S. FDA’s user fee programs is now in the works in the House of Representatives, but the legislation is fairly lean considering the number of issues facing the agency. While the draft legislation gives the FDA more authority to require postmarket studies for drugs approved under an accelerated approval program, there is no provision for FDA regulation of lab-developed tests or for a new regulatory framework for software as a medical device, just two of several device-related problems that receive no attention from the bill.

US approvals drop as FDA moves toward modernization

As the U.S. FDA transitions to another new commissioner, the number of approvals has dropped to the lowest levels in seven years and is 19% below those approved by this time last year. The Senate voted in February 50-46 to select Robert Califf as the next FDA commissioner, a position he has held before and one that has had high turnover in the past decade. Onslaughts of data and evolving industry technologies require the agency to modernize, he recently said, and $68 million in funds are included in the proposed U.S. budget to help with that task. Although approvals are down, the agency and government agencies across the globe remain busy: 901 items of regulatory news so far this year is much in line with 2021’s 906. Nevertheless, new molecular entity approvals by the FDA are also down from each of the last two years.

Also in the news

Acoustic, Aeglea, Altamira, Alzamend, Arcturus, Argenx, Astrazeneca, Aulos, Bavarian Nordic, Bayer, Belite, BPL, Cannvalate, Clover, Curebase, Editas, Elpiscience, Immunic, Incyte, Iqvia, Jiangsu Recbio, Karuna, Kempharm, Lumos, Marinus, Microba, Moleculin, Newsoara, Palisade, Paradigm, Phosplatin, Pliant, Telix, Tetra, Theranostics, Tikomed, Turning Point, Valneva, Vistagen, Xortx