Jazz Pharmaceuticals

The Oncology Market is critical in global healthcare, driven by cancer prevalence, technological advancements, and strategic collaborations. Key players like Daiichi Sankyo, Bayer AG, and others innovate in diagnostics, treatments, and precision medicine. Market growth is fueled by R&D investments, sustainability focus, and consumer awareness. Challenges include regulatory constraints and talent shortages. Technological integrations like AI and IoT enhance patient care and operational efficiency.

Jazz Pharmaceuticals to host a webcast on December 11, 2024, to discuss Ziihera® (zanidatamab-hrii), a chemotherapy-free dual HER2-targeted bispecific antibody for biliary tract cancer (BTC), approved by the FDA on November 20, 2024.

The FDA granted accelerated approval to Zymeworks Inc.'s Ziihera for treating biliary tract cancer, triggering a $25M milestone payment from Jazz Pharmaceuticals. Zymeworks could earn over $1B in milestone payments and royalties. Ziihera is a variation of Zanidatamab, developed for various cancers, and marks Zymeworks' first FDA-approved therapy.

Zymeworks Inc.’s cancer drug zanidatamab (Ziihera) received FDA approval for treating biliary-tract cancer, marking a milestone in the company’s recovery. The drug is the first bispecific antibody and chemotherapy-free treatment for metastatic HER2-positive BTC. Zymeworks, which faced a corporate crisis in 2022, has partnered with Jazz Pharmaceuticals for North America, Europe, and Japan, and with BeiGene Ltd. for other Asian markets. The approval unlocks potential peak global sales of US$55-million, with further trials potentially expanding this to US$750-million. Zymeworks is eligible for up to US$500-million in milestone payments from Jazz and royalties of 10-20% on net sales.

FDA grants accelerated approval to Zymeworks' Ziihera for bilary tract cancer, triggering $25M milestone payment from Jazz Pharmaceuticals. Zymeworks could earn over $1B in milestone payments and royalties. Ziihera is a bispecific antibody variant of Zanidatamab, developed for various cancers.

FDA approves Jazz Pharmaceuticals' Ziihera (zanidatamab), the first dual HER2-targeted bispecific antibody for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, administered every two weeks.

The Botanical Drug Market grew from USD 3.75 billion in 2023 to USD 4.01 billion in 2024, expected to reach USD 6.01 billion by 2030 with a CAGR of 6.96%. Key growth factors include increased research investments, regulatory advancements, and rising awareness of herbal medicines. The market faces challenges such as limited clinical trial data and competition from conventional pharmaceuticals. Opportunities lie in expanding product lines and entering untapped markets in developing nations.

FDA grants accelerated approval to Ziihera (zanidatamab-hrii) for HER2-positive biliary tract cancer, based on 52% objective response rate and 14.9 months median duration of response. Continued approval contingent on confirmatory trial results.

The District Court upheld FDA's decision that Avadel's Lumryz is clinically superior to Jazz's Xywav, granting Lumryz its own orphan drug exclusivity. Jazz argued FDA's decision violated the Administrative Procedure Act, but the Court found FDA's determination was within its statutory authority and not arbitrary or capricious.