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- The Unified Patent Court revoked Sanofi's patent EP 2 493 466 protecting the anti-tumor use of cabazitaxel in combination with prednisone or prednisolone for treating hormone-refractory metastatic prostate cancer. - Multiple generic companies including Accord Healthcare, Zentiva, Stada, and Dr. Reddy's successfully challenged the patent through counterclaims for revocation at the Munich local division. - The court's decision follows similar rulings in France and earlier favorable decisions for generics in the UK and Germany, allowing generic versions of the chemotherapy drug Jevtana to enter European markets.
- Zentiva announced the EU-wide launch of its first biosimilar monoclonal antibody following European Medicines Agency approval, marking the company's strategic entry into the biologics market. - The biosimilar targets bone conditions and will be progressively rolled out across European markets starting in December 2025. - This launch represents part of Zentiva's broader diversification strategy beyond traditional generics to improve patient access to affordable biologic medicines across Europe. - The move positions Zentiva for sustainable growth in the dynamic biosimilar segment, which is key to healthcare system sustainability as biologic medicines represent a growing share of European healthcare spending.
- Pharming Group N.V. announced the appointment of Kenneth Lynard as Chief Financial Officer, effective October 1, 2025, following strong first half 2025 financial results. - Lynard brings over 20 years of global leadership experience in life sciences, including senior roles at Gilead Sciences where he contributed to tripling the business following the Pharmasset acquisition. - The appointment marks a strategic move to strengthen financial leadership as Pharming continues executing its growth strategy to build a leading global rare disease company. - Lynard's experience spans both established industry leaders and growth-stage companies, with operational expertise in both U.S. and European markets.
- Cinclus Pharma has initiated the HEEALING 1 Phase III study to evaluate linaprazan glurate for treating erosive gastroesophageal reflux disease (GERD) following positive regulatory feedback. - The study will enroll approximately 500 patients across seven European countries to demonstrate superiority over existing proton pump inhibitors like lansoprazole. - Linaprazan glurate could become the first potassium-competitive acid blocker (PCAB) approved in Europe, representing a significant advancement in GERD treatment. - The company has secured a strategic partnership with Zentiva valued at EUR 220 million, with plans to extend development to the US market through a second Phase III study.
- The UPC Court of Appeal overturned a lower court decision and granted Boehringer Ingelheim a preliminary injunction against Zentiva's generic nintedanib products across 17 European countries. - The ruling protects Boehringer's EP 1 830 843 B1 patent covering nintedanib use until December 2025, preventing generic competition for Ofev, which treats idiopathic pulmonary fibrosis. - The Court found that Zentiva had "set the stage" for patent infringement by completing regulatory preparations in Portugal, with only self-restraint preventing market entry. - Zentiva was ordered to pay €199,000 in costs, and the judgment is immediately enforceable across all UPC contracting states where the patent remains valid.
- The Lisbon Local Division of the Unified Patent Court refused to grant Boehringer Ingelheim's preliminary injunction against Zentiva's marketing authorization for generic nintedanib (Ofev). - The court ruled that obtaining marketing authorization alone does not indicate imminent patent infringement, requiring assessment based on actual behavior and case facts. - This decision supports pharmaceutical companies' ability to prepare generic drugs for market entry without facing injunctions solely based on regulatory approvals.
- Lupin has entered into a strategic licensing and supply agreement with Czech-based Zentiva to commercialize its biosimilar version of Certolizumab Pegol across multiple global markets. - Under the agreement, Zentiva will handle marketing and distribution in Europe and CIS countries while Lupin retains commercialization rights in the United States, Canada, and other regions. - Zentiva will make milestone-based payments of up to $50 million to Lupin, including a $10 million upfront payment, with both companies jointly investing in biosimilar development. - The partnership aims to expand Lupin's market reach and provide cost-effective biosimilar alternatives to patients worldwide through Zentiva's extensive European commercial infrastructure.
- Cinclus Pharma has partnered with Zentiva to commercialize linaprazan glurate, a next-generation potassium-competitive acid blocker (PCAB) for severe erosive GERD, in a deal valued at €220 million. - The agreement includes an upfront payment of €13 million, with Cinclus eligible for milestone payments and tiered double-digit royalties starting in the high teens and potentially exceeding 20%. - Cinclus Pharma plans to initiate its first Phase III study for linaprazan glurate in Q3 2025, targeting an addressable market of approximately 19 million patients globally.
- The Unified Patent Court has denied Boehringer Ingelheim International's request for provisional measures against Zentiva regarding generic nintedanib medicines for lung fibrosis and cancer treatment. - The Lisbon Local Division ruled there was no imminent risk of patent infringement, determining that Zentiva's administrative steps in Portugal did not constitute concrete plans for market entry before patent expiry. - The patent for nintedanib is set to expire in April 2026, with the court finding insufficient evidence to support claims of impending infringement that would warrant preliminary injunctive relief.
• Biocon and Zentiva have secured EU approval via the Decentralized Procedure for their generic liraglutide formulation. • The approval covers generic versions of Victoza for treating Type-2 Diabetes and Saxenda for weight management. • This approval allows for the drug's sale across EU member states without requiring centralized authorization. • Liraglutide addresses the rising global prevalence of Type 2 diabetes and the need for effective weight management solutions.
