Topline Findings
- Strategic Collaboration: Boehringer Ingelheim and AnGes formalize a contract development and manufacturing agreement to advance hepatocyte growth factor gene therapy for peripheral arterial disease.
- Regulatory Progress: AnGes completes clinical trials and plans to submit a Biologics License Application to the FDA, marking a key milestone in therapy development.
- 2025 Growth Initiatives: The agreement adds to Boehringer Ingelheim’s series of partnerships and collaborations this year, reflecting its broader biopharma expansion strategy.
Boehringer Ingelheim has announced a formalized contract development and manufacturing agreement with AnGes. According to the company, the partnership will focus on the drug substance of AnGes’ investigational hepatocyte growth factor (HGF) gene therapy for peripheral arterial disease (PAD).
Boehringer Ingelheim BioXcellence, the company’s contract development and manufacturing organization arm, has been producing and supplying the active plasmid DNA ingredient of AnGes’ HGF gene therapy using proprietary E. coli technology at its Vienna site for nearly 20 years.1
What Are the Next Steps for AnGes After Completing Clinical Trials in PAD?
The announcement comes weeks after AnGes completed clinical trials for the drug substance. On August 8, 2025, AnGes also announced its intention to submit a Biologics License Application to the FDA.1,2
“We proudly collaborate with Boehringer Ingelheim BioXcellence, one of the top manufacturers of drugs and biologics in the world and look forward to our mutual efforts toward a successful FDA approval,” said Ei Yamada, PhD, president, CEO, AnGes, in a press release.
Boehringer Ingelheim Strengthens Its 2025 Expansion Strategy With High-Profile Partnerships
The agreement further underscores Boehringer Ingelheim’s active expansion strategy. It adds to a series of high-profile partnerships and acquisitions the company has secured so far in 2025:
Earlier this week, Boehringer Ingelheim announced that it had struck a global research collaboration and licensing agreement with Palatin Technologies. The deal aims to advance a first-in-class therapy for retinal diseases. Under the terms of the deal, Palatin Technologies is eligible to receive upfront, development, regulatory, and commercial milestone payments totaling up to approximately $304 million, in addition to tiered royalties on net sales.3
In late July, the company announced a licensing agreement with Re-Vana Therapeutics to develop extended-release therapies for eye diseases. Under the terms of the deal, Boehringer Ingelheim will be granted target exclusivity. Additionally, Re-Vana could potentially realize over $1 billion pending project milestones and royalty payments on product net sales.4
Earlier in July, Boehringer Ingelheim announced a global license and transfer agreement with LEO Pharma for Spevigo, a treatment for generalized pustular psoriasis. Under the terms of the deal, LEO will be responsible for commercialization and advancement of the treatment. Boehringer Ingelheim received an upfront payment of $105 million, with the potential to receive further milestone and royalty payments.5
In June, the company announced an expansion to its existing partnership with Echosens in metabolic dysfunction-associated steatohepatitis. The collaboration will shift from clinical trials to early detection, diagnosis, and broader access to care by raising awareness among patients, healthcare providers, and policymakers.6
In May, Tempus AI announced that it had entered into a strategic collaboration with Boehringer Ingelheim to support its oncology pipeline. The collaboration aims to leverage data and AI to enhance therapeutic research and development in cancer treatments.7
Boehringer Ingelheim BioXcellence Provides Manufacturing Support for Regulatory Milestones
“At Boehringer Ingelheim BioXcellence, we are committed to leveraging our expertise in biologics manufacturing,” said Ute Lehmann, head, key account management, business development, Boehringer Ingelheim BioXcellence, in the press release. “Therefore, we support our partners with high-quality, reliable manufacturing services to help them reach key regulatory milestones, such as FDA BLA approval, and to bring innovative therapies to patients worldwide. We deeply value the opportunity to collaborate with AnGes on their journey toward product launch, and we look forward to contributing to the future success of this important partnership.”
References
- Boehringer Ingelheim and AnGes sign manufacturing agreement for HGF gene therapy product. Boehringer Ingelheim. August 20, 2025. Accessed August 21, 2025. https://www.boehringer-ingelheim.com/partnering/boehringer-ingelheim-bioxcellence/hgf-gene-therapy-product
- Decision on the Development Policy for the HGF Gene Therapy Product in the United States and Regarding the Contract with Boehringer Ingelheim Biopharmaceuticals Notification Regarding the Drug Substance Supply Agreement. AnGes. August 8, 2025. Accessed August 21, 2025. https://www.anges.co.jp/pdf_news/public/LXCEiHNQqHR21aa9eVeHAvboVaLyWbcO.pdf
- Boehringer Ingelheim and Palatin Technologies to develop potential first-in-class melanocortin receptor targeted treatment for patients with retinal diseases. Palatin. August 18, 2025. Accessed August 21, 2025. https://palatin.com/press_releases/boehringer-ingelheim-and-palatin-technologies-to-develop-potential-first-in-class-melanocortin-receptor-targeted-treatment-for-patients-with-retinal-diseases/
- Boehringer Ingelheim Announces Collaboration and License Agreement with Re-Vana Therapeutics for Extended-Release Eye-Disease Therapies. PharmExec. July 29, 2025. Accessed August 21, 2025. https://www.pharmexec.com/view/boehringer-ingelheim-collaboration-license-agreement-re-vana-therapeutics-extended-release-eye-disease
- LEO Pharma and Boehringer Ingelheim agree on $105 million deal for generalized pustular psoriasis (GPP) treatment Spevigo. PharmExec. July 15, 2025. Accessed August 21, 2025. https://www.pharmexec.com/view/leo-boehringer-ingelheim-105-million-spevigo
- Echosens and Boehringer Ingelheim Expand Long-Standing Collaboration to Accelerate Progress in MASH Diagnosis and Care. PR Newswire. June 10, 2025. Accessed August 21, 2025. https://www.prnewswire.com/news-releases/echosens-and-boehringer-ingelheim-expand-long-standing-collaboration-to-accelerate-progress-in-mash-diagnosis-and-care-302476781.html
- Tempus Enters Multi-Year Strategic Collaboration with Boehringer Ingelheim to Advance its Cancer Pipeline. Tempus. May 14, 2025. Accessed August 21, 2025. https://www.tempus.com/news/tempus-enters-multi-year-strategic-collaboration-with-boehringer-ingelheim-to-advance-its-cancer-pipeline/?srsltid=AfmBOoq681AVWx8BWPqEniCpo5N_pSjC7UR7JM6AqQAIh62D_8qEHErM&utm_source=chatgpt.com
