News|Articles|September 2, 2026

Roundup: Alteogen Enters Option & License Agreement with Novartis, NewBiologix & Synastra Form BioTech Partnership, RedHill Acquires Commercialization Rights to Rebyota & Clenpiq

Listen
0:00 / 0:00

Key Takeaways

  • Novartis obtained optioned exclusivity to develop subcutaneous formulations using ALT-B4, a recombinant hyaluronidase that transiently depolymerizes hyaluronan to enhance dispersion and absorption.
  • NewBiologix will deliver a stable Research Cell Bank via its Xcell platform for Synastra’s DMD rAAV program, with a path to a commercial manufacturing license.
SHOW MORE

Alteogen grants Novartis options to develop subcutaneous formulations using its ALT-B4 hyaluronidase platform, NewBiologix and Synastra partner to develop a stable producer cell line, and RedHill acquires global commercialization rights to Ferring's Rebyota and Clenpiq.

Dealmaking this week spanned drug delivery platforms, gene therapy manufacturing, and gastrointestinal commercialization, as companies moved to license proprietary technology, build out clinical-stage manufacturing capacity, and reshape commercial portfolios through targeted acquisitions.

Alteogen strikes option and license deal with Novartis

Alteogen Inc. entered into an option and license agreement with Novartis for the development and commercialization of subcutaneous products utilizing ALT-B4, powered by Alteogen's Hybrozyme platform technology.

As part of the deal, if all options are exercised and all milestones are achieved, Alteogen would be eligible to receive up to $3.223 billion, including option exercise fees, development and commercial milestone payments, and royalties on net sales of products commercialized under the agreement.1

Under the terms of the agreement, Novartis is expected to have multiple options to obtain exclusive rights to develop and commercialize subcutaneous formulations for multiple Novartis products using ALT-B4 (berahyaluronidase alfa).1 ALT-B4 is a proprietary recombinant human hyaluronidase developed using Alteogen's Hybrozyme platform technology that enables the conversion of biologics typically administered via intravenous infusion into more convenient and rapid subcutaneous formulations. By temporarily depolymerizing hyaluronan in the extracellular matrix, ALT-B4 facilitates the rapid and efficient dispersion and absorption of co-administered therapeutics.1

"Novartis is a world-leading pharmaceutical company at the forefront of the global healthcare industry and has evaluated the application of ALT-B4 across multiple modalities for subcutaneous formulation development. This agreement demonstrates the technological strength and commercial value of Alteogen's Hybrozyme platform," said Tae-Yon Chun, Ph.D., CEO of Alteogen.

NewBiologix partners with Synastra

NewBiologix S.A., a Swiss biotechnology company developing stable cell line technologies for recombinant adeno-associated virus manufacturing, announced an agreement with Synastra Biotechnology Inc. to develop a stable producer cell line for Synastra's investigational Duchenne muscular dystrophy gene therapy program.

Under the agreement, NewBiologix is set to use its proprietary Xcell Stable Manufacturing Platform to generate and characterize a stable Research Cell Bank for Synastra's DMD gene therapy candidate, with an option to transition the program to a commercial license supporting future clinical and commercial manufacturing.2

The collaboration brings together Synastra's expertise in genomic engineering, AAV vector design, rare-disease gene therapy, and translational development with NewBiologix's proprietary cell engineering and rAAV manufacturing technologies.2

"As we head into the $500bn patent cliff between 2026 and 2032, large pharma companies will become increasingly reliant on deal-making and sourcing externally to rejuvenate and continue to grow. Great news for biotech innovators and their investors,” said Dan Chancellor, VP of Thought Leadership, Norstella in a conversation with Pharmaceutical Executive.

Duchenne muscular dystrophy is a severe, progressive, X-linked neuromuscular disease affecting approximately one in 5,000 male births, caused by mutations in the DMD gene that prevent the production of functional dystrophin and lead to progressive degeneration of skeletal and cardiac muscle. Manufacturing is particularly critical for DMD gene therapies because systemic treatment may require some of the highest vector doses in the field, making rAAV productivity, consistency, scalability and cost decisive factors in development and broad availability.2 NewBiologix is developing Xcell to address these constraints by replacing repeated transient transfection with genetically engineered, stable producer cell lines designed for reproducible and scalable rAAV manufacturing.

"Gene therapy will not reach its full potential unless manufacturing evolves with it. DMD makes this challenge particularly clear because systemic treatment can require very large quantities of rAAV vector. Conventional transient transfection remains complex, costly and difficult to scale consistently. With Xcell, we integrate manufacturing into therapy development from the outset, through stable, genetically defined producer cell lines designed to reduce complexity and variability. This agreement with Synastra is an important validation of our strategy and of our ambition to make rAAV manufacturing more scalable, reproducible and economically sustainable," said Dr. Igor Fisch, CEO and co-founder of NewBiologix.

RedHill acquires Rebyota and Clenpiq from Ferring

RedHill Biopharma announced the acquisition of exclusive global and U.S. commercialization rights to Rebyota and Clenpiq from Ferring Pharmaceuticals, as part of Ferring's ongoing strategic refocusing.

As part of the deal, RedHill obtains an exclusive global commercialization license of Rebyota and an exclusive U.S. commercialization license of Clenpiq for an upfront payment of $12 million, plus tiered royalties on net sales and potential milestones.3 The $12 million upfront payment is fully funded through the previously announced $18 million Talicia divestment. Ferring is expected to retain it’s Rebyota manufacturing facilities and is set to continue supplying Rebyota through the term of the agreement.3

Together with the previously announced Talicia strategic divestiture, the acquisition of the two larger, proprietary, established gastrointestinal FDA-approved drugs completes a major strategic repositioning of RedHill's commercial GI business, creating a catalyst for commercial growth through a materially larger GI business under RedHill's control, with a significantly stronger liquidity position.3

"Rebyota is a first-in-class microbiota-based therapy for prevention of recurrent Clostridioides difficile infection in individuals 18 years of age and older following antibiotic treatment for recurrent infection. FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and an established customer base of approximately 600 active accounts," said Rick Scruggs, RedHill's chief commercial officer. "Clenpiq, a ready-to-drink low-volume bowel preparation on the U.S. market, delivered $20.6 million in net sales in 2025, with minimal promotion. Together the two assets give RedHill a significantly stronger commercial growth engine in both the U.S. and other new territories."

Sources

  1. Alteogen Enters Option and License Agreement with Novartis for Development and Commercialization of Hybrozyme -Enabled Subcutaneous Products Alteogen Inc. September 2, 2026, https://www.prnewswire.com/news-releases/alteogen-enters-option-and-license-agreement-with-novartis-for-development-and-commercialization-of-hybrozyme-enabled-subcutaneous-products-302867513.html
  2. NewBiologix and Synastra Biotechnology Partner to Advance Stable rAAV Manufacturing for Duchenne Muscular Dystrophy Gene Therapy NewBiologix September 2, 2026, https://www.newbiologix.com/news/newbiologix-and-synastra-biotechnology-partner-to-advance-stable-raav-manufacturing-for-duchenne-muscular-dystrophy-gene-therapy
  3. RedHill Announces Transformational Acquisition of Commercialization Rights to Ferring’s Rebyota® and Clenpiq RedHill BioPharma September 1, 2026, https://www.globenewswire.com/news-release/2026/09/01/3353970/0/en/redhill-announces-transformational-acquisition-of-commercialization-rights-to-ferring-s-rebyota-and-clenpiq.html