License and Commercialization agreement between Pierre Fabre and ValenzaBio on an anti-IGF-1R antibody for the development of a novel treatment in Thyroid Eye Disease (TED)

BESTHESDA, Maryland and CASTRES, France, April 8, 2021 /PRNewswire/ -- The US biopharmaceutical company ValenzaBio and the French pharmaceutical group Pierre Fabre announced today the signing of a license agreement of a preclinical insulin-like growth factor-1 receptor (IGF-1R) antagonist antibody, for the treatment of Thyroid Eye Disease (TED), an endocrine disease with unmet medical need. ValenzaBio received from Pierre Fabre the worldwide and exclusive rights to develop and commercialize, outside of oncology, the anti-IGF-1R antibody, discovered by Pierre Fabre at its Center of immunology located in Saint-Julien-en-Genevois  (France), with the aim of treating patients suffering from TED. Other indications in rare diseases could also be developed by ValenzaBio. In parallel, Pierre Fabre is pursuing the development of its anti-IGF-1R ADC program (W0101) in oncology.

"Pierre Fabre's expertise in monoclonal antibody and on the IGF-1 biology led us to develop a compound with picomolar binding affinity and unique internalization properties. Based on these properties, this monoclonal antibody has the potential to be the best in class product for the treatment of TED. ValenzaBio has demonstrated an ability to apply thoughtful clinical and regulatory strategies to take oncology drugs into autoimmune and inflammatory settings. We are now delighted to work with the highly motivated team at ValenzaBio to bring this antibody to autoimmune patients with medical needs." said Nathalie Corvaïa, Head of Immuno-Oncology Research at Pierre Fabre.

TED is a debilitating auto-immune disease associated with eye orbital inflammation and tissue remodeling which can result in significant proptosis, and might lead to vision loss.

Steroids are currently the first-line treatment but present several drawbacks complicating patient journey (lack of long-term efficacy, burden of administration scheme, promote comorbidities).

Current evidence indicates that IGF-1R is a proven target of interest that can bring value to patients.

Under the terms of the License and Commercialization agreement, Pierre Fabre will receive an upfront payment at signature, as well as additional development and sales milestone payments and will be eligible to receive royalties on future ValenzaBio sales. In addition, Pierre Fabre will make an equity investment in ValenzaBio.

Under the planned partnership, Pierre Fabre will have the option to reclaim rights in territories outside North America upon completion of the proof of concept in the TED indication. Pierre Fabre in return would then  pay ValenzaBio royalties on sales in these territories.

Patrick J. Crutcher, President and CEO of ValenzaBio, stated : "The Pierre Fabre Group has a worldwide reputation for exceptional products and a mission-driven approach to healthcare. Pierre Fabre has also been a leader in working directly with patients, alongside their health care professionals, to ensure patients play a more active role in treating their illnesses. This patient-centric approach is fundamental to the ValenzaBio mission as well. Together, we believe we can develop transformative treatments for the TED community."

"We are delighted to make this monoclonal antibody, developed under the code name VB421 by ValenzaBio, originating from our oncology research, available to ValenzaBio and thus to contribute to the search for an innovative therapeutic solution for patients with medical need. This agreement is another example of our deliberate strategy to partner with biotechs at pre-clinical, clinical or commercialization stages." commented Eric Ducournau, CEO of the Pierre Fabre Group. 

About ValenzaBio, Inc.

ValenzaBio is a privately held biopharmaceutical company focused on developing safe and effective therapies for autoimmune and inflammatory diseases. The company is advancing a pipeline of differentiated monoclonal antibodies targeting clinically validated mechanisms of action, in order to provide improved therapies for patients with limited treatment options. ValenzaBio's lead program, VB119, is being developed for the treatment of membranous nephropathy (MN), followed by VB421, which is being developed for the treatment of thyroid eye disease. ValenzaBio is based in Bethesda, Md.

For more information, please visit www.valenzabiotech.com

About Pierre Fabre

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for non-prescription products sold in pharmacies.

In 2020, Pierre Fabre generated €2.2 billion in revenues, 65% of which came from international sales.

Established in the South-West of France since its creation, the Group manufactures over 95% of its products in France and employs some 10,000 people worldwide. Its products are distributed in about 130 countries.

Pierre Fabre is 86%-owned by the Pierre Fabre Foundation, a government-recognized public-interest foundation, and secondarily by its own employees through an international employee stock ownership plan.

In 2019, Ecocert Environment assessed the Group's corporate social and environmental responsibility approach according to the ISO 26000 standard on sustainable development and awarded it the ECOCERT 26000 "Excellence" level.

Further information about Pierre Fabre can be found at www.pierre-fabre.com, @PierreFabre

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