Inventiva Announces Exercise of Option by Boehringer Ingelheim to Jointly Develop Potential New Treatments for Idiopathic Pulmonary Fibrosis (IPF)

Regulatory News:

Inventiva (Paris:IVA), a French biopharmaceutical company developing innovative therapies, particularly for the treatment of fibrotic diseases, today announced the exercise of an option by Boehringer Ingelheim advancing the collaboration, which began in May 2016. The joint research team has validated a new fibrosis target and data generated in the program supports its therapeutic potential in fibrotic conditions and idiopathic pulmonary fibrosis (IPF) has been selected as the first indication to be investigated. Boehringer Ingelheim’s execution of this option triggers a milestone payment to Inventiva of €2.5m.

"We are very pleased with this decision by Boehringer Ingelheim, which underscores the research capabilities developed by Inventiva in fibrosis, and excited to develop this new IPF approach with Boehringer Ingelheim, a partner offering the research, development, and commercial expertise needed to develop breakthrough therapies for patients suffering from fibrotic diseases such as IPF,” said Pierre Broqua, Ph.D., Chief Scientific Officer and Co-Founder of Inventiva.

"We are excited about moving this very productive and highly interactive collaboration forward, which combines Inventiva’s strong competency and know-how in the field of transcriptional regulation and fibrosis with Boehringer Ingelheim’s expertise in the discovery and development of treatments for fibrotic diseases like IPF,” said Clive R. Wood, Ph.D., Senior Corporate Vice President Discovery Research at Boehringer Ingelheim "This collaboration with Inventiva is part of Boehringer Ingelheim’s comprehensive research and development focus on fibrotic diseases.”

In May 2016, Inventiva and Boehringer Ingelheim entered into a multi-year research and development partnership. Under the terms of the agreement, Inventiva and Boehringer Ingelheim will jointly validate a newly selected target, which potentially addresses a central mechanism driving the pathogenesis of IPF. Inventiva is eligible to receive research funding, milestone payments of up to €170m, and tiered royalty payments for any commercial product resulting from the collaboration.

Inventiva will use its fibrosis target-validation platform to study the mechanism of action of the target in several organs and provide data particularly derived from IPF patient cells which Inventiva has available in-house. Inventiva also contributes its expertise in drug discovery and a substantial collection of proprietary small molecule modulators of the target class. The drug discovery program will be jointly conducted by Inventiva and Boehringer Ingelheim teams, with the latter to take full responsibility of the preclinical and clinical development and commercialization of clinical candidates.

About idiopathic pulmonary fibrosis

IPF is a debilitating and fatal lung disease with high mortality,¹ affecting as many as 3 million people worldwide.^2,3 Progression of IPF is variable and unpredictable, and over time the lung function of an IPF patient gradually and irreversibly declines.¹ IPF causes permanent scarring or fibrosis of the lung, difficulty breathing and decreases the amount of oxygen the lungs can supply to major organs of the body.⁴ This is because over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream.⁴ As a result, individuals with IPF experience shortness of breath, a non-productive cough and often have difficulty participating in everyday physical activities.⁵

About Inventiva: www.inventivapharma.com

Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

IVA337, its lead product, is an anti-fibrotic treatment with a strong action mechanism permitting the activation of all three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing in parallel, a second clinical product, odiparcil, which is a treatment for three different forms of mucopolysaccharidosis: MPS I or Hurler/Scheie syndromes, MPS II or Hunter syndrome and MPS VI also known as Maroteaux-Lamy syndrome. Inventiva has a preclinical stage oncology portfolio.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie. Two strategic commercial partnerships, one of which is at clinical stage, have also been developed with AbbVie and Boehringer Ingelheim, making Inventiva eligible for preclinical, clinical, regulatory and commercial milestone payments, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 highly qualified employees and owns state-of-the-art R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice:

Some of the statements contained in this document are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements.

Please refer to the « Document de référence » filed with the Autorité des Marchés Financiers on April 26, 2017 under n° R.17-025 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

References:
1. Ley B., et al. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):431-40. doi: 10.1164/rccm.201006-0894CI. Epub 2010 Oct 8.
2. Nalysnyk L., et al. Incidence and prevalence of idiopathic pulmonary fibrosis: review of the literature. Eur Respir Rev. 2012;21(126):355-361.
3. Data on file. Boehringer Ingelheim. Worldwide prevalence 2016.
4. NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Accessed at: www.nhlbi.nih.gov/health/health-topics/topics/ipf/ Accessed May 2016.
5. Pulmonary Fibrosis Foundation. Symptoms. Available at: http://www.pulmonaryfibrosis.org/life-with-pf/about-pf. Accessed May 2016.

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