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Inventiva Regulatory Filings 2017

Sep 18, 2017

1448_iss_2017-09-18_f362eeea-97c4-4f3d-8837-8831719d1523.pdf

Regulatory Filings

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PRESS RELEASE COMMUNIQUE DE PRESSE Inventiva's IVA337 Given Generic Name "Lanifibranor" by the World Health Organization (WHO)

  • Lanifibranor (formerly IVA337) is the first next generation panPPAR α, δ and to receive the fibranor suffix
  • Lanifibranor is the Inventiva's lead drug candidate currently in Phase IIb development for both systemic sclerosis (SSc) and non-alcoholic steatohepatitis (NASH)

Daix (France), September 18, 2017 at 05:45pm CEST – Inventiva, a biopharmaceutical company developing innovative breakthrough therapies, particularly for the treatment of fibrotic diseases, today announced that the World Health Organization (WHO) has granted it the international non-proprietary name (INN, or generic name) lanifibranor for IVA337, its leading drug candidate, currently is in Phase IIb development for both systemic sclerosis (SSc) and non-alcoholic steatohepatitis (NASH).

"We are very pleased that the INN division of the WHO has granted the suffix "fibranor" to IVA337," said Frédéric Cren, Chief Executive Officer and Co-Founder of Inventiva. "Lanifibranor's anti-fibrotic activity ideally positions this drug candidate as a potential treatment of several fibrotic diseases, particularly systemic sclerosis and NASH. We look forward to continuing the clinical development of this drug candidate in these two indications with high unmet medical need."

About Lanifibranor

Lanifibranor is a next generation panPPAR modulator designed as a moderately potent and well balanced PPAR and . This unique profile was conceived in order to obtain an optimal therapeutic margin with strong efficacy and tolerance. Lanifibranor is currently in Phase IIb development for both systemic sclerosis (SSc) and non-alcoholic steatohepatitis (NASH). Results from the SSc clinical trial are expected in the second half of 2018, while those of the NASH trial are due for early 2019.

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.

Lanifibranor, 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.

PRESS RELEASE

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie. Two strategic commercial partnerships have also been established 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.

Contacts

Inventiva Frédéric Cren Chief Executive Officer [email protected] +33 (0)3 80 44 75 00

NewCap Julien Perez / Mathilde Bohin Investor Relations [email protected] +33 (0)1 44 71 98 52

NewCap Nicolas Merigeau / Arthur Rouillé Media Relations [email protected] +33 (0)1 44 71 94 98

LifeSci Advisors Chris Maggos Investor Relations [email protected] +41 79 367 6254

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.