Boehringer Ingelheim and Inventiva collaborate to develop potential new treatments for idiopathic pulmonary fibrosis

Ridgefield, Conn., June 6, 2016 – Boehringer Ingelheim and Inventiva, a French biopharmaceutical company that specializes in the development of innovative therapies for fibrosis, oncology and orphan diseases, today announced a new multi-year research and drug discovery collaboration and licensing agreement.

Under the terms of the agreement, the Inventiva and Boehringer Ingelheim research teams will partner to validate a new therapeutic concept aimed at discovering new medicines for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases. The partnership will combine Inventiva’s deep knowledge and proprietary technologies in the field of transcriptional regulation and fibrosis with Boehringer Ingelheim’s capabilities in drug discovery and the clinical development of new therapeutic agents.

The new collaboration is an example of Boehringer Ingelheim’s increasing focus on external innovation and builds on the company’s track record in IPF drug development. Boehringer Ingelheim has successfully developed OFEV^® (nintedanib), a small molecule tyrosine kinase inhibitor approved and marketed globally for the treatment of IPF in adults, and will be responsible for the clinical development and commercialization of the potential drug candidates that result from this collaboration.

“We are very proud to enter into this collaboration with Boehringer Ingelheim, a company well-reputed for its excellent research and development skills in the field of fibrosis, and particularly idiopathic pulmonary fibrosis,” commented Inventiva’s co-founder and CSO Pierre Broqua. We plan, alongside developing our own pipeline, on pursuing our strategy of establishing collaborative research partnerships with the world’s biggest pharmaceutical companies. This new partnership further testifies to Inventiva’s expertise and contributes to strengthening our position as a leading and innovative actor in the field of fibrosis.”

"We are enthusiastic about this partnership and look forward to collaborating with Inventiva’s team to develop a potential new therapy for the treatment of idiopathic pulmonary fibrosis,” concluded Clive R. Wood, Ph.D., Senior Corporate Vice President Discovery Research at Boehringer Ingelheim. “We are impressed by Inventiva’s research and drug discovery competencies and deep knowledge of the field. We firmly believe that joining forces with Inventiva will enable us to foster translation of an aspirational new therapeutic concept into eagerly awaited new therapies for patients.”

Inventiva will receive an upfront payment and is eligible to receive research funding, potential research, development, regulatory and commercial milestone payments of up to $189+ million and tiered royalties on net sales of the products resulting from the partnership. Full financial details remain undisclosed.

About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a rare and serious lung disease that causes permanent scarring of the lungs. It affects as many as 132,000 Americans, typically men over the age of 65. Early diagnosis and proper care are critical to helping people treat their condition.

About OFEV^® (nintedanib)
The U.S. Food and Drug Administration (FDA) approved OFEV for the treatment of idiopathic pulmonary fibrosis (IPF) on October 15, 2014. OFEV is one of the first FDA-approved drug treatments for IPF and the only kinase inhibitor approved to treat this disease.

The approval was based on findings from a robust clinical trial program involving more than 1,200 patients with IPF worldwide, and included the Phase II TOMORROW^™ trial and the Phase III INPULSIS^™ trials (INPULSIS^™-1 and INPULSIS^™-2. All these studies were randomized, double-blind, placebo-controlled trials comparing OFEV 150 mg twice daily to placebo for 52 weeks. Both INPULSIS^™ trials were identically designed while the TOMORROW^™ study design was similar.

What is OFEV?
OFEV is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if OFEV is safe and effective in children.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about OFEV (nintedanib)?

OFEV can cause harm, birth defects or death to an unborn baby.  Women should not become pregnant while taking OFEV.  Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking OFEV, tell your doctor right away.

What should I tell my doctor before using OFEV?

Before you take OFEV, tell your doctor if you have:

• liver problems
• heart problems
• a history of blood clots
• a bleeding problem or a family history of a bleeding problem
• had recent surgery in your stomach (abdominal) area
• any other medical conditions.

Tell your doctor if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV.
• are a smoker.  You should stop smoking prior to taking OFEV and avoid smoking during treatment.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. John’s wort.

What are the possible side effects of OFEV?

OFEV may cause serious side effects. 

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

• Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal or feeling tired.  Your doctor will do blood tests regularly to check how well your liver is working during your treatment with OFEV.
• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects.  Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements. 
• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath. 
• Stroke. Symptoms of a stroke may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• Bleeding problems.  OFEV may increase your chances of having bleeding problems.  Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall.  Tell your doctor if you have pain or swelling in your stomach area.

The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Click here full Prescribing Information, including Patient Information. 

About Inventiva:  www.inventivapharma.com  (link is external)

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 unique mechanism of action going through 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 IVA336, a clinical program for the treatment of three different forms of mucopolysaccharidosis (MPS I or Hurler-Sheie syndrome, MPS II or Sly syndrome and MPS VI also known as Maroteaux-Lamy syndrome), as well as a preclinical stage oncology portfolio. 

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie. A strategic partnership has also been put in place with AbbVie, making Inventiva eligible for preclinical, clinical, regulatory and commercial milestone payments, in addition to royalties on the products resulting from the partnership. 

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

About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 145 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families.  Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2015, Boehringer Ingelheim achieved net sales of about $15.8 billion (14.8 billion euros). R&D expenditure corresponds to 20.3 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.       

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