Boehringer Ingelheim and Harvard scientists establish a research alliance to find novel treatments for severe fibrotic diseases

  • Fibrotic diseases represent a serious healthcare problem, which potentially results in disability and even death for millions of people worldwide with currently only limited effective treatment options available
  • New research alliance aims to find better treatments for diseases like idiopathic pulmonary fibrosis (IPF), chronic kidney disease (CKD) and nonalcoholic steatohepatitis (NASH) by investigating common mechanisms
  • Alliance is open for other Harvard-affiliated groups interested in contributing to fibrosis research and will grow over time

Ridgefield, Conn., June 9, 2016 – Boehringer Ingelheim today announced it has established a research collaboration with the Harvard Stem Cell Institute’s - Harvard Fibrosis Network to discover new ways of treating fibrotic diseases such as idiopathic pulmonary fibrosis (IPF), chronic kidney disease (CKD) and nonalcoholic steatohepatitis (NASH). The Harvard Fibrosis Network unites Harvard investigators in several of the University’s schools and at Harvard-affiliated Massachusetts General Hospital and Brigham and Women’s Hospital.

Fibrosis is the formation of excess fibrous connective tissue in an organ or tissue and is typically associated with irreversible injury, scarring and inflammation of organs. The biology and mechanisms of progression of fibrotic diseases are poorly understood. The diseases can affect many organs, including liver, bone marrow, lung, kidney, gastrointestinal tract, skin, eye, and the heart, which may lead eventually to organ failure, severe disability and even death. They are a major cause of morbidity and mortality worldwide. Currently, treatments for fibrotic diseases are limited and new approaches are eagerly awaited by patients and physicians. Consequently, deeper insights into the common causes of fibrotic diseases are urgently needed to enable the discovery of new therapeutic approaches and better treatments. 

In collaboration with the Harvard Stem Cell Institute and the Harvard Fibrosis Network, Boehringer Ingelheim is initially sponsoring three projects to explore novel pathways and molecular targets for the treatment of IPF, CKD and NASH. Through the research collaboration, the project teams will also have access to the chemical compound collection and siRNA library at the ICCB-Longwood screening facility and will be supported by Shannan Ho Sui’s bioinformatics team at the Harvard Chan Bioinformatics Core at the Harvard Stem Cell Institute’s Center for Health Bioinformatics to discover new drivers of fibrosis.

Boehringer Ingelheim is committed to investigating underlying pathophysiological mechanisms to enable the discovery of new treatments for diseases with high unmet medical need. Consequently, a fibrosis cluster has been established in Discovery Research to support the identification of new targets for CardioMetabolic Diseases and Immunology and Respiratory Diseases. This research has already enabled the development of Ofev® (nintedanib), a compound to treat idiopathic pulmonary fibrosis, which is approved in the US, EU and other countries and is currently also being studied in systemic sclerosis with interstitial lung disease (SSc-ILD) in a Phase III clinical trial (SENSCIS™).

“We are very excited about joining forces with this renowned group of fibrosis researchers,” said Clive R. Wood, Ph.D., senior corporate vice president Discovery Research at Boehringer Ingelheim. “We strongly believe that the integration of deep medical and preclinical research expertise across multiple fibrotic disorders is centrally important for the discovery of new treatments for patients.” Furthermore, Wood emphasized, “The Harvard Fibrosis Network and Boehringer Ingelheim’s fibrosis cluster team will work closely together to translate new findings and chemical starting points into drug discovery programs at Boehringer Ingelheim.”

Joseph V. Bonventre, M.D.,Ph.D., executive committee member of the Harvard Stem Cell Institute, and chief of the Renal Unit and director of the Bioengineering Division at Brigham and Women's Hospital added, “The breadth and depth of this collaborative effort is yet another reminder of Harvard Stem Cell Institute’s power as both a convener and a driver of research and treatment development. HSCI has brought together researchers across the Harvard biomedical ecosystem who are working in multiple organ systems with a leading pharmaceutical company with the goal of bringing new therapeutic approaches to a problem which is pervasive in medicine.”

All research projects will be sponsored by Boehringer Ingelheim for an initial period of three years with additional projects added upon selection by the joint steering committee. Further details of the agreement are not disclosed.

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 the Harvard Stem Cell Institute
The Harvard Stem Cell Institue brings together more than 1,000 scientists in the schools and affiliated hospitals of Harvard, to fund novel research, and implement new collaborative academic and industrial models, all focused on advancing basic understanding of human development and disease, and on using stem cell science to develop cures and treatments for a wide range of human diseases and conditions.

About Harvard Fibrosis Network
The Harvard Fibrosis Network is a scientific collaborative of distinguished Harvard researchers led by Joseph Bonventre, Executive Committee member of Harvard Stem Cell Institute (HSCI) and Chief of the Renal Unit at Brigham and Women’s Hospital. Further leaders of the Network are, Harvard Stem Cell Institute (HSCI) researchers Andrew Tager, Principal Investigator at the Center for Immunology and Inflammatory Diseases at Massachusetts General Hospital (MGH); Raymond T. Chung, Principal Investigator and Vice Chief of Gastrointestinal Unit at MGH; and Alan Mullen, Principal Investigator in the Liver Center at MGH.

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.         

PC-OF-0137-PR