New Long-Term Data Demonstrates Continued Safety and Beneficial Effect of Ofev^® (Nintedanib) for Patients with IPF

Ridgefield, Conn., September 7, 2016 – Boehringer Ingelheim Pharmaceuticals, Inc. presented eight idiopathic pulmonary fibrosis (IPF)-related abstracts at the European Respiratory Society (ERS) International Congress 2016, including new interim data from the INPULSIS^®-ON extension trial assessing long-term treatment with Ofev^® (nintedanib). The results demonstrated that Ofev has a long-term effect on slowing disease progression and a manageable side effect profile in patients with IPF, and were consistent with results previously observed in the INPULSIS^® trials. IPF is a rare and serious lung disease causing permanent scarring of the lungs, typically affecting men over the age of 65.

The INPULSIS^®-ON interim data showed that the change from baseline in forced vital capacity (FVC) in patients continuing treatment with Ofev in the extension trial between baseline and week 48 and between weeks 48 and 96 was comparable to what was observed in patients on active treatment with Ofev in the 52-week INPULSIS^® parent trials.

"These new long-term data provide evidence that slowing disease progression with Ofev treatment is sustained for up to three years,” said Lisa Lancaster, M.D., associate professor, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center. “These results are important because they add to the consistent body of evidence demonstrating the long-term, beneficial effect of Ofev for people living with IPF.”

The following changes in FVC were seen in INPULSIS^® and INPULSIS^®-ON:

• In INPULSIS^®, for patients on nintedanib mean change in FVC from baseline to week 52 was −89mL compared to – 203mL for patients on placebo
• In INPULSIS^®-ON, for patients continuing nintedanib mean change in FVC was −96 mL from baseline to week 48
• In INPULSIS^®-ON, for patients continuing nintedanib mean change in FVC was −124mL from week 48 to week 96

Average total exposure of patients treated with Ofev in INPULSIS^® and INPULSIS^®-ONtrials was approximately three years (35.7 months). Long-term treatment with Ofev (up to 51 months) was associated with a manageable safety and tolerability profile consistent with the findings of the INPULSIS^®studies and with no new safety signals identified.  Side effects with Ofev can be effectively managed in most patients, with diarrhea being the most frequently reported side effect.

Additional INPULSIS^® analyses assessing the effect of OFEV^®

Two additional subgroup-analyses from the INPULSIS^® study examined whether disease extent at baseline as measured by the composite physiologic index (CPI) or the level of gas exchange impairment in the lungs could impact the treatment effect of Ofev. Gas exchange is the delivery of oxygen from the lungs to the bloodstream, and the elimination of carbon dioxide from the bloodstream to the lungs. The level of gas exchange was assessed by the diffusing capacity of the lungs for carbon monoxide (DLCO). Lower values of DLCO imply a higher impairment of the capacity of the lung to exchange gases. The CPI is an index that more accurately reflects the extent of fibrosis in the lungs than individual lung function tests. Both analyses confirmed the beneficial effect of Ofev on annual rate of FVC decline irrespective of the level of baseline impairment, and provide further evidence of the benefits of nintedanib in slowing disease progression in a range of IPF patients.

These data were presented at the European Respiratory Society International Congress 2016. The corresponding abstracts can be found within the online program, here: http://www.erscongress.org/programme-2016/access-the-programme.html 

About the INPULSIS^® trials
INPULSIS-1 and -2 are two global Phase III trials which evaluated the efficacy and safety of nintedanib in the treatment of idiopathic pulmonary fibrosis (IPF). The INPULSIS^® trials were identical in design, e.g., with matching dosing, inclusion criteria and endpoints. INPULSIS^® recruited a range of patient types – similar to those seen in clinical practice including patients with early disease (FVC > 90% pred), no honeycombing on HRCT and/or concomitant emphysema. Patients who completed the 52-week treatment period and a 4-week follow-up period in the INPULSIS^® trials were offered open-label treatment with OFEV^® as part of an extension trial to assess the long-term safety and tolerability of OFEV. The INPULSIS^®-ON (Clinicaltrial.gov trial identifier: NCT01619085) trial included 734 patients and is currently ongoing.

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 for full Prescribing Information, including Patient Information.

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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