New Analyses Showed Consistent Efficacy of OFEV® (nintedanib) Across Various Patient Populations with Idiopathic Pulmonary Fibrosis (IPF)

Ridgefield, Conn. and Montreal, October 26, 2015 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced the presentation of three new post-hoc analyses from the Phase III INPULSIS™ trials. The first analysis showed treatment with OFEV has similar and consistent effects on disease progression (as measured by annual rate of forced vital capacity [FVC] decline) and the amount of time to the first acute exacerbation -- regardless of whether people with IPF enrolled in the trials in the U.S. or internationally.

“In a rare lung disease like IPF, which has unique characteristics and affects people around the world, it is critical to help pulmonologists make informed treatment decisions by understanding the effectiveness of OFEV in these different patient populations,” said Dr. John Huggins, Associate Professor Department of Medicine, Medical University of South Carolina. “This new analysis showed that OFEV is comparably effective in people with IPF regardless of where they were enrolled in the trial.”

The second new analysis, showed comparable efficacy with OFEV treatment on slowing disease progression, regardless of the presence of extensive lung scarring (or honeycombing) on imaging tests at diagnosis. The two subgroup analyses were presented today at the American College of Chest Physicians Annual Meeting (CHEST 2015) in Montreal, Canada.

A third analysis evaluated the St. George’s Respiratory Questionnaire (SGRQ) as an appropriate tool to measure health-related quality of life among people with IPF (abstract 722A). This questionnaire was originally developed to assess the health status of patients living with diseases of airway obstructions, such as chronic obstructive pulmonary disease (COPD) and asthma.

Post-hoc combined analysis of U.S. versus non-U.S. patients in the Phase III INPULSIS™ trials (NCT01335464 and NCT01335477; abstract 394A)
This analysis, a comparison of adjusted annual rate of FVC decline (a measure of disease progression) and the amount of time to first acute exacerbation among U.S. and non-U.S. patients, reported that the effect of OFEV treatment was similar regardless of where patients enrolled in the clinical program.

• Annual rate of decline in FVC in U.S. patients was −94.7 mL/year with OFEV and −242.5 mL/year with placebo (difference of 147.8 mL/year [95% CI: 56.1, 239.4]) while in non-U.S. patients it was −117.0 mL/year with OFEV and −220.0 mL/year with placebo (difference of 103.0 mL/year [95% CI: 66.2, 139.7])
• The hazard ratio for time to first acute exacerbation was 0.37 (95% CI: 0.06, 2.12) in U.S. patients and 0.68 (95% CI: 0.41, 1.15) in non-U.S. patients, both in favor of OFEV.

In total, 160 patients (OFEV 98, placebo 62) were enrolled from U.S. clinical trial sites, while 901 patients (OFEV 540, placebo 361) were enrolled in clinical trials sites outside the U.S.

Adverse events were reported in 100 percent and 98.4 percent of U.S. patients; and 94.6 percent and 88.1 percent of non-U.S. patients in the OFEV and placebo groups, respectively.

“At Boehringer Ingelheim, we strive to advance the understanding of IPF,” said Danny McBryan, M.D., vice president, Clinical Development and Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. “Significant achievements have been made in the treatment of IPF, and we are committed to ongoing research that helps healthcare professionals, patients and their caregivers make the best decisions to treat this devastating disease.”

Post-hoc combined analysis of patients with or without honeycombing in the Phase III INPULSIS™ Trials (NCT01335464 and NCT01335477; abstract 361A)
This analysis examined the effect of OFEV on adjusted annual rate of FVC decline (a measure of disease progression), regardless of honeycombing seen on the lungs from high-resolution CT scans when people with IPF enrolled in the clinical program. In total, 567 patients (OFEV 326, placebo 241) had honeycombing at baseline and 494 (OFEV 312, placebo 182) did not.

The analysis reported a consistent effect of OFEV in patients whether or not honeycombing was present:

• In patients with honeycombing, the adjusted annual rate of decline in FVC was −117.8 mL/year with OFEV and −212.8 mL/year with placebo (difference of 95.0 mL/year [95% CI: 49.0, 141.0])
• In patients without honeycombing, the adjusted annual rate of decline in FVC was −109.3 mL/year with OFEV and −237.2 mL/year with placebo (difference of 127.9 mL/year [95% CI: 76.8, 179.1]).

The abstracts presented at the CHEST 2015 meeting can be downloaded here.

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) capsules
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 (NCT00514683) and the Phase III INPULSIS™ trials (INPULSIS™-1 and INPULSIS™-2; NCT01335464 and NCT01335477). 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 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
• are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.
• have 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 and your doctor should decide if you will take OFEV or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort. Keep a list of the medicines you take and show it to your doctor and pharmacist when you get a new medicine.

What are the possible side effects of OFEV?

OFEV may cause serious side effects, including:

• Liver problems. Call your doctor right away if you have unexplained symptoms such as 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 function is working during your treatment with OFEV.
• Diarrhea, nausea, and vomiting. Tell your doctor if you have these symptoms or if they do not go away or become worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements that can cause diarrhea.  While you are taking OFEV, your doctor may recommend that you drink fluids or take medicine to treat these side effects. 
• Heart attack. Tell your doctor right away if you have symptoms of a heart problem which may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• Stroke. Tell your doctor right away if you have symptoms of a stroke which 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. Tell your doctor 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.

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 146 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.

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