Boehringer Ingelheim Announces Enrollment of First Patient in Phase 3 Trial for Lead Hepatitis C Compound

Ridgefield, CT, April 26, 2011 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that enrollment has commenced at North American sites in its pivotal Phase 3 clinical trial program for BI 201335, the Company’s investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase 3 trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naïve and -experienced patients with chronic genotype-1 HCV, the most challenging HCV genotype to treat. ¹ Results from the Phase 3 studies are expected in the first half of 2013.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development program for BI 201335. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to patients earlier. ²

“We are pleased to have begun enrolling patients at North American trial sites as we continue development of BI 201335,” said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We look forward to initiating additional trials later this year in more patient populations, including HCV-HIV coinfected patients, as we continue to advance our HCV portfolio.”

BI 201335 U.S. Phase 3 Trials
There are currently three Phase 3 trials enrolling patients around the world that together seek to enroll approximately 1,875 patients. Two of the three trials have U.S. trial sites that together plan to enroll approximately 495 patients.

In the U.S., Study 1220.47 will enroll approximately 370 treatment-naïve genotype-1 HCV patients at 95 trial sites. This study will also include additional sites in Canada, Taiwan and Korea. Study 1220.7 will enroll approximately 125 treatment-experienced genotype-1 HCV patients who have failed at least 12 weeks of prior treatment with SOC at 40 trial sites in the U.S. This study also includes additional trial sites around the world. In treatment-naïve patients (Study 1220.47), BI 201335 will be dosed once-daily at either 120 mg or 240 mg for 12 or 24 weeks in combination with 24 or 48 weeks of pegylated interferon and ribavirin, the current HCV SOC. In treatment-experienced patients (Study 1220.7) BI 201335 will be dosed once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 48 weeks for prior partial and null responder patients. Patients with prior relapse will be dosed with BI 201335 once-daily at 240 mg for 12 or 24 weeks in combination with SOC for 24 or 48 weeks total duration. The primary endpoint of each trial is sustained viral response (SVR), which is considered viral cure. ³

For more information about clinical trials involving BI 201335, please visit www.clinicaltrials.gov.

About Hepatitis C Virus (HCV)
HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. ^1,4 The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year. ⁵ Only about 20-45 percent of patients clear the virus in the acute phase. ⁵ Of the remaining chronically infected patients, 20 percent will develop cirrhosis within a mean of 20 years. ¹ The mortality rate after cirrhosis has developed is two to five percent per year. ⁶ End-stage liver disease due to HCV infection currently represents the major cause for liver transplantation in the Western world. ¹

About Boehringer Ingelheim in Virology
Boehringer Ingelheim has more than 6,900 scientists working in cross disciplinary teams within our global R&D network in six large therapeutic areas, including virology. In addition to its ongoing research program for HCV, Boehringer Ingelheim has a long-standing history in virology drug development, including compounds for the treatment of HIV. The company has a well established research center in Laval, Canada, dedicated to virology research since the early 1990’s, and is committed to developing new therapies for virologic diseases with a high unmet medical need.

Boehringer Ingelheim in Hepatitis C Virus (HCV)
BI 201335 is an investigational oral HCV NS3/4A protease inhibitor, discovered from Boehringer Ingelheim’s own research and development, which has completed clinical trials through Phase 2b (SILEN-C studies). This Phase 2 program supports the investigation of BI 201335 in Phase 3 trials. Boehringer Ingelheim is also developing BI 207127, an NS5B RNA-dependent polymerase inhibitor that has completed Phase 1 clinical trials. Phase 2 trials evaluating BI 207127 with BI 201335 in interferon-sparing regimens, both with and without ribavirin, are currently underway.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

For more information, please visit https://ive.boehringer-ingelheim.com/,DanaInfo=.autBesjnyqwqp3Lw2wv30y38W0BA+ and follow us on Twitter at www.twitter.com/boehringerUS

SPIRIVA HandiHaler Prolonged Time to First COPD Exacerbation, New Study in NEJM Shows

Ridgefield, Conn. and New York, March 23, 2011 – A new study, published today in The New England Journal of Medicine (NEJM), showed that SPIRIVA ^® HandiHaler ^® (tiotropium bromide inhalation powder), a long-acting anticholinergic, was significantly more effective at preventing Chronic Obstructive Pulmonary Disease (COPD) exacerbations than salmeterol HFA-MDI (hydrofluororalkane-metered dose inhaler).  While salmeterol HFA-MDI, a beta-agonist is widely used as a COPD maintenance treatment worldwide, it is not approved in the U.S. for COPD or for reducing COPD exacerbations. The data are from The Prevention Of Exacerbations with Tiotropium (POET)-COPD ^® study, a randomized, double-blind, double-dummy, parallel-group trial involving 7,376 COPD male and female patients and conducted in 25 countries outside of the U.S. over one year. The objective of the study was to compare the effect of tiotropium HandiHaler and salmeterol HFA-MDI on moderate and severe COPD exacerbations.

The POET-COPD study primary results demonstrated that SPIRIVA HandiHaler prolonged the time to first COPD exacerbation compared to salmeterol HFA-MDI with a 17 percent reduction in risk (hazard ratio 0.83; p<0.001). In the one-year study, the risk of moderate exacerbations was reduced by 14 percent (p=0.001) and the risk of severe exacerbations requiring hospitalization was reduced by 28 percent (p<0.001) with SPIRIVA HandiHaler, compared to salmeterol HFA-MDI. SPIRIVA HandiHaler also produced an 11 percent reduction per year in the number of exacerbations experienced by COPD patients (p=0.002), and reduced the risk of exacerbations treated with systemic steroids, antibiotics, or both by 23 percent, 15 percent and 24 percent, respectively (p<0.001), compared to salmeterol HFA-MDI.

"This large exacerbation trial adds to the existing body of data regarding the efficacy and safety of SPIRIVA HandiHaler. It reinforces the evidence that, in addition to its use as a first-line maintenance bronchodilator for COPD, it also reduces COPD exacerbations," said Christopher Corsico, M.D., M.P.H., U.S. medical director, Boehringer Ingelheim Pharmaceuticals, Inc.

The study included 7,376 COPD patients, of whom 2,691 patients experienced 4,411 exacerbations; 44 percent of the patients with an exacerbation were in GOLD* Stage II (moderate COPD). The effects of SPIRIVA ^® HandiHaler ^® (tiotropium bromide inhalation powder) on time to first exacerbation and annual rate of exacerbations per patient were consistent over all pre-specified subgroup analyses for age, sex, smoking status, COPD severity (GOLD Stage), body mass index, and use of inhaled corticosteroids at baseline. Furthermore, the benefit of SPIRIVA HandiHaler compared with salmeterol HFA-MDI became apparent in this study as early as one month after commencement of treatment and was maintained over the one-year study period.

The safety profiles of SPIRIVA HandiHaler and salmeterol HFA-MDI have been well described. The POET-COPD safety analyses reaffirm the well-established safety profile of SPIRIVA HandiHaler in the treatment of COPD. The overall number of serious adverse events in the POET-COPD trial was comparable between the treatment groups (14.7 percent for SPIRIVA HandiHaler and 16.5 percent for salmeterol HFA-MDI).  

About POET-COPD ^®
Prevention Of Exacerbations with Tiotropium (POET)-COPD ^® was a one-year, multicenter (725 sites), multinational (25 countries), randomized, double-blind, double-dummy, parallel-group trial, which included 7,376 male and female COPD patients. The primary objective of this study was to compare the effect of tiotropium (18 mcg once daily) inhalation capsule via HandiHaler and salmeterol (50 mcg twice daily) via HFA metered dose inhaler (MDI) on time to first COPD exacerbation. Salmeterol HFA-MDI is not available in the U.S. and is not approved for COPD or for reducing COPD exacerbations in the U.S.

Patients included in the trial had to be =40 years of age, have a smoking history of =10 pack-years and a diagnosis of moderate to very severe COPD with a history of at least one exacerbation within the previous year requiring treatment with systemic steroids and/or antibiotics or hospitalization.

About COPD and COPD Exacerbations
COPD is a progressive, but preventable and treatable lung condition that is characterized by a restricted flow of air into and out of the lungs and loss of lung function over time.  It includes chronic bronchitis, emphysema, or both.

COPD is the fourth-leading cause of death and the second-leading cause of disability in the United States, and is projected to become the third-leading fatal illness by 2020. Each year, COPD kills 120,000 Americans – that's one death every four minutes.

The disease primarily affects current and former smokers and symptoms include shortness of breath, coughing (sometimes with phlegm or mucus) and wheezing. When most severe, COPD may even limit a person's ability to perform simple tasks such as washing and dressing. The damage in the lungs caused by COPD is not reversible, but it is treatable.

Exacerbations, also known as flare-ups, are a worsening of COPD symptoms, and frequent exacerbations indicate a deterioration and progression of the disease. They are associated with a more rapid decline in lung function over time and severe exacerbations with an increased risk of mortality, and they can severely compromise patients' health-related quality of life. Economic analyses suggest that hospitalization due to COPD exacerbations accounts for 40-70 percent of all medical expenses for patients with COPD. The cost of hospitalization for COPD patients is estimated at more than $20 billion annually.

About SPIRIVA ^® HandiHaler ^® (tiotropium bromide inhalation powder)
SPIRIVA Handihaler is a prescription medicine used once every day (a maintenance medicine) to control symptoms of chronic obstructive pulmonary disease (COPD) by relaxing your airways and keeping them open. COPD includes chronic bronchitis, emphysema, or both.

SPIRIVA HandiHaler also reduces the likelihood of flare-ups and worsening of COPD symptoms (COPD exacerbations). A COPD exacerbation is defined as an increase or new onset of more than one COPD symptom such as cough, mucus, shortness of breath, and wheezing that requires medicine beyond your rescue medicine.

Important Safety Information
Do not use SPIRIVA ^® HandiHaler ^® (tiotropium bromide inhalation powder) if you are allergic to tiotropium or ipratropium (Atrovent®). Allergic reactions may include itching, rash, or swelling of the lips, tongue or throat.

SPIRIVA HandiHaler is not a rescue medicine and should not be used for treating sudden breathing problems.

Do not swallow SPIRIVA capsules. The contents of the capsule should only be inhaled through the mouth using the HandiHaler device.

Stop taking SPIRIVA and get medical help right away if your breathing suddenly worsens, your throat, lips, or tongue swells, you get hives, you have vision changes or eye pain, or you have difficulty passing urine or painful urination.

Tell your doctor if you have glaucoma, problems passing urine or an enlarged prostate, as these may worsen with SPIRIVA. Tell your doctor if you have kidney problems or are allergic to milk proteins. Ask your doctor if you are not sure. Also discuss with your doctor all the medicines you take, including eye drops.

The most common side effect with SPIRIVA is dry mouth. Others include constipation and trouble passing urine. For a complete list of reported side effects, ask your doctor or pharmacist.

Do not get SPIRIVA powder in your eyes.

Read the Patient Information and the step-by-step Patient's Instructions for Use for SPIRIVA before you take your medicine.

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.

For full prescribing information, please visit www.spiriva.com, or call 1-800-542-6257 option #4.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

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