Takeda Provides Update on Patent Litigation for ACTOS(R) (pioglitazone HCl) and ACTOplus met(R) (pioglitazone HCl and metformin HCl) in the U.S.

OSAKA, Japan and DEERFIELD, Ill., April 28 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") announced today that Takeda and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlement agreements with six out of eight defendants in patent infringement litigation brought against these parties in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl) and ACTOplus met® (pioglitazone HCl and metformin HCl). Takeda recently concluded litigation with the sixth settling defendant.

While preparing the fiscal 2010 financial outlook and Mid-Range Plan, Takeda is operating on the assumption that the entry of generic versions of ACTOS and ACTOplus met will be August 17, 2012 and December 14, 2012, respectively. FY 2010 financial outlook, as a part of FY 2009 Earnings Release, and the Mid-Range Plan will be announced on May 12, 2010 at 3 p.m., Japan Time.

Takeda has pending patent infringement lawsuits against two companies – Teva Pharmaceutical Industries, Ltd. ("Teva") and Aurobindo Pharma Limited ("Aurobindo"). These companies seek to market generic versions of ACTOS and ACTOplus met before the expiration of several Takeda patents in mid-2016. The patents at issue claim the combinations of pioglitazone with metformin, insulin secretion enhancers, or insulin. Until these lawsuits are resolved or concluded, the dates of entry of generic ACTOS and ACTOplus met are uncertain. Additional companies may also file ANDAs for generic ACTOS products, and Takeda is aware of two other companies that have already done so. Takeda is confident in and intends to continue to enforce its patents.

Summary of Settlements To Date

Takeda has executed agreements with Mylan Pharmaceuticals, Inc. ("Mylan"), Watson Pharmaceuticals, Inc. ("Watson"), Ranbaxy Pharmaceuticals, Inc. ("Ranbaxy"), Alphapharm Pty. Ltd. ("Alphapharm"), Torrent Pharmaceuticals Limited ("Torrent"), and Sandoz, Inc. ("Sandoz") and their respective affiliates, to settle patent infringement litigation brought against them relating to their ANDAs for generic ACTOS. Takeda has granted Mylan, Watson and Ranbaxy licenses to enter the United States (U.S.) market with generic pioglitazone on August 17, 2012. The license date could be earlier than August 17, 2012 under certain circumstances. Mylan, Watson and Ranbaxy are first-filers of ANDAs with paragraph IV certifications for generic ACTOS, and it is anticipated that the U.S. Food and Drug Administration (FDA) will grant them 180-day marketing exclusivity. Takeda has granted Alphapharm, Sandoz and Torrent licenses to enter the U.S. market with generic ACTOS 180 days after Mylan, Watson and Ranbaxy.

In addition, Takeda has granted Mylan a license to enter the U.S. market with generic ACTOplus met on December 14, 2012. The license date could be earlier than December 14, 2012 under certain circumstances. Mylan is the first-filer of an ANDA with a paragraph IV certification for generic ACTOplus met, and it is anticipated that the FDA will grant it 180-day marketing exclusivity for this product. Takeda has granted Ranbaxy, Sandoz, Watson and Torrent licenses to enter the U.S. market with generic ACTOplus met beginning 180 days after Mylan.

The litigation mentioned above for ACTOS and ACTOplus met is pending in the U.S. District Court for the Southern District of New York.

About ACTOS® (pioglitazone HCl) Indications and Usage

ACTOS® (pioglitazone HCl) is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.

Important Safety Information

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.

A patient should not take ACTOS if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOS and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.

ACTOS may cause low blood sugar when taken in combination with insulin or other oral antidiabetic drugs. Lightheadedness, shakiness, dizziness, or hunger, may mean that a patient's blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them. Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult with their doctor immediately. Some patients have experienced visual changes while taking ACTOS. Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.

Individuals 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 Complete Prescribing Information, including warning about heart failure and Medication Guide, please visit www.ACTOS.com.

About ACTOplus met® (pioglitazone HCl and metformin HCl) Indications and Usage

ACTOplus met® (pioglitazone HCl and metformin HCl) is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOplus met is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. ACTOplus met has not been studied in children and is not recommended for children under the age of 18.

Important Safety Information

ACTOplus met is not for everyone. Certain patients with heart failure should not start taking ACTOplus met. ACTOplus met can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, unusual tiredness, or slow heartbeat.

Metformin, one of the medicines in ACTOplus met, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

Because lactic acidosis occurs most frequently in people with kidney problems, ACTOplus met should not be used in people with kidney disease or in people 80 years of age or older whose kidneys do not work properly. ACTOplus met should not be taken by people with metabolic acidosis. ACTOplus met should not be taken by people who drink excessive amounts of alcohol. Patients should talk to their doctor if they are going to have an X-ray procedure using injectable dye.

A patient should not take ACTOplus met if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOplus met and periodically thereafter. A patient should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes. If a patient is of childbearing age, they should talk to their doctor before taking ACTOplus met, as it could increase their chance of becoming pregnant. A patient should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

ACTOplus met may cause low blood sugar. Lightheadedness, shakiness, dizziness, or hunger may indicate low blood sugar. Patients who experience low blood sugar should talk to their doctor.

Some people taking ACTOplus met may experience flulike symptoms, mild to moderate swelling of legs and ankles, anemia, and weight gain. Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult their doctor immediately.  Some patients have experienced visual changes while taking ACTOplus met. Some people, particularly women, are at higher risk of having bone fractures while taking pioglitazone. Other side effects may include cold-like symptoms, diarrhea, nausea, headache, urinary tract infection, dizziness, sinus infection, and anemia.

Individuals 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 Complete Prescribing Information, including warnings about heart failure and lactic acidosis and Medication Guide, please visit www.ACTOS.com.

About Takeda Pharmaceutical Company Limited

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine. Additional information about Takeda is available through its corporate Web site, www.takeda.com.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology and gastroenterology treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for diabetes, cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

SOURCE Takeda Pharmaceutical Company Limited

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