Takeda Pharmaceuticals U.S.A., Inc. Announces Plans to Transform Business, Enhancing Value for Patients

DEERFIELD, Ill., March 15, 2016 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") has announced moves which will strengthen the focus on its recent product launches in inflammatory bowel disease (IBD) and major depressive disorder (MDD), including the creation of business units to capitalize on opportunities to create the most value for patients.

"Takeda is focusing resources behind opportunities where we can lead; we are making very deliberate strategic choices on where we will invest, and where we won't," said Ramona Sequeira, President, Takeda Pharmaceuticals U.S.A., Inc. "We want to ensure we are focused on areas where we can provide the most value for patients over the long-term."

In keeping with the targeted focus, Takeda has agreed to transfer back to Orexigen the rights to develop and commercialize CONTRAVE® (naltrexone HCl / bupropion HCl) in the United States, pending the parties' receipt of clearance under the Hart-Scott-Rodino Antitrust Improvement Act ("HSR Act"). This move allows Takeda to better focus promotional resources against its portfolio of medicines in areas such as MDD, IBD, gout and diabetes.

On the heels of a successful launch of ENTYVIO® (vedolizumab) in the U.S., Takeda recently created a dedicated Specialty Business Unit. Stephanie Brown joined Takeda from Biogen in the newly created role of Vice President of Specialty Business. Brown has more than 25 years of experience in the healthcare industry and brings to Takeda additional expertise in specialty therapeutics. The formation of the Specialty Business Unit will enable Takeda to develop best-in-class capabilities in areas such as patient support and evidence generation.

Takeda recently acquired a U.S.-based biologics manufacturing facility which will manufacture ENTYVIO along with other biologic products. The acquisition of the facility will allow Takeda to further support U.S. patients with moderate to severe ulcerative colitis and Crohn's disease, and allow the company to maximize global efficiencies and further enhance supply chain flexibility for ENTYVIO.

Also as part of the targeted focus, Takeda has created a General Medicine Business Unit, led by Senior Vice President Thomas Gibbs, most recently of Vanda Pharmaceuticals, to support operations and marketing of the company's medicines in the areas of central nervous system (CNS), gastroenterology, gout and diabetes. Gibbs has deep commercial experience across therapeutic areas that include CNS, diabetes and others.

The formation of the two Business Units will help Takeda support customers and patients more effectively. "The functional model of Takeda's past does not allow us to take an integrated approach to commercialization, which is what our customers need us to do as the U.S. healthcare system evolves," said Sequeira. "We need to be able to look across evidence generation, patient access, and commercialization strategies and ensure they are aligned to meet the needs of patients, payors and providers in order to truly provide value through our medicines."

In addition to bringing key leadership onboard to manage the two newly formed business units, Takeda has attracted other talented leaders to the U.S. executive team including:

• Richard Ascroft joined Takeda from Eli Lilly and Company in the newly created position of Vice President, Managed Markets and Government Affairs, and will help the company find new ways of engaging with health systems and payors.
• Nicole Mowad-Nassar, who has been with Takeda for seven years, filled a newly created role as Vice President, External Partnerships, focusing primarily on digital and big data.
• William "BJ" Jones joined Takeda from AstraZeneca as Head of Sales and Operations, General Medicine Business Unit, where he will lead Takeda's field sales and operations teams as they continue to evolve their sales model to even more patient and customer centricity.

The new U.S. strategy and organization comes under the leadership of Takeda President Ramona Sequeira, who was appointed President on June 1^st, 2015.

About CONTRAVE
CONTRAVE, approved by the United States Food and Drug Administration in September 2014, is indicated for use as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obese), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus or dyslipidemia).

The exact neurochemical effects of CONTRAVE leading to weight loss are not fully understood. CONTRAVE has two components: naltrexone, an opioid antagonist, and bupropion, a relatively weak inhibitor of the neuronal reuptake of dopamine and norepinephrine. Nonclinical studies suggest that naltrexone and bupropion have effects on two separate areas of the brain involved in the regulation of food intake: the hypothalamus (appetite regulatory center) and the mesolimbic dopamine circuit (reward system).

Four 56-week multicenter, double-blind, placebo-controlled Phase 3 clinical trials were conducted to evaluate the effect of CONTRAVE in conjunction with lifestyle modification in 4,536 subjects randomized to CONTRAVE or placebo. The most common adverse reactions (greater than or equal to5 percent) seen in patients taking CONTRAVE included nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.

Important Safety Information for CONTRAVE (naltrexone HCl and bupropion HCl) 8 mg/90 mg extended-release tablets
CONTRAVE can cause serious side effects of suicidal thoughts or actions. CONTRAVE contains bupropion HCl which has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment.

Stop taking CONTRAVE and call a healthcare provider right away if you, or your family member, have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.

While taking CONTRAVE, you and your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings, and tell your healthcare provider. CONTRAVE has not been studied in and is not approved for use in children under the age of 18.

Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and APLENZIN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids such as methadone or buprenorphine, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking; use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and you stop using them suddenly, as these may increase your chance of having a seizure; have taken medicines called monoamine oxidase inhibitors (MAOIs), including linezolid, within the last 14 days; are allergic to any of the ingredients in CONTRAVE; are pregnant or planning to become pregnant. Tell your healthcare provider right away if you become pregnant.

Tell your healthcare provider about all of your medical conditions, especially: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Swallow CONTRAVE tablets whole. Do not cut, chew, or crush CONTRAVE tablets. Do not take CONTRAVE with high-fat meals. It may increase your risk of seizures. Take CONTRAVE exactly as prescribed.

CONTRAVE may cause serious side effects, including:
Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk is higher in people who: take higher doses of CONTRAVE; have certain medical conditions; take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay. If you have a seizure, stop taking CONTRAVE, tell your healthcare provider right away, and do not take CONTRAVE again.

Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death. Get emergency medical help right away if you have trouble breathing; become drowsy with slowed breathing; have slow, shallow breathing; or feel faint, dizzy, or confused.

Sudden opioid withdrawal. Do not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines (including tramadol), cough, cold, or diarrhea medicines that contain opioids, or opioid-dependence treatments, buprenorphine, or methadone, for at least 7 to 10 days before starting CONTRAVE. This may cause you to have sudden symptoms of opioid withdrawal, which can be severe and may require hospitalization. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery.

Severe allergic reactions. Stop taking CONTRAVE and get medical help immediately if you have any signs and symptoms of severe allergic reactions: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing.

Increases in blood pressure or heart rate. Your healthcare provider should check your blood pressure and heart rate before and during CONTRAVE treatment.

Liver damage or hepatitis. Stop taking CONTRAVE if you have any symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treatment if you get signs or symptoms of a serious liver problem.

Manic episodes. CONTRAVE can cause some people who were manic or depressed in the past to become manic or depressed again.

Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your doctor to find out if you are at risk.

Increased risk of low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). Check your blood sugar before and during CONTRAVE treatment.

The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea.

These are not all the possible side effects of CONTRAVE. Tell your healthcare provider about any side effect that bothers you or does not go away.

Talk to your doctor or healthcare professional. Please see accompanying full Prescribing Information and Medication Guide for CONTRAVE.

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.

CONTRAVE® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc. All other trademarks are the property of their respective owners.

About Entyvio^® (vedolizumab)
Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Entyvio does not bind to or inhibit function of the alpha4beta1 and alpha E beta 7 integrins and does not antagonize the interaction of alpha4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The alpha4beta7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn's disease.

Important Safety Information about ENTYVIO® (vedolizumab)

• Do not receive ENTYVIO if you have had an allergic reaction to ENTYVIO or any of its ingredients.
• ENTYVIO may cause serious side effects, including:
  • Infusion and serious allergic reactions can happen while you are receiving ENTYVIO or several hours after treatment. You may need treatment if you have an allergic reaction. Tell your healthcare provider or get immediate medical help if you get any of these symptoms during or after an infusion of ENTYVIO: rash, itching, swelling of your lips, tongue, throat or face, shortness of breath or trouble breathing, wheezing, dizziness, feeling hot, or palpitations (feel like your heart is racing).
  • ENTYVIO may increase your risk of getting a serious infection. Before receiving and during treatment with ENTYVIO, tell your healthcare provider if you think you have an infection or symptoms of an infection, such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, red or painful skin or sores on your body, tiredness, or pain during urination.
  • Although it has not been reported with ENTYVIO, it may be possible for a person to get progressive multifocal leukoencephalopathy (PML) (a rare, serious brain infection caused by a virus). People with weakened immune systems can get PML, which can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any of the following symptoms: confusion or problems thinking, loss of balance, change in the way you walk or talk, decreased strength or weakness on one side of the body, blurred vision, or loss of vision.
  • Liver problems can happen in people who receive ENTYVIO. Tell your healthcare provider right away if you have any of the following symptoms: tiredness, loss of appetite, pain on the right side of your abdomen, dark urine, or yellowing of the skin and eyes (jaundice).
• The most common side effects of ENTYVIO include common cold, headache, joint pain, nausea, fever, infections of the nose and throat, tiredness, cough, bronchitis, flu, back pain, rash, itching, sinus infection, throat pain, and pain in extremities. These are not all the possible side effects of ENTYVIO. Call your healthcare provider for medical advice about side effects.
• Before receiving ENTYVIO, tell your healthcare provider about all of your medical conditions, including if you: have or think you may have an infection or have infections that keep coming back; have liver problems; have tuberculosis (TB) or have been in close contact with someone with TB; have recently received or are scheduled to receive a vaccine; or if you are pregnant, breastfeeding, plan to become pregnant, or plan to breastfeed.

Please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.

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.

More information is available at www.ENTYVIOHCP.com and www.ENTYVIO.com.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

SOURCE Takeda Pharmaceuticals U.S.A., Inc.

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