2013 FACT BOOK FACT BOOK

Transcription

1 2013 FACT BOOK FACT BOOK FACT BOOK

2 BecOming abbvie abbvie is a global biopharmaceutical company focused on developing advanced therapies that address some of the world s most complex and serious diseases. AbbVie is a leader in addressing these challenges, with an expanded focus on biologics and targeted medicine. We use our knowledge and expertise to develop therapies that address difficult conditions affecting significant patient populations. Our priority is our patients and helping them lead healthier lives. AbbVie has a solid financial foundation, a strong product portfolio, and a compelling new product pipeline that provide us with the resources we need today and for the long term. We have delivered industry-leading pharmaceutical performance over the last decade. Our senior leadership understands how to manage our company and its 21,000 employees for success and long-term, profitable growth. Our global footprint serves patients in more than 170 countries FACT BOOK 3

3 Our Therapeutic Focus AbbVie s products and pipeline are focused on a wide range of serious conditions that affect significant patient populations, including: Hepatitis C Rheumatoid arthritis Psoriasis Multiple sclerosis Alzheimer s disease Parkinson s disease Spondyloarthropathies Multiple myeloma Endometriosis FACT BOOK 2013 FACT BOOK 5

4 * abbvie markets leading products around the world FACT BOOK * Synagis is a trademark of MedImmune. Please see Uses and Important Safety Information beginning on page FACT BOOK 7

5 Our Compelling Pipeline AbbVie has a compelling new product pipeline of advanced treatments that target some of the most pressing medical conditions. We have developed proprietary technologies and methods to help us better prioritize our pipeline and investments so that we can more quickly advance the most promising compounds from laboratory to clinical trials. Over the last several years, we have tripled the number of new molecular entities. We currently are evaluating more than 20 Phase II and III clinical programs. Working to obtain 15 regulatory approvals delivering significant benefits for patients between 2013 and 2017 Ten Phase III programs, including Hepatitis C (HCV), Oncology, Immunology, Neuroscience, and Women s Health Seven programs with proof of concept moving to Phase III over the next two years Augmented pipeline with nine new molecules since 2010 Specialty-focused pipeline comprised of approximately 30 percent biologics Our Partnerships At AbbVie, we understand that progress often comes more quickly working together than alone. That s why we collaborate with external researchers, other companies, medical societies, patient advocates, and many other stakeholders to gain a better understanding of how we can make the most significant contributions in our areas of focus FACT BOOK 2013 FACT BOOK 9

6 Facts at a Glance Management Team Richard A. Gonzalez Chairman of the Board and Chief Executive Officer Laura J. Schumacher Executive Vice President, Business Development, External Affairs and General Counsel William J. Chase Executive Vice President, Chief Financial Officer Carlos Alban Executive Vice President, Commercial Operations John M. Leonard, M.D. Senior Vice President, Chief Scientific Officer Timothy J. Richmond Senior Vice President, Human Resources AZITA SALEKI-GERHARDT, Ph.d. Senior Vice President, Operations Ronald O. Robison, M.D., M.S. Vice President, Regulatory Affairs JOSE E. RIVERA, Jr Vice President, Chief Ethics and Compliance Officer GLENN S. WARNER Vice President, Strategic Initiatives Corporate Headquarters: North Chicago, Illinois, USA Stock Exchange Listing: NYSE: ABBV Number of Global Employees: Approximately 21,000 worldwide AbbVie Countries: 170+ Global Research Centers: North Chicago, Illinois, USA Redwood City, California, USA Ludwigshafen, Germany Shanghai, China Worcester, Massachusetts, USA FACT BOOK 2013 FACT BOOK 11

7 Uses HUMIRA (adalimumab) is a prescription medicine used: To reduce the signs and symptoms of: Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines. Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities. Ankylosing spondylitis (AS) in adults. Moderate to severe Crohn s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also for these adults who have lost response to or are unable to tolerate infliximab. In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-tnf medicines. To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. Important Safety Information About HUMIRA (adalimumab) What is the most important information I should know about HUMIRA? You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB. Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn t heal. What should I tell my doctor BEFORE starting HUMIRA? Tell your doctor about all of your health conditions, including if you: Have an infection, are being treated for infection, or have symptoms of an infection Get a lot of infections or infections that keep coming back Have diabetes Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis Have or have had hepatitis B Are scheduled for major surgery Have or have had cancer Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome Have or had heart failure Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines Are allergic to rubber, latex, or any HUMIRA ingredients Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol), or SIMPONI (golimumab). Tell your doctor if you have ever used RITUXAN (rituximab), IMURAN (azathioprine), or PURINETHOL (mercaptopurine, 6-MP). What should I watch for AFTER starting HUMIRA? HUMIRA can cause serious side effects, including: Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle. Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash. Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth. Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness. Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale. Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain. Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun. Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus. Call your doctor or get medical care right away if you develop any of the above symptoms. Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away. Remember, tell your doctor right away if you have an infection or symptoms of an infection, including: Fever, sweats, or chills Warm, red, or painful skin or sores Muscle aches on your body Cough Diarrhea or stomach pain Shortness of breath Burning when you urinate Blood in phlegm Urinating more often than normal Weight loss Feeling very tired HUMIRA is given by injection under the skin. This is the most important information to know about HUMIRA. For more information, talk to your health care provider FACT BOOK 2013 FACT BOOK 13

8 Use AndroGel (testosterone gel) 1.62% is a controlled substance, available by prescription, used to treat adult males who have low or no testosterone. It is not known if AndroGel 1.62% is safe or effective in children younger than 18 years old. Testosterone products that are applied to the skin may have different doses, strengths, or application instructions that may lead to different levels of testosterone in your body. IMPORTANT SAFETY INFORMATION AndroGel 1.62% can transfer from your body to others. This can happen if other people come into contact with the area where the AndroGel 1.62% was applied. Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using topical testosterone products like AndroGel 1.62%. Women and children should avoid contact with the unwashed or unclothed area where AndroGel 1.62% has been applied. If a woman or child makes contact with the AndroGel 1.62% application area, the contact area on the woman or child should be washed well with soap and water right away. To lower the risk of transfer of AndroGel 1.62%, you should apply it only to your shoulders and upper arms, areas that will be covered by a short-sleeve T-shirt. Wash your hands right away with soap and water after applying. After the gel has dried, cover the application area with clothing until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your shoulders or upper arms, first wash the application area well with soap and water. Do not apply AndroGel 1.62% to any other parts of your body such as your stomach area (abdomen), penis, or scrotum. Stop using AndroGel 1.62% and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel 1.62%. Do not use AndroGel 1.62% if you have breast cancer or have or might have prostate cancer. AndroGel 1.62% is not meant for use in women and must not be used in women who are or may become pregnant, or are breast-feeding. AndroGel 1.62% may harm the unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel 1.62% has been applied. AndroGel 1.62% can cause serious side effects, including: If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using AndroGel 1.62% (including changes in urination) Possible increased risk of prostate cancer In large doses, AndroGel 1.62% may lower your sperm count Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease Enlarged or painful breasts Having problems breathing while you sleep (sleep apnea) Blood clots in the legs; this can include pain, swelling, or redness of your legs Tell your healthcare provider about all the medicines you take, especially if you take insulin, medicines that decrease blood clotting, or corticosteroids. AndroGel 1.62% is flammable until dry. Let AndroGel 1.62% dry before smoking or going near an open flame. The most common side effects of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where the gel is applied. This is the most important information to know about AndroGel 1.62%. For further information, talk with your healthcare provider. Use SYNTHROID (levothyroxine sodium tablets, USP) is a prescription synthetic thyroid hormone that is used to treat a condition called hypothyroidism. It is intended to replace a hormone that is normally produced by your thyroid gland. Generally, thyroid replacement therapy is to be taken for life. Important Safety Information You Should Know Thyroid hormones, including SYNTHROID, should not be used either alone or in combination with other medicines for the treatment of obesity or weight loss. In patients with normal thyroid levels, doses of SYNTHROID within the typical range used for hormone replacement are not effective for weight loss. Larger doses may result in serious or even life-threatening effects, especially when used in combination with certain other drugs used to reduce appetite. Notify your physician if you are allergic to any foods or medicines, are pregnant or intend to become pregnant, are breast-feeding or are taking any other medications, including prescription and over-the-counter preparations. Notify your physician of any other medical conditions you may have, particularly heart disease, diabetes, clotting disorders, and adrenal or pituitary gland problems. Your dose of medications used to control these other conditions may need to be adjusted while you are taking SYNTHROID. If you have diabetes, monitor your blood and/or urinary glucose levels as directed by your physician and immediately report any changes to your physician. If you are taking anticoagulants (blood thinners), your clotting status should be checked frequently. Use SYNTHROID only as prescribed by your physician. Do not discontinue or change the amount you take, or how often you take it, unless directed to do so by your physician. Agents such as iron and calcium supplements and antacids can decrease the absorption of levothyroxine sodium tablets. Therefore, levothyroxine sodium tablets should not be administered within 4 hours of these agents. Take SYNTHROID as a single dose, preferably on an empty stomach, one-half to one hour before breakfast. Levothyroxine absorption is increased on an empty stomach. Notify your physician if you experience any of the following symptoms: rapid or irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleeplessness, tremors, change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, fever, changes in menstrual periods, hives or skin rash, or any other unusual medical event. Notify your physician or dentist that you are taking SYNTHROID prior to any surgery. After a stable response has been established, it is important to have follow-up laboratory tests done, as ordered by your health care provider, at least annually. This is the most important information to know about SYNTHROID. For more information, talk with your health care provider FACT BOOK 2013 FACT BOOK 15

9 2013 FACT BOOK Please contact us with your questions and comments: AbbVie Inc. 1 North Waukegan Road North Chicago, IL abbvie.com Follow us on Connect with us on Facebook at facebook.com/abbviecareers 2013 AbbVie.