Track Record

Forest's success in bringing important new drugs to market through its collaborations is well proven. During the last 5 years, we entered into more than 20 collaborations, including one company acquisition. These projects covered the full spectrum from early pre-clinical stage through co-promotion products, and many of the products have gone to market, helping millions of patients.

We have been successful in developing and commercializing products in various market conditions:

First in class. In partnership with Merz, Forest secured the approval of NAMENDA® (memantine HCI) as the first N-methyl D-aspartate (NMDA) antagonist and the first product to be approved by FDA for the treatment of moderate to severe Alzheimer's disease. Forest also managed the 2004 award-winning launch of the drug, which today is among the top-selling Alzheimer's medications.

Late entrants in highly competitive markets. Forest has a record of successfully launching differentiated products, even in crowded markets. For instance, LEXAPRO® (escitalopram oxalate), licensed from H. Lundbeck A/S, was the seventh selective serotonin reuptake inhibitor (SSRI) to be introduced in the United States for the treatment of depression and generalized anxiety disorder. Since Forest introduced it in 2002, LEXAPRO® has been prescribed to more than 18 million U.S. adults.

Similarly, BENICAR® (olmesartan medoxomil) was the seventh angiotensin II receptor blocker (ARB) introduced for the treatment of hypertension. With Daiichi Sankyo and Forest's sales and marketing teams working together, BENICAR® became the fastest-growing drug in its class and, ultimately, the second most prescribed ARB.

Another example is the recent success with BYSTOLIC® (nebivolol), a beta blocker licensed from Mylan Laboratories. Forest secured its approval in 2007 and launched the product in 2008. With strong prescription and prescriber trends, BYSTOLIC® continues to grow in a market consisting primarily of generic alternatives.

Building a market. In partnership with Cypress Bioscience, SAVELLA® (milnacipran HCI) was among the medications approved by the FDA for the management of fibromyalgia in adults. Forest and Cypress Bioscience together are marketing the selective serotonin and norepinephrine dual reuptake inhibitor (SNRI). Both prescribers and prescriptions are on the rise.

Our partnering success continues. Our recent licensing agreements and acquisitions, which have fueled the most robust product pipeline in Forest's history, focus on a broad range of therapeutic areas. These include respiratory disorders, infections, gastrointestinal indications and such central nervous system (CNS) conditions as depression, schizophrenia, and bipolar disorder.

NAMENDA (memantine hydrochloride) is indicated for the treatment of moderate to severe Alzheimer's disease. NAMENDA is available by prescription only.

Important Risk Information About NAMENDA

Who should NOT take NAMENDA?
NAMENDA should not be taken by anyone who is allergic to NAMENDA or has had a bad reaction to NAMENDA or any of its components.

What should be discussed with the healthcare provider before taking NAMENDA?
Before starting NAMENDA, talk to the healthcare provider about:

  • All of the patient's medical conditions, including kidney or liver problems. In patients with severe kidney problems, the dose of NAMENDA may need to be reduced
  • All prescription or over-the-counter medications the patient is taking or planning to take
  • The recommended dosing and administration of NAMENDA

What are the possible side effects of NAMENDA?
The most common side effects associated with NAMENDA treatment are dizziness, confusion, headache, and constipation. This is not a complete list of side effects.

Lexapro (escitalopram oxalate) is a selective serotonin reuptake inhibitor (SSRI) indicated for the acute and maintenance treatment of major depressive disorder (MDD) in adults and in adolescents aged 12-17 years. Lexapro is also indicated for the acute treatment of generalized anxiety disorder (GAD) in adults. Lexapro is available by prescription only.

Important Risk Information about Lexapro
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of depression and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. All patients starting antidepressant therapy should be monitored appropriately and observed closely. Families and caregivers should discuss with the healthcare professional right away any observations of worsening depression symptoms, suicidal thinking and behavior, or unusual changes in behavior. Lexapro is not approved for use in patients less than 12 years of age.

Who should NOT take Lexapro?
Do not take Lexapro if you are:

  • Taking or have recently taken a type of drug called a monoamine oxidase inhibitor (MAOI), such as Nardil® (phenelzine sulfate) or Parnate® (tranylcypromine sulfate)
  • Taking a type of antipsychotic medicine called Orap® (pimozide)
  • Allergic to or have had a bad reaction to Lexapro, any of the components of Lexapro, Celexa, or generic citalopram
  • Taking Celexa® (citalopram) or generic citalopram

What should I tell my healthcare professional before taking Lexapro? Before starting Lexapro, tell your healthcare professional about all of your medical conditions, including if you have:

  • History of mania or seizure disorders
  • Kidney or liver problems
  • Bleeding disorders

Also, to avoid a serious or potentially life-threatening condition, tell your healthcare professional if you are taking, or planning to take, any prescription or over-the-counter medications, including:

  • Other SSRIs, serotonin/noradrenaline reuptake inhibitors (SNRIs), certain migraine or headache medications (triptans or tramadol), or tryptophan
  • Any other medication prescribed for a psychiatric or neurological condition
  • NSAID pain relievers (such as ibuprofen or naproxen), aspirin, warfarin, or blood thinners
  • Diuretics

Tell your healthcare professional if you are pregnant, planning to become pregnant during therapy, or are breastfeeding.

What other important information should I discuss with my healthcare professional?
Patients on antidepressants and their families or caregivers should watch for new or worsening symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare professional right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or whenever there is a change in dose, either increase or decrease.

Lexapro is an integral part of a total treatment program that may include other psychological, educational, or social measures. Drug treatment may not be indicated for all adolescents with depression.

Until you see how Lexapro affects you, be careful doing activities such as driving a car or operating machinery. Avoid drinking alcohol while taking Lexapro.

Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid changes in heart rate and blood pressure. These may be signs of a rare but serious side effect.

Talk with your physician before stopping Lexapro or changing your dose. Although you may notice improvement with Lexapro therapy in 1 to 4 weeks, you should continue therapy as directed by your healthcare professional.

What are the possible side effects of Lexapro?
In clinical trials, the most common side effects associated with Lexapro treatment in adults were nausea, insomnia (difficulty sleeping), ejaculation disorder (primarily ejaculation delay), fatigue and drowsiness, increased sweating, decreased libido, and anorgasmia (difficulty achieving orgasm). Side effects in pediatric patients were generally similar to those seen in adults; however, the following additional side effects were reported commonly in pediatric patients: back pain, urinary tract infection, vomiting, and nasal congestion. This is not a complete list of side effects.

Benicar Important Safety Information

For Important Safety Information about BENICAR, please visit the Daiichi Sankyo Website, www.benicar.com.

BYSTOLIC is a prescription medicine that belongs to a group of medicines called "beta blockers." BYSTOLIC is used, often with other medicines, to treat patients with high blood pressure (hypertension).

Important Risk Information about BYSTOLIC

Who should NOT take BYSTOLIC?
Do not take BYSTOLIC if you:

  • Have heart failure. BYSTOLIC is not approved for the treatment of heart failure. If you have heart failure and the symptoms are controlled, BYSTOLIC may be used for the treatment of hypertension. Talk to your doctor if your symptoms of heart failure worsen.
  • Have a slow heartbeat or your heart skips beats (irregular heartbeat)
  • Have severe liver damage
  • Are allergic to any ingredient in BYSTOLIC. The active ingredient is nebivolol.
  • Are under 18 years of age. BYSTOLIC is not approved for use in children under 18 years of age.

What should I tell my healthcare provider before taking BYSTOLIC? Before starting BYSTOLIC, tell your healthcare provider about all of your medical conditions, including if you:

  • Have asthma or other lung problems (such as bronchitis or emphysema)
  • Have problems with blood flow in your feet and legs (peripheral vascular disease). BYSTOLIC can make symptoms of blood flow problems worse.
  • Have diabetes and take medicine to control blood sugar
  • Have thyroid problems
  • Have liver or kidney problems
  • Have had allergic reactions to medications or have allergies
  • Have a condition called pheochromocytoma (rare adrenal gland tumor)
  • Are pregnant or trying to become pregnant. It is not known if BYSTOLIC is safe for your unborn baby. Talk with your doctor about the best way to treat your high blood pressure while you are pregnant.
  • Are breastfeeding. It is not known if BYSTOLIC passes into your breast milk. You should not breastfeed while using BYSTOLIC.
  • Are scheduled for surgery and will be given anesthetic agents
  • Have had acute angina (symptoms include chest pain or discomfort) or an MI (heart attack) as BYSTOLIC has not been studied in patients with these conditions.

Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking or plan to take any prescription or over-the-counter medications, vitamins, or herbal products, including:

  • Certain CYP2D6 inhibitors (such as some antiarrhythmics like quinidine or propafenone or certain antidepressants such as fluoxetine or paroxetine, etc).
  • Other beta blockers
  • Digitalis
  • Certain calcium channel blockers (such as verapamil and diltiazem)
  • Antiarrhythmic agents (such as disopyramide)

What are the possible side effects of BYSTOLIC?
The most common side effects people taking BYSTOLIC report are headache, fatigue (tiredness), dizziness (if you feel dizzy, sit or lie down and tell your doctor right away), diarrhea, nausea, insomnia (difficulty falling or staying asleep), chest pain, bradycardia (slow heartbeat), dyspnea (shortness of breath), rash, and peripheral edema (leg swelling due to fluid retention). Other possible side effects include masking (hiding) the symptoms of low blood sugar and hyperthyroidism (overactive thyroid), especially a fast heartbeat. Tell your doctor if you gain weight or have trouble breathing while taking BYSTOLIC.

This is not a complete list of side effects. Tell your doctor if you have any side effects that bother you or don't go away.

What other information do I need to know about taking BYSTOLIC?

  • Do not stop taking BYSTOLIC suddenly. You could have chest pain or a heart attack. If your doctor decides that you should stop taking BYSTOLIC, he or she will lower your dose slowly and over time.
  • Take BYSTOLIC every day exactly as your doctor tells you. Your doctor will tell you how much BYSTOLIC to take and how often. Your doctor may start with a low dose and raise it over time.
  • Do not stop taking BYSTOLIC or change your dose without talking with your doctor.
  • Take BYSTOLIC with or without food.
  • If you miss a dose, take your dose as soon as you remember, unless it is close to the time to take your next dose. Do not take 2 doses at the same time. Take your next dose at the usual time.
  • If you take too much BYSTOLIC, call your doctor or poison control center right away.

Savella (milnacipran HCl) is indicated for the management of fibromyalgia in adults. Savella is available by prescription only.

Important Risk Information About Savella
  • Although not approved for treating depression, Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to antidepressants (drugs used for the treatment of depression and other psychiatric disorders).
  • Antidepressants can increase suicidal thoughts in children, teens, and young adults. Savella is approved only for adults 18 and over.
  • Patients on antidepressants and their families or caregivers should watch for new or worsening symptoms, unusual changes in behavior, thoughts of suicide, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity.
  • Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of treatment or whenever the dose is increased or decreased.
  • For more information about this risk, please read the Savella Patient Medication Guide.

Who should NOT take Savella?
Do not take Savella if you:

  • Are taking, or have recently taken, a type of drug called a monoamine oxidase inhibitor (MAOI), such as Nardil® (phenelzine sulfate) or Parnate® (tranylcypromine sulfate)
  • Have uncontrolled narrow-angle glaucoma (an eye disease)

What should I tell my healthcare provider before taking Savella?
Before starting Savella, tell your healthcare provider about all your medical conditions, including if you have:

  • Hypertension (high blood pressure), tachyarrhythmia (fast heart rate), or other cardiac diseases
  • Liver problems or a history of substantial alcohol use
  • Kidney problems, including dysuria (painful urination)
  • History of mania or seizure disorders
  • Bleeding disorders
  • Glaucoma

Also, to avoid a potentially serious or life-threatening condition, tell your healthcare provider if you are taking, or are planning to take, any prescription or over-the-counter medications, including:

  • Other SNRIs, selective serotonin reuptake inhibitors (SSRIs), certain migraine or headache medications (triptans), or tryptophan
  • Medication prescribed for a psychiatric or neurological condition
  • NSAID pain relievers (such as ibuprofen or naproxen), aspirin, warfarin, or other blood thinners
  • Diuretics

Tell your healthcare provider if you are pregnant, planning to become pregnant during therapy, or breastfeeding.

What other important information should I discuss with my healthcare provider?
Your blood pressure and pulse should be monitored at regular intervals when receiving treatment with Savella.

You should not operate machinery or drive until you are reasonably certain that Savella treatment does not affect your ability to engage in such activities. Avoid drinking alcohol while taking Savella.

Call your doctor if you have very high fever, rigid muscles, shaking, confusion, or rapid changes in heart rate and blood pressure. These may be signs of a rare, but serious, side effect.

Talk with your healthcare provider before stopping Savella or changing your dose. Withdrawal symptoms can occur, particularly when discontinuation is abrupt.

What are the most common side effects of Savella?
The most common side effect associated with Savella treatment is nausea. Other common side effects were headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis (excessive sweating), vomiting, palpitations, increased heart rate, dry mouth, and hypertension. This is not a complete list of side effects.

© 2013 Forest Laboratories, Inc.    085-13000011 1/13