FDA approval

August 31, 2012

On August 30, 2012 LINZESS™ (linaclotide) [pronounced lin-ZESS] was approved by the United States Food and Drug Administration (FDA) to treat adults suffering from IBS with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is the first and only treatment in a new class of drugs called GC-C agonists.

While estimates vary, as many as 13 million adults may suffer from IBS-C and as many as 35 million adults may suffer from CIC.

LINZESS is a once-daily prescription treatment that was shown in clinical trials to help relieve the chronic abdominal pain and constipation associated with IBS-C, and the constipation and hard stools associated with CIC.

LINZESS is contraindicated in pediatric patients up to 6 years of age. Use should be avoided in pediatric patients 6 through 17 years of age.

Linaclotide, the active ingredient in LINZESS, is a GC-C agonist and acts locally in the intestine. In nonclinical studies, it has been shown to accelerate gastrointestinal transit and reduce intestinal pain. The linaclotide-induced pain reduction is thought to result from an increase in cyclic GMP, which has been shown to decrease the activity of pain-sensing nerves.

The drug will be available in pharmacies nationwide in the fourth quarter of 2012. LINZESS will be co-marketed by Forest Laboratories, Inc (NYSE: FRX) and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD).
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Broadcast Quality Digital Download Available: www.vistasat.com/LINZESS (case sensitive) IBS-C and Chronic Idiopathic Constipation Facts

Irritable Bowel Syndrome with Constipation (IBS-C)
  • While estimates vary, as many as 13 million adults may suffer from IBS-C in the United States
  • A recent survey of IBS-C sufferers found that about half are diagnosed. And, almost 6 in 10 (57%) are actively seeking care for their disorder
  • According to retrospective studies, IBS sufferers use a considerable amount of healthcare services - IBS care consumes more than $20 billion annually in both direct and indirect expenditures

    Chronic Idiopathic Constipation (CIC)
  • While estimates vary, as many as 35 million adults may suffer from CIC in the United States
  • A recent survey found that, of those suffering from CIC, only 12% have been diagnosed. Yet, more than 40% of all CIC sufferers are actively seeking treatment
  • According to retrospective studies, CIC sufferers utilize a substantial amount of healthcare resources, accounting for 8 million CIC non-hospitalized visits annually over a 3-year period

    NEWSFEED CONTENTS

    B-roll: LINZESS product manufacturing, Doctor/Patient Examination,Forest Laboratories, Inc. and Ironwood Pharmaceuticals, Inc. headquarters Soundbites: Susan Lucak, MD, Columbia University Medical Center

    IMPORTANT SAFETY INFORMATION
    Important Safety Information for Patients:

    WARNING: PEDIATRIC RISK

    LINZESS is contraindicated in pediatric patients up to 6 years of age. Use should be avoided in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.

    Contraindications
  • LINZESS is contraindicated in pediatric patients up to 6 years of age.
  • LINZESS is contraindicated in adults with known or suspected mechanical gastrointestinal obstruction.

    Warnings and Precautions

    Pediatric Risk
  • LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week-old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide.
  • Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans age 12 to 17 years). Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Diarrhea
  • Diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. Severe diarrhea was reported in 2% of the LINZESS-treated patients. The incidence of diarrhea was similar between the IBS-C and CIC populations.
  • Patients should be instructed to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider, who should consider dose suspension.

    Adverse Reactions
  • In IBS-C clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence of ≥2% and greater than placebo) were diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence of ≥2% and greater than placebo) were diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%).

    Click here http://www.frx.com/pi/Linzess_pi.pdf for LINZESS full Prescribing Information.

    Fleishman-Hillard

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