Data Presented at AAAAI Annual Meeting Further Support the Safety and Efficacy of FIRAZYR® (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema

DUBLIN, and LEXINGTON, Mass., March 22, 2011 /PRNewswire/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced positive new results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of all trials studying the use of FIRAZYR® (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). The data were presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Francisco.

The data presented at AAAAI further demonstrate the efficacy of FIRAZYR on a number of clinically important parameters:

• Median time to onset of symptom relief for FIRAZYR compared to placebo was reported:
  • 2.0 hours vs. 19.8 hours; p<0.001 (50% reduction in a composite VAS symptom score assessed by the patient)
  • 1.5 hours vs. 18.5 hours; p<0.001 (30% reduction in primary VAS symptom score assessed by the patient)
• Median time to initial symptom improvement for FIRAZYR compared to placebo was reported:
  • 0.8 hours (N=43) vs. 3.5 hours (N=45); p<0.001 (as assessed by the patient)
  • 0.8 hours (N=43) vs. 3.4 hours (N=45); p<0.001 (as assessed by the investigator)
• FIRAZYR also accelerated near resolution of attack as measured by median time to "almost complete symptom relief" compared to placebo (8.0 hours vs. 36.0 hours) (p=0.012).
• No patient who received icatibant required rescue medication before the onset of symptom relief vs. 36% of subjects in the placebo group (p<0.001).
• The results for laryngeal attacks treated with icatibant were similar to the results for abdominal and cutaneous attacks treated with icatibant. The randomized portion of the study (N = 3) showed that median time to onset of symptom relief was 2.5 hours for those treated with icatibant. In addition, a post hoc analysis of 21 patients with laryngeal attacks treated with icatibant (across the double-blind and open label phases) demonstrated a median time to onset of symptom relief by composite VAS score of 2.0 hours and median time to onset of primary symptom relief of 1.8 hours.

The safety data from FAST-3 was consistent with previous studies. Transient injection site reactions were seen by all subjects who received FIRAZYR. Other common adverse events seen in the trial more often with icatibant than placebo included sinusitis, UTI, nasopharyngitis, abdominal distension, abdominal pain, diarrhea, nausea and pyrexia. There were no serious adverse events in the treatment arm and no subjects developed anti-icatibant antibodies.

"The complete FAST-3 data demonstrates FIRAZYR's efficacy and safety further illustrating the utility of a bradykinin B2 receptor antagonist to treat acute HAE attacks," said Dr. William R. Lumry, Clinical Professor of Internal Medicine at the University of Texas Southwestern Medical School, who presented the data at the AAAAI Annual Meeting. "As the global medical community evaluates HAE treatment guidelines, there is a growing consensus regarding the importance of fast-acting treatments."

About the Phase III Study

The FAST-3 study, conducted in 67 sites in 9 countries, was a randomized, double-blind, placebo controlled multicenter trial of FIRAZYR administered by subcutaneous injection for the treatment of patients with acute attacks of HAE (types I and II). A total of 88 patients who presented with moderate to very severe cutaneous and/or abdominal symptoms were enrolled in the double blind phase, with an approximately equal number in each arm of the study. Patients with HAE attacks who presented with mild to moderate laryngeal symptoms were also randomized and enrolled in the double-blind phase. Patients who presented with severe laryngeal attacks immediately received open-label FIRAZYR. All laryngeal patients were considered additional to the 88 patients with abdominal and/or cutaneous attacks who were randomized and enrolled. The primary analysis population consisted of those patients with cutaneous and/or abdominal symptoms who were randomized to either FIRAZYR or placebo (the non-laryngeal intent-to-treat population). After the first attack, patients had the option for subsequent attacks to be treated with open-label FIRAZYR.

About FIRAZYR

The active substance, icatibant, is a specific bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously-administered approach to the treatment of HAE attacks designed to block the effects of bradykinin, the key mediator of edema formation. FIRAZYR is a synthetic decapeptide (a peptide containing ten amino acids).

The European Commission has approved FIRAZYR for self-administration after training in subcutaneous injection technique by a healthcare professional. FIRAZYR is the first and only treatment for acute Type I and Type II HAE attacks licensed for self-administration in Europe.

For patients who have never previously received FIRAZYR, the first treatment should be given in a medical institution or under the guidance of a physician. In cases of insufficient relief or recurrence of symptoms after treatment with FIRAZYR, patients should seek medical advice, and subsequent doses should be given in a medical institution. The decision to initiate self-administration should only be taken by a physician experienced in the diagnosis and treatment of HAE.

Patients with laryngeal attacks should always seek medical advice and be managed in an appropriate medical institution after self-administration of FIRAZYR, until the physician considers discharge to be safe.

FIRAZYR has an orphan drug designation status in the EU and US for treatment of hereditary angioedema. Where commercially available, the drug is supplied in a pre-filled 3 ml syringe. FIRAZYR can be stored at up to 25 degrees Celsius without refrigeration.

FIRAZYR is currently approved outside of the US in 37 countries worldwide, including the countries of the European Union. In the US, FIRAZYR is under review by the FDA with a Prescription Drug User Fee Act date of August 25, 2011. Prescribing information may differ between countries.  Please consult your local prescribing information.

Important Safety Information

Almost all subjects who were treated with FIRAZYR in clinical trials developed reactions at the site of injection (characterized by skin irritation, swelling, pain, itchiness, erythema, and burning sensation). Caution should be observed when FIRAZYR is administered to patients with acute ischemic heart disease or unstable angina pectoris and in the weeks following a stroke.

About HAE

HAE is a rare genetic disease. Type I and Type II HAE are caused by low levels or a dysfunction of C1 esterase inhibitor (C1-INH).  Reduced C1-INH activity can lead to elevated plasma levels of bradykinin, the key mediator of HAE symptoms.

HAE is characterized by recurrent sudden attacks of edema (swelling) of the skin (hands, arms, feet, legs, thighs, face, genitals) or the mucous membranes (gastrointestinal tract, larynx or voicebox). The swelling can be disfiguring and painful, especially in case of abdominal attacks. Laryngeal attacks are potentially life-threatening due to the risk of suffocation. Unlike angioedemas caused by allergic reactions, signs and symptoms such as hives and itching do not occur in HAE. Signs and symptoms of HAE do not respond to standard treatments for allergic angioedema.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.  Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

SOURCE Shire plc

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