11th July 2013 | SOUDERTON, PENNSYLVANIA

Galen, a Northern Ireland based pharmaceutical company, has acquired Synera® (lidocaine 70mg/tetracaine 70mg) topical patch from ZARS Pharma Inc., a wholly owned subsidiary of Nuvo Research Inc. Synera® is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions. Galen US, Inc., a wholly owned subsidiary of Galen Ltd., will market and sell Synera® in the United States.

Galen is dedicated to supporting the development and provision of innovative medicines in an effort to improve health worldwide. Speaking about the agreement to acquire Synera®, Galen US, Inc. General Manager, Andrew Shales, commented: “We are delighted that we are now able to market and sell Synera® in the United States. Synera® addresses an important need to provide local dermal analgesia, particularly in children 3 years or older. Hospitalized patients are routinely subjected to multiple superficial venous access procedures such as IV infusions and blood draws. We entered the US market in 2012 and this acquisition provides us with the opportunity to offer an exciting and innovative technology for patients needing local dermal analgesia.”

For healthcare professionals who require further information about the product, including reimbursement, a dedicated helpline is available at 1-866-949-9277. It is the healthcare professional’s sole responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered.  Coverage, coding and reimbursement guidelines will vary according to individual insurance plans.  Healthcare professionals should contact insurers to verify correct coding procedures prior to submitting claims related to Synera®. In all cases, healthcare professionals will need to follow local payer policies for billing and reimbursement. Synera® will continue to be made available through wholesalers in the United States.

ABOUT SYNERA® (LIDOCAINE 70MG/TETRACAINE 70MG) TOPICAL PATCH

Synera® is a topical patch that combines lidocaine, tetracaine and heat, using proprietary CHADD™ [Controlled Heat Assisted Drug Delivery] technology. The integrated, oxygen-activated heating component is intended to enhance the delivery of the local anesthetic.

Synera® is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodessication and shave biopsy of skin lesions.

IMPORTANT SAFETY INFORMATION ABOUT SYNERA®

Synera® is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, local anesthetics of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity.

Keeping a patch on longer than recommended or applying multiple patches simultaneously or sequentially could result in systemic absorption sufficient to result in serious adverse effects that are typical of drugs in this class.

Even a used Synera® patch contains a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or ingesting a new or used Synera® patch may result in serious adverse effects. Store and dispose of Synera® out of the reach of children and pets.

Synera® should be used with caution in patients who may be more sensitive to the systemic effects of lidocaine and tetracaine, including the acutely ill, the debilitated, and those with compromised hepatic function. Patients with severe hepatic disease or pseudocholinesterase deficiency are at greater risk of developing toxic plasma concentrations.

Allergic or anaphylactoid reactions (urticaria, angioedema, bronchospasm, and shock) to the active or inactive components of Synera® can occur and should be managed by conventional means. Avoid contact of Synera® with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns.

Synera® is not recommended for use on mucous membranes or on areas with a compromised skin barrier. Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.

Safety and effectiveness of Synera® have been established in patients 3 years or older.

Lidocaine has been shown to inhibit viral and bacterial growth. The effect of Synera® on intradermal injections of live vaccines has not been determined.

The heating component contains iron powder, and the patch must be removed before magnetic resonance imaging.

Synera® may lead to diminished or blocked sensation in the treated skin; therefore, patients should avoid inadvertent trauma (rubbing, scratching, or exposure to heat or cold) before complete sensation returns.

In clinical studies, the most common local reactions were erythema (71%), blanching (12%), and edema (12%); these reactions were generally mild, resolving spontaneously soon after treatment.

Do not cut or remove the top cover of the patch as this could result in thermal injury.

Synera® is not for home use by patient.

PLEASE SEE FULL PRESCRIBING INFORMATION  BEFORE USING SYNERA®. 

SYNERA® IS A PRESCRIPTION DRUG. 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 (1-800-332-1088). IF YOU HAVE A MEDICAL INFORMATION INQUIRY OR WISH TO REPORT A SIDE EFFECT RELATING TO SYNERA® TO THE COMPANY, CALL 1-866-949-9277).

For further information please contact:

Galen US Incorporated:Andrew Shales

Tel: +1 (215) 660 8500Fax: +1 (215) 660 8501

Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

Galen media relations:Tristan Jervis

Tel: +44 (0)207 203 6742Direct: +44 (0)207 203 6740

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