ME Newswire / Business Wire
MISSISSAUGA, Canada - Wednesday, April 24th 2013
Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and Galderma Pharma, S.A. (Galderma), today announced the European launch of Pliaglis (lidocaine and tetracaine) Cream 7%/7%. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology. Marketing licenses have been issued in 14 of the 16 European countries which are listed in the European Marketing Application for Pliaglis.
Pliaglis is a topical local anesthetic cream that uses Nuvo’s proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. In the E.U. Pliaglis is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures.
Galderma launched Pliaglis in Argentina in 2011 and in the U.S. in March 2013 and anticipates that it will launch in Canada and a number of Central American, South American and Asian countries in 2014 and 2015.
“We are proud in being able to bring additional comfort to patients in Aesthetic treatments,” said Mr. Didier Leclercq, Managing Director of Galderma Aesthetic & Corrective Center of Excellence. “Pliaglis really sets a new standard in topical anesthetics, and is a great complementary product in our already comprehensive Aesthetic portfolio in Europe. “
“The launch of Pliaglis in the E.U. is yet another important and exciting milestone for Nuvo,” said Dr. Bradley Galer, President of Nuvo’s Pain Group. “Galderma has an excellent launch plan for the countries of Europe to introduce the benefits of Pliaglis to physicians who provide aesthetic services to their patients.”
Important Safety Information
Indication: PLIAGLIS® (lidocaine and tetracaine) Cream 7% / 7% is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures. Contraindications: PLIAGLIS® Cream is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type and is also contraindicated in patients with sensitivity to para-aminobenzoic (PABA) or any components of the product. Pliaglis should not be used on mucous membranes or on broken or irritated skin. Adverse Events: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%). The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%. Warnings/Precautions: Methemoglobinemia has been associated with use of local anesthetics such as tetracaine. PLIAGLIS® Cream should be used with caution in patients with severe hepatic disease. When using PLIAGLIS® Cream in conjunction with other local anesthetic agents, the total dose of anesthetic should be considered due to the potential for additive systemic toxic effects. Contact with the eyes should be avoided. The treated area should not be occluded before removing Pliaglis from the skin.
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.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company’s product portfolio includes Pennsaid®, Pliaglis and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, Eurocept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan®) in several European countries. The Company is also developing the compound WF10, for the treatment of immune related diseases. Further more information, please visit www.nuvoresearch.com.
About Galderma
Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime while serving healthcare professionals around the world. The company has 31 wholly-owned affiliates with a worldwide network of distributors and more than 4,000 employees. Galderma’s extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.
With approximately 20% of revenues invested each year to discover and develop new products and access innovative technologies, the company is one of the world’s leading investors in dermatology R&D. Four state-of-the-art R&D centers and four manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy.
Strategic brands include Epiduo®, Oracea®, Clobex®, Differin®, Rozex®/MetroGel®, Silkis®/Vectical®, Tri-Luma®, Loceryl®, Cetaphil®, Metvix®, Azzalure®, Restylane® and Emervel®.
Forward-Looking Statements
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the Company’s Financial Statements and Management’s Discussion and Analysis, as well as in Nuvo's Annual Information Form for the year ended December 31, 2012. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
Contacts
Galderma
Karin Falck
Public and Media Relations Officer
+41 (0) 216 427 972
Email: karin.falck@galderma.com
Website: www.galderma.com
or
Nuvo Research Inc.
Email : ir@nuvoresearch.com
Website: www.nuvoresearch.com
MISSISSAUGA, Canada - Wednesday, April 24th 2013
Nuvo Research Inc. (TSX:NRI), a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and Galderma Pharma, S.A. (Galderma), today announced the European launch of Pliaglis (lidocaine and tetracaine) Cream 7%/7%. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology. Marketing licenses have been issued in 14 of the 16 European countries which are listed in the European Marketing Application for Pliaglis.
Pliaglis is a topical local anesthetic cream that uses Nuvo’s proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. In the E.U. Pliaglis is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures.
Galderma launched Pliaglis in Argentina in 2011 and in the U.S. in March 2013 and anticipates that it will launch in Canada and a number of Central American, South American and Asian countries in 2014 and 2015.
“We are proud in being able to bring additional comfort to patients in Aesthetic treatments,” said Mr. Didier Leclercq, Managing Director of Galderma Aesthetic & Corrective Center of Excellence. “Pliaglis really sets a new standard in topical anesthetics, and is a great complementary product in our already comprehensive Aesthetic portfolio in Europe. “
“The launch of Pliaglis in the E.U. is yet another important and exciting milestone for Nuvo,” said Dr. Bradley Galer, President of Nuvo’s Pain Group. “Galderma has an excellent launch plan for the countries of Europe to introduce the benefits of Pliaglis to physicians who provide aesthetic services to their patients.”
Important Safety Information
Indication: PLIAGLIS® (lidocaine and tetracaine) Cream 7% / 7% is indicated in adults to produce local dermal anaesthesia on intact skin prior to dermatological procedures. Contraindications: PLIAGLIS® Cream is contraindicated in patients with a known history of sensitivity to lidocaine or tetracaine, or local anesthetics of the amide or ester type and is also contraindicated in patients with sensitivity to para-aminobenzoic (PABA) or any components of the product. Pliaglis should not be used on mucous membranes or on broken or irritated skin. Adverse Events: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%). The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%. Warnings/Precautions: Methemoglobinemia has been associated with use of local anesthetics such as tetracaine. PLIAGLIS® Cream should be used with caution in patients with severe hepatic disease. When using PLIAGLIS® Cream in conjunction with other local anesthetic agents, the total dose of anesthetic should be considered due to the potential for additive systemic toxic effects. Contact with the eyes should be avoided. The treated area should not be occluded before removing Pliaglis from the skin.
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.
About Nuvo Research Inc.
Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company’s product portfolio includes Pennsaid®, Pliaglis and Synera®. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, Eurocept International B.V., has initiated a pan-European launch of Synera (under the name Rapydan®) in several European countries. The Company is also developing the compound WF10, for the treatment of immune related diseases. Further more information, please visit www.nuvoresearch.com.
About Galderma
Galderma is a global company founded in 1981 committed to delivering innovative medical solutions to meet the dermatological needs of people throughout their lifetime while serving healthcare professionals around the world. The company has 31 wholly-owned affiliates with a worldwide network of distributors and more than 4,000 employees. Galderma’s extensive product portfolio is available in 70 countries and treats a range of dermatological conditions including: acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses, pigmentary disorders, skin cancer and medical solutions for skin senescence.
With approximately 20% of revenues invested each year to discover and develop new products and access innovative technologies, the company is one of the world’s leading investors in dermatology R&D. Four state-of-the-art R&D centers and four manufacturing sites are dedicated to providing a wide range of innovative medical solutions which meet the highest standards of safety and efficacy.
Strategic brands include Epiduo®, Oracea®, Clobex®, Differin®, Rozex®/MetroGel®, Silkis®/Vectical®, Tri-Luma®, Loceryl®, Cetaphil®, Metvix®, Azzalure®, Restylane® and Emervel®.
Forward-Looking Statements
This document contains forward-looking statements. Some forward-looking statements may be identified by words like "expects", "anticipates", "plans", "intends", "indicates" or similar expressions These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Nuvo considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but caution that these assumptions regarding future events, many of which are beyond the control of the Company, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations, are discussed in the Company’s Financial Statements and Management’s Discussion and Analysis, as well as in Nuvo's Annual Information Form for the year ended December 31, 2012. Nuvo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information or future events, except as required by law. For additional information on risks and uncertainties relating to these forward looking statements, investors should consult the Company's ongoing quarterly filings, annual report and Annual Information Form and other filings found on SEDAR at www.sedar.com.
Contacts
Galderma
Karin Falck
Public and Media Relations Officer
+41 (0) 216 427 972
Email: karin.falck@galderma.com
Website: www.galderma.com
or
Nuvo Research Inc.
Email : ir@nuvoresearch.com
Website: www.nuvoresearch.com