FDA Approves Evolence
FDA Approves Evolence, a New Generation Collagen-Based Facial Filler
HERZLIYA, Israel & MORRIS PLAINS, N.J.--(BUSINESS WIRE)--Jun 30, 2008 - The U.S. Food and Drug Administration ("FDA") today announced the approval of Evolence for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. Evolence is a new advanced collagen-based structural dermal filler, and a first of its kind product. The introduction of Evolence marks the first dermal filler entry for the Aesthetics Group of OrthoNeutrogena. While new to the United States, Evolence has been available in other markets such as in Canada, Western and Eastern Europe, Israel, South Korea and Russia since 2004.
"Evolence represents a new generation of facial fillers, an innovative structural agent providing beautiful, immediate results by replacing the collagen lost with long-lasting, naturally sourced collagen," said Annie Heremans, M.D., Ph.D., Vice President, responsible for the Company's research and development of the Medical and Aesthetic Dermatology franchises. "We are pleased to enter the U.S. aesthetic space with a differentiated dermal filler designed for optimal patient outcomes. Given our rich heritage in skin care and commitment to science, we anticipate Evolence will be a welcome addition to current aesthetic treatment options."
Evolence will be introduced throughout the second half of 2008, in coordination with physician training, to ensure optimal patient satisfaction and outcomes.
Evolence represents a breakthrough in aesthetics. As one of nature's most fundamental and abundant building blocks, collagen comprises up to 80% of the dermis and it helps maintain skin strength, structure and support. Collagen naturally breaks down as a person ages, leading to the appearance of wrinkles, lines and folds.
Evolence, and its proprietary Glymatrix Technology, uses naturally sourced collagen to replace the body's lost collagen, adding volume and structural support in depleted areas, for a more naturally youthful appearance. In addition, no pre-test is needed, and Glymatrix Technology delivers longer-lasting durability than previous collagen dermal fillers.
Results are visible and immediate at the time of treatment, with minimal to no bruising or swelling, allowing physician and patient to gauge the amount of wrinkle correction with more precision. Evolence is recommended for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds, to be injected in the mid-to-deep dermis.
"We now have a collagen filler that does not require a pre-test and delivers immediate, beautiful and natural-looking results that last with minimal to little downtime for the patient," said Z. Paul Lorenc, M.D., F.A.C.S., Assistant Professor of Surgery, New York University School of Medicine and Principal Investigator on the Evolence U.S. pivotal study. "Evolence provides consistent and predictable results for all patients with every treatment."
Evolence is an advanced collagen-based structural dermal filler that provides long-lasting treatment of moderate to deep facial wrinkles and folds, such as nasolabial folds. The results of treatment with Evolence are immediate, with little to no downtime post-treatment and clinically proven to last through six months. Additional data for 12-month duration approval is being filed with the FDA.
Unlike other dermal fillers that use hyaluronic acid (HA), which absorb water to create their effect, Evolence is a true structural agent due to its three-dimensional collagen matrix. This collagen structure benefits patients as it is directly linked to the minimal bruising and swelling that might result. Evolence does not use chemicals for cross-linking like many other products do, but instead uses natural sugar to improve durability. Evolence collagen is cross-linked through its patented Glymatrix Technology using the natural sugar, D-Ribose. The Glymatrix process is designed to:
-- Mimic naturally occurring collagen in the skin by creating a true structural framework with natural, durable cross-links to ensure filler longevity
-- Provide consistent and predictable results
-- Use natural ingredients for natural-looking results
The naturally sourced porcine collagen used in Evolence is the most genetically similar to human collagen and has been used safely and effectively for decades in various medical applications, including heart valve replacement.
This new generation collagen filler is intended for injection into the mid-to-deep dermis for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds. The most common side effects of Evolence injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.
Evolence has undergone rigorous testing and has been demonstrated to be safe and effective through clinical studies. For more information on the product, visit www.evolence.com.
About OrthoNeutrogena, Aesthetics Group
Evolence is marketed in the United States by the Aesthetics Group of OrthoNeutrogena, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., and part of the Johnson & Johnson family of companies. This innovative collagen structural dermal filler was developed by ColBar LifeScience, Ltd., a biotechnology company specializing in reconstructive medicine and tissue engineering. The company has perfected a technique in which collagen, a main building block of living organisms, can be purified and transformed so as to create a variety of products that are structurally stable and safe for medical applications. ColBar LifeScience Ltd., is also subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Company does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
For OrthoNeutrogena, Aesthetics Group:
Monica Neufang, 908-874-2656
Posted: June 2008