EXTON, Pa.--(BUSINESS WIRE)--Fibrocell Science, Inc. (OTCBB: FCSC) today announced revised pricing for LAVIV® (azficel-T) reflecting the growing value of the product to both physicians and patients. LAVIV is the first and only FDA-approved product that uses the patient’s own collagen-producing fibroblast cells to improve the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. The product continues to gain acceptance in the premium aesthetic market, and the new pricing better reflects the value of this unique product. LAVIV has received recognition in national beauty and fashion magazines, including receipt of the prestigious Allure magazine ‘Breakthrough Award’ in 2011. The product has also been recognized for its innovation, including in the 12th Annual Wall Street Journal Technology Innovation Awards program.
An introductory price for LAVIV was originally set in order to stimulate usage and generate clinical experience with the product. With LAVIV now in the market for more than a year, the company has established a new suggested retail price of $19,900 effective May 1, 2013 for a patient’s full course of treatment—three treatment sessions spaced at intervals of three to six weeks. The commercial introduction of LAVIV has been driven primarily by positive patient and physician experience.
LAVIV launched in January 2012 and is marketed to leading aesthetic physicians in major U.S. markets as an important addition and complement to existing aesthetic offerings. LAVIV addresses a patient’s desire for a more natural approach. With age, fibroblast cells, which produce collagen, diminish, resulting in the dermis layer growing thinner, less resilient and more prone to wrinkling. Unlike any other product on the market, LAVIV contains a patient’s own fibroblast cells which are harvested from behind the ear and then re-injected into smile lines.
“We believe the use of the patient’s own fibroblast cells helps enable an optimal aesthetic result. These sentiments are echoed by our customers, who are leaders in the aesthetic field, and who see firsthand the benefits LAVIV offers their patients,” said David Pernock, Chief Executive Officer and Chairman of the Board, Fibrocell Science. “As a pioneer in personalized medicine, it is our pleasure to offer a premium aesthetic product to our customers and their patients. We believe this is just the beginning of the significant role our autologous fibroblast technology will play in addressing patient needs.”
Fibrocell is leveraging its technology and expertise to expand into other medical applications in which fibroblasts have the potential to treat unmet medical needs, including restrictive burn scars, vocal cord scars, acne scars and rare genetic collagen deficiencies such as Recessive Dystrophic Epidermolysis Bullosa (RDEB). The company plans to initiate Phase II trials for the treatment of restrictive burn scars and vocal cord scars later this year. The company is also in discussions with the FDA regarding the next phase in its program to explore the treatment of moderate to severe acne scars. There are currently no FDA-approved products to treat these indications.
Recently the company entered an exclusive channel collaboration with Intrexon Corporation. The collaboration leverages Fibrocell’s fibroblast expertise and Intrexon’s synthetic biology expertise. One of the collaboration’s goals is to treat the rare genetic condition, Recessive Dystrophic Epidermolysis Bullosa, using a patient’s own fibroblasts to produce functional collagen VII. “RDEB is a very serious genetic disorder,” said Professor Jouni Uitto, Chair, Department of Dermatology & Cutaneous Biology at Thomas Jefferson University, Philadelphia, PA. “It is characterized by the presence of extremely fragile skin and recurrent blister formation, resulting from minor mechanical friction or trauma and often leading to early demise of the affected individuals. An estimated 1 out of every 20,000 births are affected with some type of EB. The disorder occurs in every racial and ethnic group throughout the world and affects both sexes equally.”
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (FCSC) is an autologous cell therapy company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit www.fibrocellscience.com.
About LAVIV® (azficel-T)
LAVIV is an autologous cellular product indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established.
Important Safety Information About LAVIV® (azficel-T)
LAVIV (azficel-T) is an autologous cellular product for intradermal injection only. LAVIV is contraindicated for allogeneic use, in patients with allergy to gentamicin, amphotericin, dimethyl sulfoxide (DMSO) or material of bovine origin and in patients with active infection in the facial area. The following reactions have been reported following treatment with LAVIV: hypersensitivity reactions, bleeding and bruising at the treatment site, vasculitis, herpes labialis, basal cell cancer; keloid and hypertrophic scarring may occur following post-auricular skin biopsies or LAVIV injections. Additional warnings and precautions to be considered include the use of LAVIV in patients with genetic disorders or formation of normal collagen matrices and in immunosuppressed patients, or those patients undergoing chemotherapy for malignancies or receive immunomodulatory therapies for autoimmune diseases.
The most common adverse reactions, occurring in ≥1% of patients who receive LAVIV, were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis and pruritus.
For more information about LAVIV, please see the accompanying full Prescribing Information or visit www.mylaviv.com.
Forward-Looking Statements
All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as updated in “Item 1A. Risk Factors” in the Company’s Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company’s public filings with the SEC.
