Yahoo! Finance Story - SCULPTRA(TM) From Dermik Laboratories Receives Recommendation for Approval With Conditions From FDA Advisory Panel

March 26, 2004

Bill Hanna (billhanna@...) has sent you a news article. (Email address has not been verified.)

Personal message:

Sculptra (New Fill) hopefully headed for approval? As a satisfied user, I think this is great news -

SCULPTRA From Dermik Laboratories Receives Recommendation for Approval With Conditions From FDA Advisory Panel

http://biz.yahoo.com/prnews/040326/nyf041_1.html

Search - Finance Home - Yahoo! - Help

Welcome [sign In]

To track stocks more, Register

Financial

NewsEnter

symbol(s) BasicPerformanceReal-time MktDetailedChartResearchOptionsOrder

Book

Symbol Lookup

Press ReleaseSource:

Dermik Laboratories

SCULPTRA From Dermik Laboratories Receives Recommendation for Approval With Conditions From FDA Advisory PanelFriday March 26, 11:47 am ET

BERWYN, Pa., March 26 /PRNewswire/ -- Dermik Laboratories, the U.S.

dermatology arm of Aventis (NYSE: AVE - News), announced today that a U.S. Food and

Drug Administration (FDA) advisory committee has unanimously recommended, with

conditions, U.S. marketing approval of SCULPTRA (injectable poly-L-lactic

acid) for the proposed indication to correct shape and contour deficiencies

resulting from facial fat loss (lipoatrophy) in people with human

immunodeficiency virus.ADVERTISEMENT

"Dermik is pleased with the panel's recommendation," said

Bitterman, president of Dermik. "Many people with human immunodeficiency virus

desperately need a safe and effective treatment for facial lipoatrophy. By

granting the product an expedited review, the FDA recognized that SCULPTRA

satisfies an unmet medical need, and Dermik will work with the Agency to bring

SCULPTRA to market as rapidly as possible."Facial lipoatrophy is the loss of fat that supports the fullness, shape

and contour of the face. Clinical trials with SCULPTRA, in people with

lipoatrophy associated with human immunodeficiency virus, demonstrated

noticeable results that typically lasted for up to two years after the first

session. Adverse effects were generally limited to the site of the injection

and included temporary redness and swelling and small, typically non-visible

bumps."The physical signs of lipoatrophy resulting from HIV infection and its

associated anti-retroviral therapy can be so distressing that people may

discontinue life-preserving treatment. The FDA panel's recommendation is a

critical first step toward bringing a safe and effective treatment for facial

fat loss to people with HIV," said Marcus Conant, MD, clinical professor, UCSF

Medical Center. "SCULPTRA would give those patients an important

treatment for long-lasting correction of facial shape and contour

deficiencies."The panel recommended approval of the product with conditions: a post-

approval study, a physician training program, product use limited to people

with human immunodeficiency virus who have lipoatrophy, provision of product

specification information, and wording changes to the proposed label.SCULPTRA is marketed outside of the United States under the trade name

NEW-FILL. The French Notified Body G-Med (Department of Evaluation of

Medical Devices) approved the product in 1999 as a wrinkle filler and in 2004

for large volume corrections of the signs of lipoatrophy. The product has

been used by an estimated 150,000 people in more than 30 countries in Europe,

South America, and Australia to treat a variety of facial volume and contour

deficiencies, including signs of aging such as wrinkles, folds and sunken

cheeks.Because poly-L-lactic acid is a polymer synthetically derived from natural

components and is a biocompatible substance, there is no need to test for

allergic reactions. It has been used in surgical products for more than 20

years as a component of dissolvable sutures and is used as a vehicle for

several sustained release injectable medications.About Dermik LaboratoriesDermik Laboratories conducts the North American business of Aventis

Dermatology, the global dermatology unit of Aventis. Dermik is dedicated to

providing innovative dermatological products to satisfy the needs of health

care providers and patients. Dermik continues its strong commitment to

innovative treatments for skin and nail conditions, including acne, nail

fungus, pre-cancerous skin lesions, psoriasis and rosacea. It is

headquartered in Berwyn, Pennsylvania.Please visit our Web sites at http://www.dermik.com and

http://www.skinhealthsolutions.com .About AventisAventis is dedicated to treating and preventing disease by discovering and

developing innovative prescription drugs and human vaccines. In 2003, Aventis

generated sales of EUR 16.79 billion (US $18.99), invested EUR 2.86 billion

(US $3.24) in research and development and employed approximately 69,000

people in its core business. Aventis corporate headquarters are in

Strasbourg, France. The company's prescription drugs business is conducted in

the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in

Bridgewater, New Jersey. For more information, please visit:

http://www.aventis-us.com .Statements in this news release containing projections or estimates of

revenues, income, earnings per share, capital expenditures, capital structure,

or other financial items; plans and objectives relating to future operations,

products, or services; future economic performance; or assumptions underlying

or relating to any such statements, are forward-looking statements subject to

risks and uncertainties. Actual results could differ materially depending on

factors such as the timing and effects of regulatory actions, the results of

clinical trials, the company's relative success developing and gaining market

acceptance for new products, the outcome of significant litigation, and the

effectiveness of patent protection. Additional information regarding risks

and uncertainties is set forth in the current Annual Report on Form 20-F of

Aventis on file with the Securities and Exchange Commission and in the current

Annual Report -- "Document de Reference" -- on file with the "Autorite des

marches financiers" in France.Pursuant to Article 7 of the COB Regulation no. 2002-04, this press

release was transmitted to the Autorite des marches financiers before its

release.

Source:

Dermik Laboratories

Email this story

-

Set

a News Alert

Sign In

Yahoo! Finance Story - SCULPTRA(TM) From Dermik Laboratories Receives Recommendation for Approval With Conditions From FDA Advisory Panel

Recommended Posts

Guest guest

Link to comment

Share on other sites

Join the conversation

Activity