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Connetics Files Citizen Petition for Soriatane With the FDA; Emphasizes Need for Rigorous Bioequivalency Testing for Generic Acitretin.


PALO ALTO, Calif. -- Connetics Corporation (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CNCT CNCT Connect
CNCT Certified Network Computer Technician
), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced the filing of a Citizen Petition with the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) to request that any generic products that reference Soriatane(R) (acitretin) meet several criteria in addition to rigorous bioequivalency testing prior to approval. The criteria outlined in the Citizen Petition will ensure that patients are adequately protected from generic versions of acitretin that might not be comparable in safety and efficacy to the branded product.

Subtle differences between Soriatane and a generic acitretin that change the extent or route of metabolism, absorption, distribution or elimination of acitretin can significantly increase the risks associated with the well-known conversion of acitretin to the potent teratogen teratogen /ter·a·to·gen/ (ter´ah-to-jen) any agent or factor that induces or increases the incidence of abnormal prenatal development.teratogen´ic

te·rat·o·gen
n.
, etretinate, and therefore reduce the effectiveness of current safeguards to manage these risks. The Citizen Petition outlines several ways in which the FDA can confirm that a generic acitretin is in every way the same as Soriatane, in order to ensure that the labeling instructions and other safeguards put in place for Soriatane are sufficient to give the same level of protection to patients who receive generic acitretin.

"In the Citizen Petition, Connetics has outlined certain tests we strongly believe the FDA should require of any company to ensure its generic product is the same as Soriatane with regard to important attributes that are related to product safety," said Thomas G. Wiggans, Chairman and Chief Executive Officer of Connetics. "Typically, a few basic bioequivalency tests are required for an amended new drug application (ANDA ANDA
abbr.
abbreviated new drug application
). But the overall pharmacologic equivalence of a generic takes on greater significance for a product with the chemical complexities of acitretin, which directly impact the way it can be most safely used."

About Soriatane

Soriatane is a once-daily oral retinoid retinoid /ret·i·noid/ (ret´i-noid)
1. resembling the retina.

2. retinal, retinol, or any structurally similar natural derivative or synthetic compound, with or without vitamin A activity.
 medication that is supplied in 10 mg and 25 mg capsules for the treatment of severe psoriasis in adults, including plaque, erythrodermic, pustular pus·tu·lar
adj.
Of, relating to, or consisting of pustules.



pustular

pertaining to or of the nature of a pustule; consisting of pustules.
, guttate gut·tate or gut·tat·ed
adj.
1. Having the shape of or resembling drops, as certain cutaneous lesions.

2. Spotted as if by drops.



guttate

resembling a drop.
 and palmar-plantar. Soriatane is the only oral once-a-day medication approved for both initial and maintenance treatment for severe psoriasis in adults. Acitretin is a metabolite metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food.  of the teratogen etretinate, and for women should only be considered for those with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments. Soriatane is contraindicated in females who are pregnant or who intend to become pregnant during therapy or at any time for at least three years following discontinuation of therapy.

About Connetics

Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics has branded its proprietary foam drug delivery vehicle VersaFoam(R). The Company's marketed products are OLUX(R) (clobetasol propionate clobetasol propionate (klōbā´tsol´ prō´pē ) Foam, 0.05%, Luxiq(R) (betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or  valerate) Foam, 0.12%, Soriatane(R) (acitretin) capsules and Evoclin(R) (clindamycin) Foam, 1%. Connetics is developing Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin tretinoin /tret·i·noin/ (tret´i-noin?) the all-trans stereoisomer of retinoic acid, used as a topical keratolytic in the treatment of acne vulgaris and disorders of keratinization and administered orally in the treatment of acute ) Gel, for treating acne; Desilux(TM) (desonide) VersaFoam-EF, 0.05%, a low-potency topical steroid formulated to treat atopic dermatitis; Primolux(TM) (clobetasol propionate) VersaFoam-EF, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; and Extina(R) (ketoconazole ketoconazole /ke·to·co·na·zole/ (ke?to-kon´ah-zol) a derivative of imidazole used as an antifungal agent.

ke·to·co·na·zole
n.
) VersaFoam-HF, 2%, to treat seborrheic dermatitis. Connetics' product formulations are designed to improve the management of dermatological diseases and provide significant product differentiation. In Connetics' marketed products, these formulations have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com.

Forward Looking Statements

Except for historical information, this press release includes "forward-looking statements" within the meaning of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 Reform Act. All statements included in this press release that address activities, events or developments that Connetics expects, believes or anticipates will or may occur in the future, including, particularly, statements about the filing of its Citizen Petition and Soriatane (acitretin), are forward-looking statements. All forward-looking statements are based on certain assumptions made by Connetics' management based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond Connetics' control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks and other factors that are discussed in documents filed by Connetics with the Securities and Exchange Commission from time to time, including Connetics' Annual Report on Form 10-K for the year ended December 31, 2005. Forward-looking statements represent the judgment of the Company's management as of the date of this release, and Connetics disclaims any intent or obligation to update any forward-looking statements.

Press Release Code: (CNCT-G)
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 3, 2006
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