Printer Friendly
The Free Library
14,678,741 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Connetics to Resume Extina Development with New Phase III Trial.


PALO ALTO, Calif. -- Connetics Corporation (Nasdaq:CNCT CNCT Connect
CNCT Certified Network Computer Technician
), a specialty pharmaceutical company focused on dermatology, announced today that after additional discussions with the 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.
 it will resume development of Extina(R), an investigational new drug formulation of 2% 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.
 for the treatment of seborrheic dermatitis Seborrheic Dermatitis Definition

Seborrheic dermatitis is a common inflammatory disease of the skin characterized by scaly lesions usually on the scalp, hairline, and face.
. The Company received a non-approvable letter for Extina in November 2004 due to insufficient clinical data. As a result of meetings between Connetics and FDA officials regarding requirements for the Extina NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any , Connetics will recommence Re`com`mence´   

v. i. 1. To commence or begin again.
2. To begin anew to be; to act again as.
He seems desirous enough of recommencing courtier.
- Johnson.

v. t. 1. To commence again or anew.
 development by initiating a final Phase III trial intended to demonstrate that Extina is superior to placebo foam.

The Phase III trial is expected to commence in the third quarter of 2005 which should position Connetics to resubmit Verb 1. resubmit - submit (information) again to a program or automatic system
feed back

return, render - give back; "render money"
 the NDA for Extina to the FDA by the end of 2006 with an anticipated review time of up to six months. Incremental development expenses associated with Extina for the second half of 2005 are estimated to be approximately $1.0 million.

"Over the past several months we have worked with the FDA to get clarity on the requirements for FDA approval of Extina," said Thomas G. Wiggans, chief executive officer of Connetics. "Returning Extina to our pipeline is an important decision that leverages our formulation and development achievements with the drug candidate and positions Connetics to potentially launch the product in 2007. We believe that the design of the proposed study will provide the data necessary to address the FDA's desire to see statistical superiority to placebo foam. We continue to view Extina as an important product that addresses a significant need within the topical anti-fungal market."

Acting on the Company's original NDA submission in November 2004, and consistent with prior disclosure by the Company, the FDA concluded that Extina did not show superiority to placebo foam. Previously announced results from Connetics' Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the  with Extina demonstrated non-inferiority to Nizoral(R) (ketoconazole) 2% Cream as measured by the endpoint of the Investigator's Static Global Assessment.

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(TM) (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 Atopic Dermatitis Definition

Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and
, 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), a foam formulation of the antifungal drug ketoconazole. Connetics' product formulations aim 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

This press release contains "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. Statements about the impact of our plans for Extina, including plans for the Phase III trial and resubmission of the NDA based on anticipated results, and about the projected launch date and value of Extina, are forward-looking statements. These statements are based on certain assumptions made by Connetics' management based on 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 filed for the year ending December 31, 2004 and form 10-Q for the quarter ended March 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 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jun 8, 2005
Words:725
Previous Article:Bank One to 'Say Hello to Chase' as Name Changes at All Colorado Locations; Combined company provides more services to customers.
Next Article:Curis Announces Dosing of First Patient in Phase I Clinical Trial for Basal Cell Carcinoma.
Topics:



Related Articles
Connetics completes patient enrollment in three separate clinical trials; rapid pace of enrollment is achieved.
Connetics Announces Completion of Patient Enrollment for Scleroderma Pivotal Trial.
Connetics Expands Clinical Development Program for ConXn; Peripheral Vascular Disease Is Third IND for ConXn.
Connetics Receives $5 Million Payment for Relaxin Biotechnology Program; Completion of Commercial Manufacturing Scale-Up.
Connetics Announces Pivotal Trial Results of Relaxin for Scleroderma; Trial Did Not Reach Primary Endpoint; Relaxin Development Program in Other...
Connetics Receives FDA Non-Approvable Letter for Extina; Conference Call to Be Held Wednesday, November 24th at 9:00 a.m. Eastern/6:00 a.m. Pacific.
Connetics Commences Phase III Clinical Trial With Primolux for Atopic Dermatitis and Psoriasis; Second Drug Program to Include Connetics' Patented...
Connetics Announces Highlights of Discovery Day 2005; Live Webcast Begins at 3:00 p.m. Pacific Time Today.
Connetics Reports Positive Results From Second Phase III Clinical Trial of Extina(R) (Ketoconazole) Foam, 2%; NDA Resubmission Anticipated by...
Connetics Reports Third Quarter Financial Results.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles