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Cellegy Selects QUMAS DocCompliance to Manage Regulatory and Clinical Documentation.


Business Editors/Biotech Writers

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Oct. 11, 2001

Biopharmaceutical specialty firm taps DocCompliance to automate

management of regulatory submissions, protocols and reports

QUMAS Inc., (www.qumas.com) the leading provider of Enterprise Compliance Management Solutions for regulated industries, today announced that Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY) has selected QUMAS DocCompliance(R), a complete, out-of-the-box compliance solution designed to exclusively manage the full lifecycle of regulatory controlled documentation throughout the enterprise.

Cellegy is a specialty biopharmaceutical company engaged in the development of prescription drugs and high performance skin care products. The firm plans to use DocCompliance with an Oracle database to automate the management of large volumes of regulatory and clinical documentation.

Cellegy's Senior Vice President, Clinical & Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas:
, Dr. Daniel Azarnoff, said, "We investigated the available software solutions that would help us reduce the amount of paper documentation we physically manage, that would also meet the FDA's requirements for electronic submissions, which will soon be mandatory. After speaking with industry peers and experts about the various systems available, we have chosen QUMAS DocCompliance to handle both tasks for us."

Cellegy Pharmaceuticals has two products, Anogesic(R) (nitroglycerin nitroglycerin (nī'trōglĭs`ərĭn), C3H5N3O9, colorless, oily, highly explosive liquid. It is the nitric acid triester of glycerol and is more correctly called glycerol trinitrate.  ointment ointment /oint·ment/ (oint´ment) a semisolid preparation for external application to the skin or mucous membranes, usually containing a medicinal substance.

oint·ment
n.
) and Tostex (testosterone gel) in advanced clinical development around the world. In drugs like this, it can be important to reduce the time spent managing documentation, enabling them to reach the market faster.

Automating the management of regulated documentation with DocCompliance can help reduce the time and resources needed to bring new drugs such as Anogesic from discovery to submission for approval by 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.
.

QUMAS President, Kevin O'Leary Kevin O'Leary is the name of:
  • Kevin O'Leary (jurist) (born 1920), Australian jurist.
  • Kevin O'Leary (entrepreneur) (born 1954), Canadian entrepreneur.
, said, "We are very pleased to have Cellegy select QUMAS DocCompliance to handle the management of their critical regulatory and clinical documentation. Over the years, we have built a solid base of pharmaceutical and medical device customers and their success is spawning exponential growth Extremely fast growth. On a chart, the line curves up rather than being straight. Contrast with linear.  into the biopharmaceutical and clinical research markets. We are finding more and more referrals coming from users within these industries, and Cellegy's selection of DocCompliance is yet another example of the strength of our referral business."

About Cellegy

Cellegy Pharmaceuticals, Inc. (Nasdaq: CLGY) is a specialty biopharmaceutical company engaged in the development of prescription drugs and high performance skin care products.

During October 2001, Cellegy successfully completed its confirmatory 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  using Anogesic to treat pain associated with chronic anal fissures and plans to file a final 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  with the U.S. Food and Drug Administration before year-end 2001.

Cellegy is also conducting two Phase II clinical trials using Anogesic to treat hemorrhoids hemorrhoids (hĕm`əroidz) or piles, dilatations of the veins about the anus (external hemorrhoids) or those higher up inside it (internal hemorrhoids). , a related condition which afflicts over nine million people in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  alone. The Company is nearing completion of a Phase III Noun 1. phase III - 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 FDA  trial for Tostrex, a testosterone gel product for the treatment of male hypogonadism.

Assuming successful trial results, Cellegy intends to file for marketing approval of its products in major markets around the world. For more information, contact Richard Juelis at Cellegy (650) 616-2210 or the Web www.cellegy.com.

About QUMAS

QUMAS, Inc. is the leading developer of Enterprise Compliance Management Solutions designed to help regulated industries ensure regulatory compliance.

For over a decade, QUMAS has been providing industry-proven Enterprise Compliance Management solutions to market leaders in the pharmaceutical, medical device, biotechnology, and contract research industry sectors, and was recently named as Ireland's 12th fastest-growing technology company for 2000 by Deloitte & Touche, and recognized in Software Magazine's 2000 Software 500.

Using advanced technology and regulatory domain intelligence, QUMAS' pre-packaged compliance management solutions automate critical document processes and dramatically reduce document cycle times.

QUMAS solutions deploy rapidly to deliver FDA (including 21 CFR CFR

See: Cost and Freight
 Part 11 ruling on electronic signature and records), EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets.  and ISO-related best practices for the automation of controlled documentation and electronic regulatory submissions. QUMAS is based in Cork, Ireland with US headquarters in Florham Park, NJ and additional offices throughout the United States.

For more information, please visit our Web site www.qumas.com or contact QUMAS at (973) 377-8750 (North America) or + 353 21 4320050 (Europe).

This press release contains certain forward-looking statements that are subject to material risks and uncertainties. Investors should not place undue reliance on these forward-looking statements, which address circumstances only as of the date of this press release.

Both Cellegy and QUMAS assume no duty to update the information in this press release regardless of whether any forward-looking statement later turns out to be inaccurate. Risks and uncertainties that may affect future results include, but are not limited to, the following: the timing and cost of completion of Cellegy's clinical trials, potential delays in planned regulatory filings, the scope of patent coverage, and the safety and efficacy of actual clinical trial results. For more information on risk factors please review Cellegy's Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2000.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 11, 2001
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