Navigation Links
Evaluating the Efficacy and Safety of Once-Daily Anti-Inflammatory,Dose Doxycycline for the Treatment of Rosacea

NEWTOWN, Pa.--(BUSINESS WIRE)--Apr 30, 2007 - CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) today announced that a new report in the May 2007 issue of the Journal of the American Academy of Dermatology evaluating two randomized phase III clinical trials, demonstrated the efficacy and safety of anti-inflammatory dose doxycycline (Oracea(R), 40-mg doxycycline, USP capsules) for the treatment of rosacea. This report has concluded these studies establish the first important body of evidence supporting the use of a systemic therapy for rosacea that is devoid of antibiotic activity.

The study further concludes that "the antibacterial effects of doxycycline or other antibiotics have not been shown to be of therapeutic importance in rosacea, therefore an effective and safe formulation of this drug that does not exhibit antibiotic selection pressure is clinically significant."

Lead clinical investigator in these clinical trials, James Q. Del Rosso. DO, Department of Dermatology, University of Nevada School of Medicine, states, "This discussion of the significance of these phase III studies is of utmost importance to the way in which rosacea patients are treated going forward. The option of an effective systemic treatment for rosacea that is devoid of antibiotic activity helps dermatologists reduce their use of antibiotics. Antibiotic use correlates with a rise in bacterial resistance, a problem of global concern." Anti-inflammatory dose doxycycline was proven to be safe in both studies. The frequency of adverse events was similar to those of patients taking placebo. Of significant note was the finding that in both studies vaginal candidiasis and photosensitivity were not observed in the patients treated with anti-inflammatory dose doxycycline.

Also noteworthy was the fact that once daily dosing, based on a review of several studies, appears to be the dosing regimen associated with the highest rate of pati ent compliance. Since it is commonly known that an inverse relationship exists between compliance and dosing frequency, this finding holds significant promise for successful treatment of the papulopustular form of rosacea targeted for treatment by anti- inflammatory dose doxycycline.

The study concludes that "anti-inflammatory dose doxycycline is the only tetracycline agent proven to be effective for the treatment of rosacea in pivotal phase III clinical trials and exhibits a pharmacokinetic profile that separates the anti-inflammatory effects from antibiotic activities."

"The advent of this systemic treatment for rosacea portends a greater population of patients who experience satisfaction from the regimen recommended by their physician because the therapy is easy to comply with and avoids the consequences of antibiotic exposure for a disease where it has not been shown that an antibiotic effect is needed," said Dr. Del Rosso.

About CollaGenex

CollaGenex Pharmaceuticals, Inc. is a specialty pharmaceutical company currently focused on developing and marketing proprietary, innovative medical therapies to the dermatology market. In July 2006, CollaGenex launched Oracea(R), the first FDA-approved systemic product for the treatment of rosacea. CollaGenex's professional dermatology sales force also markets Pandel(R), a prescription topical corticosteroid licensed from Altana, Inc., Alcortin(R) (1% iodoquinol and 2% hydrocortisone), a prescription topical antifungal steroid combination, and Novacort(R) (2% hydrocortisone acetate and 1% pramoxine HCl), a prescription topical steroid and anesthetic. Alcortin and Novacort are marketed by the Company under a Promotion and Cooperation agreement with Primus Pharmaceuticals, Inc. CollaGenex is conducting a 400-patient, Phase II dose-finding study to evaluate its second dermatology candidate, incyclinide, for the treatment of acne. CollaGenex is also conducting Phase I clinical trials to evaluate COL-1 18, a topical compound based on the SansRosa technology, for the treatment of redness associated with rosacea and other skin disorders.

Research has shown that compounds can be created by chemically modifying certain tetracyclines and that these new compounds have properties that may make them effective in treating diseases involving inflammation and/or destruction of the body's connective tissues. CollaGenex is evaluating various chemically modified tetracyclines (so called "IMPACS" compounds because they are Inhibitors of Multiple Proteases And CytokineS") to assess whether they are safe and effective in these applications. The Company has a pipeline of innovative product candidates with possible applications in dermatology and other disease states. In addition, CollaGenex has acquired the SansRosa(TM) technology, which consists of a class of compounds that have shown promise in reducing the redness associated with rosacea, and the Restoraderm(R) technology, a unique, proprietary dermal drug delivery system. CollaGenex plans to leverage these platforms to develop a range of topical dermatological products with enhanced pharmacologic and cosmetic properties.

To receive additional information on the Company, please visit our Web site at www.collagenex.com, which does not form part of this press release.

Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to the Company's plans, timing and success related to its patent applications and the launch of Oracea for the treatment of inflammatory lesions of rosacea, may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. CollaGenex' actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including those factors contained in the most recent Form 10-K for the yea r ended December 31, 2006 under the section "Risk Factors" as well as other documents that may be filed by CollaGenex from time to time with the Securities and Exchange Commission. Forward-looking statements include statements regarding CollaGenex' expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate", "believe", "could", "estimate", "expect", "intend", "may", "should", "will", and "would" or similar words. CollaGenex assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Periostat(R), Restoraderm(R) and Oracea(R) are registered trademarks and IMPACS(TM) is a trademark of CollaGenex Pharmaceuticals, Inc.

All other trade names, trademarks or service marks are the property of their respective owners and are not the property of CollaGenex Pharmaceuticals, Inc. or any of our subsidiaries.

Novacort(R) and Alcortin(R) are trademarks of Primus Pharmaceuticals, Inc.

Pandel(R) is a trademark of Taisho Pharmaceuticals.

Atridox(R), Atrisorb(R) and Atrisorb-D(R) are registered trademarks of Tolmar, Inc.

Contact

CollaGenex Pharmaceuticals, Inc.
Nancy C. Broadbent
215-579-7388
or
Financial Dynamics
Evan Smith, CFA / Erica Pettit
212-850-5606 / 212-850-5614
or
The Lane Communications Group
Suzanne Lane / Alexis Fabricant
212-757-6880


'"/>




Related medicine technology :

1. Aspreva and Roche Announce Preliminary Results for Phase III Study Evaluating CellCept in Lupus Nephritis
2. Second Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
3. Second Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
4. Phase III Study Evaluating Gileads Viread for the Treatment of Chronic Hepatitis B Virus Meets Primary Endpoint
5. New Studies Evaluating NexiumIn Pediatric GERD To Be Presented At Annual Digestive Disease Week Meeting
6. King Pharmaceuticals Announces Plan to Present Results from Phase III Clinical Trial Evaluating ALTACE as Monotherapy and in Combination with Hydrochlorothiazide at the American Society of Hypertension Annual Meeting
7. King Pharmaceuticals Announces Plan to Report Positive Data from Phase III Clinical Trial Evaluating the Combination of Altace with Hydrochlorothiazide
8. Corcept Therapeutics Announces Phase 3 Study Evaluating Corlux for Psychotic Major Depression Misses Primary Endpoint
9. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
10. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
11. New Phase 3 Study Published in The Lancet Evaluates Efficacy and Safety of Prezista/Ritonavir vs. Kaletra as Part of HIV Combination Therapy in Treatment-Experienced Adults With HIV
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016  MedSource announced today that it ... software solution of choice.  This latest decision demonstrates ... to their clients by offering a state-of-the-art electronic ... establishes nowEDC as the EDC platform of choice ... clients.  "nowEDC has long been a preferred EDC ...
(Date:6/23/2016)... -- In a startling report released today, National Safety Council ... comprehensive, proven plan to eliminate prescription opioid overdoses. Prescription ... are tackling the worst drug crisis in recorded U.S. history, assigned ... Kentucky , New Mexico , ... 28 failing states, three – Michigan , ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/27/2016)... KS (PRWEB) , ... June 27, 2016 , ... TopConsumerReviews.com ... retailers of Eyeglasses . , Millions of individuals in the United States and ... have become a way to both correct vision and make a fashion statement. Even ...
(Date:6/26/2016)... ... ... On June 10-11, 2016, A Forever Recovery, a holistic treatment center for ... Table in Battle Creek, MI, where the rehabilitation facility is located. This annual celebration ... world’s leading providers of cereal and other breakfast foods. Its residents often refer to ...
(Date:6/26/2016)... ... , ... PawPaws brand pet supplements owned by Whole Health Supply ... health of felines. The formula is all-natural and is made from Chinese herbs that ... Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... ... fertility once they have been diagnosed with endometriosis. These women need a treatment ... also require a comprehensive approach that can help for preservation of fertility and ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can now ... and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings ... The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the ...
Breaking Medicine News(10 mins):