Collagenex Pharmaceuticals Inc · 8-K · For 11/10/03 · EX-99

Filed On 11/10/03 3:33pm ET   ·   SEC File 0-28308   ·   Accession Number 903100-3-373

Current Report   ·   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Collagenex Pharmaceuticals, Inc.                       4     15K 
 2: EX-99       Collagenex Pharmaceuticals, Inc.                       4     20K 

EX-99   ·   Collagenex Pharmaceuticals, Inc.

EX-99
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                                                                    Exhibit 99.1

Immediate Release:                        Company Contact:                      
------------------                        ----------------                      
November 10, 2003                         Nancy C Broadbent                     
                           Chief Financial Officer
                  (215) 579-7388

                       Investor Relations:
                       -------------------
                  Lisa M. Wilson
                          In-Site Communications
                  (212) 759-3929

 CollaGenex Pharmaceuticals Settles West-ward Patent
 ---------------------------------------------------
 Infringement Case
 -----------------

NEWTOWN,  PA., NOVEMBER 10, 2003 - CollaGenex  Pharmaceuticals,  Inc. (Nasdaq:  
CGPI) today  announced  that it has settled  all pending  litigations  between  
CollaGenex and West-ward Pharmaceutical Corporation.                            

      CollaGenex sued West-ward and other defendants ("West-ward") in the United
States  District  Court for the  Eastern  District  of New York,  alleging  that
West-ward infringes  CollaGenex's  patents for Periostat(R) for the treatment of
adult  periodontitis.   CollaGenex's   complaint  also  alleged  that  West-ward
infringed CollaGenex's patent rights under the Hatch-Waxman act by submitting an
Abbreviated New Drug Application ("ANDA") with the Food and Drug Administration,
seeking FDA approval to market a generic capsule version of Periostat(R).       

      In a separate  action in the United States District Court for the District
of Columbia,  CollaGenex sought and, on July 23, 2003, was granted a preliminary
injunction  preventing the FDA from approving  generic versions of Periostat(R),
including West-ward's version. West-ward intervened in that case.               

      "We are pleased to resolve these disputes with  West-ward,"  said Brian M.
Gallagher,   Ph.D.,  chairman,   president,   and  chief  executive  officer  of
CollaGenex.  "The settlement,  which followed  extensive  pre-trial  activities,
eliminates  the need to devote  substantial  financial  resources and management
time to completing discovery and preparing for the trial of the West-ward case."

      In the  settlement,  West-ward  agreed  and  confessed  to  judgment  that
CollaGenex's  Periostat(R)  patents  are valid and  infringed  by the  filing of
West-ward's  ANDA.   West-ward  also                                            

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agreed and confessed to judgment that CollaGenex's Periostat(R) patents would be
infringed  by the  manufacture  and sale of a generic  version of  Periostat(R).
West-ward  consented to a Judgment  enjoining  West-ward and any party acting in
concert with West-ward from making and selling a generic version of Periostat(R)
until CollaGenex's  patents expire or are declared invalid or unenforceable by a
court of competent jurisdiction.  Finally, West-ward agreed to withdraw from the
FDA case in the District of Columbia.                                           

      CollaGenex agreed to pay a portion of West-ward's actual legal expenses in
the  amount  of  $700,000.   In  keeping  with  generally  accepted   accounting
principles,  a charge of approximately $0.06 per basic and diluted share will be
recorded in the third  quarter of 2003.  Accordingly,  net income  allocable  to
common  stockholders during the third quarter of 2003,  previously  announced in
the  Company's  October 28, 2003 earnings  release,  will be adjusted to reflect
this  charge,  and  earnings per share will be adjusted to $0.07 per basic share
and $0.06 per diluted share.  The Company's  financial  statements for the third
quarter of 2003 will be filed on Form 10-Q with the United States Securities and
Exchange Commission on or about November 14, 2003.                              

      Paul Lubetkin,  senior vice  president and general  counsel of CollaGenex,
noted that,  "West-ward's  recognition  of  CollaGenex's  intellectual  property
rights  and  agreement  to be  enjoined  from  marketing  a generic  version  of
Periostat(R)  is a  `significant  acquiescence  of  CollaGenex's  rights  in the
industry,'  which is a factor  weighing in favor of CollaGenex  if, for example,
the Company seeks an injunction against other generic drug companies  attempting
to manufacture and sell Periostat(R)."                                          

      CollaGenex  has  separately  sued  United   Research   Laboratories/Mutual
Pharmaceuticals  Company  (Mutual) in the United States  District  Court for the
Eastern  District  of New York,  claiming  that Mutual  infringes  the claims of
CollaGenex's  Periostat(R)  patents.  Mutual has sued  CollaGenex  in the United
States District Court for the Eastern  District of  Pennsylvania,  alleging that
CollaGenex  engaged in tortuous and  anticompetitive  behavior to prevent Mutual
from  commercializing  a  generic  version  of  Periostat(R).  Mutual  has  also
intervened  the FDA action in the United States  District Court for the District
of Columbia.                                                                    

      In addition,  CollaGenex on July 14, 2003 submitted a Citizen  Petition to
the  FDA  requesting   that  it  refuse  to  approve                            

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any generic version of Periostat(R),  submitted by Mutual on the ground that the
bioequivalence studies Mutual submitted are insufficient to show that the Mutual
product is bioequivalent to Periostat(R).  The FDA has not reached a decision on
CollaGenex's  Citizen  Petition.  The resolution of the West-ward cases does not
resolve any of the pending Mutual litigations or administrative proceedings.    

      "CollaGenex  will  vigorously  enforce its patent rights against all those
who infringe or state their intention to infringe those rights. We will continue
to  pursue  any  unauthorized  use  of  our  intellectual  property,   seek  the
enforcement  of our  rights,  and protect  the  Company  against any  infringing
party's  tactics.  In addition,  we remain  committed to the  development of our
once-daily  formulation of Periostat(R)  and are working  towards  expanding the
Periostat(R)   franchise  for  applications  in   dermatology,"   concluded  Dr.
Gallagher.                                                                      

      CollaGenex  Pharmaceuticals,  Inc. is a specialty  pharmaceutical  company
currently  focused on providing  innovative  medical therapies to the dental and
dermatology markets.  Currently,  the Company's  115-person  professional dental
pharmaceutical  sales  force  markets  Periostat(R),  which is  indicated  as an
adjunct to scaling and root planing for the  treatment  of adult  periodontitis.
Periostat(R) is the first and only  pharmaceutical to treat periodontal  disease
by  inhibiting  the enzymes that destroy  periodontal  support  tissues,  and by
enhancing bone protein synthesis.                                               

      The sales force also promotes Vioxx(R), a Merck & Co. drug that CollaGenex
co-promotes  for the  treatment of acute dental pain;  Pandel,  a  prescription,
topical corticosteroid licensed from Altana, Inc.; Sirius Laboratories' AVAR(TM)
product line for the topical  control of acne  vulgaris,  rosacea and seborrheic
dermatitis;  and Atridox(R),  Atrisorb(R)  FreeFlow(TM) and Atrisorb-D FreeFlow,
Atrix Laboratories Inc.'s products for the treatment of adult periodontitis.    

      Research has shown that certain  unique  properties  of the  tetracyclines
discovered  during the  development of  Periostat(R)  may be applicable to other
diseases  involving  inflammation  and/or  destruction of the body's  connective
tissues,  including acne,  rosacea,  meibomianitis and cancer metastasis,  among
others.  CollaGenex  is  further  evaluating  Periostat(R),  as  well as the new
IMPACS(R)  compounds,  to assess  whether  they are safe and  effective in these
applications.   In  addition,   CollaGenex  has  licensed  the   Restoraderm(TM)
technology,  a unique,  proprietary                                             

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dermal  drug  delivery   system,   in  order  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.     

      This press release contains forward-looking  statements within the meaning
of Section 21E of the Securities and Exchange Act of 1934, as amended. Investors
are cautioned that  forward-looking  statements involve risks and uncertainties,
which may affect the Company's business and prospects. The Company's business of
selling, marketing and developing pharmaceutical products is subject to a number
of significant  risks,  including  risks relating to the  implementation  of the
Company's sales and marketing plans for Periostat(R) and other products that the
Company markets,  the outcome and consequences of the patent litigation  against
Mutual and the outcome of  litigation  initiated  by Mutual,  risks that the FDA
will approve generic products, such as Mutual's products, that will compete with
and  limit  the  market  for  Periostat(R),   risks  inherent  in  research  and
development  activities,  risks associated with conducting  business in a highly
regulated  environment and  uncertainty  relating to clinical trials of products
under  development,  all as discussed in the Company's periodic filings with the
U.S. Securities and Exchange Commission.                                        

Periostat(R),   IMPACS(R)  and  Metastat(R)  are  registered   trademarks,   and
Restoraderm(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.                                                     

Pandel(R) is a trademark of Taisho Pharmaceuticals.                             

VIOXX(R) is a trademark of Merck & Co., Inc.                                    

AVAR(TM) is a trademark of Sirius Laboratories, Inc.                            

Atridox(R) and  Atrisorb(R)  are registered  trademarks,  and  FreeFlow(TM) is a
trademark, of Atrix Laboratories, Inc.                                          

###   

Dates Referenced Herein   and   Documents Incorporated By Reference

				Referenced-On Page
This 8-K Filing		Date		First		Last			Other Filings
		7/14/03		2					8-K
		7/23/03		1					8-K
		10/28/03		2					8-K
Filed On / Filed As Of / For The Period Ended		11/10/03		1
		11/14/03		2					10-Q
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