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
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
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
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.
###