Contract
| 000 Xxxxxxxx Xxxxx Xxxx Xxxxxxxxx Xxxx, XX 00000 000-000-0000 |
N E W S R E L E A S E | |
| CONTACT: Xxxxx X. Xxx, 000-000-0000 | EMAIL: xxxx@xxxxxxxx.xxx |
Xxxx and Shire Sign Three Agreements: A Product Acquisition Agreement for ADDERALL®; A
Product Development Agreement; and A Settlement and License Agreement for ADDERALL XR®
Parties Agree to Settle Pending Patent Litigation Regarding ADDERALL XR®; Form Strategic
Development Partnership on Six Proprietary Products
WOODCLIFF LAKE, NJ – August 14, 2006...Xxxx Pharmaceuticals, Inc. (NYSE: BRL) (“the Company”) today
announced that its subsidiary Duramed Pharmaceuticals, Inc. (“Duramed”) and Shire plc (LSE: SHP,
NASDAQ: SHPGY, TSX: SHQ) have signed a Product Acquisition Agreement for ADDERALL®
(immediate-release mixed amphetamine salts) tablets and a Product Development Agreement for six
proprietary products, and that its subsidiary Xxxx Laboratories, Inc. (“Xxxx”) has signed a
Settlement and License Agreement relating to the resolution of two pending patent cases involving
Xxxxx’s ADDERALL XR®. The agreements will be submitted to the United States Federal
Trade Commission as required by law and become effective upon the Courts’ signing of consent
judgments in the two pending cases.
“We believe the agreements announced today provide an equitable resolution to our ADDERALL XR
patent litigation that creates a significant benefit for consumers, as well as the Company’s
shareholders,” said Xxxxx X. Xxxxxx, Xxxx’x Chairman and Chief Executive Officer. “First and
foremost, the agreements enable a pro-competitive and pro-consumer introduction of a generic
version of ADDERALL XR more than nine years earlier than might otherwise have been possible. It
will also result in an investment in research and development for six products initially, which
will enhance our ability to expand our proprietary development activities. Finally, it provides us
immediate access to the immediate-release ADDERALL brand product, a generic version of which we
have manufactured and marketed since 2002.”
The Product Acquisition Agreement provides for Duramed to purchase Shire’s ADDERALL®
(immediate-release mixed amphetamine salts) tablets. Under the terms of the agreement, Duramed will
pay Shire $63 million. This agreement is subject to reporting under the United States
Xxxx-Xxxxx-Xxxxxx Act.
Xxxx currently manufactures and markets a generic version of ADDERALL that it first launched in
February 2002. ADDERALL is indicated as an integral part of a total treatment program which
typically includes other remedial measures (psychological, educational, social) for a stabilizing
effect in children with behavioral syndrome characterized by the following group of
developmentally inappropriate symptoms: moderate to severe distractibility, short attention span,
hyperactivity, emotional lability and impulsivity. Current annual sales for the branded ADDERALL
product for the twelve months ended June 2006 are approximately $40 million, based on industry
sources.
Product Development Agreement
In a separate Development Agreement, Duramed has granted Shire a license to obtain regulatory
approval for and market in certain specified territories Duramed’s recently approved
SEASONIQUE™ (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl
estradiol tablets 0.01 mg) extended-cycle oral contraceptive product and five products in various
stages of development utilizing Duramed’s transvaginal ring technology. Shire has agreed to pay
Duramed an initial $25 million payment for previously incurred product development expenses, and
will reimburse Duramed for development expenses incurred going forward up to a maximum of $140
million over an eight year period, not to exceed $30 million per year. Upon approval of these
products, Duramed will retain rights to market and promote these products in North America, Central
and Eastern Europe and Russia and Shire will maintain the same rights in the rest of the world,
including five countries in Western Europe.
Settlement and License Agreements
The Settlement and License Agreements permit Xxxx to launch a generic version of ADDERALL XR, under
terms of a license commencing on April 1, 2009, more than nine years earlier than the
last-to-expire Shire patent listed in the U.S. Food and Drug Administration’s Orange Book, or
earlier under certain circumstances such as the launch of another party’s generic version of
ADDERALL XR. The license will be exclusive for the first 180-days following Xxxx’x launch. Xxxx
would pay Shire a royalty equal to a portion of profits generated from the sales of generic
ADDERALL XR during the time that Xxxx is the only generic marketing a generic version of ADDERALL
XR. As part of the settlement, Xxxx admits that Xxxxx’s patents are valid and enforceable and that
Xxxx’x generic product infringes one of the Shire patents.
About Xxxx
Xxxx Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Xxxx Laboratories,
Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary
pharmaceuticals. For more information about Xxxx, please visit
Xxxx’x website at xxx.xxxxxxxx.xxx.
Forward-Looking Statements
Except for the historical information contained herein, the statements made in this press release
constitute forward-looking statements within the meaning of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be
identified by their use of words such as “expects,” “plans,” “projects,” “will,” “may,”
“anticipates,” “believes,” “should,” “intends,” “estimates” and other words of similar meaning.
Because such statements inherently involve risks and uncertainties that cannot be predicted or
quantified, actual results may differ materially from those expressed or implied by such
forward-looking statements depending upon a number of factors affecting the Company’s business.
These factors include, among others: the difficulty in predicting the timing and
outcome of legal proceedings, including patent-related matters such as patent challenge
settlements
and patent infringement cases; the outcome of litigation arising from challenging the validity or
non-infringement of patents covering our products; the difficulty of predicting the timing of FDA
approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend
exclusivity periods for their products; our ability to complete product development activities in
the timeframes and for the costs we expect; market and customer acceptance and demand for our
pharmaceutical products; our dependence on revenues from significant customers; reimbursement
policies of third party payors; our dependence on revenues from significant products; the use of
estimates in the preparation of our financial statements; the impact of competitive products and
pricing on products, including the launch of authorized generics; the ability to launch new
products in the timeframes we expect; the availability of raw materials; the availability of any
product we purchase and sell as a distributor; the regulatory environment; our exposure to product
liability and other lawsuits and contingencies; the increasing cost of insurance and the
availability of product liability insurance coverage; our timely and successful completion of
strategic initiatives, including integrating companies and products we acquire and implementing our
new enterprise resource planning system; fluctuations in operating results, including the effects
on such results from spending for research and development, sales and marketing activities and
patent challenge activities; the inherent uncertainty associated with financial projections;
changes in generally accepted accounting principles; and other risks detailed from time-to-time in
our filings with the Securities and Exchange Commission, including in our Annual Report on Form
10-K for the fiscal year ended June 30, 2005.
The forward-looking statements contained in this press release speak only as of the date the
statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or
revise any forward-looking statements, whether as a result of new information, future events or
otherwise, except to the extent required under applicable law.
[EDITOR’S ADVISORY: Xxxx Pharmaceuticals, Inc. news releases are available free of charge through
PR Newswire’s News On-Call site at
xxxx://xxx.xxxxxxxxxx.xxx/xxxx/000000.xxxx. Xxxx news releases
and corporate information are also available on Xxxx’x website (xxx.xxxxxxxx.xxx). For
complete indications, warnings and contraindications, contact Xxxx’x Drug Information Department at
1-800-Xxxx Lab. All trademarks referenced herein are the property of their respective owners.]
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