Biotech Values

[rkrw]

Here's what I was talking about, a win/win settlement that gives something back to the consumer. This should pass at the ftc with flying colors.

Incidentally the settlement should help out nrph, making a supposedly harder to abuse adderall with shire.

Press Release Source: Barr Pharmaceuticals, Inc.


Barr and Shire Sign Three Agreements: A Product Acquisition Agreement for ADDERALL(R); A Product Development Agreement; and A Settlement and License Agreement for ADDERALL XR(R)
Monday August 14, 8:45 pm ET
Parties Agree to Settle Pending Patent Litigation Regarding ADDERALL XR(R); Form Strategic Development Partnership on Six Proprietary Products


WOODCLIFF LAKE, N.J., Aug. 14 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL - News; "the Company") today announced that its subsidiary Duramed Pharmaceuticals, Inc. ("Duramed") and Shire plc (Nasdaq: SHPGY, TSX: SHQ, LSE: SHP) 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 Barr Laboratories, Inc. ("Barr") has signed a Settlement and License Agreement relating to the resolution of two pending patent cases involving Shire'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.
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"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 Bruce L. Downey, Barr's 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."

Product Acquisition Agreement

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 Hart-Scott-Rodino Act.

Barr 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(TM) (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 Barr 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 Barr's launch. Barr would pay Shire a royalty equal to a portion of profits generated from the sales of generic ADDERALL XR during the time that Barr is the only generic marketing a generic version of ADDERALL XR. As part of the settlement, Barr admits that Shire's patents are valid and enforceable and that Barr's generic product infringes one of the Shire patents.