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Forest Laboratories Inc. Message Board

  • frankposting frankposting Oct 26, 2012 2:38 PM Flag

    Bystolic Cliff Is Coming Sooner Than Namenda Cliff

    Since Bystolic's exclusivity ending 12/17/2012, and FDA's 30-month stay on the first ANDA ending 5/19/2014, if FRX lose to any of challengers (seven at least) in the court, generic Bystolic will be in the market on 12/17/2012, otherwise generic Bystolic will be in the market on 5/19/2014. Oh, a Bystolic Cliff is coming earlier than the Namenda Cliff!

    "NEW YORK--(BUSINESS WIRE)--

    Forest Laboratories, Inc. (FRX) and Forest Laboratories Holdings, Ltd. (collectively, “Forest”) announced today that they have entered into a settlement agreement with Hetero Labs Ltd. and Hetero USA Inc. (collectively, “Hetero”) in patent infringement litigation brought by Forest in response to Hetero’s ANDA seeking approval to market generic versions of Forest’s BYSTOLIC® (nebivolol) tablets. Specifically, under the terms of the settlement agreement and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide a license to Hetero that will permit it to launch its generic version of BYSTOLIC® as of the date that is the later of (a) three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Hetero receives final FDA approval of its ANDA, or earlier in certain circumstances. Similar patent infringement litigation brought by Forest against Alkem Laboratories, Ltd., Indchemie Health Specialties Pvt. Ltd., Glenmark Generics Inc., Watson Pharmaceuticals Inc., Torrent Pharmaceuticals Ltd., Amerigen Pharmaceuticals Ltd., and related companies and subsidiaries, remains pending in a multidistrict litigation established in the U.S. District Court for the Northern District of Illinois."

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    • A sort of "pay ($9M to Glenmark) for delay generics." Seemingly, Glenmark will be settled.

      Still two more (Amerigen and Watson) to go.

      By Zacks Equity Research | Zacks – 4 hours ago..
      12/31

      Forest Labs (FRX) and Glenmark Pharmaceuticals S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India, recently signed a collaboration agreement. The companies will work on the development of novel mPGES-1 inhibitors for the treatment of chronic inflammatory conditions, including pain.

      Potential candidates have already been identified by Glenmark. Glenmark is conducting pre-clinical studies with these candidates prior to the initiation of human studies.

      Glenmark will receive an upfront payment of $6 million from Forest Labs. Moreover, Forest Labs will pay $3 million to fund the next phase of work. Additional payments will be made by Forest Labs in fiscal 2014 to support the development program. Once phase I development is completed, Forest Labs has an exclusive option to acquire licensing rights to the program.

    • A buyout?

      Don't kidding!

      No Pharma has the stomach of taking two cliffs (Bystolic and Namenda) and losing 60% sales in the next 30 months.

    • Very interesting development (seems the verdict is coming).

      NEW YORK--(BUSINESS WIRE)--

      Forest Laboratories, Inc. (FRX) and Forest Laboratories Holdings, Ltd. (collectively,“Forest”) announced today that they have entered into settlement agreements with Alkem Laboratories, Ltd. ("Alkem"), Indchemie Health Specialties Pvt. Ltd. ("Indchemie"), and Torrent Pharmaceuticals Ltd. and Torrent Pharma Inc. (collectively, "Torrent") in patent infringement litigation brought by Forest in response to abbreviated new drug applications (ANDAs) filed by Alkem, Indchemie and Torrent each seeking approval to market generic versions of Forest’s BYSTOLIC® (nebivolol) tablets. These settlement agreements are in addition to the previously announced Bystolic patent infringement settlement agreement with Hetero Labs Ltd.

      Specifically, under the terms of the settlement agreements and subject to review of the settlement terms by the U.S. Federal Trade Commission, Forest will provide licenses to each of Alkem, Indchemie and Torrent that will permit these companies to launch their generic versions of BYSTOLIC® as of the date that is the later of (a) three calendar months prior to the expiration of U.S. Patent No. 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date each company receives final FDA approval of its ANDA, or earlier in certain circumstances.

      Similar patent infringement litigation brought by Forest against Amerigen Pharmaceuticals Ltd., Glenmark Generics Inc., Watson Pharmaceuticals Inc., and related companies and subsidiaries thereof, remains pending in a multidistrict litigation established in the U.S. District Court for the Northern District of Illinois.

    • frankpostin......you r on my ignore list now.

    • My point is described by the tittle: Bystolic Cliff is coming sooner than Namenda Cliff (May 2015).

      Let me add more colors.

      The product was in R&D since 1980s. Mylan owned it with IP (patent application since 1988) before 2000, then sold to Jassen. Jassen inherited the patent application and had the 6545040 issurance in 2003 (expiring 2020) and product approval in 2007. FRX was the partner and then becomes the solo owner.

      As an expert of challenging patents, Mylan should have sufficient reasons for selling Bystolic and its patent application to others.

      In seven current paraghraph-IV challengers, Alkem, Hetero, Indchemie, Glenmark and Torrent are indian companies. Watson is #3 of largest generic companies. Amerigen is a US-China generic company, and Amerigen is a first-to-file for genericizing Bystolic.

      • 1 Reply to frankposting
      • Perhaps, all 7 are first-to-file: very hard for FRX to deal with, particularly, Watson:

        PARSIPPANY, N.J., March 14, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Nebivolol Hydrochloride Tablets, 2.5 mg, 5 mg, 10 mg and 20 mg. Watson's ANDA product is a generic version of Forest Laboratories' BYSTOLIC®, which is a beta-adrenergic blocking agent that is approved for the treatment of hypertension.

        Forest Laboratories filed suit against Watson on March 13, 2012, in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 6,545,040. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until June 17, 2015 or final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

        Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of BYSTOLIC® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

        For the twelve months ending January 31, 2012, BYSTOLIC® had total U.S. sales of approximately $391 million according to IMS Health data.

    • Let me provide more info:

      1) The first-to-file:
      East Brunswick NJ, USA, March 15 th, 2012 – Amerigen Pharmaceuticals Limited today confirmed that its subsidiary Amerigen Pharmaceuticals Inc. has filed an Abbreviated New Drug Application (“ANDA”) containing a paragraph IV certification for a generic version of BYSTOLIC® with the US Food & Drug Administration (“FDA”) and is seeking approval to market its nebivolol hydrochloride tablets prior to expiration of U.S. Patent 6,545,040.

      On March 13th 2012, Forest Laboratories and Janssen Pharmaceutica filed suit for patent infringement against Amerigen in the District of Delaware.

      Based upon available information, Amerigen believes that it may be a first applicant to file an ANDA for a generic version of BYSTOLIC® containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA for nebivolol hydrochloride tablets be approved by the FDA, Amerigen believes that its product may be entitled to 180 days of generic marketing exclusivity.

      For the twelve months ending December 31st, 2011, Forest reported US net sales of BYSTOLIC® of approximately $324MM.

      BYSTOLIC® is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.

      2) In accord with FDA's rules, if a first-to-file-generic-drug-maker received final approval, they have to launch the product within 75 days, otherwise they will lose the 180-day exclusivity -- i.e., greatly cutting the profitability.
      Seems that Oct 26 PR was intentional to be fuzzy about the date.

    • for the record,patent #6545040,also known as the 040 patent expires on april 2020,also frx has a file to extend this patent until december,2021.

 

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