Mr. Patrick Joseph Igoe

GLG News^SM Analyses by Patrick Joseph Igoe

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Generic ADDERALL XR Launched By Teva (NasdaqGS:TEVA) - VYVANASE Sales Of Shire PLC (NasdaqGS:SHPGY) Might Decrease

April 2, 2009

Analysis of:Teva Introduces First Generic Adderall XR® Capsules in the United States | www.tevapharm.com

(1) As stated in the 02 Apr 2009 Press Release, Teva Pharmaceutical Industries Ltd. (NasdaqGS:TEVA) has launched its generic versions corresponding to the FDA-approved Orange Book Reference Listed Drug (RLD) medical products of ADDERALL XR Capsules (mixed salts of a single-entity amphetamine product; strengths/mg: 5 10 15 20 25 30) of Shire PLC (NasdaqGS:SHPGY).  This event, although unfavorable to Shire, was clearly a known possibility.  Its anticipated impact will likely be a decrease in Shire's American sales of ADDERALL XR Capsules.  (2) Spillover damage for American sales of VYVANSE Capsules (lisdexamfetamine dimesylate; strengths/mg: 20 30 40 50 60 70) might be possible.  The nexus between ADDERALL and VYVANASE follows. VYVANASE's Active Product Ingredient (API) is lisdexamfetamine dimesylate; a prodrug of dextroamphetamine.  ADDERALL's APIs are a mixture of 4 related amphetamines.  Thus, ADDERAL and VYVANASE are related medical products.

OXYCONTIN Update: Ratiopharm And Sandoz Infringe 2 European Patents Controlled By Napp And Purdue

April 2, 2009

Analysis of:OXYCONTIN Update: England Patent Infringement Victory {Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH [2009] EWCA Civ 252 (01 April 2009)} | www.bailii.org

(1) In this article, the London 01 Apr 2009 html version of judgment of the England and Wales Court of Appeal (Civil Division), a recent appellate court decision provides Napp and Purdue, in protecting OXYCONTIN, with a definitive patent infringement victory over both Ratiopharm GmbH and Sandoz Ltd (winners at the prior lower court).  (2) Its conclusion at Paragraph No. 117 is clear and unambiguous.  "The patents are valid and infringed."  (3) This important decision reverses a prior 16 Dec 2008 decision.  From a financial point of view OXYCONTIN is vital - "Its importance is shown by its sales figures - of the order of £32 million per annum in the UK alone." (Paragraph No. 4)

COPAXONE Update: Teva (NasdaqGS:TEVA) Continues FDA And Patent Fights To Delay Or Prevent Launch Of Generic COPAXONE By Novartis (NYSE:NVS) In Collaboration With Momenta Pharmaceuticals (NasdaqGM:MNTA)

March 30, 2009

Analysis of:Teva (NasdaqGS:TEVA) Announces FDA Response to Citizen Petition (Re COPAXONE ANDA) | www.tevapharm.com

As stated in the 25 Mar 2009 press release by Teva (NasdaqGS:TEVA), the FDA recently denied Teva's Citizen Petition (CP) which was previously filed 26 Sep 2008.  Teva is now fully-engaged in its dual efforts to protect its American COPAXONE sales.  These dual efforts are (1) at the FDA: through petition practice, Teva seeks to have the FDA undertake specific action which in effect would either delay or prevent FDA review or approval of the now pending Novartis-Momenta Abbreviated New Drug Application No. 90-128 for generic COPAXONE; and (2) at the United States District Court for the Southern District of New York (USDC/SDNY): in Case No. 1:08-cv-07611-BSJ-JCF, Teva as Plaintiff has sued Novartis (NYSE:NVS) and Momenta (NasdaqGM:MNTA) for patent infringement of multiple FDA Orange Book patents [7 patents are listed in the FDA Orange Book 5981589 6054430 6342476 6362161 6620847 6939539 7199098].

CUBICIN (daptomycin for inection) Patent Litigation Starts As Cubist (NasdaqGS:CBST) Sues Teva (NasdaqGS:TEVA)

March 25, 2009

Analysis of:Cubist Pharmaceuticals Files Patent Infringement Lawsuit Against Teva Parenteral Medicines, Inc. | www.cubist.com

As noted in the Mon 23 Mar 2009 press release, Cubist has sued Teva in response to Teva's Abbreviated New Drug Application (ANDA) seeking FDA approval of a generic version of CUBICIN.  This patent dispute is critical because, as noted in recent SEC filings, CUBICIN sales account for substantially all of Cubist's revenues.  Within the 3 patents-in-suit, 2 patents (US Patent Nos. 6468967 6852689) contain only method claims while the remaining 1 patent (US Reissue Pat. No. 39071) contains compound, composition, formulation, and method claims.

MULTAQ (dronderone hydrochloride) NDA - Sanofi-Aventis Awaits FDA Final Decision

March 23, 2009

Analysis of:Heart-Drug Review Gives Sanofi Shot at $1.9 Billion (Update2) | www.bloomberg.com

As indicated in the Tue 17 Mar 2009 Bloomberg article, the FDA has provided Sanofi-Aventis SA (NYSE:SNY) with a positive viewpoint for current NDA No. 22-425 [submission date: 31 Jul 2008], the New Drug Application for MULTAQ (dronderone hydrochloride).  However, this positive viewpoint is not the same as FDA final approval for MULTAQ; rather, it is a nonbinding and nonfinal recommendation of a committee.  Analysis of the public FDA documents on this matter indicate that the positive recommendation is both complicated and nuanced.

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