GLG News by Generic Drug Economic Experts

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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].

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

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.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

TARCEVA Patent Infingement Battle Begins As OSI Pharmaceuticals Sues Teva And Mylan

March 20, 2009

Analysis of:OSI Pharmaceuticals Files Patent Infringement Lawsuits Against Teva Pharmaceuticals USA and Mylan Pharmaceuticals | phx.corporate-ir.net

As stated in a Thu 19 Mar 2009 press release, OSI Pharmaceuticals (OSIP), in protection of its TARCEVA cancer drug, has filed separate lawsuits against each of Teva and Mylan.  As the innovator company for TARCEVA [a FDA Orange Book Prescription (Rx) Referencle Listed Drug (RLD) Product with 3 listed patents - 5747498 6900221 7087613 - and with New Chemical Entity (NCE) exclusivity 5-year expiration date of 18 Nov 2009] OSIP has now started its formal Hatch-Waxman patent offense against the Paragraph (iv) ANDA Filers, Teva and Mylan.  At the commercial level, TARCEVA is manufactured for OSIP by Schwarz Pharma and it is distributed by Genentech.  TARCEVA is an extremely important revenue source for OSIP; in a recent SEC filing (Form 10K Annual Report filed 27 Feb 2009) OSIP indicates that approximately 88% of its total 2008 revenues are TARCEVA-related.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

VANCOCIN - ViroPharma Fights FDA's Possible Decision Allowing ANDA Filers To Establish Bioequivalence With In-Vitro Dissolution Testing

March 19, 2009

Analysis of:ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance | phx.corporate-ir.net

In reaction to the December 2008 FDA release of its Draft Guidance on Vancomycin Hydrochloride, ViroPharma announced Wed 18 Mar 2009 its submission of comments to the FDA.  As the innovator company for VANCOCIN, a FDA Orange Book Rx Reference Listed Drug without any listed patents nor any listed exclusivities, ViroPharma's point of view directly against the FDA's Draft Guidance is expected.  Analysis of the merits of these opposing viewpoints [FDA: in the Draft Guidance versus ViroPharma: in its comments] requires in-depth understanding of the underlying technical details within the context of the controlling laws and regulations.

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant

SOLODYN/FDA Denies Medicis Citizen Petition Seeking 30-Month Stay Against ANDA Filers

March 19, 2009

Analysis of:SOLODYN/Medicis SEC Filing, 18 Mar 2009, Form 8-K Current Report | idea.sec.gov

The FDA, acting with surprising speed, recently denied a Citizen Petition (CP) filed 13 Feb 2009 by Medicis (NYSE: MRX) in support of SOLODYN.  If FDA's denial of this CP is not reversed, then the current 3 ANDA filers [Mylan (NasdaqGS: MYL);  Barr/Teva (NasdaqGS: TEVA); and Sandoz/Novartis (NYSE: NVS)] will not be subject to a 30-month stay of FDA final approval of each of their respective ANDAs.

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

No Bidding War For CV Therapeutics From Astellas

March 17, 2009

Analysis of:Astellas to Terminate Offer for CV Therapeutics | www.pipelinereview.com

I read this news with great interest since I have worked with Astellas (Yamanouchi). Based on my experience with Astellas I am not surprise that Astellas did not increase prices (although Astellas had so much to gain from a merger with CV) due the these reasons: * Astellas (as a Japanese company) is a disciplined acquirer * $20 per share offer from Gilead, which values the company at around $1.4 billion is too expensive for Astellas * Astellas now needs to look elsewhere in order to find a company or products * Astellas will follow other Japanese drug companies like Takeda and Eisai

Kuldeepak SharmaPresident/Pharmaceutical ConsultantDr. Kuldeepak Sharma

Multivitamin Supplements can not prevent Cancer or Heart Disease.

March 12, 2009

Analysis of:Multivitamins: Fact or Fiction | www.usatoday.com

As a pharmaceutical consultant, I read this article with great interest. Overall this article support my thinking that multivitamin supplements can not prevent Cancer or Heart Disease due to these reasons: Our Daily requirements of Multivitamins supplements are very low and food is the best source of vitamins and minerals is from our body Multivitamins should be used as part of an overall healthy lifestyle Despite many health warnings, the quest for the right multivitamin still uncontrollable.

Aemad AslamPresidentMindPharma

Aurobindo Pharma's Escitalopram will be a big mover ... when it comes out in 2011

March 5, 2009

Analysis of:Aurobindo Pharma receives tentative approval for Escitalopram | www.indiainfoline.com

Forest's Lexapro commands a $2.5+ billion USD market share, just in the US.  Due to such a high volume of the brand product, Aurobindo's tentative approval on Lexapro's generic Escitalopram will be a great opportunity - primarily if they can procure a 6 month period of exclusivity from the FDA.  Additionally, despite being a brand name product, Lexapro holds an 8%+ year over year increase in the past 3 years.  Hence, the market for the drug in September of 2011 when the patent runs out will be closer to a $3 billion market.                

Aemad AslamPresidentMindPharma

Teva's Generic Imitrex commands market of Sumatriptan

February 26, 2009

Analysis of:Teva Announces Approval and Launch of Generic Imitrex(R) Tablets | www.pipelinereview.com

With the 180 day exclusivity, Teva is already commanding the market of the generic Imitrex - Sumatriptan oral tablets.  Teva maintains an AB rating of the generic that will render most insurance companies to push brand name Imitrex by GlaxoSmithKline to a non-formulary tier, skyrocketing the generic's sales.  Already, different wholesalers are reporting a backorder on Teva's generics.  Additionally, Teva's pricing point is very favorable to itself, despite Dr Reddy's prior entrance.

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