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GLG News by Generic Drug Economic Experts

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

McKesson Gets Out of Pharmacy Outsourcing

April 8, 2008

Comprehensive Pharmacy Services to Acquire McKesson Medication Management | www.businesswire.com

McKesson (MCK) is selling its pharmacy outsourcing business to Comprehensive Pharmacy Services (CPS). McKesson has been the most active out of the big 3 in adjusting its health care business portfolio. For example, the company sold its acute care supply business to Owens & Minor last year. Last week, McKesson acquired Rosebud Solutions, a provider of software solutions to track and manage instruments, endoscopes and tissue implants for surgical services. I expect McKesson to continue tweaking its business mix over the coming year.

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Surprising Growth by Independent Pharmacies

April 8, 2008

IMS Health Reports U.S. Prescription Sales Grew 3.8 Percent in 2007, to $286.5 Billion | www.imshealth.com

According to IMS, independent pharmacies were the fastest growing pharmacy channel in 2007.  In fact, independents grew more than 5 times as fast as chains.  This growth is surprising given the heated rhetoric around the “debilitating consequences” of Part D, Wal-Mart’s “predatory pricing,” and the “devastating impacts” of AMP. Like it or not, US retailing continues to become more concentrated and increasingly dominated by chain stores, warehouse clubs, home centers, and big box superstores. Retail pharmacy is now undergoing a similar shakeout that will leave us with fewer, but larger, independents.

Eric Gruff, Principal

Eric GruffPrincipalE4 Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Insurers Should be the First Line of Defense Against Vytorin

April 8, 2008

Will Insurers Reduce Coverage For Vytorin? | www.pharmalot.com

The pharmaceutical industry continues to lay its collective head on the chopping block by pushing drugs like Vytorin that demonstrate at best marginal activity. Insurers have a fiduciary duty to push back against the poor judgement of drugmakers who take advantage of confusion and DTC advertising to make money.

Eric Gruff, Principal

Eric GruffPrincipalE4 Consulting What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Pfizer's Melanoma Treatment Setback Has Bigger Implications

April 8, 2008

Pfizer Ends Clinical Trial Of Melanoma Treatment | online.wsj.com

While disappointing for patients and caregivers, Pfizer's loss of a late-stage treatment for melanoma casts an even darker shadow on the ability of pharmaceutical and biotech companies to successfully bring new treatments to market. Coupled with other recent Phase 3 failures, this latest outcome points to the need for even more investment in better biomarkers.

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

California Delays Drug Tracking Law to 2011

April 2, 2008

California Delays Plan to Track Prescription Drugs | www.nytimes.com

As predicted, the California Board of Pharmacy announced its decision to extend the deadline for implementation of e-pedigree laws to 2011.  The timing was unexpected but not the outcome.  The Board now avoids the embarrassment of having a legislative or legal solution imposed on them.  Let's hope that the Board members can put aside their pharma-bashing and get on with the hard work needed over the next 33 months.

Evan SiegelAdjunct Professor THE UNIVERSITY OF QUEENSLAND What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Just a Matter of Time

April 1, 2008

The Drug Scare That Exposed a World of Hurt | www.nytimes.com

Overseas manufacturing controls for both APIs and finished drug products will need to be improved and the FDA will closely monitor compliance in an increased fashion. Drug regulation itself is not likely to change, but more inspections and more thorough review of DMFs and information submitted in support of late-stage INDs and NDAs/BLAs will occur. The FDA has been lax in assuring that the veritable explosion of outsourcing of raw material and API manufacture to third-world and emerging nations has been closely monitored for compliance with purity, potency and other requirements.

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Patent Win Protects Eisai's Aricept Against Teva's Potential Generic Product Launch Via Preliminary Injunction

March 31, 2008

WSJ/Aricept Maker Wins Injunction In Patent Case | online.wsj.com

* As noted in the Wall Street Journal article, Aricept® is a blockbuster drug for the treatment of Alzheimer's disease.  And, as noted in Judge Ackerman's ruling, Aricept sales are a huge source of Eisai's revenue - "sales of Aricept® in the United States constitute 70% of Eisai’s U.S. subsidiary’s profits, and 25% of Eisai’s revenues worldwide". * In patent infringement litigation at a Federal trial court, a preliminary injunction in favor of Eisai and against Teva has just been granted which orders Teva not to sell generic Aricept® as claimed in US Patent 4895841. * The Fri 28 Mar 2008 26-page Opinion & Order (Doc #191) by Judge Harold A. Ackerman of the United States District Court for the District of New Jersey grants Eisai's Motion for Preliminary Injunction (Doc #141).

Patrick Joseph Igoe, Life Sciences Patent Attorney

Patrick Joseph IgoeLife Sciences Patent AttorneyIndependent IP Litigation Consultant What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

Amgen's EPO Patent Win At The Federal Circuit

March 19, 2008

WSJ/Court Sends Mircera Case Back To Trade Commission | online.wsj.com

(1) The US Court of Appeals for the Federal Circuit - in a complicated 22-page split Opinion earlier today Wed 19 Mar 2008 - provided Amgen another victory in its long patent battle(s) with Hoffmann-LaRoche. (2) Amgen's Aranesp® and EPOGEN® (each a prescription only product that relates to EPO/erythropoietin) are protected by multiple US patents. (3) As indicated in the Wall Street Journal article, Aranesp® and EPOGEN® are each critical revenue-producers for Amgen with combined sales in excess of $6 billion. (4) Further ITC proceedings may ultimately transform the current intermediate patent victory into a more effective and more valuable ruling in favor of Amgen.

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

WSJ Hypes McKesson Buyout (Again)

March 19, 2008

As the Market Falls, It's Time to Shop | online.wsj.com

The Wall Street Journal published another article speculating on the possibilities of a private equity buyout of McKesson (MCK).  I still view McKesson as the most logical LBO target among the Big 3 wholesalers, especially given its business mix, current operating platform, age (and stability) of its management team, and potential for a value-creating restructuring. However, the turmoil in the credit markets makes a near-term deal seem unlikely as the credit crunch grips private equity.

Adam Fein, Founder & President

Adam FeinFounder & PresidentPEMBROKE CONSULTING INC What is a GLG Leader?|GLG Leaders are a separate tier of Council Members with a Council Rank in the top 5%. These GLG Member Program participants are eligible for ongoing, in-depth consultative relationships with GLG clients.

The DEA's Anti-Diversion Strategy

March 17, 2008

Cardinal Health Names Michael C. Kaufmann to Lead Pharmaceutical Segment | sev.prnewswire.com

The recent uptick in the DEA’s enforcement activities with wholesalers is likely to continue as the DEA seeks to combat diversion of legitimate controlled substances. As I see it, the increase stems from a combination of changing political priorities, new detection capabilities, and new approaches to the pharmacy supply chain.  recent Congressional testimony by the DEA shed some light on their strategy behind license suspensions at seven (not four) wholesale distribution centers. Expect more, not less, enforcement action in the future. Meanwhile, wholesalers are struggling to balance their enforcement responsibilities with the legitimate needs of pharmacies and patients.

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