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GLG News by Generic Drug Economic Experts

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.

Link to Pancreatitis is Bound to Negatively Impact Byetta Sales

August 21, 2008

FDA Alert: Hemorrhagic or Necrotizing Pancreatitis in Patients Taking Byetta | www.fda.gov

The recent publication of new cases of pancreatitis that are occurring in patients taking Byetta (exenatide) can't be good for Amylin/Lilly. While Byetta and investigational GLP-1 analogs are still very viable therapeutics for Type 2 Diabetes, prescribers will have to reassess the risk-benefit ratio for many patients given the new information. The long-acting form of Byetta (LAR) may suffer the most since its long half-life will make reversal of pancreatitis that much more difficult and may lead to additional damage.

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino 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.

Astra-Zeneca and Abbott partner on promoting Crestor..should Pfizer beware?

August 15, 2008

Abbott signs deal to promote Crestor in U.S. | www.chicagotribune.com

-Crestor sold 2.8 billion dollars in sales in the recent year, will this partnership result in long term exponential growth? -What are the implications for Crestor with generic simvastatin and with Lipitor going generic in the next few years? -Is a combination product going to bolster Crestor sales?

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.

A Complex Personal and Societal Issue

July 17, 2008

Costly Cancer Drug Offers Hope, but Also a Dilemma | www.nytimes.com

The issues associated with expensive therapeutics are multifaceted and involve personal, professional and societal components. Value related to medical treatment is uniquely assessed by each individual with respect to his/her financial burden, overall lifestyle and quality of life, societal role, and belief structure. Society itself is beset with contrary stakeholders in the insurance, governmental, medical and belief-centered establishments. This article is important in that it lays out some fundamental questions that wealthy countries face with respect to cost vs. benefit for new therapies in an environment relatively little constrained by cost-containment in the medical arena.

Joseph Bertino, Independent Consultant

Joseph BertinoIndependent ConsultantBertino 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.

The New PhRMA “Code on Interactions with Health Care Professionals”: What will it mean?

July 17, 2008

PhRMA “Code on Interactions with Health Care Professionals” | www.thepinksheet.com

-The new code will limit all gifts and meals to healthcare professionals, thus reducing pharmaceutical representative contact time. -Medical education programs will follow guidelines established by professional education groups -The guidelines do not go far enough for sales representative-healthcare professional interactions

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 Debates a Tougher Drug Supply Chain Law

July 9, 2008

Time To Protect The Pharmaceutical Supply Chain | www.capitolweekly.net

State Senator Mark Ridley-Thomas’ editorial argues California needs its own pharmaceutical supply chain security laws because the Federal government has failed to implement the Prescription Drug Marketing Act (PDMA). However, it does not necessarily follow that every individual state pharmacy board should establish unique documentation requirements for manufacturers, wholesalers and pharmacies operating within each state. This approach has already created a disparate patchwork of inconsistent regulations for tracking pharmaceuticals in the U.S. supply chain. In the absence of federal standards, ambitious local politicians around the country are establishing their own incompatible systems, raising costs, reducing product availability, and lowering patient safety. 

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.

A Word to the Wise...

July 8, 2008

Drug Makers Say FDA Safety Focus Is Slowing New-Medicine Pipeline | online.wsj.com

1. Sponsors need to be "squeaky clean" with respect to their assessment of signals of toxicity in drug develpment programs. 2. This assessment should be made at the preclinical and early clinical stages of the process, irrespective of political and financial considerations. 3. The per cent of failures in Phase 2 and 3 will be higher unless programs are honestly and thoroughly assessed according to the above. Even so, there will likely be more failures in late-stage programs as clinical data are generated. The FDA will spend more time and effort on safety assessment to avoid large populations being exposed in the marketing environment to new drugs.

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.

A Faulty Track-and-Trace Cost Model for Pharmacies

July 2, 2008

Pharmacies May Face More Than $110,000 Costs Per Store in First-Year to Implement Drug Track and Trace Technology if Mandated; Safety of Normal Distribution Channel Affirmed | www.nacds.org

A new report from Accenture attempts to assess the financial costs of implementing a serialized track-and-trace system for the U.S. pharmacy supply chain. But even if we assume that Accenture did a credible and impartial job building their pharmacy cost models, the estimates in this report reflect an extreme situation that no one is seriously advocating. In other words, Accenture’s calculations may not be technically wrong, but its conclusions are highly misleading given actual proposals and practices regarding supply chain security. Thus, you should think of this report as the inflated, upper bound, "worst case" costs of a track-and-trace thought experiment.

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.

Rite-Aid: From Worse to Awful

July 2, 2008

Acquired Stores Weigh on Rite Aid | online.wsj.com

Perpetual also-ran Rite-Aid (RAD) reported another quarter of weak results. When Rite-Aid Brooks/Eckerd came together in August 2006, the deal seemed to make sense given the marketplace dynamics although none of the companies were as well run as CVS or Walgreens. However, the company’s ongoing struggles support the folk wisdom saying: “If you tie two rocks together, they still won’t float.”  The widespread $4 generics strategy will hurt the company even more.

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.

Walgreens’ $4.33 Surrender to Wal-Mart

July 2, 2008

Walgreens prescribes more club card use | www.suntimes.com

Walgreens (WAG) has begun touting its Walgreens Prescription Savings Club, which offers a 3-month supply of over 400 generics for $12.99 (plus an annual membership fee). Walgreens latest move suggests that the low-priced generic wave is having a bigger effect that many people (including me) expected. It also means that competition in the private sector is now removing generic margin from the channel much faster than an Average Manufacturer Price (AMP)-based FUL ever could have.

William FinkPresidentManaged Care Pharmacy Consultants, 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.

Trends for Chronic Kidney Disease (CKD)

June 26, 2008

Resource Article: “Chronic Kidney Disease Prevalence Increases, Awareness Remains Low,” Drug Benefit Trends (vol. 20, no. 5, May 2008) | jama.ama-assn.org

There will be an increased use of costly diaylsis, especially among those people 70 years or older.  One would think that there would be a greater awareness of a disease consting $31 billion dollars a year.  However, this does not seem to be the case.

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