Pharmaceutical Commerce - March/April 2011 - (Page Cover1)

Business Strategies for Pharma/Bio Success www.PharmaceuticalCommerce.com MARCH/APRIL 2011 Brand Marketing | Communications Business | Finance With a Few Stumbles, REMS Begins to Hit Its Stride Nearly 200 drugs now carry requirements for a risk management program, as FDA evaluates the initial follow-up reporting from manufacturers By Suzanne Shelley Forecasting Returns When Patents Expire Overestimating product reserves as loss of exclusivity (LoE) approaches can be a $75-million mistake By Joshua I. Halpern and Jeffrey Borman, Integrichain, Inc. T he Risk Evaluation and Mitigation Strategies (REMS) program of FDA, brought into being by a 2007 law, is now approaching its fourth birthday. As of mid-March, 179 newly introduced or already commercial drugs, branded or generic, have a REMS attached to them (one drug, Sucraid [sacrosidase], had a REMS requirement lifted last December after field reporting showed minimal allergic risk). The original logic of REMS was to allow drugs that had significant risks—primarily of side effects—associated with them to enter or remain on the market, while more rigorous post-marketing education, data collection and monitoring would be performed to minimize these risks. REMS hasn’t enabled a spurt of new drugs to be approved, although numerous product launches have arguably occurred sooner than they would have without the program. Conversely, the burden on many drug sponsors has turned out to be less than initial expectations—even while members of the healthcare provider community, who have to take extra steps in many cases when REMS drugs have been prescribed, complain of an added burden that complicates patient treatment. Meanwhile, FDA has an open docket on proposed changes to how the REMS program operates, including separating out the most common type of REMS action, a medication guide for patients. Overall, since the start of the program, one out of every three new molecular entities has required a REMS, and among specialty or biologic products, the ratio climbs to one out of every two new products, says Jeff Fetterman, president of ParagonRx International LLC (Wilmington, DE), a division of inVentiv Health. However, he notes that while the prevalence of REMS “has probably been higher than a lot of people expected, the severity of most REMS requirements has been somewhat less than what most people expected early on.” “When REMS first came out, it really was a ‘four-letter word’ and many feared that the majority would require more-strict Elements to Assure Safe Use (ETASU) provisions but this has not been borne out by the data,” says Terri Madison, PhD, MPH, VP, Epidemiology and Risk Management, for Xcenda (Palm Harbor, FL), a part of AmerisourceBergen Consulting Services. continued on page 16 > From 2011 to 2015, patent exclusivity will expire for drugs totaling more than $140 billion in sales. This staggering number has drawn much of the industry’s attention to the impact on top-line sales. Yet the risk of unexpected product returns – the inventory that will come back from the channel after loss of exclusivity (LoE) – has quietly become a focus for CFOs faced with blockbuster patent expirations. Over the past decade, CFOs were regularly surprised by the volume and duration of post-LoE returns on smaller brands. Now, with billion-dollar blockbusters facing generic competition, the problem is far more acute. If the returns reserve is off by just one week of inventory, the impact on the balance sheet can be tens of millions of dollars. In response to this risk, leading Finance, Forecasting and Trade departments are collaborating on new approaches to returns forecasting and returns optimization. continued on page 12 > Manufacturing & Packaging UDP Gains Prominence in Improving Medication Adherence By F.J. Quinn For years now, contract packagers (or repackagers) who have been waging a hearts-and-minds battle with pharma brand managers to make the investment in unit-dose packaging (UDP; comprising blister cards, wallets, foil and pouches). Lately—with a view toward the shift in healthcare from the next new blockbuster to improved outcomes—they have been reinforcing the good story they have to tell on medication adherence. The Healthcare Compliance Packaging Council’s (Bon Air, VA) upcoming national meeting (see box) has been renamed “RxAdherence 2011,” and its members are involved with a new study on the subject with M.D. Anderson Cancer Center (Houston). The UDP-adherence connection is also being promoted by new studies form the Agency for Healthcare Quality and Research (AHRQ) of HHS. On the plus side, UDP proponents have solid data that demonstrate that this form of packaging maintains better compliance with treatment regiments; that it affords numerous branding and patient-interaction pathways; and that it meshes well with workflows in patient settings like hospitals (so much so that many hospitals repackage pharmaceuticals continued on page 22 > MENDOTA, IL PERMIT 200 PRSRT STD US POSTAGE PAID http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - March/April 2011

Pharmaceutical Commerce - March/April 2011
Contents
Editorial
Op-Ed
Top News
Business | Finance
Brand Marketing | Communications
Supply Chain | Logistics
Information Technology
Manufacturing & Packaging
Legal | Regulatory
Executive Training & Development
Meetings & Editorial Index

Pharmaceutical Commerce - March/April 2011

Pharmaceutical Commerce - March/April 2011 - Pharmaceutical Commerce - March/April 2011 (Page Cover1)
Pharmaceutical Commerce - March/April 2011 - Pharmaceutical Commerce - March/April 2011 (Page Cover2)
Pharmaceutical Commerce - March/April 2011 - Pharmaceutical Commerce - March/April 2011 (Page 3)
Pharmaceutical Commerce - March/April 2011 - Contents (Page 4)
Pharmaceutical Commerce - March/April 2011 - Contents (Page 5)
Pharmaceutical Commerce - March/April 2011 - Editorial (Page 6)
Pharmaceutical Commerce - March/April 2011 - Op-Ed (Page 7)
Pharmaceutical Commerce - March/April 2011 - Top News (Page 8)
Pharmaceutical Commerce - March/April 2011 - Top News (Page 9)
Pharmaceutical Commerce - March/April 2011 - Top News (Page 10)
Pharmaceutical Commerce - March/April 2011 - Top News (Page 11)
Pharmaceutical Commerce - March/April 2011 - Business | Finance (Page 12)
Pharmaceutical Commerce - March/April 2011 - Business | Finance (Page 13)
Pharmaceutical Commerce - March/April 2011 - Brand Marketing | Communications (Page 14)
Pharmaceutical Commerce - March/April 2011 - Brand Marketing | Communications (Page 15)
Pharmaceutical Commerce - March/April 2011 - Brand Marketing | Communications (Page 16)
Pharmaceutical Commerce - March/April 2011 - Brand Marketing | Communications (Page 17)
Pharmaceutical Commerce - March/April 2011 - Supply Chain | Logistics (Page 18)
Pharmaceutical Commerce - March/April 2011 - Supply Chain | Logistics (Page 19)
Pharmaceutical Commerce - March/April 2011 - Information Technology (Page 20)
Pharmaceutical Commerce - March/April 2011 - Information Technology (Page 21)
Pharmaceutical Commerce - March/April 2011 - Manufacturing & Packaging (Page 22)
Pharmaceutical Commerce - March/April 2011 - Manufacturing & Packaging (Page 23)
Pharmaceutical Commerce - March/April 2011 - Legal | Regulatory (Page 24)
Pharmaceutical Commerce - March/April 2011 - Legal | Regulatory (Page 25)
Pharmaceutical Commerce - March/April 2011 - Executive Training & Development (Page 26)
Pharmaceutical Commerce - March/April 2011 - Executive Training & Development (Page 27)
Pharmaceutical Commerce - March/April 2011 - Executive Training & Development (Page 28)
Pharmaceutical Commerce - March/April 2011 - Executive Training & Development (Page 29)
Pharmaceutical Commerce - March/April 2011 - Executive Training & Development (Page 30)
Pharmaceutical Commerce - March/April 2011 - Meetings & Editorial Index (Page 31)
Pharmaceutical Commerce - March/April 2011 - Meetings & Editorial Index (Page Cover4)
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