Generics line up waiting for big-name patents to expire

BY Amanda Baltazar

Close to $63 billion worth of branded drugs are set to lose their patents between 2007 and 2012, paving the way for generic replicas. This year, to date, the biggest drug to lose its patent has been Sanofi-Aventis’ $2.2-billion sleep medication, Ambien.

This spawned the approval of 13 generic equivalents of zolpidem tartrate within two days, under a cluster approval, a process that now is being adopted by the Food and Drug Administration to quickly bring more drugs to market. (Sanofi-Aventis’ extended-release Ambien CR isn’t available in generic versions.) Generics approvals were given to companies including Teva, Mylan, Dr. Reddy’s and Watson. Prasco has released an authorized generic.

Another cluster approval this year was awarded for generic Lamisil tablets (terbinafine hydrochloride). The FDA approved products from companies including Apotex, Aurobindo Pharma, Dr. Reddy’s, Glenmark and Wockhardt. This antifungal medication from Novartis saw annual U.S. sales of approximately $687 million for the 12 months ended March 2007, according to IMS Health data.

At the end of last year, the FDA approved the first generic versions of GlaxoSmithKline’s Wellbutrin XL (bupropion hydrochloride) extendedrelease tablets, which are indicated for the treatment of major depressive disorder. Wellbutrin XL was the 21st highest-selling brand name drug in the United States in 2005, with sales totaling $1.3 billion, and Anchen Pharmaceuticals was first to market with the generic product, for which it received 180 days of marketing exclusivity. There are now generics available from Watson and Teva.

Also toward the end of 2006, Pfizer lost patent protection on Norvasc, the world’s most-prescribed branded medicine for treating hypertension. The FDA approved generic amlodipine besylate 2.5 mg, 5 mg and 10 mg tablets from Mylan, giving the generic drug maker 180 days of exclusivity on the market. This period now has expired, and other generics are on the market from companies including Teva, Ranbaxy and Roxane Laboratories.

Still to come this year is a generic version of Schering-Plough’s Clarinex. This drug was launched in 2002 when Schering-Plough lost its patent on the antihistamine blockbuster Claritin. Clarinex is, essentially, a tweaked version of its predecessor, and sales have been disappointing: $722 million in 2006, a fraction of the $3 billion a year the drug maker saw for Claritin. Clarinex loses its patent on Oct. 1.

Migraine medication Imitrex from GSK lost its patent in June. GSK has granted Dr. Reddy’s authorized generic status for sumatriptan succinate, which is expected to launch at the end of next year.

Meridian from Abbott Labs loses its patent protection on Dec. 11. This obesity drug had global sales of $345 million worldwide last year, $60 million of which originated in the United States. Generic versions of this drug may not be as attractive to manufacturers since the launch this year of FDA-approved OTC product Alli from GSK.

Pfizer’s antihistamine Zyrtec loses patent protection on Dec. 25. The FDA has granted tentative approval to an abbreviated new drug application from Caraco for cetirizine hydrochloride, 5 mg and 10 mg immediate release tablets. Zyrtec had U.S. sales of approximately $1.21 billion for the 12-month period ended Dec. 31, 2006, according to IMS Health data.

The last patent expiration of this year looks likely to be schizophrenia medication Risperdal from Janssen Pharma, which had annual sales of $4 billion.

Moving into 2008, branded drug patents will be falling by the wayside. Depakote (Abbott), Fosamax (Merck), Advair (GSK), Serevent (GSK), Effexor XR (Wyeth), Lamictal (GSK) and Topamax (Ortho McNeil) are all expected to go head-to-head with generic competition.


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Grocer sings new tune in community involvement


Meijer is taking another step in community relations, to the tune of promoting and selling CDs of local musicians.

The Michigan-based 176-unit grocery chain launched the Outside the Mainstream promotion in February with a solo CD from Josh Davis, a singer from Lansing, Mich., whose Fool Rooster CD was recognized by Performing Songwriter magazine for its lyric.

Each month, the chain is featuring a new performer in its circulars, which are sent weekly to 7 million households in Ohio, Michigan, Illinois, Indiana and Kentucky, according to company vice president of public affairs Stacie Behler. Meijer purchases 1,000 of the artist’s CDs and offers them for sale in all the chain’s stores for $7.49.

“The goal of the program is to bring some of the talent that we find in our own backyards to a wider audience than they can normally reach by themselves,” Behler said. “And by supporting this with a low price and a feature in our circular, hopefully it will lead people to gamble on the purchase of music that is worthy of discovery.”

Meijer, according to Behler, is trying to create regional loyalty to its stores by promoting local talent.

CDs chosen for promotion, according to the chain, must have a UPC and be professionally duplicated. Submitted CDs are sorted according to state and chosen on the basis of whatever state will be featured that month and how different the music is from the previous month.

Featured in April is Michigan-based Potato Moon with its CD “The Life of The Lonely Jones.”


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CVS wins Caremark battles

BY Antoinette Alexander

WOONSOCKET, R.I. —The battle for Caremark Rx has finally come to an end. And, to the dismay of Express Scripts, CVS has emerged the winner, creating a $75 billion pharmacy benefit management powerhouse that is likely to serve as a benchmark for additional mergers within the industry.

“CVS/Caremark will offer end-to-end services, from plan design to prescription fulfillment, as well as the opportunity to improve clinical outcomes, which will result in better control over health care costs for employers and plan providers,” stated Tom Ryan, president and chief executive officer of CVS/Caremark, late last month when the deal closed. “The company will improve the delivery of pharmacy services and health care decision-making, enabling consumers to benefit from unparalleled access, greater convenience and more choice.”

With the close of the transaction—ultimately valued at $27 billion—CVS/Caremark has moved into a strong, competitive position. The combined company will be No. 1 in pharmacy sales, PBM-managed lives, specialty pharmacy sales and retail-based health clinics. It will be No. 2 in mail services.

That adds up to a lot of extra leverage for the retail health care juggernaut with suppliers, as well as insurers and payers.

In terms of synergies, CVS expects to realize between $800 million to $1 billion in revenue synergies in 2008, and significantly more thereafter. The company expects about $500 million in cost savings, largely related to better purchasing.

“We would like to note that every deal that both CVS and Caremark have done historically has yielded synergies significantly in excess of original guidance,” stated Citigroup analyst Deborah Weinswig in a recent research note. “We believe this deal will be no exception.”

Charles Boorady, also of Citigroup, believes that if the company achieves cost savings from the drug-procurement process, it likely will come from a combination of the following: manufacturers accepting the lower price or offering greater rebates, the wholesalers and distributors accepting lower prices and manufacturers bypassing the wholesalers and selling directly to the combined CVS/Caremark entity.

While many industry observers view the merger as a boon for the companies, it undoubtedly will have major implications on the industry, in general, as vertical integration is a new paradigm that—if successful—could clear the way for more mergers moving forward, with Medco and Express Scripts likely being the next targets.

“The fragmentation in the past may be the reason why vertical integration did not work, but the sheer scale of the CVS/Caremark company may be able to make it work,” Boorady said. “The only test will be whether customers buy into the concept or the concerns over the perceived channel conflict will outweigh it.”

Either way, Boorady sees it as a win-win for rival PBMs. “I see Medco and Express Scripts winning either way. If this integration works, they are likely to be the ones that are acquired next. If it doesn’t work then they could stand to gain customers that prefer a standalone [PBM] instead of a vertically integrated model.”

Another issue such a deal brings to the forefront is network restriction. If customers are willing to restrict the retail pharmacy so that employees can get their prescriptions filled at a single chain, or just a few chains in the market, then it will make the synergy from a vertical integration more obvious, according to Boorady.

However, this has been a concern for several years and has yet to materialize.

“I think most employers have concluded, and will continue to conclude, that the sheer hassle factor that you are putting on your employees by making them go to a CVS instead of a Walgreens, or vice versa, isn’t really worth what little savings you can get relative to other things you can do that present less of a hassle to the employee but can save a lot more money,” Boorady said.

However, prior to the deal, CVS Pharmacare controlled a provider network of more than 56,000 retail pharmacies. Meanwhile, Caremark’s network numbered more than 60,000 retail pharmacies, so it is unlikely that the combined company, post-merger, would suddenly pull back the size of its network—particularly, if the end goal is to remain attractive to insurers and payers and competitive with stand-alone PBMs.

According to William Blair & Co. analyst Mark Miller, the combined company is facing its first big test as it expects an announcement on the large Federal Employee Program contract—currently up for negotiation—as early as May. Three years ago, Caremark won this contract from Medco and it is likely that the two PBMs, among others, will bid for this business aggressively.

“While there are many moving parts to these types of negotiations, this will be the first big test for the new CVS/Caremark, and may provide some incremental perspective on the current state of the competitive environment,” Miller stated in a research note.

In related news, CVS/Caremark has announced the members of the company’s board of directors. As previously disclosed, the 14-member board was evenly split among designees from CVS and Caremark.

Former Caremark chairman and chief executive officer Mac Crawford has been elected chairman of the board of the combined company. Ryan will continue to serve as president and chief executive officer.

The following individuals named to the board from CVS are:

Ryan, president and chief executive officer of CVS/Caremark Corp.

David W. Dorman, senior advisor and partner, Warburg Pincus LLC.

Marian L. Heard, president and chief executive officer, Oxen Hill Partners.

William H. Joyce, chairman and chief executive officer, Nalco Co.

Terrence Murray, former chairman and chief executive officer, FleetBoston Financial Corp.

Sheli Z. Rosenberg, former vice chairman, president and chief executive officer, Equity Group Investments LLC.

Richard J. Swift, former chairman, president and chief executive officer, Foster Wheeler Ltd.

The following individuals named to the board from Caremark are:

Mac Crawford, chairman of CVS/Caremark Corp.

Edwin M. Banks, founder, Washington Corner Capital Management LLC.

C. David Brown II, chairman, Broad and Cassel.

Kristen E. Gibney Williams, former executive of Caremark’s Prescription Benefits Management division.

Roger L. Headrick, managing general partner, HMCH Ventures; president and chief executive officer, ProtaTek International

Jean-Pierre Millon, former president and chief executive officer, PCS Health Systems

C.A. Lance Piccolo, chief executive officer of HealthPic Consultants


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Which area of the industry do you think Amazon's entry would shake up the most?