Big Pharma teaches old drugs new tricks

NEW YORK (CNNMoney.com) -- As Big Pharma faces patent expirations on some of its most lucrative drugs, the industry is trying to reinvigorate sales by finding creative ways to land new patents - but on the same old drugs.

The industry is losing some $16 billion worth of annual sales this year because of patents that will expire; last year it suffered $23 billion in patent losses, according to the research firm IMS Health. And despite clever reformulations of popular patented drugs like Lipitor and Zyrtec, Pfizer (up $0.13 to $25.67, Charts) and other industry leaders are discovering that there is no substitute for the ever-elusive new blockbusters.

But since new blockbusters are hard to find, drug companies are tweaking their existing drugs -- by creating extended release versions for instance -- in order to get new patents on old drugs. Drugmakers are also combining drugs whose patents are set to expire with other drugs to create entirely new products, and new patents. These patent-extension tricks certainly help to cushion the blow of the sales vacuum created by patent expirations, but they're no substitute for new products worth billions.

Les Funtleyder, analyst for Miller Tabak, said that Big Pharma is paying the price for its "innovative black hole," and has "relatively few tools in the tool kit" to address the impending post-patent sales dips.

"At some point, all big drugs are going to go off patent, and the question is: What does Big Pharma do next?" said Funtleyder. "They could innovate their way out of the problem, or they could buy a pipeline, or they could go out of business."

Pfizer's patent for Norvasc, the company's second-biggest drug, expires in September. That marks the beginning of the end for a blood pressure drug that racked up nearly $5 billion in 2006 sales. In the year after a drug patent expires, sales typically plunge 80 percent as generic drugmakers produce competing, low-cost versions.

But Pfizer, the New York-based drug giant, has put a new spin on Norvasc by combining it with Lipitor, the cholesterol-lowering drug that's also the industry's biggest seller, with nearly $13 billion in 2006 sales. The resulting combo, called Caduet, totaled $370 million in 2006 sales, a figure that pales in comparison to the nearly $18 billion in combined annual sales for Lipitor and Norvasc.

"With a product like [Norvasc], you just have to take the hit," said James McKean, analyst for Atlantic Equities. "They tried to shift prescriptions to Caduet, a combo of Norvasc and Lipitor, but it hasn't been all that successful."

Pfizer's patent on its allergy blockbuster Zyrtec is also set to expire in September, and the company is trying to protect those sales with a patented spin-off called Zyrtec-D, an extended-release version of the drug.

"[Zyrtec-D] has helped to protect some of the brand, but it doesn't protect the whole thing," said McKean of Atlantic Equities. "It's a slightly less precipitous fall, but you [still] expect a sales decline."

The impact of Zyrtec-D on company sales isn't exactly clear. Pfizer reported more than $1.5 billion in 2006 sales for its Zyrtec franchise, but didn't break out revenue for the extended release version.

Other companies have protected sales through drug combinations. Merck (up $0.37 to $44.00, Charts), the New Jersey-based drugmaker, combined Zocor, an anti-cholesterol blockbuster that lost patent protection in 2006, with Schering-Plough's (up $0.56 to $24.31, Charts) cholesterol drug Zetia. The combination totaled nearly $4 billion in 2006 sales, which was divided between Merck and Schering-Plough.

New Jersey-based Schering-Plough has been particularly successful in protecting sales using patent extensions. When the company lost its patent on the antihistamine blockbuster Claritin in 2002, it protected those sales by launching a generic over-the-counter version of the allergy drug Claritin RX, and also launched a tweaked prescription version called Clarinex. Clarinex sales totaled $722 million in 2006 and OTC Claritin sales totaled $356 million. That total is a fraction of Claritin's $3 billion-a-year sales history, but it exceeds the billion-dollar mark that distinguishes a blockbuster.

GlaxoSmithKline (up $0.31 to $55.93, Charts) has also added patents to try and ward off a sales plunge. The British drugmaker lost the patent on its former blockbuster antidepressant Paxil in 2003, but still managed to glean more than $600 million in 2006 sales with new, tweaked versions of the drug.

Indeed drug companies' products consistently come under assault from generic drugmakers even before their patents expire. On Tuesday, Pfizer successfully defended in a New Jersey court three patents on its arthritis painkiller Celebrex, worth more than $2 billion in 2006 sales, against a challenge by the biggest generic drug giant in the world: the Israeli company Teva Pharmaceuticals (up $0.38 to $36.96, Charts). The court ruling bars Teva from producing a generic version of Celebrex until the patent runs out in 2015.

Bristol-Myers Squibb (up $0.45 to $27.60, Charts) suffered a similar assault on its anti-clotting blockbuster drug Plavix in 2006, when the privately-held Canadian company Apotex flooded the market with a low-cost generic version of Plavix despite the fact that the patent doesn't expire until 2012.

Bristol managed to get Apotex legally blocked from continuing to produce the generic, but not before sustaining a 53 percent hit to Plavix sales in the fourth quarter, down to $496 million. Plavix sales totaled $3.4 billion in 2006, down 15 percent from the year before. This was the final straw in a string of failures and missteps that led to the ouster of Bristol's former chief executive Peter Dolan.

Big Pharma's battles to extend and protect its drug patents are hard-fought, but they ultimately cannot compensate for a weak research and development pipeline.

Miller Tabak analyst Funtleyder of compared the drug companies' methods of extending patents and creating partnerships to "rearranging deck chairs on the Titanic."

"You should never look revenue in the mouth, but the key driver on pharma is new products," said Funtleyder.

The analysts quoted in this story do not own shares of company stocks mentioned here, but A.G. Edwards conducted non-investment banking securities-related services for Pfizer and Bristol within the last 12 months.