ZURICH (Dow Jones)--Swiss drugmaker Novartis AG (NVS) said Friday it is evaluating whether to launch its new high-blood pressure treatment Exforge early after a U.S. court invalidated the patent of one of the pill's two active ingredients [the Norvasc component].
The good news came with a twist though, because the same drug is also a key ingredient in an older Novartis hypertension treatment, a pill called Lotrel, which may now also face competition from generics earlier-than-anticipated.
A U.S. appeals court Thursday invalidated Pfizer Inc.'s (PFE) patent on the hypertension drug Norvasc, opening the way for generic competition to the company's second-best selling drug after Lipitor as well as to an early launch of Novartis' Exforge. Norvasc was expected to lose patent protection in September. The drug's active ingredient, amlodipine besylate, is a component of both Exforge and Lotrel. "We are assessing the potential options," said spokesman John Gilardi, when asked if Novartis will launch Exforge, which last year already won tentative approval by the U.S. Food and Drug Administration, ahead of schedule.
Exforge combines Novartis' best-selling product Diovan and amlodipine, a drug that lowers blood pressure in a different way, in a single pill.
"The invalidation of the Norvasc substance patent allows a launch of Exforge in the U.S. ahead of the original September launch schedule and thus adds an important catalyst to the pharmaceutical division in 2007," said Karl-Heinz Koch, pharmaceutical analyst in Zurich with private bank Vontobel, who rates the stock outperform.
Some analysts say the main advantage of Exforge to Novartis is that it will help protect Diovan sales when the company's bestseller loses patent protection in 2012, but others expect it to become a blockbuster drug with annual sales of more than $1 billion in its own right.[I’m in the latter camp.]
The market for medicines that treat high blood pressure is huge. The condition affects around 50 million people in the U.S. alone. The World Health Organization estimates that around 7.1 million people die each year due to complications from the condition.
While numerous drugs are available to treat high blood pressure, none of them is perfect. Some can be slow to work, while others disappear from the body too quickly. For most patients, no single drug lowers blood pressure sufficiently.
As a result, more doctors are treating hypertension patients with a combination of drugs, trying to find the most effective mix for each individual. And researchers are developing drugs that attack hypertension in new ways.
The immediate impact from the Norvasc ruling on Novartis sales is unclear, because the benefits from a possible early launch of Exforge could be offset from an earlier-than-expected onset of generic competition to Lotrel, which generated sales of $1.35 billion last year.
At 1030 GMT, Novartis shares were up 0.3% at CHF69.65, in a flat broader market.
The tentative U.S. approval for Teva Pharmaceutical Industries Ltd (TEVA) generic version of Lotrel could now turn into a full approval, allowing Teva to launch at risk any time, said Bear Stearns pharmaceutical analyst Alexandra Hauber in a note to clients. She has an overweight rating on Novartis.
Litigation for the Lotrel combination patents is ongoing. Launching at risk means that a company starts selling a generic before patent disputes have been settled.
"Assuming a positive outcome of the Lotrel patent litigation, we see upside of more than $1 billion to our sales forecasts," from an early Exforge launch, said Vontobel's Koch. <<
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