The Basel, Switzerland-based outfit indicated today that its branded drug business is healthy with its disclosure that phase 3 data for two new compounds -- LAF237 for type 2 diabetes and SPP100 for hypertension -- were strong enough to warrant filing paperwork for Food and Drug Administration approval in 2006. Both experimental medications may be firsts in new classes of drugs for their respective indications, and both have blockbuster potential. Naturally, there is no guarantee that either drug will get a green light, but Novartis has an impressive track record when it comes to bringing medicines to market. The company has introduced 13 new medications in the U.S. since 2000, more than any other major pharmaceutical company.
The two new compounds' progress is a major positive, but a less attention-grabbing development in the company's more bland generic unit could have an even bigger impact on future earnings. The Wall Street Journal reported last week that Novartis' generic unit Sandoz is suing the FDA for allegedly keeping Omnitrope, Sandoz's version of human growth hormone, in "perpetual limbo." Novartis filed for Omnitrope's approval more than a year ago, but the FDA has been unable to come to a decision, in part because of legal ambiguities concerning generic copies of branded biologic drugs. Novartis claims that Omnitrope is indistinguishable from Pfizer's
As the Journal noted, if the FDA caves and approves Omnitrope, many more generic biotech medicines could reach the market. And, as it turns out, Novartis is especially well positioned to deliver such generics. The company has years of biopharmaceutical manufacturing experience, and its expertise is such that it currently provides bio-manufacturing services for other companies. Further, with its purchase of Sabex last year, Novartis has a sizable "fill-finish" platform in North America able provide ready-to-use injectable bio-generics to the U.S. market.
The approval of two new experimental compounds and a breakthrough in the bio-generics market are tantalizing possibilities, though, admittedly, favorable outcomes are not certain. At the very least, though, Novartis may be the most interesting pharmaceutical company around.
Pfizer is a Motley Fool Inside Value recommendation.
Fool contributor Brian Gorman is a freelance writer in Chicago. He does not own shares of any companies mentioned in this article.