Sandostatin LAR, Novartis
Sandostatin LAR (octreotide acetate)
Global Sales 2012: $1.512 billion
U.S. Sales 2012: $649 million
Expiration Date: June 2014
Sandostatin LAR isn't among the most visible drugs in the Novartis ($NVS) portfolio. Lately, in fact, it's been playing second fiddle to Afinitor in press releases as Novartis works to develop the latter for broader treatment of endocrine tumors. Sandostatin, approved to treat acromegaly, a rare endocrine disorder, has been the base for Afinitor's add-on in a couple of recent trials. That's not unusual, of course, for a drug nearing the end of its exclusive hold on a market. Nor is it unusual for Novartis to trumpet the fact that a potential Sandostatin follow-up--Signifor, a.k.a. pasireotide--beat the older drug at controlling acromegaly symptoms in a recent trial.
What is unusual is that Sandostatin LAR figured prominently in recent whistleblower accusations of bribery in China. A former Novartis rep claims that her manager urged her to bribe doctors to increase use of the drug; the company is investigating the allegations. Another unusual feature of Sandostatin LAR's market position is that it already faces generic competition in most world markets, where patents expired in 2010. In the U.S., however, the drug doesn't lose exclusivity till June--and Novartis may soon be ready to follow up with Signifor. FDA-approved last December to treat Cushing's disease, another rare endocrine disorder, Signifor could be submitted for an acromegaly indication by the end of 2013. Its patent won't expire in the U.S. until 2026.