WHAT IT MEANS AND WHY IT'S IMPORTANT — For all the fears about the patent cliff, at least one disease state seems to be on the up-and-up in terms of new drug development and new products.
(THE NEWS: FDA approves Bydureon. For the full story, click here.)
In the past week, the Food and Drug Administration has approved two new drugs for Type 2 diabetes: Bydureon (exenatide), made by Amylin Pharmaceuticals and Alkermes, and Jentadueto (linagliptin and metformin), made by Eli Lilly & Co. and Boehringer Ingelheim.
With most of the nearly 26 million Americans with diabetes having the Type 2 variety — a figure that's expected to rise in the coming decades — and no cure in sight, the need for new and better therapies to manage the disease remains strong, and drug makers are responding in kind.
And they could stand to make a lot of money as well: According to some analysts, Bydureon could achieve annual sales of $1 billion, and some also expect it to displace Novo Nordisk's Victoza (liraglutide). At the same time, healthcare market research firm Decision Resources expected Bydureon to gain a Type 2 diabetes market share of 2.6% by 2020.
But diabetes isn't the only primary care-driven disease state seeing increased activity these days. According to the Pharmaceutical Research and Manufacturers of America, more than 50 drugs currently are under development for chronic obstructive pulmonary disease, which is estimated to affect more than 13 million adults in the United States, as well as potentially 12 million more who don't know they have it.
The dominant trend over the past several years has been the patent cliff, with the assumption that primary care drugs would start to decline thanks to loss of patent protection and generic competition, with companies instead focusing on specialty drugs for conditions like cancer, multiple sclerosis and autoimmune disorders. That trend still is on, but it also appears that development of new drugs for conditions like diabetes and COPD will continue.
Whether they will achieve the kinds of mega-blockbuster sales of medicines like Pfizer's cholesterol drug Lipitor (atorvastatin) — which achieved sales of more than $8 billion in 2011 and recently lost patent protection — remains to be seen, but the continued need for new drugs for old diseases remains strong.