By Bill Berkrot
Jan 14 Regeneron Pharmaceuticals Inc will report about $400 million in U.S. sales of its high-profile eye drug Eylea for the fourth quarter of 2013, bringing the total for the year to about $1.4 billion with lots of room for future sales growth, the U.S. biotech company's chief executive said on Tuesday.
Regeneron CEO Len Schleifer called the Eylea franchise far from mature and said sales of the drug have "plenty of room for growth" in both the United States and Europe through approvals for additional uses and other initiatives.
Schleifer also said the company has the potential for five major regulatory submissions or approvals in the next five years, including expanded approvals for Eylea, as well as drugs for rheumatoid arthritis, asthma, atopic dermatitis and its closely watched drug to lower "bad" LDL cholesterol from a highly promising new class of medicines called PCSK9 inhibitors.
Regeneron shares jumped more than 9 percent following Schleifer's comments during a presentation at the JP Morgan Healthcare Conference in San Francisco.
The $400 million in U.S. fourth-quarter sales is up from $363 million in the third quarter despite holidays in the period that cut down on doctor visits. Regeneron reports U.S. sales of the drug used to treat wet age-related macular edema - the leading cause of blindness in the elderly - while Bayer AG sells Eylea in Europe.
Sales growth of Eylea has slowed from its rocket-like rise following a late 2011 approval in part because patients who have been taking the drug for several months typically move to less-frequent injections.
Regeneron expects applications seeking approval of the PCSK9 cholesterol fighter, alirocumab, to be filed in Europe in early 2015 and for the United States later that year, the CEO said.
Schleifer said he believes the drug could win initial approval before completion of a lengthy heart safety study as long as that study is well underway.
Regeneron is developing the drugs in its pipeline in partnership with French drugmaker Sanofi, which owns about 16 percent of the biotech and pays the lion's share of research and development expenses for the joint projects.
Sanofi is expected to spend more than $1 billion on the Regeneron pipeline in 2014, Schleifer said.
"We have lots going on," he added.
Regeneron shares were up $24.76, or 9.2 percent, at $293.44 in afternoon trading on Nasdaq. Sanofi rose 1.3 percent in Paris.