Novo Nordisk A/S, the world’s biggest maker of insulin for diabetics, has sought patent protection for a synthetic version of an intestinal hormone as part of an effort to develop medicines for treating obesity.
Novo Nordisk filed a patent application for analogues of the hormone PYY with the World Intellectual Property Organization, which published the application last month, the U.S. Federal News Service reported on March 30. Companies can seek protection by filing applications with Geneva-based WIPO, which administers a global patent filing system. Individual countries still must grant patents.
“There is a serious unmet need for adjunct therapy, something to aid those who have a serious obesity problem with handling their condition, together with a good lifestyle and behavior modification,” Chief Science Officer Mads Krogsgaard Thomsen said in a phone interview. “We believe we have a role to play.”
Novo Nordisk is using experience in creating synthetic hormones, gained from work on insulin, to expand its lineup of medicines. The Bagsvaerd, Denmark-based drugmaker has several hemophilia treatments in development and aims to produce new obesity drugs based on hormones that the body produces normally to regulate appetite, Thomsen said by phone on April 1. Novo is already testing a synthetic version of the gut hormone GLP-1.
“We tend to believe we should play around with Mother Nature’s own appetite modulators,” he said.
No drug manufacturer has introduced an obesity medicine in the U.S. in more than a decade after treatments repeatedly faltered in trials because of potential ties to higher blood pressure, heart damage and birth defects. The U.S. Food and Drug Administration has asked for more studies before approving experimental weight- loss treatments by Vivus Inc., Orexigen Therapeutics Inc. and Arena Pharmaceuticals Inc.
Amylin Pharmaceuticals Inc. and Takeda Pharmaceutical Co. suspended joint mid-stage testing of a combination of two synthetic hormones last month after some patients in an earlier test developed antibodies which may neutralize the medicine’s effect and even lead to increased eating.
Obesity drugs can be “a graveyard” for manufacturers, Thomsen said. Still, Novo has confidence in its use of gut hormones which, unlike older medications, don’t speed up the body’s metabolism, affecting the heart and driving up blood pressure, he said.
PYY helps signal the brain when to stop eating. People who are obese have low levels of the hormone, and “targeting the PYY system may offer a therapeutic strategy to help treat obesity,” Efthimia Karra, a researcher at University College London’s Centre for Diabetes and Endocrinology, said in the January 2009 edition of The Journal of Physiology medical publication.
Pfizer Inc. conducted an early stage clinical trial of a PYY-based drug in 2006. The same year, Merck & Co. terminated an agreement with Nastech Pharmaceutical Inc. for the development of a nasal-spray version after early studies showed it wasn’t effective.
Novo is experimenting with manufactured PYY versions that patients would inject, much like liraglutide, the company’s synthetic GLP-1 drug for diabetics that it markets as Victoza. Thomsen declined to specify how many projects Novo is working on, saying they’re at very early stages. The company will target severely obese patients, especially those who also have other conditions such as pre-diabetes, he said.
Revenue from Victoza jumped 26-fold last year to 2.32 billion kroner ($443 million), making it Novo’s fastest-growing product. The drug won FDA approval as a diabetes treatment in January 2010, contingent upon further post-approval studies into potential cancer risks after earlier test results led to a delay in regulatory clearance.
Novo plans to begin the last phase of testing liraglutide as an obesity treatment this year. Victoza could produce additional annual sales of as much as $5 billion should it win the approval as an obesity drug, Mark Dainty, an analyst at Citigroup Global Markets Inc., said in a December report to investors.