August 14, 2015
By Alex Keown, BioSpace.com Breaking News Staff
KALUNDBORG, Denmark -- Novo Nordisk , the world’s largest maker of insulin for diabetics may expand its manufacturing operations to the United States, Bloomberg Business reported this morning.
If a U.S. site is built, the facility will focus on manufacturing semaglutide, a medication for type 2 diabetes, Bloomberg said. During an interview with Lars Soerensen, Novo Nordisk’s chief executive officer, he said the experimental semaglutide could “revolutionize the company.” The GLP-1 drug is designed to stimulate natural production of insulin. The medication is currently available as an injectable, but the company is looking to develop it into an oral medication. Soerensen told Bloomberg the company would soon announce whether or not it would move the experimental drug into a late stage trial
In July Novo Nordisk terminated its 18 month partnership with Zosano Pharma Corporation to use that company’s micro-needle application to deliver glucagon-like peptide-1 (GLP-1) analogues for the treatment of type 2 diabetes.
Novo Nordisk manufactures the bulk of its insulin products at its Kalundborg, Denmark, plant. That site makes Novo’s newest insulin Tresiba and has about 2,800 employees, Bloomberg said. The Denmark site makes approximately half the insulin used by diabetics around the world, the company said. The company manufactures a number of diabetes treatments, including Victoza, NovoLog and Levemir.
The company said it plans on ramping up production of insulin to more than double its current output as more and more diagnoses of diabetes are made. In 2012 nearly 10 percent of the U.S. population had been diagnosed with some form of diabetes, according to the American Diabetes Association. Type 2 diabetes is on the rise in the United States, driven partly by the increase in the waistlines of Americans. A 2014 study published in the Annals of Internal Medicine showed a steady increase in diagnoses of the disease over the past decade.
Building a manufacturing facility in the United States would take about five years in order to meet federal regulatory standards for drug manufacturing, Soerensen said.
Novo Nordisk already has a manufacturing footprint in the United States, with facilities in North Carolina and New Hampshire for the manufacture of hemophilia treatments. Soerensen did not disclose to Bloomberg if these two states were being eyed for a possible insulin manufacturing facility. There are numerous steps to be made before construction of any sort of facility could begin. First semaglutide would have to be approved as an oral medication. Additionally, a site would have to be selected and approved for construction by local government bodies, architectural plans would have to be drawn up and approved and construction bids would have to be prepared before a site can be built. Soerensen did not give Bloomberg any indication on how large such a facility would be or how many it would employ
Bloomberg noted there would be several advantages to having an insulin manufacturing facility in the U.S., including help with recruiting talent and protections against fluctuating currency rates.
A U.S. manufacturing facility could also put Novo Nordisk in greater competition with Indianapolis-based Eli Lilly and Company , which has one of its insulin manufacturing sites in its hometown of Indianapolis. Since that site opened in 1982, insulin production has grown 20-fold, the Indianapolis Star reported. Lilly also has insulin plants in Puerto Rico and China.
In April, Novo Nordisk announced its Saxend, a once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults, was available for sale in the United States. Obese individuals often develop type 2 diabetes.
While Novo Nordisk is looking westward for its GLP-1 drugs, earlier this summer Israel-based Oramed Pharmaceuticals Inc. signed an exclusive agreement with a Chinese investment firm to market its GLP-1 insulin drugs in China. Diagnoses of type 2 diabetes have increased substantially in China over the past three decades. There are an estimated 100 million people in China living with diabetes, Medscape reported. Eleven percent of adults in China have diabetes, while 50 percent have prediabetes, which means there is a ripe market for Oramed’s products.
