Pills, pens bring hope for drug companies in diabetes crunch

Drugmakers facing a price war in the diabetes market are betting on new technologies to withstand the competition.

Novo Nordisk A/S, the industry’s biggest player, is investing in diabetes drugs that can be given as a pill rather than by injection, while Sanofi and Google parent Alphabet Inc. are committing about $500 million to a venture aimed at combining software and medicine to help patients manage the disease.

Researchers elsewhere are working on the first artificial pancreas to take over for the malfunctioning organ and “smart patches” to deliver insulin patients need to keep sugar from pooling in their blood.

“It’s getting crowded, and in order to differentiate it’s not just sufficient any longer to have the best insulin,” said Stefan Oelrich, head of Sanofi’s global diabetes franchise. “You have to go beyond that. I think this is going to be the way over time to do that, to integrate, to take data from patients and come up with more personalized solutions.”

Demand is on the rise. By 2040, more than 640 million people globally are forecast to have diabetes, most of them with a form that takes root later in life as a result of sedentary lifestyles and poor nutrition. Yet drug developers attending the annual European Association for the Study of Diabetes meeting in Munich this week are hunting for new ways to spur growth because a stream of copycat medicines is crimping sales of their top products.

It’s not just about new drugs, but new ways of delivering them. San Diego-based Companion Medical’s insulin pen paired with a smartphone app was cleared in the U.S. in July for use with Indianapolis-based Eli Lilly and Co.’s blockbuster treatment Humalog or Novo’s top-selling NovoLog, allowing patients to track and calculate doses and send information to health-care providers.

Researchers at the University of North Carolina at Chapel Hill and North Carolina State University also said in March they developed a patch covered in tiny needles that can secrete insulin to control blood-sugar levels on demand, though further tests are needed. Medtronic Plc, meanwhile, has filed for U.S. approval of the first artificial pancreas—a device the size of a smartphone that wirelessly connects an insulin pump and glucose monitor. The equipment can take over for the organ that produces insulin, the hormone that converts blood sugar to energy, and malfunctions in diabetes.
Dreaded Injection

“There’s a huge need for new ways of thinking about it and treating it,” said Simon O’Neill, director of health intelligence at Diabetes U.K., a non-profit group in London. “We’ve got cheap generic drugs but can we come up with better solutions? There’s a potentially huge market if they can do something that makes peoples’ lives easier.”

The industry has long sought to shift away from the dreaded injection. Novo is in advanced testing of an oral version of a GLP-1, a class of drugs that stimulate the pancreas, and until now only available as an injection, and the company is also working on an oral insulin. Oramed Pharmaceuticals Inc. of Israel is walking down a similar path, and expects its own oral insulin to enter late-stage trials next year, said Chief Medical Director Roy Eldor.

“The only way you can insulate yourself from pricing pressures is by long-term introducing new and better products,” Lars Rebien Soerensen, outgoing chief executive officer of Denmark-based Novo Nordisk, said in an interview last month. “Our strategy is one of innovation.”

Many have tried and failed to develop an insulin tablet, as Novo readily acknowledges. A successful pill must be hardy enough to withstand acid attacks in digestion and nimble enough to pass the filter of the gut wall to enter the bloodstream. Soerensen, who will retire by the end of the year after 16 years at the helm, called oral treatments the “biggest research area in the company’s history.” His successor, Lars Fruergaard Joergensen, said investors shouldn’t expect a significant change in strategy.

If Novo overcomes those challenges, it would give the company an edge and help offset some of the pressure it faces, said Kim Nielsen, a fund manager at Carnegie Asset Management in Copenhagen and a Novo investor. The company has said it’s seeing unprecedented competition in the U.S., its biggest market, and last month disclosed it lost a “sizable” contract for NovoLog.

“An oral insulin could be a major breakthrough,” Nielsen said. “If somebody succeeds in bringing a product to market that is good and reliable, it also will be a big leap forward in convenience.”

Also on the convenience front, Paris-based Sanofi is investing $248 million in a venture with Verily Life Sciences LLC on technology that could enable patients and their doctors to respond more quickly to peaks and troughs in blood sugar and avoid long-term complications associated with poor management of the disease, which include heart attacks and cancer. That followed a deal between Google and Novartis AG to develop contact lenses that use tiny sensors to read blood-sugar levels from tears, rather than blood.

The number of people with the disease has almost quadrupled since 1980 with overweight and obesity among the factors driving the increase, according to the World Health Organization. Complications can lead to heart attacks, strokes, blindness, kidney failure and lower-limb amputation.

At the meeting in Munich, Novo will disclose the full data on a cardiovascular test of its drug semaglutide, allowing analysts and doctors to determine whether it’s better than a rival Lilly medicine at protecting patients from heart attacks and strokes. Sanofi’s portfolio includes a once-a-day shot that combines two drugs and could help offset the impact of cheaper copies on its best-selling Lantus insulin.

“We’re starting to see these mechanisms come out, all this technology that we’ve been talking about for a long time,” said Oramed’s Eldor. “I think we’re going to see huge advancements both in our understanding of the origin of the disease but also in our capabilities of treating it.”