Novo weight drug targets market where others failed

WASHINGTON — A weight-loss drug from Novo Nordisk helped people get thinner, U.S. regulators said Tuesday, as the Danish drugmaker became the latest to push a pharmaceutical remedy for America’s obesity woes.

Novo’s drug, to be named Saxenda, helped 60 percent of patients studied lose at least 5 percent of their weight and 31 percent lose more than 10 percent, according to a report Tuesday by U.S. Food and Drug Administration staff. The agency is also set to decide by Sept. 11 on an obesity treatment developed by Orexigen Therapeutics.

Drugmakers are trying to produce new weight-loss medicines even as sales for previously approved obesity pills have fallen short of estimates. Belviq, a drug from Arena Pharmaceuticals and Eisai, was approved in June 2012, the first such treatment cleared in 13 years. Belviq was followed three weeks later by Vivus’s Qsymia. High out-of-pocket costs kept patients away and sales didn’t meet analyst expectations.

The newest treatments may finally spur consumer acceptance, said Charles Duncan, an analyst with Piper Jaffray. “Being third is absolutely a good thing,” Duncan said in a telephone interview, referring to Orexigen’s product. “Being first was not good because there was virtually zero reimbursement for drug-based therapy before. There needed to be a kind of change in the attention toward obesity and the usefulness of a drug for that.”

About 50 percent of people with private insurance receive at least some coverage for diet drugs, Duncan said. Many insurers place Qsymia and Belviq in the third tier of medicines they’ll cover, meaning patients pay a large chunk of the bill out of their own pockets.

Government insurance programs such as Medicare and Medicaid don’t pay for the drugs, Duncan said. He anticipates coverage will expand if La Jolla, Calif.-based Orexigen’s weight-loss drug, known as NB32, is approved.

The FDA is expected to decide whether to clear Saxenda for sale by the end of October. The drug goes by the chemical name liraglutide and Bagsvaerd, Denmark-based Novo already sells it as a diabetes treatment under the name Victoza to help adults with Type 2 diabetes control blood sugar levels.

Novo Nordisk has proposed selling the injection to adults who are considered obese or are overweight and have another disease as a result of their condition, such as diabetes. Liraglutide helps patients achieve weight loss, FDA staff said in their report, released Tuesday ahead of an advisory panel meeting on Thursday.

In March 2013, the FDA said it is reviewing a possible link between diabetes drugs called incretin mimetics, including Victoza, and the risk of developing an inflammation of the pancreas tied to cancer. The FDA staff report on Novo’s drug raised these concerns and pointed out the safety of liraglutide “has been characterized in the diabetes treatment program and in the post-marketing experience.”

Novo Nordisk is conducting a post-marketing trial to determine Victoza’s effect on the heart, which the FDA staff says will be adequate for liraglutide’s use in weight loss as well. The cancer links are also being monitored while Victoza is on the market, according to the report.

Liraglutide is associated with an increase in resting heart rate though the consequences remain unclear, FDA staff said.

Liraglutide is estimated to generate $556 million in weight-loss sales in 2018, added to $3.2 billion for its use against diabetes as Victoza, according to analysts’ estimates compiled by Bloomberg.

The estimate is higher than others on the market because Novo Nordisk already has established relationships with insurers and doctors are already familiar with the drug, Ronny Gal, an analyst with Sanford Bernstein, said in an email. Novo Nordisk also has a large sales force that a smaller company like Vivus can’t match, Gal said.

Prescriptions for Qsymia and Belviq have fluctuated since the introduction of the pills. Estimates for Qsymia sales have plummeted to $141 million in 2016 from $1.2 billion projected for that year when the drug was approved in 2012. Belviq is estimated to generate $118 million in sales for Tokyo-based Eisai.

Orexigen’s NB32 may provide $740 million in sales in 2018, Marko Kozul, a former analyst with Leerink Parters estimated earlier this year. Japan-based Takeda Pharmaceutical, Asia’s largest drugmaker, will market the drug in the U.S.

Orexigen will receive $100 million in milestone payments from Takeda for approval of NB32 and the start of sales. The company may receive royalty payments from Takeda of $215 million in 2018, Kozul said.

None of the three weight-loss pills is on the market in Europe. Orexigen’s treatment is currently positioned to become the first for sale there in 2015.

Weight-loss drugs have a checkered past. The appetite- suppression drug fen-phen was taken off the market in 1997 and Abbott Laboratories’ Meridia was pulled in 2010, both for heart- related side effects.

Qsymia is associated with a risk of increased heart rate and Belviq can cause heart-valve abnormalities, according to each of their warning labels. Both are being studied while on the market to determine their effect on the heart.

There were concerns that Orexigen’s NB32 raises blood pressure like Abbott’s Meridia. Orexigen presented an interim analysis of a cardiovascular study the FDA asked for in 2011 to show its drug didn’t present excess risk.

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