Lilly to delay U.S., EU approval of basal insulin
Although the experimental diabetes drug is in final-stage testing and showing promising results, Lilly wants to better understand its effect on liver fat.
Although the experimental diabetes drug is in final-stage testing and showing promising results, Lilly wants to better understand its effect on liver fat.
PTS Diagnostics engineered an about-face on its business plan five years ago, ditching its retail strategy to focus on serving physicians and nurse practitioners. This year, PTS is on pace to record revenue of nearly $50 million, up from $17 million two years ago.
Indianapolis-based private investment company LDI Ltd. has acquired a small biotech manufacturer in a deal it says could be the launching point for many more acquisitions.
The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes, which affects more than 26 million Americans.
Lilly is finally putting meat on the bones of its predictions about its experimental diabetes and cancer drugs. That gives investors the certainty they crave that Lilly’s future revenue won’t remain in its 2014 doldrums.
The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.
Lantus, which garnered $7.8 billion in sales for Paris-based Sanofi in 2013, loses patent protection in Europe in May next year.
Advisers to the Food and Drug Administration voted 13-1 and 14-0 that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the panel’s recommendation.
Indianapolis-based Lilly is expected to garner $518 million in annual sales from Jardiance by 2019, according to the average of five analyst estimates compiled by Bloomberg.
The Lilly-Boehringer drug empagliflozin is projected to reach sales of $295 million for Lilly in 2019, but it won’t be able to sell it until issues are resolved at a German plant.
The Indianapolis drugmaker said dulaglutide performed as well as Victoza, a best-selling drug for Type 2 diabetics made by Denmark-based Novo Nordisk. Analysts think dulaglutide could reach annual sales of $1.5 billion.
U.S. sales are plunging for Roche Diagnostics Corp. and its fellow makers of diabetes-care devices because of lower reimbursements from the federal Medicare program. In five years, two of the four largest companies will have sold or closed their diabetes businesses, according to two industry analysts.
The move includes a $45 million investment for Lilly's operations in Indianapolis, on top of $400 million in investments the company announced over the past two years.
In a new round of predictions this month, Wall Street analysts indicated they expect Eli Lilly and Co.’s revenue to fall next year and to remain below 2013 levels until 2020.
Eli Lilly and Co. is counting on the quality of a diversified product portfolio over boosting its sales forces to grab a bigger slice of the $22 billion U.S. diabetes market, a difference in strategy to some of its rivals.
With a half-dozen new products lined up for approval within two years, the fight to win the growing $22 billion U.S. diabetes market is expected to intensify.
Lilly has set up not one, not two, but five head-to-head trials of its experimental drug dulaglutide against other leading diabetes therapies. So far, dulaglutide’s record is four wins, no losses.
Roche’s diabetes care unit, which employs more than 900 in Indianapolis, suffered a 14-percent decline in revenue during the first half of 2013. Roche has reportedly put the unit up for sale.
Lilly’s drug, if approved, may be a significant competitor to Novo Nordisk A/S’s Victoza, which generated $1.64 billion in 2012.
Major drugmakers, including Indianapolis-based Eli Lilly and Co., are closely watching Pfizer Inc.’s plan to sell Viagra directly to consumers. The bold move blows up the drug industry’s distribution model.