1:41 a.m. Sept. 28, 2021
- By Ciara Linnane
Eli Lilly to reduce list price of Insulin Lispro injection by an additional 40% from Jan. 1, restoring it to 2008 levelsEli Lilly & Co. said Tuesday it is reducing the list price of Insulin Lispro Injection in the U.S. by another 40% effective Jan. 1, 2022, bringing the price down to 2008 levels. "Lilly's Insulin Lispro Injection, 100 units/mL -- first introduced at half the list price of branded Humalog(R) (insulin lispro injection, 100 units/mL) in 2019 -- will now have a 70% lower list price than Humalog U-100," the company said in a statement. People using any of Lilly's insulin products can fill their monthly prescription for $35 through the Lilly Insulin Value Program, for those with commercial insurance or who are uninsured, while seniors can use a program that is part of Medicare Part D plans. "We hope this additional 40 percent cut can expand affordable insulin to more people with diabetes," Lilly Chief Executive David Ricks said in a statement. Lilly shares were down 0.4% premarket.
3:12 a.m. July 29, 2021
- By Jaimy Lee
Viatris gets FDA approval of first biosimilar version of Sanofi's insulin LantusShares of Viatris Inc. gained 3.3% in premarket trading on Thursday, the day after the Food and Drug Administration approved the first biosimilar verson of insulin glargine from Viatris and Biocon Biologics Ltd. Biocon is a privately held biopharma company based in India. The newly approved treatment, Semglee, is a biosimilar and interchangeable version of Lantus, Sanofi's once-blockbuster long-actin insulin. Semglee will be sold exclusively by the companies for 12 months before the FDA can approve another biosimilar version of Lantus. Biosimilar drugs are copies of complex biologic drugs; this is somewhat similar to how generic drugs compare to brand-name prescription medications, in that that biosimilars and generic drugs are less expensive than the brand-name alternatives. Viatris shares are down 24.0% so far this year, while the broader S&P 500 is up 17.1%.
2:00 a.m. July 14, 2021
- By Ciara Linnane
Eli Lilly buys remaining shares of Protomer Technologies in glucose-responsive insulin playEli Lilly & Co. said Wednesday it is acquiring the shares of Protomer Technologies it does not already own, in a deal it says has a potential value of more than $1 billion based on future development and commercial milestones. Lilly had previously purchased a 14% stake in the company, which has a proprietary peptide- and protein-engineering platform that can be used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity. Protomer was founded in 2015 in Pasadena, California. "Protomer has used this approach toward advancing a portfolio of therapeutic candidates, including glucose-responsive insulins that can sense sugar levels in the blood and automatically activate as needed throughout the day," Lilly said in a statement. Lilly said the deal will not impact its 2021 non-GAAP EPS. Lilly shares were not yet active premarket, but have gained 39% in the year to date, while the S&P 500 has gained 16%.
8:04 a.m. March 10, 2021
- By Jaimy Lee
Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetesShares of Vertex Pharmaceuticals Inc. were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 has rallied 41.1%.
The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial.
About Type 1 Diabetes
T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death.
Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events.
There are currently limited treatment options beyond insulin for the management of T1D.
2:48 a.m. March 10, 2021
- By Jaimy Lee
Lannett plans to file experimental insulin product with FDA sometime this yearShares of Lannett Co. Inc. gained 7.3% in premarket trading on Wednesday after the company said it received feedback from the Food and Drug Administration about the ongoing development of a biosimilar version of insulin glargine. This type of long-acting insulin is considered a biologic and was initially developed by Sanofi under the brand name Lantus. Lannett said it submitted the clinical-trial protocol to the FDA in November and has since updated it with the regulator's feedback. The company plans to file an investigational new drug application sometime in 2021, with a goal to eventually launch the product in the market in 2023. Lannett's stock is down 15.3% over the past 12 months, while the S&p 500 has gained 41.1%.
9:46 p.m. Feb. 2, 2021
Novo Nordisk posts forecast-beating earnings riseDanish pharmaceutical company Novo Nordisk AS on Wednesday posted a forecast-beating rise in fourth-quarter net profit but said fewer new patients are starting treatment due to social-distancing regulations around the world.