Insulin Glargine(Boehringer Ingelheim)

30-week results from the Phase 4 INHALE-3 study expand upon the positive 17-week data presented earlier this year at the American Diabetes Association’s 84th Scientific SessionsSwitching to, or remaining on Afrezza allowed twice as many people to get to goal during the extension phase DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase. The completer analysis which included all people on inhaled insulin, evaluated two separate groups – one that utilized Afrezza® (plus basal insulin) over 30 weeks, and a second group of patients who switched to Afrezza at week 17 from usual care, defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation. “The data from the extension phase of this study showed that more people living with T1D are able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care – whether they are using multiple daily injections or pumps,” said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation. “We believe this data demonstrates to healthcare practitioners that Afrezza is an effective tool for their patients who want to improve their glycemic control.” Key Findings:There was continued improvement in the Afrezza (plus degludec)-treated group, with additional subjects achieving A1c <7% at 30 weeks – a 100% increase from baseline: Switching from usual care to Afrezza (plus degludec) at week-17 allowed more than double the subjects to achieve A1c <7% at week-30, compared to the number at goal at week-17: “With the positive data received at both 17- and 30-weeks, we continue to affirm that Afrezza is an important option for adult patients managing their diabetes,” said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. “We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025.” About the INHALE-3 StudyThe INHALE-3 study is a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control. The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The 17-week results previously shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks. More information on the INHALE-3 study is available at: ClinicalTrials.gov(NCT05904743). About AfrezzaAfrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycemic control in adults with diabetes mellitus. Limitations of Use: Not recommended for the treatment of diabetic ketoacidosis or in patients that smoke or have recently stopped smoking. Important Safety Information WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE Acute bronchospasm has been observed in Afrezza-treated patients with asthma and COPDAfrezza is contraindicated in patients with chronic lung disease such as asthma or COPDBefore initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation. Please see additional Important Safety Information, Full Prescribing Information, including BOXED WARNING, available on Afrezza.com/safety. About MannKindMannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, nontuberculous mycobacterial (NTM) lung disease, pulmonary fibrosis, and pulmonary hypertension. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation, depending on the target indication. With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life. Please visit mannkindcorp.com to learn more, and follow us on LinkedIn, Facebook, X or Instagram. Forward-Looking Statements [to be updated as necessary]This press release contains forward-looking statements about the planned release of results from a clinical study that involves risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intends”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risk that we may not achieve our projected development goals in the timeframes we expect as well as other risks detailed in MannKind’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release. AFREZZA and MANNKIND are registered trademarks of MannKind Corporation. Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/31d76640-1047-4108-b133-36b48e91775d https://www.globenewswire.com/NewsRoom/AttachmentNg/650dc7f2-1e72-487b-9047-d0fdce0a795f https://www.globenewswire.com/NewsRoom/AttachmentNg/040e275d-bd09-4b8c-abff-4b7d76b32321 https://www.globenewswire.com/NewsRoom/AttachmentNg/72bbb5f4-f42f-4a1e-9121-3d4ff8c57790 This press release was published by a CLEAR® Verified individual.

Novo Nordisk has told government and global nonprofits that it plans to significantly downsize its manufacturing of some of its insulin pens, according to one of the groups, and will transition a portion of its global supply to insulin vials and syringes that are easier to make but less convenient for patients. The company’s plans were disclosed in recent discussions with Doctors Without Borders, who described them to Endpoints News , as well as the WHO, the Australian government, and other governments and regulators. “We are not halting production of insulin in pens,” Novo said in an email to Endpoints. “In some cases, we will no longer make human insulin available in pens. It will be made available in a vial and disposable syringe.” While some countries, like Australia and South Africa, are now seeking alternatives, the full extent of Novo’s plans isn’t immediately clear. The company declined to comment further to Endpoints on exactly which markets would be affected. And it said that some — but not all — insulin pens would be affected by the shift. And it emphasized that the changes would happen slowly, over a period of years. While South Africa in June announced shortages of insulin pens due to Novo’s decision to deprioritize their manufacture and supply, Doctors Without Borders’ pharmacist coordinator Christina Cepuch told Endpoints Friday that the latest announcement would go much further, based on the company’s comments to the groups. Geneva-based Doctors Without Borders is also known as Médecins Sans Frontières, or MSF. The WHO lists Novo’s insulin pens on its essential medicines list , and will also have to find alternatives, Cepuch said. The WHO did not immediately respond to a request for comment. “What does the WHO do about this? There’s not going to be any left. I mean, Lilly makes these, but they don’t make large volumes,” Cepuch said. “And what is WHO going to tell member states? Change everyone to glargine pens or go back to vials?” Glargine is a form of long-acting insulin, and Novo is currently in the process of phasing out its own long-acting insulin, called Levemir. On Tuesday, the Therapeutic Goods Administration, Australia’s drug regulator, released a short notice saying Novo will discontinue “some of its earlier generation insulin products” over the next two years. Scant on details, the notice said Australia is looking into alternatives. Novo emphasized to Endpoints that it is expanding its overall drug manufacturing significantly with the acquisition of Catalent and other new investments. Earlier this week, the Danish company’s CEO Lars Fruergaard Jørgensen testified before the US Senate at a hearing on drug prices and was asked by Sen. Tammy Baldwin (D-WI) about its insulin manufacturing plans. Baldwin asked Jørgensen if he would commit to “continue to have a focus on providing critical insulin. You will not reduce your manufacturing capacity in that area.” “The world market for insulin is actually declining, so there’s less demand,” Jørgensen responded. “But we are committed to supply to the patient that has been using our insulin for years also into the future.” Cepuch suggested that the company might decide to use freed-up pen capacity for its GLP-1 obesity products, which are also in shortage, or other insulins. Novo said the insulin and GLP-1 pens are different.