chrismiss_everyday
2 months ago
MannKind to Establish Boston-Area Research & Development Foothold and Expand Portfolio of Dry Powder Inhalation Technology in Transaction With Pulmatrix
05/29/24
Immediate opportunity to increase capacity for formulation and early asset development in upgraded Boston area R&D space
Non-cash deal includes royalty-free iSPERSE™ technology license in exchange for access to MannKind’s Cricket® inhaler
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 29, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced today that it has agreed to in-license iSPERSE™ technology from Pulmatrix for certain indications in exchange for an out-license of MannKind’s Cricket® inhaler to Pulmatrix for inhaled delivery of dihydroergotamine (DHE) for migraine treatment. The two companies also agreed that Pulmatrix will transfer its Bedford, Mass. R&D facility to MannKind, along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory in non-cash transaction.
“We are delighted to grow our Boston-area presence as we continue to progress our pipeline efforts, and in particular, our expanding orphan lung programs,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “We have formulated two FDA-approved products utilizing our proven Technosphere® dry powder technology, and this agreement affords us access to another option for future development opportunities.”
“Our Technosphere technology, which is a unique carrier-based, dry powder inhalation platform used in tandem with our proprietary inhaler, provides deep and effective penetration of lung tissue that is well suited for many active ingredients,” said Dr. Burkhard Blank, Executive Vice President, Research & Development and Chief Medical Officer of MannKind Corporation. “However, for some drug candidates, such as Clofazimine, that may require a significantly higher drug payload, the iSPERSE formulation technology may be better suited for developing viable powders.”
The royalty-free licensing structure will allow MannKind to have exclusive use of the iSPERSE technology for clofazimine, NTM, and insulin, and non-exclusive use for endocrine diseases and interstitial lung diseases (ILD) including idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis (PFF) and other related lung diseases. In exchange, Pulmatrix will receive a royalty-free, exclusive license to MannKind’s single-use Cricket inhalation device for inhaled delivery of DHE in any formulation and non-exclusive use for neurological diseases.
MannKind expects to consolidate its Boston presence by transitioning its Marlborough staff into the newly renovated, fully outfitted R&D facility in Bedford. To maintain continuity of iSPERSE platform knowledge, MannKind plans to hire some members of current Pulmatrix R&D staff.
The agreement is anticipated to close in July 2024.
chrismiss_everyday
2 months ago
06/05/24
17-week endpoint results comparing Afrezza® head-to-head with multiple daily injections (MDI) and insulin pumps
INHALE-3 Study Protocol Chair Dr. Irl. B. Hirsh joined by investigational team to deliver presentation moderated by Jaeb Center founder Dr. Roy W. Beck
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced that the 17-week endpoint results from the INHALE-3 study will be presented during a 90-minute symposium and livestream on Saturday, June 22, at the American Diabetes Association’s (ADA) 84th Scientific Sessions. The presentation will be delivered by INHALE-3 Study Protocol Chair Dr. Irl B. Hirsh and the investigational team and will be moderated by Jaeb Center founder Dr. Roy W. Beck.
“We are excited for the first read-out of results from the largest post-market clinical trial MannKind has conducted with Afrezza in the last 10 years,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “The results will speak to the common question about Afrezza: ‘How does inhaled insulin fare when compared head-to-head with usual care?’ The full 30-week results of INHALE-3 will be available later this year.”
Title:
The Efficacy and Safety of Inhaled Insulin Used with Insulin Degludec Compared with Automated Insulin Delivery or Multiple Daily Injections in Adults with Type 1 Diabetes
Date: Saturday, June 22, 2024
Times: 8:00-9:30 AM (ET) with topics/presenters to include:
Inhaled Insulin’s History and Study Rationale – Dr. Halis Akturk
Study Methods & Participant Baseline Characteristics – Dr. Yogish Kudva
Study Results I: Comparison of Inhaled Insulin vs. Rapid Acting Analogue Insulin in Users of AID or
MDI During Standardized In-Clinic Meal Challenge –Dr. Ruth S. Weinstock
Study Results II: Primary Efficacy, Safety, and Quality of Life Outcomes – Dr. Carol J. Levy
Study Results III: Effect of Inhaled Insulin-Degludec Compared with AID and in Subgroups According
to Participant Characteristics – Dr. Grazia Aleppo
Critique of Study Design and Results – by Dr. Irl B. Hirsch
Use of Afrezza in Clinical Practice – by Dr. Thomas Blevins
Question and Answer Session – Moderated by Dr. Roy W. Beck
Location: W320 Chapin Theatre at the Orange County Convention Center (+livestream)
Livestream:
Please refer to https://professional.diabetes.org/scientific-sessions for access details
MannKind will host booth# 1307 in the Exhibit Hall throughout the Scientific Sessions as well. Members of MannKind’s Clinical Education Team will be available for scientific exchange in the medical section of the booth.
chrismiss_everyday
1 year ago
https://investors.mannkindcorp.com/news-releases/news-release-details/correction-mannkind-corporation-reports-2023-first-quarter
DANBURY, Conn. and WESTLAKE VILLAGE, Calif., May 09, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by MannKind Corporation (Nasdaq: MKND), please note in the second table, titled "CONDENSED CONSOLIDATED BALANCE SHEETS", the right column header was incorrectly labeled as "March 31, 2022", when it should be labeled "December 31, 2022". The corrected release follows:
1Q 2023 Total Revenues of $41 million; +239% vs. 1Q 2022
1Q 2023 Revenues associated with Tyvaso DPI of $23 million
1Q 2023 Loss from operations decreased 72% vs. 1Q 2022 to $6 million
$167 million of Cash, Cash Equivalents and Investments at March 31, 2023
MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended March 31, 2023.
“Demand for Tyvaso DPI® has been very strong, which resulted in $23 million in revenues in the first quarter of 2023,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. “I'm excited about our inhaled platform and orphan lung pipeline as we get ready to launch our Phase 2/3 inhaled clofazimine trial for patients in the second half of 2023.”
chrismiss_everyday
2 years ago
Well…plenty of other good things on the way!
Clofazimine, sold under the brand name Lamprene, is a medication used together with rifampicin and dapsone to treat leprosy. It is specifically used for multibacillary leprosy and erythema nodosum leprosum.
Nintedanib, sold under the brand names Ofev and Vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.
Dornase alfa is used to reduce the number of lung infections and to improve lung function in patients with cystic fibrosis.
Transforming growth factor-beta (TGFß) is a secreted cytokine, which intricately controls a plethora of physiological and pathological processes during development and carcinogenesis. TGFß exerts antiproliferative effects and functions as a tumor suppressor during early stages of tumorigenesis, whereas at later stages it functions as a tumor promoter aiding in metastatic progression through an autocrine TGFß loop. Intricate knowledge of TGFß signaling and its regulation are still evolving. In this review, we make an attempt to showcase the associated enigma of TGFß signaling in its dual functional role as tumor suppressor and metastatic promoter during early and late stages of carcinogenesis, respectively.
bakersson
3 years ago
MNKD partners with NRx Pharmaceuticals
https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-partners-nrx-pharmaceuticals-explore-dry-powder
MannKind Partners With NRx Pharmaceuticals To Explore A Dry Powder Formulation Of ZYESAMI™ (aviptadil) Based On The Technosphere® Platform
08/04/21
PDF Version
NRx was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for ZYESAMI™ (aviptadil) for the treatment of Critical COVID-19 with respiratory failure; currently in clinical trials
WESTLAKE VILLAGE, Calif., Aug. 4, 2021 /PRNewswire/ -- MannKind Corporation (Nasdaq: MNKD) has partnered with NRx Pharmaceuticals (Nasdaq: NRXP) (NRx) to evaluate the feasibility of formulating a dry powder formulation of ZYESAMI™ (aviptadil), a synthetic form of human Vasoactive Intestinal Peptide (VIP) – an endogenous substance produced by the body that helps protect cells against inflammatory conditions. An intravenous formulation of ZYESAMI is currently in clinical trials, having been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of Critical COVID-19 with Respiratory Failure.
"We continue to explore ways that our Technosphere technology can deliver unique compounds in a targeted and convenient manner for patients with serious lung diseases," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "The novel coronavirus continues to be a factor around the world, and we are just beginning to bear witness to its long-term effects on the lungs."
Rapid recovery from Critical COVID-19 with Respiratory Failure has been reported in patients treated with open label VIP under a Phase 2b/3 clinical trial and in an FDA Expanded Access Program. Emerging data indicates that VIP binds uniquely to receptors on Alveolar Type II cells preventing cell death, stopping replication of the coronavirus in the Type II cells and upregulating the production of surfactant – the loss of which is increasingly implicated in COVID-19 respiratory failure.
"As we continue to identify beneficial effects of VIP in treating various respiratory disorders, development of a convenient dosing method that offers stability at room temperature is key to long term success," said Prof Jonathan Javitt, MD, MPH, CEO and Chairman of the Board, of NRx. "We are pleased to be working with MannKind to develop an inhaled form of ZYESAMI which may offer patients an easier and more therapeutic option."
MannKind will begin exploring formulation potential at its research and manufacturing facility located in Danbury, Conn., which features a full range of development and manufacturing capabilities, including analytical, chemical, formulation, filling and packaging. It has sufficient filling capacity to produce more than 300 million cartridges of inhaled drug annually.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled ultra-rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the Company's partner, Biomm SA. MannKind was established in 1991, and is headquartered in Westlake Village, Calif., with a manufacturing and R&D facility based in Danbury, Conn. The Company also employs field sales and medical representatives across the U.S. Please visit mannkindcorp.com to learn more.
Forward-looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. Words such as "plans," "expects," "intend," "will," "targeted," "potential" and similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements regarding the potential to create a dry powder formulation of a new compound and to treat certain diseases. Such 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 continued testing of product candidates may not yield successful results. These and other risks are detailed in MannKind's filings with the Securities and Exchange Commission ("SEC"), including under the heading "Risk Factors" in MannKind's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 12, 2021. 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.
ZYESAMI is a trademark of NRx Pharmaceuticals, Inc.
AFREZZA and TECHNOSPHERE are registered trademarks of MannKind Corporation.
Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/mannkind-partners-with-nrx-pharmaceuticals-to-explore-a-dry-powder-formulation-of-zyesami-aviptadil-based-on-the-technosphere-platform-301347875.html
SOURCE MannKind Corporation
For MannKind: Christie Iacangelo, Corporate Communications, (818) 292-3500Email: media@mannkindcorp.com; Rose Alinaya, Investor Relations, (818) 661-5000, Email: ir@mannkindcorp.com; For NRx: Jack Hirschfield, Head of External Affairs, (512) 674-5163, Email: jhirschfield@nrxpharma.com; John Mulally, Investor Relations, (617) 429-3548, Email: jmulally@lifesciadvisors.com
chrismiss_everyday
3 years ago
MC- "And we're looking forward to hopefully having an acceptance from the FDA with ILD later this quarter in approval by year end. On the pipeline side, we completed our first toxicology studies for clofazimine, which is MNKD-101."
Looks like leprosy and tuberculosis treatment potential?
"Clofazimine is a highly lipophilic antimicrobial riminophenazine dye used in combination with other agents, such as dapsone, for the treatment of leprosy. It was originally described in 1957 and was the prototypical riminophenazine dye - a bright-red dye that, in its clinical use, results in long-lasting discoloration of the skin and bodily fluids.2 Although it carries in vitro activity against other mycobacterium, such as Mycobacterium tuberculosis, it is generally considered an ineffective treatment in comparison to classic tuberculosis treatments such as rifampicin and isoniazid."
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