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MannKind Announces Direct Purchase Insulin Program Providing Afrezza® for as low as $4 a Day
GlobeNewswire•January 16, 2019
More than 65,000 patients currently pay cash for their daily insulin each month
WESTLAKE VILLAGE, Calif., Jan. 16, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, today announced a direct purchase program to help those with diabetes obtain the company’s inhaled insulin, Afrezza, for as little as $4 a day. Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
“It is important for MannKind to help those whose lives depend on insulin, and, unfortunately, over 65,000 uninsured or under-insured patients today must pay cash for their insulin each month, typically at the pharmacy counter at prices that reflect the costs of the pharmaceutical distribution chain,” said Michael Castagna, Chief Executive Officer of MannKind. “Our new Afrezza Patient Direct Program enables us to streamline the numerous costs and inefficiencies that exist in today’s healthcare system, so we can pass along the savings directly for these patients. We want to be part of the solution for the future of healthcare and healthy living.”
Participation in this innovative cash program, which is available to all eligible patients with a valid prescription, is simple. The first 1,000 people to register at www.insulinsavings.com will gain access to introductory pricing for the Afrezza Patient Direct Program, giving them the opportunity to purchase Afrezza for as little as $4 a day for the first twelve months. All participants who sign up for the program will gain access to attractive cash pricing for Afrezza.
Additional program information is available online at www.insulinsavings.com. Patients who would like to enroll should click the “Register Now” button and follow the instructions. MannKind has partnered with Eagle Pharmacy to process patients’ prescriptions and to ship Afrezza directly to their home. Payment is made using any major credit card.
MannKind has also launched an enhanced copay and savings card program that will enable patients with commercial insurance to fill their prescription at their local pharmacy for as low as $15. The card, along with complete program details, can be downloaded at www.afrezzasavingscard.com.
“Our founder Al Mann had a vision of making Afrezza available to all people living with diabetes, and it’s concerning that rising costs may cause some with diabetes to go without insulin,” Castagna said. “We hope that our new programs will have an impact and help many in need.”
About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
About MannKind Corporation
MannKind Corporation (MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve 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 detailed in MannKind's filings with the SEC. For a discussion of these and other factors, please refer to MannKind’s quarterly report on Form 10-Q for the quarter ended September 30, 2018 as well as MannKind’s other filings with the SEC. 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.
MannKind Contact:
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com
Contact:
massives Cash und Verwässerungsproblem
- Cashbestand nach Q3/18 ~11 Mio. $
- Kapitalerhöhung 12/18 (~40 Mio. $ / 26,66 Mio. Stück zu 1,50$)
- Cashbestand neu: ~51 Mio. $
- Verlust in Q3/18 ~24 Mio. $
- Verlust nach 9 Monaten ~77 Mio. $
- bei den Zahlen reicht das Cash nur ca. 2 Quartale (Q4/18 und Q1/19) bis zur nächsten Kapitalerhöhung und Verwässerung
- hohe Verschuldung
- negatives Eigenkapital
http://investors.mannkindcorp.com/news-releases/...-quarter-financial
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GlobeNewswire•February 20, 2019
WESTLAKE VILLAGE, Calif., Feb. 20, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) today announced additional positive Afrezza clinical data to be presented in an oral presentation on Thursday, February 21, 2019 and a poster on Wednesday, February 20, 2019 at the 12th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2019).
“The data to be presented provide additional insight into the pharmacodynamic effects produced by the ultra-rapid pharmacokinetic profile of inhaled Afrezza insulin compared to those associated with subcutaneous rapid acting insulin,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “By delivering a time-action profile closer to that of physiologic insulin action, post-prandial glucose levels and other markers of glycemic control were significantly improved compared to injected insulin in meal-challenge tests in patients with type 2 diabetes.”
Other data presented at this meeting showed that the pulmonary function of patients with diabetes is more impacted by factors such as high body mass index, elevated HbA1c levels and the time since onset of diabetes than by the effect of inhaled insulin. Kendall added “we believe that these and other recently published data significantly advance our understanding of the treatment opportunity that Afrezza therapy can offer.”
Oral Presentation Highlights
Title: Ultra-rapid profile of insulin human inhalation powder mimics time-action profile of physiologic absorption of glucose from mixed-meal tolerance tests in type 2 diabetes
ATTD 2019 Thursday, February 21st (Hall M4): 17:20-17:30
Presenter: Marshall Grant, Senior Director, Head of Pharmaceutical Research, MannKind Corporation
Description: This analysis was based on a randomized cross-over mixed-meal tolerance test study in type 2 diabetes and conducted to determine how the ultra-rapid PK/PD profile of Afrezza affects various facets of glucose control
Highlights: Compared to subcutaneous rapid-acting insulin, the ultra-rapid PK profile of Afrezza resulted in:
reduced glucagon exposure by 30-35%
reduced C-peptide exposure out to 3 hours
better early post-prandial glucose control
a longer period of tight glucose control with higher doses of Afrezza
earlier reductions in free fatty acids and endogenous glucose production
Poster Presentation Highlights
Title: Diabetes Duration, BMI, and HbA1c Have Greater Effects on Pulmonary Function (PF) Than Inhaled Technosphere® Insulin (Encore, previously presented at EASD)
ATTD 2019 Wednesday, February 20th (poster presentation Friday, February 22nd 10:20-10:25 Exhibition Area)
Presenter: Frank Pompilio, PharmD, VP, Medical Affairs, MannKind Corporation
Description: Data from a pulmonary function (PF) study of patients with type 1 and type 2 diabetes was utilized to compare the effects of diabetes duration, body mass index (BMI), and HbA1c on baseline PF and changes in PF during 24 months of treatment between patients receiving Afrezza and those receiving usual care.
Highlights: The magnitude of Afrezza’s effect on FEV1 was comparable to those normally associated with diabetes-related factors such as high BMI, elevated HbA1c and long-standing diabetes
No effects were clinically significant
Afrezza-related decreases in FEV1 were small, non-progressive and reversible after two years of treatment
About ATTD Annual Meeting
The ATTD is a scientific program that brings leading international experts together to discuss breakthroughs in diabetes treatments, technological innovations and showcase the latest developments in new insulin analogues, delivery systems, pumps, glucose sensors, closed-loop systems and much more.
About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is a rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
About MannKind
MannKind Corporation (MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve 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 detailed in MannKind's filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2017. 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.
MannKind Contact:
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com
Contact:
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IndyCar Driver Living with Diabetes Helps Raise Awareness for Diabetes Treatment Options
WESTLAKE VILLAGE, Calif., March 14, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) announced today it is sponsoring Conor Daly as he makes his debut with the Andretti Autosport team at the 103rd Running of the Indianapolis 500 on May 26, 2019. MannKind is an associate sponsor of Andretti Autosport for this race and will partner with Daly on his No. 25 U.S. Air Force Honda. Daly was diagnosed with Type 1 diabetes at the age of 14, and now lends his racing career to raise awareness of diabetes treatment options and innovations.
“Living with diabetes since age 14 has been a challenge, but one that I’ve always faced head on,” said Daly. “Managing my diabetes properly has been a key to being able to live my racing dream. Diabetes should never stop you from pursuing what you want in life! Thanks to MannKind I will be able to share my story and live my dream at a higher level than ever."
“MannKind is continually seeking platforms to increase awareness around the challenges, opportunities and successes people living with diabetes encounter on a daily basis,” says Michael Castagna, CEO of MannKind. “Seeing someone like Conor take on a challenging sport such as IndyCar racing, while having to manage his diabetes, is an inspiration to all those living with diabetes. We are excited to be associated with Conor and Andretti Autosport for the Indy 500 and look forward to a partnership where we can help educate people on treatment options for managing their diabetes.”
As an associate sponsor of Daly at the Indy 500, MannKind is planning events and experiences that build awareness of innovation in diabetes treatment. The events and sponsorship promotion will also allow for Daly to share his story about living with diabetes.
About MannKind Corporation
MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing and research facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
About Andretti Autosport
Led by racing legend Michael Andretti, Andretti Autosport boasts a wide racing portfolio rooted in tradition and designed for success.
Under the banners of Andretti Autosport, Andretti Rallycross and Andretti Formula E, the Indianapolis-based team fields multiple entries across the IndyCar Series, Indy Lights, the FIA Formula E Championship, the GT4 America Series and Americas Rallycross. Additionally, the team competes as Walkinshaw Andretti United in the Australian Supercars category through partnership with Walkinshaw Racing and United Autosports.
The global racing enterprise boasts four IndyCar Series championships, three Indy Lights titles, one Pro Mazda championship and one USF2000 championship, and has captured victory five times at the famed Indianapolis 500-Mile Race. Additionally, the team holds two X Games Gold Medals and four U.S. rallycross championships.
To share in the Andretti story, please visit online at AndrettiAutosport.com and follow along on social media with #AllAndretti.
Company Contact:
Rose Alinaya
SVP, Investor Relations
818-661-5000
ir@mannkindcorp.com
MannkindLogoStackedPreferd.jpg
Source: MannKind
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Auf geht's zur nächsten Kapitalerhöhung.
Mannkind´s Zahlen für 2018
- Umsätze 28 Mio. $
- Produktumsätze 17 Mio. $
- Kollaborationsumsätze 11 Mio. $
- Produktumsätze 17 Mio. $
- Verlust 87 Mio. $
- davon 10 Mio. $ in Q4/18
- davon 10 Mio. $ in Q4/18
- Cash 71 Mio. $
- negatives Eigenkapital 175 Mio. $
http://investors.mannkindcorp.com/news-releases/...-end-2018-earnings
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WESTLAKE VILLAGE, Calif., April 01, 2019 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ: MNKD) today announced that it achieved the first of several specified development milestones under its licensing and collaboration agreement with United Therapeutics for the development and commercialization of a dry powder formulation of treprostinil. Treprostinil Technosphere (“TreT”) is an investigational product currently being evaluated in clinical trials for the treatment of pulmonary arterial hypertension. Pursuant to the agreement, MannKind is eligible to earn additional payments up to $37.5 million upon the achievement of other defined development milestones. MannKind will also be entitled to receive low double-digit royalties on net sales of TreT.
MannKind also announced that it filed a new shelf registration statement on Form S-3 with the Securities and Exchange Commission on March 29, 2019, which, when effective, will replace the existing shelf registration statement that expires on April 27, 2019.
About MannKind Corporation
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) Inhalation Powder, the Company's first FDA-approved product and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S.
For further information, visit www.mannkindcorp.com.
Company Contact:
Rose Alinaya
SVP, Investor Relations
818.661.5000
ir@mannkindcorp.com
MannkindLogoStackedPreferd.jpg
Source: MannKind
Mannkind meldet Zahlen für Q1/19
- Umsatz 17 Mio. $
- Verlust 15 Mio. $
- Cash 60 Mio. $
- negatives Eigenkapital 188 Mio. $
http://investors.mannkindcorp.com/news-releases/...-quarter-financial
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Wertpapier: MannKind Corp |
Zahlen für Q3/19
- Umsatz 15 Mio. $
- Verlust 10 Mio. $
- Cash 50 Mio. $
- negatives Eigenkapital 185 Mio. $
- MK 232 Mio. $
http://investors.mannkindcorp.com/news-releases/...uarter-preliminary
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MannKind Presents Novel Scientific Data at 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020)
[GlobeNewswire]
GlobeNewswire•February 20, 2020
WESTLAKE VILLAGE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- MannKind Corporation (MNKD) today announced the presentation of results from multiple clinical studies of Afrezza® (insulin human) Inhalation Powder and MannKind’s BluHale® technology system. These data are being presented in both oral and poster presentations during the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2020) in Madrid Spain, February 20-22, 2020.
“We are very pleased to have the opportunity to highlight these positive results during this year’s ATTD,” stated Dr. David Kendall, Chief Medical Officer of MannKind. “These presentations highlight original studies of Afrezza in individuals with both type 1 and type 2 diabetes, and include initial studies of Afrezza in pediatric patients. In addition to the results of clinical studies, we are pleased to disclose novel data on the use of BluHale, our Bluetooth-enabled technology for real-time profiling of inhalation effort and other parameters associated with the use of our inhaler. Collectively, these data further expand our understanding of the unique clinical profile of Afrezza, and highlight the potential use of Afrezza in children and adolescents, as well as advancing the opportunity to create connected technology for our drug delivery system.”
Highlights of the original scientific disclosures:
Preliminary data from an independent, investigator initiated study of Afrezza on the background of closed loop pump insulin delivery by means of an “artificial pancreas” system showed that pulmonary dosing allows for titration to higher unit doses in individuals with type 1 diabetes (presented by Alfonso Galderisi MD, PhD from Yale University).
Clinical use of Afrezza in adults with uncontrolled type 2 diabetes on two or more glucose lowering therapies resulted in a significant (1.6%) drop in A1c levels and a significant increase in time in range (presented by Dr. Philip Levin MD, Endocrinology, MODEL Clinical Research).
Pharmacokinetics (and pharmacodynamics) of Technosphere insulin in children and adolescents ages 8-17 with type 1 diabetes showed that the ultra rapid rise in insulin concentrations corresponded with early post-prandial glucose control within the first hour post-dose, similar to what has been observed in adult patients.
Two poster presentations highlighting the use of MannKind’s unique Bluetooth enabled technology for enhanced instruction on use of the Afrezza inhaler and as a tool to provide connected dose information on top of continuous glucose monitoring data.
Dr. Phillip Levin, Principal Investigator from MODEL Clinical Research in Baltimore, MD and lead author on the study of uncontrolled type 2 diabetes patients, noted that “the addition and rapid titration of Afrezza in patients with type 2 diabetes not currently at goal using two or more glucose lowering therapies, resulted in a 1.6% reduction in A1C and significantly increased time in range as measured by CGM. Our study provides additional clarity on both dose requirements and the clinical impact of adding ultra rapid-acting Afrezza therapy in uncontrolled type 2 diabetes.”
In addition to the original scientific disclosure presented at this year’s ATTD meeting, Dr. Kendall will participate as faculty in the “Ultra-rapid Insulin Analogues” session on Saturday, February 22, during which he will provide a current perspective on the clinical use of Afrezza, including evidence that ultra rapid-acting Afrezza can be safely and effectively titrated in fixed dose increments and that speed of insulin action may supersede dose precision for achieving post-prandial glucose control.
The full title of each of the presentations, presenting author, and the date and time of each disclosure are provided below.
ORAL PRESENTATION HIGHLIGHTS
Title: Technosphere® Insulin Provides Better Early Postprandial Glucose Control Than Subcutaneous Rapid-Acting Analogue
(ATTD 2020 - Saturday February 22, 2020; 8:50 – 9:00 a.m. – Berlin Room)
Presenter: David Kendall, MD, MannKind Corporation
ELECTRONIC POSTER PRESENTATION HIGHLIGHTS
Title: Patient Trainer Experience with BluHale® V1.0 for Proper Technosphere® Insulin Administration
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
Presenter: Nadia Zaveri, PharmD, MannKind Corporation
Title: Safety and Pharmacokinetics of Technosphere® Insulin in Pediatric Patients
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
Presenter: David Kendall, MD, MannKind Corporation
Title: Insights to Improve Use of Technosphere® Insulin Provided By BluHale®, a Digital Diabetes Tool
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
Presenter: Benoit Adamo, MannKind Corporation
Title: Effective Treatment of Patients with Uncontrolled Type 2 Diabetes On Multiple Diabetes Medications By Adding Mealtime Ultra-rapid Technosphere® Insulin
(ATTD 2020 – Thursday, February 20, 2020; 8 a.m.)
Presenter: Philip Levin, MD, Endocrinology, MODEL Clinical Research
Title: Afrezza® Pre-meal Bolus Reduces Early Glycemic Excursion During Hybrid Closed Loop Treatment
(ATTD 2020 – Saturday, February 22, 2020; 8:30 a.m.)
Presenter: Alfonso Galderisi, MD, PhD, Yale University
About ATTD Annual Meeting
The ATTD is a scientific program that brings leading international experts together to discuss breakthroughs in diabetes treatments, technological innovations and showcase the latest developments in new insulin analogues, delivery systems, pumps, glucose sensors, closed-loop systems and much more.
About Afrezza®
Available by prescription, Afrezza® (insulin human) Inhalation Powder is an ultra rapid-acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus. Afrezza consists of a dry powder formulation of human insulin delivered from a small and portable inhaler. Administered at the beginning of a meal, Afrezza dissolves rapidly upon inhalation to the lung and passes quickly into the bloodstream (in less than one minute). This rapid absorption allows Afrezza to begin reducing blood sugar levels within about 12 minutes of administration. Afrezza is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder that can be used, as prescribed by a health care professional, in combination with other diabetes medications to achieve target blood sugar levels. For Afrezza doses exceeding 12 units, patients may use a combination of existing cartridge strengths. For more information on Afrezza, please visit www.afrezza.com.
About MannKind
MannKind Corporation (MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. 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. MannKind is headquartered in Westlake Village, California, and has a state-of-the art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.
Zahlen für Q4/19
- Umsatz 16 Mio. $
- Verlust 14 Mio. $
Zahlen für 2019
- Umsatz 63 Mio. $
- Verlust 52 Mio. $
- Cash 50 Mio. $
- negatives Eigenkapital 191 Mio. $
- MK 279 Mio. $
http://investors.mannkindcorp.com/news-releases/...rter-and-full-year
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Mannkind refokussiert seine Pipeline
http://investors.mannkindcorp.com/news-releases/...-covid-19-pandemic
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