At MannKind, we’re developing new ways to help people take control of their health and get the most out of life. Our ultra rapid-acting, inhalable insulin, Afrezza®, offers glucose management in the moment for people living with diabetes, and our novel inhalation-based technologies have the potential to lead to freer, healthier, and happier lives.
By working with other organizations, our breakthroughs can help more people live life more humann. From formulation and reformulation ideas to global licensing opportunities for Afrezza®, we have the capabilities to create partnerships that can create a world without limit for all.partner with us explore our pipeline
For too long, many fast-acting medications have required injections—and all the pain and inconvenience that comes with them. MannKind’s Technosphere® Technology is an innovative, dry-powder formulation technology that allows medication to be delivered through the lungs instead.
Technosphere® powders are based on our proprietary excipient, fumaryl diketopiperazine, which is a pH-sensitive organic molecule that self-assembles into small particles under acidic conditions. Certain drugs, such as insulin or treprostinil, can be loaded onto these particles by combining a solution of the drug with a solution or suspension of Technosphere® material, which is then dried to powder form. The resulting powder has a consistent and narrow range of particle sizes with good aerodynamic properties that enable efficient delivery deep into the lungs. Technosphere® powders dissolve quickly when the particles contact the moist lung surface with its neutral pH, releasing the drug molecules to diffuse across a thin layer of cells into the arterial circulation, bypassing the liver to provide excellent systemic exposure.
We have successfully prepared Technosphere® formulations of anionic and cationic drugs, hydrophobic and hydrophilic drugs, proteins, peptides, and small molecules. We have also successfully formulated a wide variety of API, from small molecules to proteins (like insulin) to address a variety of health conditions.
MannKind has also developed an innovative line of breath-powered, dry powder inhalers for use with Technosphere® formulations. Our inhalers are easy to use, cost-effective and can be produced in both a reusable (chronic treatment) and a single-use (acute treatment) format. Both the reusable and single-use inhaler formats use the same internal air-flow design. Being breath-powered, our inhalers require only the patient’s inhalation effort to deliver the powder. To administer the inhalation powder, a patient loads a cartridge into our inhaler and inhales through the mouthpiece. Upon inhalation, the dry powder is lifted out of the cartridge and broken (or de-agglomerated) into small particles. The inhalers are engineered to produce an aggressive airstream that de-agglomerates the powder while keeping the powder moving relatively slowly. This slow-moving powder effectively navigates the patient’s airways to reach the deep lung with minimal deposition at the back of the throat. Our inhalers show very little change in performance (i.e., efficient cartridge emptying) over a wide range of inhalation efforts.
Technosphere® Technology can be applied to a number of important therapeutic areas, including metabolic diseases like diabetes, respiratory diseases, and other conditions requiring acute drug delivery, such as pain management.
Most importantly, inhaled medicine offers an alternative to injections, helping people get the therapies they need and get back to being humann. MannKind has partnered with several organizations to leverage Technosphere® Technology to help change more lives for the better.
In September 2018, we entered into an exclusive global license and collaboration agreement with United Therapeutics for the rights to our dry powder formulation of treprostinil (TreT), and the associated drug delivery device. United Therapeutics is responsible for global development, regulatory and commercial activities with respect to TreT, and we are responsible for manufacturing all supplies of TreT.
Through a 2016 collaboration and license agreement, Receptor Life Sciences, Inc., acquired an exclusive license to our formulation and drug delivery technology in order to develop products that deliver cannabinoids via oral inhalation. Apart from some initial formulation and technology transfer obligations, our role in this collaboration is limited. Receptor is responsible for all development, manufacturing, and commercialization activities.
Diabetes has shaped the lives of people around the world. In 2019, 463 million adults were living with diabetes, and about 700 million will be by 2045.1
To provide more carefree, worry-free moments to this growing group of people, MannKind has developed Afrezza®. An ultra rapid-acting, inhaled insulin, Afrezza® offers glucose management in the moment for adults living with type 1 or type 2 diabetes. Now, we’re working to offer Afrezza® to more people globally. We currently have partnerships in Brazil and India; for commercial opportunities in other regions, contact firstname.lastname@example.org.
1. International Diabetes Federation, “Diabetes facts & figures.” https://www.idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html. Accessed March 2020.
In May 2017, MannKind entered into a supply and distribution agreement with Biomm SA to bring Afrezza® to Brazil. After obtaining regulatory approval of Afrezza® from the Agência Nacional de Vigilância Sanitária (“ANVISA”) and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos (“CMED”), Biomm launched Afrezza® in Brazil in January 2020.
In May 2018, we entered into an exclusive agreement with Cipla Ltd. to market and distribute Afrezza® in India. Cipla is responsible for obtaining regulatory approvals to distribute, market, and sell Afrezza® in India, and is currently conducting a safety and efficacy study in advance of filing. We are responsible for supplying Afrezza® to Cipla.
BluHale® helps make our simple inhaler even easier to use. The novel device is mounted on the inhaler and senses the change in pressure when a user inhales through the mouthpiece. This information is relayed via a Bluetooth connection to a smartphone app, helping the user learn more effective inhalation techniques.
Our BluHale® Pro edition is coming soon for healthcare providers to use during in-office training, and we are working on a BluHale® consumer edition that will include additional sensors to detect device orientation and dosage strength. While BluHale® is not used to diagnose or manage health, we envision BluHale® as part of a connected care ecosystem that will be used to help people more easily manage their conditions and more fully live their lives.
Together, we can bring life more humann to more people across the country.
MannKind has built a sales force of more than 80 dedicated pharmaceutical professionals who call on prescribers nationwide, supported by field-based managers and managed care executives. Our corporate headquarters is home to our Customer Experience Center, which helps prescribers and everyone who uses our therapies with reimbursement, product training, and other questions.
We believe our team can be leveraged to support additional products associated with diabetes or orphan lung diseases. Contact us for more information.partner with us