What exactly is the Technosphere® Platform?

One of the largest organs in your body are the lungs. Picture the size of a full tennis court and that is roughly the surface area of both lungs in a typical adult. Running through those lungs are airways whose total length measures 1,500 miles – that’s the distance between Chicago and Las Vegas, New York to Albuquerque, and Los Angeles to Nashville.

Simply put, the lungs create a wonderful platform for effective drug delivery. MannKind’s Technosphere technology recognizes this and provides the distinct advantage of rapid, deep lung drug delivery. The effect is similar to intravenous delivery (I.V.; within a vein) and has the added benefit of bypassing the liver which can be especially helpful in reducing systemic side effects.

Examining it closer, it helps to look at inhalation, air flow travel, and the exhale. When you breathe in, air is drawn into the lung and flows down curving, narrowing airways that end in the air sacs or alveoli. When air is exhaled, the flow is reversed. Between the end of an inhalation and the start of exhalation, the air in the lung is stationary. To reach the deep lung, inhaled particles must be carried by the air stream and have enough momentum to continue through the stationary air to collide with the lung surface.

Particles that can reach the lung have aerodynamic diameters between 0.5 µm and 5-6 µm (1 µm is 1 micro-meter or about 0.00004 inches). Particles that are larger than 6 µm will leave the air stream and hit the back of your mouth and throat; smaller than 0.5 µm wouldn’t have the ability to reach the lungs and would simply get exhaled.

“The average Technosphere particle is about 2-2.5 µm which is in the middle of the respirable range,” explains Marshall Grant, PhD, MSc, Executive Director, Clinical Pharmacology & Research for MannKind Corporation. “The particle size distribution is a major reason Technosphere powders are highly efficient in delivering drug to the lungs than other dry powder inhalers (DPIs).”

The Technosphere particles in FDA-approved Afrezza® (insulin human) Inhalation Powder and Tyvaso DPI™ (treprostinil) Inhalation Powder are manufactured by different processes and possess different characteristics. But both are made up of small crystals of FDKP (fumaryl diketopiperazine), MannKind’s proprietary molecule. FDKP provides high solubility and fast dissolution at physiologic pH – and more importantly – can crystallize and form particles in the range appropriate for optimum delivery to the lungs.

When Technosphere powder reaches the lung surface, the FDKP and drug dissolve. The FDKP is then rapidly cleared from the lung into systemic circulation. The FDKP is not metabolized, but rather excreted primarily in the urine. Another value of Technosphere powders has been their versatility – they are compatible with a wide range of doses with different types of drugs.

MannKind’s Technosphere powders are delivered into the lung’s airstream via an inhalation device or DPI (dry powder inhaler). The breath-powered inhalers (Dreamboat® being the most common version) provide excellent delivery efficiency and are proven to deliver up to 70% of the dry-powder dose deep into the lungs. Our DPI are designed to be simple, easy to use and discreet. For patients, imagine having a drug in the convenient form of an inhaler that fits in the palm of your hand. This approach allows patients to not only take control of their health but do it while going about their day and enjoying life more humann.

picture 1

NTM Lung Disease on the Rise

“I cough every morning upon waking, so I don’t feel rested.” “Imagine not being able to breathe.” “Anxiety ruins everything about you – it’s not a normal life.” “You just exist from day to day and week to week.” These are a sampling of comments about the most bothersome symptoms from living with Nontuberculous Mycobacteria (NTM) shared in a study from NTM Info & Research, Inc. The statements are unfortunately typical and those with NTM often have unpredictable day-to-day health functioning and reduced quality of life.

NTM lung disease is a serious infection that is caused by bacteria that are common in the environment and can cause lung damage. The reality is that we are all exposed to these bacteria in our day-to-day lives – more than 120 species of mycobacteria have been identified. These common bacteria exist in water and soil particles that are in the air, wet places like hot tubs, steamy bathrooms, dishwashers, and even the dewy ground we walk on at the park. But not everyone is at risk of getting NTM lung disease just because they are exposed.

Those predisposed often have underlying conditions such as asthma, COPD, and bronchiectasis, which makes them prone to NTM infection. NTM is not considered to be contagious. Women over the age of 65 make up the majority of those impacted, with a predominance in those of Caucasian and Asian descent.

A rare disease, NTM can often be difficult to diagnose. Many will experience coughing, fatigue, weight loss and shortness of breath – all of which are common with other lung disease symptoms and other conditions like tuberculosis. With NTM, symptoms often worsen, and that is a marker not to be ignored.

It is estimated that some 86,000 individuals are living with NTM lung diseases, and it is on the rise growing 8% each year. Coastal regions including Gulf States have higher rates of infection accounting for 70% of annual NTM cases.

While no cure is available, treatments to manage NTM are available. Treatment for NTM involves antibiotic and multidrug regimens with duration lasting from months to years with tolerability and adverse reactions to treatment which often leads to a lack of adherence to therapy.

There is a valuable need to develop medicines that are well tolerated and effective that lends to consistent patient use and alleviates symptoms of NTM lung disease. MannKind continues to progress MNKD-101 (Clofazimine) for the treatment of NTM.

picture 1

Release Details

MannKind and Sagard Healthcare Enter Into Royalty Purchase Agreement for Up to $200 Million

01/02/24
PDF Version
  • Sagard Healthcare purchased a 1% royalty in Tyvaso DPI® net sales
  • Purchase price of $150 million; additional potential milestone payment of up to $50 million

WESTLAKE VILLAGE, Calif., Jan. 02, 2024 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) announced that on December 27, 2023 it sold a 1% royalty in net sales of Tyvaso DPI® (treprostinil) inhalation powder in exchange for up to $200 million, including the purchase price of $150 million and an additional potential milestone payment of up to $50 million.

United Therapeutics Corporation licensed Tyvaso DPI from MannKind in 2018 and began marketing it in June 2022 for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease following U.S. FDA approval. Pursuant to a license agreement with United Therapeutics, MannKind is entitled to a 10% royalty on net sales of Tyvaso DPI, subject to certain reductions.

Under the terms of the royalty purchase agreement, Sagard Healthcare will receive royalty payments equal to 1% of the net sales of Tyvaso DPI that occur between October 1, 2023 and December 31, 2042, with MannKind retaining a 9% royalty. MannKind received a $150 million purchase payment for the 1% royalty and is entitled to receive a milestone payment as follows:

  • $50 million in the event that the trailing 12-month net sales of Tyvaso DPI equals or exceeds $1.9 billion by December 31, 2026; or
  • if the preceding milestone is not achieved, $45 million in the event that the trailing 12-month net sales of Tyvaso DPI equals or exceeds $2.3 billion by September 30, 2027.

If neither sales milestone is achieved, then (i) MannKind will not receive a milestone payment and (ii) Sagard Healthcare will not be entitled to any portion of the royalties payable to MannKind in respect of net sales of Tyvaso DPI that exceed $3.5 billion in any calendar year.

Additional information regarding the royalty purchase agreement is provided in a Current Report on Form 8-K filed by MannKind with the U.S. Securities and Exchange Commission.

Morgan Stanley & Co. LLC acted as sole structuring agent on the transaction. MannKind was represented in the transaction by Cooley LLP. Sagard was represented in the transaction by Sidley Austin LLP.  

Conference Call
MannKind will host a conference call and presentation webcast to discuss this transaction January 3, 2024 at 9:00 a.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind's website for 14 days.

About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative 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, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. 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.

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, Twitter or Instagram.

About Sagard
Sagard is a multi-strategy alternative asset management firm with over US$15B under management, 125 portfolio companies, and 350 professionals. We invest in venture capital, private equity, private credit, real estate, and royalties. We deliver flexible capital, an entrepreneurial culture, and a global network of investors, commercial partners, advisors, and value-creation experts. Our firm has offices in Canada, the United States, Europe and the Middle East.

For more information, visit www.sagard.com or follow us on LinkedIn @Sagard

TYVASO DPI is a registered trademark of United Therapeutics Corporation.


MANNKIND CONTACTS:
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email:media@mannkindcorp.com

Rose Alinaya, Investor Relations
(818) 661-5000
Email:ir@mannkindcorp.com

SAGARD CONTACTS:  
Media: bristol@bevelpr.com  
Investor Relations: ir@sagardholdings.com 

Primary Logo

Source: MannKind