MannKind Refocuses Pipeline Resources in Response to COVID-19 Pandemic
March 17 2020 - 9:00AM
MannKind Corporation (NASDAQ: MNKD), a
company focused on the development and commercialization of inhaled
therapeutic products, today announced that it is adjusting research
and development resources that were reserved for its pipeline of
investigational products for treating serious lung diseases, with
the goal of prioritizing work on new compounds that may have the
potential to address the morbidity and mortality associated with
respiratory viral infections, such as COVID-19.
Specifically, MannKind has initiated a
collaboration with Immix Biopharma, Inc. to prepare a dry powder
formulation of a compound with the potential to treat acute
respiratory distress syndrome, a complication of COVID-19.
The immediate focus of this effort is to rapidly develop prototype
powders, which will then be assessed for their potential to be used
therapeutically. Other collaborations are being actively
explored at this time.
MannKind is committed to joining the global
effort to overcome the COVID-19 crisis. MannKind’s
formulation and drug development expertise as well as its excess
manufacturing capacity will be deployed as necessary to help
protect humankind from this global health crisis.
Formulations for Pulmonary
DeliveryMannKind’s Technosphere® technology is an
innovative, dry-powder formulation technology that allows
medication to be delivered to the lungs. MannKind has
successfully prepared Technosphere formulations of anionic and
cationic drugs, hydrophobic and hydrophilic drugs, proteins,
peptides and small molecules. Technosphere powders are based on a
proprietary excipient, fumaryl diketopiperazine (FDKP), which is a
pH-sensitive organic molecule that self-assembles into small
particles under acidic conditions. Active pharmaceutical
ingredients can be loaded onto these particles, which are 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.
Drug Delivery DevicesMannKind
has also created an innovative line of breath-powered, dry powder
inhalers. Its 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. 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.
MannKind’s inhalers show very little change in performance (i.e.,
efficient cartridge emptying) over a wide range of inhalation
efforts.
Manufacturing
CapabilityMannKind’s 328,000 square foot R&D and
manufacturing facility is located in Danbury, Connecticut and has a
full range of development and manufacturing capabilities, including
analytical, chemical, formulation, filling and packaging. The
facility houses two 61 square meter lyophilizers and has sufficient
filling capacity to produce more than 300 million cartridges of
inhaled drug annually. The quality management systems of the
facility have been certified to be in conformance with the ISO
13485 and MD-SAP standards and was inspected most recently by the
U.S. Food and Drug Administration in June 2018, at which time there
were no inspectional observations.
About Immix BiopharmaImmix
Biopharma, Inc. is a privately-held, biopharmaceutical firm focused
on developing safe and effective therapies for cancer patients. The
company was founded by Vladimir Torchilin, Ph.D., D.Sc., Director
of the Center for Pharmaceutical Biotechnology and Nanomedicine at
Northeastern University; physician-scientist and clinical
researcher Ilya Rachman, MD, PhD, MBA; and Sean D. Senn, JD, MSc.,
MBA, a senior biotechnology patent attorney. Immix is focused on
harnessing scientific advances in order to engineer transformative
and effective cancer treatments. For more information visit
www.immixbio.com.
About MannKind 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 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.
Forward-Looking StatementsThis 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 annual report on Form 10-K for the year
ended December 31, 2019 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 Contacts: Investor
Relations818-661-5000 ir@mannkindcorp.com
Collaborations(818)
661-5001BD@mannkindcorp.com
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