Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company
developing innovative therapies for patients with rare
cardiopulmonary diseases, and Pharmosa Biopharm (Pharmosa)
today announced that they have amended the current exclusive
licensing agreement for the development and commercialization of
L606, an inhaled, sustained-release formulation of treprostinil
currently being evaluated in a clinical trial for the treatment of
pulmonary arterial hypertension (PAH) and pulmonary hypertension
associated with interstitial lung disease (PH-ILD). The amended
agreement expands Liquidia’s licensed territory beyond North
America to include key markets in Europe, Japan and elsewhere.
Pharmosa will retain certain territories, including China, Korea,
Taiwan, Middle East, North Africa, Turkey and Southeast Asia.
Liquidia has also obtained certain rights to Pharmosa’s
next-generation smart-technology nebulizers for use with its
proprietary liposomal drug formulations. Unlike current nebulized
treatments for PAH and PH-ILD, these palm-sized, lightweight,
virtually silent nebulizers provide portability like a dry-powder
inhaler and rapidly deliver a dose using breath-actuated smart
technology that adapts to a patient’s normal breathing pattern.
Dr. Rajeev Saggar, Chief Medical Officer of Liquidia, stated:
“This is a great example of our approach to research and
development in pulmonary hypertension. This partnership has the
potential to be transformational for people living with PAH and
PH-ILD, as it will combine Liquidia’s expertise as a leader in the
field of pulmonary hypertension with Pharmosa’s deep experience in
inhaled liposomal formulations. We are delighted by the interest
from the global medical and patient communities, many of which lack
access to inhaled formulations of treprostinil, as we prepare to
initiate the L606 pivotal study in PH-ILD later this year. We are
also encouraged by the recent scientific advice from the European
Medicines Agency that supports our plan to proceed with the study
as designed.”
Pei Kan, Ph.D., President of Pharmosa, added: “This expanded
partnership with Liquidia is a strong endorsement for our L606
programs and our contribution to the fight against pulmonary
hypertension including PAH and PH-ILD. With more than 100,000 PAH
and PH-ILD patients in the major countries outside North America,
improvements of the treatment strategies in this region are
essential since there is no approved treatment for PH-ILD outside
the U.S. We believe Liquidia’s commitment to move quickly and
execute its global clinical program will accelerate the potential
for long-term value creation for both parties in this
partnership.”
Consistent with the agreement from June 2023, Liquidia will be
responsible for the development, regulatory and commercial
activities of L606 in the expanded territory. Pharmosa will
continue to manufacture clinical and commercial supplies of L606.
In consideration for these incremental exclusive rights, Liquidia
will pay Pharmosa an upfront payment of $3.5 million and up to
$157.75 million in additional milestone payments for the
development of PAH and PH-ILD indications and commercial sales
outside of North America. Royalties payable by Liquidia to Pharmosa
on global net sales of L606 have not changed and remain two tiers
of low, double-digit royalties as set forth in the original
agreement.
Clinically, L606 continues to generate encouraging data in an
open-label safety study in the United States in both PAH and
PH-ILD. As reported in a poster presentation at the 2024 American
Thoracic Society International Conference, the tolerability and
titratability profile of L606 observed to date has been favorable
up to the maximum dose allowed in the study of 378 mcg twice daily,
a dosage comparable to 26 to 28 breaths of Tyvaso administered four
times daily. Pharmacokinetic studies in healthy volunteers
demonstrated therapeutic levels of L606 up to 12 hours and 7-times
lower peak plasma concentration compared to Tyvaso®. The increased
apparent half-life of L606, in concert with comparable systemic
exposure and clearance rate, suggests that L606 provides
controlled, continuous drug coverage during sleeping and waking
hours, and supports twice-daily administration using a
breath-actuated, smart-technology nebulizer.
About L606 (liposomal treprostinil) Inhalation
Suspension
L606 is an investigational, liposomal formulation of
treprostinil administered twice-daily with a short-duration
next-generation nebulizer. The L606 suspension uses Pharmosa’s
proprietary liposomal formulation to encapsulate treprostinil which
can be released slowly at a controlled rate into the lung,
enhancing drug exposure over an extended period and reducing local
irritation of the upper respiratory tract. L606 is currently being
evaluated in an open-label study in the United States for treatment
of pulmonary arterial hypertension (PAH) with a planned pivotal
study for the treatment of pulmonary hypertension associated with
interstitial lung disease (PH-ILD).
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a rare, chronic,
progressive disease caused by hardening and narrowing of the
pulmonary arteries that can lead to right heart failure and
eventually death. Currently, an estimated 45,000 patients are
diagnosed and treated in the United States. There is currently no
cure for PAH, so the goals of existing treatments are to alleviate
symptoms, maintain or improve functional class, delay disease
progression, and improve quality of life.
About Pulmonary Hypertension Associated with
Interstitial Lung Disease (PH-ILD)
Pulmonary hypertension (PH) associated with interstitial lung
disease (ILD) includes a diverse collection of up to 150 different
pulmonary diseases, including interstitial pulmonary fibrosis,
chronic hypersensitivity pneumonitis, connective tissue disease
related ILD, and sarcoidosis among others. Any level of PH in ILD
patients is associated with poor 3-year survival between 30 to 35%.
A current estimate of PH-ILD prevalence in the United States is
greater than 60,000 patients, though population growth in many of
these underlying ILD diseases is not yet known due to factors
including underdiagnosis and lack of approved treatments until
March 2021 with inhaled treprostinil.
About Liquidia Corporation
Liquidia Corporation is a biopharmaceutical company
developing innovative therapies for patients with rare
cardiopulmonary disease. The company’s current focus spans the
development and commercialization of products in pulmonary
hypertension and other applications of its proprietary
PRINT® Technology. PRINT enabled the creation of Liquidia’s
lead candidate, YUTREPIA™ (treprostinil) inhalation powder, an
investigational drug for the treatment of pulmonary arterial
hypertension (PAH) and pulmonary hypertension associated with
interstitial lung disease (PH-ILD). The company is also
developing L606, an investigational sustained-release formulation
of treprostinil administered twice-daily with a next-generation
nebulizer, and currently markets generic Treprostinil Injection for
the treatment of PAH. To learn more about Liquidia, please
visit https://www.liquidia.com.
About Pharmosa Biopharm
Pharmosa Biopharm Inc. (PBI) is a Taiwan-based biotechnology
company focused on developing new drugs by exploiting its
proprietary liposomal formulations and manufacturing technology.
With regional and global strategic partnerships, PBI develops
products through 505(b)(2) or hybrid applications to regulatory
authorities with the intent to expand the clinical potential of
existing drugs by exploiting innovative delivery formulations and
medical devices. For more information, please visit
https://www.pharmosa.com.tw.
Tyvaso® is a registered trademark of United Therapeutics
Corporation
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Contact Information
Investors:Jason
Adair919.328.4350jason.adair@liquidia.com
Media:Patrick
Wallace919.328.4383patrick.wallace@liquidia.com
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