- Abingworth, a leading transatlantic life sciences investment
firm and part of global investment firm Carlyle (NASDAQ: CG),
led financings and was joined by Carlyle, OrbiMed, and Pathalys'
founding investors Catalys Pacific and DaVita Venture
Group
- Transaction is expected to fully fund upacicalcet through
pivotal phase 3 studies and pre-commercialization
activities
- Collaboration leverages clinical development experience of
Launch Tx and Pathalys' extensive dialysis expertise to advance the
upacicalcet development program
RESEARCH
TRIANGLE PARK, N.C. and BOSTON, Jan. 18,
2023 /PRNewswire/ -- Pathalys Pharma, Inc., a
private, late-stage biopharma company co-founded by Catalys Pacific
and DaVita Venture Group, and Launch Therapeutics (Launch Tx), a
clinical development company, today announced a collaboration to
advance phase 3 clinical trials for upacicalcet (designated PLS240
for clinical trials) for the treatment of secondary
hyperparathyroidism (SHPT) in patients on hemodialysis. Launch Tx
is backed by funds managed by global investment firm Carlyle
(NASDAQ: CG) and its life sciences franchise Abingworth.
Pathalys Pharma Raises $150 Million in Secured Product Financing and
Equity
Pathalys also announced it has raised $150 million through a combination of secured
product financing and equity to support the two phase 3 clinical
trials, registration efforts and pre-commercialization activities
for upacicalcet. Abingworth led both financings and was joined by
Carlyle and OrbiMed, along with Pathalys' founding investors
Catalys Pacific and DaVita Venture Group. Pathalys retains
worldwide commercial rights to upacicalcet, outside Japan and Asia, and has the option to prepay its
obligations in full at any time.
"Pathalys is very excited to collaborate with Launch Tx and to
have the backing of such an esteemed group of healthcare investors.
Through this collaboration and transaction, Pathalys expects to be
fully funded through the completion of its planned phase 3 trials,
and pre-commercialization efforts for upacicalcet." said
Neal Fowler, Chief Executive Officer
at Pathalys. "We look forward to working closely with Launch Tx to
advance upacicalcet toward registration in the U.S. with the goal
of making this important product candidate available for dialysis
patients with SHPT."
The co-development agreement creates a collaboration that
combines the exceptional clinical development resources available
through Launch Tx and the extensive dialysis expertise of Pathalys
to advance the upacicalcet clinical development program. Launch Tx
will have the lead role in the operational execution and management
of the planned clinical trials and Pathalys will retain primary
responsibility for manufacturing, FDA regulatory interactions and
commercialization.
Anshul Thakral, CEO of Launch Tx,
commented, "We are thrilled to collaborate with Pathalys to advance
upacicalcet. Launch Tx will bring deep clinical and operational
resources to this phase 3 program to accelerate the path
to regulatory approval. We offer a unique approach that helps
both pharma and biotech companies develop their late-stage
therapies and plan to demonstrate that approach through
our collaboration with Pathalys."
Earlier this year, Pathalys disclosed its plans to initiate two
phase 3 clinical trials to evaluate upacicalcet as a treatment
alternative to currently available calcimimetics. Upacicalcet is a
novel calcimimetic that performed exceptionally well in phase 3
studies in Japan where it was
approved last year for the treatment of SHPT in patients on
dialysis. An intravenous calcimimetic like upacicalcet may
allow patients on dialysis better control of serum parathyroid
hormone levels in SHPT in a convenient and compliant way, without
increasing their calcium-phosphorus production while, more
importantly, lowering their risk for vascular calcifications.
About Upacicalcet
Upacicalcet is an intravenously administered investigational
small molecule calcimimetic that may control intact parathyroid
hormone (iPTH) levels in patients with secondary
hyperparathyroidism (SHPT) receiving hemodialysis. Upacicalcet was
granted Marketing Authorization in Japan in 2021, under the brand name UPASITA®,
based on a phase 3, 24-week double-blind, placebo-controlled
dose-titration study and a second phase 3, 52-week open-label,
dose-titration study. In these studies, upacicalcet was shown to
significantly reduce iPTH and maintain long-term iPTH suppression,
as well as demonstrate the potential for fewer adverse events (AEs)
than currently available therapies.
About Pathalys Pharma
Pathalys Pharma, Inc. is a private, late-stage clinical
biopharmaceutical company committed to the development of multiple
advanced therapeutics that address unmet needs in the management of
end-stage kidney disease (ESKD). Pathalys' initial asset is
upacicalcet, a novel calcimimetic with the potential to improve the
treatment of SHPT in hemodialysis patients. Beyond upacicalcet,
Pathalys continues to identify other high priority needs and
potential solutions for patients with ESKD. Pathalys was co-founded
by Catalys Pacific and DaVita Venture Group and is headquartered in
Research Triangle Park, North
Carolina.
For more information about Pathalys, please
visit www.pathalys.com.
About Launch
Therapeutics
Launch Therapeutics (Launch Tx) is a clinical development
company with a mission to disrupt the late-stage development
paradigm, accelerate timelines to regulatory success, and bring new
medicines to patients faster. Launch Tx offers pharmaceutical and
biotech companies a variety of innovative models that combine
access to capital with deep drug development, medical, clinical
operations, regulatory, and commercialization expertise. These
models include significant risk financing, clinical co-development,
and full in-licensing, all of which offer partners an aligned and
efficient approach to realizing the potential of late-stage
clinical programs across any therapeutic area. Founded in 2022,
Launch Tx is backed by leading investors, Carlyle and its life
sciences franchise, Abingworth, and is led by a committed,
experienced team with an enthusiastic passion to fulfil its
mission.
For more information, visit launchtx.com and follow us
on LinkedIn.
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SOURCE Pathalys Pharma