Long-Term Agreement Secures Dedicated
Capacity for Multi-Ton Annual Supply of VK2735 Active
Pharmaceutical Ingredient
Secures Dedicated Fill/Finish Capacity for 100
Million Annual Autoinjector Supply and Additional 100 Million
Annual Vial/Syringe Supply
Provides Annual Capacity of Over 1 Billion
Oral Tablets
Viking to Make Prepayments Totaling
$150 Million Between
2025-2028
SAN
DIEGO, March 11, 2025 /PRNewswire/ -- Viking
Therapeutics, Inc. ("Viking") (NASDAQ: VKTX), a clinical-stage
biopharmaceutical company focused on the development of novel
therapies for metabolic and endocrine disorders, today announced
that it has signed a broad, multi-year manufacturing agreement with
CordenPharma, an industry-leading contract development and
manufacturing organization (CDMO), covering both the active
pharmaceutical ingredient (API) and final finished product supply
for its VK2735 program for obesity. The agreement provides Viking
with sufficient long-term supply of both subcutaneous and oral
VK2735 product forms to support a potential multi-billion-dollar
annual product opportunity.
Under the terms of the agreement, Viking
has secured dedicated capacity for the manufacture of, and a
commitment to supply annually, multiple metric tons of VK2735
API. In addition, CordenPharma will provide fill/finish
capacity for both the injectable and oral formulations of VK2735.
This includes dedicated manufacturing lines and an annual
commitment to supply 100 million autoinjectors and an
additional 100 million vial and syringe products for the
subcutaneous formulation, as well as an annual capacity of over one
billion oral VK2735 tablets. These API and final finished product
capacities are further expandable at Viking's
option.
"We are excited to enter into this agreement with
one of the world's leading CDMOs in the peptide space," said
Brian Lian, Ph.D., chief executive
officer of Viking Therapeutics. "We have a long history of working
with CordenPharma and are happy to extend and strengthen our
relationship with this agreement. CordenPharma's established
presence in commercial peptide manufacturing gives us confidence in
their ability to deliver supply commensurate with what we
anticipate will be significant commercial demand. In
addition, CordenPharma's ability to provide dedicated capacity
across the supply chain, from API through finished commercial
products, makes them a uniquely qualified partner to work with in
bringing this important therapy to the market."
In exchange for dedicated API and fill/finish
capacity, Viking will make prepayments totaling $150 million, to be paid over the period from
2025 to 2028. Prepayments will be credited against future orders.
Viking retains ownership of all global rights to VK2735 under the
agreement and expects to maintain standard pharmaceutical product
margins.
VK2735, the company's dual agonist of the
glucagon-like peptide 1 (GLP-1) and glucose-dependent
insulinotropic polypeptide (GIP) receptors, is being developed in
both oral and subcutaneous formulations for the potential treatment
of various metabolic disorders such as obesity. Viking is currently
conducting the Phase 2 VENTURE-Oral Dosing Trial of VK2735 dosed as
an oral tablet once daily for 13 weeks. Additionally, the company
plans to initiate Phase 3 development with the subcutaneous
formulation of VK2735 in the second quarter of 2025.
About GLP-1 and Dual
GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1
(GLP-1) receptor has been shown to decrease glucose,
reduce appetite, lower body weight, and improve insulin sensitivity
in patients with type 2 diabetes, obesity, or both. Semaglutide is
a GLP-1 receptor agonist that has been approved by the
U.S. Food and Drug Administration and is currently marketed in
various dosage strengths and forms as Ozempic®,
Rybelsus®, and Wegovy®. More recently,
research efforts have explored the potential co-activation of the
glucose-dependent insulinotropic peptide (GIP) receptor as a means
of enhancing the therapeutic benefits of GLP-1
receptor activation. Tirzepatide is a dual GLP-1/GIP
receptor agonist that has been approved by the U.S. Food and Drug
Administration and is currently marketed in various dosage
strengths and forms as Mounjaro® and
Zepbound®.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage
biopharmaceutical company focused on the development of novel
first-in-class or best-in-class therapies for the treatment of
metabolic and endocrine disorders, with three compounds currently
in clinical trials. Viking's research and development
activities leverage its expertise in metabolism to develop
innovative therapeutics designed to improve patients'
lives. Viking's clinical programs include VK2735, a novel dual
agonist of the glucagon-like peptide 1 (GLP-1) and
glucose-dependent insulinotropic polypeptide (GIP) receptors for
the potential treatment of various metabolic disorders. Data from a
Phase 1 and a Phase 2 trial evaluating VK2735 (dosed
subcutaneously) for metabolic disorders demonstrated an encouraging
safety and tolerability profile as well as positive signs of
clinical benefit. Concurrently, the company is evaluating an oral
formulation of VK2735 in a Phase 2 trial. Viking is also developing
VK2809, a novel, orally available, small molecule selective thyroid
hormone receptor beta agonist for the treatment of lipid and
metabolic disorders. The compound successfully achieved both the
primary and secondary endpoints in a recently completed
Phase 2b study for the treatment of biopsy-confirmed
non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase
2a trial for the treatment of non-alcoholic fatty liver disease
(NAFLD) and elevated LDL-C, patients who received VK2809
demonstrated statistically significant reductions in LDL-C and
liver fat content compared with patients who received
placebo. The company's newest program is evaluating a series
of internally developed dual amylin and calcitonin receptor
agonists (or DACRAs) for the treatment of obesity and other
metabolic disorders. In the rare disease space, Viking is
developing VK0214, a novel, orally available, small molecule
selective thyroid hormone receptor beta agonist for the potential
treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase
1b clinical trial in patients with
the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to
be safe and well-tolerated, while driving significant reductions in
plasma levels of very long-chain fatty acids (VLCFAs) and other
lipids, as compared to placebo.
For more information about Viking Therapeutics,
please visit www.vikingtherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking
statements regarding Viking Therapeutics, Inc., under the safe
harbor provisions of the U.S. Private Securities Litigation Reform
Act of 1995, including statements about Viking's expectations
regarding its clinical and preclinical development programs; its
agreement with CordenPharma, including the expected sufficiency of
the supply of subcutaneous and oral VK2735 product forms under the
agreement; the potential annual product opportunity for
subcutaneous and oral VK2735; the anticipated timing for reporting
clinical data and cash resources. Forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially and adversely and reported results should not
be considered as an indication of future performance. These risks
and uncertainties include, but are not limited to: risks associated
with the success, cost and timing of Viking's product candidate
development activities and clinical trials, including those for
VK2735, VK0214, VK2809, and the company's other incretin receptor
agonists; risks that prior clinical and preclinical results may not
be replicated; risks regarding regulatory requirements; risks
relating to the manufacturing of API and product supply for VK2735;
and other risks that are described in Viking's most recent periodic
reports filed with the Securities and Exchange Commission,
including Viking's Annual Report on Form 10-K for the year ended
December 31, 2024, including the risk
factors set forth in those filings. These forward-looking
statements speak only as of the date hereof. Viking disclaims any
obligation to update these forward-looking statements except as
required by law.
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SOURCE Viking Therapeutics, Inc.
