Ligand Acquires Milestone and Royalty Rights to SB206 from Novan, Inc.
May 06 2019 - 9:00AM
Business Wire
Phase 3 drug candidate targeting
molluscum
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announces the acquisition of economic rights to SB206 from Novan,
Inc. SB206 is a Phase 3 topical antiviral gel for the treatment of
skin infections, including molluscum contagiosum. Ligand will pay
$12 million to Novan and in return will be entitled to receive a
tiered royalty of 7% to 10%, as well as up to $20 million in
regulatory and commercial milestones. Novan is responsible for all
expenses to develop or commercialize SB206, and will use 100% of
the proceeds from this transaction in the development and pursuit
of regulatory approval for SB206.
“This deal enables Ligand to participate in the potential future
revenue of a promising Phase 3 stage asset with a potential
commercial launch in 2021. The drug candidate targets a condition
mostly affecting children and with a significant unmet medical
need,” said John Higgins, Chief Executive Officer of Ligand. “We
believe Novan is a well-capitalized company with an experienced
management team. This deal adds an attractive late-stage asset to
our growing list of partnered programs that could be approved and
launch within the next three years.”
About SB206
Novan is developing SB206 as a nitric-oxide-based topical gel
for the treatment of viral skin infections, with a current focus on
the treatment of molluscum contagiosum, a contagious skin infection
caused by the molluscipoxvirus. There are currently no therapies
approved by the U.S. Food and Drug Administration (FDA) for the
treatment of molluscum. Nitric oxide has diverse biological
activity within the body, affecting the immune, cardio/pulmonary
and neurological systems, and depending on dose and release
kinetics, nitric oxide can have agonistic or antagonistic effects.
The role and mechanics of nitric oxide have been well researched.
Novan’s technology platform is the first macromolecular platform to
achieve stable, tunable and druggable delivery of nitric oxide.
SB206, if approved, could be a topical, at-home, caregiver-applied
therapy with a rapid treatment benefit. Novan’s issued U.S. and
foreign patents and pending U.S. and foreign patent applications,
if issued, relating to SB206 are projected to expire between 2026
and 2034.
About Molluscum
Molluscum contagiosum is a contagious skin infection caused by
the molluscipoxvirus. Molluscum affects approximately six
million people in the U.S. annually. The greatest incidence is in
children aged one to 14 years. The average time to resolution is 13
months, and 13% of children experience lesions that may not resolve
in 24 months. There is no FDA approved treatment for molluscum, and
caregivers are faced with potentially painful in-office,
physician-administered treatments or off-label prescriptions with
no molluscum indication, no proven clinical efficacy and
tolerability issues. As a result of the inadequate treatment
paradigm, over 50% of patients diagnosed with molluscum are
untreated. The majority of patients that receive treatment undergo
procedures with painful effects such as scraping, freezing, burning
and blistering, and the remainder are often prescribed products
indicated for the treatment of external genital warts.
About Novan
Novan, Inc. is a clinical development-stage biotechnology
company focused on leveraging nitric oxide’s naturally occurring
anti-microbial and immunomodulatory mechanisms of action to treat a
range of diseases with significant unmet needs. Novan believes that
by deploying nitric oxide in a solid form, on demand and in
localized formulations allows the company to potentially improve
patient outcomes in a variety of dermatology, women’s health and
gastrointestinal diseases.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on developing or
acquiring technologies that help pharmaceutical companies discover
and develop medicines. Our business model creates value for
stockholders by providing a diversified portfolio of biotech and
pharmaceutical product revenue streams that are supported by an
efficient and low corporate cost structure. Our goal is to offer
investors an opportunity to participate in the promise of the
biotech industry in a profitable, diversified and lower-risk
business than a typical biotech company. Our business model is
based on doing what we do best: drug discovery, early-stage drug
development, product reformulation and partnering. We partner with
other pharmaceutical companies to leverage what they do best
(late-stage development, regulatory management and
commercialization) to ultimately generate our revenue. Ligand’s
Captisol® platform technology is a patent-protected, chemically
modified cyclodextrin with a structure designed to optimize the
solubility and stability of drugs. OmniAb® is a patent-protected
transgenic animal platform used in the discovery of fully human
mono-and bispecific therapeutic antibodies. Ligand has established
multiple alliances, licenses and other business relationships with
the world's leading pharmaceutical companies including Amgen,
Merck, Pfizer, Gilead, Janssen, Baxter International and Eli
Lilly.
Follow Ligand on Twitter @Ligand_LGND.
Forward-Looking Statements
This news release contains forward-looking
statements by Ligand that involve risks and uncertainties and
reflect Ligand's judgment as of the date of this report. These
forward-looking statements include comments regarding Novan’s
planned clinical development program for SB206; the potential for
future regulatory and commercial milestones as well as royalties
from net sales of SB206, if approved; Ligand’s expectations that it
will not incur additional cash expenses in connection with the
development or commercialization of SB206 and the expectation that
Novan will have sufficient capital to complete its planned clinical
trials for SB206; the possibility that the Phase 3 clinical trial
could be the basis for registration, which means it would be
sufficient to submit a new drug application (NDA) to the FDA for
SB206; the possibility that SB206 will show clinical benefit to
treat patients with molluscum contagiosum; the size of the
molluscum patient population; potential for product approvals by
Ligand’s partners within the next three years; and Novan’s
expectations regarding the length and scope of patents covering
SB206. Actual events or results may differ from Ligand's
expectations. For example, the development of SB206 is entirely
dependent on Novan’s success and Ligand will have no ability to
direct the development program; Novan may abandon the development
of SB206 if commercially reasonable; there can be no assurance that
Novan will be able to successfully develop SB206, including
initiation of a Phase 3 clinical trial or filing an NDA to the FDA;
the FDA could require additional clinical trials than the planned
clinical trials and the Phase 3 clinical trial may not be able to
serve as a sufficient basis for an NDA filing with the FDA; Novan’s
planned Phase 3 clinical trial could fail to reach its primary
endpoints or show sufficient safety or efficacy to continue
development or submit an NDA to the FDA; even if approved, Novan
may not successfully launch SB206; other products that Ligand
expects will be launched by partners may fail their respective
clinical development programs or may fail to launch successfully;
and patents covering SB206 could be challenged or may not provide
the expected scope of coverage to exclude other products used to
treat molluscum. Many of these risks also apply to the other
programs which comprise Ligand’s shots-on-goal portfolio. The
failure to meet expectations with respect to any of the foregoing
matters may reduce Ligand's stock price. Additional information
concerning these and other important risk factors affecting Ligand
(including Ligand’s current reliance on revenues based on sales of
Kyprolis®, and various risks to which Ligand’s Captisol®
cyclodextrin operations are subject) can be found in Ligand's prior
periodic filings with the Securities and Exchange Commission
(including its Form 10-K filed on February 28, 2019), available at
www.sec.gov, as updated by future period reports filed with the
Securities and Exchange Commission. Ligand disclaims any intent or
obligation to update these forward-looking statements beyond the
date of this report. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of
1995.
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Ligand Pharmaceuticals IncorporatedTodd
Pettingillinvestors@ligand.com(858) 550-7893@Ligand_LGND
LHABruce Vossbvoss@lhai.com(310) 691-7100
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