Ligand’s Partner Melinta Therapeutics Announces U.S. FDA Approval of Baxdela™ (Delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
SAN DIEGO--(BUSINESS WIRE)--
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that
partner Melinta Therapeutics, a privately held company focused on
discovering, developing, and commercializing novel antibiotics to treat
serious bacterial infections, announced yesterday that the U.S. Food and
Drug Administration (FDA) has approved Baxdela™ (delafloxacin),
indicated in adults for the treatment of acute bacterial skin and skin
structure infections (ABSSSI) caused by susceptible bacteria. Baxdela is
a fluoroquinolone that exhibits activity against both gram-positive and
gram-negative pathogens, including MRSA (methicillin-resistant
Staphylococcus aureus), and is available in both intravenous (IV) and
oral formulations. Baxdela IV utilizes Ligand’s Captisol®
technology. As a result of the approval, Ligand has earned a $1.5
million milestone payment and will earn a 2.5% royalty on Baxdela IV
sales.
“We congratulate Melinta for this first regulatory approval for
Baxdela,” said John Higgins, Chief Executive Officer of Ligand. “Melinta
has been an excellent partner, efficiently managing their clinical
development work and collaboratively interfacing with Ligand’s technical
team in successfully leveraging our Captisol technology for the IV
formulation of Baxdela. We have identified this program as one of
Ligand’s Big Six partnered pipeline assets given its medical importance
and stage of development. This approval and Melinta’s recently-announced
commercial and co-development agreement with Menarini Group position
Baxdela for global commercial success.”
“The approximately 3 million patients hospitalized each year in the U.S.
with ABSSSI often present treatment challenges owing to their underlying
medical conditions, making optimal antibiotic selection difficult.
Baxdela provides a treatment option for adult patients with ABSSSI based
on its coverage spectrum, IV and oral dosing flexibility, efficacy and
safety profile,” said Eugene Sun, M.D., CEO of Melinta. “The approval of
Baxdela demonstrates FDA’s commitment to making new and effective
antibiotics available to address unmet needs for hospitalized ABSSSI
patients.”
“Antibiotic resistance is a growing concern, and physicians need more
tools in the fight against this threat to modern medicine. Approval of
new therapies like Baxdela, which is effective against MRSA and other
serious pathogens, provides physicians another option in addressing the
challenges of ABSSSI patients,” said Dr. David Hooper, professor of
medicine, Harvard University, and chief of Infection Control, associate
chief, Division of Infectious Diseases, Massachusetts General Hospital.
The Baxdela New Drug Application (NDA) approvals were supported by two
Phase 3 studies in patients with ABSSSI, demonstrating that IV and oral
Baxdela monotherapy was statistically non-inferior to the combination of
vancomycin plus aztreonam at the FDA primary endpoint of early clinical
response at 48-72 hours. Baxdela was well tolerated with a 0.9%
discontinuation rate in the Phase 3 studies due to adverse events. In
addition, Baxdela has not shown any potential for QT prolongation or
phototoxicity in definitive clinical studies. There have been no signals
of adverse effects on liver function, kidney function, or glucose
regulation in controlled clinical studies. The 450 mg tablet is
bioequivalent (area under the curve) to, and interchangeable with the
300 mg IV dose, and can be dosed without regard to food. There are no
anticipated drug-drug interactions with delafloxacin other than
co-administration with chelating agents, such as antacids.
Full prescribing information and medication guide for Baxdela will be
made available at www.baxdelarx.com.
For questions or comments, call 1-844-MELINTA (1-844-635-4682).
About Baxdela
Baxdela (delafloxacin) tablets and intravenous injection are approved
for the treatment of ABSSSI (Acute Bacterial Skin and Skin Structure
Infections). Baxdela was given priority review by the FDA due to its
designation as a Qualified Infectious Disease Product (QIDP) under the
Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP
designation qualifies Baxdela for certain incentives related to the
development of new antibiotics, including a five-year extension of any
non-patent exclusivity period awarded to the drug.
Indication & Usage
Baxdela is indicated in adults for the treatment of acute bacterial skin
and skin structure infections (ABSSSI) caused by susceptible isolates of
the following:
Gram-positive organisms: Staphylococcus
aureus (including methicillin-resistant [MRSA] and
methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus,
Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus
anginosus group (including Streptococcus anginosus, Streptococcus
intermedius, and Streptococcus constellatus), Streptococcus pyogenes,
and Enterococcus faecalis;
Gram-negative organisms: Escherichia coli,
Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
IMPORTANT SAFETY INFORMATION:
WARNING: SERIOUS ADVERSE
REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY,
CENTRAL NERVOUS SYSTEM EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS
Fluoroquinolones have been associated with disabling and potentially
irreversible serious adverse reactions that have occurred together,
including:
• Tendinitis and tendon rupture
• Peripheral neuropathy
• Central nervous system effects
Discontinue Baxdela immediately and avoid the use of
fluoroquinolones, including Baxdela, in patients who experience any of
these serious adverse reactions.
Fluoroquinolones may exacerbate muscle weakness in patients with
myasthenia gravis. Avoid Baxdela in patients with known history of
myasthenia gravis.
Contraindications
Baxdela is contraindicated in patients with known hypersensitivity to
Baxdela or other fluoroquinolones.
Warnings and Precautions
Risk of tendinitis, tendon rupture, peripheral neuropathy and central
nervous system effects is increased with use of fluoroquinolones.
Discontinue Baxdela immediately at the first signs or symptoms of any of
these serious adverse reactions.
Avoid Baxdela in patients with known history of myasthenia gravis.
Hypersensitivity Reactions may occur after first or subsequent doses of
Baxdela. Discontinue Baxdela at the first sign of hypersensitivity.
Clostridium difficile-associated diarrhea has been reported in users of
nearly all systemic antibacterial drugs, including Baxdela. Evaluate if
diarrhea occurs.
Prescribing Baxdela in the absence of a proven or strongly suspected
bacterial infection is unlikely to provide benefit to the patient and
increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in patients treated with Baxdela were
nausea (8%), diarrhea (8%), headache (3%), transaminase elevations (3%),
and vomiting (2%).
Use in Specific Populations
In patients with severe renal impairment (eGFR of 15-29 mL/min/1.73 m2)
dosing of Baxdela should be dosed at 200 mg IV every 12 hours or 450 mg
orally every 12 hours. Baxdela is not recommended in patients with End
Stage Renal Disease [ESRD] (eGFR of <15 mL/min/1.73 m2) due to
insufficient information to provide dosing recommendations.
About Melinta Therapeutics
Melinta Therapeutics, Inc. is dedicated to saving lives threatened by
the global public health crisis of bacterial infections, through the
development and commercialization of novel antibiotics that provide new
and better therapeutic solutions. Melinta’s lead product is Baxdela, an
antibiotic approved for use in the treatment of acute bacterial skin and
skin structure infections (ABSSSI). Melinta is also committed to
developing, through the application of Nobel Prize-winning science, a
new class of antibiotics designed to overcome the multi- and
extremely-drug-resistant pathogens for which there are few to no
options, known collectively as ESKAPE pathogens (Enterococcus faecium,
Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii,
Pseudomonas aeruginosa, Enterobacter species and Escherichia coli),
which cause the majority of life-threatening hospital infections.
Melinta Therapeutics is privately held and backed by Vatera Healthcare
Partners (www.vaterahealthcare.com)
and Malin Corporation plc (www.malinplc.com),
among other private investors. The company is headquartered in New
Haven, CT with offices in Lincolnshire, IL. Visit www.melinta.com
for more information.
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 Novartis, Amgen, Merck, Pfizer,
Celgene, 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 release. These include statements regarding Melinta will
successfully launch Baxdela or that Baxdela will be successful following
launch. Further, the size of the patient population may be smaller than
anticipated or the medical field may identify greater concerns which may
negatively impact the success of Baxdela. Actual events or results may
differ from our expectations. For example, there can be no assurances
that Melinta will successfully launch Baxdela or that Baxdela will be
successful following launch. Further, the size of the patient population
may be smaller than anticipated or the medical field may identify
greater concerns which may negatively impact the success of Baxdela. 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 can
be found in Ligand's prior press releases available at www.ligand.com
as well as in Ligand's public periodic filings with the Securities and
Exchange Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release, except
as required by law. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170620005605/en/
Ligand Pharmaceuticals Incorporated
Todd Pettingill, 858-550-7500
investors@ligand.com
@Ligand_LGND
or
LHA
Bruce
Voss, 310-691-7100
bvoss@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released June 20, 2017