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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170620005605/en/
Ligand Pharmaceuticals IncorporatedTodd Pettingill,
858-550-7500investors@ligand.com@Ligand_LGNDorLHABruce Voss,
310-691-7100bvoss@lhai.com
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