Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics, today announced that on December 31, 2018,
the Company granted stock options and restricted stock units to
four new employees of the Company. These awards were granted
pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan,
as amended, which was approved by the Company's board of directors
on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing
Rules, for equity grants to employees entering into employment or
returning to employment after a bona fide period of non-employment
with the Company, as an inducement material to such individuals
entering into employment with the Company. The stock options
are to acquire, in the aggregate, 8,400 shares of the Company’s
common stock at a per share exercise price of $5.13, the closing
sales price on December 31, 2018, and shall vest over a four-year
vesting period, under which 25% of the shares will vest after 12
months of employment, with the remaining shares vesting monthly
thereafter over the remaining 36-month period, subject to the
employee’s continuous service. The restricted stock units are to
acquire, in the aggregate, 5,550 shares of the Company’s common
stock and shall vest upon the conclusion of a 36-month vesting
period, under which one hundred percent 100% of the restricted
stock units will vest after 36 months of employment, subject to the
employee’s continuous service. The stock options and restricted
stock units are subject to the terms and conditions of the Paratek
Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, and the
terms and conditions of the stock option agreement and restricted
stock unit award agreement covering each grant.
About Paratek Pharmaceuticals, Inc. Paratek
Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics. The company’s lead commercial product,
NUZYRA™ (omadacycline) is a once-daily intravenous and oral
antibiotic for the treatment of adult patients with CABP and
ABSSSI. Paratek is also studying NUZYRA for the treatment of
urinary tract infections (UTI). Paratek has submitted a
marketing authorization application for omadacycline in
the European Union. Paratek has entered into a collaboration
agreement with Zai Lab for the development and
commercialization of omadacycline in the greater China
region and retains all remaining global rights. Under a
research agreement with the U.S. Department of
Defense, omadacycline also is being studied against
pathogenic agents causing infectious diseases of public health and
biodefense importance, including plague and anthrax.
Paratek’s second FDA approved commercial product,
SEYSARA™ (sarecycline), will be marketed by Almirall, LLC in
the U.S. as a new once-daily oral therapy for the treatment of
moderate to severe acne vulgaris. Paratek retains development and
commercialization rights to sarecycline in the rest of
the world. Recognizing the serious threat of bacterial
infections, Paratek is dedicated to providing solutions
that enable positive outcomes and lead to better patient
stories.
For more information, visit www.ParatekPharma.com or
follow @ParatekPharma on Twitter.
About NUZYRA NUZYRA (omadacycline) is a novel
antibiotic with both once-daily intravenous (IV) and oral
formulations for the treatment of community-acquired bacterial
pneumonia (CABP) and acute bacterial skin and skin structure
infections (ABSSSI). A modernized tetracycline, NUZYRA is
specifically designed to overcome tetracycline resistance and
exhibits activity across a spectrum of bacteria, including
Gram-positive, Gram-negative, atypicals, and other drug-resistant
strains. Indications and Usage NUZYRA™ is a
tetracycline class antibacterial indicated for the treatment of
adult patients with the following infections caused by susceptible
microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by
the following: Streptococcus pneumoniae, Staphylococcus
aureus (methicillin-susceptible isolates), Haemophilus influenzae,
Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella
pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
caused by the following: Staphylococcus aureus
(methicillin-susceptible and -resistant isolates), Staphylococcus
lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
(includes S. anginosus, S. intermedius, and S. constellatus),
Enterococcus faecalis, Enterobacter cloacae, and Klebsiella
pneumoniae. Usage To reduce the development
of drug-resistant bacteria and maintain the effectiveness of NUZYRA
and other antibacterial drugs, NUZYRA should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. Important Safety
InformationContraindications NUZYRA is
contraindicated in patients with known hypersensitivity to
omadacycline or tetracycline class antibacterial drugs, or to any
of the excipients. Warnings and Precautions
Mortality imbalance was observed in the CABP clinical trial with
eight deaths (2%) occurring in patients treated with NUZYRA
compared to four deaths (1%) in patients treated with moxifloxacin.
The cause of the mortality imbalance has not been established. All
deaths, in both treatment arms, occurred in patients > 65 years
of age; most patients had multiple comorbidities. The causes of
death varied and included worsening and/or complications of
infection and underlying conditions. Closely monitor clinical
response to therapy in CABP patients, particularly in those at
higher risk for mortality. The use of NUZYRA during tooth
development (last half of pregnancy, infancy and childhood to the
age of 8 years) may cause permanent discoloration of the teeth
(yellow-gray-brown) and enamel hypoplasia. The use of NUZYRA during
the second and third trimester of pregnancy, infancy and childhood
up to the age of 8 years may cause reversible inhibition of bone
growth. Hypersensitivity reactions have been reported with NUZYRA.
Life-threatening hypersensitivity (anaphylactic) reactions have
been reported with other tetracycline-class antibacterial drugs.
NUZYRA is structurally similar to other tetracycline-class
antibacterial drugs and is contraindicated in patients with known
hypersensitivity to tetracycline-class antibacterial drugs.
Discontinue NUZYRA if an allergic reaction occurs. Clostridium
difficile associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents and may range in severity from mild
diarrhea to fatal colitis. Evaluate if diarrhea occurs. NUZYRA is
structurally similar to tetracycline-class of antibacterial drugs
and may have similar adverse reactions. Adverse reactions including
photosensitivity, pseudotumor cerebri, and anti-anabolic action
which has led to increased BUN, azotemia, acidosis,
hyperphosphatemia, pancreatitis, and abnormal liver function tests,
have been reported for other tetracycline-class antibacterial
drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of
these adverse reactions are suspected. Prescribing NUZYRA 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 (incidence ≥2%) are nausea,
vomiting, infusion site reactions, alanine aminotransferase
increased, aspartate aminotransferase increased, gamma-glutamyl
transferase increased, hypertension, headache, diarrhea, insomnia,
and constipation. Drug Interactions Patients who
are on anticoagulant therapy may require downward adjustment of
their anticoagulant dosage while taking NUZYRA. Absorption of
tetracyclines, including NUZYRA is impaired by antacids containing
aluminum, calcium, or magnesium, bismuth subsalicylate and iron
containing preparations.
Use in Specific Populations Lactation:
Breastfeeding is not recommended during treatment with NUZYRA.
To report SUSPECTED ADVERSE REACTIONS,
contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835
or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.Please see full Prescribing
Information for NUZYRA at www.NUZYRA.com.Forward
Looking Statements This press release contains
forward-looking statements including statements related to our
overall strategy, product candidates, clinical studies, prospects,
potential and expected results, including statements about the
timing of commercializing NUZYRA, periods of expected exclusivity
of NUZYRA, advancing omadacycline and otherwise preparing for
clinical studies, the timing of enrollment in our
clinical studies and our reporting of the results of such
studies, the potential for omadacycline to serve as an empiric
monotherapy treatment option for patients suffering from ABSSSI,
CABP, UTI, and other bacterial infections when resistance is of
concern, the prospect of omadacycline providing broad-spectrum
activity, and our ability to make and sell NUZYRA,
obtain certain regulatory
approvals of omadacycline. All statements, other
than statements of historical facts, included in this press release
are forward-looking statements, and are identified by words such as
"advancing," "believe," "expect," "well positioned," "look
forward," "anticipated," "continued," and other words and terms of
similar meaning. These forward-looking statements are based upon
our current expectations and involve substantial risks and
uncertainties. We may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in our
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Our actual results and the
timing of events could differ materially from those included in
such forward-looking statements as a result of these risks and
uncertainties. These and other risk factors are discussed under
"Risk Factors" and elsewhere in our Annual Report on Form 10-K
for the year ended December 31, 2017, our Form 10-Q filed
for the quarter ended September 30, 2018 and our other
filings with the Securities and Exchange Commission. We
expressly disclaim any obligation or undertaking to update or
revise any forward-looking statements contained herein.
CONTACT:Investor and Media Relations:
Ben Strain
617-807-6688 ir@ParatekPharma.com
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