Harrow (Nasdaq: HROW), an eyecare pharmaceutical company
exclusively focused on the discovery, development, and
commercialization of innovative ophthalmic therapies, today
announced that it has entered into a binding agreement for the
acquisition of the exclusive U.S. commercial rights to five
FDA‑approved ophthalmic products from the Novartis group of
companies (“Novartis”). This acquisition, when closed, will further
expand and diversify Harrow’s portfolio of branded pharmaceutical
products and its ability to serve the U.S. ophthalmic surgical and
acute care markets. Subject to customary closing conditions, this
acquisition is expected to close in early 2023.
This transaction, which is the second acquisition transaction
between Harrow and Novartis, transfers exclusive U.S. rights to the
following ophthalmic products:
- ILEVRO® (nepafenac ophthalmic suspension) 0.3%, a
non-steroidal, anti-inflammatory eye drop indicated for pain and
inflammation associated with cataract surgery.
- NEVANAC® (nepafenac ophthalmic suspension) 0.1%, a
non-steroidal, anti-inflammatory eye drop indicated for pain and
inflammation associated with cataract surgery.
- VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%,
a fluoroquinolone antibiotic eye drop for the treatment of
bacterial conjunctivitis caused by susceptible strains of
organisms.
- MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%, a steroid
eye drop for steroid-responsive inflammatory conditions of the
palpebral and bulbar conjunctiva, cornea, and anterior segment of
the globe.
- TRIESENCE® (triamcinolone acetonide injectable suspension) 40
mg/ml, a steroid injection for the treatment of certain ophthalmic
diseases and for visualization during vitrectomy.
Mark L. Baum, Chairman and CEO of Harrow, stated, “This is a
landmark transaction for Harrow, catapulting Harrow into a
leadership position in the U.S. ophthalmic pharmaceuticals market.
Following the satisfaction of the relevant closing conditions,
these products will be immediately accretive to our revenues and
excellently complement our current portfolio of ophthalmic
prescription products.
“We know these products very well and have long appreciated and
admired them for the value they have delivered to thousands of U.S.
eyecare professionals and many millions of their patients. We
believe the addition of these five products to our ophthalmic
pharmaceutical portfolio, which includes newly FDA‑approved
IHEEZO®, MAXITROL® 3.5mg/10,000 units/0.1%, IOPIDINE® 1%, and the
market-leading ImprimisRx compounded formulary, will be of
tremendous value to our customers – giving them more choices and
flexibility when considering the best treatment options for their
patients and the specific needs of their practices.
“Our market research indicates an increasing demand for the
indications these products treat. Based on U.S. demographic growth,
favorable competitive trends, and broad public and private payor
reimbursement, revenue contribution from these products is expected
to grow for many years. Assuming this transaction closes during the
first quarter of 2023, Harrow expects 2023 net revenues to be
between $135 million and $143 million and adjusted EBITDA to be
between $44 million and $50 million, with both net revenues and
adjusted EBITDA ramping up during 2024 and beyond.”
Under the terms of the agreement:
- Harrow will make a one-time payment of $130 million at closing,
with up to an additional $45 million payable in a milestone payment
upon the commercial availability of TRIESENCE, which is expected in
the second half of 2023.
- During an estimated 6-month NDA transfer period, Novartis will
continue to sell the products in the U.S. market and will transfer
all net profits to Harrow.
- Following the NDA transfer period, Harrow will assume control
over all U.S. market activities and will begin a process to have
the products manufactured by third parties.
- Novartis will retain all rights to the products outside of the
U.S.
- The transaction is expected to close in the first quarter of
2023, subject to the satisfaction of customary closing conditions,
including clearance under the Hart-Scott Rodino Antitrust
Improvements Act.
About ILEVRO® (nepafenac ophthalmic suspension) 0.3%:
INDICATIONS AND USAGE
ILEVRO® (nepafenac ophthalmic suspension) 0.3% is a
nonsteroidal, anti-inflammatory prodrug indicated for the treatment
of pain and inflammation associated with cataract surgery.
IMPORTANT SAFETY INFORMATION
Contraindications
ILEVRO® 0.3% is contraindicated in patients with previously
demonstrated hypersensitivity to any of the ingredients in the
formula or to other nonsteroidal anti-inflammatory drugs
(NSAIDs).
Warnings and Precautions
- Increased Bleeding Time – There exists the potential for
increased bleeding time. Ocularly applied NSAIDs may cause
increased bleeding of ocular tissues (including hyphema) in
conjunction with ocular surgery.
- Delayed Healing – Use may slow or delay healing. Concomitant
use of topical NSAIDs and topical steroids may increase the
potential for healing problems.
- Corneal Effects – Use may result in keratitis. In some
patients, continued use of topical NSAIDs may result in epithelial
breakdown, corneal thinning, corneal erosion, corneal ulceration,
or corneal perforation. These events may be sight threatening.
- Patients with complicated ocular surgeries, corneal
denervation, corneal epithelial defects, diabetes mellitus, ocular
surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or
repeat ocular surgeries within a short period of time may be at
increased risk for corneal adverse events, which may become sight
threatening.
- Use more than 1 day prior to surgery or use beyond 14 days
post-surgery may increase patient risk and severity of corneal
adverse events.
- Contact Lens Wear – ILEVRO® 0.3% should not be administered
while using contact lenses.
Adverse Reactions
The most frequently reported ocular adverse reactions following
cataract surgery occurring in approximately 5% to 10% of patients
were capsular opacity, decreased visual acuity, foreign body
sensation, increased intraocular pressure, and sticky
sensation.
For complete product information about ILEVRO® 0.3%, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f089b583-0310-4ca8-8d41-52b06b08d1ed.
About NEVANAC® (nepafenac ophthalmic suspension)
0.1%:
INDICATIONS AND USAGE
NEVANAC® is a nonsteroidal, anti-inflammatory prodrug indicated
for the treatment of pain and inflammation associated with cataract
surgery.
IMPORTANT SAFETY INFORMATION
Contraindications
Hypersensitivity to any of the ingredients in the formula or to
other non-steroidal anti-inflammatory drugs (NSAIDS).
Warnings and Precautions
- Increased Bleeding Time – There exists the potential for
increased bleeding time due to interference with thrombocyte
aggregation. There have been reports that ocularly applied NSAIDs
may cause increased bleeding of ocular tissues (including hyphema)
in conjunction with ocular surgery.
- Delayed Healing – Use may slow or delay healing. Concomitant
use of topical NSAIDs and topical steroids may increase the
potential for healing problems.
- Corneal Effects – Use may result in keratitis. In some
susceptible patients, continued use of topical NSAIDs may result in
epithelial breakdown, corneal thinning, corneal erosion, corneal
ulceration, or corneal perforation. These events may be sight
threatening.
- Postmarketing experience with topical NSAIDs suggests that
patients with complicated ocular surgeries, corneal denervation,
corneal epithelial defects, diabetes mellitus, ocular surface
diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat
ocular surgeries within a short period of time may be at increased
risk for corneal adverse events, which may become sight
threatening.
- Postmarketing experience with topical NSAIDs also suggests that
use more than 1 day prior to surgery or use beyond 14 days
post-surgery may increase patient risk and severity of corneal
adverse events.
- Contact Lens Wear – NEVANAC® 0.1% should not be administered
while using contact lenses.
Adverse Reactions
Most common adverse reactions (5% to 10%) are capsular opacity,
decreased visual acuity, foreign body sensation, increased
intraocular pressure (IOP), and sticky sensation.
For complete product information about NEVANAC®, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a2909252-c5f1-421f-9073-b7be90b45b51.
About VIGAMOX® (moxifloxacin hydrochloride ophthalmic
solution) 0.5%:
INDICATIONS AND USAGE
VIGAMOX® is a topical fluoroquinolone anti-infective indicated
for the treatment of bacterial conjunctivitis caused by susceptible
strains of the following organisms: Corynebacterium species*,
Micrococcus luteus*, Staphylococcus aureus, Staphylococcus
epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis,
Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus
viridans group, Acinetobacter lwoffii*, Haemophilus influenzae,
Haemophilus parainfluenzae*, and Chlamydia trachomatis.
*Efficacy for this organism was studied in fewer than 10
infections.
IMPORTANT SAFETY INFORMATION
Contraindications
VIGAMOX® is contraindicated in patients with a history of
hypersensitivity to moxifloxacin, to other quinolones, or to any of
the components in this medication.
Warnings and Precautions
- Hypersensitivity Reactions – Hypersensitivity and anaphylaxis
have been reported with systemic use of moxifloxacin.
- Prolonged Use – May result in overgrowth of non-susceptible
organisms, including fungi.
- Avoid Contact Lens Wear – Patients should not wear contact
lenses if they have signs or symptoms of bacterial
conjunctivitis.
Adverse Reactions
The most frequently reported ocular adverse events were
conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular
discomfort, ocular hyperemia, ocular pain, ocular pruritus,
subconjunctival hemorrhage, and tearing. These events occurred in
approximately 1%-6% of patients.
Nonocular adverse events reported at a rate of 1%-4% were fever,
increased cough, infection, otitis media, pharyngitis, rash, and
rhinitis.
For complete product information about VIGAMOX®, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ad783689-2b59-448c-b0d6-e8b70cf8b062.
About MAXIDEX® (dexamethasone ophthalmic suspension)
0.1%:
INDICATIONS AND USAGE
Steroid-responsive inflammatory conditions of the palpebral and
bulbar conjunctiva, cornea, and anterior segment of the globe, such
as allergic conjunctivitis, acne rosacea, superficial punctate
keratitis, herpes zoster keratitis, iritis, cyclitis, selected
infective conjunctivitides when the inherent hazard of steroid use
is accepted to obtain an advisable diminution in edema and
inflammation; corneal injury from chemical, radiation, or thermal
burns, or penetration of foreign bodies.
IMPORTANT SAFETY INFORMATION
Contraindications
MAXIDEX® 0.1% is contraindicated in acute, untreated bacterial
infections; mycobacterial ocular infections; epithelial herpes
simplex (dendritic keratitis); vaccinia, varicella, and most other
viral diseases of the cornea and conjunctiva; fungal disease of
ocular structures; and in those persons who have shown
hypersensitivity to any component of this preparation.
Warnings and Precautions
Prolonged use may result in ocular hypertension and/or glaucoma,
with damage to the optic nerve, defects in visual acuity and fields
of vision, and posterior subcapsular cataract formation. Prolonged
use may suppress the host response and thus increase the hazard of
secondary ocular infections. In acute purulent conditions or
parasitic infections of the eye, corticosteroids may mask infection
or enhance existing infection. In those diseases causing thinning
of the cornea or sclera, perforations have been known to occur with
the use of topical corticosteroids. If these products are used for
10 days or longer, intraocular pressure (IOP) should be routinely
monitored even though it may be difficult in children and
uncooperative patients.
Employment of corticosteroid medication in the treatment of
herpes simplex other than epithelial herpes simplex keratitis, in
which it is contraindicated, requires great caution; periodic
slit-lamp microscopy is essential.
Adverse Reactions
In clinical studies with MAXIDEX, the most frequently reports
adverse reactions were ocular discomfort occurring in approximately
10% of the patients and eye irritation occurring in approximately
1% of the patients. All other adverse reactions from these studies
occurred with a frequency less than 1%, including keratitis,
conjunctivitis, dry eye, photophobia, blurred vision, eye pruritis,
foreign body sensation, increased lacrimation, abnormal ocular
sensation, eyelid margin crusting, and ocular hyperemia.
For complete product information about MAXIDEX®, including
additional important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=603f0bac-16b8-42f5-985e-fb0d73ee284d.
About TRIESENCE® (triamcinolone acetonide injectable
suspension) 40 mg/ml:
INDICATIONS AND USAGE
TRIESENCE® suspension is a synthetic corticosteroid indicated
for treatment of sympathetic ophthalmia, temporal arteritis,
uveitis, and ocular inflammatory conditions unresponsive to topical
corticosteroids as well as visualization during vitrectomy.
IMPORTANT SAFETY INFORMATION
Contraindications
TRIESENCE® is contradicted in patients with systemic fungal
infections or hypersensitivity to triamcinolone or any component of
this product.
Warnings and Precautions
TRIESENCE® suspension should not be administered
intravenously.
- Ophthalmic effects – May include cataracts, infections, and
glaucoma. Monitor intraocular pressure.
- Hypothalamic-pituitary-adrenal (HPA) axis suppression,
Cushing's syndrome and hyperglycemia: Monitor patients for these
conditions and taper doses gradually.
- Infections – Increased susceptibility to new infection and
increased risk of exacerbation, dissemination, or reactivation of
latent infection.
- Elevated blood pressure, salt and water retention, and
hypokalemia – Monitor blood pressure and sodium, potassium serum
levels.
- GI perforation – Increased risk in patients with certain GI
disorders.
- Behavioral and mood disturbances – May include euphoria,
insomnia, mood swings, personality changes, severe depression, and
psychosis.
- Decreases in bone density – Monitor bone density in patients
receiving long term corticosteroid therapy.
- Live or live attenuated vaccines: Do not administer to patients
receiving immunosuppressive doses of corticosteroids.
- Negative effects on growth and development: Monitor pediatric
patients on long-term corticosteroid therapy.
- Use in pregnancy – Fetal harm can occur with first trimester
use.
- Weight gain – May cause increased appetite.
Adverse Reactions
The most common reported adverse events following administration
of triamcinolone acetonide were elevated intraocular pressure and
cataract progression. These events have been reported to occur in
20‑60% of patients.
For complete product information about TRIESENCE®, including
important safety information, please visit:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3f045347-3e5e-4bbd-90f8-6c3100985ca5.
About Harrow
Harrow (Nasdaq: HROW) is an eyecare pharmaceutical company
exclusively focused on the discovery, development, and
commercialization of innovative ophthalmic prescription therapies
for the U.S. market that are accessible and affordable. For more
information about Harrow, please visit the Investors section of the
corporate website, harrow.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such “forward-looking statements.”
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the
statements contained herein. Some of the potential risks and
uncertainties that could cause actual results to differ from those
predicted include the continued impact of the COVID-19 pandemic and
any future health epidemics on our financial condition, liquidity
and results of operations; our ability to make commercially
available our FDA-approved products and compounded formulations and
technologies in a timely manner or at all; market acceptance of the
Company’s products and challenges related to the marketing of the
Company’s products; risks related to our pharmacy operations; our
ability to enter into other strategic alliances, including
arrangements with pharmacies, physicians and healthcare
organizations for the development and distribution of our products;
our ability to obtain intellectual property protection for our
assets; our ability to accurately estimate our expenses and cash
burn, and raise additional funds when necessary; risks related to
research and development activities; the projected size of the
potential market for our technologies and products; unexpected new
data, safety and technical issues; regulatory and market
developments impacting compounding pharmacies, outsourcing
facilities and the pharmaceutical industry; competition; and market
conditions. These and additional risks and uncertainties are more
fully described in Harrow’s filings with the Securities and
Exchange Commission, including its Annual Report on Form 10-K and
its Quarterly Reports on Form 10-Q. Such documents may be read free
of charge on the SEC's website at www.sec.gov. Undue reliance
should not be placed on forward-looking statements, which speak
only as of the date they are made. Except as required by law,
Harrow undertakes no obligation to update any forward-looking
statements to reflect new information, events, or circumstances
after the date they are made, or to reflect the occurrence of
unanticipated events.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221213005815/en/
Investors Jamie Webb
Director of Communications and Investor Relations
jwebb@harrowinc.com 615-733-4737
Media Deb Holliday Holliday
Communications, Inc. deb@hollidaycommunications.net
412-877-4519
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