JERUSALEM--(BUSINESS WIRE)--Jun. 9, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of generic Pataday®1 (olopatadine
hydrochloride ophthalmic solution) 0.2%, in the U.S.
Olopatadine hydrochloride ophthalmic solution 0.2% is a mast cell
stabilizer indicated for the treatment of ocular itching associated with
allergic conjunctivitis.
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly 600
generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market and holds the leading
position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in six generic prescriptions
dispensed in the U.S. is filled with a Teva product.
“Olopatadine hydrochloride ophthalmic solution 0.2% is an important
treatment for our patients and a key addition to our generics product
portfolio,” said Dipankar Bhattacharjee, Teva’s President and CEO,
Global Generic Medicines. “This launch marks another successful
first-to-file product for Teva, bringing the only generic version of
this product on the market.”
Pataday® had annual sales of approximately $303 million in
the U.S., according to IMS data as of March 2017.
About Olopatadine Hydrochloride Ophthalmic Solution 0.2%
Olopatadine hydrochloride ophthalmic solution 0.2% is indicated for the
treatment of ocular itching associated with allergic conjunctivitis.
Important Safety Information
Olopatadine hydrochloride ophthalmic solution 0.2% is for topical ocular
use only. It is not for injection or oral use. As with any eye drop, to
prevent contaminating the dropper tip and solution, care should be taken
not to touch the eyelids or surrounding areas with the dropper tip of
the bottle. Patients should be advised not to wear a contact lens if
their eye is red. Olopatadine hydrochloride ophthalmic solution 0.2%
should not be used to treat contact lens related irritation. The
preservative in olopatadine hydrochloride ophthalmic solution 0.2%,
benzalkonium chloride, may be absorbed by soft contact lenses. Patients
who wear soft contact lenses and whose eyes are not red, should
be instructed to wait at least ten minutes after instilling olopatadine
hydrochloride ophthalmic solution 0.2% before they insert their contact
lenses. The most common adverse reactions reported (incidence of
approximately 10%) were symptoms similar to cold syndrome and
pharyngitis.
For more information, please see accompanying Full
Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200 million
patients in 100 markets every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its portfolio of
more than 1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva's net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of Teva's generic version of
Pataday®, which are based on management’s
current beliefs and expectations and are subject to substantial risks
and uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from that
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include risks
relating to:
-
commercial success of Teva's generic version of Pataday®;
-
our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Allergan plc’s worldwide
generic pharmaceuticals business (“Actavis Generics”); our ability to
realize the anticipated benefits of the acquisition (and any delay in
realizing those benefits) or difficulties in integrating Actavis
Generics; the increase in the number of competitors targeting generic
opportunities and seeking U.S. market exclusivity for generic versions
of significant products; price erosion relating to our generic
products, both from competing products and as a result of increased
governmental pricing pressures; and our ability to take advantage of
high-value biosimilar opportunities;
-
our business and operations in general, including: uncertainties
relating to our recent senior management changes; our ability to
develop and commercialize additional pharmaceutical products;
manufacturing or quality control problems, which may damage our
reputation for quality production and require costly remediation;
interruptions in our supply chain; disruptions of our or third party
information technology systems or breaches of our data security; the
failure to recruit or retain key personnel, including those who joined
us as part of the Actavis Generics acquisition; the restructuring of
our manufacturing network, including potential related labor unrest;
the impact of continuing consolidation of our distributors and
customers; variations in patent laws that may adversely affect our
ability to manufacture our products; adverse effects of political or
economic instability, major hostilities or terrorism on our
significant worldwide operations; and our ability to successfully bid
for suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; and
-
compliance, regulatory and litigation matters, including: costs and
delays resulting from the extensive governmental regulation to which
we are subject; the effects of reforms in healthcare regulation and
reductions in pharmaceutical pricing, reimbursement and coverage;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; product liability claims; increased
government scrutiny of our patent settlement agreements; failure to
comply with complex Medicare and Medicaid reporting and payment
obligations; and environmental risks.
and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”) and in our other filings
with the U.S. Securities and Exchange Commission (the “SEC”).
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are cautioned not to rely on these forward-looking statements. You are
advised to consult any additional disclosures we make in our reports to
the SEC on Form 6-K, as well as the cautionary discussion of risks and
uncertainties under “Risk Factors” in our Annual Report. These are
factors that we believe could cause our actual results to differ
materially from expected results. Other factors besides those listed
could also materially and adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of
1995.
1 Pataday® is a registered trademark of Alcon
Laboratories, Inc., a Novartis company.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170609005372/en/
Source: Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin C. Mannix, 215-591-8912
Ran
Meir, 215-591-3033
or
Israel
Tomer Amitai, 972
(3) 926-7656
or
PR Contacts:
Israel
Iris Beck
Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
Nancy Leone, 215-284-0213