Sun Pharma and SPARC Announce US FDA Approval of XELPROS™ to Treat Open-angle Glaucoma or Ocular Hypertension

XELPROSTM (latanoprost ophthalmic emulsion)
0.005% for topical ophthalmic use is the first and only benzalkonium
chloride-free (BAK-free) form of
latanoprost

MUMBAI, India & PRINCETON, N.J.–(BUSINESS WIRE)–#BAK–Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN,
NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries
and/or associate companies) and Sun Pharma Advanced Research Company
Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872,
“SPARC”) today announced U.S. Food and Drug Administration (USFDA)
approval for the New Drug Application (NDA) of XELPROSTM
(latanoprost ophthalmic emulsion) 0.005% for the reduction of elevated
intraocular pressure (IOP, or pressure inside the eye) in patients with
open-angle glaucoma or ocular hypertension. This approval is from Sun
Pharma’s Halol (Gujarat, India) facility.


Sun Pharma in-licensed XELPROSTM from SPARC in June 2015 and
this approval will trigger a milestone payment to SPARC. SPARC is also
eligible for milestone payments and royalties on commercialization of
XELPROSTM in the US.

XELPROSTM is the first and only form of latanoprost that is
not formulated with benzalkonium chloride (BAK), a preservative commonly
used in topical ocular preparations. XELPROSTM is developed
using SPARC’s proprietary Swollen Micelle Microemulsion (SMM) technology.

As the only BAK-free version of latanoprost, XELPROSTM will
be an important and alternative treatment option for individuals with
open-angle glaucoma or ocular hypertension,” said Abhay Gandhi, CEO,
North America, Sun Pharma. “This approval, coming less than one month
following the approval of CEQUA™
(cyclosporine ophthalmic solution) 0.09%, reaffirms the strength of Sun
Pharma’s fast-growing Ophthalmics division and its commitment to serving
the needs of patients with ocular disorders.”

Anil Raghavan, CEO, SPARC said, “Approval of XELPROSTM by
USFDA is a significant milestone for SPARC. It is also a validation of
our SMM technology which helps to solubilize drugs that have limited or
no solubility thus eliminating the need for benzalkonium chloride (BAK).”

In randomized, controlled clinical trials of patients with open-angle
glaucoma or ocular hypertension with a mean baseline Intraocular
pressure (IOP) of 23-26 mmHg, XELPROSTM lowered IOP by a mean
of up to 6-8 mmHg.

XELPROSTM will be commercialized in the U.S. by Sun
Ophthalmics, the branded ophthalmic division of Sun Pharmaceutical
Industries Ltd.’s wholly owned subsidiary.

About XELPROS

XELPROSTM (latanoprost ophthalmic emulsion) 0.005%, a
translucent ophthalmic emulsion, is a topical formulation of
latanoprost, a prostaglandin analogue that is used as first-line
treatment for open-angle glaucoma or ocular hypertension. It is the
first and only BAK-free form of latanoprost. The recommended dosage of
XELPROSTM is one drop in the affected eye(s) once daily in
the evening. If one dose is missed, treatment should continue with the
next dose as normal. Reduction of IOP starts approximately 3 to 4 hours
after administration and the maximum effect is reached after 8 to 12
hours.

Across multiple XELPROSTM clinical trials, the most
frequently reported ocular adverse reactions were eye pain/stinging upon
instillation and ocular hyperemia (redness), reported in 55% and 41% of
patients treated with XELPROSTM, respectively. Less than 1%
of patients discontinued therapy because of intolerance to these adverse
events.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

XELPROSTM is contraindicated in patients with known
hypersensitivity to latanoprost, or any other ingredients in this
product.

WARNINGS AND PRECAUTIONS

Pigmentation: XELPROSTM may cause changes to pigmented
tissues. The most frequently reported changes are increased pigmentation
of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is
expected to increase as long as XELPROSTM is administered.
After discontinuation of XELPROSTM iris pigmentation is
likely to be permanent. Patients who receive treatment should be
informed of the possibility of increased pigmentation. The long-term
effects of increased pigmentation are not known.

Eyelash Changes: XELPROSTM maygradually
cause changes to eyelashes, vellus hair in the treated eye including
increased length, thickness, pigmentation and number of lashes. The
changes are usually reversible upon discontinuation of treatment.

Intraocular Inflammation: XELPROSTM should be used
with caution in patients with a history of intraocular inflammation
(iritis/uveitis) and should generally not be used in patients with
active intraocular inflammation.

Macular Edema: XELPROSTM should be used with caution
in aphakic patients, in pseudophakic patients with a torn posterior lens
capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis: XELPROSTM should be used with
caution in patients with a history of herpetic keratitis. XELPROSTM
should be avoided in cases of active herpes simplex keratitis because
inflammation may be exacerbated.

Bacterial Keratitis: There have been reports of bacterial
keratitis associated with the use of multiple-dose containers of topical
ophthalmic products.

Use with Contact Lens: Contact lenses should be removed prior to
administration of XELPROSTM and may be reinserted 15 minutes
following administration.

ADVERSE REACTIONS

The most common ocular adverse reactions reported in clinical trials
(incidence ≥5%) for XELPROSTM are: eye pain/stinging, ocular
hyperemia, conjunctival hyperemia, eye discharge, growth of eyelashes,
and eyelash thickening.

DRUG INTERACTIONS

Precipitation may occur if drugs containing thimerosal are used
concomitantly with XELPROSTM. If such drugs are used, they
should be administered at least five (5) minutes apart.

Please click here for Full
Prescribing Information
& for more information visit www.MyXelpros.com

About Open-angle Glaucoma

Open-angle glaucoma (also known as primary or chronic glaucoma) is the
most common form of glaucoma, accounting for more than 90% of cases. It
is caused by clogging of the drainage canals in the eye, resulting in
elevated intraocular pressure (IOP). A lifelong condition, open-angle
glaucoma develops slowly, causing ocular nerve damage that gradually
affects a patient’s visual function.

In the U.S., glaucoma is a leading cause of irreversible blindness,
second only to macular degeneration. More than 2.25 million Americans
older than 40 years have open-angle glaucoma. Worldwide, glaucoma is the
second leading cause of blindness, surpassed only by cataracts; more
than 2 million people around the world will develop open-angle glaucoma
each year, and more than 3 million are bilaterally blind (i.e., in both
eyes) from open-angle glaucoma1.

About Ocular Hypertension

Ocular hypertension is a condition in which IOP is greater than 21 mmHg,
the widely accepted upper limit of normal IOP in the general population.
In individuals with ocular hypertension, fluid from the front of the eye
does not drain properly, causing IOP to build up. Although ocular
hypertension can cause glaucoma, it is not the same as glaucoma; with
ocular hypertension, the optic nerve appears normal and there are no
signs of vision loss. However, individuals with ocular hypertension are
considered “glaucoma suspects,” and should visit their ophthalmologist
regularly to be checked for glaucoma. Population studies in various
countries suggest that ocular hypertension affects an estimated 4-10% of
individuals older than 40 years. The prevalence of ocular hypertension
is 10-15 times greater than that of open-angle glaucoma.

References

  1. Biggerstaff KS. Primary open-angle glaucoma (POAG). Medscape, 2018. https://emedicine.medscape.com/article/1206147-overview#a6.
    Accessed September 5, 2018.

Disclaimer:

Statements in this “Document” describing Sun Pharma’s and SPARC’s
objectives, projections, estimates, expectations, plans or predictions
or industry conditions or events may be “forward looking statements”
within the meaning of applicable securities laws and regulations. Actual
results, performance or achievements could differ materially from those
expressed or implied.

About Sun Ophthalmics

Backed by Sun Pharma’s global expertise in R&D, Sun Ophthalmics (the
branded ophthalmic division of Sun Pharma’s wholly owned subsidiary) is
leading the way through the development of innovative products and in
partnership with eye care professionals. In the U.S., Sun Ophthalmics
market BromSite® (bromfenac ophthalmic solution) 0.075%, and
will soon commence marketing CEQUA™
(cyclosporine ophthalmic solution) 0.09% and XELPROS™ (latanoprost
ophthalmic solution) 0.005%, both of which were recently approved by the
USFDA. Sun Ophthalmics’ dedicated team is focused solely on the needs of
eye care professionals, offering timely, knowledgeable support at every
turn. The company strives to deliver products built on unique platforms
that integrate seamlessly into the eye care practice, helping eye care
professionals to continue providing quality medicine. Discover a
brighter future in eye care at www.sunophthalmics.com.

About Sun Pharmaceutical Industries Ltd. (CIN –
L24230GJ1993PLC019050):

Sun Pharma is the world’s fifth largest specialty generic pharmaceutical
company and India’s top pharmaceutical company. A vertically integrated
business, economies of scale and an extremely skilled team enable us to
deliver quality products in a timely manner at affordable prices. It
provides high-quality, affordable medicines trusted by customers and
patients in over 150 countries across the world. Sun Pharma’s global
presence is supported by 42 manufacturing facilities spread across 6
continents, R&D centers across the globe and a multi-cultural workforce
comprising over 50 nationalities. In India, the company enjoys
leadership across 13 different classes of doctors with 32 brands
featuring amongst top 300 pharmaceutical brands in India. Its footprint
across emerging markets covers over 100 markets and 6 markets in Western
Europe. Its Global Consumer Healthcare business is ranked amongst Top 10
across 3 global markets. Its API business footprint is strengthened
through 14 world class API manufacturing facilities across the globe.
Sun Pharma fosters excellence through innovation supported by strong R&D
capabilities comprising about 2,000 scientists and R&D investments of
approximately 8% of annual revenues. For further information, please
visit www.sunpharma.com
& follow us on Twitter @SunPharma_Live.

About Sun Pharma Advanced Research Company Ltd.
(CIN – L73100GJ2006PLC047837):

Sun Pharma Advanced Research Company Ltd. (SPARC) is a clinical stage
bio-pharmaceutical company focused on continuously improving standards
of care for patients globally, through innovation in therapeutics and
delivery. SPARC aims to consistently lower costs and improve operational
efficiencies to advance availability and affordability of cures for
patients across the world. More information about the company can be
found at www.sparc.life

Contacts

Sun Pharma
Investors:
Nimish
Desai
Tel +91 22 4324 4324, Xtn 2778
Tel Direct +91 22 4324
2778
Mobile +91-98203 30182
nimish.desai@sunpharma.com

or
Media:
Gaurav Chugh
Tel +91 22 4324
4324, Xtn 5373
Tel Direct +91 22 4324 5373
Mobile +91 98104
71414
gaurav.chugh@sunpharma.com
or
US
Media:

Reba Auslander, +1 917-836-9308
reba@raliancecommunications.com
or
SPARC
Investors
& Media:

Jaydeep Issrani
Tel +91 22 6645 5645, Xtn 5787
Tel
Direct +91 22 6645 5787
Mobile +91-98202 16916
Jaydeep.issrani@sparcmail.com