Santen and Glaukos Enter into Collaboration and Distribution Agreement for Exclusive Distribution of the MicroShunt (DE-128) in the United States

OSAKA, Japan & SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Santen Pharmaceutical Co., Ltd. (“Santen” TSE: 4536) and Glaukos
Corporation (“Glaukos” NYSE: GKOS), announced today that Santen’s U.S.
subsidiary, Santen Inc., has entered into a multi-year agreement whereby
Glaukos will become the exclusive distributor of the MicroShunt
(development code: DE-128) solely in the U.S. market.

The MicroShunt is a novel, minimally-invasive, ab-externo surgical
device being developed for primary open-angle glaucoma (POAG). Glaucoma
is a leading cause of irreversible blindness, affecting several million
people in the United States. POAG is the most common form of the disease
in people aged 40 years and older.

The MicroShunt is being studied in a U.S. Food and Drug Administration
(FDA) pivotal trial (NCT01881425) for intraocular pressure (IOP)
reduction in patients with POAG where intraocular pressure is
uncontrolled with maximum tolerated medical therapy or where the
progression of the disease warrants surgery. Following anticipated
completion of the premarket approval (PMA) submission in 2019, Santen
intends to seek U.S. FDA PMA and, if approved, launch of the product in
the United States is targeted within calendar year 2020.

“Santen is very excited to partner with Glaukos whose proven surgical
glaucoma expertise and established distribution and sales infrastructure
in the United States are unparalleled,” said Shigeo Taniuchi, President
and Chief Operating Officer at Santen. “We strongly believe that this
partnership will bring MicroShunt, if approved, to physicians and
patients in the United States in the most timely, efficient and
effective way possible.”

“We expect Santen’s MicroShunt to complement our expanding portfolio of
ab-interno MIGS products by providing glaucoma patients with this
ab-externo alternative to conventional filtration surgeries,” said
Thomas Burns, Glaukos’ President and Chief Executive Officer. “We are
enthusiastic about the opportunity to leverage our best-in-class sales
organization and established commercial presence to partner with Santen
and bring this novel technology to the United States if approved by the
FDA.”

The agreement stipulates that upon potential U.S. regulatory approval,
Glaukos will be the exclusive distributor of the MicroShunt in the
United States, responsible for sales and distribution of the product.
Santen will be responsible for marketing activities as well as
maintaining responsibility for all aspects of the product’s manufacture,
quality and safety controls, regulatory activities, life-cycle
management and post-approval marketing requirements. Financial terms of
the agreement were not disclosed.

About MicroShunt (DE-128)

In the United States, the MicroShunt (DE-128) is an investigational
ab-externo, minimally-invasive surgical implant being studied for the
treatment of primary open angle glaucoma (POAG) in patients where
intraocular pressure (IOP) is uncontrolled under maximum tolerated
medical therapy or where the progression of disease warrants surgery.
Made of a proprietary, biocompatible material called SIBS
[poly(styrene-block-isobutylene-block-styrene)], the MicroShunt is the
first glaucoma device to be compared head-to-head with trabeculectomy,
in a prospective, randomized, masked, multicenter study. MicroShunt has
been marketed under a CE mark in Europe as InnFocus MicroShunt and is
now in the process of rebranding under the new global commercial name of
PRESERFLO® MicroShunt.

About Santen

As a specialized company dedicated to ophthalmology, Santen carries out
research, development, marketing, and sales of pharmaceuticals,
over-the-counter products, and medical devices. Santen is the market
leader for prescription ophthalmic pharmaceuticals in Japan and its
products now reach patients in over 60 countries. With scientific
knowledge and organizational capabilities nurtured over a nearly
130-year history, Santen provides products and services to contribute to
the well-being of patients, their loved ones and consequently to
society. For more information, please visit Santen’s website (www.santen.com).

About Glaukos

Glaukos (www.glaukos.com)
is an ophthalmic medical technology and pharmaceutical company focused
on the development and commercialization of novel surgical devices and
sustained pharmaceutical therapies designed to transform the treatment
of glaucoma, one of the world’s leading causes of blindness. The company
pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the
traditional glaucoma treatment and management paradigm. Glaukos launched
the iStent®, its first MIGS device, in the United
States in July 2012 and launched its next-generation iStent inject®
device in the United States in September 2018. Glaukos is leveraging its
platform technology to build a comprehensive and proprietary portfolio
of micro-scale injectable therapies designed to address the complete
range of glaucoma disease states and progression. The company believes
the iStent inject, measuring 0.23 mm wide and 0.36 mm long, is
the smallest medical device ever approved by the FDA.

Santen Forward-Looking Statements

Information provided in this press release contains forward-looking
statements. The achievement of these forecasts is subject to risk and
uncertainty from various sources. Therefore, please note that the actual
results may differ significantly from the forecasts. Business
performance and financial conditions are subject to the effects of
changes in regulations made by the governments of Japan and other
nations concerning medical insurance, drug pricing and other systems,
and to fluctuations in market variables such as interest rates and
foreign exchange rates.

Glaukos Forward-Looking Statements

All statements other than statements of historical facts included in
this press release that address activities, events or developments that
we expect, believe or anticipate will or may occur in the future are
forward-looking statements. Although we believe that we have a
reasonable basis for forward-looking statements contained herein, we
caution you that they are based on current expectations about future
events affecting us and are subject to risks, uncertainties and factors
relating to our operations and business environment, all of which are
difficult to predict and many of which are beyond our control, that may
cause our actual results to differ materially from those expressed or
implied by forward-looking statements in this press release. These
potential risks and uncertainties include, without limitation, whether
the MicroShunt will receive FDA approval, the extent to which the
MicroShunt device will or will not demonstrate continued significant
sustained IOP reductions; the ability of Glaukos to successfully
leverage its sales organization and establish a commercial presence for
the MicroShunt, resulting in any incremental revenue for Glaukos; and
the extent to which Glaukos and Santen can work cooperatively under the
terms of the Collaboration and Distribution Agreement. These risks,
uncertainties and factors are described in detail under the caption
“Risk Factors” and elsewhere in our filings with the Securities and
Exchange Commission, including our Annual Report on Form 10-K for the
year ended December 31, 2018. Our filings with the Securities and
Exchange Commission are available in the Investor Section of our website
at www.glaukos.com
or at www.sec.gov.
In addition, information about the risks and benefits of our products is
available on our website at www.glaukos.com.
All forward-looking statements included in this press release are
expressly qualified in their entirety by the foregoing cautionary
statements. You are cautioned not to place undue reliance on the
forward-looking statements in this press release, which speak only as of
the date hereof. We do not undertake any obligation to update, amend or
clarify these forward-looking statements whether as a result of new
information, future events or otherwise, except as may be required under
applicable securities law.

Contacts

Christopher Hohman
General Manager, Corporate Communications Group,
Santen
+81-6-4802-9360
[email protected]

Tanya Shnaydman
Director, Corporate Communications, Santen
617-688-4858
[email protected]

Glaukos Media Contact:
Cassandra Dump
619-971-1887
[email protected]

Glaukos Investor Contact:
Chris Lewis
Director, Investor
Relations, Corporate Development & Strategy, Glaukos
949-481-0510
[email protected]

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