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  2. Research and development
  3. The development pipeline

The development pipeline

Merging global experience and technology to offer patients a brighter future

To promote our network-based drug discovery and global R&D efforts, Santen is placing significant emphasis on strengthening our relationships with universities, research organisations and other pharmaceutical firms to conceive new treatments for patients around the world. We hope such relationships will lead to the discovery and launch of novel therapies for severe dry eye disease, glaucoma, diabetic macular oedema and uveitis, a condition with limited treatment options.

Pipeline of prescription pharmaceuticals (clinical stage) As of 1 August 2019

Filter indication

Sirolimus (DE-109)

An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Started an additional Phase 3 in December 2018 and planning to complete in approx. FY2022 in the U.S. NDA filed in April 2015 in Asia.

Indication
Original/Licensor
Uveitis
Original
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Japan
Europe
Asia
Apr 2015
Tafluprost/timolol maleate (DE-111)

A fixed dose combination drug of a prostaglandin F2α derivative and a beta-adrenergic receptor blocker. Launched in Japan in November 2014. Launched successively in European countries since January 2015. Launched successively in Asian countries since April 2016. Started Phase 3 in January 2019 and planning to complete in the 1st half of FY2020 in China.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Co-development with AGC
 
P1
P2
P3
NDA filed
Approved
Launched
China
Epinastine hydrochloride (DE-114A)

An H1 receptor antagonist with membrane-stabilising function, as treatment for allergic conjunctivitis. High dose drug. Filed for manufacturing and marketing approval in September 2018 and planning to receive approval by December 2019 in Japan.

Indication
Original/Licensor
Allergic conjunctivitis
Nippon Boehringer Ingelheim
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Sep 2018
Omidenepag isopropyl (DE-117)

An EP2 receptor agonist with a new mechanism of action. Started Phase 3 in September 2018 and planning to complete in January ~ June 2020 in the U.S. Launched in November 2018 in Japan. Filed for marketing approval in Korea in April 2019 with successive filings in Asian countries and planning to receive approvals starting from the 1st half of FY2020.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Co-development with Ube Industries
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Japan
Nov 2018
Asia
Apr 2019
Carotuximab (DE-122)

An intravitreal injection of anti-endoglin antibody. Started Phase 2a in July 2017 and planning to complete in the 2nd half of FY2019 for development in the U.S.

Indication
Original/Licensor
Wet age-related macular degeneration
TRACON Pharmaceuticals
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
(Phase 2a)
Sepetaprost (DE-126)

A prostaglandin analogue eye drop drug product with a novel mode of action that is both FP and EP3 receptors dual agonist for the treatment of glaucoma and ocular hypertension. Started Phase 2b in July 2017 in the U.S. and Japan.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
ONO PHARMACEUTICAL
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
(Phase 2b)
Japan
(Phase 2b)
Atropine sulfate (DE-127)

Muscarinic antagonist which reduces juvenile myopia progression. Planning to start Phase 2/3 in the 1st half of FY2019 in Japan. Started Phase 2 in November 2017 and planning to complete in the 2nd half of FY2019 in Asia.

Indication
Original/Licensor
Myopia
Singapore Health Services, Nanyang Technological University
 
P1
P2
P3
NDA filed
Approved
Launched
Asia
Japan
PRESERFLO™ MicroShunt* (DE-128)

In August 2016, Santen acquired InnFocus, developer of PRESERFLO™ MicroShunt*, a drainage implant device designed to lower and sustain intraocular pressure (IOP) for the treatment of primary open-angle glaucoma through the drainage of aqueous humour. Conducting Phase 2/3 in the U.S. and Europe in advance of application to FDA. Planning to complete PMA rolling submission in 2019 and launch in 2020 in U.S. Received CE Mark in Europe.

Indication
Original/Licensor
Glaucoma
Original
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
(Phase 2/3)
Europe

*PRESERFLO™ is the new trademark of Innfocus MicroShunt®. PRESERFLO™ MicroShunt will replace Innfocus MicroShunt® in the future.

Ciclosporin (DE-076C)

An ophthalmic emulsion which improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue penetration. Received the Marketing Authorisation Application approval from the European Commission Agency in July 2018 and launched in October 2018 in U.K. Filed for marketing approval in November 2018 and planning to receive approval in July ~ December 2019 in Asia. Received marketing approval in December 2018 and planning to launch in 2019 in Canada.

Indication
Original/Licensor
Vernal keratoconjunctivitis
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Europe
Oct 2018
Asia
Nov 2018
Others
Dec 2018
Latanoprost (DE-130A)

An ophthalmic emulsion of a prostaglandin F2α derivative, for the treatment of glaucoma and ocular hypertension. Started Phase 3 in April 2019 and planning to complete in 2021 in Europe and Asia.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Europe
Asia
Intraocular lens (MD-16)

A toric intraocular lens for correcting astigmatism, which be implanted into an aphakia after cataract surgery. Filed for manufacturing and marketing approval in May 2019 and planning to receive approval in January ~ June 2020 in Japan.

Indication
Original/Licensor
Cataract
Oculentis
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
May 2019

Changes from Q4 FY18 (9 May, 2019)

Dev. code Changes
MD-16 Filed for manufacturing and marketing approval in May 2019 in Japan.
DE-109 Plan to complete an additional Phase 3 in approx. FY2022 in the U.S.

Santen discloses the information on the ongoing clinical studies to confirm safety and efficacy of our drugs on the websites as below.