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  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 October 2021

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Ciclosporin DE-076C (STN1007603)

An ophthalmic emulsion that improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue penetration. Launched successively in European countries since October 2018. Launched successively in Asian countries after receiving approval for an indication extension for Ikervis in August 2019. Launched in November 2019 in Canada. Received marketing approval in June 2021 in U.S. and filed for marketing approval in April 2021 in China.

Indication
Original/Licensor
Vernal keratoconjunctivitis
Original
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Jun 2021
China
Apr 2021
Diquafosol sodium DE-089C (STN1008903)

A dry eye treatment which stimulates secretion of mucin and aqueous components from the corneal and conjunctival epithelium. Long-lasting drug. Filed for manufacturing and marketing approval in August 2021 in Japan.

Indication
Original/Licensor
Dry eye
Merck Sharp & Dohme Corp. (U.S.)
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Aug 2021
Sirolimus DE-109 (STN1010900)

An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Started an additional Phase 3 in December 2018 in the U.S. Filed for marketing approval in April 2015 in Asia.

Indication
Original/Licensor
Uveitis
Original
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Japan
Europe
Asia
Apr 2015
Sirolimus (STN1010905)

An ophthalmic suspension which improves meibomian gland function via mTOR inhibition. Started Phase 2a in October 2021 in Japan.

Indication
Original/Licensor
Meibomian gland dysfunction
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
(Phase 2a)
Tafluprost/timolol maleate DE-111A (STN1011101)

A fixed dose combination drug of a prostaglandin F 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 in China.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Co-development with AGC
 
P1
P2
P3
NDA filed
Approved
Launched
China
Omidenepag isopropyl DE-117 (STN1011700)

An EP2 receptor agonist with a new mechanism of action. Filed for marketing approval in November 2020 in the U.S. Launched in November 2018 in Japan. Filed successively for marketing approval in Asian countries and launched in February 2021 in Korea.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Co-development with Ube Industries
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Nov 2020
Japan
Nov 2018
Asia
Feb 2021
Sepetaprost DE-126 (STN1012600)

A prostaglandin analogue eye drop drug product with a novel mode of action that is a dual agonist for both FP and EP3 receptors for the treatment of glaucoma and ocular hypertension. Started an additional Phase 2 in December 2020 in the U.S. Completed Phase 2b in Japan. Started Phase 2 (exploratory study) in September 2021 in Europe.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
ONO PHARMACEUTICAL
 
P1
P2
P3
NDA filed
Approved
Launched
U.S.
Japan
(Phase 2b)
Europe
(Ex. study)
Atropine sulfate DE-127 (STN1012700)

Non-selective muscarinic antagonist which reduces juvenile myopia progression. Started Phase 2/3 in August 2019 in Japan. Started Phase 1 in September 2021 in China. Completed Phase 2 in April 2020 in Asia.

Indication
Original/Licensor
Myopia
Singapore Health Services, Nanyang Technological University
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
(Phase 2/3)
China
Asia
Glaucoma implant device DE-128 (STN2000100)

In August 2016, Santen acquired InnFocus, developer of 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. Filed for marketing approval in May 2021 in Japan. Launched in Europe in April 2019. Filed successively for marketing approval in Asian countries since March 2020 and received approval in September 2021 in Singapore. Received rejection letter in April 2021 but considering re-filing in Korea.

Indication
Original/Licensor
Glaucoma
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
May 2021
Europe
Apr 2019
Asia
Sep 2021

License-out to Glaukos in Americas, Australia and New Zealand in May 2021. Completed premarket approval rolling submission to the FDA in June 2020 and have received FDA's notification on assessment in the end of February 2021 and continued negotiation in the U.S. Received marketing approval in March 2021 in Canada and in May 2021 in Australia. Glaukos is preparing to launch. 

Latanoprost DE-130A (STN1013001, Catioprost)

An ophthalmic emulsion of a prostaglandin F derivative for the treatment of glaucoma and ocular hypertension. Started Phase 3 trials in April 2019 in Europe and Asia.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Original
 
P1
P2
P3
NDA filed
Approved
Launched
Europe
Asia
AFDX0250BS (STN1013400)

Selective muscarinic M2 antagonist which reduces juvenile myopia progression. Reduce mydriasis to selectively inhibit a subtype of receptors. Started Phase 1 in July 2021 in Japan.

Indication
Original/Licensor
Myopia
Boehringer Ingelheim
 
P1
P2
P3
NDA filed
Approved
Launched
Japan
Netarsudil dimesylate AR-13324 (STN1013900)

A ROCK (Rho-associated kinase) inhibitor. Developed and sold by Aerie in the U.S. Started Phase 3 in November 2020 in Japan.

Indication
Original/Licensor
Glaucoma
• Ocular hypertension
Aerie
 
P1
P2
P3
NDA filed
Approved
Launched
Japan

Changes from Q1 FY21 (6 August 2021)

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

Dev. code Changes
STN1008903/DE-089C Filed for manufacturing and marketing approval in August 2021 in Japan.
STN1010905 Started Phase 2a in October 2021 in Japan.
STN1012600/DE-126  Started Phase 2 (exploratory study) in September 2021 in Europe.
STN1012700/DE-127  Started Phase 1 in September 2021 in China.
STN2000100/DE-128 Received approval in September 2021 in Singapore.