R&D Pipeline

Glenmark’s R&D is committed to identifying products that fulfill unique and unmet medical needs in inflammation disorders, especially in respiratory and dermatology therapies and also oncology.

Therapy

Molecule

Indication

MoA/Class

Pre-Clinical

Phase 1

Phase 2 a

Phase 2 b

Phase 3

Approval

Respiratory

Ryaltris™ - GSP 301

Steroid + AH

Allergic Rhinitis

Respiratory

MoA/Class:Allergic Rhinitis

Indication:Steroid + AH

Overview

Ryaltris™ (olopatadine hydrochloride and mometasone furoate) Nasal Spray is the company’s leading respiratory pipeline asset and is currently under review with the U.S. Food and Drug Administration (FDA) as a treatment for seasonal allergic rhinitis in the USA. The extended PDUFA date for Ryaltris™ remains June 21, 2019. Further, in May 2019, Glenmark announced positive results from a Phase 3 study of Ryaltris™ in patients aged 6 to under 12 years wherein it met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evening Reflective Total Nasal Symptom Score (rTNSS) compared to placebo.

Glenmark has studied Ryaltris™ in seven clinical trials involving more than 4,000 adult and adolescent patients (12 years of age and older). Results from those clinical trials of Ryaltris™ have been previously presented at key medical meetings and full results from the study of Ryaltris™ in pediatric patients aged 6 to under 12 years of age will be published and presented at future meetings

Respiratory

GBR 310

Biosimilar

Asthama,CIU

Respiratory

MoA/Class:Biosimilar

Indication:Asthama,CIU

Overview

GBR 310 is a biosimilar candidate being developed for the treatment of allergic asthma and chronic idiopathic urticaria (CIU). GBR 310 has the potential to be among the first biosimilar candidates to be submitted to the FDA for approval for a respiratory or allergic disease in the US .

During FY 2018-19, Glenmark announced results from a Phase 1 study that suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between GBR 310, and the reference product, omalizumab, marketed in the US under the brand name Xolair®. Glenmark is in active discussions with potential partners and is targeting to conclude a deal before initiating Phase 3 studies.

Asthma is one of the most common diseases in children and affects more than 18 million people older than 18 in the US Allergic asthma is unique because it is triggered by exposure to year‐round allergens like pet dander and dust mites. Allergies trigger asthma attacks in 60‐90 percent of children and in approximately 50 percent of adults with asthma. Urticaria is a common skin disease that presents as spontaneously recurring hives or welts. It occurs across all age groups and about one percent of the population suffers from a chronic form of the disease. Among this group, 70% of people report symptoms that last for more than one year and 14% report symptoms that last for more than five years.

Respiratory

GSP 304

LAMA

COPD

Respiratory

MoA/Class:LAMA

Indication:COPD

Overview

GSP 304 is a long‐acting muscarinic antagonist administered by nebulization being studied for the long term, once‐daily, maintenance treatment of bronchospasm associated with COPD. The GSP 304 program is ongoing and is currently in Phase 2 for patients with mild to moderate COPD as established by the Global Initiative for Chronic Obstructive Lung Disease.

Immunology

GRC 39815

ROR y t Inhibitor

COPD

Immunology

MoA/Class:ROR y t Inhibitor

Indication:COPD

Overview

GRC 39815 is a NCE currently being evaluated as an inhaled compound for the possible treatment of Chronic Obstructive Pulmonary Disorder (COPD). It is an inhibitor of the Retinoid-related Orphan Receptor gamma t (RORγt). The compound is currently in pre-clinical development and the Company plans to initiate a Phase 1 study in FY 2019-20.

Based on the most recent estimates COPD affects approximately 64 million people worldwide. COPD is an incurable disease and based on the most recent data is the third leading cause of death worldwide.