Glenmark Pharmaceutcials is an Indian multinational pharmaceutical company headquartered in Mumbai, India. Over the years, the pharma major has played a crucial role in discovering advance therapies.
Glenmark has focused on building a global Innovative/Specialty, Generics and OTC business in the therapy areas of Dermatology, Respiratory and Oncology. It also has strong regional/country-specific presence in other therapeutic areas like diabetes, cardiovascular and oral contraceptives.
Earlier this week, the Competition Commission of India (CCI) has granted approval for Nirma Ltd to acquire a majority shareholding in Glenmark Life Sciences Limited. his transaction values Glenmark Lifesciences at approximately Rs 6,700 crore.
In an E-mail interaction with Financial Express.com, Glenn Saldanha, Chairman & Managing Director, Glenmark Pharmaceuticals Ltd. spoke about his upcoming plans, market expectations, complex generics and more. Excerpts:
Glenmark has a strong presence in dermatology, respiratory, and oncology segments. What are your upcoming plans in these areas for the global markets including India?
Over the past four and a half decades, Glenmark Pharmaceuticals has made significant strides with its core therapeutic areas – dermatology, respiratory and oncology – and established successful franchises with end-to-end capabilities for fulfilling the unmet needs in the treatment of patients. As we move up the value chain and offer specialty medicines in addition to generic, developing a comprehensive portfolio of products for the global market continues to be our key priority. During 2023, we launched a number of new products in various parts of the world.
RYALTRIS, our first branded specialty product for treating allergic rhinitis, is now available in nearly thirty countries across the globe. We have a strong pipeline of complex respiratory products across branded and generic segments – clinical trials are ongoing for generic Flovent pMDI and we expect to file it in FY24. We also plan to file at least one more generic respiratory pMDI in the U.S. in FY25 and continue the filing momentum beyond FY25. Glenmark continues to target Loss of Exclusivity (LOE) opportunities in the U.S. in complex products such as inhalation, injectables, and other non-solid oral dosage categories.
As a leader in dermatology, we have actively sought opportunities to leverage our know-how and establish our presence across the world. Glenmark was looking for a unique product to raise its profile and establish itself as a serious dermatology player in the European region. We recently signed an exclusive distribution and license agreement with Cosmo Pharmaceuticals N.V. for acne treatment ointment, Winlevi, for Europe and South Africa. Its launch in the next fiscal year will have a synergistic beneficial effect for our dermatology portfolio.
Glenmark has been building up its oncology portfolio over the years; more recently, we entered into an exclusive collaboration with Helsinn, a Swiss biopharma group company, to launch in India an innovative I.V. injection formulation, AKYNZEO I.V. This ground-breaking treatment is designed to alleviate chemotherapy-induced nausea and vomiting (CINV) and is the first of its kind in the country. We will continue to explore opportunities for in-licensing in our core therapeutic areas. Glenmark is committed to continued geographical expansion within India to sustain our growth momentum. We hold a substantial product pipeline spanning various therapeutic areas, primed for commercialization in rapidly expanding markets. We will continue to broaden our base in emerging markets such as Asia, the Middle East and Africa, while leveraging our existing product portfolio and new product launches to enter new markets in key regions such as Europe and Asia.
In October this year, Glenmark signed licensing agreement with Astria Therapeutics for the OX40 antagonist monoclonal antibody portfolio. What are your market expectations from this deal?
Glenmark’s 100% subsidiary Ichnos Sciences’ recent out-licensing agreement with Astria Therapeutics is an important part of our strategy of moving up the value chain. Ichnos Sciences, entered into an exclusive worldwide licensing agreement for OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics. Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialization of the licensed therapeutic program for all indications. In exchange, Ichnos will receive up to $320 million in upfront, development, regulatory and sales milestone payments in addition to up to low double-digit royalties. Ichnos has also agreed to allow Astria to draw down on its existing investigational drug substance and drug product stocks at normalized costs to facilitate development.
How is Glenmark planning to move up the value chain in complex generics and innovative products?
Glenmark has been a prominent player in the Indian pharmaceutical industry with a strong focus on developing branded and generic products in its core therapy areas of Dermatology, Respiratory and Oncology. Over the last five years, we have made significant efforts to move up the value chain globally by developing specialty medicines and high end innovation. Additionally, we have a strong pipeline of differentiated complex generics products such as injectables, drug device combinations, respiratory and dermatology products for the U.S. market.
As part of our value chain strategy, we successfully developed, RYALTRIS, which has been steadily gaining market share across various regions like Australia, South Africa and markets across Europe, thereby fueling our aspirations to be a global player in the respiratory segment. The recent in-licensing of Winlevi will help drive Glenmark’s strategic focus to move up the value chain by establishing a formidable presence in dermatology. Winlevi is the first new chemical entity (NCE) for the
topical treatment of acne in 40 years and has been approved by the United States Food & Drug Administration (U.S. FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients aged 12 years and older.
Our quest, to be among the few Indian pharmaceutical companies to develop an innovative drug for the world, has driven us to tread two parallel paths. One pursues us to scale up the value chain by creating specialty products like RYALTRIS that address gaps in treatment. The second has led us pursuing the discovery of novel chemical and biological entities. Between Glenmark and our subsidiary Ichnos Sciences, we have a robust pipeline consisting of seven innovative molecules – four molecules in oncology, two in immunology and one in respiratory – in various stages of clinical development. We also intend to monetize these assets through strategic licensing deals with trusted partners, and have executed close to ten out-licensing agreements over the past twenty years with prominent global pharmaceutical companies, including Eli Lilly, Merck KGaA, Sanofi, Almirall, and Astria.
Is Glenmark planning to diversify into other therapeutic areas? What are your upcoming plans with respect to portfolio expansion?
In addition to our core therapeutic areas of dermatology, respiratory, and oncology, Glenmark also has a strong regional/country-specific presence in diabetes, cardiovascular and women’s health. We periodically evaluate our business and product range, and consistently work towards strengthening our market position in these therapeutic areas through the expansion of our product portfolio and consolidating our presence in the existing markets. We have continued to take strides towards building a robust global respiratory portfolio, by submitting marketing applications for RYALTRIS in more than 70 countries, and launching the product in around 30 countries across the world. We plan to commercialize the product across more markets in Africa, Asia, Europe and the Middle East by the next fiscal year. We will also be launching Winlevi across markets in Europe and South Africa in the next fiscal year, which will help elevate our profile in the global dermatology
market.
The non-communicable diseases (NCDs) continue to be a major burden in India. What are Glenmark’s plans for this especially in India?
In India, non-communicable diseases (NCDs) such as allergic rhinitis, asthma, chronic obstructive pulmonary disease (COPD), cancer, diabetes, and cardiovascular diseases present a serious health risk. Their growth is attributed to various factors, including urbanization, changes in lifestyle, and limited access to healthcare. Glenmark is continuously working towards launching products that are ‘first in the market’ in our key therapy areas, namely, dermatology, respiratory, oncology, diabetes, and cardio-vascular.
For instance, Glenmark has a strong legacy of bringing in new, effective, and affordable treatment options for diabetic patients, especially for those suffering from uncontrolled Type 2 diabetes. In 2015, we were the first to launch the DPP4 inhibitor, Teneligliptin (Zita Plus and Ziten), followed by a FDC of Teneligliptin + Metformin (Zita-Met Plus and Ziten-M). We later introduced Remogliflozin (Remo and Remozen), a novel SGLT-2 inhibitor in 2019; and subsequently, its combinations (Remo-V, Remozen-V, Remo MV, and Remozen MV). Sitagliptin (Sitazit) and its FDCs were launched in 2022. Then came Lobeglitazone (LOBG) and additional FDCs of Teneligliptin, including its combinations with Pioglitazone (Zita Pio), Pioglitazone + Metformin (Zita-PioMet), Dapagliflozin (Zita-D), and Dapagliflozin + Metformin (Zita DM).
What are your upcoming plans for the innovation pipeline?
We continue to leverage the potential of innovation to move up the value chain while maintaining a consistent focus towards bringing novel drugs to the patients. We are performing clinical trials for various drug molecules that will help in the treatment for oncology, auto-immune and respiratory. It enables us to create a strong pipeline of drugs that are both more effective and sensitive to shifts in the treatment paradigms.
Between Glenmark and subsidiary Ichnos Sciences Inc., the current pipeline consists of seven molecules in various stages of clinical development, including 2 small molecules (New Chemical Entities) and 5 large molecules (New Biological Entities or Biologics). The small molecules in our pipeline include GRC 54276 (hematopoietic progenitor kinase 1 [HPK1] inhibitor for solid tumors), which has achieved a significant milestone with the acceptance of its Investigational New Drug (IND) application by the U.S. FDA. The compound is currently progressing towards the Phase 1/2 clinical study stage. GRC 39815 (RORyt Inverse Against for COPD) in respiratory is currently in Phase 1 of development in the US.
The biologics in our pipeline include the ISB 830, which was recently licensed to Astria Therapeutics, and ISB 880 (IL-1RAP antagonist monoclonal antibody for auto-immune disease), which was licensed to Almirall S.A. in December 2021. The initiation of dosing in a Phase 1 study of ISB 880/ALM27134 was announced by Almirall in September 2022.
Among the other biologics in pipeline, ISB 1442 (CD38 x CD47 BEAT bispecific antibody) was granted Orphan Drug Designation for multiple myeloma by the FDA in March 2023. ISB 2001 (BCMA x CD38 x CD3 TREAT trispecific antibody) received Orphan Drug Designation from the FDA for ISB 2001 for the treatment of multiple myeloma, and the first patient was dosed in November 2023. for ISB 1342 (CD38 x CD3 BEAT bispecific antibody for multiple myeloma), the strategy is to out-license the asset and allow a potential partner to continue the escalation/expansion now that clinical proof-of-mechanism and proof-of-concept have been established with acceptable immunogenicity on pair with other bispecifics.
There are a lot of drugs that are going to be off-patent in the coming months. Are there any plans to launch a generic formulation for the same in India?
At Glenmark, we strive to bring effective and affordable treatment options to patients, while also bolstering our market position in our key therapeutic areas of dermatology, respiratory, oncology, as well as diabetes and cardio-vascular in India. Over the past few years, we have had numerous first-to-market launches,
including Zita-DM and Zita-PioMet for Type 2 Diabetes, AKYNZEO I.V. (Fixed I.V. Antiemetic Combination for the Prevention of CINV), and MINYM® GEL – India’s first topical minocycline 4% gel for the treatment of moderate to severe acne. We will continue to assess and plan more product launches across our key therapeutic segments.
What are the challenges that Indian pharmaceutical companies are facing at the moment? How Glenmark is tackling these hurdles?
The Indian pharmaceutical industry is dealing with issues such as market access pressures, complicated intellectual property laws, and regulatory compliance. Regular updates are required to comply with both domestic and international regulatory standards, and managing patent laws and generic competition can be challenging. Complexity is increased by supply chain interruptions, as was exemplified by the COVID-19 pandemic. We are committed to our current priorities, which include supply chain resilience enhancement, worldwide expansion, R&D focus, stringent regulatory compliance, and strategic alliances with the central strategy of moving up the value chain in complex generics and specialty medicines, all while keeping the patient requirements right at the forefront.
In the sustainability segment, what are Glenmark’s upcoming plans and strategy?
Promoting sustainability in all that we do is an integral aspect of our operations. It aligns with our core values and our commitment to our planet. Through the year under review, we diligently worked towards achieving our goals of becoming water neutral by 2025, achieving zero waste to landfill across all our plants by 2027, and carbon neutral by 2030.
Accessibility and availability of clean water are essential for community well-being and empowerment. Recognizing this, we aim to alleviate water scarcity and enhance the lives of the communities we serve through this program. We initiated the “Jal Kavach” project in Maharashtra, India to achieve water neutrality. The project was carried out in over 19 villages in Maharashtra and is aligned with the UN Sustainable Development Goals.
As part of our efforts to become carbon neutral, we are striving to raise the proportion of renewable energy in our energy mix. Our initiatives extend across multiple operational areas, including manufacturing and supply chain management. We are honored to be the second Indian pharmaceutical Company to have our targets certified by the Science Based Targets initiative (SBTi). We are working to reduce our absolute scope 1 and 2 GHG emissions by 35% by FY 2035, along with a 28% reduction in Scope 3 GHG emissions from various activities related to pharmaceutical products. Focused on enhancing carbon efficiency in our operations, we have reduced our carbon emission intensity by around 10% through our efforts over the last three years.
