Fostering a Culture
of Innovation

Lupin strives to reduce disease burden for patients and societies around the world. By focusing on innovation, we are able to deploy cutting-edge technologies to develop new and high-quality generic medicines to improve patient quality of life. In FY22, we invested INR 14,024 Mn in Research and Development. We believe that our investment in R&D will lead to sustained value creation both in terms of topline growth and improving access and affordability of our medicines to patients around the world.

We aim to enrich our portfolio by identifying and developing new and improved products as well as partnering across the value chain to achieve scale and impact.

INR
14,024 Mn

Invested in R&D

61 Patents

Secured in FY22

1,008

Active Patents

Filing and Approvals Trend

R&D Infrastructure and Key Developments

With R&D centers in seven locations across the globe, employing over 1,400 personnel, we innovate by leveraging advanced technologies, superior competencies and strategic alliances. We are proud of our state-of-the-art R&D Lupin Research Park (LRP) located in Pune, India, which functions as the hub of our global research activities.

This campus houses our generic research unit, encompassing API and finished product research, our Novel Drug Discovery and Development (NDDD) unit and from recently, our biosimilar research unit. Over the years, we have transitioned from an oral solids portfolio to include a wide array of complex generics such as injectables, biosimilars and inhalation products.


Bioclinical Research, Pune

The Lupin Bioresearch Centre (LBC) is located in Pune and commenced its operations in the year 2009. The LBC has been involved in the operations to conduct in-vitro/in-vivo bioequivalence/PK-PD studies on different formulations including but not limited to Oral, Injectables, Inhalations, and Biosimilar formulations.

LBC has been successful through 26 regulatory inspections conducted by both local and international regulatory agencies. US FDA has audited the site 9 times, while other regulatory agencies such as U.K. MHRA, EMA, ASNM(France), and WHO have had audited the site once each.

The Indian Regulator, Drug Controller General of India (DCGI) has periodically assessed six times, while the National Accreditation Board for Testing and Calibration Laboratories (NABL) has accredited the pathology lab seven times. On the regulatory front, the facility has consistently demonstrated outstanding performance.

In FY22, we conducted 67 in-vivo pivotal BE studies, 79 in-vivo pilot BE studies and six in-vitro BE studies and have cumulatively established over 344 validated analytical methods to date.

Inhalation Research Centre, Coral Springs

Lupin’s Inhalation Research Centre in Coral Springs, Florida, is a specialized facility focused on research and development of inhalation products for the treatment of asthma and chronic obstructive pulmonary diseases (COPD) as well as other respiratory conditions. The expertise of Coral Spring has enabled us to set our vision of becoming a market leader in the inhalation space.

Complex Injectables Platform, Nanomi

Nanomi is Lupin’s subsidiary in Netherlands, a leader in microsphere and nanoparticle Research and Development of long-acting injectables. Nanomi’s core expertise is its Microsieve technology. We have leveraged this expertise and achieved significant milestones in the last year with respect to clinical trials and scale up activities for our long-acting injectable portfolio.

Initiatives on Green Chemistry

Enzymatic technology for green chemistry are being pursued for select products, including Dalbavancin and Levetiracetam amongst others. We intend to pursue even more products through this platform to create efficient, sustainable processes.

Access to Medicines

Lupin provides high-quality APIs and Finished Product to underserved countries by:

  • Ensuring backward integration of its supply chain
  • Increasing manufacturing capacities to meet global demands
  • Obtaining prequalification from regulatory agencies like the World Health Organization (WHO) by manufacturing drugs in compliance with Good Manufacturing Practices
  • Focusing on a comprehensive portfolio in sync with treatment guidelines
  • Focusing on competitive pricing, quality that is consistent, in-house scalability, and manufacturing in accordance with compliance with regulations in multiple countries

Tuberculosis

Lupin’s Global Institutional Business (GIB) collaborates with global stakeholders in the fight against Tuberculosis (TB). We have been reliable supply partners for first-line agents for treatment of TB for several decades.

We have a strong backward integration to manufacture key first-line agents for treatment of TB consisting of Rifampicin, Ethambutol and Pyrazinamide. In addition to our active pharmaceutical ingredients (APIs), our finished dosage formulations are prequalified by the World Health Organization (WHO). They are supplied to emerging markets in order to ensure both affordability and accessibility.

HIV

We have recently forayed into Antiretroviral (ARV) therapy for providing high quality, affordable generics to emerging countries for the management of HIV infection. We are also working on a range of new generic products for the treatment of pediatric HIV.

Non-dystrophic myotonia (NDM)

NDM is a collection of rare conditions that affect the muscles. Around one in 100,000 people suffer from these conditions worldwide. Lupin is committed to improving the care of patients with non-dystrophic myotonia (NDM), whose lives are affected by symptoms of myotonia. These efforts extend beyond facilitating access to NaMuscla (the only licensed antimyotonic available in the EU and U.K.).

As with many of the other 7,000 rare diseases, it often takes more than 10 years for people with NDM to receive a correct diagnosis. Consequently, lack of awareness and delayed diagnosis often limit access to people with the disease. Lupin strives for the following:

  • Data generation to understand the impact of myotonia symptoms on affected people and their caregivers through Myopath Survey and IMPACT survey (understanding how a patient is affected due to a lack of access to licensed myotonia treatment) and Orphan maintenance assessment report for NaMuscla (mexiletine hydrochloride)4 to understand the journey of pediatric patients with myotonic disorders from the first symptom(s) to diagnosis, treatment and management.
  • Developing print/electronic resources for healthcare professionals (HCPs) to support their patient engagement. This helps improve care once diagnosed through patient information booklets (explaining NDM and myotonia symptoms), HCPpatient discussion guide (supporting HCPs in explaining treatment being prescribed to improve patient compliance and adherence), Phenotype booklet (explaining the different types of NDMs in terms of phenotypes, symptoms, etc.), and Impact Differential Diagnosis (assisting HCPs in understanding the differential diagnosis of the different NDM’s to shorten time to diagnosis).

Managing Intellectual
Property

We are committed to enhancing our product portfolio by securing intellectual property rights on our innovations. The value of our patent portfolio is testament to this commitment. Lupin settled 15 patent litigations in the United States in FY22. In the European Patent Office, Lupin’s Lacosamide patent was found valid in a postgrant opposition proceeding.

1008 Active
Patents

API, Formulation, NDDD, Biosimilar, Brand (~14% increase from previous FY)

61 Patents

secured in FY22 (~69% increase from FY21)

3,950 Trade
Marks

registered (until March 2022)

19 ANDA
filings

during the FY22, including 7 FTFs (3 exclusive FTFs)

Filed 185 patent
applications

including 58 formulation, 20 API, 10 biotech, and 97 NDDD patent applications

Product Recalls and Quality Monitoring

Lupin’s Quality SOPs elaborate the procedures for monitoring product quality and initiating recalls, where warranted. These are regularly updated as per the latest FDA guidelines. (https://www.fda.gov/ safety/recalls-market-withdrawals-safety-alerts/ industry-guidance-recalls). These FDA guidelines describe the reasons which can trigger a recall and the timelines that need to be followed. Lupin takes actions proactively, often in an abundance of caution, to ensure that patient safety is not compromised. The status of recalled batches is updated and monitored on a weekly basis, and the progress is reported to the regulatory coordinators, as required.

Novel Drug Discovery & Development

Lupin’s Novel Drug Discovery and Development efforts continue to yield new and highly differentiated therapeutics in the areas of oncology, immunology, and metabolic diseases, with two promising agents currently undergoing human clinical trials.

Our oncology research focuses on approaches to treat patients based on specific gene mutations or alterations, regardless of cancer type. Lupin Oncology Inc. was incorporated to strengthen our commitment to successfully translate our drug discovery efforts into clinical trials and bring novel oncology products to market. Our strong oncology pipeline includes frontier approaches of exploiting immunology,

synthetic lethality, epigenetic changes, and cancer metabolism. We are committed to successfully translating these R&D efforts from bench to bedside. This approach is tumor agnostic and aims to treat patients based on specific gene mutations/alterations regardless of cancer type.

Our partnerships with AbbVie and Boehringer Ingelheim are testament to the quality of our innovation. As part of our partnership with Boehringer Ingelheim, we are developing a clinical stage MEK inhibitor which is a RAS targeted therapy. According to the terms of our agreement, we have received USD 50 Mn by hitting key development milestones.

Biosimilar Research

Biosimilars are niche products that require substantial capital and revenue investment over an extended period of time before they can be brought to market.

Lupin’s key markets for biosimilars include the United States, Europe and Japan, along with India and other emerging markets. We are one of the few Indian companies engaged in development of biosimilars, compliant to the most stringent quality standards, that would withstand regulatory scrutiny in developed as well as emerging markets.

We currently have nine molecules in various stages of development and commercialization.

Despite the technical complexity and regulatory/ IP challenges, we have achieved notable milestones and made significant progress towards the global development of biosimilars. We received market authorization and successfully commercialized biosimilar Etanercept (Nepexto®) in key EU markets with our marketing partner, Viatris. Etanercept is a complex fusion protein and Lupin is the only Indian company which has successfully made this product in-house. It is manufactured at our biotech site in Pune, which was inspected and approved by the European and Japanese authorities over the last few years. Lupin’s Etanercept has also been commercialized in India, following prior approval from DCGI.

We continuously enhance our biosimilars portfolio by identifying and developing new products as well as leveraging our partnerships across the value chain.

Our pipeline includes:

  • Pegfilgrastim (Peg GCSF): We have reached a significant milestone with this product after submitting our BLA (Biological License Application) to the US FDA at the end of FY21. We now await US FDA approval for Peg GCSF. We also have a follow-on Peg GCSF On Body- Injector in advanced stages of development.
  • In the ophthalmic products category, the Ranibizumab Phase III clinical study in India was successfully completed and therapeutic equivalence to the reference product was proven, in terms of primary and secondary endpoints. The product launch in India is targeted in FY23. In parallel, a global Phase III study is being conducted with sites in India, EU and the U.S.. Lupin’s in-house clinical development team has the capability to manage such global trials with diverse ethnic groups.
  • Aflibercept, another ophthalmic drug and complex fusion protein is under development and expected to cater to unmet medical needs in age-related macular degeneration. The Phase III clinical trial is expected to be initiated in FY23. Lupin is a strong proponent of government-industry partnerships and has received a prestigious grant from National Biopharma Mission (BIRAC) for development of this product.
  • Lupin has a basket of next generation mAbs, such as Denosumab, Pertuzumab, and Certolizumab under development that are expected to be in clinic soon.

Biosimilar Aflibercept: Poised to Enhance Patients’ Access and Affordability

With the demand for treating age-related macular degeneration growing exponentially, Alfibercept is a promising biologic to be considered for biosimilar development. This addition will strengthen our biosimilar portfolio and complement the Ranibizumab Biosimilar that we intend to launch earlier.

This drug has proven to benefit patients with AMD and DME, however, the current cost of therapy is very high and unaffordable to the larger population of India. Through our development, we are poised to deliver a cost-effective biosimilar version, thereby enhancing patient access to the medicine and improving their quality of life. This biosimilar is expected to cost the patients more than 40% lesser compared with the current innovator price.

With the support and funding from BIRAC, we have fast-tracked this project and also receive timely guidance on the overall development. Through this project, we are well on the path to delivering a world-class Biosimilar to Indian patients at an affordable price.

Technology

We are driving digital transformation across our organization and integrating new technologies to protect our intellectual capital The advent of new-age technologies has simplified the research process; however, they have also introduced newer ways in which information can be compromised and intellectual property thefts. To combat product piracy and counterfeiting, we design and implement effective IP strategies.

Information Security Management System

The Information Security Management System (ISMS), KAVACH, ensures effective security controls and safeguards, and promotes awareness regarding data security. KAVACH protects our information through a framework of policies, procedures, and guidelines. The Information Security Management Systems at our Head Office, Pune Research Park, manufacturing facilities at Biotech, Mandideep and Pithampur have been accredited with ISO/IEC 27001:2013 for Information Security. This certification list will be expanded to include our Ankleshwar and Vizag sites.

The ISO 27001:2013 standards specifies that IT systems undergo periodic security assessments at least once a year or on need basis to ensure that known vulnerabilities are not exploited by threats.

An annual ISO 27001:2013 internal and external audit is conducted and the results are shared with the Steering Committee.

We regularly create, update, and review relevant security policies and procedures as part of ISMS implementation. These policies and procedures are also periodically audited internally and externally. As part of our commitment to information security, we have implemented project “SHIELD” across all our global sites to provide information security assurance.

Security incidents can be reported to kavach@lupin.com and shield@lupin.com

ZERO consumer complaints have been received regarding data privacy and cybersecurity aspects in FY22

Information Security (IS) Incident Management Procedure

Policies

Lupin has established a policy that categorizes data as Confidential, Internal and Public.

We have implemented Privileged Identity Management (PIM), Active Directory (AD) with conditional access, Zero Trust policy for remote access, Mobile Device Management, and more. A comprehensive perimeter architecture is implemented, including Next Generation Firewall (NGFW), Domain Name System (DNS) Security, Web Application Firewall (WAF), Advanced Threat Protection, and Secure Internet and Email Gateway.

Along with our threat intelligence team, we have a Security Incident Event Management (SIEM) and Security Operations Center (SOC) platform for monitoring cybersecurity threats.

Training

The ISMS policies have been published on Lupin’s intranet, and we share the guidelines via multiple security sessions and emails. We also conduct regular trainings throughout the year in the following ways:

Governance

Lupin has defined a Security Organization Structure led by the Steering Committee. The Committee is headed by a Certified Information Security Manager (CISM) and consists of the CIO, CISO, CSO and a representative from HR.

Together with the CIO, the CISO apprises senior management on the security position of Lupin periodically through various forums, such as the Steering Committee, the Risk Committee, and the Audit Committee.

Others

Cybersecurity incidents and breaches of information technology security are covered by our insurance policy. This may include fraudulent acts by employees, cyber extortion costs, business interruption losses, civil fines and penalties, privacy notification and forensic investigation costs, crisis management costs, disclosure liability/media liability, network disruption caused by computer attacks, and data loss liability.

Digital innovation

Lupin uses Information Technology to improve its performance across internal functions, as follows:

Finance Synergies:

  • Integrating systems such as Open Text solution enables multiple departments to centrally manage an invoice’s life cycle. With this, users can approve, check the status, and clarify any issues relating to invoices and payments
  • Concur tool for employee travel, stay and reimbursements has been implemented with direct posting to SAP
  • Migration to SAP S4HANA simplifies the financial transaction process and enhances the performance of the system

Procurement Synergies:

The new Blockchain application "Schrocken" enables multiple Lupin internal and external vendor teams to transact in one platform for CMO operations. As a result, this platform connects directly to their respective ERP systems and updates them, reducing the need to re-enter the transactions in the respective ERP systems.

Learning and Development Initiatives for R&D Personnel

At Lupin, we believe in investing in our employees’ growth and development. We are implementing several learning and development initiatives across our R&D centers, which are outlined below:

INFLUENCE

Lupin Leadership Competencies with the Lupin Values at their core are the foundation of all that we do at Lupin. The Influence Program is a competency-based immersion program designed to build the behavioral competencies required to perform optimally. Each of the byte sized modules corresponds to a competency or a set of competencies that are critical to the success of a role (e.g., Individual Contributor or People Manager).

Gurukul

With Gurukul, R&D professionals are able to stay up to date on the latest scientific developments. In this program, an individual is nominated every fortnight to present on a topic relevant to the functional or futuristic competency needs of the department. As a result, every employee, regardless of grade or experience, has the opportunity to present to the entire team, thus developing both public speaking skills and competencies that are essential for a futureready organization. In FY22, a total of 162 knowledge sharing sessions were conducted.

IGNITE

IGNITE is a Management Development program. Lupin’s IGNITERs are critical to the growth engine of the company - its people, processes, and business. In the IGNITE program, senior managers are trained in essential skills to help them engage in meaningful pursuits with their teams in order to accelerate professional and personal success.

IDP | Individual Development Plan

IDP focuses on the individual development of employees. IDP is the result of a collaborative discussion between the employee and the reporting manager. This program focuses on the development of skills and competencies that our employees should enhance in order to be able to perform optimally and to achieve overall professional development.

iMpact

The iMpact program is a mentoring program, specially designed for women employees at Lupin. As a twopronged initiative, iMpact focuses on developing the leadership skills of senior leaders who will mentor their peers, as well as providing a platform for female mentees to participate in development conversations and seek support and guidance.

Academic and Research Partnership — ASCENT

Lupin is a knowledge and science driven company, so obtaining a PhD (doctoral degree) is one of the highest qualifications which our employees aspire to. As part of the ASCENT program, we aim to enable and support this aspiration for our scientists in R&D. ASCENT is facilitated in partnership with the Manipal Academy of Higher Education and Symbiosis – both of which are premier universities in the fields of Scientific and Management studies. During the PhD program, Lupin provides complete monetary and professional support to selected personnel. The company facilitates timely coordination and review with appropriate guides (internal and external), submission of the thesis, and offers guidance from experts throughout the duration of the PhD. The minimum program duration is four years.