Alchemy For Growth - Research & Development

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Alchemy For Growth

Research & Development

Research and development by numbers Lupin

Lupinytt at work at our Indore facility, India


The world of life sciences is converging like never before and the convergence of pharmaceutical, biotechnology and medical technology would improve outcomes that could dramatically alter drug development and delivery.

Today, over 1700 Lupin scientists spread across research hubs in India, US, Japan and Europe are working to make Lupin a key part of this evolving journey of Innovation. We are excited about the possibilities of what can be; pushing boundaries to broaden our understanding to create quality products that improve and simplify delivery and access. That is why Lupin is stepping on the gas and investing ahead of the curve. FY 2016 was a remarkable transformational year for our Research and Development, where the Company upped the ante by investing 17,318 million in Research & Development (R&D) programs.

We have had 10 years of sustained growth built on our investments in research. We have mined our experiences, learning from our failures as much as from our successes in our quest to bring relevant products and technologies to our markets globally. That is Lupin’s Alchemy for Growth.

Novel Drug Discovery & Development (NDDD)

Lupin’s strong NDDD team has built a pipeline of over 10 highly differentiated and innovative new chemical entities in therapies such as CNS disorders, Oncology, Immunology, Pain & Inflammation and Metabolic disorders.

Key Targets & Status

CNS: Clinical Phase-II efficacy study in Alzheimer’s disease patients is progressing well in Europe; study to be completed this year.

Cancer: Clinical Phase-I study successfully completed in Europe in terminally-ill patients (Lung Cancer, Melanoma & Colon Cancer).

Endocrine: Clinical Phase-I study successfully completed in Europe meeting approvable primary end-point.

R & D Investments (RS. million)

Immunology: Clinical Phase-I study successfully completed in Europe. Two proofs of concept Phase-II studies in Europe (Rheumatoid Arthritis and Psoriasis) have been initiated. We have the potential to be the first-in-class in this area.

Biotechnology Development Program

Lupin’s 200+ strong Biotechnology Group has developed a robust pipeline of biosimilars addressing therapies like Oncology, Anti-Inflammatory, Anti-Virals, Rheumatoid Arthritis, Endocrinology, Diabetes, Ophthalmology and Women’s Health.

Over the last 8 years, the Company has gained deep insight in terms of product development, market intelligence regulatory and Intellectual Property.

Highlights - FY 2016

  • Successful commercialization of its first two Oncology biosimilars in India - Lupifil® (Filgrastim) and Lupifil-P® (Peg-Filgrastim) in India
  • Global Phase III comparative clinical trial for Etanercept on track across geographies such as Japan and multiple countries within the European Union
  • Completed Phase-I PK/PD trial for 2 products and pre-clinical studies for 2 products in India
  • Scale-up and technology transfer for 5 products successfully mediated from research to commercial

The Company is also making significant investments to augment its Biotech Manufacturing and R&D infrastructure. Lupin’s own fill finish facility is expected to be operational in FY 2017.

Generic Pharmaceutical and API Research

Lupin’s Generic Pharmaceutical and API Research programs have been the foundation of our growth and evolution as a Global Generic Pharmaceutical powerhouse. FY 2016 was a great year with industry-leading performance in terms of number of filings. The Company continued to make strategic investments for the future having fully operationalized a new Injectable product development laboratory at its global R&D hub in Pune, India. Lupin’s state-of-the-art R&D facility in Coral Springs, Florida was inaugurated in August, 2015. Lupin is now amongst the few pharmaceutical majors with the capability to develop world-class inhalation products.

The Company’s generic pipeline focus is to develop relevant products for advanced markets, specifically the complex ones losing patent protection. A majority of our pipeline is made up of products with high barriers to entry like complexities associated with developing complex formulations, device combinations and clinical trials. Development timelines are often longer and costs are typically much higher than those for other generic drug development programs. These factors help limit the number of companies capable of pursuing such generic products and considerably increase the commercial potential of these products. This is complemented by a comprehensive pipeline of oral solids. Lupin has a balanced pipeline of products which will help Lupin establish even higher levels of leadership as a generics player and will play an important role in building Lupin’s specialty pharmaceutical portfolio in the near future.

Scientists at Lupins Biotech facility in Pune, India

Cumulative DMF Filings

Highlights - FY 2016

Filed 36 ANDAs (20 oral, 10 dermatology, 2 ophthalmic, 1 inhalation and 3 other products), including 2 First-to-File (FTF) products with the US FDA. The Company received 39 approvals in FY 2016. Cumulative ANDA filings with the US FDA now stand at 343 with 180 approvals received to date. Lupin now has a total of 45 FTF ANDAs, which include 25 exclusive FTF opportunities

8 MAAs were filed with European regulatory authorities and 3 approvals were received. Cumulative filings with European authorities now stand at 67 with the Company having received 52 approvals to date.

Filed 16 US DMFs, taking the cumulative total to 172 DMF filings. Additionally filed 3 EDMF, 2 CEP and 2 Japan DMFs.

The team received further milestone payments of USD 3 million for 2 of its products that are being jointly developed with Medicis Pharmaceuticals Corporation, now Valeant

Intellectual Property Management Group (IPMG)

Lupin’s Intellectual Property Management Group (IPMG) is responsible for building Lupin’s global generic product pipeline as well as creating, managing and protecting its high-value patent estate. The Company’s IPMG has become a benchmark in the industry for its litigation track record and carrying out patent challenges successfully.

In FY 2016, Lupin successfully launched the generic versions of Glumetza®, Intermezzo®, Loestrin® 24 Fe, Phoslo Gelcaps®, Generess®, Mircette®, Lofibra®, Ortho Tri-Cyclen Lo® to name a few.

During the year, the Company also settled 5 pending litigations as well as got favorable decisions or oppositions on Celebrex®, Intermezzo® and Teneligliptin.

Cumulative DMF Filings

In FY 2016, the Company filed 325 patent applications including 136 new inventions taking the cumulative total to 2,525 patents filed till date in India and other countries. This included 57 Formulation patents, 75 API/Process patents, 33 Biotech and 160 NDDD patents. Lupin received approvals for 22 Formulation patents, 11 API patents and more importantly 41 NCE patents in the year.

Cumulative DMF Filings

Lupin Bioresearch Center

The Lupin Bioresearch Center (LBC) located in Pune, India is responsible for conducting bioequivalence studies for Lupin’s generic products and branded formulations. LBC also manages Lupin’s outsourced bioequivalence studies, clinical end-point studies as well as studies for the Company’s drug delivery program. LBC has both clinical and bioanalytical capabilities and houses 2 clinics, a bioanalytical lab with 12 state-of-the-art LC-MS/MS systems, 2 Ion Chromatography (IC) systems and a clinical chemistry lab that has been accredited by National Accreditation Board of Laboratories (NABL). FY 2016 saw LBC establish the in-vitro BE laboratory to meet regulatory requirements of respiratory product development program. LBC completed 36 full studies during FY 2016, taking the cumulative tally to 225 studies till date. LBC has had a stellar compliance record and successfully underwent US FDA, DCGI and French regulatory (ANSM) inspections during FY 2016.

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