Glenmark
Glenmark
Glenmark
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• Focus on higher-growth therapeutic segments in the branded generics market. We intend to<br />
focus our branded generics strategy on markets we have identified as key, growth markets for our<br />
business, such as Brazil, Russia and CEE markets including Poland, Romania and the Czech<br />
Republic using a specialised approach. This will involve consolidating our position across<br />
existing territories and applying our existing business models across newer markets such as Egypt,<br />
Thailand, the UAE and Mexico. We intend to access these newer markets either by acquiring<br />
entities or products or by way of green-field entry by leveraging our branded generic model. We<br />
will look at launching our formulations in the relevant markets, supplemented by in-licenced<br />
products as are deemed necessary to strengthen the product suite. We have developed good<br />
relationships with medical professionals in India, and our established reputation with the<br />
specialists in particular segments offers opportunities to maintain our market position by building<br />
on our brand equity. We have replicated the same ‘branded generic’ model in the markets of the<br />
Asia Pacific, Africa/Middle East, Russia, the CIS, CEE and Latin America. We have over 800<br />
sales personnel in these markets promoting our brands to doctors. We will continue with our<br />
product registration program and seek additional approvals and launches.<br />
• Continue to invest in discovery research. The focus of our proprietary branded business is on the<br />
advancement of one of our NCEs Melogliptin, which is a type II diabetes compound into Phase III<br />
of clinical development. Oglemilast (GRC 3866) recently completed an unsuccessful Phase IIb<br />
study for the treatment of COPD though it continues to be the subject of Phase IIb asthma trials,<br />
which are nearing completion. Similarly we are aiming to progress two more of our NCEs,<br />
Revamilast, which is a rheumatoid arthritis/multiple sclerosis/inflammatory disorder compound,<br />
and GRC 10693, which is a neuropathic pain/osteoarthritis/inflammatory pain compound, to Phase<br />
IIb of clinical development. Both Revamilast and GRC 10693 have successfully completed Phase<br />
I clinical trials. We aim to progress GBR500, which is a multiple sclerosis/inflammatory disorder<br />
compound, GBR 600, which is an anti-platelet compound and GRC 15300, which is an<br />
osteoarthritic pain/neuropathic pain compound, to Phase I level of clinical development. We are<br />
also preparing regulatory submissions and launch preparations for the anti-diarrhoeal drug<br />
Crofelemer, in respect of which we have commercial rights in over 140 countries. We continue to<br />
focus on novel targets in the areas of metabolism, inflammation, pain and oncology.<br />
• Capitalise on partnering opportunities. We intend to continue our focus on the development of<br />
NCEs and NBEs with a view to out-licencing them as appropriate. To date, we have successfully<br />
out-licenced three molecules to four partners and have received a total of U.S.$117 million in upfront<br />
and milestone payments. Two of the four out-licencing agreements have now been<br />
terminated. We intend to focus our R&D efforts on research in specific therapeutic segments<br />
which we believe offer out-licencing potential, such as the metabolic diseases, pain and<br />
inflammation therapeutic areas. Our policy is to develop promising molecules up to the early<br />
clinical stage and then out-licence to international pharmaceutical companies. The molecules are<br />
out-licensed primarily for the North American, European and Japanese regions. If the molecule is<br />
successful and reaches the market, we will receive royalties from subsequent drug sales in these<br />
markets. The royalties are in addition to upfront and milestone payments we receive as the<br />
molecule progresses through various stages of clinical development. For the rest of the world, the<br />
rights remain with us and we can launch the product on its own in these markets (which include<br />
India).<br />
• Capitalise on the opportunities for generics in the regulated markets. We intend to continue to<br />
exploit our low-cost advantage and development capabilities in the implementation of our<br />
expansion plans to overseas regulated markets. In the United States and European generics<br />
markets, we intend to continue to sell specialty APIs to companies and develop long-term business<br />
opportunities. We continue to focus on the filing of ANDAs in the United States and on the filing<br />
of drug master files (“DMFs”) focused on differentiated and niche products. We have diversified<br />
into, and intend to seek Paragraph II, III and IV filings in niche areas such as dermatology,<br />
hormones, oncology, controlled substances and modified release medications. Paragraph II filings<br />
are filed post the expiry of the patent relating to the innovator brand, Paragraph III filings are filed<br />
prior to expiry of the patent relating to the innovator brand, but the product is launched post-expiry<br />
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