Glenmark
Glenmark
Glenmark
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approval for the manufacture of ointments and creams.<br />
2007 We entered the Czech Republic and Slovakia markets through our acquisition of<br />
Medicamenta a.s. (“Medicamenta”).<br />
2008 We reorganised our business structure into two separate strategic business units.<br />
Competitive strengths<br />
The following are our key strengths which we believe enable us to compete in our principal markets:<br />
• Strong NCE and NBE R&D capabilities. We have demonstrated our discovery research strength<br />
in the past by out-licencing three of our molecules for a cumulative payment (upfront and<br />
milestone) of U.S.$117 million. We completed out-licencing deals with Forest Laboratories, Inc.<br />
in 2004, with Teijin Pharma in 2005, with Merck KGaA in 2006 and with Eli Lilly & Co. in 2007.<br />
The out-licencing deals with Merck KgaA and Eli Lilly & Co. have since terminated.<br />
Currently, we have seven NCEs in clinical development and two NBEs in various stages of<br />
development. One of the NCEs, Crofelemer, is in-licenced. We are constantly looking for<br />
opportunities for partnering for the development of these pipeline molecules.<br />
We are committed to our discovery research efforts and have invested extensively in setting up a<br />
R&D centre for NCEs at Mahape, Navi Mumbai in India, a R&D centre for NBEs at Canton of<br />
Neuchatel in Switzerland and a clinical R&D centre at Oxford in the United Kingdom. We have<br />
research centres in India, where we undertake small molecule research, Switzerland, where we<br />
undertake biologics research, Oxford, where we undertake clinical research and the United States,<br />
where we carry out IP management, regulatory and global business development. Our R&D<br />
efforts are concentrated on analogue research in specific therapeutic segments which we believe<br />
offer out-licencing potential, such as the asthma, diabetes, osteoarthritic, multiple sclerosis and<br />
obesity segments.<br />
We are focused on attracting and retaining a dedicated and experienced R&D team. As of March<br />
31, 2009, we had approximately 700 employees employed in R&D, including 600 scientists.<br />
• Generics Business - Focus on niche segments. We believe that we have several advantages in the<br />
generic formulations business based on high-technology formulations development and<br />
manufacture which is not easy to replicate. In particular, we are diversified into niche areas such<br />
as dermatology, hormones, oncology, modified release and controlled substances. Products within<br />
those areas can be difficult to manufacture, which can result in less competition and higher<br />
margins. We have formulations manufacturing facilities in Goa, India and have over 45 products<br />
in the United States market.<br />
We currently have over 45 USFDA ANDAs in the pipeline, of which 4 are intended to be sole<br />
first-to-file Paragraph IV filings. For example, we filed an abbreviated new drug application<br />
(“ANDA”) with a Paragraph IV certification against the generic version of Schering Plough &<br />
Merck Shering Plough company LLC's hypercholesterolemia treatment Zetia (Ezetimibe) seeking<br />
regulatory approval to market a generic version of Ezetimibe (Zetia). In the event that we<br />
successfully challenge Schering's patents, we will be entitled to a 180 day exclusivity period. We<br />
received 180 day exclusivity for our Oxcarbazepine product in the North American market and we<br />
have filed first-to-file applications in respect of Tarka (a Trandolapril and Verapamil product),<br />
Malarone (a tablet-form Atovaquone and Proguanil Hydrochloride product) and Cutivate (a<br />
Fluticasone lotion) where we were sole first-to-file applicant. We also have another first-to-file<br />
opportunity in respect of Eszopiclone tablets. On March 20, 2009, Sepracor Inc. filed suit in the<br />
United States District Court seeking to prevent us (and nine other companies) from proceeding<br />
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