India's Glenmark pioneering through prioritising preclinical

Glenmark is one of a handful of pharma firms in India pushing forward a preclinical programme as a priority. took a tour of one of its facilities on a recent trip to India and was told that: "Glenmark thinks differently to other Indian pharmaceutical companies."Since its inception the company's core goal has been to produce new chemical entities (NCEs) and partner these out. Research and Development (R&D) was the first function at its Navi Mumbai site when it opened in 1999.

"This activity is used to fund the other parts of the business, not the other way around as is the 'norm' with most other Indian pharmaceutical companies," said company CEO Glen Sablahna. The other main areas of its global business include active pharmaceutical ingredient (API) manufacturing and formulation and process development for generic drugs. Within three years of starting its R&D work Glenmark licensed out its first compound for $25m (€17m), which was in Phase I at the time, and has since licensed another.

"Once we discover a new compound, we aim to have it in the clinical within ten years," Laxmikant Gharat, general manager of Chemical Research, told Today, the company has a pipeline of 11 molecules; three of which are in clinical development and the other eight are at various stages of preclinical development and discovery.At its R&D facility the firm has six discovery chemistry laboratories; pharmacokinetics, pharmacology, toxicology, analytical chemistry labs; as well as an animal house with rodents. The three broad areas of therapeutic focus are diabetes, pain and inflammatory diseases such as asthma. The site also has full cell culture capabilities for the in vitro testing of its NCEs, although all of its Phase I studies are carried out by contract research organisations (CROs) in the regulated markets of US and Europe because these are the company's target markets and so "it is better," said Gharat.

Although its R&D facility is the smallest of its kind in the country, with only 120 staff, Glenmark has big plans for the future. Its strategy is to keep bringing NCEs through its pipeline and partner them out, but eventually also be in the position to keep certain molecules in order to develop them in-house and bring them to commercialisation. This approach is fairly unique for an Indian pharma services firm. India currently dominates the world's active pharmaceutical ingredient (API) manufacturing arena although it is presently severely deficient in innovation. So far, the country has only managed to attract $360m in drug discovery investment by foreign multinationals - a pitiful sum compared to the billions of dollars it attracts in manufacturing revenue.

Despite this, Indian firms have been slowly moving up the learning curve through their dealings with multinational companies - by entering partnership and co-development arrangements and collaborative discovery deals, as well as providing some services in this field, and this has put them in a position to begin to dabble more and more in this new business area.Delegates at this year's CPhI trade show in Mumbai heard that in order to really succeed in this space manufacturers need to rid themselves of their generic mindset."For example, currently, a generics firm that is doing well will allocate some money to R&D, but when times get tough, innovative research is the first thing to get cut," said Sanjiv Kaul, managing director of outsourcing-focused private equity firm Chrys Capital.

"The current short-to medium-term view held by most firms needs to be changed to transcend to a medium-to long-term view."Satish Reddy, managing director and chief operating officer of Dr Reddy's Laboratories echoed this sentiment: "Firms need to start now in finding a way to strike a balance between making high investments in innovation to help drive future growth, while still generating short term revenue growths, in order to partake the high risk drug development market," he said.With these words in mind, Glenmark will be an interesting company to watch.

By Kirsty Barnes

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