India's peptide drug major, Jupiter Bioscience Limited is gearing up to implement a Peptide API (active pharma ingredient) manufacturing unit at Maryland in the USA to cater to the regulated markets at an initial investment of $ 4 million. The facility is being hired for rent and the company is making efforts to move in its own equipment and commission operations in June 2007.

For its move to US, Jupiter is currently raising funds through Qualified Institutional Buyers (QIB) placements in India, Financial Institutional Investors and Mutual Funds.

The production plant in the US comes in as a part of its forward integration strategy to consolidate our presence in the global markets where we export a range of peptide API raw materials to the USA, Europe and Japan, Venkat R Kalavakolanu, chairman and managing director told Pharmabiz in a telephonic interview. It recently bagged an order from Swiss Bachem AG a global leader in pesticides. Jupiter's niche expertise has allowed it to take on contract research projects.
The company has collaborated with the Switzerland-based Clariant, which markets the peptide capabilities of Jupiter to their preferred customers mainly multinational companies.

While the company specializes in the area of peptide raw materials, and specialty chemicals in the area of peptides, it will commence production of APIs in the next five months and also produce formulations by the year-end, stated the Jupiter Bioscience chief.

The Hyderabad-based ISO 9001:2000 Certified company commenced the peptide research in 1995 under by its founder late KS Sarma. In 1998, it commercialised peptide raw material. It is a recognized integrated peptide pharmaceutical enterprise with capabilities spanning manufacture, marketing, research and process Development Programme. The main focus to introduce peptide chemistry products via process innovation which helped the company save Rs 75 crore in 1997 to launch the first peptide raw material.

In the last 11 years, the company invested around Rs 30 crore for research, process development and scale up, stated Kalavakolanu.
The Rs 80 crore Jupiter Bioscience has 45 per cent of its business generated from the peptide programme alone. It holds a monopoly status in peptides research and manufacture in the country.

According to Kalavakolanu, there is a shortfall of skilled and highly educated manpower in all the sectors of the pharmaceutical and biotech. "Jupiter is encouraging reverse brain drain of researchers and post-doctoral researchers. It also people from the pharma industry to fulfil the requirements of the company, he added.

The applications of the Peptide Reagents and derivatives are for Peptide Diagnostics, Peptide Therapeutics and Peptide Vaccines. Current therapeutic areas covered by peptides are cardio vascular diseases, immunology, Oncology, AIDS and growth hormones. All these will be included in Jupiter's production schedule, informed Kalavakolanu.

Worldwide, there are around five bulk peptide manufacturers: Mallinckrodt, Akzo Nobel's Diosynth, UCB, Bachem, PolyPeptide Laboratories, Peninsula and an emerging player: SNPE Neosystems.

The major peptide based drugs are Somatostatin with sales in US$ 70 million, Desmopressin ($117 million) Leuprolide ($ 1008 million) and Calcitonin ($ 784 million). Globally, the manufacturers are segregated as component, custom, catalog peptides and bulk peptides. There are 270 Peptides in the clinical phase, 400 peptides in the Pre-Clinical phase and there is a definitely growth potential in the future years to come especially, in the areas of Peptide Antibiotics, peptide Vaccines, Peptide Diagnostics and peptide Nutraceuticals, informed Kalavakolanu.