Encorium, Amarex, Paragon Biomedical, Pacific Biometrics and Parexel – Clinical contract news

Encorium Group​ has bagged two deals of late, one being a $3.8m (€2.8m) contract for a Phase IIb clinical trial for a herpes zoster (shingles) antiviral treatment, with a new, undisclosed client. Encorium will provide multiple services including program consulting, project management, site management and monitoring, data management, biostatistical support, and medical writing. Revenue recognition will begin during the current second quarter and continue on a proportional performance basis over the life of the contract as services are performed, said the firm. Meanwhile, Oramed Pharmaceuticals has also hired the contract research organisation (CRO) to initiate an investigational new drug (IND) application in the US on its behalf. The Israeli pharma firm hopes to use Encorium to expedite the development of its lead product, an oral insulin drug. Encorium will assist in the design, implementation, advancement and oversight of a sound scientific and regulatory strategic plan for the filing and ultimate approval of the drug on a worldwide basis, said Oramed, with the initial focus being channelled towards the US Food and Drug Administration (FDA). The firm then plans to evaluate the oral bioavailability of the insulin product from the gastrointestinal tract in humans as well as the impact of the oral formulation on blood glucose levels. Commenting on the deals, Kenneth Borow, Encorium's president and CEO said: "We are now beginning to see the benefits of our expanded global business development efforts. We anticipate announcing additional signed contracts over the next several months as well as further elaborating on other initiatives that we are pursuing." ​ In other deals, Vedic Lifesciences has signed a deal with Amarex​, a US-based CRO, to provide combined services for botanical drugs development in the US and in India. The two companies believe their respective expertise complement each other - Amarex focuses on Phase I to IV clinical development while Vedic specialises in pre-clinical development services. "Amarex's growing involvement with botanical drug development is a good fit with Vedic's special expertise with such compounds. It is clear that having an Asian partner will provide certain advantages to our clients' drug development needs,"​ said Kazem Kazempour, President and CEO, Amarex. Vedic expects this deal to give the company the opportunity to reach the US market where the market for botanical drugs has been growing in the past few years, especially since the US Food and Drug Administration (FDA). Vedic Lifesciences partners with US based CRO came up with new regulations on this type of drugs in 2003. Another Indian-focused alliance was also recently formed, when Texas-based HemoBioTech announced it has engaged fellow US firm Paragon Biomedical​ to provide regulatory and clinical services in India related to the company's human blood substitute, Hemo Tech - a potential world first. Under the terms of the agreement, Paragon will submit preclinical data regarding a Hemo Tech study that was run in Zaire in 1991, with the aim of receiving permission to commence clinical studies of the experimental blood substitute in India. "HemoBioTech considers India a key component of our global strategy to commercialise HemoTech,"​ said Arthur Bollon, chairman and CEO of HemoBioTech. "With a population of 1.1 billion people, a significant middle class, and a good infrastructure for clinical studies, HemoBioTech considers India as a potential standalone market for HemoTech." ​ In addition, Pacific Biometrics​ has been handed a research contract to provide supporting laboratory data for the clinical development of an osteoporosis drug. The contract was received by a global central laboratory, who is in turn working for the pharma firm who is developing the drug. Work has already begun (in May) and the company said it expects it to continue until the end of 2008, bringing in around $500,000 in revenue, an amount that it described as 'meaningful'. Finally, Valeant Pharmaceuticals International has enlisted Parexel​ to develop, coordinate and prepare the NDA and the European Marketing Authorization Application (MAA) for its investigational anti-epileptic compound, retigabine. The drug is currently in Phase IIII trials and Valeant said it hopes the NDA and MAA applications will be ready to file in mid-2008.