Contract manufacturing news in brief

Granules India is to receive a $15m (€11m) investment from International Finance Corp (IFC), the World Bank's private sector arm.

The Indian contract manufacturer said it will use the money - which comprises $9m in long-term loan and $6m in equity - to expand its active pharmaceutical ingredient (API) and granulation capacities.

When the financing is completed, Granules will have added significant scale capacities for its target customers, which will enhance its competitiveness, the company said.

"We feel that this relationship gives us a wider horizon to explore possibilities for innovative financing," said Krishna Prasad, managing director of Granules.

The deal will give around 2.2m shares to IFC which represents an 11 per cent stake in the post-issue capital of Granules.

This is the latest of a succession of equity placements through which the Indian company has been raising funds in order to support its vertical integration strategy.

IFC will join US firms Ridgeback Capital Investments and ISP Investco that have recently agreed to inject $5m each through equity investment in the Indian CMO.

Meanwhile, Canadian contract manufacturer Dalton Pharma Services said it has inked a long-term deal with X-Gen Pharmaceuticals, a New York-based pharma company.

Under the terms of the deal, Dalton will fill/finish sterile commercial products for X-Gen under current good manufacturing practice (cGMP) standards.

"Our Establishment License from [Canadian regulator] Health Canada, combined with our expert capabilities in analytical services and sterile manufacturing capacity, solidified the manufacturing agreement," said Peter Pekos, Dalton's CEO.

Dalton supplies chemistry and analytical services to its pharma clients in the areas of medicinal chemistry, fine chemical manufacture, custom peptides and antisense oligo production.

The CMO provides cGMP manufacturing and sterile filling services at any stage of the regulatory process from Phase I to commercial.

X-Gen is a generic drug company specialising in the manufacturing and distribution of mature anti-infective pharmaceutical products.

In other news, Austrian contract biopharmaceutical company Polymun has signed a supply deal with US biotech firm ProNAi Therapeutics to produce the company's DNA interference (DNAi)-based cancer drug.

Under the terms of the contract, Polymun will use its proprietary cross-flow injector technology to manufacture ProNAi's liposome-formulated lead drug candidate - PNT2258 - currently in final stage of preclinical toxicology testing.

The Michigan-based company said it expects to bring the product to investigational new drug (IND) submission later this year.

"ProNAi is confident that Polymun's manufacturing processes and technology are up to the task of formulating our oncology drug candidate, which features our novel oligo delivery method for the safe and effective administration of nucleic acid-based therapies," Dr Richard Gill, CEO of ProNAi.

Finally, Danish firm CMC Biopharmaceuticals has signed a manufacturing contract with Morphotek for the clinical supply of the US company's anti-cancer therapeutic antibody.

CMC will provide Morphotek - a subsidiary of Eisai - with development, GMP manufacturing and regulatory documentation support of MORAb-028, a human IgM monoclonal antibody targeting for advanced melanoma, brain cancers and non-small cell lung carcinoma.

MORAb-028 is being prepared to enter clinical trials in 2008 and represents a growing list of therapeutic monoclonal antibodies being developed by Morphotek for the treatment of cancer.