Laureate Pharma has entered into an agreement with Cytheris to manufacture its lead product candidate, Interleukin-7 (IL-7) for use in ongoing international clinical trials that are being conducted for the treatment of HIV, hepatitis C virus and cancer.

IL-7 is a fully glycosylated recombinant human protein and a critical growth factor for immune T-cell recovery. Studies thus far have suggested its potential to expand and protect CD4+ and CD8+ T-cells.

"As we move towards large scale production of our IL-7 biotherapeutic, we are pleased to continue our strong working relationship with Laureate Pharma," said Michel Morre, president and CEO of Cytheris.

"With Laureate's demonstrated skill in successful transfer of process technology, we look forward to continuing to work together in the process scale-up, engineering and clinical material production of IL-7 for our ongoing clinical trials investigating multiple indications."

No other terms of the arrangement between the two firms was revealed.

Recently, Australian firm Progen Pharmaceuticals has announced that it will outsource the commercial manufacture of its cancer drug PI-88 to an "established biopharmaceutical manufacturing facility that has a long-standing history of producing commercial biopharmaceuticals with US Food and Drug (FDA) approvals".

Progen said it expects the technology transfer of PI-88 to occur in the next 12 to 18 months.

After this time, the company will retain its current PI-88 manufacturing facility in Brisbane as part of a separate business providing process development services and the contract manufacture of drug development material.

The unit will run on existing contracts as a break even operation, and Progen indicated it would be assessing its options as to whether it will either increase facility profitability through additional manufacturing contracts and/or seek a commercial buyer.

"Our manufacturing division has been of great value and has served Progen very well in the past, having made all PI-88 to date, including the supply to be used in the Phase III PATHWAY trial as well as having played and continuing to play an important role in supplying contract manufacturing services globally," said Progen's CEO, Justus Homburg.

"However, as far as PI-88 is concerned, the facility was never designed for the manufacture of commercial quantities".

PI-88 is the most advanced compound within Progen's oncology pipeline and is one of a new class of multi-targeted cytostatic cancer therapeutics, with a first-in-class mechanism as a heparan sulfate mimetic.

A side-effect of the company´s outsourcing move is that it will eventually result in eight redundancies in the manufacturing division and four in the drug discovery unit.

Through this Progen said is aiming to "conserve current cash reserves for driving present and future lead compounds towards commercialisation".

The firm said it will be retaining key staff for the continuing development of Progen's discovery heparanase inhibitor programme; for biological assessment of the expanded Progen portfolio of preclinical compounds; and to manage the technology transfer and the submission of the chemistry, manufacturing and controls (CMC) parts of the new drug application (NDA).

Meanwhile, the company said that after several years of in-house drug development, it has now completed the chemistry on its newly identified lead compound PG545, which has been selected for investigational new drug (IND) enabling studies, which are also being outsourced.

In other contract manufacturing news, Indian pharma firm Alembic is reportedly finalising an agreement with an undisclosed international pharma company to make active pharmaceutical ingredients (API) for bulk drug applications.

The deal is said to be worth between $25m-$30m a year for Alembic, and will initially run for three years, although it could be extended to five. Alembic described it as one of the "largest drug outsourcing contracts in the country".

Over the next three years the firm indicated it is planning to focus on gaining new business in the lucrative western markets of Europe and North America, as well as the API manufacturing hotspot of South America.

"It's our strategy to become part of the backend supply chain of large companies", said Alembic chairman and managing director Chirayu Amin.