Pharmaceutical manufacturing: news in brief

Drug delivery specialist Nastech has been forced to initiate restructuring measures, cutting jobs and hiving off its subsidiary MDRNA as an independent company.

The company recently lost development partner Procter and Gamble (P&G) , leaving them to work on an osteoporosis nasal spray product alone.

The restructuring announced this week aims to enable Nastech to become more cost efficient and focus on its Phase II clinical programmes.

Initial targets for Nastech's resources include the osteoporosis product shunned by P&G, PTH1-34, and additional nasal spray products for diabetes and obesity.

Establishing MDRNA as an independent company is hoped to allow Nastech the freedom to focus on the development of peptide and protein drug delivery techniques, whilst pursuing independent investment to fund MDRNA's activities.

GPC Biotech has also been forced to announce job cuts for the second time in a matter of months, following a series of blows for its oral cancer drug, satraplatin.

While retaining its key personnel, the firm is now reducing its workforce by 44 per cent, taking it down to a core team of 114 in its Munich and US offices.

A facility in Massachusetts is also due to shut down in the next few weeks.

It's been a tough year for the company, with an FDA advisory committee in July recommending that approval of the company's drug not be granted until additional survival rate data came in.

A week later the company had withdrawn the satraplatin new drug application , and a few weeks after that was hit with a class action lawsuit - all of which prompted a 15 per cent cut in headcount at the firm.

Two weeks ago saw yet another blow for the company, as final statistics for the Phase III satraplatin trial showed no difference between the satraplatin treatment and the control arm.

The restructuring announced this week is intended to allow the GPC to focus on a limited number of development stage oncology projects, whilst increasing licensing efforts and actively pursuing merger and acquisition opportunities.

Abbott has received US Food and Drug Administration (FDA) approval for its low dose HIV combination drug, Kaletra (lopinavir, ritonavir).

The paediatric form of the protease inhibitor is smaller in size, does not require refrigeration and can be taken with or without a meal.

The drug has been approved for use in children weighing 15kg or more who are able to swallow the tablet whole.

The new child strength Kaletra will contain 100mg lopinavir/25mg ritonavir, half the strength of the original formulation.

The price will also be half that of the original strength product in developing countries.

The low dose formulation will be available in the US this month, though Abbott is still waiting to hear back from EU regulators regarding approval in Europe.

Catalent Pharma Solutions, the former Cardinal Health contract manufacturing unit, was recently pleased to announce the completion of the first flu vaccine manufacturing campaign from its new plant in Brussels.

The first production run at the prefilled syringe manufacturing plant churned out 21 million syringes for a number of 'major customers.'

The new plant is a prefilled syringe filling/finishing facility which doubles the company's previous prefilled syringe production capacity.

The site is due to replace an existing facility nearby, and having already received EU regulatory approval in 2006, the company anticipates having the first FDA-approved product at the facility next year.

Novartis yesterday announced promising results for its quadrivalent conjugated meningitis vaccine Menveo, presenting it as the only effective option to protect infants a young as six months.

The company has managed to develop a vaccine that appears to protect infants against four common meningococcal meningitis serogroups (A, C, W-135 and Y), expanding the range of currently available vaccine for teenagers and adults.

According to Novartis, while there are other polysaccharide vaccines available that cover these serogroups, they are only approve in certain countries for children two years or older due to poor efficacy, while a conjugated vaccine approved for use in infants is only available against the C serogroup.

The company expects regulatory submission for the vaccine in 2008, and is also in the process of developing a recombinant vaccine to protect against the B serogroup, for which there is currently no vaccine available.