Pharmaceutical manufacturing: news in brief

By Staff Reporter

- Last updated on GMT

Related tags: Pharmaceutical supply chain, Pharmacology brings you a selection of recent
headlines from around the pharmaceutical manufacturing industry.

Javelin Pharmaceuticals launched its IV bolus formulation of diclofenac sodium, Dyloject, in the UK this week. "Today is a watershed in Javelin's evolution from a development company to a revenue-generating organisation. Pricing publication marks the UK launch of Dyloject, our proprietary injectable NSAID for the treatment of acute moderate-to-severe pain,"​ Javelin chief executive and chief medical officer Dr Daniel Carr said. Dyloject employs a proprietary solubilising agent that is significantly less irritating to veins than the organic solvents used in the currently marketed IV diclofenac formulation. Dyloject's UK label includes two routes of administration, intramuscular injection and rapid (IV bolus) injection. Javelin intends to file additional marketing applications through the mutual recognition process in a number of EU member countries. A New Drug Application is expected to be filed in the US in the first half of 2009. UK-based Prosonix has received £5m in funding, which will go towards moving onto the next stage of commercialising the Prosonitron commercial scale sonocrystallization technology. ​ The technology, used in the pharmaceutical crystallisation process, helps control crystal size, shape, purity and the selective production of polymorphs, thereby enhancing both manufacturing productivity and ultimate formulation performance. The company has conducted six successful pilot trials with the technology this year and the technology will be used at full commercial scale for the first time next year. "Today is a very significant milestone in Prosonix's development. Following the funding Prosonix will have a very strong balance sheet from which we will be able to accelerate our growth plans to build an exciting and long term profitable business,"​ Prosonix chief executive David Hipkiss said. Solon Ventures led the investor round. Pantec Biosolutions has raised $5.67m in its Series A equity investment round. ​ Pantec will further develop its device and drug patch technology with the aim of replacing the required hormone treatment regime of daily injections made over a period of several weeks during in vitro fertilisation. The company has developed a laser micro-poration device LEDDT (laser easy drug delivery technology) for large molecular weight drug delivery such as IVF hormones. Gamma Capital Partners are leading the investment round. Bayer Schering Pharma has submitted for registration the first combined oral contraceptive product based on estradiol and the progestin dienogest to all member states of the EC. ​ A comparative clinical study showed the combination drug resulted in good cycle control, comparable to combined oral contraceptives with 20 micrograms ethinylestradiol. The drug has also been seen to have a less pronounced impact on the liver and metabolic parameters. The product is the first oral contraceptive that is based on a bio-identical estrogen. The drug is also being studied for the treatment of prolonged, frequent and excessive bleeding. Cardinal Health has had its license to distribute controlled substances from its Lakeland centre suspended by the US Drug Enforcement Administration. ​ The move was effective from December 10. "Anything less than best-in-class controls for the pharmaceutical supply chain is unacceptable. We will do what it takes to address this execution issue with changes to our processes and systems. The security of the pharmaceutical supply chain is core to our business and we are committed to the highest standards as we work with the DEA to resolve this matter,"​ Cardinal Health chairman and chief executive R. Kerry Clark said. To ensure continuity of service, the company is making arrangements to distribute controlled substances to affected customers from other facilities within its network of 25 pharmaceutical distribution centres. Cardinal Health has been reviewing its controlled substance procedures and is implementing enhancements that further guard against distribution to pharmacies engaged in diversion.

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