GlaxoSmithKline has suspended four clinical trials of a new infection treatment, according to partner Anacor Pharmaceuticals.
The latter firm revealed that GSK has voluntarily paused enrollment in its current studies of GSK ‘052 “due to a recently identified microbiological finding in a small number of patients” in the Phase IIb trial of the systemic antibiotic for the treatment of complicated urinary tract infections (cUTI).
In addition, GSK ‘052 is in a Phase IIb study in complicated intra-abdominal infections and two Phase I trials. While the microbiological finding seen in the cUTI study is not related to the safety of the drug, “the potential to negatively impact efficacy led GSK to voluntarily suspend enrollment in all four studies”, notes Anacor. Subjects who are currently in the studies may continue at the discretion of the investigator.
GSK is in the process of obtaining additional information “in order to better understand the data, but will not resume the trials until it has concluded its investigation”. David Perry, Anacor’s chief executive, noted that the review “could take several months” and “we respect GSK’s decision”.
Anacor investors seem concerned this could be end of the road for the drug, which GSK got access to after exercising an option in July 2010. The US firm’s stock ended the day down 3.2% to $7.18.
GSK invests A$60 million to extend Melbourne
Meantime, GSK says it is investing A$60 million, about $64.3 million, to expand manufacturing and new drug development activities at its Boronia site outside Melbourne.
The move, which will create 58 “new highly-skilled jobs by 2017”, is taking place at a facility that makes most of GSK’s key drugs and is its largest site globally for the production of liquid products that utilise state-of-the-art ‘blow-fill-seal’ (BFS) technology. The investment will allow GSK to potentially double its current BFS manufacturing capacity by installing new production technology.
The investment will also support the creation of a pilot scale industrialisation facility for new powder and sterile liquid pharmaceuticals. The facility will support the continuation of GSK’s R&D collaboration with the Monash Institute of Pharmaceutical Sciences in developing next-generation drugs and the healthcare giant also plans to make this new facility accessible for local companies for contract manufacturing.
Boronia site director Troy Webb said this was “a unique opportunity” to put the state of Victoria and Australia “on the map when it comes to scientific innovation, particularly around ophthalmic, biological and consumer healthcare products. He praised the Victorian government which recently unveiled a A$55 million plan to promote biotechnology-enabled innovation in the state.
Each year, GSK spends on average A$30 million a year on R&D in Victoria and exports more than A$300 million per annum in pharmaceutical products from the state. In September 2011, the company said it would be selling off a third (about 7.34 hectares) of the land at Boronia which lay largely vacant following the relocation of its commercial division to Abbotsford, central Melbourne in 2010.
