Contract manufacturing news in brief
periodic round-up of new deals and developments in the
pharmaceutical contract manufacturing sector.
Swiss firm Lonza and Singapore's Bio One Capital have entered into a joint venture to establish a contract manufacturing organisation in Singapore for the production of commercial biopharmaceuticals. Financial details of the agreement are not disclosed.
The plant will be realized in two phases, with construction of the shell as the first commencing at end-2005. The final build-out of the facility will be completed within 24 months of the shell being erected, according to the companies.
Lonza, which generated revenues of 2.18 billion Swiss francs (€1.41 billion) in 2004, said that the project "further strengthens its leading position as a global custom manufacturer of biopharmaceuticals entering the fast-growing Asian market."
US contract manufacturer Omnia Biologics has joined forces with lentiviral vector manufacturer Lentigen Corp. The two companies have signed a master services agreement for Omnia to provide Lentigen with access to its cGMP facilities and services.
Omnia Biologics (Omnia) is a contract manufacturer focused on clinical trials material manufacture of innovative biopharmaceuticals. Lentigen is a contract manufacturer of research and clinical grade lentiviral vectors, used in gene therapy, research and industrial biologics production.
Cobra Biomanufacturing of the UK is to provide scale up and cGMP manufacturing services and supply of drug for Phase II/III clinical trials to US firm Auxilium Pharmaceuticals.
The contract relates to Auxilium's biopharmaceutical AA4500, in development as a potential treatment of Peyronie's disease and Dupuytren's disease, two disorders caused by the formation of fibrosis (scarring). The drug is in early-stage clinical testing and has been granted orphan drug status by the FDA.
Cobra said the deal was valued at more than $3.3 million and extends through to 2006.
US vaccines company AlphaVax has taken its manufacturing activities in-house, ending a contract manufacturing agreement it had with Greer Laboratories of Lenoir, North Carolina. The company has signed a new lease agreement with Greer, giving it direct responsibility for vaccine manufacturing operations using Greer's vaccine production facility, including employment of several Greer staff who are involved in making AlphaVax vaccines.
Andrew Graham, vice president of development at AlphaVax. Said the move was necessary because "the manufacturing process is a critical, rate-limiting step in the development of a new, complex biological technology like ours. Unlocking the potential of our core technology so that it can successfully support a broad array of new vaccine products depends on how effectively a company solves the challenges of manufacturing within the strict demands of FDA regulation."
AlphaVax announced plans last year to expand its manufacturing capacity by renovating another leased manufacturing facility in North Carolina, near its central laboratory and office facilities in Research Triangle Park.
Neurobiological Technologies has signed agreements with Germany's Nordmark Arzneimittel and Baxter Pharmaceutical Solutions of the US to manufacture, fill and package Viprinex (ancrod), a drug in Phase III clinical trials in acute ischaemic stroke.
Nordmark will manufacture the biological active ingredient, ancrod, which is derived from the venom of the Malayan pit viper, while Baxter will aseptically fill and package the drug product, Viprinex, into its finished form, along with the corresponding placebo. The Phase III clinical trials are scheduled to start in the third quarter of this year.
