Pharmaceutical manufacturing: news in brief

By Staff Reporter

- Last updated on GMT

Related tags Bristol-myers squibb Food and drug administration Fda brings you a selection of recent
headlines from around the pharmaceutical manufacturing industry.

CDI-Life Sciences has won a contract from CJ CheilJedang to provide engineering design for a major new grassroots pharmaceutical manufacturing complex to be located in Osong, Korea. ​ The complex will be the manufacturing centre for global distribution of oral solid and sterile liquid drug products. "Our past experience in designing pharmaceutical and biotech facilities in Korea and our ability to assist clients in gaining both FDA and EU regulatory approvals for their facilities played an important role in the awarding of this project,"​ CDI Engineering Solutions president Robert Giorgio said. Korean biopharmaceutical company Celltrion has received approval from the US Food and Drug Administration (FDA) to serve as a contract manufacturer to produce Orencia (abatacept). ​ The biologic drug, indicated for the treatment of rheumatoid arthritis, is developed by Bristol-Myers Squibb. The Supplemental Biological License Application was submitted by BMS to meet expected long-term demand for Orencia. Celltrion is the largest biopharmaceutical manufacturing facility in the Asia-Pacific region, and the only Asian large-scale cell-culture contract manufacturing facility which has successfully obtained approval from the FDA. BioSante Pharmaceuticals has received a $3.5m milestone payment from Bradley Pharmaceuticals in regards to Elestrin (estradiol gel), a gel formulation absorbed through the skin after topical application for the treatment of menopausal symptoms. ​ The payment is the second of two triggered by the December 2006 FDA approval of Elestrin and brings the total upfront and milestone payments received to $14m. BioSante could receive up to an additional $40m for achieving sales-based milestones. "We are pleased to receive this Elestrin milestone payment. We look forward to a full year of marketing in 2008 and expect that Elestrin sales will increase as prescribing physicians become more familiar with it,"​ BioSante president and chief executive Stephen Simes said. OxfordGenome Sciences (OGeS) and Amgen have joined together to discover, develop and commercialise novel therapeutic antibodies for the treatment of cancer. ​ The collaboration will allow OGeS to strengthen its pipeline of fully human therapeutic antibodies in cancer based on the target discovery capabilities of its unique Oxford Genome Anatomy Project (OGAP) database. The collaboration will see the use of Amgen's XenoMouse technology to generate antibodies. The antibodies generated will be raised against the novel druggable targets identified in OGAP, which has been developed into the world's largest cancer protein database to discover novel clinically relevant drug targets and diagnostics. The deal covers up to six oncology programmes. Amgen has the right to select up to three programmes, while OGeS will retain rights to the remainder. Once Amgen has produced the initial antibody leads, OGeS will carry out the initial preclinical assessment of each antibody programme. GlaxoSmithKline has received a complete response letter from the FDA related to its application for the cervical cancer vaccine Cervarix, signifying that questions remain to be answered prior to approval. "We have already started addressing the questions and will be engaged in discussions with the FDA to finalise our responses,"​ GSK North American vaccine development vice president and director Barbara Howe said. Cervarix has been approved in 45 countries around the world.

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