NEWS
Mymetics selects RSV vaccine as lead development programme
Switzerland-based Mymetics Corporation, which specialises in the development of mucosal and virosomal-based vaccines for infectious diseases, has decided to select its respiratory syncytial virus (RSV) vaccine candidate as the lead programme from its proprietary second-generation virosome platform. The RSV vaccine candidate demonstrated preclinical efficacy and safety. RSV is a major unmet clinical need in both the elderly and pediatric populations. Mymetics’ RSV vaccine candidate is based on the company’s innovative and proprietary second-generation virosome platform along with an approved adjuvant incorporated into the viral membrane to stimulate a balanced immune response. The vaccine, composed of the natural RSV membrane containing the natural RSV antigens, but without the infectious genetic material, generates an immune response similar to a normal infection, but with the safety profile of a killed virus vaccination. The two critical hurdles to successfully
developing an RSV vaccine are to generate not only neutralising antibody responses that mimic native viral proteins, but also a balanced TH-1-oriented immune response. The Mymetics RSV candidate, through the
incorporation of a TLR-4-directed adjuvant, has the potential to meet these two critical requirements.
RSV annually causes an epidemic of respiratory tract infections in patients of all ages. It has a high prevalence in developed countries, affecting those with weak immune systems, and is a major cause of lower respiratory tract infection during infancy, and of life- threatening pulmonary disease among elderly patients. Currently, there is no prophylactic vaccine against RSV.
Takeda completes construction of Russian manufacturing facility
Takeda Pharmaceutical International GmbH has completed construction of its pharmaceutical manufacturing facility in Yaroslavl, Russia. The company has invested about €75 million in the 24,000 sq m production plant, which is expected to be fully operational by 2014. Takeda was one of the first major international companies to have invested in high-quality pharmaceutical manufacturing in Russia. Based on sales, the company is the seventh-largest pharmaceutical company in Russia. According to IMS Health, Russian pharmaceutical sales totaled $14.7 billion in 2011, making it the eleventh-largest pharmaceutical market in the world. Market sales in Russia/CIS are expected to grow at a compound annual rate of 11 per
cent between 2012 and 2016 and Takeda plans to outgrow the market with an annual growth rate of 15 per cent over the same period. The Yaroslavl facility will enable
Takeda to meet demand in Russia, initially for cardiomagnyl, actovegin and calcium tablets. It will lead to creation of initially about 200 positions for managers and technical staff. The plant is about 280
kilometres from Moscow and has been constructed GMP standards, also complying with the latest safety and
environmental standards. It will have initial capacity to manufacture 90 million sterile ampoules and more than two billion tablets per year. Liquid sterile production includes solution preparation, washing of ampoules, sterilisation, filling,
inspection, and packaging. Solid production will comprise all stages from weighing, mixing and granulation to compression, coating, and packaging. Takeda Pharmaceuticals International GmbH, headquartered in Zurich, Switzerland, is a wholly owned subsidiary of Takeda
Pharmaceutical Company Limited. Takeda is the largest pharmaceutical company in Japan and has a commercial presence in about 70 countries, with particular strength in Asia, North America, Europe and fast- growing emerging markets including Latin America, Russia- CIS and China. Its areas of focus include cardiovascular and metabolic diseases, immunology and respiratory diseases, oncology and central nervous system diseases, among others.
AmpliPhi offers to acquire Special Phage Services
AmpliPhi Biosciences Corporation has offered to acquire Australian company Special Phage Services (SPS) which would result in the creation of an anti-infective company focused on developing phage- based therapies to treat antibiotic- resistant infection. In a share exchange transaction, AmpliPhi Australia Pty Limited, a wholly owned subsidiary of USA-based AmpliPhi, has offered to acquire Sydney-based Special Phage Holdings Pty Ltd (SPH), the holding company of SPS. AmpliPhi has offered up to 40 million shares of its common stock in exchange for all of the fully diluted share capital of SPH. Completion of the share
exchange acquisition of SPH by Ampliphi is subject to standard conditions, including acceptance of Ampliphi’s offer by a sufficient number of SPH shareholders, completion of regulatory approvals, and execution of certain ancillary agreements. The combination would bring together complementary technologies and expertise in bacteriophage-based therapies to create a company with a development-stage pipeline of innovative anti-bacterials addressing the antibiotic-resistant infections market.
AmpliPhi was the first company to present evidence of the clinical efficacy of phage therapy. Its leading therapeutic programmes
target areas of significant unmet clinical need. Its proprietary technology also has potential application in the treatment of orphan indications. Historically, Ampliphi’s development programmes targeted gram- negative bacterial infections that are often resistant to existing antibiotic treatments. These include BioPhage-PA for the treatment of chronic and acute lung infections in cystic fibrosis and VAP (ventilator associated pneumonia) patients. In addition to its pipeline of phage products against the major hospital-related infections, the acquisition of SPS would bring added expertise in veterinary medicine.
Solvay doubles speciality fluorinated derivatives capacity
Solvay is doubling its production capacity for speciality fluorinated aliphatic derivatives at its Salindres, France plant to meet growing demand in strategic markets, including
pharmaceuticals. The Group is investing more than €10 million in
this capacity expansion, which is already underway with the first additional volumes available later this month. The company is increasing production capacity for triflic acid and triflic anhydride (TA, TAA), as well as for lithium bis(trifluoromethanesulfonyl)imid
e (LiTFSI), to meet rapidly expanding requirements for electronic applications and the pharmaceuticals market. Solvay offers a broad range of products in markets including consumer goods, energy, electronics, and pharmaceuticals.
September/October 2012 sp2 Inter-Active 9
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