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Pharma/fine chemicals roundup—23 April
12:16 PM MDT | April 23, 2013 | By DEEPTI RAMESH
Hikma to retain injectables business
Hikma Pharmaceuticals (London) says it has concluded a review of the strategic options for its global Injectables business and decided that this business should remain part of the Hikma group. Hikma's operations are conducted through three pharmaceutical businesses—branded, injectables, and generics, based mainly in the Mideast and North Africa regions, the United States, and Europe. Hikma recorded sales of about $1.1 billion in 2012. “After a thorough review of strategic options for the injectables business, we are confident that retaining and continuing to invest in this business is the best option for shareholders,” says Said Darwazah, CEO of Hikma. “Injectables offer excellent long-term growth prospects and will remain an integral part of our overall growth strategy. By retaining the business, we will also continue to benefit from our diversified business model, which combines our global injectables business with our oral generic business in the United States and our extensive presence and experience in the Mideast and North Africa.”
DSM biopharmaceutical plant in Australia to open in June
DSM Pharmaceutical Products (Parsippany, NJ), the custom manufacturing and technology business of DSM, says that the previously announced new custom biopharmaceutical manufacturing plant at Brisbane, Australia, will open in June. The DSM facility was built with cooperation from the Queensland and Australian governments, and will provide cGMP mammalian cell-culture contract manufacturing services from process development through to commercial manufacturing.
“Our partnership with the government of Queensland and Australia has led to this important addition to the Australian biotechnology industry and will be a key contributor to the entire Asia/Pacific region,” says Karen King, president of DSM Biologics, the biopharmaceutical manufacturing business of DSM Pharmaceutical Products. Australia has a vibrant biotechnology industry, but previously had no custom mammalian-based biopharmaceutical manufacturing operation in country, DSM says. The Queensland government formed BioPharmaceuticals Australia (Brisbane), which has partnered with DSM to bring this new facility and operation to Brisbane. “The opening of this facility satisfies a national capability gap,” says David Hughes, CEO of BioPharmaceuticals Australia. “Our partnership gives Australia and the wider region access to DSM's extensive experience, expertise, and ongoing commitment to developing improved bioprocessing technologies.”
Explosion at site in Latvia halts production at two lines
An explosion occurred at pharmaceutical company OlainFarm's (Olaine, Lativia) production site at 9.20 a.m. on 17 April, caused by a toluene vapor leak at the site's nitrofurantoine manufacturing plant. The facility's windows were blown out by the shockwave following the explosion, but operations at only two production lines have been halted. The rest of the company's plant continues to operate normally. Two people were injured in the explosion and were hospitalized, the company says. OlainFarm is one of the biggest pharma companies in Latvia, specializing in the manufacture of basic pharmaceuticals and preparation products. The company achieved €9.7 million ($12.7 million) in profit and €52.2 million in sales in 2011.
Reliable Biopharmaceutical expands high purity ingredient suites
Reliable Biopharmaceutical (St. Louis) says it has invested several million dollars into its high-purity production suites. These investments will nearly triple the production capacity in its high-purity ingredients (HPI) line. RBC develops and manufactures active pharmaceutical ingredients and HPIs for pharmaceuticals and biologics, and is a leading developer and manufacturer of complex, generic, injectable APIs.
SK Biopharmaceuticals enters into a strategic alliance with SK Chemicals
SK Biopharmaceuticals (Seoul) has entered into a codevelopment agreement with SK Chemicals (Songnam, South Korea) for its novel new small molecule YKP10811, which is being developed for the treatment of irritable bowel syndrome with constipation. Both companies are part of the SK Group, the third-largest conglomerate in South Korea. SK Chemicals, under the deal, will conduct later-stage clinical phase two and three trials in South Korea for an expected launch in 2018. SK Chemicals will have marketing rights in South Korea. SK Biopharmaceuticals will develop YKP10811 in the rest of the world for all applicable indications. SK Biopharmaceuticals focuses on the discovery and development of new drugs for the treatment of central nervous system disorders. SK Biopharmaceuticals also provides custom services for the manufacture of active pharmaceutical ingredients and pharma intermediates at its facility at Taejon, South Korea.
Beyond IHS Chemical Week:
EMA updates database with GMP data to strengthen supply chain safety
The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance.