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Pharma/fine chemicals roundup—10 June 2014
12:20 AM MDT | June 10, 2014 | By DEEPTI RAMESH
Johnson Matthey's fine chemicals business reports rise in sales
Johnson Matthey's (London) fine chemicals business reports a 7.5% rise in sales for the company’s fiscal year, ended 31 March, compared with the previous fiscal year, to £371 million ($623 million). Underlying operating profits for the business increased 9.8%, to £84.1 million. During the fiscal year, the fine chemicals business performed steadily, and its return on sales improved by 1.2%, to 26.1%, benefiting from increased sales in the higher margin API manufacturing business, Johnson Matthey says.
Within fine chemicals, the API manufacturing business grew its sales by 6.0%, to £211 million, and underlying operating profit was further ahead, Johnson Matthey says. Sales of opiate-based APIs grew, partly driven by a customer's new generic product for treating drug addiction. The business benefited from strong demand for APIs used to treat attention deficit/hyperactivity disorder. This benefit includes additional revenue following some supply shortages for a generic product that resulted in an increase in its prices. At this stage, it is unclear how long these higher prices will continue, Johnson Matthey says. The business also continued to benefit from oxymorphone patent revenue from Endo, the US-based health-care company. “The UK government has yet to confirm its future intentions on the importation of controlled substances. However, we have completed the restructuring at our UK API manufacturing operation, which represents around 40% of our API manufacturing business, and the business is now better positioned to compete in today’s more open market,” Johnson Matthey says.
European regulatory authorities to reinstate GMP certificate for Ranbaxy’s API plant at Toansa
After assessing Ranbaxy Laboratories' (Gurgaon, India) active pharmaceutical ingredient (API) manufacturing facility at Toansa, India, European regulatory authorities say the company has instituted corrective measures and are satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site, the European Medicines Agency (EMA; London) announced on 5 June. As a consequence, EU authorities will reinstate the GMP certificate that was suspended in January, EMA says. The assessment follows a US FDA inspection, which revealed areas of noncompliance with GMP at the Toansa site. Earlier this year, Ranbaxy temporarily suspended shipping APIs produced at its plants at Toansa and Dewas, India, following an FDA announcement on 23 January prohibiting Ranbaxy from manufacturing and distributing APIs from its Toansa facility for FDA-regulated drug products. The inspection team from Europe concludes that no medicines on the EU market that have an API manufactured at Toansa were of unacceptable quality or a risk to the health of patients taking them. Samples of these medicines were tested, and all met the correct quality specifications, EMA says. European regulatory authorities, however, have identified the need to keep the Toansa site under close supervision, which will be done in collaboration with India and other regulatory authorities around the globe, EMA says.
Dottikon narrows loss
Fine chemicals company Dottikon (Dottikon, Switzerland) reports a net loss of 2.6 million Swiss francs ($2.9 million) for the company’s fiscal year ended 31 March 2014, compared with a net loss of SF7.2 million in the previous fiscal year. Full-year sales increased 6.9%, to SF89.9 million. Growth came from pharma products and performance chemicals, the company says. Dottikon manufactures performance chemicals, intermediates and exclusive active pharmaceutical ingredients (APIs) for the chemical and pharmaceutical industry.
ScinoPharm and TaiGen sign API manufacturing deal
ScinoPharm (Tainan, Taiwan), a company that develops and manufactures active pharmaceutical ingredients (APIs), says that it has signed a manufacturing contract with TaiGen Biotechnology (Taipei), for the clinical supply of the API for Burixafor, a new chemical entity discovered and developed by TaiGen. The API will be manufactured at ScinoPharm’s plant at Changshu, China. “Burixafor is a 100% in-house developed product that can be used in the treatment of various intractable diseases. The cooperation between TaiGen and ScinoPharm will not only be a win-win for both companies, but will also provide a high-quality novel dug for patients worldwide,” says Ming-Chu Hsu, chairman and CEO of TaiGen.
Bayer appoints new head of pharmaceuticals business
Bayer says that Dieter Weinand will become president of Bayer HealthCare Pharmaceuticals (Berlin) effective 1 August and that he will also join the executive committee of Bayer HealthCare (Leverkusen). Bayer HealthCare Pharmaceuticals generated sales of about €11.9 billion ($15.1 billion) in 2013 and employs over 38,000 people worldwide. Weinand will join Bayer HealthCare Pharmaceuticals from Otsuka Pharmaceutical Development & Commercialization (Princeton, NJ), where he is currently president/global commercialization and portfolio management for a $13-billion health-care business, Bayer says. Weinand will succeed Andreas Fibig, who is leaving Bayer HealthCare Pharmaceuticals to become the CEO of International Flavors & Fragrances (IFF), effective 1 September.
Lubrizol introduces a new pharmaceutical excipient
Lubrizol says that its life science polymers business has introduced a new pharmaceutical-grade excipient, Pathway. As pharmaceutical companies face the challenge of the patent cliff, the development of new routes of administration for existing drug products is an important potential strategy these companies can use to maintain the success of their product franchises. Pathway excipients help drug manufacturers achieve their goals of developing these novel, controlled-release drug products, Lubrizol says. With the implementation of the GMP-quality system at Lubrizol's facility at Wilmington, MA, earlier this year, the company can now offer pharmaceutical-grade thermoplastic polyurethane (TPU) polymers in addition to medical-grade ones. TPU is very versatile compared with traditional materials used in drug delivery applications, Lubrizol says. It can be designed at various shore hardness while simultaneously varying the water uptake characteristics. Lubrizol says it can also tailor the polymer to meet a manufacturer's drug delivery requirements.
Major Chinese API producers report improved results
The active pharmaceutical ingredient (API) industry in China recorded total revenue of about 382 billion renminbi ($61.6 billion) in 2013, and China produced a total of about 2.7 million m.t. of APIs in 2013, says a recent report by a market research firm. Zhejiang Hisun Pharmaceutical (Taizhou) and Zhejiang Huahai Pharmaceuticals (Linhai) are key suppliers of APIs in China, and in 2013, the total revenues from APIs for the two companies were Rmb3.22 billion, up by 19.5% compared with 2012, the report says. Zhejiang Xianju Pharmaceutical (Taizhou), a leading supplier of hormone APIs, posted total revenue of Rmb2.23 billion from APIs and formulations in 2013, up 16.2% compared to 2012. Tianjin Tianyao Pharmaceuticals (Tianjin) is another leading supplier of hormone APIs. North China Pharmaceutical Group Corp. (NCPC; Shijiazhuang) and Northeast Pharmaceutical Group (Shenyang), which are major suppliers of APIs in China, recorded total revenues of Rmb5.69 billion from their API businesses in 2013, the report says.