Pharma/fine chemicals roundup—27 January 2015
2:30 AM MST | January 27, 2015 | By DEEPTI RAMESH
Fine chemicals: Stringent regulations prompt return of manufacturing to the West
Pharmaceutical ingredient manufacturers are witnessing a rise in demand, and they remain positive about the near-term outlook for the industry. Increasingly stringent regulations on manufacturing standards, however, are causing some manufacturing to return from Asia to the West. Nevertheless, companies in countries such as India do not see their roles diminishing, and they expect to be crucial in the worldwide industry in the future.
Industry players and experts say that the environment in the pharmaceutical ingredient manufacturing industry is positive yet challenging. The European Fine Chemicals Group (EFCG; Brussels), an industry association that forms part of Cefic, says, “The environment is positive as increasing API [active pharmaceutical ingredient] business is being reported as innovator and generic customers are moving [away from] total dependency from Asian suppliers, plus there are new outsourcing opportunities. The environment is also challenging because of the need to be compliant with continuing regulatory changes globally and where new investment decisions are needed to cope with the extra demand,” says Tony Scott, adviser at EFCG. Formed in 2004, EFCG is the representative body for Europe-based producers of fine chemicals.
FDA issues import alert against Ipca API plant
FDA, on 22 January, issued an import alert for an active pharmaceutical ingredient (API) manufacturing facility of Ipca Laboratories (Mumbai), located at Ratlam, India. An import alert allows FDA to detain, without physically examining, products that either have or potentially could violate the Food, Drug, and Cosmetic Act. Ipca manufactures APIs and formulations. Ipca today confirmed the FDA import alert through a statement issued to the Bombay Stock Exchange (Mumbai). Four APIs manufactured at the Ratlam plant—hydroxychloroquine sulfate, propanolol hydrochloride, trimethoprim, and ondansetron—have been excluded from the import alert, Ipca says.
In July 2014, Ipca voluntarily decided to temporarily suspend API shipments from its manufacturing facility at Ratlam to the United States in order to resolve issues identified during a FDA inspection of the facility.
Lonza reports huge rise in profits
Lonza recorded net profits of 237.0 million Swiss francs ($274.9 million) for 2014 compared with profits of SF87.0 million in 2013. Sales for 2014 increased by 1.6%, to SF3.64 billion. Lonza’s specialty ingredients and pharma and biotech market segments both performed solidly despite currency headwinds and the performance of the water treatment business, and most of the individual businesses performed according to expectations, Lonza says.
“For the third consecutive year, our full-year results demonstrate that we’re making good progress in transforming Lonza. … We will continue our journey from a product-focused organization into a market-driven one,” says Richard Ridinger, CEO of Lonza. “Our focus on quality and operational improvements produced positive results in 2014.”
BASF plans worldwide expansion of PVP
BASF plans to invest €56.0 million ($63.5 million) to expand capacity for polyvinylpyrrolidone (PVP) at Geismar, LA; and Ludwigshafen and build new capacity for PVP at the company’s Shanghai site. A majority of BASF’s PVP capacities are used in the pharmaceutical industry. BASF markets PVP under the Kollidon brand, and the product is mainly used as an excipient in tablets with binding and disintegrant functionality. As a binder, it enables the individual active ingredients of a tablet to form a homogenous entity, and as a disintegrant it ensures that the tablets break up in liquid and release the active ingredient quickly, BASF says. The investment will increase BASF’s PVP capacity by 6,000 m.t./year.
Mitsubishi Gas Chemical subsidiary and Catalent sign deal for biosimilars
MGC Pharma (Tokyo), a wholly owned subsidiary of Mitsubishi Gas Chemical (MGC); and Catalent Pharma Solutions (Somerset, NJ), a leading contract manufacturer of pharmaceuticals, have entered into an agreement to jointly research, develop, and produce biosimilars. Biosimilars are approved versions of innovator biopharmaceutical products made after the innovator product’s patent expires. MGC Pharma, under the agreement, will use antibody-drug producing cells produced with Catalent’s GPEx technology to develop processes for biosimilars used to treat respiratory syncytial virus infections, cancers, and rheumatism with the aim of winning active pharmaceutical ingredient production contracts.
Actavis to acquire UK-based generics firm for $462 million
Specialty pharmaceutical company Actavis (Dublin) says that it has reached a definitive agreement with the owners of Auden Mckenzie (Middlesex, UK), a company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the UK, under which Actavis will acquire Auden Mckenzie for about £306 million ($462 million) in cash, plus a two-year royalty on a percentage of gross profits of one of Auden Mckenzie's products. The acquisition will make Actavis the number one supplier of generic pharmaceuticals in the UK. The acquisition is expected to close in the first quarter of 2015.
“Auden Mckenzie is one of the leading pharmaceutical companies in the UK, and the opportunity to combine this profitable and growing company into the Actavis UK business demonstrates our commitment to invest in and expand strategically in our global generics business,” says Brent Saunders, CEO and president of Actavis.
Actavis currently markets more than 650 generic products in the UK, and has about 85 additional products under registration and development. The combination with Auden Mckenzie is anticipated to add about 175 new generic and branded products, as well as a pipeline of about 40 additional products, in various dosage forms, for treatments across a broad spectrum of therapeutic areas.
FDA appoints deputy commissioner for medical products
The US Food and Drug Administration commissioner Margaret Hamburg appointed Robert Califf, a recognized global leader in cardiology, clinical research, and medical economics, as FDA deputy commissioner for medical products and tobacco. Califf will join the FDA in late February. Califf is currently serving as vice chancellor of clinical and translational research at Duke University. In this position, Califf will provide executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products.
Sigma-Aldrich and VIB form alliance to provide translational research tools
Sigma-Aldrich’s (St. Louis) research business unit, an industry leader in supporting translational researchers by supplying the products, services, and solutions needed to enable scientific discoveries, has formed an alliance with VIB (Ghent, Belgium), a leading life science research institute focused on translational research in medical, agricultural, and industrial applications. The alliance will focus on the commercialization and supply of new tools and technologies to help meet the evolving needs of translational researchers.
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