IHS Chemical Week


Pharma/fine chemicals roundup—18 March 2014

2:44 AM MDT | March 18, 2014 | By DEEPTI RAMESH

DSM and JLL create $2-billion pharma services firm DPx

DSM and private equity firm JLL Partners (New York) say that they have created DPx Holdings, a new privately held company, by combining DSM Pharmaceutical Products (Parsippany, NJ), the custom manufacturing and technology business of DSM, with Patheon (Toronto), a portfolio company of JLL. DSM and JLL first announced plans to create the new company in November 2013. DPx, which is a leading global contract development and manufacturing organization (CDMO) for the pharmaceutical industry with anticipated annual sales of about $2 billion and more than 8,000 employees, became operational on 11 March 2014. DPx is 51% owned by JLL and 49% by DSM, and its headquarters is located at Durham, NC.

FDA issues warning letter to API plant in India

FDA issued a warning letter at the end of February 2014 to the active pharmaceutical ingredient (API) manufacturing facility of Canton Laboratories (Vadodara, India) located at Vadodara for violations of cGMP. An FDA inspection from 1-9 April 2013 at the Vadodara API facility identified significant deviations from cGMP for the manufacture of APIs, FDA says. The warning letter was published in the FDA website last week. The violations at the API site include failure to perform laboratory testing of APIs to ensure conformance to specifications and to accurately report results on certificates of analysis (CoA); failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards; failure to ensure equipment is cleaned in a reproducible and effective manner to prevent contamination of a material that would alter the quality of the APIs; and failure to ensure that APIs are produced according to pre-approved instructions and that batch production records include complete information pertaining to the production of each batch, FDA says.

Codexis sells its operations in Hungary to US biotech firm Intrexon

Codexis (Redwood City, CA), a developer of biocatalysts for the pharmaceutical and fine chemical industries, says it has sold its subsidiary and laboratory operations at Budapest, to biotechnology company Intrexon (Germantown, MD), for a purchase price of $1.5 million. The transaction closed on 13 March. No proprietary Codexis materials or intellectual property were included in the transaction, Codexis says. Intrexon says that the acquisition will expand its strain and protein development capabilities, as well as strengthen fermentation process optimization and scale-up. Intrexon's industrial products division, under the deal, will absorb the Budapest laboratory staff.  Integration of the Budapest team and their expertise with Intrexon's suite of synthetic biology technologies and capabilities will allow Intrexon to better serve current collaborators and to attract new opportunities for active pharmaceutical ingredients (API) and industrial and consumer product collaborations, Intrexon says.

Novo Nordisk invests over $100 million in new purification plant in Denmark

Health-care company Novo Nordisk (Bagsvaerd, Denmark) says it is increasing its drug development capacity by investing 550 million Danish kroner ($102 million) in a new facility at Bagsvaerd. The purification plant will expand the company’s capacity to produce active pharmaceutical ingredients for a growing number of diabetes drugs under development, Novo Nordisk says.

Codexis narrows loss

Codexis (Redwood City, CA), a developer of biocatalysts for the pharmaceutical and fine chemical industries, reports a net loss of $9.81 million in the fourth quarter of 2013 compared with a net loss of $15.53 million in the fourth quarter of 2012. Fourth-quarter sales increased 20.4%, to $9.52 million.

Merck Serono appoints Meeta Gulyani to executive committee as head of strategy and global franchises

Merck KGaA says that its biopharmaceutical division, Merck Serono (Darmstadt, Germany), has appointed Meeta Gulyani to the position of head of strategy and global franchises effective 7 May 2014. Gulyani will be based at Boston and will report to Belén Garijo, president and CEO of Merck Serono. Gulyani joins Merck Serono from Roche (Basel), where she was most recently general manager for South Asia, covering India, Sri Lanka, Bangladesh and Nepal, and previously v.p./global portfolio management. Prior to joining Roche in 2010, Gulyani spent eight years at Sanofi (Paris).

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