Business Concentrates INSTRUMENTATION REGULATION
Europe reexamines Merck’s Sigma buy European antitrust regulators have charged Merck KGaA with holding back important information before completing its late-2015 acquisition of lab chemicals maker Sigma-Aldrich for $17 billion. The lapse won’t scuttle the two-year-old deal that formed the research chemicals powerhouse MilliporeSigma, but it could result in a fine of up to $165 million, equal to 1% of Merck’s annual revenues. In applying for approval of their merger, Merck and Sigma-Aldrich didn’t reveal information about newly developed technology affecting “certain laboratory chemicals,” the European Commission says. Had regulators known about the technology, the commission says, they would have ordered it to be divested along with the manufacturing assets and lab chemical brands that they required to be sold for antitrust reasons. Honeywell bought the assets and brands in October 2015. The commission didn’t disclose the technology, saying only that it “was closely linked to the divested business and had the potential to substantially increase its sales.” A Merck spokesperson says the technology, not yet on the market, involves a packaging innovation “which has several potential applications outside the divested portfolio.” Merck ultimately licensed the technology to Honeywell “free of charge” a year after the acquisition closed and after Honeywell told the commission of the disclosure lapse, the spokesperson says. Merck counters that it acted in good faith and “is confident this issue will be resolved in a satisfactory manner.”—MARC REISCH
Agilent buys into Raman spectroscopy Agilent Technologies has entered the Raman spectroscopy market with the acquisition of the British firm Cobalt Light Systems for about $52 million. Based in Oxfordshire, England, Cobalt was formed in 2008 as a spin-off from the U.K. Science & Technology Facilities Council. Today it has 52 employees and claims as customers 20 of the 25 largest drug companies and more than 75 airports across Europe and Asia. Cobalt’s product line includes Cobalt’s products are bench- this handheld device. top and portable Raman spectrometers that allow identification of chemicals and materials without opening containers. Applications include materials identification in pharmaceutical quality control and screening of containers for explosives in airport security checks. Conventional spectroscopy is poor at detecting materials through sealed, nontransparent containers. With the acquisition, Agilent gets Cobalt’s spatially offset Raman spectroscopy (SORS) technology. Invented by a group at the Science & Technology Facilities Council that included Cobalt’s chief scientific officer, Pavel Matousek, SORS uses two or more measurements to obtain greater Raman contribution from the contents than the container. A second Cobalt technology, transmission Raman spectroscopy (TRS), is an alternative to conventional chemistry-based analytical testing such as HPLC. TRS takes seconds per drug tablet or capsule and does not require preparative steps, the firm says. Paul Loeffen, Cobalt’s CEO, says the combination of his firm’s patented technology with Agilent’s product-development knowhow, manufacturing skills, and customer base “will allow us to scale our operations to take advantage of this rapidly growing market.”—MICHAEL MCCOY
REGULATION
In a change of heart, the U.S. Food & Drug Administration has told Amicus Therapeutics it can seek approval for its Fabry disease treatment migalastat. Shares of the rare-disease-focused biotech firm soared by more than 25% on news of the regulatory shift, which trims at least three years off the development time for the drug. Migalastat stabilizes the enzyme responsible for breaking down globotriaosylceramide (GL-3), a fatty substance that accumulates in the lysosomes of people with Fabry disease. In November, FDA asked the company to conduct a new study of the drug to collect more gastrointestinal
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calling for “slashing the restraints” on FDA. data. The company did not expect to comMoreover, newly appointed FDA Complete the study until 2019. missioner Scott Gottlieb has in the past Now, Amicus will file for regulatory made clear he thinks the agency could be approval in the U.S. in the fourth quarter, more progressive in how it repotentially putting the drug on HO views drugs for rare diseases. the market in the second half of NH Leerink Partners stock an2018. FDA’s changed stance on OH HO alyst Joseph P. Schwartz told migalastat, which is already apinvestors that he “cannot rule proved in the European Union, OH out the political influence of prompted much speculation Migalastat a new Administration (and from industry insiders. In a its inclination toward approving medFebruary address to Congress, President icines for deadly afflictions) having an Donald J. Trump highlighted Amicus CEO influence” on the announcement.—LISA John Crowley’s daughter Megan, who has Pompe disease, another rare disease, while JARVIS
C R E D I T: COBA LT L I GH T SYSTE M S
FDA shifts on rare-disease drug approval
