General News

CPhI: Novasep builds big in chromatography, changes CEO

Facility to be largest of its kind in pharma industry

Novasep has announced plans to spend €30 million to build a large chromatography plant for the production of a large volume, highly purified API from a complex mixture commercial at its site in Mourenx, France. The investment, the company’s third this year, came shortly after it emerged that the founder, Roger-Marc Nicoud, was to step down as CEO.

The new plant, which will be operational and validated within 18 months, and the development of an advanced purification process “are results of the sharp increase in the projected demand for a large volume, highly purified API”, the company said. Novasep was a pioneer in continuous chromatography for pharmaceutical manufacturing under the Varicol brand name. This and its simulated moving bed techniques are used in the commercial-scale production of several chiral APIs.

The new plant is the third of its kind to be built by Novasep. Designed by an in-house engineering team, it will include Varicol systems with 1,200 mm columns that can operate at up to 70 bar and will be the largest ever seen in the pharmaceuticals industry. It will also integrate recovery systems for the recycling of 99.9% of the solvents. Funding towards this was given by various local and national government bodies, though the respective amounts were not stated.

Shortly beforehand, Novasep had announced that Nicoud would step down as president and CEO, becoming non-executive board chairman. His replacement, with effect from 1 October, is Patrick Glaser, head of the Novasep Synthesis division since May 2010. Nicoud had headed the company for more than 20 years. He commented that “it is the right time for a change in the company’s leadership”, following a refinancing and the completion of a new ownership structure.

A €310 million recapitalisation process was completed in March, taking in some €30 million from France's strategic investment fund, the Fonds Stratégique d'Investissement (FSI), which thus became a shareholder. Three American hedge funds collectively hold about half of Novasep, with management owning most of the rest.

This became necessary after Novasep lost several key contracts and struggled to repay its debts. Eventually, with state help, the FSI and other creditors agreed to convert some €200 million of debt into equity. Recapitalisation gave Novasep over €40 million to finance growth projects, mostly in purification, while also significantly reducing interest expenses and freeing more cash for investment. It has since started to spend some of this.

In April, the company opened a new 2,000 m2 facility in Shanghai's Pudong district, replacing an earlier facility, which it had outgrown. The facility includes 800 m2 dedicated to innovation and process development through new laboratory, piloting and FAT testing areas. It supplies purification processes for pharmaceuticals biopharmaceuticals and industrial biotechnology applications.

Subsequently, in July, €3 million was spent to expand highly potent API production at Le Mans, France, mainly for novel anti-cancer therapies. This facility, which should be in operation by the start of 2013, will perform cryogenic chemistry at -60°C in hastelloy reactors, plus large-scale HPLC chromatography and drying in confined areas to manufacture antibody-drug conjugate toxins at commercial scale.