Busy time for Actavis

The last month has been a busy time for Iceland’s Actavis, a firm which only a few weeks ago had to reassure the industry that it was protected from the crisis enveloping the Icelandic financial system. Towards the end of October, the firm announced that it was formally launching its presence in the French generics market, having been preparing the ground since 2007. Just a few days later the firm announced that it was expanding its presence in India by constructing new solid oral dosage facilities at its existing site in Alathur. The firm added that three construction projects were underway in India, and reported at the same time that it had inaugurated new laboratories at Ticel Bio Park in Chennai, India. Actavis’ physical presence was also boosted on 3rd November, with the news that the firm had opened new expansions to analytical and development laboratories to expand its R&D efforts in Florida.

Actavis has also announced plans to expand through alliances. On 30th October, the firm reported that it had entered into an exclusive distribution agreement for a number of generic products with J&M Pharma, a South Korean-owned and operated pharmaceutical firm. Actavis commented that this would be an important step in its plans to build its presence in the Korean market. A few weeks later, Actavis announced that it had concluded a preliminary agreement with ASKA Pharmaceutical, through which the two firms would establish a joint company through which Actavis could enter the Japanese generic market. Clearly, with the building work in India and the agreements in Korea and Japan, Actavis is looking to the Asia Pacific region to provide new sources of revenue.

Actavis has also been busy with product launches, announcing on 28th October that it had launched its atorvastatin product, Atacor, in Serbia. A few weeks later, on 13th November, the firm announced that it had launched its azithromycin product and Chlamydia testing kit in the United Kingdom.

However, for all these steps forward, Actavis has also found itself taking a step back. On 14th November, the US Department of Justice announced that the US was seeking a permanent injunction to bar Actavis Totowa and Actavis, as well as two of their leading officers, from the manufacture and distribution of generics until Actavis Totowa, the firm’s plant in New Jersey, was in compliance with Good Manufacturing Practices. Actavis Totowa, which had previously been the plant for Amide Pharmaceuticals before Actavis acquired the firm, has not had a good year, finding itself on the wrong side of a number of FDA inspections. The plant and Actavis has also found itself involved in congressional efforts to carry out an investigation into the plant, as part of oversight efforts regarding the FDA. Events came to a head after a batch of Actavis’ digoxin tablets from the plant were found to have double the stated dosage. Although Actavis has put the best spin it can on events, underlining its commitment to work with the FDA to resolve the issues and get the plant back on line, this must nonetheless be a disappointing end to an exciting few weeks for the firm.

Ian Platts - Editor, World Generic Markets