Barr Pharmaceuticals stepped up the pressure to buy Croatian generics company Pliva yesterday after filing its intentions formally with global regulators, including the US Federal Trade Commission and in Germany. It says it intends now to proceed under Croatian takeover law and is looking to firm up the deal as quickly as possible.

“On Wednesday, we held preliminary discussions with members of the FTC during which no substantial preliminary issues surfaced that we believe would pose an impediment to the potential acquisition of Pliva from the US perspective,” it said in a statement.

But it is not as easy as all that. Earlier this week, Iceland's Actavis filed its $2.3 billion takeover offer for Pliva with the Croatian regulatory authorities after revealing it had already snapped up some 20% of the latter's shares on the open market - a strategy presumably designed to make it more difficult for Barr, Pliva's preferred marriage partner. It has also filed with the FTC.

Actavis has offered 723 kunas per share for Pliva, while Barr has pledged 743 kunas. Both offers are in the region of $2.3 billion.

The US generics firm asserts that its is the better offer, with “limited, if any, overlap,” and has highlighted its intentions for Pliva - including expanding its injectables, creams and ointments technologies into the USA, boosting operating margins by improving production facilities outside the USA, making new product filings, cutting clinical trial costs by using Pliva's established resources in India, introducing Barr's products into European and Russian markets and using more of Pliva's active pharmaceutical ingredient capabilities to boost profitability of the global generics business.

Meanwhile, Pliva this morning said the US Food and Drug Administration has given final approval to its antibiotic azithromycin and the blood thinner warfarin, as well as tentative approval for odansetron - the generic version of GlaxoSmithKline's Zofran, an anti-emetic. The move follows corrective action at its facility in Zagreb to address issues raised in a warning letter from the US drug regulator in May.

Zofran, which is used in chemotherapy and radiation patients as well as to prevent nausea and vomiting post-operatively, is a big drug for GSK, with sales during the first quarter of this year of £230 million (up 13%; $423 million).

Pliva is to launch azithromycin this week, with warfarin to be pushed onto the market at a later date. It expects full approval of its copycat version of Zofran in June 2007, following expiry of the 180-day exclusivity period awarded to the first-to-file generic applicant.