AstraZeneca has announced that its combination drug for asthma, Symbicort, is on sale in the USA, almost a year after it was approved by regulators there.
The Anglo-Swedish drugmaker says that Symbicort (budesonide/formoterol) is now available in a pressurised metered dose inhaler (pMDI) for the long-term maintenance treatment of asthma in patients aged 12 and older. The company, which is marketing the product in two doses, said that the combination treatment – an inhaled corticosteroid (budesonide), and a rapid and long-acting beta2-agonist (formoterol) offers improved asthma control as early as day one that is sustained over 12 weeks. Symbicort also delivers improved lung function occurring within 15 minutes of beginning treatment, and AstraZeneca stressed that it does not replace fast-acting inhalers for sudden attacks.
Symbicort has been available outside the USA, in over 90 countries, for some time and brought in $354 million into AstraZeneca’s coffers, a rise of 19% compared with the same period last year, and this figure should rise considerably as it makes in-roads into the US market. Approval was granted in the USA after just ten months last year, which took the firm somewhat by surprise and the year-long wait for launch was due to the fact that AstraZeneca’s manufacturing facilities were not yet ready to supply the lucrative market across the Atlantic.
The company is now ready to do battle with GlaxoSmithKline's Advair/Seretide (fluticasone/salmeterol), the only other fixed dose ICS/LABA combination product on the US market but Symbicort has some ground to make up as Advair sales reached $1.64 billion in the first quarter. GSK’s drug is approved for the maintenance treatment of asthma in patients aged four years and older and chronic obstructive pulmonary disease sufferers.
Supreme Court rejects tamoxifen lawsuit
AstraZeneca received another boost across the pond with the news that the Supreme Court is refusing to consider a lawsuit which alleged that the firm, along with Barr Laboratories, conspired to monopolise the market for the breast cancer drug tamoxifen.
In the case, plaintiffs claimed that a pact signed between AstraZeneca and Barr was anticompetitive and artificially inflated the price of the treatment, which the former sold as Nolvadex. In 1992, a federal judge ruled that AstraZeneca's patent on the drug tamoxifen was invalid, after a challenge by Barr but the latter firm then began to sell its own generic tamoxifen product under a distributorship deal with AstraZeneca, well before the expiration of the aforementioned patent. Barr also received a $21 million payment and AstraZeneca also agreed to pay $45 million over 10 years to Barr's intended supplier.
The ruling comes after a US district court dismissed lawsuits related to the agreement between the two firms, and a court of appeals upheld that decision in 2005. US Solicitor General, Paul Clement, noted that although the appeals court "applied an insufficiently stringent standard in scrutinising the settlement… "it does not appear to present an appropriate opportunity for [the Supreme Court] to establish the correct standard for distinguishing legitimate patent claims”.
Barr’s chief executive Bruce Downey said that "we have always believed that our patent challenge settlement” related to tamoxifen “was pro-consumer and pro-competitive, and this has now been definitively confirmed by the courts".