Circassia gets dual boost for US COPD drugs

UK biotech Circassia has had two key decisions go in its favour with FDA, as the company continues with its efforts to rebuild its business after a series of disastrous allergy drug trial failures.

However the success means Circassia is looking for ways to pay a series of fees due to AstraZeneca as part of a licensing deal.

Circassia gave up on developing a series of drugs for cat, house dust mite, grass, and rag weed allergies after a series of trial flops earlier in the decade.

The former darling of UK biotech had raised £200 million with an initial public offering (IPO) to develop the allergy drugs, but switched to a back-up plan by picking up US rights for two unwanted respiratory drugs from AstraZeneca in a deal signed two years ago.

Tudorza and Duaklir are inhaled respiratory drugs for chronic obstructive pulmonary disease (COPD) – and at the time of the deal Tudorza (aclidinium bromide), a long-acting muscarinic agonist (LAMA) was already launched in the US and gained approval from the FDA in 2012.

Duaklir, which combines aclidinium with a long-acting beta agonist, formoterol fumarate, has just been approved by the FDA, after AstraZeneca agreed to complete ongoing clinical research, with a contribution of up to $62.5 million towards development activities.

At the end of 2018 Circassia exercised an option over Tudorza and now has full US commercial rights to both products.

Approval of Duaklir by the FDA also triggers payment from Circassia to AstraZeneca, under the 2017 agreement

A contingent option fee of $20 million becomes due to AstraZeneca within 30 days of the FDA approval of Duaklir, and final deferred consideration of $100 million is due by 30 June 2019.

Circassia is in talks with third party finance providers to satisfy all or part of these payments, and if this financing is not forthcoming, Circassia plans to use a loan facility provided by AstraZeneca under the companies’ agreement to satisfy the outstanding amount.

The drug will also be competing in a highly competitive market after a launch planned in the second half of 2019 – there are cheap generic competitors to GlaxoSmithKline’s ageing blockbuster Advair (fluticasone+salmeterol), which are approved in COPD albeit with a slightly different mechanism of action.

There are also more modern LAMA+LABA combination drugs, such as GSK’s Anoro Ellipts (umeclidinium and vilanterol).

In a separate decision the FDA said Circassia could add data showing COPD exacerbations, and no increase in major cardiovascular events compared with placebo to the drug’s label.

Tudorza will be the only product in its class with these data from the phase 4 ASCENT trial on the label, adding to the drug’s marketability compared with rival LAMA monotherapies in the US.

After patents expired on several blockbusters, AstraZeneca has sold a raft of old or unwanted drugs in order to prop up its revenues until a new generation of medicines in its pipeline are approved and generating new income.