SkyePharma has posted an impressive set of results for the first half of 2013, with a huge sales hike largely driven by growing sales of asthma drug Flutiform across the globe.
The group saw turnover shoot up 58% to £31.3 million, with growing revenue from Flutiform (fluticasone and formoterol) leading the way, helping to push pre-exceptional operating profit up 24% to £4.6 million.
Total net loss after tax from continuing operations came in at £1.7 million, compared to £2.6 million in the first half of 2012.
Flutiform has now been approved in 21 European countries and launched in ten by partner MundiPharma, including its recent approval and rollout in Italy which triggered a £1.7 million milestone payment to the UK drug delivery specialist.
Thus far, things seem to be going very well for its now flagship product. When compared with the most recent launch of a new non-generic combination brand in the ICS/LABA market segment, “Flutiform continues to track or exceed in-market value of sales for the same period post launch”, SkyePharma said.
Further European launches are expected during 2013/14, once pricing and reimbursement processes are concluded, a launch in Australia is also imminent, and the product was also recently recommended for approval in Japan. Marketing authorisation applications have also been filed in a number of countries in the Asia-Pacific region and approval has been granted in Hong Kong.
In Mexico, Central and South America, the Group’s licensee, Sanofi, is expected to start filing NDAs for flutiform shortly.
Going forward, milestones over the next six months include £2.6 million from the product’s launch in France and several million US dollars on its approval in Japan, though it is not certain that these will fall into 2013.
GSK products to drive growth
Speaking to PharmaTimes this morning, Peter Grant, chief executive of SkyePharma, said two GlaxoSmithKline combination products – BREO Ellipta (fluticasone furoate/vilanterol) and ANORO Ellipta (umeclidinium/vilanterol) – utilising the firm’s technology are also likely to be key growth drivers going forward.
BREO Ellipta was approved in the US for COPD in May, and is under review (as RELVAR Ellipta) in Europe for COPD and Japan for asthma. A US review date for ANORO Ellipta in the US is looming in December (it is also filed in Europe and Japan) and, if approved, these products could together bring revenues of about £9 million a year to the group’s coffers.
Financially, post-surgical analgesia drug Exparel (bupivacaine liposome injectable suspension) is also important, as it could also bring substantial milestones to the firm, given that it is entitled to 3% of revenues booked by partner Pacira, he said. And according to analysts at N+1 Singer, an $8 million milestone for when sales of the drug hit $100 million is likely to be released in 2015.
Elsewhere, other products continue to provide a steady stream of revenue. As Grant told PT, despite increasing competition and generic launches, many of SkyePharma’s products are proving to be “life-long revenue generators,” such as Paxil (paroxetine), sales of which grew despite copycat challenge because of its launch in new territories.
Looking further forward, SkyePharma is working on new oral delivery technologies to meet an unmet need. Although specific details have not been released, Grant says proof-of-concept for one of these should be completed next year, and he said the firm “is internally excited about their prospects”.
