Posted 7 September 2017
Lilly has flagged its latest biological oncology drug Lartruvo as a perfect candidate for the new Provisional Approval pathway proposed for 2018 after the drug was rushed through the US and European regulatory systems.
Speaking exclusively to Pharma in Focus this week, Lilly's new General Manager, Australia and New Zealand, Libby Driscoll described Lartuvo (olaratumab) as a "really exciting therapy".
"Lartruvo has now been approved in the US and this is something we would really love to bring to Australia as quickly as possible," Driscoll said, adding legislation for a provisional approval pathway was "critical to be able to bring innovation faster to people in Australia".
Lartruvo is just one of a number of new products in Lilly's bulging pipeline, with the recently-appointed Driscoll preparing the local Lilly team for a raft of drug launches over the next 10 years.
"Our goal is to have at least one if not two and maybe more new products or new indications launched every year for the next decade," she said, adding the products would fall into three 'buckets' - diabetes, oncology and biomeds including immunology, neurodegenerative and pain.
"We are focused on those big buckets," Driscoll said. "You don't see Lilly doing vaccines, or antibiotics or cardiology any more. We have definitely chosen some specific research areas.
"We are entering an unprecedented period of growth with these new products and more coming. We will truly have a full portfolio in diabetes; a full portfolio in rheumatology and some later-stage drugs coming in oncology."
Plaque psoriasis drug Taltz (ixekizumab) was PBS-listed in February and Lilly hopes to follow it up with diabetes drug Trulicity (dulaglutide) and rheumatoid arthritis drug Olumiant (baricitinib). Both will be considered at the PBAC's final meeting for 2017.
Backed by strong clinical data, Driscoll expressed confidence in both getting positive recommendations, saying they had the evidence and offered the value required for PBS listing.
Next on Driscoll's Australian reimbursement list is the TGA-registered stomach cancer drug Cyramza (ramucirumab), with Driscoll saying the company is compiling a reimbursement submission, meaning a 2018 PBAC agenda item can be expected.
"There are a lot of companies working in cancer but Lilly's approach is to find those unmet medical needs; trying to find those medications that really can make a profound impact on people's lives," she said.
Lung cancer therapy Portrazza (necitumumab) and breast cancer drug abemaciclib are two such oncology therapies while migraine biological galcanezumab is also on track for global filing later this year, as well as pain drug tanezumab.
With such a strong pipeline, Driscoll is keen to accelerate the time taken to establish new treatments in Australia.
"The world is changing," she said. "If you look at 10 years ago when we were launching into a new class of medications you probably had a good three to five years before your next competitior entered the market. Now, you're lucky to have a few months.
"Our go-to-market strategy has to look and feel much different in the next five years than it did in the last five years so we can keep up with that pace of change."
Megan Brodie
megan.brodie@lushmedia.com.au