Data And More Data Expected To Drive BTG Towards Triple-Growth Target
This article was originally published in Clinica
Interventional medicine specialist BTG plc has set its sights high. Its largest franchise, interventional oncology, reported sales of £75.5m ($112m) for fiscal 2015 and the UK company is aiming to at least triple this figure to $300-400m by 2021. With 2016 already upon us, time is ticking by.
The firm, however, does not plan to cut corners. In an interview with Clinica at BTG’s London headquarters, Russell Hagan, chief technology officer for interventional oncology, underlined the importance of gathering strong clinical evidence to get the buy-in from oncologists. It is the oncologists on whom the company ultimately relies to refer patients onto the interventional radiologist for treatment with BTG’s bead devices.
“We have a very good relationship with the interventional radiologists, the ‘treaters’ in this space. But the key to growth in this area will come from how interventional radiologists are positioned within the multidisciplinary oncology environment and this, in turn, will come from increasing the understanding of the oncologist about the value that the interventional radiologist can bring on board,” said Hagan.
“Oncologists are very clinical data-driven. They will want to see randomized controlled trials that support the use of [our bead products],” he continued. “Historically, medical devices have not worked that way. They are launched very early in the life cycle and then generate data as they go along. What we’re finding in the oncology space is that you need to invest in those clinical trials to convince the oncologist of their clinical efficacy, and also to demonstrate how our products can be used in combination with [the existing chemotherapies that] they know.”
BTG had moved into the interventional oncology space some five years ago when it bought Biocompatibles in a deal worth £177.2m. The portfolio consisted of embolization beads, which block arteries to deprive tumors of blood and nutrients, and drug-eluting beads, which also deliver a chemotherapeutic drug directly to the tumor. BTG added a radioembolization technology, TheraSphere, in 2013 when it bought the targeted therapies division of Canadian firm Nordion for $200m. Most of the products are used primarily for liver cancer.
Merit Medical Systems is another significant player in the embolization technology field, and Boston Scientific recently bought the interventional radiology business from CeloNova. But BTG is the only company that offers both drug-eluting and radioembolization beads.
It is TheraSphere which BTG believes will be a key driver in getting the interventional oncology business to hit its $300-400m 2021 sales target.
TheraSphere is already CE-marked and used in Europe and Canada, and it already generates more revenue than BTG’s other interventional oncology bead devices (TheraSphere 2014/2015 sales: £44.9m vs Beads 2014/2015: £30.6m). However, radioembolization is a relatively new discipline, compared to the other embolization technologies. TheraSphere comprises radioactive microspheres that are much smaller (20-30 microns) than a typical embolization or drug eluting bead (BTG’s smallest embolic bead, M1, is 70-150 microns). In an outpatient procedure, the glass spheres containing radioactive yttrium-90 are injected into the artery of the patient’s liver, thus enabling a high concentration of radiation to be delivered directly to the tumor while limiting damage to surrounding healthy tissue and avoiding the systemic side effects you would get from oral chemotherapy.
The company is conducting clinical trials of TheraSphere to gain US premarket approval for treating patients with advanced hepatocellular cancer (HCC). The study will also hopefully demonstrate the product’s superiority over sorafenib (Nexavar, by Bayer/Amgen), the only approved targeted therapy for advanced or metastic HCC. “These drugs are not well tolerated – the benefits are marginal, for some patients the benefits are there, for others they’re not. With TheraSphere, we are hoping to show it is clinically more effective than sorafenib, in terms of improving overall survival and having less impact on quality of life of those patients.”
Along with clinical efficacy, BTG will also be gathering health economic data to further strengthen TheraSphere’s value proposition. “If you look at the economics, very simply, a course of sorafenib typically would be $30,000-50,000 in the US. A single treatment with our radioembolization device would be $10,000-15,000. So economically, TheraSphere already makes more sense – provided the oncologist see that benefit and our data show that our device can deliver an effect that is as tolerable or better tolerated and has better efficacy than what oncologists see with chemotherapy.“
While BTG is investing most heavily in TheraSphere, it has continued to innovate and expand its existing embolization product lines. In December, the company received US FDA clearance for LC BEAD LUMI, making it the first radiopaque embolic bead available on the market. Currently, embolization beads are delivered under contrast imaging. “But you never quite know whether you’ve completely covered the target or whether there are some off-target effects going on, because the beads themselves are not visible on CT,” said Hagan. LC BEAD LUMI allows the interventional radiologist to target the beads more precisely and ensure they are being delivered to the right place, and also to better guide any necessary follow-up treatment. “[With LC BEAD LUMI], you have a permanent record of where the beads are. The interventional radiologist may see that they have left 20% of the tumor untreated and they can then go back and identify where that 20% is and treat it.”
With the 510(k) clearance for LC BEAD LUMI under its belt, BTG will start gathering clinical evidence in the new year to demonstrate the value the product’s improved imageability can bring to treatment outcomes. Additionally, the firm intends to expand the geographic reach of LC BEAD LUMI and conduct the trials necessary to gain regulatory approval in more jurisdictions.
Another innovation that BTG is working on is drug-eluting bead that will be preloaded with a proprietary drug for liver cancer. The drug, which the firm licensed from “a major pharma company”, is already available in an oral form (while BTG did not disclose which pharma company this is, Hagan mentioned in the interview that it was “a targeted therapy agent”; sorafenib, as mentioned earlier in this article, is the only approved targeted therapy for primary and secondary liver cancer – Ed).
“By delivering the drug locally [via the drug-eluting bead] you can potentially deliver a higher dose without systemic effects,” said Hagan. The product is about to go into first human clinical studies and early clinical data will be expected at the end of 2016.
“These are all long-term clinical investments,” said the chief technology officer. “We expect in the next 3-5 years that we’ll have the data in place and the buy in from the oncologist and we’ll continue to see adoption of our products.”