Cancer supportive care will not strike most biotech watchers as a hot area of innovation or investor returns, but Riccardo Braglia, chief executive of the private Swiss group Helsinn, seems to have spotted an opportunity here.
As therapeutic progress comes on in leaps and bounds “cancer is becoming a chronic disease”, he tells EP Vantage, and patients who are now living longer have obvious extra needs. More importantly, a patient who can be made stronger can likely tolerate further therapy and comply with multiple lines of treatment.
The area is complex and good data hard to come by, as Helsinn knows all too well. But novel approaches have thrown up new types of side effects that, one way or another, have to be dealt with. A perfect example is immuno-oncology, which though highly efficacious causes a different range of ill effects than older treatments.
At least in theory this could provide an opportunity for Helsinn, a business that was founded by Mr Braglia’s father and which is still 100% family owned.
On Mr Braglia’s watch Helsinn’s focus has expanded beyond treating chemotherapy-induced vomiting, where through Aloxi the group has a key position, to cancer cachexia. Future areas of focus include pruritus and chemotherapy-induced neuropathic pain.
Helsinn’s ghrelin agonist anamorelin had already made a splash at the Esmo conference as a potential cachexia treatment, though important questions remain about an approvable endpoint and side effects (Esmo – Cachexia progress at last, but watch the diabetes, September 27, 2014).
Speaking to EP Vantage at last week’s Jefferies conference in London the chief exec said the diabetes side effect was obvious given the ghrelin mechanism, and, in fact: “We actually expected more [diabetes]. We expect a warning on the label."
Harder to forecast is whether anamorelin’s failure to improve muscle strength will be a problem. Mr Braglia reckons the EMA will have few concerns, since it is most interested in quality of life and lean body mass improvements.
The US FDA is a different matter. Right now the plan is to hold a pre-NDA meeting in January, once one-year survival data are in and the Romana-3 extension study reads out. Even Romana-3, with an extra 12 weeks’ treatment, is unlikely to hit the muscle endpoint, Mr Braglia concedes.
He also accepts that anamorelin has had a rocky ride, having been passed from Novo Nordisk to a company that became Sapphire Therapeutics and was bought by Helsinn. In fact, the project has been around for so long that US patent coverage ends in 2020, so Helsinn will have to rely heavily on market exclusivity.
But there is an intriguing plan to start patients on anamorelin earlier – as soon as a cachexia diagnosis is made, in fact. The model here is chemotherapy-induced vomiting, and it could give patients a better chance to respond.
In addition Mr Braglia plans to expand anamorelin, should it be approved, beyond use in NSCLC to pancreatic, colon and even breast cancers. A second-generation anamorelin, which crosses the blood/brain barrier better, is in development.
And the project extends beyond anamorelin to a ghrelin antagonist for obesity. Clearly Helsinn is not an obesity company, and plans to take this through phase IIa proof of concept and license it out.
Talk of licensing takes Mr Braglia to another subject – that of Helsinn scouring the industry for projects to buy. As the range of debilitating side effects grows, so too does the list of potential licensing opportunities.
In the case of immuno-oncology the side effects include lupus and Crohn’s disease, and Mr Braglia says he has taken a look at all the industry’s lupus projects. In fact, he held talks with the UK’s Immupharma on two occasions, but says he did not consider its Lupuzor project promising.
How about the licensing budget? Helsinn might be private, but Mr Braglia is open about its finances: “We made SFr320m ($331m) in sales last year, and this year expect SFr330m. We have an 18-22% (pretax profit) margin, and reinvest some 22% of sales in R&D, though given anamorelin this was 28% last year.”
Helsinn has sunk no less than SFr150m into the development of anamorelin. The controlling family is able to advance loans of SFr40-50m to the company for an acquisition war chest, and right now the firm is investigating raising SFr150-250m in debt.
There are no plans to raise new equity, let alone take the group public, though “we run Helsinn almost like a public company, from a compliance and legal perspective”, says the chief exec. “In theory we’re ready to go public within three months.”
Investment bankers, take note.