Sobi Ups 2016 Revenue Expectations Marking A Year Of Evolution
This article was originally published in Scrip
Swedish Orphan Biovitrum AB (Sobi) has updated its earnings outlook for this year following a positive recommendation for approval of its Biogen-partnered hemophilia B product, Alprolix (rFIXFc), in Europe.
Alprolix, which was approved by the US FDA in 2014, received a positive recommendation from the European Medicines Agency's scientific committee, the CHMP, last week on Feb. 26 and is now expected to gain marketing approval in Europe in the second quarter of 2016. Sobi has therefore raised its guidance, estimating that revenues for the full year will be in the range of SEK4.8bn ($561m) to SEK5bn ($584m). Previously the firm had forecast revenues of SEK4.3bn to SEK4.5bn for the year.
The company noted that it was expecting revenues to include one-time credits for its licensed products Elocta (rFVIII; approved for treatment of hemophilia A) and Alprolix of SEK300m to SEK325m each.
Sobi CEO and president, Geoffrey McDonough, said this year represented a "really dynamic time" for the company. "We are not a very big company –only around 700 employees – but we have quite a diverse portfolio," McDonough noted.
Alongside Alprolix's expected approval and eventual launch in Europe, Sobi is also in the early stages of launching Alprolix's "big brother" product, Elocta. "This is another major goal for us this year. We will be getting the totality of this franchise on its feet in our territory."
McDonough added that Sobi is launching a portfolio in a therapeutic area that resonates with its history. "We are returning to hemophilia and it is a nice moment. We get to see Sobi become a more ambitious company as it grows in the coming years."
Sobi has recently seen a change at the top, with the chair of the board of directors, Bo Jesper Hansen, standing down after more than five years in the position. Former CEO of Nycomed, Håkan Björklund, will be proposed as the new chair at Sobi's 2016 general meeting. Currently he is chair of Lundbeck and an executive advisor at Avista Capital Partners and previously served as a board member for various life science companies including Alere, Coloplast, and Danisco.
McDonough said this transition was timely with Sobi's evolution to a clinically and commercially focused company. "Our incoming chair has a slightly different profile and he has expertise that is well suited to how Sobi is evolving," he said. "We have spent the last four to five years stabilizing and growing the company, to make it a sustainable and cash-flow positive business. Now we are launching our hemophilia products and looking forward to a period of growth based on our own pipeline in addition to new external partnerships or licensing deals."
Sobi's chief noted that 2016 would see the company get its hemophilia portfolio off the ground in Europe and launch a liquid formulation of one of its largest genetic disease products, called Orfadin – which is approved for hereditary tyrosinemia type 1. "That launch is ongoing in Europe but we also hope to have an FDA approval in the second quarter of the year," McDonough said.
He added that the company will also focus on some key development milestones, with two clinical trials launching this year. These are for Kineret (anakinra) in acute gout and in Still’s disease – both IL1-driven diseases. "We also have an active early stage portfolio and we hope to see those programs move forward this year."
Alprolix In Europe
McDonough expects first launches of Alprolix in Europe to begin mid-year, following a traditional route in terms of which countries the company will target first. "We have a standard launch plan in Europe, which is governed less by us and more by how specific countries establish or introduce new products. Countries like Germany or Denmark that have relatively free pricing immediately after approval are higher in the launch cascade, followed by Ireland and the UK, and then countries with lengthy pricing appraisal systems like France and Italy come a little later. Overall it takes around 12-18 months to launch across our territory," McDonough said.
On pricing in Europe, Sobi's chief said: "We have not chosen a price yet for Alprolix but I expect us to take a similar approach to what we have done with Elocta; we tried to engage with payers and physicians to understand how they see the value of these products."
He said Sobi had noticed the number one comment the company gets from physicians is that they see these extended half-life products as the future of treatment for hemophilia and that there is a huge variety of scenarios where extended half-life products can be used.
"Their biggest wish is to see us price these products in a way that they can become mainstream treatments," McDonough told Scrip. "Their fear is that if we charge a large premium, the treatment will be reserved for just a few niche patients. So we are looking for a pricing strategy that will allow Elocta, and eventually Alprolix, to become mainstream clotting factors. This implies that we will be as close to approximating the price of current treatments as possible so patients are free to switch therapies."
Sobi is very concerned with sustainability of healthcare in general, particularly in Europe. "Every one of our products is priced according to the environment it is moving into and also its potential to impact that environment. We think we can impact the standard of care in hemophilia broadly with our products and we recognized that we won't be able to do this unless patients have access."
Alprolix's positive recommendation in Europe is based on results from two global, Phase III trials: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12.
The CHMP said, "The benefits with Alprolix are its ability to stop the bleeding when given on demand and prevent bleeding when used as routine prophylaxis or for surgical procedures."
The committee noted that the most common side effects recorded were headache. There was one case each of oral paresthesia and of obstructive uropathy.
Alprolix is a long-acting Factor IX fusion protein, consisting of a single molecule of Factor IX attached to the constant region of immunoglobulin G, in order to extend the half-life of the protein and enable less frequent infusions in hemophilia B patients. The product was originally developed by Biovitrum (a forerunner to Sobi) and Syntonix (a company later acquired by Biogen). In 2015, Sobi exercised its opt-in right to take over final development and commercialization of Alprolix, for the treatment of hemophilia B, in Europe, North Africa, Russia and certain Middle Eastern markets. Meanwhile, Biogen – which markets Alprolix in the US – has licensed the drug to UCB in South Korea, Hong Kong, Thailand, Singapore, Malaysia, Taiwan, and China.
The treatment is currently approved for use in hemophilia B patients in the US, Canada, Japan, Australia and New Zealand – where it was the first hemophilia B therapy approved to provide prolonged protection from bleeds.