Pending EU Approval Of Eloctate, Sobi Opts In To Second Hemophilia Program With Biogen
This article was originally published in The Pink Sheet Daily
Executive Summary
Sobi also gets two oral formulations of Orfadin for the rare genetic disorder HT-1 and is starting over with a new candidate in a collaboration with Affibody.
Having decided in November to take an expensive option to co-market Biogen’s hemophilia A drug Eloctate, Swedish Orphan Biovitrum AB made the second and final big call under its nearly decade-long partnership with the big biotech, electing also to option co-commercialization rights for Alprolix in hemophilia B.
The Stockholm-based specialty firm announced the decision in tandem with its second quarter earnings call July 16. The company also reported that it brought in revenues of SEK 764 million ($89.6 million) during the period, up 15% year over year. Revenues included SEK 593 million ($69.6 million) in product sales, which was a 25% increase from one year earlier.
Sobi’s decision on whether to co-commercialize Alprolix, a recombinant DNA-derived formulation of Coagulation Factor IX, was triggered by Biogen’s filing of a Marketing Authorization Application for the drug with the European Medicines Agency. The application was accepted for review on June 26. The Swedish firm now must make a $10 million option payment to Biogen, although that sum will be held in escrow pending the regulatory approval in Europe.
The partnership stems from an agreement signed by a pair of predecessor companies in January 2006, when Biovitrum AB, which since merged with Swedish Orphan International AB, agreed to co-develop and co-commercialize a Factor IX candidate for hemophilia B with Syntonix Pharmaceuticals [See Deal].
Biogen inherited the deal upon buying Syntonix in 2007, and the collaboration eventually was expanded to include a candidate for hemophilia A, the recombinant Factor VIII Fc fusion protein marketed in the U.S. as Eloctate. Sobi is awaiting EU approval of the drug, under the brand name Elocta, which is expected during the fourth quarter of 2015.
Last November, Sobi opted in to share in final development and marketing of Elocta in Europe, North Africa, Russia and most Middle East markets, paying the same escrowed $10 million exercise fee. But the company also is required to reimburse Biogen a portion of its development and manufacturing costs for the drug; Sobi’s share was estimated at about $180 million in November, with the possibility that total could increase to $240 million.
The option for Alprolix covers the same geographies and requires reimbursement of development and manufacturing costs to Biogen under similar terms. In addition to the U.S., Alprolix is approved in Canada, Australia and Japan. Prior to launch in April 2014, Biogen decided to price Alprolix on par with the existing standard of care, Pfizer Inc.’s Benefix, in hopes of both winning market share and avoiding controversy over high prices for specialty drugs (Also see "Biogen Plays It Safe With Pricing Of Hemophilia Drug Alprolix" - Pink Sheet, 21 Apr, 2014.).
The companies will pay single- and double-digit sales royalties from their commercialization territories for both drugs under the partnership.
New Orfadin Formulations Approved
In addition to the milestones in hemophilia, Sobi CEO Geoff McDonough pointed to two other important events that occurred during the past quarter. The company obtained approval of oral liquid and 20 mg capsule formulations of Orfadin (nitisinone), approved for treatment of the rare genetic disorder hereditary tyrosinemia type-1 (HT-1), which can cause liver failure, kidney dysfunction and neurological disorders.
“We’ve worked for quite a long time on the oral suspension and 20 mg capsule for Orfadin,” McDonough said. “These are formulations and formats which will allow for more precise dosing in pediatric and adolescent patients and, in our view, will make a real contribution to more sustainable adherence for patients around the world.”
Orfadin brought in SEK 189 million in sales on the quarter, up 35% year-over-year, senior VP and chief operating officer Alan Raffensperger said. Sales of the drug also were up 71% for the first six months of the year compared to the same period in 2014.
Sobi also brought in SEK 175 million on partnered products during the quarter, with Xiapex (collagenase clostridium histolyticum) for Dupuytren’s contracture one of the products leading to 10% growth in that group. Auxilium Pharmaceuticals Inc. signed Sobi as its marketing partner for Xiapex in more than 70 EU, Central Eastern Europe/Commonwealth of Independent States, Middle Eastern and North African markets in 2013, replacing its previous partner, Pfizer (Also see "Auxilium Signs Sobi As Pfizer Replacement In Europe" - Pink Sheet, 16 Jul, 2013.). Raffensperger noted that Sobi is completing launch preparations for Xiaflex in a second indication, Peyronie’s disease, in its territories.
In addition, McDonough revealed that Sobi has terminated development of Phase I candidate SOB1002, a complement factor C5 therapy partnered with Affibody AB[See Deal]. It is advancing a new molecule from that collaboration into preclinical development instead, he said. The new candidate will be a novel C5 inhibitor with “a different configuration and a few different features,” the exec explained.