Dive Brief:
- Bioverativ Inc. and U.K.-based Oxford BioMedica plc have inked a licensing agreement focused on the production of lentiviral vectors for hemophilia drugs.
- The deal pertains specifically to gene therapy drugs, a Bioverativ spokesperson told BioPharma Dive. It also carries an option for the companies to enter a clinical supply agreement that would require Oxford, through methods that meet good manufacturing practice standards, to produce gene therapy-related hemophilia products.
- Oxford, which functions as both a drugmaker and contract manufacturer, is taking home $5 million upfront for its services. Additionally, it could grab at least $100 million more through milestone payments and undisclosed royalties on net sales of Bioverativ’s lentiviral vector hemophilia products.
Dive Insight:
Bioverativ raked in more than $1 billion from its two marketed products in 2017, representing a nearly 30% increase year over year. Eloctate (antihemophilic factor, Fc fusion protein) had a particularly stellar performance, with revenue growth shooting 41% to $725 million.
Looking to keep the momentum going, Bioverativ has been nurturing its network of manufacturing providers to ensure a steady stock of Eloctate and Alprolix (coagulation Factor IX, Fc fusion protein).
When Bioverativ officially split off from Biogen Inc. early last year, for instance, the smaller drugmaker agreed to a production and supply deal under which its former parent would create drug substance, product and finished goods — as well as provide fill and finish, labeling, packaging, distribution and logistics services — for Eloctate, Alprolix and clinical candidates.
For the time being, the pact remains in tact, according to the Bioverativ spokesperson.
Bioverativ has also been on the lookout for partnerships with other third party providers, an initiative that may ease its transition into becoming a Sanofi-owned company, after the French pharma bought Bioverativ for $11.6 billion in January.
Sanofi, while it is partnered with Alynylam Pharmaceuticals Inc. on an RNA interference drug aimed at hemophilia, hasn't been too active in developing or manufacturing hemophilia products.
"We have increased and continue to increase our level of direct contractual responsibility with other third party contract manufacturing organizations, logistics providers and distributors as we scale up our internal supply management capabilities," Bioverativ said in its most recent Form 10-K filing with the Securities and Exchange Commission. The company noted that its full-year cost of sales rose $41.7 million, or 18%, versus 2016, due in part to higher contract manufacturing expenses.
The new agreement with Oxford, therefore, fits into Bioverativ's larger plans. Per deal terms, Bioverativ is responsible for financing process development and scale-up activities for its lentiviral vector hemophilia products at Oxford's facilities.
From its end, Oxford gains another sizable biopharma partner. The company already works with Novartis AG and licenses its technology out to Sanofi and GlaxoSmithKline plc.
Oxford shares, which trade on the London Stock Exchange, were up 3% to £11.06 (about $15.56) apiece at Thursday's market open. They rose further to £12.06 (about $16.97) by mid-morning.
Editor's note: This story has been updated to reflect information provided by Bioverativ.