On 5 November 2019, SymBio announced it obtained positive results in its pivotal Phase III clinical trial of Treakisym (bendamustine) in patients with relapsed and refractory diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint of improvement in response rates, although the company did not give detailed data in its announcement. SymBio guided toward submission of the data to the PMDA in H120 and we expect initial sales in 2021, driving sustained profitability.
SymBio has entered into a global licensing agreement for brincidofovir from Chimerix for $5m upfront, $180m in milestones and double-digit royalties. The drug is an antiviral for DNA viruses that has been investigated to treat opportunistic infections. The company intends to pursue the drug for viral hemorrhagic cystitis (vHC) and HHV-6 encephalitis, starting in Japan then in the rest of the world, potentially transforming SymBio into a multinational specialty pharma company.
SymBio also announced that it has submitted an NDA for the approval of the RTD formulation of Treakisym, which is a difficult molecule to dissolve in water, necessitating extended prep times. The development of the RTD formulation is meant to enhance the convenience of the product for practitioners. The goal with the new formulations is to convert doctors over to the more convenient forms before the entry of generic bendamustine into the market in 2022. The company is targeting a launch of the RTD formulation in Q121.
We have increased our valuation to $300m (¥32.7bn) or $12.31 (¥1,342) per share from $255m (¥28.9bn) or $10.49 (¥1,185) per share. This is driven primarily by an increase in the probability of success for Treakisym in DLBCL to 90% from 60%. Additionally, the valuation is increased by the inclusion of brincidofovir in our model and offset by the upfront payment to Chimerix. At this time we only include revenues for vHC in Japan, but we expect to update this in the future if the program progresses into other indications and geographies.