Sobi Maintains Grip On RSV Market – For Now

Vaccines and new antibody drugs are set to transform the respiratory syncytial virus space but for now, the Swedish rare disease specialist’s 25-year old offering Synagis is enjoying increased demand.

Source: Sobi

 

The respiratory syncytial virus (RSV) market looks set for disruption with vaccines from Pfizer Inc. and GSK plc moving towards approval and AstraZeneca PLC/Sanofi's long-acting monoclonal antibody Beyfortus recently getting the thumbs-up in the EU, but Synagis, the old standard of care from Swedish Orphan Biovitrum AB (Sobi), is still holding its own commercially.

The Stockholm-headquartered group's financials for 2022 show that fourth-quarter sales of Synagis (palivizumab) rose by 36% to SEK1.85bn ($175.8m). The figures were helped by the strong Swedish krona but Sobi noted that the rise reflected increased use as well as favorable price developments for the drug which was approved by the US Food and Drug Administration over a quarter of a century ago and went off-patent in 2015.

CEO Guido Oelkers said during an analyst call on 8 February that Synagis accelerated after a later start to the RSV season, adding that infections in the US have begun to decrease markedly. He stated that Sobi continued to anticipate a "2022-2023 season that will follow a pattern closer to a normal season than in 2021," noting that the company was pleased at the level of compliance seen with Synagis, which is administered as a series of five injections for high-risk newborns and infants.

However, the landscape is starting to change. In November, Beyfortus (nirsevimab) was approved by the European Commission for the prevention of RSV in newborns and infants, based on data from the Phase III MELODY, the Phase II/III MEDLEY program and several Phase IIb trials. The AstraZeneca/Sanofi product comes with the convenience of a single shot rather than five injections that are spread out but Oelkers was relaxed about the impending competition.

Approval for Beyfortus in the all-important US market is not expected before the third quarter and on that basis Oelkers said: "We will obviously maintain a large chunk of the Synagis business in 2023 given the late launch of the new competitor." He added that a number of factors have to be considered before Sobi can give specific guidance on future Synagis sales, such as the label for Beyfortus in the US and how the big pharmas manage the "very significant complexity of the launch."

However, he pointed out that "we're actually quite insulated and there are scenarios where we could end up with a significant upside." When Sobi acquired the US commercial rights for Synagis from AstraZeneca in November 2018, the deal also gave the Swedish company the right to payments from the UK major from the US profits from Beyfortus.

Those profits may take a while to come through and Oelkers acknowledged that as well as making a $175m milestone payment to AstraZeneca after the biologics license application for nirsevimab was made and an extra $90m once US approval is gained, Sobi will also contribute to Sanofi's launch costs for Beyfortus. "It could negatively affect our earnings, that's for sure, but considering that it will very likely be a product for a very, very large target audience, we consider these investments as a happy problem," he added.

In addition to Beyfortus, the vaccines are coming. GSK and Pfizer expect to hear from the FDA in May about their respective offerings and Moderna is also coming on the rails with its mRNA-based vaccine. (Also see "Strong RSV Vaccine Results Gives GSK An Edge Over Rival Pfizer" - Scrip, 13 Oct, 2022.) (Also see "Phase III Results Show Moderna Could Challenge In Blockbuster RSV Vaccine Market" - Scrip, 18 Jan, 2023.)

Sobi's other big earner in the quarter was Doptelet (avatrombopag), its oral thrombopoietin receptor agonist which is approved for primary chronic immune thrombocytopenia (ITP). Revenues shot up by more than 150% to SEK771m thanks to sales worth SEK317m to Shanghai Fosun Pharmaceutical (Group) Co., Ltd., Sobi's partner in China, increased uptake in the US and ongoing launches in Europe.

Oelkers also highlighted the successful launch of the Apellis Pharmaceuticals, Inc.-partnered complement C3 inhibitor Empaveli/Aspaveli (pegcetacoplan) for paroxysmal nocturnal hemoglobinuria. Fourth-quarter sales reached SEK87m after being launched in Germany, the UK, France and parts of the Middle East.

Cautious On Zynlonta

He was a bit more reserved when it came to Zynlonta (loncastuximab tesirine), the recently approved antibody-drug conjugate developed by ADC Therapeutics SA to which Sobi owns the European rights. The drug was granted conditional marketing authorization by the European Medicines Agency at the end of last year for the treatment of relapsed or refractory diffuse large B-cell lymphoma. (Also see "Sobi To Start Selling Zynlonta After Sealing EU Approval" - Scrip, 21 Dec, 2022.)

Oelkers said that the first launch for Zynlonta would be in Germany in May. "In terms of resources, we have a lot on our plate right now," he said, notably with EU launches of Doptelet, "so we want to manage this. As we always said, it is a good opportunity that we consider more as an hematology product than an oncology product [and] we see it as a nice addition."

He concluded by saying there was a clear unmet medical need for Zynlonta, adding that "KOLs are waiting for the product, so we think we can sell it, but I think for this year, we need to manage expectations, this is not going to be a main commercial event."