In August this year, Sweden’s Xbrane Biopharma set itself a stark deadline: it must secure an out-licensing deal by October for either its XB003 rival to Cimzia (certolizumab pegol) or its Xdivane (nivolumab) proposed biosimilar to Opdivo, in order to satisfy the company’s working capital requirements from the beginning of November 2024 onwards.
The urgency came as a result of Biogen at the start of August calling time on its development deal with Xbrane for the Cimzia biosimilar, which Xbrane at the time admitted was an “unforeseen event” that “significantly impacted the company’s expected income during the coming six-to-12 months.”
Last month, the Swedish firm bought itself a little more breathing space – reaching an agreement for prolonged payment plans with its main suppliers, extending the previous timing to the end of November – as it signaled that it had reached the agreement negotiation stage for Xdivane while receiving the first non-binding proposals on XB003.
And now, with just days to go until the end-of-November deadline, Xbrane has today announced that it has entered into a global licensing agreement with Intas for the nivolumab biosimilar, with the Indian giant set to commercialize the PD-1 inhibitor through its Accord Healthcare subsidiary.
Upfront Payment Of €10m; Intas To Fund Development
It seems that Intas may have obtained a potentially valuable asset at a competitive price: in exchange for giving Intas exclusive global rights to the biosimilar, Xbrane will receive an upfront payment of €10m ($10.6m), development milestones of €3m, and “double-digit royalties on profits” following launch.
However, Intas will now be on the hook for development costs. Under the terms of the alliance, the Indian firm “will finance and oversee the clinical and regulatory development activities” for the nivolumab candidate, as well as handling global commercialization.
That said, the development program for nivolumab could be less expensive than most biosimilars, after Xbrane recently revealed that the US Food and Drug Administration had agreed with the European Medicines Agency that the Swedish firm could pursue to a streamlined single clinical trial approach instead of separate Phase I and III trials, allowing it to complete its development program faster and cheaper.
Citing Opdivo brand sales up by almost a tenth to $9bn in 2023, the firms said the partnership with Xbrane “strengthens Intas’s global biosimilar portfolio, emphasizing its commitment to expanding its pipeline through collaborations and enhancing access to high-quality medicines worldwide.”
Noting that Accord “plays a significant role in the global biosimilar market,” the partners said that “with a strong focus on oncology, Accord has extensive commercial expertise and currently supplies about one-third of injectable oncology medicines in Europe.”
And offering expectations on timing, the firms said they “intend to launch the product in the US upon loss of exclusivity by December 2028,” while “launch in Europe could take place after June 2030, after expiry of relevant patents in Europe.”
Opdivo Set To Be First Off-Patent PD-1 Inhibitor
Commenting as Xbrane announced the deal, CEO Martin Åmark – who earlier this year spoke with Generics Bulletin about why the firm favored molecules such as nivolumab over higher-profile targets like Keytruda (pembrolizumab) – said that “we are now, with this partnership, very well positioned to bring our nivolumab biosimilar candidate to launch at the time of patent expiration of Opdivo in the US in December 2028 and June 2030 in Europe,” adding that the firm expected to “generate significant income from profit-sharing from that point and onwards.”
“Opdivo will be the first PD-1 inhibitor to go off patent and has reported global sales of $9bn in 2023 with 9% growth,” Åmark highlighted. “We are convinced that Intas, given its vast capabilities in biosimilar development, is the perfect partner to finalize the development in a timely manner.”
“We are also convinced that Intas’ commercialization arm Accord, given its previous achievements and track record with oncology biosimilars such as Pelgraz (pegfilgrastim), Accofil (filgrastim) and Zercepac (trastuzumab) will do a phenomenal job in commercializing our nivolumab biosimilar in global markets,” he added.
“We believe that introducing biosimilars for core oncology treatments, particularly PD-1 inhibitors, plays a critical role in advancing cancer care,” Åmark concluded. “By making these foundational therapies more accessible, biosimilars enable healthcare systems to allocate more resources towards innovative combination treatments, which have the potential to improve overall treatment outcomes.”
Meanwhile, Intas executive chairman and managing director Binish Chudgar said the partnership “marks a significant milestone in Intas’ global biosimilar strategy.”
“Developing nivolumab as a high-quality, next-generation biosimilar to Opdivo aligns with our ‘patient first’ philosophy, paving the way for innovative and combinatory treatments that improve patient safety, treatment outcomes, and to expand access worldwide,” Chudgar explained. “By leveraging our strong leadership and commercialization capabilities, we are committed to our shared mission of transforming oncology care with accessible and groundbreaking solutions.”
And Paul Tredwell, executive vice president for the EMENA region at Accord, said he was “delighted that Accord Healthcare has strengthened its position as a leader in specialty medicines, particularly in oncology, through its collaboration with Xbrane on developing and commercializing nivolumab.”
“This partnership complements Accord’s existing platform, which supplies up to 25% of chemotherapy medicines in the region,” Tredwell noted, “and further solidifies Accord’s commitment to our mission to improve access to value-based medicines for patients.”
