Source : 'Scrip Intelligence'
Ipsen SA ’s specialty care business expects headwinds in 2021 from a phased launch of a generic version of its somatostatin analog Somatuline (lanreotide) in Europe and a limited impact from a potential launch of octreotide (another somatostatin analog) or lanreotide generics in the US.
Nonetheless, the mid-sized Paris-headquartered pharmaceutical company is expecting group sales to increase by more than 4% in 2021 at constant currency, with a -3% impact of currency based on January 2021 exchange rates. Core operating margin is expected to be greater than 30%, the company said.
The 2021 guidance follows a year in which Ipsen met its financial target, with group sales in 2020 growing by 3% (at constant exchange rates (CER), or +0.6% as reported) to reach €2.6bn, driven by growth of its specialty care business, where sales grew by 5.9% to €2.4bn; specialty care products now account for 91.9% of the multinational’s total sales. In contrast, sales in Ipsen’s consumer healthcare business declined by 21.3% during 2020 to reach €210.6m, mostly due to the impact of COVID-19.
Among its specialty care products, the anticancer agent Cabometyx (cabozantinib, licensed from Exelixis, Inc.) showed the highest growth rate, up by 20.8% at CER to reach €288.9m, while its top-selling product, Somatuline, had sales of €1.1bn, up by 13.1%. The hormonal therapy Decapeptyl (triptorelin) achieved sales of €390.5m in 2020, down 3.1%, due to lower sales in China impacted by COVID-19. The closure of treatment centers due to the pandemic also had an adverse effect on Dysport (botulinum toxin type A) sales, which declined by 9% to €388.3m.
As part of a new business strategy outlined last year by the newly appointed CEO David Loew, the building of a high-value sustainable R&D pipeline is one of four priorities for Ipsen. “We recognize we have an unbalanced pipeline with relatively few early stage clinical and preclinical assets,” Loew noted during an analysts briefing on 11 February.
“We aim to bring in assets across all stages of development,” Loew reported, and across its three key therapeutic areas of oncology, rare diseases and neuroscience. The company aims to extend its anticancer efforts to hematologic cancers, niche tumor targets and candidates with life-cycle extension potential; the company’s “firepower” for business development transactions increased to €1.3bn by the end of 2020 (see sidebar) .
That said, Ipsen is also making launch preparations for its next likely marketed product, palovarotene, which is on track to be filed for approval with the US Food & Drug Administration and the European Medicines Agency in the first half of 2021, for the treatment of fibrodysplasia ossificans progressive (FOP). A follow-on candidate for FOP, IPN60130 (BLU-782) is on track to begin a Phase II program this year.
Loew noted that regulatory decisions on the use of Cabometyx as a first-line therapy in renal cell carcinoma are expected by the middle of this year, and the unblinding of the COSMIC 312 study of Cabometyx in hepatocellular carcinoma is expected in the first half of 2021. Phase III studies are underway with Cabometyx in non-small cell lung cancer and metastatic castration-resistant prostate cancer, with approval submissions penciled in for 2023.
In the first half of 2021, Ipsen also expects interim analysis of the second-line use of Onivyde (irinotecan) in small cell lung cancer in the RESILIENT study, which has potential for gaining an accelerated approval; if the ongoing NAPOLI 3 study of Onivyde as a first-line therapy for pancreatic cancer is successful, the product could be submitted for approval in 2023.
By John Davis