After a couple of pipeline setbacks, Celgene has said it is preparing to file five new products between now and the end of 2020 that analysts say will reduce its reliance on cancer cash-cow Revlimid.
The five are all “potential blockbusters”, according to Celgene’s chief executive Mark Alles on the company’s third-quarter results call. The statements came as Celgene reported expectation-topping sales and earnings driven by Revlimid (lenalidomide) and new psoriasis therapy Otezla (apremilast).
The five blockbusters-in-waiting are multiple sclerosis therapy ozanimod – which has been delayed by the FDA’s refusal to accept the company’s regulatory filing earlier this year – fedratinib for myelofibrosis, thalassaemia therapy luspatercept, and CAR-T candidates lisocabtagene maraleucel (liso-cel) for lymphoma and bb2121 for multiple myeloma.
Analyst Andy Hsieh at William Blair said the launch schedule for the pipeline products “could offset the company’s reliance on Revlimid”, which accounted for $2.45bn of its $3.89bn in revenues in the third quarter but is just a few years away from patent expiry and generic competition. The two CAR-Ts could be approved in 2020, while the other three candidates are due to be submitted from the end of this year through the first half of 2019.
“We believe Celgene is gradually emerging from several execution setbacks in the past year by regaining operating momentum and investor trust,” said Hsieh, who reckons the new drugs could reach $9bn in peak sales. For comparison, Revlimid sales are expected to come in at around $9.7bn this year.
The late-stage pipeline is setting Celgene up for a busy American Society of Haematology (ASH) meeting in December, with new data expected on both CAR-T therapies as well as read-outs from the MEDALIST trial of luspatercept in myelodysplastic syndrome (MDS) and the BELIEVE trial in beta-thalassaemia. Also on the agenda is a closer look at the AUGMENT trial of Revlimid with Roche’s Rituxan (rituximab) in relapsed/refractory indolent lymphoma.
Looking at the quarterly figures, the standouts were Revlimid’s 18% gain, a 23% rise for blood cancer stable mate Pomalyst (pomalidomide) to $513m, and a 40% boost for Otezla to $432m, which Celgene said puts it on course for around $1.6bn in 2018, its first full-year on the market.
The company is also trying to extend use of Otezla into additional indications, and despite reporting mixed phase 2 data in ulcerative colitis earlier this year has moved ahead with a registration trial in this indication – TRUE NORTH – as well as studies in Crohn’s disease.
Celgene also bolstered its management team in the quarter, and announced the appointments of Dr Alise Reicin as president, global clinical development, and Aijaz “Jazz” Tobaccowalla as chief digital & information officer.
“Celgene’s fundamentals are strong, including robust commercial performance, a broad transformative pipeline, and a strengthened management team,” said Alles on the call.
“We look forward to reporting on and realizing the benefits of several near-term catalysts, starting with an extremely promising ASH meeting in just a few short weeks.”