Celgene predicts trio of blockbusters
pharmafile | June 5, 2013 | News story | Sales and Marketing | Celgene, Pomalidomide, Revlamid, Velcade
Europe’s medicines committee the CHMP has just adopted a positive opinion for Celgene’s new multiple myeloma treatment Pomalidomide Celgene (pomalidomide).
Celgene has grown rapidly in recent years, thanks to its focus on developing drugs for cancer, and in particular blood cancers, and is now set to extend its franchise.
Pomalidomide is just one of three drugs now under review by regulators, and the US firm says they are all likely to exceed the $1 billion peak sales ‘blockbuster’ mark.
Celgene’s flagship product is multiple myeloma drug Velcade (bortezomib), which is forecast to reach $4.1 billion in sales this year, accounting for most of Celgene’s total revenues of $6 billion.
Pomalidomide, the firm’s next-generation multiply myeloma treatment, is already on the US market, and analysts predict peak sales over $1 billion.
Third line treatment
Once approved in Europe, pomalidomide would be used in combination with dexamethasone for relapsed and refractory multiple myeloma (rrMM) in patients who have received at least two prior therapies, including both Revlamid (lenalidomide) and Velcade (bortezomib), and have demonstrated disease progression while on their last therapy.
“Celgene is the first company in more than 40 years to deliver two oral treatments for multiple myeloma,” said Alan Colowick, president of Celgene Europe, the Middle East and Africa.
“These treatments continue to play an important role in increasing overall survival for patients living with this rare disease. Following the final decision by the European Commission within the next few months, we hope to bring oral pomalidomide, Celgene’s third and important treatment option for patients who have fully benefitted from other treatments including lenalidomide and need new options to help treat their disease.”
The CHMP positive opinion was based on the results of the MM-003 study, a Phase III, multi-centre, randomised (2:1), open-label study in 455 patients. The trial evaluated use of oral pomalidomide plus low-dose dexamethasone (n=302) compared with high-dose dexamethasone (n=153) in patients with rrMM.
All patients were to have been treated with both bortezomib and lenalidomide prior to study entry. Trial results show that progression-free survival, the primary endpoint, was significantly longer in patients on pomalidomide plus low-dose dexamethasone (15.7 weeks) compared with those who received high-dose dexamethasone alone (8 weeks [HR, 0.45; P<0.001]).
Median overall survival, the secondary endpoint, was also significantly improved for pomalidomide plus low-dose dexamethasone arm, compared with high-dose dexamethasone only (due to patients still on therapy in the pomalidomide plus low-dose dexamethasone arm, the median has not yet been reached vs. 34 weeks in the high-dose dexamethasone arm [HR, 0.53; P<0.001]).
The most common grade 3/4 haematologic toxicities for the pomalidomide plus low-dose dexamethasone arm and high-dose dexamethasone arms were neutropenia, thrombocytopenia and febrile neutropenia.
Risk programme
Pomalidomide, like Revlamid (lenalidomide) is an analogue of thalidomide, and is the result of Celgene’s attempts to create a drug with greater potency against cancers, whilst reducing the seen side effects in these patients taking thalidomide.
Thalidomide is of course infamous for having caused birth defects when pregnant women were prescribed the drug as a morning sickness treatment in the late 1950s and 1960s. Because Pomalidomide also poses this embryo-foetal risk, the FDA stipulated that it can only be made available only through a Risk Evaluation and Mitigation Strategy (REMS) Programme, similar to existing ones for thalidomide and lenolidomide.
Common side effects include neutropenia, fatigue and weakness, low red blood cell count (anemia), constipation, diarrhoea, low levels of platelets in the blood (thrombocytopenia), upper respiratory tract infections, back pain and fever.
Despite the need for these safety measures, the demands for the drug is expected to be strong. Onyx’s Kyprolis is one of the drug’s main competitors, and was approved in July 2012.
Pomalyst does carry a higher price than Kyprolis, but analysts are tipping it to come out on top, thanks to Pomalyst’s clinical data, as well as Celgene’s heritage and marketing experience in the multiple myeloma market.
One further advantage pomalidomide has it is an oral medication, while Kyprolis has to be injected.
Other major launches
Celgene has two other very promising new drugs approaching the market. Apremilast has been filed with EU and US regulators for the treatment of psoriatic arthritis. The drug has produced very encouraging Phase III data, and its oral formulation means it could displace TNF drugs such as Abbott’s Humira for many patients.
Finally Abraxane is a hi-tech reformulation of paclitaxel, which binds the drug to protein particles, allowing the chemotherapy to reach target tumours more effectively. It has also been filed with EU and US regulators, and has been given ‘priority review’ status with both agencies.
All three products are predicted to break the $1 billion barrier if approved, which Celgene predicts will keep it growing rapidly over the next 5-10 years.
Andrew McConaghie
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