(By Balaseshan) Celgene Corp.'s (NASDAQ:CELG) subsidiary has decided to withdraw the new indication application for Revlimid (lenalidomide) in newly-diagnosed and maintenance multiple myeloma from the Committee for Medicinal Products for Human Use (CHMP), sending its shares down 12.52% in premarket.
In response to the CHMP's request, the company intends to re-submit with more mature data, which allows CHMP to conclude a clear benefit/risk ratio. Celgene International Sàrl provided a regulatory update for Revlimid (lenalidomide) and pomalidomide as treatments for multiple myeloma.
The company reaffirmed its 2012 adjusted earnings guidance of $4.70 to $4.80 per share, and adjusted revenue outlook of $5.40 billion to $5.60 billion, while Street analysts predict profit of $4.79 per share on revenue of $5.47 billion. Revlimid net product sales is expected to be in a range of $3.75 billion to $3.85 billion.
In addition, for the fiscal 2015, Celgene reaffirmed its adjusted earnings forecast of $8.00 to $9.00 per share and adjusted revenue estimate of $8.0 billion to $9.0 billion.
Celgene is proceeding with submissions for Revlimid (lenalidomide) in newly diagnosed multiple myeloma in Switzerland, Australia and other core markets. In the U.S., the company is currently re-evaluating its Revlimid (lenalidomide) newly diagnosed submission to FDA and anticipate submitting an application in 2013.
Celgene's new drug application (NDA) for pomalidomide plus low-dose dexamethasone for patients with relapsed and refractory multiple myeloma was accepted for standard review by the FDA, with a Prescription Drug User Fee Act (PDUFA) date of February 10, 2013.
The company is seeking approval to market pomalidomide in combination with low-dose dexamethasone as a potential treatment for relapsed and refractory multiple myeloma patients who have received at least two prior therapies of established benefit, including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.
The NDA is based on data from a phase 2 study (MM-002) of pomalidomide. Results from this study were most recently presented at the 2012 American Society of Clinical Oncology annual meeting. The company's international, randomized, placebo-controlled phase 3 study (MM-003), in relapsed and refractory multiple myeloma is anticipated to complete enrollment this July. Data are expected by the end of this year.
Celgene has submitted a Marketing Authorisation Application (MAA) for pomalidomide in combination with dexamethasone to the EMA for the treatment of patients with relapsed and refractory multiple myeloma.
CELG closed Wednesday's regular session down 0.68% at $67.16. The stock has been trading between $51.70 and $80.42 for the past 52 weeks.