Key Developments For Celgene Corporation
Celgene Corporation (CELG.O) (Nasdaq)
Celgene Corporation Updates FY 2009 Guidance In Line With Analysts' Estimates-Conference Call
Celgene Corporation reiterated fiscal 2009 outlook and expects non-GAAP total revenue of $2.6-$2.7 billion and non-GAAP diluted earnings per share (EPS) of $2.05-$2.10. According to Reuters Estimates, analysts were expecting the Company to report revenues of $2.6 billion and EPS of $2.05 for the same period.
Celgene Corporation Updates Data From Randomized Controlled Phase II Study Evaluating Oral Apremilast in Psoriatic Arthritis Demonstrates Sustained Response At Six Months
Celgene Corporation announced that updated results of a phase II, multi center, randomized, double blind, placebo controlled, three arm study of apremilast in adult patients with psoriatic arthritis (CC-10004-PSA-001) were presented at the American College of Rheumatology (ACR) 2009 annual meeting in Philadelphia, PA. Earlier in the year, the core phase of PSA-001 demonstrated that 43.5% of patients in the 20mg BID (p<0.0001) and 35.8% of patients in the 40mg QD daily arm (p=0.002), respectively, achieved an ACR20 compared to 11.8% of patients taking placebo. The ACR20 criteria measure a 20% improvement in tender and swollen joint counts, as well as pain, physical function, an inflammation laboratory marker and overall disease activity. ACR20 is the primary assessment used by the U.S. Food and Drug Administration for assessment of efficacy in psoriatic arthritis, as well as in rheumatoid arthritis. Based on evaluation of ongoing trials, pivotal phase III studies will include doses of 20mg twice per day, as well as 30 mg twice per day, to optimize the therapeutic potential of apremilast. As announced in February 2008, this dosing schedule is also being investigated in a phase IIb study in moderate to severe plaque type psoriasis with results expected in the first half of 2010. PSA-001 also assessed secondary 12 week endpoints including ACR50 and ACR70, defined as the percentage of patients achieving 50% and 70% improvements, respectively, according to ACR criteria.
PTC Therapeutics Announces Celgene Corporation Exercised Option to Drug Discovery Collaboration
PTC Therapeutics announced that Celgene Corporation has exercised its option to collaborate on advancing drug discovery efforts on an oncology target addressed through the application of PTC's GEMS (Gene Expression Modulation by Small-molecules) technology. In September 2007, Celgene made a $20 million equity investment in PTC, which included an option for an exclusive research agreement. Under the terms of the research collaboration agreement, PTC will receive substantial milestone payments for achieving certain discovery, development, regulatory and commercial objectives.
Lawsuit Claims Celgene Corporation Misappropriated The Idea Behind Its Multiple Myeloma Treatments
Beth R. Jacobson (formerly Beth R. Wolmer) has filed suit on August 24, 2009, against Celgene Corporation under the claims of misappropriation of an idea and unjust enrichment regarding the Company's sale of thalidomide (THALOMID and REVLIMID) for the treatment of multiple myeloma. The suit alleges that Ms. Jacobson developed the original and novel idea for treating multiple myeloma with thalidomide and is therefore entitled to compensation consistent with established legal precedent. Ms. Jacobson is represented in this suit by Goodwin Procter LLP. The suit, which was filed in U.S. District Court in Newark, New Jersey, seeks a minimum of $300 million as past damages and 25 percent of the future profits resulting from the sale of Celgene's thalidomide products (THALOMID and REVLIMID) for the treatment of multiple myeloma.
Celgene Corporation Announces Final Results From Two Company Sponsored Studies of Amrubicin In Relapsed Small Cell Lung Cancer
Celgene Corporation announced the presentation of final results from two company sponsored studies of Amrubicin in relapsed small cell lung cancer (SCLC) at the 13th World Conference on Lung Cancer in San Francisco, Calif. The presentations included safety and efficacy data of two phase II studies of therapy in second line patients with SCLC both sensitive and refractory to first line platinum based chemotherapy, respectively. A third presentation detailed the results of a pooled cardiac safety analysis from the phase II studies. Amrubicin is an anthracyline like molecule with potent topoisomerase II inhibition and represents the first solid tumor focused compound to complete phase II studies for Celgene. The study demonstrated that the overall response rate (ORR) was significantly higher in patients treated with Amrubicin (44.0%) compared to patients treated with topotecan (11.5%) (p=0.005), meeting the primary endpoint of the study (to demonstrate an Amrubicin ORR of ? 25%). In addition, the complete response rate was 12% for the Amrubicin arm compared to 4% for the topotecan arm. Of note, for patients aged 65 years or older, the ORR for patients receiving Amrubicin was 46% compared to 7% for patients receiving topotecan. The median overall survival for patients receiving Amrubicin was 9.3 months (95% CI, range 5.8-12.2) compared to 7.7 months for patients receiving topotecan (95% CI, range 4.5-14.0).
