Celgene (CELG) announces the publication of Phase 3 data from MM-003.
The results show oral pomalidomide plus low-dose dexamethasone demonstrated significant PFS improvement compared to high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma who have failed at least two prior therapies with both bortezomib and lenalidomide. (PR)
Data from a Phase II study of a Revlimid/ dexamethasone combo followed by Revlimid (CELG +1.6%) maintenance therapy in patients with high-risk asymptomatic smoldering multiple myeloma have been published in the August 1 edition of the New England Journal of Medicine.
Primary endpoint results: At a median follow-up of 40 months, median time to progression was "significantly longer in the treatment group compared with the observation group." (PR, full article)
Celgene (CELG) intends to offer, subject to market and other conditions, senior unsecured notes under a shelf registration statement.
Interest rate, maturity dates and other key terms of the offering to be determined at the time of pricing.
CELG will use the net proceeds from the offering for general corporate purposes, "which may include, without limitation, further development of Celgene's clinical and pre-clinical programs, capital expenditures, general corporate development activities, meeting working capital needs, share repurchases of Celgenes common stock and repayment of some or all of Celgenes outstanding commercial paper."
Barclays (BCS) Citigroup (C), Deutsche Bank Securities (DB) and J.P. Morgan (JPM) acting as joint book-running managers.
Array BioPharma (ARRY) says it will receive up to $387M in upfront and potential milestone payments under a new collaboration with Celgene (CELG) for its preclinical development program targeting an inflammation pathway.
Under the terms of the agreement, ARRY will receive an upfront payment of $11M and give CELG the exclusive option to license multiple clinical development candidates.
Additionally, it will potentially receive up to $376M in potential milestone payments based upon meeting certain development, regulatory and sales goals, as well as royalties on sales of all drugs.
ARRY will retain all rights to the program if CELG doesn't exercise its option.
Celgene (CELG -0.7%) enters into a strategic collaboration and will make a $100M upfront cash payment for an exclusive option giving it the right to buy Acetylon Pharmaceuticals - a developer of small molecule drugs that target epigenetic mechanisms for the treatment of cancer and other critical human diseases.
Acetylon will retain control of its drug development program during the option period.
If Celgene exercises its option, an upfront payment with a minimum floor of $500M, will be paid at closing.
Additionally, Acetylon shareholders will be eligible to receive potential future milestone payments totaling up to $1.1B depending upon certain targets.
More on Celgene (CELG +2.1%) Q2: net profit +30% to $478M; adjusted net profit +20% to $653M. Revenue +16.8% to $1.6B. Revlimid (multiple myeloma) sales $1.05B vs forecasts of $1.04B. Abraxane sales $155M and Pomalyst (recently launched) $66M; both are cancer drugs. Raises FY guidance: EPS seen at $5.80-5.90 vs $5.55-5.65 prior forecast and consensus of $5.77; net product sales seen at $6.2B vs $6B and $6.18B.
Celgene (CELG -2.5%) has halted a Phase III trial of its Revlimid blood cancer drug following a higher number of deaths among patients who were taking the drug than among those taking a placebo. The study was testing the drug on previously untreated, elderly patients with B-cell chronic lymphocytic leukemia. All other Revlimid trials for chronic lymphocytic leukemia are proceeding. (PR)
The FDA approves the first brain wave test that could help diagnose children and teens with ADHD. Called the NEBA system, the 20-minute test uses an electroencephalogram to calculate the ratio of two brain wave frequencies, called theta and beta, which studies have shown is higher in children and teens with ADHD. The device can be used in patients between the ages of 6 and 17 as part of a complete psychological examination to either help confirm diagnosis or bolster a doctor's decision that more testing is needed.
"We expect upside for shares on this derisking event," Wells Fargo says, referencing data released today by Celgene (CELG +7%) on Revlimid's performance in Phase III multiple myeloma trials. "We would remain buyers," analyst Brian Abrahams notes, adding that he "expects favorable detailed data at ASH."
Celgene (CELG) has paid $15M for the right to first negotiation for the Neo-Kidney Augment product of closely held Tengion. The product is in Phase I trials and is designed to restore renal function in patients with chronic kidney disease. Celgene has also obtained an exclusive option to acquire assets such as Tengion's technology for growing esophageal implants, and it has received stock warrants. Celgene invested $5M in Tengion in October 2012. (PR)
Onyx (ONXX) shares rocket 51% to $130.98 after the company says that it's rejected a $120/share offer from Amgen (AMGN +0.6%) and that it's seeking buyers after receiving inquiries. There's no shortage of speculation about who could acquire Onyx, with Bayer (BAYZF.PK), Celgene (CELG), Novartis (NVS), Bristol-Myers (BMY), AstraZeneca (AZN), Eli Lilly (LLY), Gilead (GILD) and Pfizer (PFE) all mentioned. However, Forbes' Matthew Herper notes that potential blockbuster blood-cancer drug Kyprolis has only received accelerated FDA approval, which can be revoked. Big Pharma may have wanted to await further trial results later this year amid concerns about Kyprolis' safety.