The rumored deal between Jazz Pharmaceuticals and Celator has just been confirmed by the companies, with Jazz to acquire Celator for $1.5 billion. The Irish company will pay $30.25 per share in a cash-only deal.
The main driver behind the deal was Celator’s experimental acute myeloid leukemia drug, Vyxeos (CPX-351), which recently received a breakthrough therapy designation from the US Food and Drug Administration (FDA). This coveted FDA designation means the agency will hasten its review of Vyxeos, potentially getting it to market sooner.
The drug is designed to treat patients with two subtypes of the blood cancer: therapy-related acute myeloid leukemia, and myelodysplasia-related changes. A recent Phase III clinical trial conducted by Celator successfully met its primary endpoint of improving overall survival.
Compared to a chemotherapy drug called 7+3, median overall survival for patients taking Vyxeos was significantly improved; the Vyxeos group showed a survival rate of 9.56 months, compared to the chemotherapy group at just 5.95 months.
After a year of treatment, 41.5 percent of patients randomly assigned to the treatment arm were still alive, compared to 27.6 percent of those in the chemotherapy group. After two years, there was a 31.1 percent survival rate in participants treated with Vyxeos, with a 12.3 percent survival rate for the 7+3 arm.
Overall, acute myeloid leukemia has a poor survival rate. According to Celator, less than 10 percent of all patients with high-risk variants of the disease survive longer than five years post diagnosis.
Vyxeos is a 5:1 combination therapy of the cancer drugs cytarabine and daunorubicin. The difference is Celator’s nanomedicine drug delivery platform, which the company says can increase the efficacy of the drugs and reduce the risks associated with individual administration of each drug.
“Celator Pharmaceuticals is a strong strategic fit with Jazz Pharmaceuticals. Vyxeos will further diversify our product portfolio and is complementary to our clinical and commercial expertise in hematology/oncology,” said Bruce Cozadd, CEO of Jazz Pharmaceuticals. “As Celator is currently preparing a regulatory submission in the U.S. for Vyxeos, this acquisition would add a new orphan product with the potential for short- and long-term revenue generation and expansion of our international commercial platform.”
The merger is expected to be completed by the end of the third quarter, by which time Celator had previously announced it would be filing a new drug application (NDA) for Vyxeos with the FDA. Despite its current lack of revenue, Celator was valued at about $740 million before the buyout. Considering Jazz is paying nearly double the previous evaluation for the biotech, they must see great promise in the experimental cancer therapy.
“The planned combination of Jazz and Celator is highly complementary, as both companies are dedicated to bringing differentiated therapies to patients who have high unmet medical needs,” said Scott Jackson, CEO of Celator. “We believe that Jazz Pharmaceuticals’ clinical and commercial expertise in hematology/oncology and existing international infrastructure will help realize the value of Vyxeos as a treatment to patients with AML. After thoroughly evaluating our strategic options, our board of directors has unanimously determined that this all-cash transaction is in the best interest of our stockholders.”