May 31, 2016
By Alex Keown, BioSpace.com Breaking News Staff
DUBLIN – Shares of New Jersey-based Celator Pharmaceuticals have soared more than 70 percent this morning after news broke that Jazz Pharmaceuticals plc struck a deal to acquire Celator and its promising leukemia drug for approximately $1.5 billion.
Jazz said the acquisition of Celator and its lead drug VYXEOS will advance the company’s growth strategy and broaden its hematology and oncology portfolios.
VYXEOS is an investigational product in development as a treatment for acute myeloid leukemia and other blood cancers. Earlier this month, VYXEOS received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). The designation is primarily based upon the positive results from the pivotal Phase III clinical trial in older patients with previously untreated high-risk (secondary) AML, Celator said in a May 19 statement. AML is the most common form of leukemia in adults, with more than 20,000 new cases diagnosed annually in the United States.
“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,” Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc, said in a statement. “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 FDA typically awards Breakthrough Therapy designation in order to expedite the development and review of new medicines that are intended to treat serious or life-threatening diseases when the therapy has demonstrated substantial improvement over available therapies on at least one clinically significant endpoint or when there is significant unmet medical need. During its Phase III trial, VYXEOS demonstrated a statistically significant improvement in overall survival for those AML patients, which is one of the points that attracted the interest of Jazz Pharmaceuticals. Celator plans to submit a New Drug Application to the FDA by the end of the third quarter of 2016.
“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,” Scott Jackson, chief executive officer of Celator, said in a statement.
The transaction is expected to close later this year. According to the agreement, Ireland-based Jazz Pharmaceuticals will pay $30.25 per share in cash for the company. Shares of Celator are trading at $29.98 this morning, up from its closing price of $17.43 per share.
The AML market is a broad one, with multiple companies developing products to treat patient segments. California-based startup FLX Bio, which just snagged $50 million in funding, is developing an early-stage selective inhibitor of FLT3 and CDK4/6 for the treatment of AML. Earlier this year, Astex Pharmaceuticals, Inc., a subsidiary of Japan-based Otsuka Pharmaceutical Co. Ltd., forged a deal with Genentech to develop a combination treatment for acute myeloid leukemia.
