Four days after Acerta Pharma quietly posted some promising early-stage data on its Bruton's tyrosine kinase (Btk) inhibitor acalabrutinib, AstraZeneca ($AZN) has popped up as a potential buyer. The Wall Street Journal reported Friday afternoon that the pharma giant is well down the road in talks to buy Acerta Pharma for more than $5 billion, potentially landing another cancer drug for its growing oncology pipeline. And the pharma giant confirmed Monday morning that it's in "strategic" talks with the biotech.
"There can be no certainty that any transaction will ultimately be entered into, or as to the terms of any transaction," AstraZeneca noted in a statement.
Acerta's lead drug is being positioned as a possible rival to Imbruvica (ibrutinib) from Johnson & Johnson ($JNJ) and AbbVie ($ABBV), which have been building their case to use the drug as a frontline therapy for chronic lymphocytic leukemia. Back in March, AbbVie paid $21 billion to buy Pharmacyclics and get its hands on a major share of the Imbruvica revenue.
AstraZeneca would appear to be angling for a piece of that market.
Tested in 65 patients, investigators reported that acalabrutinib (ACP-196) garnered an impressive 95% response rate among patients with relapsed chronic lymphocytic leukemia, a common form of adult leukemia. Those data were compiled at a median follow-up of 14.3 months. The low-profile biotech, which has Dutch roots and a U.S. HQ in Redwood City, CA, is also developing CP-319, a PI3k delta inhibitor.
In addition to the solo drug studies it has underway, Acerta is collaborating with Merck on a combination study using Keytruda, a landmark PD-1 checkpoint inhibitor. While there isn't a lot of publicly available information on the company, the Dutch venture group BioGeneration Ventures provided an A round around 2013, placing Edward van Wezel on the board.
AstraZeneca, which has been pummeled by generic drug competition, has been hard at work in building its cancer drug pipeline. The pharma giant nabbed an FDA approval for Tagrisso (AZD9291) just weeks ago, marking a major win for the pharma giant. It's also looking for a near-term approval for its PD-L1 drug durvalumab, though CEO Pascal Soriot recently noted that their first approval may not come as soon as the company had hoped, with rival therapies from Merck ($MRK) and Bristol-Myers Squibb ($BMY) already on the market.
Top analyst Tim Anderson at Bernstein sees the deal as a potential plus for AstraZeneca, which may have been attracted by the ex-Pharmacyclics execs who are running Acerta.
"Despite being privately held, Acerta is running an impressive 21 clinical trials in the blood cancer space, including two phase 3 trials ..." says Anderson. "These are audacious but shrewd trials that signal confidence in their drug and a sophisticated understanding of the CLL landscape. Acerta means business."
Biopharma companies have been wheeling and dealing on the M&A side, with Celgene ($CELG) leading the way and Allergan ($AGN) and others following suit. Some Big Pharma companies have been content to sit on the sidelines this year to wait for lower valuations, but at $5 billion-plus the early-stage, private Acerta would appear to be a pricey prize.
- here's the report