Allergan chases high-dose, low side effects Alzheimer’s combo in biotech buy

Brent Saunders has been a man M&A possessed since escaping the clutches of Pfizer in April

Allergan. M&A of an SME biotech. Millions of dollars involved, biobucks down the line. Seem familiar? Well, the co, still paving an independent path forward after not being subsumed by Pfizer in the spring, is at it again, this time buying out Chase Pharma in a $125 million deal.

What it’s got are two generic APIs combined together: the first being the copycat form of Pfizer and Eisai’s Alzheimer’s med Aricept (donepezil) and the second Astellas’ Vesicare (solifenacin), a peripherally acting cholinergic blocker, used for urinary issues such as overactive bladder disorder.

This combined med, known as CPC-201 (and with its own patent), is set to use both meds together as it appears to allow for a higher dose of Aricept but without higher side effects rates, and thus could boost efficacy from the med.

In its most recent phase 2 trials, 29 out of 33 patients (88%) reached 40 mg per day of donepezil (the maximum dose allowed), without experiencing dose-limiting adverse events, and new owner Allergan is now prepping a phase 3 registration study for next year to show whether it can boost its efficacy against the memory-stealing disease in a bigger test.

Aricept, which recently begun losing patent protection, has only a modest impact in helping Alzheimer’s patients, and there remains a major unmet need in this space, with the R&D pipelines of many biopharmas littered with costly failures.

This new approach, however, could yield a bright spot, although much still remains in the balance. In an analyst note from Bernstein, the firm said it did some digging, and found two patents assigned to Chase: 8,404,701 and 9,044,472 (both expire March 2028) that go some way to explain what the theory behind this combo med is.

“The ‘701 patent claims a method of raising the therapeutic effect of acetyl choline esterase inhibitors (i.e. Aricept) by adding a peripheral muscarinic anticholinergic agent (PAChA). The patent goes on to claim that the dose-limiting side effects of Aricept are due to action in the periphery and thus by giving non-CNS penetrant PAChA, the side effects can be removed. The ‘472 patent claims the formulation of the two drugs together.

“Thus, it seems that the objective of the acquisition and the phase 3 is to confirm the highest dose of Aricept can be reached with lower side effects and to presumably test if dosages higher than 40mg can provide added efficacy. We expect this drug would reach the market by ~2020.”

It said that, assuming the data affirms the news, “this is certainly an intriguing product and well worth the $125 million spent on the acquisition.” 

The analysts added: “A decade ago, this could have been a multi-billion blockbuster drug. Now, it seems more dependent on how good the amyloid beta based drugs will be [currently being tested by companies such as Lilly, although it failed its test today]. Still, we expect that for patients who are candidates for Aricept, this could be an improvement. Further, given Allergan’s existing commercial infrastructure, the return on investment could be high.”

The deal also makes sense given that it had been run by ex-Allergan president Doug Ingram, who helped raise $12 million for the biotech back in March. 

Allergan, which in April escaped the clutches of a potential $160 billion merger deal from Pfizer, has been racking up its own M&As and bolt-on pacts in 2016, with a slew coming in the last month alone.

This includes a $60 million upfront asset deal with gene therapy specialist RetroSense; a $639 million buyout of small-cap dermatology biotech Vitae; and then the up to $1.7 billion acquisition of Tobira and the most recent $50 million upfront for Akarna.

The company has felt the weight of its wallet since selling off its generics to Teva for over $40 billion (which includes a 10% ownership in the Israeli generics giant) in July.

And last month it signed a deal potentially worth up to $1.5 billion with AstraZeneca for an exclusive worldwide license to develop and commercialize its experimental GI candidate MEDI2070.