Correction: The first version of this column stated incorrectly that Amarin has no composition of matter patents filed for AMR101. The company has both composition of matter and method of use patents. The column has been update to reflect the correct information.
) --I have a lot more to say about
in this week's Biotech Stock Mailbag. The Hostile React-o-Meter spun outta control (!!!) in response to my column Wednesday discussing the
high-level meeting that took place in June between FDA and Amarin executives
Before I dive back into Amarin, however, let's discuss
and the announcement that's expected soon of results from a mid-stage study of its rheumatoid arthritis drug Synavive.
@delta4_98 tweets, "Adam, I am curious to hear your opinion on ZLCS Synavive AR."
Zalicus was formerly known as CombinatoRx, and as the old name implies, the company believed combining old, generic and seemingly disparate drugs into a single pill could yield new treatments for a variety of diseases.
Synavive, also known as CRX-102, combines a low dose of prednisone, a commonly used and cheap steroid, with dipyridamole, a drug first approved in 1961 that is usually prescribed along with other drugs to prevent blood clots after heart surgery.
Prednisone is a standard therapy for rheumatoid arthritis patients along with other medications to reduce the painful swelling of joints. The idea behind Synavive is that dipyridamole and prednisone act synergistically, allowing a lower dose of prednisone in the combo pill to be just as effective and better tolerated compared to the higher dose of the steroid prescribed today.
Zalicus will be announcing top-line results from a phase IIb study of Synavive in the third quarter, most likely in August. The study enrolled 250 patients with moderate to severe rheumatoid arthritis and randomizes them to one of five treatments: Synavive (2.7 mg prednisone/360 mg dipyridamole), dipyridamole alone, prednisone (2.7 mg) alone, prednisone (5 mg) alone or a placebo.
The study lasts for 12 weeks, after which patients will be assessed for response using the Disease Activity Score in 28 Joints (DAS28), a common efficacy measure used in rheumatoid arthritis clinical trials.
Obviously, Synavive shouldn't have a tough time beating placebo so the more important comparison will be Synavive's activity compared against the drug's individual components and the 5 mg dose of prednisone. The latter is probably the most important hurdle in this phase II trial. Prednisone literally costs pennies per pill, so if Synavive can't demonstrate better efficacy with fewer side effects, its commercial potential dwindles to nothing.