The renewed orthovisc agreement runs out in Nov 2017... so needs renegotiating end of THIS year. Anika would be mad not to use all the tricks to get a better price and terms: it's "our" brand" after all and they get it for a generic price. I'd say jnj get the lot at a higher price in 2017... However, Anika would use the profits to market its own other products - which would eat up the benefits?.At this rate cingal will not be on the market until 2018, if then - if another trial is demanded - so timing isn't as sweet as it seemed in 2015.... Plan B would be to take back all rights in 2017 ... sure they would lose sales and share for a while but the profits are staggering even on less sales. Plan B is high risk, but also puts the company in play - at the moment it can't be because of jnj.
I am more worried about the fda relationship than direct sales!
Well, someone got nervous, but the marketer jnj was upbeat for this quarter. More than sales, people wil want to hear how cingal is doing vv fda. Clealry no actual progrees as no pr yet....jnj:
"Orthopedic sales growth was driven by worldwide knees and hips and U.S. trauma and spine. Market growth and the success of product launches drove results for the U.S. orthopedics business. Pricing pressure continued across the major categories, partially offset by positive mix for trauma and spine products. The success of the TFNA nailing system in trauma, the ATTUNE platform in knees, our primary stem platform in hips, and ORTHOVISC/MONOVISC and new spine product introductions made important contributions to results.
They are spending 5m a quarter even before the trial starts.. expect rd to double when trial starts - so that is 30/ year for 2 years with 20 in cash now. Numbers do not add up. At minimum an interim look a year into the trial would attract. The drug method and indication all look fine, unfortunate situation.
So far -7%... or then back to where we were before so: plusminuszero. So far, data shows non-inferiority to in.pact, in real-world SFA. What we were not told is bail-out stenting rate, etc. Most important would be better function, is 84% better or even meaningful?! Less drug is safer, but needs a good end result, too in SFA. So far, all else has failed to improve on plain balloon in BTK, so if Stellarex has the right trade-offs there, then it's all worth it. At least the lead here PRof. Zeller is the most critical in the business, so i think we can trust the numbers, if not the spin. 2 days til chance to ask questions is a long time...
Showing fairly good results. This earlier data were from a very small group at 2 sites,so this result de-risks the program big-time. As to whether the dcb works better than in.pact... hard to say. The Medtronic trial results were from a "manipulated" trial and were not so great in the real world study. So what's new. Also,functional benefit was no better than plain PTA... but the latter requred reops. This release says 84% walked farther, but not by how much. The in.pact study showed that at least for their's the critical period was 13-15 m... during whic there was a step fall off in effectiveness. Hopefully, with no mention of MACE or mortality, safety not an issue. In the medtronic case mortality was overlooked in approval. Looks goo, but all the bad stuff happens in the next 12 m, if it happens!