Persistence has paid off for Anika Therapeutics, taking the market by surprise. The Massachusetts company has managed to secure US premarket approval (PMA) for its single-injection osteoarthritis treatment Monovisc at the third attempt. The 49% rise in Anika’s shares in early trading today, to $50.25, points to the unexpected nature of the FDA’s decision.
Monovisc is a follow-up to Anika’s earlier hyaluronate product, Orthovisc, which requires three injections and currently has a 12% share of the US viscosupplementation market. But single-injection versions are already sold by Genzyme and Zimmer, and Anika and its US partner DePuy Synthes will have to fight for share.
It could have a fair chance in such a fight, at least: trial data indicate that Monovisc has a more rapid onset of pain reduction and longer-lasting effect than the Genzyme and Zimmer products.
One against three
It will certainly be a relief for Anika not to have to rely on Orthovisc. While Orthovisc is the market leader in the US multi-injection segment, and the number-two US brand in viscosupplementation overall, patients are understandably turning away from multi-shot therapies. One-off injections are the future.
Monovisc is a resorbable viscoelastic fluid injected into the synovial fluid of an osteoarthritic joint to relieve joint pain. It has been available in Europe since 2008, and Anika has been trying to get it onto the US market since 2009 (Anika’s treasure hunt remains stuck in reverse, December 6, 2012). The company responded to the most recent rejection by submitting more data last July.
Anika can now look forward to the $5m it will receive from Johnson & Johnson's DePuy Synthes subsidiary, which has US rights to the drug, when Monovisc goes on sale. Launch is set for March. Royalties and other fees will follow, which will come in handy as Anika is putting another osteoarthritis project, Cingal, through phase III.
Cingal is a slight departure from Anika’s central strategy focus on hyaluronate formulations as it also contains the long-acting corticosteroid triamcinolone. The phase III trial is aimed at securing a CE mark – Anika’s therapies are regulated as devices – and should complete recruitment of 370 patients in the second quarter. This study is expected to cost around $5m, much of which Anika has already paid out.
Aside from veterinary and aesthetic candidates, the only other product in Anika’s pocket is Incert, intended to prevent surgical adhesions – scar tissue that forms after operations, connecting tissues that should not be attached. Incert is already CE marked, so perhaps Anika’s next move will be to get FDA approval, providing another revenue stream to help fund Cingal’s development.
However Anika decides to prioritise the development of its current projects, expectations will be higher as of today. It has triumphed with a product that had been all but written off. Investors may well expect similar miracles in future.