Celgene's ($CELG) Otezla has been rolling along in the U.S. toward its aspirations as a blockbuster, picking up an approval for psoriatic arthritis before grabbing an FDA nod for the much wider use for psoriasis. But the Summit, NJ-based biotech has hit a snag with the notoriously difficult German cost watchdog IQWiG, which said it just doesn't see the added benefit over treatments already on the market.
The finding, if it stands, makes it hard for Celgene to market the next-generation autoimmune drug at its full price there. As PMLive reports, the cost reviewer said that the company didn't offer data in which it pitted Otezla against an appropriate comparable drug for either plaque psoriasis or active psoriatic arthritis. It provided only comparisons to placebos, making it hard for the group to determine any added benefit to what's already on the market.
Of course there are some well-established drugs it is pitted against, including AbbVie's ($ABBV) top seller Humira and Enbrel from Amgen ($AMGN) and Pfizer ($PFE) and Johnson & Johnson's ($JNJ) Remicade. In fact, they are the three best-selling drugs in the world. But those are injections while Otezla is a pill and it is the first of a new generation of autoimmune treatments for the painful conditions.
How Germany finally decides to price Celgene's drug will be watched closely by a host of drugmakers. Eli Lilly ($LLY), Novartis ($NVS), Amgen, AstraZeneca ($AZN), Merck ($MRK), and Johnson & Johnson all have their own new psoriasis treatments in the works. Lilly and Novartis last year both offered up some promising data for their contenders. The recommendation must still go to a review board that will have the final say on what price to put on the drug in Germany, one of the largest markets in the world, so Celgene may yet clear this hurdle.
As for Otezla's cost, Celgene actually brought it to market at a discount to the entrenched competitors. It has a wholesale price in the U.S. of $22,500, which analysts said was about a 30% discount to Humira and Enbrel but higher than some expected. At that price they told investors, it would make it easier to break into a tough market while still providing Celgene with some unexpected upside.
Otezla (apremilast) is expected to hit blockbuster territory by 2018, with $1.3 billion in sales by then and Celgene has said it thinks the pill can perform even better than that. It is projecting peak sales of up to $2 billion. To reach that realm, the drugmaker is working on other indications for Otezla, including rheumatoid arthritis, a market that would go a long ways toward providing those kinds of returns.
Special Reports: Top 10 best-selling drugs of 2013 - Humira - Enbrel - Remicade
Celgene's Otezla nabs psoriasis approval, launching next-gen showdown
Big Pharma, Big Biotech prepare for showdown in next-gen psoriasis market
Lilly's strong results for psoriasis drug come on heels of data from Novartis
Novartis' Enbrel beater nears a soon-to-crowd psoriasis market
Celgene thinks its Otezla pill will be easy for the market to swallow