Eyeing rival mAb mob, Novartis touts PhIII secukinumab psoriasis data

Investigators for Novartis pumped out more positive Phase III data for its psoriasis therapy secukinumab over the weekend, adding some patient satisfaction scores on the self-injected treatment as the company positions this new product against a host of rivals that promise to quickly crowd the field.

The pharma giant ($NVS) had no trouble illustrating a dramatic difference in efficacy between secukinumab (AIN457) and a placebo. The therapy had already beat out much tougher competition in a head-to-head with Enbrel and a 300 mg and 150 mg dose scored high response rates in both Phase III studies, compared with no response in the placebo arms. The data were presented at the American Academy of Dermatology in Denver.

But Novartis, which has already filed its IL-17A inhibitor for an approval, won't be competing with placebos in the marketplace. Even Enbrel isn't likely to be a long-term factor. The company's big hurdle will be facing challengers now in Phase III.

Celgene ($CELG) just won an approval for Otezla (apremilast) for psoriatic arthritis on Friday and filed its application on psoriasis last fall. Celgene went to Denver to tout new extended Phase III results for its oral therapy. Amgen ($AMGN) and AstraZeneca ($AZN) pushed their IL-17 treatment brodalumab into Phase III in the fall of 2012. In the fall of last year Amgen's Sean Harper boasted that the therapy achieved primary and secondary endpoints in Phase II, with bullish expectations for their Phase III program. Eli Lilly ($LLY) has an IL-17 drug as well, ixekizumab, which is in Phase III. Merck's ($MRK) MK-3222 is also coming along. And cheaper biosimilars of Enbrel have been pushed along by Cipla and Novartis and others.

Coming up from behind is Johnson & Johnson's ($JNJ) guselkumab, which targets  IL23p19 and is partnered with MorphoSys AG. The drug is touted as a top contender in J&J's pipeline, with a prospective approval coming in the 2015-2017 time frame. In a Phase IIb unveiled in Denver, investigators found that 86% of patients taking the 100 mg dose experienced very high clearance scores, according to Reuters. And some doses also beat out Humira.

Complicating this rivalry, all of these drugs are posting high clearance rates, making for a brutal showdown if they all get to the marketplace.

That's one reason why Novartis highlighted patient satisfaction in self-administering the drug with a pre-filled syringe or autoinjector pen. This condition afflicts some 125 million people and patient satisfaction on an easy delivery method will be crucial to its success on the market.

"Treating psoriasis can be challenging as not all treatments are appropriate or effective in every patient," said Dr. Andrew Blauvelt, an investigator in the secukinumab clinical trial program, in a statement. "The clinical data we have seen with secukinumab suggest it may offer a new therapeutic approach for patients living with moderate-to-severe plaque psoriasis."

Tim Anderson at Bernstein has estimated that the Big Pharma companies are angling for a market likely to deliver anywhere from $500 million to $700 million a year for each product by 2020, with Novartis coming out on the top of that range. Some analysts expect that new psoriasis treatments could double the overall market by 2022.

- here's the press release
- read the story from Reuters

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