Biggest Clinical Wins of the Week: Large-Cap Edition

Last week, big pharma icons Pfizer (NYSE: PFE  ) , and Novartis (NYSE: NVS  ) stayed just even with the broad market despite posting some great news from the clinic. Celgene (NASDAQ: CELG  ) announced some results that could quickly lead to a revenue-boosting label expansion. Even great news from the biotechnology giant wasn't enough to avoid the industrywide sell-off last week.

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Moving quickly
Almost immediately following FDA approval for Otezla in psoriatic arthritis, Celgene posted trial data supporting its case for the broader psoriasis population. Patients receiving Otezla for 52 weeks demonstrated a mean psoriasis area and severity index improvement of 81%. Patients with psoriasis in difficult-to-treat areas, like the fingernails and scalp, also demonstrated positive response.

Assuming approval for the the larger plaque psoriasis population, potential sales estimates for the oral PDE4 inhibitor vary. Celgene suggests between $1.5 billion and $2 billion by 2017. EvaluatePharma's consensus puts peak sales at just $1 billion. With 2013 revenue of just $6.5 billion, even the low-end estimates represent a big win if the drug is approved.

While analysts can't agree on Otezla's sales potential, most think the competition will be fierce. AbbVie (NYSE: ABBV  ) , Amgen (NASDAQ: AMGN  ) , and Pfizer aren't about to let Otezla take market share from Humira and Enbrel without a fight. They have plenty of sales and marketing muscle to make a successful launch difficult for Celgene.

Luckily, Otezla brings some important features to the table. Patients suffering from sore injection sites ought to be interested in a well-tolerated pill. At just $22,500 per patient per year, Otezla is priced lower than most biologics. Considering the savings, government and private payers have good reasons to give patients the option. 

Just better
Pfizer posted three big clinical wins last week. Its next-generation cholesterol drug, bococizumab, met its primary endpoint in a phase 2b trial. A week earlier, it was Amgen posting great results with its PCSK9 program. Pfizer also hit the mark in a phase 3 Genotropin growth hormone study. Children 24 to 30 months old and considered too small for their age who took the drug grew faster than the control group.

The biggest win for Pfizer last week put Xalkori a step closer to expanding into first-line lung cancer. In a head-to-head test with standard platinum-based chemotherapy regimens, Xalkori was better at prolonging progression-free survival.

The most troubling part of the announcement was that it provided no figures. Pfizer didn't quantify just how much longer it prolonged survival or what percentage of patients responded. Data from this study will be submitted for presentation at an undisclosed future medical meeting. Investors want to keep their eyes open for that data and recognize that approval is by no means assured.

The oral ALK inhibitor won an accelerated approval in 2011 for treatment of metastatic lung cancer with ALK-positive tumors. It isn't the company's biggest seller, but it is its fastest-growing revenue stream. Xalkori sales jumped 129% last year to $282 million. Analysts estimate a label expansion to first-line treatment could raise it to blockbuster status, if competing ALK inhibitors from Novartis, Roche, and Ariad don't invade its market.

Majority response
Hot on the heels of Pfizer's Xalkori release, the New England Journal of Medicine published interim results from a phase 1 study of Novartis' ALK inhibitor, ceritinib. The overall response rate was a whopping 58%, with progression-free survival of seven months.

One of the problems with Xalkori is that many patients develop a resistance that leaves them short on treatment options. If approved, ceritinib could become a powerful competitor. More than two-thirds of the patients in the trial had progressed after or during Xalkori treatment. About 56% of those patients responded to ceritinib.

This was just an early stage trial, but Novartis intends to include these results in a new drug application. The FDA has already granted ceritinib a Breakthrough Therapy designation, and I think its chances are good. Xalkori resistant lung cancer is effectively a life-threatening condition with unmet need. Given these results, it looks like ceritinib fits the bill.

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