With the election over and the market's fear of drug price controls rapidly weakening, up-and-coming blockbusters are set to become big catalysts for the pharmaceuticals industry again. Among those companies, Johnson and Johnson (JNJ 0.64%) stands out. Why? The healthcare titan has been lifted onto a new growth path with its high-margin specialty drugs, with one cancer-fighter in particular -- Darzalex -- looking absolutely spectacular.
Let's zero-in on this drug, because recent trial results opened the door to the possibility of Darzalex becoming a transformational drug for all stages of multiple myeloma, with $5 billion-plus in peak sales.
Unprecedented action, standout data, landmark advance
While oncologists are generally loath to praise drugs, Mayo Clinic's Dr. Kapoor described Darzalex's performance as "unprecedented in myeloma." Meanwhile, last quarter, J&J put it at the top of its list of drugs "with higher certainty and higher value than originally anticipated."
While J&J has been beating the drum for this drug, it flew under the radar of most analysts since FDA clearance limited it to myeloma patients who failed three previous therapies, a last ditch market already crowded with other treatments, such as Celgene's Pomalyst and Amgen's Kyprolis.
But fast-forward to October 6, 2016 and a phase 3 trial reported in the New England Journal of Medicine (NEJM) showed data so impressive that study authors said it should be the "new standard of care for multiple myeloma."
Myeloma is an aggressive disease, and with each relapse it becomes more challenging to treat. Despite that, in its POLLUX trial on relapsed patients failing at least one prior therapy, a Darzalex combo cut the risk of disease progression 63% more than the current standard of care. To put that in context, Bristol-Myers Squibb's new myeloma fighter Empliciti is generally believed to be an excellent medication, but it reduced the risk of progression by only 30% in its ELOQUENT-2 trial.
J&J rushes Darzalex into 28 clinical trials
The FDA granted Darzalex a breakthrough designation for an expanded indication with a PDUFA date on February 17, 2017. That's a catalyst date investors might want to keep an eye on, but trial results and submissions will keep coming afterwards. Danish company Genmab (with whom J&J has a worldwide license to develop and commercialize the drug) announced last quarter that J&J was fast-forwarding Darzalex's clinical development program, moving it from 11 clinical studies at the beginning of the year to an eye-popping 28.
While the bulk of Darzalex's trials focus on relapsed myeloma patients, several early stage trials aim at approval as a first-line treatment for newly diagnosed patients. Going forward, investors particularly need to keep their eye on a key trial teaming it with cancer giant Roche Holding's anti-PDL1 therapy atezolizumab.
If that collaboration sees early success, that's great news for J&J, but it could be worrisome to Celgene investors, since it means Darzalex could pose a threat to that company's prized myeloma fighter, Revlimid. The impact on Celgene will likely be muted, however, since Revlimid and Celgene's newer drug Pomalyst are also in combo trials with Darzalex. In addition, three days ago, Amgen announced Darzalex is being teamed up with Kyprolis, and the two drug giants will be collaborating in multiple clinical trials.
Given that the myeloma market is expected to climb to $18.4 billion by 2020, Darzalex has a tremendous opportunity. In fact, Dr. Antonio Palumbo, lead study author on one Darzalex trial, as quoted in Forbes, said the drug could end up being the single treatment used in all myeloma patients. But Darzalex's opportunity doesn't end there since it is rapidly being moved into development in other disease areas. Those include studies in lymphoma, as well as a study teaming it with Roche's anti-PDL1 therapy for solid tumor cancers.
J&J's R&D effectiveness should overcome biosimilar headwinds
You should never buy a stock based on its prospects with one drug -- certainly not when the company is as large and diversified as J&J. But Darzalex is one of the biggest opportunities I've seen in pharma recently, and its success heralds the kind of high profit margins that will allow J&J to dedicate significant financial resources to R&D, leading to even more drugs of Darzalex's caliber.
J&J's earnings surpassed expectations last quarter. However, shares ticked downward on concerns about future growth prospects for top-selling drug Remicade. While Pfizer's announcement that it will launch a biosimilar of Remicade in November is a headwind, given Remicade's long-term safety record and the biosimilar offering only a 15% discount, Pfizer's launch will face some big headwinds of its own. In fact, in Canada and Brazil, where a Remicade biosimilar is already readily available, J&J has maintained more than 90% volume share.
More to the point, though, J&J's pipeline is not just on track, the company led the market in FDA approvals from 2011 to 2016. Going forward, the company plans on 10 large-scale drugs reaching the market between 2015 and 2019, with 40 line extension filings planned in the same time frame. In other words, J&J has more than enough fuel in its tank, and with the election over, I'd start planning how to squirrel away more shares.