January 25, 2017
By Mark Terry, BioSpace.com Breaking News Staff
No one can really predict the future of healthcare, but Keith Speights and George Budwell, writing for The Motley Fool, take a look at two biopharma companies they feel are going to have the biggest impact in the upcoming years.
1. Roche
At times, Roche seems dwarfed by the accomplishments of its subsidiary, Genentech . However, the Swiss-based company operates worldwide under two divisions, Pharmaceuticals and Diagnostics. Other subsidiaries include Roche Diagnostics (ROG.VX), Chugai Pharmaceuticals, Ventana Medical Systems, InterMune , Syntex, and Anadys Pharmaceuticals . The company’s market cap is over $200 billion.
But Speights notes that despite its size, the company is nimble. “Roche ranks as one of the most innovative biopharmaceutical companies in the world, with more breakthrough therapy designations over the last four years than any other drugmaker.”
And although he notes how much of a powerhouse the company is in the pharmaceutical market, the primary reason he thinks Roche will dominate health care is its dominance in diagnostics. In the past few years, it’s acquired CAPP Medical, Signature Diagnostics, Ariosa Diagnostics, Genia, and other companies, including partnerships with genetic sequencing companies Pacific Biosciences and Stratos.
“Precision medicine,” Speights writes, “should play an enormous role in the future of healthcare. And it requires diagnostics to match the right therapies to the right patients. With Roche claiming lead positions in both the diagnostics and biopharmaceutical arenas, the mega-cap company has a pretty good shot at being a dominant force for years to come.”
2. Kite Pharma
George Budwell focuses on a specific technology, in this case chimeric antigen receptor T cell (CAR-T) therapy. CAR-T are engineered molecules that are grafted onto a monoclonal antibody to attack specific tumor cells. It is at the forefront of the field of immuno-oncology.
The leader in the field for some time was Juno Therapeutics , but after several deaths in a Phase II clinical trial for its CAR-T product last summer resulted in a clinical hold by the U.S. Food and Drug Administration (FDA), and a voluntary hold in November, Juno has been passed in the race to the market by Kite Pharma (KITE).
Budwell writes, “Fortunately, the steady migration away from largely ineffective and highly toxic chemotherapies is about to kick into high gear with the potential approval of the first chimeric antigen receptor C cell (or CAR-T) therapy later this year. These modified cell-based cancer therapies, while suffering from their own serious toxicity issues, have produced unprecedented responses in several hard-to-treat blood cancers in the clinic.”
On December 4, 2016, Kite announced that it had initiated the rolling submission with the FDA for the Biologics License Application (BLA) for KTE-C19 for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant (ASCT). The company expects to complete the submission by the end of the first quarter of 2017. If approved, it will have the U.S. name of axicabtagene ciloleucel, with a market name of Axi-Cel. And if approved, it’ll probably have what Budwell calls a “top-flight pricing point.”
On a broader perspective, immuno-oncology is likely to be the path of the future for oncology treatments. Generally two-pronged, immuno-oncology involves stimulating the body’s immune system to specific attack cancer cells, while simultaneously cutting off the tumors’ ability to hide from the immune system. For the most part, companies like Kite and Juno and others are working on first-generation immuno-oncology therapeutics.
As both Kite and Juno have shown in clinical trials, however, there are still potentially severe adverse affects related to immuno-oncology. Brand new companies, such as Cambridge’s Cue Biopharma, are starting to look at a second-generation of approaches to immuno-oncology using similar, but different technology.
