January 5, 2017
By Mark Terry, BioSpace.com Breaking News Staff
The J.P. Morgan Healthcare Conference is where biopharma and life science executives, investors and analysts gather to make their predictions, projections and wild guesses about what will be going on with the industry in the upcoming year. It will be held in San Francisco from January 9 through 11. Adam Feuerstein, writing for TheStreet, aims his crystal ball at 13 companies that will be present and what the hot topics are expected to be.
1. Celgene
Since Celgene is already exceeding expectations and projections for 2017, the question is, will they update their guidance? What does the company plan to do to diversify beyond Revlimid?
Just yesterday, it was announced that Gilead Sciences had poached Alessandro Riva from Novartis Oncology , which sets up expectations that the company plans to push its forays into the cancer market, whether by M&A or by R&D. And there’s no doubt that investors want them to. Feuerstein writes, “The hiring of former Novartis executive Alessandro Riva to run the foundering hematology/oncology business is once again raising hopes that Gilead WILL. BUY. SOMETHING. MEANINGFUL. MAYBE.”
3. Biogen
Biogen recently named its new chief executive officer, Michel Vounatsos. The company also had positive Phase Ib data for its Alzheimer’s drug, aducanumab, and even more immediately positive, it just received approval for Spinraza (nusinersen) for spinal muscular atrophy (SMA). If given wide a label expansion approval, analysts project annual sales of approximately $2 billion. So everyone wants to know: What’s next?
Alexion Pharma ran into some trouble in early November when it failed to file a 10Q report with the U.S. Securities and Exchange Commission (SEC) and canceled an appearance at a healthcare conference. The 10Q has been filed now with few if any repercussions. Feuerstein writes, “But interim CEO David Brennan will still need to field questions about how bad ‘tone’ led to the sacking of the former CEO and CFO and how he intends to move Alexion forward in the right direction after a really bad year.”
Sarepta Therapeutics wins the award for Most Dramatic Regulatory Rollercoaster Ride for 2016, but after multiple hearings and reports of internal feuds at the FDA, its Exondys 51 for Duchenne muscular dystrophy (DMD) was approved. The questions now are whether insurance companies will pay for it and how it’s doing since it was launched late last year.
2016 was a relatively quiet year for Vertex Pharma , noted mostly for inking a research and licensing deal to develop messenger RNA therapeutics to treat cystic fibrosis (CF) with Moderna Therapeutics. Feuerstein writes, “The company has made a lot of excuses over the past 18 months to explain the slow commercial launch of Orkambi. This year, the Street is expecting the drug’s sales to reach $1.45 billion, or a 50 percent bump from 2016. No more excuses. It’s time for Vertex to execute.”
After a debacle in 2016 with its own DMD drug, it’s nonetheless made headway with its other drugs for rare diseases. Will 2017 be the year it breaks even? BioMarin Pharma is expected—or hoped—to update data on its gene therapy product, BMN270, for hemophilia A.
8. Editas
Editas is expected to discuss LAC10, the first CRISPR gene-editing drug and how it’s progressing toward the clinic. Feuerstein also adds, “Note to Editas CEO Katrine Bosley: Please don’t bore us with talk of CRISPR patents.”
Those patents are of interest, since multiple players are involved in patent lawsuits. But even though oral arguments were heard in early December 2016, most observers think they won’t be resolved any time soon.
Most conference attendees are interested in any updates on three of its drugs this year, sarilumab, dupilumab and Praluent. For Regeneron Pharma , Feuerstein notes, “The consensus sales estimates for Eylea in 2017 is $3.7 billion, an increase of 12 percent year over year.”
10. Seattle Genetics
On December 27, 2016, the FDA placed a clinical hold or partial clinical hold on several early stage clinical trials of Seattle Genetics ' vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). Obviously, investors want an update and reassurances—if possible. Feuerstein writes, “2017 is the make-or-break year for Adcetris, with results expected from the front-line Hodgkin’s lymphoma ‘Echelon’ study. The drug is either a blockbuster and justifies Seattle Genetics’ lofty valuation, or look out below.”
11. Ariad Pharma
Most of the interest in Ariad Pharma is likely to revolve around its drug, Iclusig, price increases, and how it will respond to a Congressional inquiry into price increases. Aside from that? If brigatinib is approved, investors will want to know how the company plans to compete against other ALK inhibitors on the market.
12. Incyte
An always popular discussion is: Who should buy Incyte ? The company’s Jakafi is a JAK1 and JAK2 inhibitor to treat polycythemia vera. In May 2016 it acquired the European rights to leukemia drug Iclusig from Ariad Pharmaceuticals. The leading company investors encourage to buy Incyte is Gilead. But are they interested? Inquiring minds want to know.
13. Kite Pharma
2017 is expected to be a big year and conference attendees will be watching closely for signs of optimism and strategy. For Kite Pharma , Feuerstein writes, “First up, six-month response durability data from the ZUMA-1 study of KTE-C19, followed by the filing of the biologic license application, a likely FDA advisory committee, the approval decision, and if approved, the commercial launch.”
