JPM need-to-know, Part 2: Launch woes, crossed fingers, a 'bulletproof' FDA review and more

San Francisco
The J.P. Morgan Healthcare Conference began another day Tuesday with another round of news and buzz. (Anthony Quintano via Flickr)

The J.P. Morgan Healthcare Conference opened Tuesday with some anticipation for GlaxoSmithKline CEO Emma Walmsley's talk, what with the pharma giant's recent deal to buy cancer drugmaker Tesaro. And ahead of Amgen CEO Bob Bradway's morning presentation, the company rolled out another round of price cuts on its cholesterol drug Repatha, which Bradway talked up along with its new migraine drug Aimovig.

But pricing hasn't been much on the agenda, except at Alexion, which says it needs an entirely new strategy. What has? Drug launches—Lilly's Aimovig rival Emgality, for one—and hoped-for FDA nods; diabetes rivalries and deal integrations; FDA tea leaves and, yes, one unexpected tax bill.

We're chronicling the daily events with continuously updated roundups, from news stories to executive remarks to excerpts from our own sideline interviews. If you missed our Monday rundown, with its latest additions a few hours before Tuesday's schedule began, find it here. And for all our FiercePharma coverage over the course of the conference, keep tabs on this page, and look here for FierceBiotech's own news.

At Novartis, artificial intelligence is hard at work in the sales department, not just the R&D world, pharma CEO Paul Hudson told us. Reps are using an AI assistant that suggests physicians to visit—and what to tell them. While at J.P. Morgan, Hudson was meeting with far more tech companies this year than in years past, when he mostly checked in with small biotechs for potential partnerships. This year it's about half health-tech. The way he sees it, 2019 will be the “beginning of the tech disruption” for pharma. Interview

Johnson & Johnson knows immunology is crowded. But that doesn’t mean it doesn’t still see tons of opportunity there—even in the ultracompetitive psoriasis market, where its Tremfya brand is facing down Novartis' Cosentyx and Eli Lilly's Taltz, among others. The way Jennifer Taubert, EVP and worldwide pharma chairman, sees it, that disease is still "dramatically underpenetrated" by biologics. Overall, J&J sees immunology as “very, very attractive, and in certain areas, there’s so much unmet medical need,” Taubert said during a fireside chat. Story

AbbVie Vice Chairman and President Michael Severino, M.D., once again tried to reassure investors that the company can keep growing even as the world’s bestselling drug, Humira, faces stepped-up competition. Just how much? To $35 billion in sales by 2025, up from $28.2 billion in 2017. Never mind that Humira already faces biosimilars in Europe—and has made some price concessions to get business there—while rivals are creeping up in the U.S. The company has new hepatitis C drug Mavyret, cancer drugs Imbruvica and Venclexta, plus others ready to carry the torch, Severino said. And to get to that lofty $35 billion figure, the company expects its immunology franchise to evolve from Humira into a stable of drugs that would “restate our current leadership position and move into attractive new areas.” It also has ambitions to move Imbruvica and Venclexta into new cancer types, and advance other pipeline drugs. M&A? Investors hope so, particularly after Rova-T's recent failures. On that subject, Severino said the company will use its “strong balance sheet" to keep building out its pipeline through licensing, acquisitions and partnering. 

Emma Walmsley

GSK chief Emma Walmsley put oncology back on the front burner last year, and now she's touting the company's progress since. One big boost? Obviously, the $5 billion Tesaro buyout, announced last month, she said. With it, Glaxo gets up-and-coming PARP inhibitor Zejula, plus a PD-1 inhibitor that's admittedly way behind in the field but useful for developing in-house combination therapies, she said. All in all, GSK’s oncology pipeline is "gaining strength and will start to impact our revenue growth outlook from next year,” she said. Meanwhile, GSK's current stronghold, HIV, is anticipating approvals for its once-daily dolutegravir/lamivudine combo this year, and looking ahead with its long-acting HIV injectable now in testing. The drug promises a “truly differentiated approach to treatment," Walmsley said. Patients say daily pills are a constant reminder of their disease, and the monthly or bimonthly injection could make HIV a “smaller part” of their lives. Story

Alexion is looking to pivot this year from an ultrarare-disease company to a rare-disease company—and to do so, its pricing strategy has to change. “This is about a story of innovation and volume. It is not going to be a story about price and price increases and so on,” CEO Ludwig Hantson said during a Tuesday morning presentation. Alexion's lead drug, Soliris, has long been one of pharma’s most expensive. But the company rolled out follow-up Ultomiris, which just recently snagged an FDA green light, with a 10% discount on maintenance doses “to make sure we’re ready from a global reference pricing perspective,” Hantson said. “We want to be ready when one of you comes back with, ‘do you see what’s going on in Washington?’” he told investors. Article 

Eli Lilly's Christi Shaw acknowledges that Emgality didn't take the first-to-market crown in the budding CGRP field of migraine prevention drugs. It didn't even come in second. But Shaw told FiercePharma that Lilly has what it takes to make Emgality not only stand out from the crowd but also become the cornerstone of a migraine and pain franchise. For one thing, the company has expertise in "consumer driven" fields like migraine, where patients tend to ask for a particular brand. And there are reasons they'd push for Emgality, she figures: The drug has strong numbers on efficacy, and its injection device is easier to use compared with those of its rivals, Amgen's Aimovig and Teva Pharmaceutical's Ajovy. Interview 

Regeneron investors had been worried that growth for Regeneron’s Eylea was slowing down, but the New York drugmaker kicked off the J.P. Morgan Healthcare Conference with an attempt to allay those fears. It laid out growth numbers for its star eye drug showing that it posted sales expansion of 10% over the previous year, checking in with sales of $4.07 billion. And there’s more to come, CEO Len Schleifer promised during a presentation, assuring investors that the “Eylea franchise is certainly far from done.” Story

Mylan CEO Heather Bresch skated around questions about the company’s strategic review on Tuesday, but she andHeather Bresch President Rajiv Malik did dish new info on a topic that’s perhaps just as closely followed: generic Advair. Expected to be a big money-earner for the generics giant, the respiratory drug has been held up for months now, and at this point, it’s all on the FDA, Malik said. Just yesterday, the agency told Mylan that it’s simply trying “to make sure it’s bulletproof, in their words,” he added. But is there a hint of imminent action? Maybe so. The agency rolled out a label update today, Malik said, for all products that contain fluticasone—which Advair, the behemoth GSK brand, and its knockoffs most certainly do. The FDA may have wanted to get that out of the way before approving a new drug that’ll need that same label language. “Today is at least an indication of some administrative work that perhaps they needed to get out there before an approval,” Bresch said. “We believe today is a step in the right direction.”

Clovis Oncology and its fellow PARP players have had trouble convincing doctors to prescribe their ovarian cancer drugs in the maintenance setting, so Clovis is ramping up its efforts around the importance of maintenance therapy. “We need to create an urgency around maintenance,” CEO Patrick Mahaffy said, and “it’s not just about our share.” With a new initiative it’s calling “Act,” “what we’re trying to help people understand” is that “to make a disease like ovarian cancer a chronic disease, you actually have to chronically maintain” treatment. And if its push works, it will benefit not only Rubraca, but the rest of the class, too, “as we grow adoption in this space.”

Amgen CEO Bob Bradway figures the company's diverse set of offerings in cancer, cardiovascular disease, migraine and beyond will help it weather the “volatile” environment in pharma. Plus, biosimilars will “begin to contribute significantly” to Amgen’s revenues this year. (Of course, it's facing biosimilar competition of its own, too.) On the new-brand side, Bradway talked up the company's debut migraine drug Aimovig. Since its launch last May, 150,000 patients have started on the drug and 18,000 providers have prescribed it. As for PCSK9 cholesterol drug Repatha, Bradway reported that it held 64% of the market at the end of 2018. Amgen has actually slashed the list price on that medication—not just its net price—and just this week announced price cuts for two device-based versions.

Takeda wrapped up its $62 billion Shire acquisition in just eight months, from announcement to close. And it’s hoping to integrate its buy at the same breakneck pace, CEO Christophe Weber said. “For an acquisition of this size, this complexity, we are very pleased with the timeline,” he said, adding that the Japanese drugmaker is “expecting to have the same…pace for the integration.” Later this week, it’ll convene its top 200 managers for a leadership conference. “We don’t want to lose momentum in the business. We want to integrate the two companies very quickly and really gain the full benefit of the integration as soon as possible,” Weber said. He also expects to see “a minimum level of disruption” thanks to some geographic overlap between the two companies.

Can Eli Lilly’s Trulicity keep up its rapid growth? If the GLP-1 class keeps growing—and company CEO David Ricks thinks it will. “We believe, as I think our competitors do, that GLP should be the first injection experience with Type 2 diabetes,” he said during a Tuesday fireside chat—yet in the U.S., less than 30% of patients have that experience. With that stat in mind, “we see the potential for 60% to 100% more growth in the GLP class,” he said. Of course, Trulicity won’t capture all of that growth for itself. Novo Nordisk’s new weekly injectable Ozempic and forthcoming pill semaglutide, which share an active ingredient, are expected to give Trulicity a run for its money. “Novo’s a tough competitor,” and “it’s a good drug,” Ricks said of Ozempic, but “we think we have a better one.”

Novartis partner Pear Therapeutics has posted $64 million in new fundraising as its CEO contemplated a business model once called "ridiculous." Pear chief Corey McCann, M.D., Ph.D., said, “I joke a little that we've seen this evolution—where in the first year or two, people had no idea what we were talking about. After that, people acknowledged the idea but thought it was ridiculous." Fast forward and now, "last year and this year, I think that they think it was all their idea—which is exactly where we want to be.” The new funding round comes on the heels of scoring an FDA clearance last month for its prescription software to treat opioid addiction and on the eve of the app’s commercial launch. Story

Sanofi’s new CFO, Jean-Baptiste Chasseloup de Chatillon, stepped in for injured CEO Olivier Brandicourt—who had hurt his back over the weekend—to outline the French drugmaker’s prospects, and he dropped the headline comment within five minutes: Diabetes will once again be a drag this year. “The diabetes impact will be less than last year but will still affect 2019,” he said, as he made the case that Sanofi’s other franchises—and its rare blood disorders business acquired with Bioverativ last year—will drive 2019 growth despite any remaining headwinds. The “pipeline in a drug” Dupixent, now approved for asthma as well as severe eczema, is rolling along nicely, and it’s on its way to a potential new use in nasal polyps—plus revving for launch in more European countries, Chasseloup said. Its new checkpoint inhibitor Libtayo is targeting a skin cancer type that no other PD-1/L1 has taken up, its new aTTP drug Cablivi launched in Europe and is up for FDA approval this year, and a new diabetes launch—the SGLT1/2 drug Zynquista for Type 1 disease—is on tap, provided it wins FDA approval after its FDA advisory panel review next week. And the company has high hopes for its flu shots, despite the fact that the field is “highly competitive,” partly because of its first-ever cell culture flu vaccine Flublok, he said. The new launches “will lay a foundation for a new growth profile,” he said. 

FDA Commissioner Scott Gottlieb, M.D., phoned in for Tuesday’s keynote discussion with J.P. Morgan analysts, discussing a range of efforts underway at the agency to adapt to new trends in drug development as well as cost and competition concerns. He said the agency shouldn’t be an arbiter of cost-effectiveness, but that it’s working to bring competition to drug markets where it’s currently lacking. This year, the agency plans to work on challenges facing complex generics, patent issues, and the U.S. biosimilars market, among other areas of focus. Story

When Perrigo CEO Murray Kessler was deciding whether to take the job, the consumer industry vet knew the company had some issues. Amazon had stolen OTC business from traditional retail stores, which put pressure on Perrigo’s core business. The company had moved to Ireland in a tax inversion, taking some of its core service functions with it—and in the process made it tougher to run the U.S. business. Perrigo had also gone through multiple CEOs in recent years, “which is probably the worst offense,” he said in a Tuesday presentation. None of those things came as surprises—but the Irish Office of the Revenue Commissioners’ assertion that Perrigo owed €1.64 billion in back taxes sure did. That tax bill surprised investors, too, who tanked shares in response. But Kessler sees Perrigo’s current stock price as an investment opportunity, he said. “We don’t have a clear understanding yet on why they believe 20 years of filings are wrong,” he said, but “we believe ultimately we will win.”

GW Pharmaceuticals' claim to fame is its first-ever FDA-approved cannabinoid drug, but CEO Justin Gover said the company has ambitions far beyond the rare epilepsy approvals it's racked up now—and beyond Epidiolex itself. That drug rolled out Nov. 1, and four of the five largest payers have started covering it. Gover wouldn't reveal sales data yet—we'll have to wait for the company's fourth-quarter results next month—but GW's slides did disclose an expected average gross price for the first year at $32,500. Meanwhile, GW is plotting more CBD drug testing this year, targeting autism spectrum disorders, Rett syndrome and neonatal hypoxic-ischemic encephalopathy, while continuing its work in glioblastoma and schizophrenia. Plus, it's already on its way to bringing its EU-approved drug Sativex—used to treat spasticity caused by multiple sclerosis—to the U.S. this year, thanks to meetings with the FDA about its NDA pathway, Gover said. As for Epidiolex, GW is pushing on other indications, including in epilepsy in patients with tuberous sclerosis complex. It's planning a fourth-quarter FDA filing for that label expansion and expects to launch a phase 3 trial in Rett syndrome, looking for benefits in cognition, behavior and quality of life.

Guardant Health has launched its Lunar liquid biopsy test for researchers aimed at spotting cancer in its early stages, by detecting both genomic alterations and epigenomic signatures through a single blood draw. It's designed for studies that involve screening for tumor DNA, choosing a course of adjuvant therapy, or monitoring treatment and recurrence. Guardant's academic and biopharma partners "are thinking more and more about taking their clinical programs into adjuvant and neoadjuvant settings,” said Daniel Simon, SVP of biopharma business development, in a presentation. “This is a really interesting application within that space.” Story

Reva Medical, aiming for rollouts in the next three to 12 months, has struck new partnerships to expand its commercial footprint into seven European countries, including Russia, with a potential $290 million device market. And it's meanwhile working on piling up evidence for its bioresorbable stents, an alternative to traditional metal. Metal may be a "great solution if you have coronary artery disease, but bioresorbable is a better solution,” CEO Reggie Groves said at the conference. “You only need the stent for three, four or five months, and if you leave a foreign body in there—particularly if you're under 65 years old—you've got a long life expectancy,” Groves said. “Or God forbid you have a nickel allergy. You just weren’t meant to have a permanent implant in there.” Article