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 launchesâLilly’s Aimovig rival Emgality, for oneâand hoped-for FDA nods; diabetes rivalries and deal integrations; FDA tea leavesÂ and, yes, oneÂ unexpected tax bill.
We’reÂ 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,Â find it here.Â And for all our FiercePharma coverage over the course of the conference, keep tabs onÂ this page, and lookÂ hereÂ 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 visitâand 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 âbeginning of the tech disruptionâ for pharma. Interview
Johnson & Johnson knows immunology is crowded. But that doesnât mean it doesnât still see tons of opportunity thereâeven 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 âvery, very attractive,Â and in certain areas, thereâs so much unmet medical need,â Taubert said during a fireside chat. Story
AbbVieÂ Vice Chairman and President Michael Severino, M.D., once again tried to reassure investors that the company can keep growing even as the worldâs 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 HumiraÂ already faces biosimilarsÂ in Europeâand has made some price concessions to get business thereâwhile rivals areÂ creeping up in the U.S. The company has new hepatitisÂ C drug Mavyret, cancer drugs Imbruvica andÂ Venclexta, plus othersÂ 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 thatÂ would ârestateÂ our current leadership position and move into attractive new areas.â It also has ambitions to move Imbruvica andÂ VenclextaÂ 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 âstrong balance sheet” to keep building out its pipeline through licensing, acquisitions and partnering.Â
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 TesaroÂ buyout, announced last month, she said. With it, Glaxo gets up-and-coming PARP inhibitorÂ Zejula, plus a PD-1 inhibitor that’s admittedly way behind in the field but useful for developing in-house combination therapies, she said.Â All in all, GSKâs oncology pipeline is “gaining strength and will start to impact our revenue growth outlook from next year,â 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 promisesÂ a âtruly differentiated approach to treatment,” WalmsleyÂ said. Patients say daily pills are a constant reminder of their disease, and the monthly or bimonthly injection couldÂ makeÂ HIV a âsmaller partâ of theirÂ lives. Story
Alexion is looking to pivot this year from an ultrarare-disease company to a rare-disease companyâand to do so,Â its pricing strategy has to change. âThis is about a story of innovation and volume. It is not going to be a story about price and price increases and so on,â CEO Ludwig Hantson said during a Tuesday morning presentation. Alexion’sÂ lead drug, Soliris, has long been one of pharmaâs most expensive. But the company rolled out follow-up Ultomiris, which just recentlyÂ snaggedÂ an FDA green light, with a 10% discount on maintenance doses âto make sure weâre ready from a global reference pricing perspective,â Hantson said. âWe want to be ready when one of you comes back with, âdo you see whatâs going on in Washington?ââ he told investors. ArticleÂ
Eli Lilly’s Christi Shaw acknowledges thatÂ EmgalityÂ 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 crowdÂ 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. InterviewÂ
Regeneron investors had been worried that growth for Regeneronâs 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 thereâs more to come, CEO Len Schleifer promised during a presentation, assuring investors that the âEylea franchise is certainly far from done.â Story
Mylan CEO Heather Bresch skated around questions about the companyâs strategic reviewÂ on Tuesday, but she and President Rajiv Malik did dish new info on a topic thatâs 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, itâs all on the FDA, Malik said. Just yesterday, the agency told Mylan that itâs simply trying âto make sure itâs bulletproof, in their words,â 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 fluticasoneâwhich 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 thatâll need that same label language. âToday is at least an indication of some administrative work that perhaps they needed to get out there before an approval,â Bresch said. âWe believe today is a step in the right direction.â
Clovis Oncology and its fellow PARP players have hadÂ troubleÂ 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. âWe need to create an urgency around maintenance,â CEO Patrick Mahaffy said, and âitâs not just about our share.â With a new initiative itâs calling âAct,â âwhat weâre trying to help people understandâ is that âto make a disease like ovarian cancer a chronic disease, you actually have to chronically maintainâ treatment. And if its push works, it will benefit not only Rubraca, but the rest of the class, too, âas we grow adoption in this space.â
Amgen CEO Bob Bradway figures the company’s diverse set of offeringsÂ in cancer, cardiovascular disease, migraine and beyond will help itÂ weather the âvolatileâ environment in pharma. Plus, biosimilars will âbegin to contribute significantlyâ to Amgenâs revenues thisÂ 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 itsÂ launch last May, 150,000 patients have started on the drug and 18,000 providersÂ have prescribed it.Â 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 medicationânot just its net priceâand just this week announced price cuts for two device-based versions.
Takeda wrapped up its $62 billionÂ ShireÂ acquisitionÂ in just eight months, from announcement to close. And itâs hoping to integrate its buy at the same breakneck pace, CEO Christophe Weber said. âFor an acquisition of this size, this complexity, we are very pleased with the timeline,â he said, adding that the Japanese drugmaker is âexpecting to have the sameâŚpace for the integration.â Later this week, itâll convene its top 200 managers for a leadership conference. âWe donât 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,â Weber said. He also expects to see âa minimum level of disruptionâ thanks to some geographic overlap between the two companies.
Can Eli Lillyâs Trulicity keep up its rapid growth? If the GLP-1 class keeps growingâand company CEO David Ricks thinks it will. âWe believe, as I think our competitors do, that GLP should be the first injection experience with Type 2 diabetes,â he said during a Tuesday fireside chatâyet in the U.S., less than 30% of patients have that experience. With that stat in mind, âwe see the potential for 60% to 100% more growth in the GLP class,â he said. Of course, Trulicity wonât capture all of that growth for itself. Novo Nordiskâs new weekly injectableÂ OzempicÂ and forthcoming pill semaglutide, which share an active ingredient, are expected to give Trulicity aÂ run for its money. âNovoâs a tough competitor,â and âitâs a good drug,â Ricks said of Ozempic, but âwe think we have a better one.â
Novartis partnerÂ Pear Therapeutics has posted $64 million in new fundraising as its CEO contemplated a business model once called “ridiculous.” Pear chiefÂ Corey McCann, M.D., Ph.D., said, âI joke a little that we’ve seen this evolutionâwhere 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 ideaâwhich is exactly where we want to be.â The new funding round comes on the heels of scoring an FDA clearance last month for its prescription software to treat opioid addiction andÂ on the eve of the appâs commercial launch. Story
Sanofiâs new CFO, Jean-Baptiste Chasseloup de Chatillon, stepped in for injured CEO Olivier Brandicourtâwho had hurt his back over the weekendâto outline the French drugmakerâs prospects, and he dropped the headline comment within five minutes: Diabetes will once again be a drag this year. âThe diabetes impact will be less than last year but will still affect 2019,â he said, as he made the case that Sanofiâs other franchisesâand its rare blood disorders business acquired with Bioverativ last yearâwill drive 2019 growth despite any remaining headwinds. The âpipeline in a drugâ Dupixent, now approved for asthma as well as severe eczema, is rolling along nicely, and itâs on its way to a potential new use in nasal polypsâplus 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 launchâthe SGLT1/2 drug Zynquista for Type 1 diseaseâis 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 âhighly competitive,â partly because of its first-ever cell culture flu vaccine Flublok, he said. The new launches âwill lay a foundation for a new growth profile,â he said.Â
FDA Commissioner Scott Gottlieb, M.D., phoned in for Tuesdayâs 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 shouldnât be an arbiter of cost-effectiveness, but that itâsÂ workingÂ toÂ bring competition toÂ drug markets where itâs currently lacking.Â 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 toÂ take the job, the consumer industry vetÂ knew the company had some issues. Amazon had stolen OTC business from traditional retail stores, which put pressure on Perrigoâs core business. The company had moved to Ireland in a tax inversion, taking some of its core service functions with itâand in the process made it tougher to run the U.S. business. PerrigoÂ had also gone throughÂ multiple CEOsÂ in recent years, âwhich is probably the worst offense,â he said in a Tuesday presentation. None of those things came as surprisesâbut theÂ Irish Office of the Revenue CommissionersâÂ assertionÂ that Perrigo owed âŹ1.64 billion in back taxes sure did. That tax bill surprised investors, too, who tanked shares in response. But Kessler sees Perrigoâs current stock price as an investment opportunity, he said. âWe donât have a clear understanding yet on why they believe 20 years of filings are wrong,â he said, butÂ âwe believe ultimately we will win.â
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 upÂ nowâand 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 yetâwe’ll have to wait for the company’s fourth-quarter results next monthâbut 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, targetingÂ 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 bringingÂ its EU-approved drug Sativexâused to treat spasticity caused by multiple sclerosisâto 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,Â 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,â said Daniel Simon, SVP of biopharma business development, in a presentation. âThis is a really interesting application within that space.â 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,â CEO Reggie Groves said at the conference. âYou only need the stent for three, four or five months, and if you leave a foreign body in thereâparticularly if you’re under 65 years oldâyou’ve got a long life expectancy,â Groves said. âOr God forbid you have a nickel allergy. You just werenât meant to have a permanent implant in there.â Article