JPM need-to-know: Lilly's deal hints, Novartis' launch plans, Dynavax hep B ramp-up, and more

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The J.P. Morgan Healthcare Conference in San Francisco got underway Monday, promising a newsfest for days. Get continuous updates here.

SAN FRANCISCO—The 2018 J.P. Morgan Healthcare Conference is starting to recede in biopharma's rearview mirror, but industry watchers are still digesting the comments from top executives and analysts—and the news announcements, sparse as they were.

On JPM Thursdays, the exodus continues, and plenty of this year's attendees are ready to get out from under the San Francisco clouds. Whether you're now waiting at your gate at SFO, in the air or safely back to the office, check in with us. We're still updating with the latest, including exclusive interviews, and our conference postmortems are still yet to come. Find the newest articles up top and scroll down to see all the JPM news we've collected. All update times PST.

Thursday, 11:35 a.m.: Eli Lilly has steered away from megadeals, and a big influx of cash from U.S. tax reform won’t change that, Darren Carroll, SVP of corporate business development, told FiercePharma. Behemoth buys will see the biggest boost as companies bring their overseas earnings home, he predicted, but “those deals, frankly, we don’t believe are very helpful for shareholders on either side of the equation.” Instead, the Big Pharma is shopping for immunology and cancer buys.

Thursday, 11:30 am.: Novartis has finally ramped up sales of its heart failure drug Entresto, and pharma chief Paul Hudson predicted a continued sales surge this year, fueled by geographic expansion and the company's already-stepped-up sales force. And it's pushing for new indications that would broaden the drug's target market, with FDA filings planned for 2019. Novartis also has big plans for Cosentyx, the immunology drug that's racked up about $1.5 billion so far this year, with two head-to-head studies against Humira already in the works, and another two—one against the brand, one against a biosimilar—announced this week. Slides

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Thursday, 8:10 a.m.: Dynavax fought hard to win FDA approval with its twice-rejected hepatitis B vaccine, but now that it has launched its Heplisav-B shot—just this week—the small biotech's work is only just starting. With some tough competition ahead from entrenched player GlaxoSmithKline, Dynavax has been busy staffing up to support the rollout. And CEO Eddie Gray told FiercePharma that Heplisav-B's premium list price—$115 per dose—won't hold it back. Story

Thursday, 8:12 a.m.: Aimmune has been charging ahead on its peanut allergy treatment, with phase 3 data to read out in the first quarter and plans to submit a BLA at the end of the year. Now, the company is teeing up to expand its platform to egg and milk allergies. The new indications would allow patients to reintroduce foods into their diets, unlike the peanut product, which protects against accidental exposure. Developing the products is tricky, CEO Stephen Dilly told FierceBiotech: “The hardest thing for us to make is the first dose,” he said. Story

Wednesday, 6:57 a.m.: Roche expects further biosim erosion in 2018, CFO Alan Hippe said, but the company is leaning on new products such as Ocrevus, Tecentriq, Perjeta and Alecensa to keep growing. At the same time, the company is moving to increase its R&D, operational and marketing efficiency. Ocrevus has gotten off to a hot start, he said, as 30,000 patients have received the multiple sclerosis drug since its March approval. Tax reform will be a positive for Roche, according to Hippe, but he didn't offer any details on that topic. 

Wednesday, 6:50 a.m.: Mylan CEO Heather Bresch said she expects the U.S. generic pricing situation to "continue to be chaotic," but she told investors the company's portfolio of complex generics can help it withstand the pressure. As other drugmakers consider jettisoning parts of their generic businesses, Mylan is keeping an eye on every opportunity, President Rajiv Malik said. Executives updated on the company's Advair generic application, saying there's "nothing outstanding" on Mylan's end.

Wednesday, 6:02 a.m.: Sanofi CEO Olivier Brandicourt touted the company's Dupixent and Kevzara launches in a presentation, and Sanofi Genzyme chief Bill Sibold gave FiercePharma the backstory: The launches for Kevzara and Dupixent were vastly different, because Sanofi has had to build a new market with Dupixent and enter an extremely competitive field with Kevzara. For the latter, the challenge is, "how do you come into this incredibility competitive market and try to differentiate yourself? On both fronts, I am very satisfied with how we have launched," Sibold said. Story

Wednesday, 5:45 a.m.: Johnson & Johnson CEO Alex Gorsky waxed poetic Monday about the impact Silicon Valley is having on the biopharma industry. “Going forward we won’t be classifying ourselves as just a healthcare or biopharmaceutical industry, but we’ll be a healthcare biopharmaceutical technology industry,” he told investors. But the way a pair of EY’s experts see it, that time is still very far off. “No one can see it at the moment,” Pamela Spence, EY’s global life sciences industry leader, said. In their view, it’s more likely that pharma gets caught with its tail between its legs when a true tech player comes in to disrupt the market. Story

Wednesday, 5:20 a.m.: New GlaxoSmithKline CEO Emma Walmsley has a lot of work ahead of her when it comes to building out the company’s pharma unit. But aside from that task, the company is also “very focused on driving cultural change,” she told investors on Tuesday. GSK is “remaining a company that is underpinned so fundamentally by values and purpose,” she said, but also “introducing more pace and performance edge.” To do that, Walmsley has rolled out just three key priorities for the entire company: innovation, performance and trust.  And when it comes to delivering on them, “what matters most is the caliber of our team in our top roles,” she said. Walmsley has already made key exec team hires and changed almost 40% of the direct team’s exec reports, as FiercePharma reported Tuesday; the company is determined to put “the best talent possible” in its 370 most critical posts, she said. More on Walmsley's changes here.

Wednesday, 5:17 a.m.: Bristol-Myers Squibb CEO Giovanni Caforio said people often ask how much growth is still ahead for Eliquis. "The answer is, there’s still significant growth ahead,” Caforio told investors on Tuesday. While Eliquis and others in its class of next-gen anticoagulants are “rapidly penetrating” the warfarin market from a total prescriptions perspective, in the U.S., the class still boasts just 55% of the market. And the way Caforio sees it, as that number picks up, Eliquis—the class’s “leading agent”—is “clearly going to be growing disproportionately.”

Wednesday, 4:45 a.m.: Are smaller biotechs indeed more innovative and “hungry” than pharmas, which often mine smaller companies for their latest treasures? Panelists at the FierceBiotech Executive Breakfast on Tuesday disagreed on that question, and a discussion on whether bigger is indeed better—big ideas, big capital, big hype—led into a debate on how money, and more of it, affects a company’s behavior. Story

Wednesday, 4:41 a.m.: Eli Lilly CEO David Ricks sees two reasons why pharma needs to do something to make drugs more affordable. One, there's a new FDA chief who understands the industry. There are "people in power who understand … the fragile balance between reward for innovation and access," Ricks said. "We need to take advantage of that." Two? This is a big one: "If not, people will do things for us," the helmsman said. Article

Wednesday, 4:30 a.m.: Outgoing Perrigo CEO John Hendrickson is confident his replacement, German glass packaging exec Uwe Röhrhoff, is the right pick to take the company forward. “His management skills on a complex infrastructure, complex businesses, multiple customers, multiple countries, all make him a great fit because as many of you know, Perrigo is that,” Hendrickson told investors on Tuesday. And Röhrhoff will have his work cut out for him in 2018, with generic buying consortiums expected to continue putting the squeeze on drugmakers. “Industry pricing pressure’s still there,” Hendrickson said.

Wednesday, 2:34 a.m.: David Hung is the CEO who sold his company, Medivation, to Pfizer for $14 billion. He got the plaudits, a big payday, and seemingly a free pass to almost any biopharma job he wanted. He chose Axovant and its suite of pharma castoffs, including an Alzheimer’s drug, intepirdine, that had been dumped by GlaxoSmithKline. This week, with two sets of negative data on hand, Axovant tossed intepirdine onto the ever-growing pile of discarded Alzheimer’s drugs. And Hung was forced to talk about not only that failure but also a data mix-up on a second candidate. Story

Tuesday, 7:34 a.m.: Will Johnson & Johnson change up its M&A game plan now that tax reform is set to bring back a trove of ex-U.S. cash? Not likely. “I think we’ll see basically a continuation or consistency of our strategy,” CEO Alex Gorsky told investors on Monday during a fireside chat. Then again, J&J is one of the few companies that didn’t spend 2017 waiting around for the new legislation, instead kicking off the year with a $30 billion deal for Actelion’s stable of marketed drugs.

Tuesday, 7:32 a.m.: Regeneron CEO Len Schleifer humorously reminisced Monday about the company’s beginnings in 1988. That year’s safe harbor statement read simply, “Regeneron is a risky investment,” he noted, and “some people say things have not changed at all in 30 years, that I’ve been carried around on [CSO George Yancopoulos’s] back.” A photo of him doing just that accompanied the jest. Later, Yancopoulos quipped to Schleifer that “after 30 years I shouldn’t be surprised that you left me very little time and a lot of work to do” during their joint presentation, before outlining some of the highlights from Dupixent’s clinical development program. That drug, which he called “truly a pipeline in a single medicine,” will soon enter a phase 3 COPD trial, and the company has “a lot of hope” for its potential in food allergies such as peanut, too. For more on Dupixent, see here.

Tuesday, 7:20 a.m.: Some biotechs are born with the goal of cashing out. But not Alnylam. The company, which spent the first 15 years of its life in R&D mode, will commercialize its first treatment this year—with plans to keep them coming. “This is always where we intended to be,” Alnylam President Barry Greene said in an interview with FierceBiotech. “Our desire is to be as innovative in the commercial space as we have been in the R&D space.”

Tuesday, 6:30 a.m.: Merck CEO Ken Frazier had some sanguine words on pricing pressure Monday: It's not likely to get worse. His company published a "transparency report" disclosing 40% rebates last year—up from 27.5%—but Frazier sees no sign that payers or politicians will tighten the clamps again in 2018. Tax benefits from the Republican legislation? M&A? He had a few words on those, too. Report 

Tuesday, 5:04 a.m.: Since new CEO Kåre Schultz rolled out Teva’s $3B cost-cutting plan a few weeks back, “some have asked me, ‘how on earth is this possible?’” he said Monday. One word: Structure. And two follow-ups: Past mistakes. More

Monday, 6:16 p.m.: Allergan has an update on those Restasis generics investors have been seriously dreading: They’re “unlikely” to arrive before the second quarter. So CEO Brent Saunders said Monday as the company unveiled its expectations for the coming year. Allergan’s now predicting $15 billion to $15.3 billion in revenues and $15.25 in non-GAAP earnings per share. But “if Restasis comes later, that floor goes higher,” Saunders told investors. Story

Monday, 2:12 p.m.: Can Amazon break into the drug distribution business? "Certainly," the way Endo's CEO sees it. "I think the market is rife for an Amazon-like entrant," he told investors Monday morning, and he intends to "try to get a little bit out in front of that." But drugmakers should remind themselves to think about what Amazon's asks will be and what will happen after products are under contract, he said. "Where you lose your leverage is once you're under contract; that's the name of the game with consortiums," he cautioned. And speaking of consortiums, "don't ever underestimate the strength" of the three that are currently driving generics price erosion across the industry. "They are our partners," he said, adding that "we need to learn to continue to work with them through this assumption that a fourth party will eventually break in."

Monday, 1:03 p.m.: Vertex CEO Jeffrey Leiden said his company is ready to do some deals, and he served up some hints to its M&A strategy. He's shopping assets that could fit into Vertex's cystic fibrosis franchise, of course, but also eyeing platform tech—such as CRISPR and mRNA—and other early-stage assets. Size? "Perhaps some of these will be larger than the [deals] we have already done,” Leiden said. Story

Monday, 10:56 a.m.: Last year, activists began pushing troubled Acorda Therapeutics to sell—and it looks as if the company may be heeding that advice. The Ardsley, New York-based drugmaker is exploring a buyout with help from Centerview Partners and MTS Health Partners, The Wall Street Journal reports, though the process is still in the early stages and may not amount to an eventual deal. Story

Monday, 9:33 a.m.: Celgene, looking to recover from a tough year, rolled out its 2018 guidance on Monday at the J.P. Morgan Healthcare conference, predicting it will generate sales of $14.4 billion to $14.8 billion this year. The Big Biotech also touted strong growth for some of its stalwart meds in unaudited 2017 results. Overall, in its unaudited 2017 results—released early on Monday—Celgene disclosed that it generated $13 billion in the year, good enough for 16% growth. Article

Monday, 8:15 a.m.: Sanofi and Regeneron have high expectations for Dupixent, their severe eczema drug launched last year—including new uses in asthma and beyond. And to make sure their Great Hope pays off, they're plowing $1 billion-plus into two new meds, Dupixent included. And with a vaunted AbbVie rival on the horizon, Dupixent can use as big a lead in the market as it can get. How do the partners intend to keep that trajectory going? Furthering their pipeline-in-a-drug strategy for the IL-13 inhibitor, for one. Story

Monday, 7:19 a.m.: Shire has a penchant for making headlines at the J.P. Morgan Healthcare Conference, and it did so again early Monday. The company, which has been weighing options for its neuroscience unit since last August, said it would hang onto the business for the time being and create two operating divisions within the company—one for neuroscience and one for rare diseases. More

Monday, 7:14 a.m.: Pfizer has set up a new partnering network to try to foster collaborations with top-tier universities, shortly after stripping out a chunk of its in-house R&D effort. The new Innovative Target Exploration Network has already forged ties with Oxford and Cambridge universities in the U.K. as well as the University of Texas Southwestern. Pfizer said it hopes the effort will “deliver novel therapeutic targets and mechanisms of action to underpin future drug discovery in core areas of interest.” Article

Monday, 6:33 a.m.: Axovant’s run of bad news shows no signs of letting up, with negative results in a phase 2b trial in Lewy body dementia spelling the end for lead candidate intepirdine. Prospects for intepirdine were already looking shaky last year when the MINDSET trial showed no benefit for the drug in mild-to-moderate Alzheimer’s disease. “Based on the totality of intepirdine data to date, there is no evidence to support its further development," said Axovant CEO David Hung, M.D., a serial biotech entrepreneur who engineered Medivation's sale to Pfizer last year. News

Monday, 3:52 a.m.: Alnylam has stepped up its commitment to pioneering RNAi drug patisiran by retooling its agreement with Sanofi. The revised deal returns full global control of the ATTR amyloidosis drug to Alnylam and sees Sanofi obtain worldwide rights to hemophilia candidate fitusiran. That means the partnership is now mostly divided up by asset, not geography, with some potential royalties going both ways. Story

Monday, 12:33 a.m.: But first, Celgene unveiled a much-discussed deal: The big biotech says it will spend $1.1 billion upfront for Impact Biomedicines, a tiny startup that got a $22 million series A just three months ago, all for JAK2 inhibitor fedratinib, a Sanofi castoff. The deal includes up to $4.5 billion in potential milestones, if fedratinib pays off as Celgene hopes. News