JPM recap: Must-reads of the week, from FDA to IPO to M&A and more

Big deals, attempts at decent deals and impending IPOs—as usual, the J.P. Morgan Healthcare Conference was awash in deal buzz as well as the occasional rainfall. But that's far from all the talk that came out of meeting rooms, restaurants and hotel lobbies.

FDA Commissioner Scott Gottlieb chose his keynote speech to announce a new science office at the agency designed to speed up drug development, for instance. From small companies anticipating their first human data to drug giants talking up drug launches and AI, there was plenty of ground to cover. Below you'll find the most-read stories from both FierceBiotech and FiercePharma, with a couple of extras thrown in. Interested in the full roundups? Check out part one and part two.

Bristol-Myers Squibb and Celgene sent 2019's first big shockwave throughout pharma with last week's $74 billion megamerger announcement. And they immediately touched off questions about the deal: Analysts called it too expensive, not to mention risky on the patent side and pipeline. But even as market watchers continued to offer up their reservations on Monday, executives took to the stage in a fireside chat to fire back with their own detailed case for the deal. Story

Merck & Co. hasn’t made a big acquisition lately. But that's not because it doesn’t want to. “We’re very active,” CEO Ken Frazier said during a Monday afternoon fireside chat at the J.P. Morgan Healthcare Conference, adding “the fact that you haven’t seen a large deal coming out of Merck recently is not reflective of the fact that we’re not looking at those large acquisitions.” So what’s been the holdup for the New Jersey drugmaker, which Frazier has said has the capacity to do deals “of all sizes and all types?” Every time it gets close, something gets in the way. Story

FDA Commissioner Scott Gottlieb, M.D., unveiled the agency's plans for a new office of drug development science to cut the cost of bringing new medicines to patients. Staff at the office will create tools that sponsors and the FDA can use to streamline the development and regulatory assessment of drugs, the commissioner said via videolink in the conference's Monday keynote. Gottlieb thinks the FDA can leverage improved understanding of biomarkers and other advances to build tools that take some of the risks and costs out of drug development. Article

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

Not just deals, but IPOs. It felt like there was a little more than just precipitation in the air this year: a dash of optimism and cash. By Monday, Eli Lilly had snapped up biotech-of-the-moment Loxo Oncology for $8 billion and Bristol-Myers Squibb was elucidating on its left field purchase of Celgene. And as JPM 2019 ramped up, three small biotech companies were revving up their IPO pitches: bladder cancer biotech Anchiano Therapeutics, which has filed for a $35 million public offering; Poseida Therapeutics, which wants $115 million for its BCMA CAR-T therapy work; and a $150 million attempt from Alzheimer’s biotech Alector, a 2015 Fierce 15 winner. Story

Speaking of Eli Lilly, on the first day of the conference, the Big Pharma confirmed that big-ticket M&A is back in fashion in the industry. Lilly announced its $8 billion deal for cancer drugmaker Loxo Oncology, a transaction that gives the Indianapolis Big Pharma the TRK inhibitor Vitrakvi, the first drug approved by the FDA to target tumors according to a genetic abnormality rather than the location of the cancer. The $235-per-share offer is a 68% premium over Loxo's most recent closing price. Why the premium? Filling up the cancer pipeline, just as Lilly promised it would a year ago. Story

Genevant scored a new hire from Roche, showing that, despite a few noticeable high-profile blow-ups and departures from the Vant constellation of biotechs, Vivek Ramaswamy is still able to lure the big guns to his startups. The latest is Margrit Schwarz, Ph.D., MBA, former VP and global head, external innovation at Roche, who now joins Genevant as its new chief of R&D and CSO. Genevant is one of the latest "vants" from Ramaswamy, with parent company Roivant and Arbutus back in April pooling their resources to create the RNA-focused biotech. Article

Meanwhile, Novartis may have been hamstrung by CAR-T manufacturing problems, but the company still figures it can build a cell and gene therapy platform strong enough to deliver success not only with Kymriah but a full "game board" of treatments for many more diseases, CEO Vas Narasimhan said Monday. The company is partnering up to boost Kymriah supplies and has inked gene therapy deals while working on "innovative" deals with payers to cover treatments that can potentially cure diseases, but at record-breaking price tags. Article

Teva’s leaders have dropped bad news at J.P. Morgan in the past, but not this year. “The take-home is that everything’s on plan … now you know what’s coming,” CEO Kåre Schultz said to open his presentation. The company is “very much on track” to hit the $3 billion in cost savings it promised, and it’s whittled its debt down to $27.6 billion from $35 billion over the last nine months. But what about Teva’s ability to keep revenue flowing in? Schultz acknowledged that the company has faced a fair amount of skepticism, but “I think we’ve proven that we can do that,” he said, pointing to new migraine drug Ajovy—which is capturing 30% of new-to-brand prescriptions—and CNS drug Austedo, which still has plenty of room to grow. On the flip side, Teva has also stemmed the decline of some key moneymakers, including Copaxone, which is hanging on to 70% share despite generic competition. Teva’s own copycat unit is also out of the “death spiral of price declines,” Schultz said, though investors should make no mistake about what that means. “That does not mean that we get back to where we were,” before pricing pressure ravaged the generics industry, he noted. “It just means that this constant reduction of the marketplace has stopped, and that’s of course very important for us.” Story

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

Tmunity Therapeutics raised $100 million last year to develop better and safer T cell treatments, and now the company is getting ready to present data, unveil new targets and boost its headcount in 2019. The Philadelphia-based biotech is targeting ASCO in June for the first release on its CAR-T treatment for castration-resistant prostate cancer and ASH in December for its CRISPR-edited T cell receptor therapy for melanoma, myeloma and synovial sarcoma, CEO Usman “Oz” Azam said at the J.P. Morgan Healthcare Conference. “We’ve hired out our full management team and great people in our R&D organization,” Azam said. With phase 2 in the offing, he will look to build Tmunity’s manufacturing team, “mainly around process science development and vector knowhow.” Article

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 

As the conference was opening, biotech Xencor announced a split with Novartis, showing it wasn't all dealmaking in the air. Citing “strategic pipeline reprioritization by Novartis,” Xencor said its partner is handing back the research and sales rights to a bispecific antibody penned under a multibillion-dollar biobucks deal in 2016. Back then, Novartis and Xencor signed up to a $150 million upfront, $2.41 billion biobucks deal that saw Novartis agree to develop a pair of candidates: XmAb14045 for acute myeloid leukemia and XmAb13676 for B-cell malignancies. Not anymore. Story

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 

Another Novartis partner, Pear Therapeutics, 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

Cellectis CEO André Choulika contends that the future of CAR-T is off the shelf. Allogeneic CAR-T therapy, which uses donor T cells, has the potential to clear the hurdles that come with autologous CAR-T, which uses a patient’s own T cells. “With off-the-shelf CAR, you don’t ask patients to provide part of the raw materials for their treatment,” Choulika said at the J.P. Morgan Healthcare Conference. And the allogeneic approach could expand the reach of CAR-T treatments beyond certain indications, namely those in which patients don’t need that particular tissue to survive. “If the target is expressed on myeloid progenitor cells … the patient cannot rebuild blood, even red blood cells,” Choulika said. “You don’t want the CAR to stay there forever, so it doesn’t really make sense to make an autologous CAR.” Story