UPDATED: JPM: Glaxo ready to shift off Advair; BMS isn't afraid of Merck; Roche eyes combos and M&A

By Carly Helfand and Tracy Staton

SAN FRANCISCO--Here's a game to play at the annual JP Morgan Healthcare Conference. Attend presentations by executives at Big Pharma, Big Biotech, and slightly less big biopharma companies, hoping to hear something new and different they're willing to say in public. Here's the latest from FiercePharma's notebook. For more, check out Tuesday morning's roundup, and our separate stories on Johnson & Johnson's new yen for slimming down and Merck & Co.'s Keytruda progress.

  • Last year, GlaxoSmithKline's ($GSK) Breo and Anoro--respiratory drugs meant to step in for aging giant Advair--got off to a sluggish start. Entering 2015, you don't need to tell the British drugmaker what needs to happen. It expects Advair to be a "an ongoing drag" as its sales decline 20% to 25% in the U.S., Chief Strategy Officer David Redfern said late Tuesday afternoon, and "it's really the year where we have to make significant progress shifting the business … into the much broader portfolio." That'll involve taking advantage of increased Medicare Part D coverage for the newcomer duo, with Breo now boasting 76% coverage and Anoro 65%. "We're in a much better position" in 2015 than in 2014, Redfern said, and "clearly one of our big challenges through the first part of this year and through '15 is to convert that greater access to real scripts and to real business and build momentum behind these brands." Slides

  • Bristol-Myers Squibb ($BMY) may be squaring off against Merck's ($MRK) ‚ÄčKeytruda in the anti-PD-1 market, but the drugmaker isn't scared of a little market face-down. The company is "very committed to strengthening our commercial capabilities" and innovating when it comes to marketing strategies, COO Giovanni Caforio said Tuesday; after all, this is the company that launched the market's first immunotherapy drug in melanoma fighter Yervoy nearly four years ago. But BMS's commercial innovation extends outside of oncology, too, he noted. Just look at Eliquis, which a year ago was buckling under the weight of analysts' expectations and lagging far behind its next-gen anticoagulant competitors. BMS and partner Pfizer ($PFE) made targeted investments in medical education and DTC advertising in the U.S., and it shows: In the U.S., in cardiology Eliquis is now the No. 1 agent in terms of new-to-brand prescriptions, Caforio said. Meanwhile, Bristol-Myers rolled out some Opdivo R&D news; the company is teaming up with Eli Lilly ($LLY) to study Opdivo along with Lilly's galunisertib in several cancers. Plus, BMS plans blood cancer studies teaming Opdivo with Seattle Genetics' ($SGEN) treatment Adcetris. Release | Release

  • Gilead Sciences ($GILD) may have a pair of next-gen hep C meds putting up ultrahigh cure rates as they take the market by storm. But the way the California drugmaker sees it, there's still room for improvement. "Despite the rapid advance of Sovaldi and Harvoni, we think there is still opportunity for innovation in the HCV area," John Milligan told presentation watchers Tuesday morning. The company has four Phase III studies in progress testing hot-launcher Sovaldi with its GS-5816, a combo it's examining across all genotypes, at 12- and 24-week durations, and in patients with and without cirrhosis, Milligan said. It's also testing those two with another experimental med, protease inhibitor GS-9857, in ongoing Phase II studies; last year, three-drug cocktails showed "very high response rates" in 6 weeks of therapy only. In the meantime, solo Sovaldi is still rolling, with reimbursement negotiations in Europe having gone "much faster than normal," according to Milligan. Gilead expects to see full launches in France, Germany and the U.K. in the first quarter of this year. Webcast Recording

  • PCSK9 drugs are the next big market waiting to happen, and with rivals Sanofi ($SNY)/Regeneron ($REGN) and Amgen ($AMGN) ahead in the development race, Pfizer ($PFE) wants to make sure it can lock down a solid share of the market. So beyond in-development anti-cholesterol antibody bococizumab, it's working on a wider PCSK9 "franchise," R&D chief Mikael Dolsten said Tuesday. That will include a small-molecule PCSK9 inhibitor that has already triggered "a substantial reduction" in cholesterol in preclinical animal studies--expected to start human trials later this year--and a vaccine candidate. "It's a very substantial effort," he said. "We think this franchise opportunity that we are pushing forward with is an opportunity for us to be a leader and to build a portfolio with complementary positioning for patients and payers in this very large segment of cholesterol management." Presentation

  • Combos are the name of the game going forward for oncology leader Roche ($RHHBY), according to company CFO Alan Hippe. The Swiss pharma is studying its big-name cancer fighters Avastin, Gazyva and others in immunotherapy cocktails, which it sees as "the ultimate goal, especially if you move into the first line or second line or the adjuvant setting," he said. Those pairings could eventually help build on the success of giants already well into the blockbuster strata, racking up sales the Basel-based drugmaker hopes to turn into cash. It's looking to provide "a good cash generation moving forward, which certainly is also a major trigger for our financial flexibility," Hippe said. In other words, Roche could be headed for the M&A market in the not-too-distant future. And speaking of M&A, what of Esbriet, the recently launched IPF med the company snagged in last year's InterMune buyout? Hang in there until the half-year mark if you want to hear good rollout results, warns Hippe. "Esbriet moves well so far," he said. "Don't judge it on the Q1 data." Slides (PDF download)

  • When looking for an acquisition, you want to look at things a company does well. But you also want to look at things you can do better than they can do, Shire ($SHPG) chief Flemming Ornskov says. When it comes to the recent pickup NPS Pharma ($NPSP), a deal for which the Dublin drugmaker announced Sunday, "We have global imprint. We have patient services. We have the ability to launch products. We are in many more countries [than] they are. We have much larger sales forces. We have the infrastructure to maximize the assets to the benefits of the patients," Ornskov said. All of those will help it take the commercial success of NPS' GI drug Gattex to the next level, it believes. It's already prepping for integration with the same team that helped fold in 2013 acquisition ViroPharma to generate tax, cost and revenue synergies 9 months after that deal's close. The NPS pact is only "the first step on the journey," for Shire, too, which Ornskov says will have enough cash left after this deal to consider other targets. Presentation

  • Teva ($TEVA) has said just about everything it can about buyouts without name-dropping its targets. Tuesday afternoon, CEO Erez Vigodman went through the qualifications: Its potential pickups should match its focuses for 2015-2017, which are complex generics, emerging markets and a handful of key therapeutic areas on the branded side. They should help Teva "play by the rules that pervade the industry," meaning accretive EPS is important--but what's more important is value for shareholders, so ROI trumps it. And size doesn't matter, the helmsman said: "We will not be hesitating to be engaged in large transactions to the extent they provide for us value which is significant enough." Now, the only question is when those long-absent business development moves will show up. Webcast

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