Industry Pulse aims to complement BioPharma Dive’s daily news coverage with a data-driven look at a few of the top stories from the previous quarter. This edition focuses on biopharma's endless quest to reinvent itself with new drugs and new revenue streams.
More than many other industries, drugmaker revenues have a clear time limit. Cheap generics wait in the wings for branded drug patents to expire, presenting a clear threat to future growth. That looming competition forces biotech and pharma companies to spend hundreds of millions on uncertain R&D, searching for new medicines to reinvent themselves.
The patent cliff that began at the end of the last decade brought generic competition for many of the industry's top-earning drugs, decimating sales and forcing pharma companies to turn to new sources of growth. Now, biosimilar competition threatens to do the same for some biologic drugs.
Across the industry, executives talk up the prospects of new launches and promising pipeline candidates. With the 2017 coming toward its close, here's a look at how those efforts are faring for seven biotech and pharma companies.
For Swiss pharma Roche, its three top biologic drugs — Rituxan (ritxuimab), Avastin (bevacizumab) and Herceptin (trastuzumab) — collectively earned about $21 billion last year. Inbound biosimilar competition to that trio threatens to erode those sales, though, potentially denting profits given the high margins for those products.
While Roche is confident it can continue to grow through this biosimilar erosion curve, that growth will need to come more and more from newer products.
Drugs like Ocrevus (ocrelizumab), Tecentriq (atezolizumab) and Alecensa (alectinib) will be crucial contributors. Two quarters into launch, Ocrevus is already pacing to be a blockbuster. Maintaining that growth, while building other launches will make Roche's balancing act that much easier.
See Also: Roche feeling first effects of biosimilar Rituxan»
Crosstown rival Novartis AG has already absorbed a generic hit to its once top-selling cancer drug Gleevec (imatinib). Yet, the pharma believes as many as 12 of its newly launched or late-stage products could eventually become blockbusters.
In the present, Novartis' new drug hopes rest first on the IL-17A inhibitor Cosentyx (secukinumab) and the heart drug Entresto (sacubitril/valsartan).
Cosentyx has quickly made its mark, becoming one of the fastest launches in the drugmaker's recent history. Entresto, on the other hand, has largely failed to live up to its blockbuster billing, running into payer hurdles and lower-than-expected uptake.
See Also: Novartis sets Cosentyx hopes higher»
An R&D dry spell has left British drugmaker GlaxoSmithKline plc with few major novel drugs to hang its hat on in recent years. In July, CEO Emma Walmsley unveiled a plan to overhaul R&D, underscoring the need to focus resources more narrowly on the company's core areas.
GSK is counting on combos, HIV meds and a new vaccine
|First approved||2017 YTD sales (millions)||Outlook|
|Breo Ellipta||May 2013||£710||Growth accelerating|
|Juluca||Nov. 2017||—||Gilead combo could be potential rival|
|Nucala||Nov. 2015||£223||Competitive threat from AstraZeneca's Fasenra|
|Tivicay||Aug. 2013||£1,005||Likely to be boosted by Juluca approval|
|Trelegy Ellipta||Sept. 2017||—||IMPACT study should broaden approval|
|Triumeq||Aug. 2014||£1,808||Market share steady; Gilead's bictegravir looms|
GSK expects gradual growth
But that new approach will take years to bear fruit. In the meantime, GSK hopes three new launches — the two-drug HIV regimen Juluca (dolutegravier/rilpivirine), the three-in-one respiratory medicine Trelegy (fluticasone furoate/umeclidinium/vilanterol) and the shingles vaccine Shingrix — will see it through looming generic competition to its mainstay Advair franchise.
See Also: GSK overhauls R&D, axes 30 programs to regain edge»
Since 2014 Eli Lilly & Co. has quietly built a roster of new drugs, launching nine new medicines if its collaboration with Boehringer Ingelheim is taken into account. Some of them, such as Portrazza (necitumumab) and Lartruvo (olaratumab), look to be relatively minor contributors.
But others such as Trulicity (dulaglutide) and Taltz (ixekizumab) should drive sales growth in the future — particularly as payer pushback leads to higher and higher rebates in Lilly's core insulin franchises.
Lilly's recent R&D success was marred, however, by a rejection for its arthritis drug baricitinib from the Food and Drug Administration. The Indianapolis pharma will have a chance to resubmit in early 2018, but the initial thumbs down from the U.S. regulator looks to be a costly delay.
See Also: Lilly speeds up timeline for refiling of baricitinib»
In biotech, Biogen Inc.'s spinal muscular atrophy drug Spinraza (nusinersen) adds a new franchise to a company that has long been focused on multiple sclerosis.
While the company's multiple sclerosis meds will continue to drive growth for the company, Spinraza helps to diversify Biogen's future revenue — particularly after it divested its hemophilia business in the first quarter this year.
Flat sales of the drug in the U.S. last quarter, however, gave investors a cause for concern. Biogen explained the plateau as a factor of dose timing that will equalize in coming quarters. Any slow spots in the future, though, could prompt more probing questions.
See Also: US Spinraza sales cause concern among Biogen investors»
Biotech investor circles were more rattled by Celgene Corp.'s unexpected cut to its long-term guidance in October. Notably, the biotech predicted slower growth for its inflammatory disease drug Otezla (apremilast), while cutting back forecasts for its new hematology and oncology candidates.
Celgene's Revlimid (lenalidomide) franchise, in other words, will continue to be a key source of growth for the company through the end of the decade — a prospect that worries some who had been hoping to see greater contributions from the rest of the company's portfolio.
See Also: Slow Otezla growth dampens Celgene's long-term prospects »
Counting the world's best-selling drug among its products has earned AbbVie, Inc. a long stretch of year-over-year revenue growth. While AbbVie has a promising pipeline and a growing oncology franchise, the biopharma's near future will remain centered on Humira (adalimumab).
Humira's inexorable growth is both a strength and a vulnerability. While patent protection lasts, the drug's mega-blockbuster earnings can compensate any R&D setbacks. But over the longer term, relying on one drug for more than 60% of revenue could leave AbbVie exposed if its pipeline candidates and new launches hit any bumps in the road.
See Also: AbbVie's anti-inflammatories key to growth»