Biogen’s big late-stage play in Alzheimer’s has just crashed. And the damage will be extensive.
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Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.
Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.
The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.
It's how we roll at Endpoints News.
Here is a quick summary of the rest of the top 10:
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By Lucy Clossick Thomson, Senior Director of Oncology Project Management, Icon
Clinical trials in oncology can be costly and challenging to manage. One factor that could reduce costs and reduce barriers is harnessing the patient voice in trial design to help accelerate patient enrollment. Now is the time to adopt patient-centric strategies that not only focus on patient needs, but also can maintain cost efficiency.
Merck’s recent deals to buy up two bolt-on biotechs — Tilos and Peloton — weren’t an aberration. Instead, both acquisitions mark a new strategy to beef up its dominant cancer drug operations centered on Keytruda while looking to address growing concerns that too many of its eggs are in the one I/O basket for their PD-1 program. And Merck is going after more small- and mid-sized buyouts to calm those fears.
Catalent is staying on the growth track.
Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.
There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.
This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.
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A day after Pfizer bought Array and its approved cancer combo, BeiGene and Pfizer spinout SpringWorks have partnered in launching a new biotech that has an eye on the very same market the pharma giant just paid billions for. And they’re planning on using an ex-Pfizer drug to do it.
In a nutshell, China’s BeiGene is tossing in a preclinical BRAF inhibitor — BGB-3245, which covers both V600 and non-V600 BRAF mutations — for a big stake in a new, jointly controlled biotech called MapKure with Bain-backed SpringWorks.
Technology is bleeding into healthcare, and big pharma is riding the wave. Sanofi $SNY appointed its first chief digital officer this February, following the footsteps of its peers. By May, the French drugmaker and some of its big pharma compatriots joined forces with Google parent Alphabet’s Verily unit to augment clinical trial research. On Tuesday, the Parisian company tied up with Google to access its cloud computing and artificial intelligence tech to spur the development of new therapies.
While it’s waiting to hear back from FDA regulators, Roche is beginning the victory lap for entrectinib in Japan.
Roche is giving Bayer a run for their money with this tumor-agnostic drug, which targets NTRK gene fusions. Now dubbed Rozlytrek, it’s sanctioned to treat adult and pediatric patients in Japan with neurotrophic tyrosine receptor kinase fusion-positive, advanced recurrent solid tumors.
→ Rare disease player Ultragenyx $RARE is expanding its alliance with Arcturus $ARCT, paying $24 million for equity and another $6 million in an upfront as the two partners expand their collaboration to include up to 12 targets. “This expanded collaboration further solidifies our mRNA platform by adding additional targets and expanding our ability to potentially treat more diseases,” said Emil Kakkis, the CEO at Ultragenyx. “We are pleased with the progress of our ongoing collaboration. Our most advanced mRNA program, UX053 for the treatment of Glycogen Storage Disease Type III, is expected to move into the clinic next year, and we look forward to further building upon the initial success of this partnership.”