As discussed in a previous post, though increasingly the need for newer and better antibiotics has become a high-profile issue (i.e., Superdrugs for Superbugs), unfortunately, follow-through has been lacking where arguably it matters most—innovation in the labs of Big Pharma, which generally has the most resources and the deepest pockets.
According to a New York Times story: “fifteen of the 18 largest pharmaceutical companies have abandoned the antibiotic market entirely,” and only “19 new antibiotics were approved by the F.D.A. from 1980 to 1984,” compared to 13 from 2000-2014. As a result, the pipeline for antibiotics, especially new classes of anti-infectives, has mostly run dry (“sputtering”)—indeed, it’s been 25 years since the last novel class of antibiotics was approved.
The pharmaceutical companies that exited the field decade ago did so due to poor ROIs... simply not enough money in bug-killing, however Bad or Super-Bad, the Bugs. Why devote a decade’s worth of time, and spend many hundreds of millions of dollars, even billions, to develop a new antibiotic that sells for a few thousand dollars, when resources could be allocated to, say, the oncology blockbuster drug that generates over $100,000 per patient per year, year after year?
But the sentiment seems to be changing. And fast.
New market incentives (proposed innovation prizes and funds), and governmental actions (more grants, the drafting of new laws meant to spur antibiotic research; see the 21st Century Cures Act with its “Limited Population Antibacterial Drugs” or LPAD language) have won over increasingly more pharmaceutical companies.
This article—“There’s Big Money Again in Saving Humanity With Antibiotics”—captures the renewed enthusiasm for anti-infectives quite well. It notes many pharmaceutical companies expect to increase antibiotic development budgets and expand research staff. A number of large antibiotics deals also have been struck, both outright acquisitions of companies and lucrative licensing deals. In August 2014, Pfizer bought AstraZeneca’s antibiotics business for approximately $1.6 billion. In December 2014, Merck paid $8.4 billion to acquire Cubist, a market leader in antibiotic development. Its main antibiotic, Cubicin (Daptomycin), has generated over $1 billion in annual sales and is an antibiotic that Brilacidin has performed comparably to, both in the literature and in clinical trials, where Brilacidin went head-to-head with it in Phase 2 trials.
Brilacidin, and the larger Innovation HDP-mimics antibiotics platform, with gram-negative and anti-fungal compounds in pre-clinical development, one day might prove to be as valuable. The average market valuation of antibiotics companies, for some time now, have been deemed under-priced, and may be due for an upwards correction.
A December 15, 2016, Reuters story, "The Uncounted: As 'Superbugs' Strengthen, an Alarming Lack of New Weapons to Fight Them," and an associated video clip, provides additional information on the early development of Brilacidin.