The Antidote: Inside the World of New Pharma

Image of The Antidote: Inside the World of New Pharma
Release Date: 
February 4, 2014
Simon & Schuster
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In The Antidote, Barry Werth continues the saga of Vertex Pharmaceuticals, a journey begun in his previous book The Billion Dollar Molecule. Vertex was a startup company founded by the visionary Joshua Boger, who had a new idea of what a pharmaceutical company should aim for: to produce drugs faster and better.

Werth very aptly captured the drama of the pharmaceutical industry in which, although great profits are possible, great risks are also taken. A 30:1 failure rate takes place even after a drug candidate reaches human testing to bring the drug to market. Drug development represents an investment of millions of dollars and many years of research. The Antidote amply illustrates that even after FDA approval of a drug, a company must act quickly on their marketing strategy, as competitors are always at their back. The time of profitability may be short indeed.

Werth was able to obtain extraordinary inside information on the workings of the pharmaceutical industry. He was able to capture the emotional and psychological state of the players, the day-to-day workings of the companies with failures and successes of research, as well as collaborations with other companies and acquisitions.

Werth was able to present very complex disease and disorder topics in a succinct and understandable manner as well as the rationale for choices of experimental drugs. He used an excellent choice of words, including appropriate metaphors.

The pharmaceutical industry that Joshua Boger worked in was dependent on Wall Street for funding. The Street demanded a continuation of quick profits and had little patience for long-term goals. Companies responded by bringing to market new drugs that were only slightly different than current drugs at higher prices. They had little motivation to innovate breakthrough drugs to treat new conditions.

In Part 1, Feeding the Beast, Vertex explored several promising areas of drug discovery. The first foray was with HIV. Vertex developed a better molecule than the protease inhibitor drug currently on the market. Lacking adequate research facilities to study the molecule, Vertex entered into partnership with Glaxo to develop the drug. Although the drug was eventually approved for marketing, its success was limited due to problems in formulation.

Another disease area studied was rheumatoid arthritis. Vertex developed a kinase inhibitor against the disease, identified as VX-745. This research inspired Boger to develop the strategy of designing drugs against gene families, coined chemogenomics. Unfortunately, VX-745 failed due toxicity in dogs.

In Part 2, Game Worth the Candle, Vertex focused on developing drugs against hepatitis c and cystic fibrosis. Hepatitis C was an unusual candidate in that it had a whole host of developmental challenges, and the need for the drug was obscure (not in the public spotlight). Cystic fibrosis, although a dreaded disease, affected only a small population and thus represented a small market. At this time, the company was buffeted by events and begun to question if it could remain faithful to its founding principles.

Part 3, Showtime, described the unfolding drama surrounding the approval of Vertex’s first drug, Incivek, against hepatitis C.  Vertex was running neck-in-neck with Merck to obtain approval for hepatitis C drugs, navigating the ins-and-outs of dealing with the FDA.  Once approved, Vertex had to quickly get its marketing plan in operation to maximize sales before competitive products reached the market.

Vertex’s drug against cystic fibrosis, Kalydeco, was approved about a year later, but the FDA put label restrictions on the conditions of use, limiting its value.

Vertex had vindicated its position that research was paramount; however, it could not rest on its laurels, realizing it must continually strategize in order to survive.