The Antidote: Inside the World of New Pharma (40 page)

Vertex was squarely “in the hunt,” as Weet put it. Merck had announced the previous Friday that the FDA had accepted its new drug application for boceprevir. At Vertex, everyone automatically back-calculated sixty days and realized that Merck’s submission date was on or about November 6. Merck seized bragging rights to beating Vertex to a crucial milestone in the race to market, a race that Vertex had led at each juncture. But Vertex was close enough behind to guarantee back-to-back AdComms, which in real terms mattered substantially more than a symbolic gain of two weeks. Kauffman did not have to get really mad.

Emmens was unfazed by the mismatch in size and resources. He told the Dow Jones Newswires that he didn’t believe the companies were in a race or that being first to market would be a significant advantage. He said quality is better than quantity in fielding sales reps in a specialty market and that the average person on Vertex’s sales team had fourteen years of prior experience, with eight years spent marketing antivirals. What worried him wasn’t his people but the uncertainties of the market. No one knew how many patients would show up for treatment—the biggest variable. Sales and marketing could accomplish only so much. “There is room for both of us,” he commented diplomatically.

A few days after Emmens, Smith, and Vertex’s investor relations and press teams returned from San Francisco, plunging back into making good on the company’s promise—after more than two decades—to show a regular profit starting in the second half of the year, Vertex received its filing approval. It contained a late-May deadline for an official decision on telaprevir. Delivered by fax, the FDA letter started the clock on a heated sprint to market. The company had four months to prepare to go toe-to-toe with the remaining industry giant most committed to an R&D-based formula for success—albeit one still struggling to find its post-Vioxx footing. It was a long-anticipated showdown that the business press began to relish more now that the dates were set. With priority review assured for both medicines, Weet, Kauffman, Condon, Cozzolino, and their teams mobilized quickly to beat the new hypercompressed timetable.

In December Vertex had run a “tablet validation campaign” for telaprevir—a test run of its virtual supply chain. For five years, Condon’s small staff and groups from business development and legal affairs had hopscotched across continents, assembling the elements. After leaving the manufacturing sites in China, the molecular components known as the Fab Five were flown to northern England, where Vertex had partnered with an Indian company to build out designated capacity to synthesize up to fifty tons per year of the inhibitor. From there, the active ingredient was flown to Portugal, where another pharmaceutical manufacturer had built at its own an expense a three-story reactor to mix that compound with the polymer that Trish Hurter and her group had chosen to keep it from crystallizing.

The drug molecules were dissolved in solvent and sprayed through high-speed nozzles into two five-thousand-liter tanks. Inside the chambers, heated with nitrogen, a whirling column of gas, a cyclone, sucked off the solvent while the amorphous dispersion, a blend of the polymer and 950, fell to the bottom like snow from snow guns, a fine powder, highly stable. Spray drying, first used to make powdered milk, had become an effective technology for rendering highly insoluble drugs bioavailable.

The resulting powder, not a drug product per se but an intermediate, was shipped across the Atlantic Ocean to Cincinnati to be mixed with other chemical agents—some to help it adhere to itself to deliver precise dosages and enhance exposure, others to ensure that the tablets didn’t stick to the machines that churned them out. The ratio of drug to excipients—the other chemicals in pills that make a molecule druggable—was 70/30, a striking feat of process chemistry that Boger enjoyed referencing whenever others brought up Lilly’s prediction that VX-950 could never be manufactured. From there the tablets were taken by truck to a packaging company in Illinois and readied to go into blister packs and boxes. “It was all happening as we were building it,” Condon recalls. “The WuXi plant started really cranking in 2010. What we were trying to do was time it so that we had the active ingredient sitting in front of the spray dryer, and that we could start to make the spray-dry
dispersion as close as we could to the time we had to ramp the tablet production, to have enough tablets produced to feed the launch.”

Condon believed he could wait until April to scale up full production of the drug, preserving shelf life. Throughout Vertex, the launch was paramount, but before the launch loomed the AdComm. The company advising Vertex, ProEd, arranged two mock sessions where outside experts would be brought in to play the part of commission members. In each of Weet’s four previous launches, the head of regulatory affairs introduced the study presentation, which was usually conducted by a high-level physician—often the company’s chief medical officer. He believed that ProEd agreed with him, and he started planning for the first “mock,” in mid-February. Kauffman, too, started thinking harder about how the story of telaprevir should be told and who should tell it.

On the commercial side, Wysenski had hired as head of managed markets a graduate of the Virginia Military Institute and a former Pfizer executive, Jeff Henderson; and as head of HCV marketing, a rising star at Merck named Paul Daruwala. Huddling with Cozzolino, the three of them built out an operations plan that they would roll out in late January, when the field force would meet for the first time in Miami.

For a company that planned to post a loss of almost $750 million for the year, the FDA letter wasn’t money in the bank but it represented substantial collateral. On January 24, less than a week after it was issued, Emmens signed a letter of intent to relocate Vertex’s headquarters from Cambridge, where it had run out of room to grow and the political environment was less favorable, to a long-struggling harborside complex in Boston, Fan Pier. The company planned to take about 1.1 million square feet, filling a pair of eighteen-story buildings as the first major tenant in what Mayor Thomas Menino had been trying to rebrand as an “Innovation District” by offering tax breaks and other inducements to companies to locate there. Beyond allowing Vertex to consolidate its 1,300 local workers, now scattered across ten buildings, and giving city and state politicians something to crow about, the agreement made headlines as the largest commercial lease in Boston history and the anchor of possibly the largest privately developed project in the country since the onset of the recession. Of course, it was contingent on FDA approval of telaprevir.

Cumbo felt beat, but relieved. He had done what he had set out to do, hire an elite sales force. “I feel good, I’m working for Joe, I’ve got my team in place, I’ve got a good team,” he thought. Enjoying his first free weekend in six months, he flew home to Tampa before the sales meeting, picked up his wife and children, and drove down to Marathon Key to buy a vacation home. He promised to spend much more time with them after the launch.

After arriving in Miami a day later than Cozzolino and the sales team, he roamed the first-day training sessions. Monday afternoon, as the sessions wound down for the day and everyone prepared for an off-site banquet, Cozzolino gave him a dollar bill, a pat on the back for a job well done. It was meant as a joke. Back in his room, he got a call on his personal phone from Wysenski. “I’ve got to meet with you in fifteen minutes” she said. Cumbo, alarmed, texted Cozzolino: “Joe, I’ve got an emergency. Nancy just called me and wants to meet with me. What’s going on? Am I in trouble?” Cozzolino reassured him, “Everything’s all right. You’ll be fine.”

When Cumbo got downstairs, Wysenski pulled him into a private room. She said Cozzolino had just resigned, and she needed Cumbo to take over as the interim VP of sales. Cumbo reeled. He told her about the dollar bill, hoping for some misunderstanding. “No,” she said, “he’s no longer here.”

The managerial revolving door—the Vertex vortex, if you will—swept Cumbo in at warp speed. One minute his world felt right, made sense; the next, his knees went out. “This is January. You’re four months from launch. The whole launch was in peril at that point. Everything. Nancy goes, ‘I’m gonna make an announcement first thing in the morning, eight o’clock. And I’m gonna call you onstage. And I need you to give a speech and tell the team why everyone needs to stick with you.’ I said, ‘I don’t know if I can do this.’ And she says, ‘Well, I need you to. And oh, by the way, you can’t tell anyone.’ ”

The lavish half-acre rooftop lounge at the Perry South Beach Hotel girdled a 110-foot outdoor pool with music piped underwater. Waves lapped eighteen floors below, and in the distance, the causeways crossing
Biscayne Bay and the waterside towers of the downtown skyline glittered—a mirage of prosperity, as the city still reeled from the real estate collapse and a record number of skyscrapers were vacant. “See-throughs.” There was a shark tank down in the sleek lobby.

Cumbo mingled at the bar and around tented chaise pods, each with its own flat-screen TV, in a crowd that included Emmens, most of the ET, and several new vice presidents. (Boger, chairing in “retirement” a half dozen boards, including the trustees of Wesleyan University and Harvard Medical School, couldn’t make the meeting but had been “telepresent” earlier, telling the team members via satellite that they were “fabulous” and half-joking that if he were younger, “I’d be right out there with you.”) People kept asking where Cozzolino was. “I acted like I had no idea,” Cumbo says. “I didn’t sleep at all. I tried to close my eyes, but I was sick to my stomach. I’m like, ‘What am I gonna say to these people?’ ”

Boger’s efforts to build Vertex into an organization capable of transforming lives ultimately relied on self-selection. Cumbo, who’d joined Vertex less than a year earlier and hadn’t talked with Cozzolino or anyone else in the company, found himself overnight having to explain on his own to its newest, most vulnerable employees—all people he’d hired—why they shouldn’t be alarmed by the abrupt, unexplained departure of their sales lead four months before launch.

The next morning, Wysenski announced that Cozzolino had left the company. There was a gasp. People were crying. Then she said Cumbo would start immediately as interim vice president, and everyone clapped. Cumbo had no speech, nothing prepared at all. Afterward, he wouldn’t remember walking to the stage or what he said.

“From what people can recall, I talked about how I started at GSK in HIV and how I watched how people went from dying to living, how protease inhibitors changed their entire lives. I said, ‘I’m here not because of Joe. I’m here because I want to be here, and I want to be with you. This is bigger than one person.’ I said, ‘We’re gonna make history, and we’re gonna make history together. I’m here, and I’m gonna support you, and I’m gonna lead you through this.’ I was practically in tears. I know the audience was in tears. They gave me a standing ovation for five minutes,
so long that I actually got off the stage shaking, and I walked out of the room, and everyone kept clapping.”

The first mock was held on February 10, off-site. It might have been odd at another company for the head of corporate communications to attend an early prep session for a regulatory hearing, but Megan Pace was responsible for the company’s messaging and optics, and the AdComm and launch were once-in-a-corporate-life-cycle opportunities for Vertex to define itself. So far, as Boger would be first to agree, Vertex had not really attended to public relations—not since it wheat-pasted AIDS broadsides at night in the 1990s. Michael Partridge ran
investor
relations, but that was talking with people who might want to trade shares of VRTX, not branding a biopharma for the rest of the world. Sachdev spoke with Washington and the states, but not with people who associate drug companies with their products and behavior. Vertex would soon be introduced to the general public, and Pace, who’d joined from Genentech, where she’d been spokeswoman through both its blockbuster phase and the Roche buyout, was deeply involved with all aspects of the rollout. Blond and willowy, she was thirty-five, a brisk native of Orlando, Florida.