SAN FRANCISCO — If T.S. Eliot were alive, and milling around San Francisco's Union Square, he might observe how the third day of J.P. Morgan's annual healthcare conference came and went — not with a bang, but a whimper.
This year's conference was more measured in tone from the start, although Wednesday did provide several candid moments. The CEO of Amarin, in particular, turned the questioning typically lobbed at companies around on his investor audience.
Additionally, gene therapy was again a focal point, as Editas, Solid Bio and Adverum Biotechnologies delivered corporate updates.
'Are you all on Vascepa?'
Investors peppered Amarin CEO John Thero with questions on the company's sales strategy, patent litigation and possible commercial partnerships for its fish oil-derived pill, Vascepa, in a closely-watched Wednesday breakout session.
The drug has transformed the company into a nearly $7 billion biopharma, supported by long-term clinical data released in 2018 showing Vascepa reduces the risk of heart attacks and strokes in a broad group of patients.
Since then, takeout speculation has run rampant given the opportunity and big pharma's never-sated search for new blockbuster drugs. But a deal hasn't come, even as the Food and Drug Administration cleared a long-sought label expansion last month.
Thero, though, defended the decision to go it alone in the U.S., detailing progress in expanding the company's salesforce from 150 to 800 representatives.
The executive sees "no value" in co-promoting Vascepa in the U.S., arguing that would give away value and dilute shareholders. In Europe, meanwhile, it's "too early," Thero said, as the drug remains before European regulators for its crucial approval expansion.
After a flurry of questions, the typically straight-shooting CEO inquired to the room full of investors and Wall Street analysts about their own prescriptions.
"Are you all on Vascepa? Have you asked your doctor about Vascepa?" he asked, adding he is taking Vascepa himself. "Probably didn't expect that at this panel."
Biohaven's Allergan headache
Any day now, Connecticut-based Biohaven Pharmaceuticals expects regulators will clear its new migraine drug for market.
There's just one catch: late last month, Allergan received approval for its own migraine medicine that works in the same way as Biohaven's. Directly competing against a much larger rival can be a daunting task — especially if that rival is about to be acquired by an even bigger company with a vaunted sales operation.
But Biohaven's chief executive says he's confident his company can carve out a significant portion of the acute migraine market, backed by data showing its drug works fast and is active for hours.
"The reality is: choice is good for patients," CEO Vlad Coric told BioPharma Dive. "They're going to have two choices in the oral space, us and Allergan. I think both of us would do very well."
Biohaven expects its sales force will fall somewhere between a few hundred and 1,000 representatives, with a focus on being quicker than rival companies.
"I'm not going to outline exactly how we're going to do that, but I think the days of putting a drug rep on every single physician is over," Coric said. "There is probably a critical mass of drug reps that you do need in this space, but you have to leverage e-commerce, telemedicine, social media."
Piper Sandler has modeled $40 million in annual sales for Biohaven's drug in 2020 and $3.4 billion by the end of 2028.
Orchard not itching to sell
Gene therapy is one of the hottest areas of drugmaking, and of dealmaking. The last couple years saw AveXis, Spark Therapeutics and Audentes Therapeutics get bought by larger pharmaceutical companies.
Like those biotechs, gene therapy developer Orchard Therapeutics has begun testing its medicines in people. The company already has a marketed product in Strimvelis — licensed from GlaxoSmithKline — and intends to submit three more medicines for approval before the end of 2021. European regulators are reviewing the first of these, a treatment for a rare disorder of the nervous system, and Orchard intends to file in the U.S. sometime this year or early next.
Notably, though, company leaders told BioPharma Dive they have no plans to give up the Orchard steering wheel.
"We're setting out our stall to build a global company and to bring these to patients — and my experience, having been 20-something years in the rare disease field, is these highly focused, smaller teams do a very, very good job of serving rare disease communities. So I think we can do that," CEO Mark Rothera said in an interview.
"If we only had one product, I would say maybe somebody else could do it," Rothera added. "But we have three near-term filings; we have four more [treatments] in the clinic. So I think we have a lot of ammunition to fuel that platform."
On the other hand, management said Orchard would consider partnerships under the right circumstances, such as if the gene therapy was going after a larger indication that required more resources to commercialize.