Editor’s Note: As the Biotech industry faces unprecedented levels of uncertainty in the midst of a trying macroeconomic environment, it’s more critical than ever for commercial stage innovators to deploy effective go-to-market strategies that generate sustainable brand growth. Sustainable growth strategies are those that maximize adoption (amongst patients & HCPs) while also protecting gross-to-net by avoiding free good overutilization. Such strategies can extend cash runways, provide a positive story for investors, and can even position biotechs for a successful acquisition. However, the current realities of the modern drug channel have introduced significant complexities in the form of fierce competition in nearly every therapeutic category and steep utilization management requirements that can limit patient access. The prospect of daunting prior authorization management requirements results in many manufacturers over utilizing their uncovered coupons to drive adoption; a strategy that is both unsustainable and particularly perilous in an environment where access to capital is tight. Commercial stage biotechs would be wise to make patient access a top priority in 2023, and PHIL can help optimize your gross-to-net while delivering brand growth. Check out this case study to learn about how PHIL unlocked patient access and supported a successful acquisition for a commercial stage biotech in the Ophthalmology space.
Eli Lilly's Renee Williams arrived in New York City this week ready to mix and mingle with dozens of biotechs that had descended on the Big Apple itching to strike a deal.
The draw was the Biotechnology Innovation Organization's CEO and Investor Conference, a business development bonanza centered on partnerships and dealmaking. For the smaller companies in attendance, the mission was simple: find enough capital to keep going. In a financing environment that remains perilous for new biotechs, the stakes are high.
Even so, Williams, who leads external innovation for Lilly's genetic medicine unit, cautioned against desperation.
“I definitely get the sense that people need to find a way to return for their investors, to return their own costs probably out of their pockets,” she said. “It's translating to perhaps maybe not typical business practices.”
While big-ticket licensing deals are at the top of the list for smaller biotechs, Williams highlighted Lilly's other offerings, such as data and strategy consulting in exchange for some royalties or commercialization rights. The proposal underscores how much the ball is in Big Pharmas court with respect to dealmaking—and what companies may need to give up in exchange for even a limited relationship with the industry's biggest players.
“Having dollars doesn't mean that you run your experiments in a way that necessarily we want to see them,” said Williams. Still, she emphasized the company is open for business, reiterating an often-heard call from pharma executives.
But Big Pharmas need the biotech ecosystem just as much to top up their pipelines—hence why people like Williams were there, to meet the small biotech executives who could hold the next big thing.
The juxtaposition between Big Pharma's available cash to spend and the sheer volume of potential partnerships sets the scene for a competitive and dogged financing environment. It's been made even more difficult as IPOs have become increasingly difficult to pull off, M&A has not returned to expected volumes and trepidation has crept into private financing, particularly in follow-up raises. Yet the sentiment among conference attendees was largely hopeful.
That was certainly Talia Biran’s mood. As president of the U.S. subsidiary of the Japanese biotech Oncolys BioPharma, Biran is shopping for two distinct opportunities. The first is finding a commercial partner for the company’s soon-to-be-submitted oncolytic virus therapy, suratadenoturev, in Japan, with phase 2 data expected before the end of the year and an approval application slated to be submitted in 2024.
The other goal is to find a development partner in the U.S., where suratadenoturev is being tested in conjunction with chemoradiotherapy in a phase 1 trial and alongside Merck & Co.'s Keytruda in a phase 2 trial. The company has tried before with no luck. But this time is different, as Biran says Oncolys now has clinical data plus the prospect of bringing in revenue from Japan, bolstering the prospects of landing a coveted licensing deal.
“I think the issue was that we didn't have data at the time that Oncolys tried a few years ago,” she said. “Now, four years fast forward, we have more convincing data that was generated in the U.S. that I feel more confident to showcase the virus and to get the licensing deal.”
While Biran wishes Oncolys could commercialize the drug by itself, they simply can’t afford it. She guessed that before the end of the year, the company would at least be able to nail down a partner in Japan.
Ulrich Dauer, Ph.D., CEO of Vivoryon, finds himself in a similar situation as the company sets its sights on a phase 2 readout for Alzheimer’s disease treatment varoglutamstat in the first quarter of 2024. He says the goal is to find a partner to fund additional clinical development. His pitch comes as Alzheimer’s drug development is at a fever pitch, with Eisai’s lecanemab nabbing accelerated approval and Eli Lilly’s donanemab nearing a phase 3 readout.
“Now having kind of the first successes, there seems to be an increasing interest to look on, you know, various approaches in the field and we are experiencing that,” said Dauer. The inspired pursuit for more money that drove most companies at the conference means that the options for people like Williams were in abundance. Her pitch to them was succinct.
“People just have to come and ask—everything is not just give me a dollar. We have a lot to offer,” she said.
Our consultants will work with you to analyze your current channel strategy and make recommendations for how to improve patient access and increase the percentage of scripts getting covered by insurance.