What’s an example of a well-executed drug launch? Look no further than Reata’s commercialization of Skyclarys, the first treatment for the rare degenerative disease Friedreich’s ataxia (FA).
The therapy, which hit the market in late June 2023, racked up sales of $93 million last year, routing the analyst consensus expectation of $44 million. How did the 22-year-old, Texas-based company pull off such a successful start?
In its annual white paper analyzing the launch performance of pharmaceutical products, consulting firm Trinity Life Sciences provides several reasons Reata excelled in its first crack at commercializing a drug.
The company invested in patient identification and emphasized patient access and support. It also used a focused commercial approach, employing just 50 sales reps who targeted 2,500 healthcare professionals.
“There’s been nothing out there to treat these patients. It’s a really high unmet need patient population and they still did all of this work to say we’re gonna connect patients and physicians, and with the right physicians that are able to deliver this treatment,” Krista Perry, Trinity’s partner and head of launch excellence, said in an interview with Fierce. “White glove service is becoming the base, the foundation, nowadays. They did a really nice job creating that foundation that was able to not only push demand but to pull through those patients.”
The strategy and the quick uptake of Skyclarys helped attract Biogen, which paid $7.3 billion to acquire the biotech. The deal, which was announced in July 2023 and was a 59% markup on Reata’s shares, took just two months to complete. Biogen has kept Skyclarys’ launch momentum rolling as it has generated $280 million in sales in the first three quarters of 2024.
Successful launches of drugs for unmet needs
According to Trinity’s report: "Moving the Needle: Lessons from the 2023 Launch Class," Skyclarys supports one of the key findings of the 2023 analysis, which held that several companies—both big and small—had successful launches of drugs that address an unmet need. Trinity defines a successful launch as one in which sales exceed analyst expectations.
Some of the other launches of drugs for unmet needs that exceeded expectations were Tarsus Pharmaceuticals’ debut of eye disease drug Xdemvy, Apellis’ launch of geographic atrophy (GA) treatment Syfovre and Iveric Bio’s competing launch of GA treatment Izervay.
“Apellis began unbranded campaigns in 2022, launching both dedicated eye care professional and patient-focused campaigns to generate early understanding of the condition and foster interest in new available treatments,” Trinity said in its report.
Trinity added that, while these pre-launch, market-shaping efforts helped facilitate the uptake of Syfovre upon its market debut in February 2023, they also likely had a spillover effect, helping allow Iveric’s Izervay to have similar success upon its launch six months later.
Iveric, which was acquired by Astellas before the launch but continued to operate independently of the Japanese company until the buyout was complete, took the launch a step further with a “fit-for-purpose engagement model,” Perry said, which used a data-driven approach to match patients with specialists best suited to prescribe and deliver the treatment.
“They were very precise in who they targeted,” Perry added. “That enabled Astellas to come in and boost their footprint very quickly.”
Three more successful launches cited by Trinity were for RSV vaccines, each of which significantly exceeded expectations. Those shots were GSK’s Arexvy, Pfizer’s Abrysvo and Sanofi and AstraZeneca’s Beyfortus. GSK’s Arexvy outdid every new product that was launched in 2023, generating sales of $1.5 billion, which massively went above analysts’ consensus forecast.
“Vaccines kind of took a hit from COVID. My guess is that analysts were a little gun shy about overestimating vaccine demand,” Perry said. “But too, there was a high unmet need population and all three—GSK, Sanofi, Pfizer—are all established vaccine players that have the portfolio they could lean on, that have the experience they could lean on. It was sort of a perfect storm for them.”
In established markets, experience matters
The second key finding of Trinity’s report was that for products launched in established or more competitive markets, companies with experience in the therapeutic area fared better than those that were launching drugs for the first time. This tendency was particularly evident in the launches of oncology drugs.
An example is Eli Lilly’s launch of Jaypirca. The company’s overwhelming success with diabetes and obesity drugs Mounjaro and Zepbound has overshadowed its growing presence in oncology, which has helped pave the way for a successful launch of Jaypirca, which was initially approved for mantle cell lymphoma, followed by nods for chronic lymphocytic leukemia and small lymphocytic lymphoma.
Genmab and AbbVie’s debut of Epkinly for patients with diffuse large B-cell lymphoma has also exceeded expectations in its battle with Roche's Columvi.
“The company’s go-to-market strategy focused on leveraging the first-mover advantage with a focus on key accounts and customers, utilizing field medical, sales and market access teams across both Genmab and AbbVie,” Trinity wrote. “Genmab and AbbVie’s combined experience in hematology-oncology certainly helped navigate the early diagnosis, treatment and reimbursement realities inherent in complex new therapies of this type.”
On the flip side, there were three examples of oncology drugs that were brought by less experienced companies that underperformed. They were Gamida’s cell therapy Omisirge, BioLineRx’s multiple myeloma treatment Aphexda and Coherus and Junshi’s head and neck cancer drug Loqtorzi.
“The main thing that we pointed to, was the lack of experience, the lack of foundational understanding of oncology,” Perry said. “[AbbVie and Lilly] could lean on their understanding of the stakeholders. They could lean on their understanding of the process and the guidelines of what it takes. There was just sort of a head start there, setting up that foundation versus the others that kind of had to build that from scratch.”
Trinity also pointed out that emerging oncology companies are more apt to experience challenges with manufacturing and supply.
“If not addressed quickly, these can serve as a cautionary tale of how operational or technical elements of commercialization can constrain an emerging biotech company’s ability to achieve their ambition for these therapies,” Trinity wrote.
Other 2023 drug launch notes
In its report, Trinity pointed out that companies can recover from underperforming in the first year after launch. Examples include Bristol Myers Squibb’s multiple sclerosis drug Zeposia and Roche’s spinal muscular atrophy treatment Evrysdi, both of which overcame slow starts and are now on track to achieve blockbuster status.
Perry pointed out that larger companies have an advantage in waiting out underperforming products.
“The first 12, 18, 24 months, you’ve [go to] have the right strategy and approach for first-launch biotechs, otherwise you’re either downsizing and cutting back or you’ve flopped,” Perry said. “For mid and large pharma, they can withstand a soft or an underperforming launch and then inflect.”
Since Trinity began analyzing drug launches in 2020, companies undertaking their first launch have become more successful at meeting first-year sales expectations. From 2020 to 2023, of the 44 drugs launched from first-time drugmakers, 20% have overperformed their sales expectations, compared to 33% of the nine drugs that reached the market in 2023.
Similarly, companies launching non-rare specialty and large market treatments also had more success in 2023, with 36% of the 14 products overperforming their sales expectations compared to 18% of the 55 drugs launched between 2020 and 2023.
Aside from the three RSV drugs that routed their sales expectations by more than 600% each, the drug that most exceeded analyst consensus was Acadia Pharmaceuticals’ Rett syndrome treatment Daybue, which recorded sales of $177 million after its launch in April 2023, while it was expected to generate only $29 million.
Another company leveraging its therapeutic area expertise to facilitate the launch of a new product—though not in oncology—was Sarepta with Duchenne muscular dystrophy (DMD) gene therapy Elevidys, which is the fourth DMD treatment the company has brought to the market since 2016. The quick uptake of Elevidys is particularly rare for a gene therapy, Trinity pointed out.