Vyndaqel, Ibrance boost Pfizer as it eyes COVID-19 vaccine launch this year

Pfizer sign
Pfizer and partner BioNTech aims to seek emergency use authorization of their mRNA COVID-19 vaccine as early as October, Pfizer CEO Albert Bourla said. (Tracy Staton)

Add another name to the list of pharmas reporting sales declines amid the pandemic. But this company, Pfizer, is still dialing up its full-year revenue expectations—not that it’s counting any contribution from a closely watched COVID-19 vaccine candidate it’s hoping to launch this year.

In the second quarter, Pfizer recorded revenues of $11.8 billion, a 3% year-over-year decline at constant currencies, excluding the loss from merging its consumer health business into a joint venture managed by GlaxoSmithKline.

But after taking out the Upjohn generics business—which is on its way to Mylan by year’s end—Pfizer’s remaining innovative biopharma business saw sales increase by 6% to $9.8 billion, buoyed by heart med Vyndaqel, breast cancer drug Ibrance and Bristol Myers Squibb-shared anticoagulant Eliquis, among others.

Vyndaqel sales in Q2 hit $277 million, with $145 million coming from the U.S., compared with Q1’s $231 million total haul and the U.S.’s $127 million. The drug’s ATTR-CM indication was approved in EU in February, more than eight years after its initial nod in hereditary ATTR-polyneuropathy.

The success of Vyndaqel is dependent on raising disease awareness of ATTR-CM. In the second quarter, the diagnosis rate reached around 16% in the U.S., up from around 1% to 2% before the drug’s FDA nod last May, even after COVID-19 lockdowns slowed new diagnoses, Pfizer CEO Albert Bourla told investors during a conference call on Tuesday.

Just as Vyndaqel cruises toward blockbuster land, Pfizer is blaming the U.S. government’s anti-kickback rules for turning away some Medicare-covered patients who are unable to afford the orphan drug’s out-of-pocket cost without financial assistance.

Ibrance, meanwhile, enjoyed a 9% sales increase to $1.35 billion, even though pricing pressure pushed down sales in Europe by 10%.

The drug recently suffered a setback, failing the phase 3 Pallas trial, which showed adding it on top of standard postsurgery endocrine therapy couldn’t prolong the time before invasive disease returned in patients with HR-positive, HER2-negative early breast cancer. Analysts have pegged that missed adjuvant opportunity at around $3 billion to $4 billion.

To rub salt in the wound, on the heels of Pfizer’s failure, Eli Lilly turned up positive results for its CDK inhibitor rival Verzenio in a similar early breast cancer population. That monarchE phase 3 win prompted some industry watchers to question whether the Lilly option will shift physician preference even in the metastatic treatment setting.

RELATED: Lilly's Verzenio shows up Ibrance, hitting its goal in early breast cancer after Pfizer's drug faltered

But during Tuesday’s conference call, Pfizer’s biopharma group chief Angela Hwang pointed to recently unveiled real-world data as Ibrance’s strength. In the study, women with HER2-negative metastatic breast cancer lived a median 19.1 months without disease progressing when treated with Ibrance and an aromatase inhibitor, longer than the median 11.9 months observed for an aromatase inhibitor alone.

Megablockbuster pneumococcal vaccine Prevnar 13, for its part, decreased 2% to $1.12 billion, mainly because of a sharp 22% decline in the U.S. as COVID-19 disrupted patients’ doctor visit plans. The gap was too big to be made up by 18% growth in international markets, which resulted from significantly increased adult uptake in Germany and continued strong pediatric use in China.

Pfizer is now aiming to safeguard its pneumococcal vaccine market dominance in the face of potential threat from Merck & Co. While Pfizer’s experimental 20-valent shot is neck and neck with Merck’s 15-valent candidate in adult clinical development, it’s about a year behind in the pediatric realm. Pfizer just rolled 20vPnC into two phase 3 studies in infants a month ago.

Speaking of vaccines, Pfizer, through a partnership with German firm BioNTech, is one of the leaders in COVID-19 vaccine development, having just advanced its mRNA candidate, BNT162b2, into late-stage trials.

RELATED: Pfizer, BioNTech start their COVID-19 vax phase 3, squaring off with Moderna

Bourla stressed the importance of the effect of a second boosting dose of the vaccine in preliminary studies. “We believe this is a strength of the mRNA platform,” he said during the call. “The ability to boost is important because if immunity fades over time, it can potentially be restored by repeating immunizations.”

Pfizer and BioNTech are hoping to seek emergency use authorization as early as October if the phase 2/3 trial turns out successful, Bourla said. Once it crosses that regulatory hurdle, the pair plans to supply up to 100 million doses of the vaccine globally this year and potentially 1.6 billion doses next year.

As patient visits with physicians, vaccination rates and surgical procedures gradually recover from a low level in the second quarter, Pfizer expects to see its full-year revenue climb. It lifted its 2020 expectations by $100 million to a range of between $48.6 billion to $50.6 billion. The increase does not include any purchases for the COVID-19 vaccine.

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