Merck’s Prevnar challenger nabs FDA ‘breakthrough’ tag: Should Pfizer worry?

Merck & Co.’s endeavor to challenge Prevnar 13, the world’s best-selling vaccine, just got a speed-up. But it doesn’t appear to have too much of a lead over rival Pfizer.

The New Jersey pharma said Wednesday its 15-strain pneumococcal vaccine candidate, V114, has nabbed an FDA “breakthrough” designation in pediatric patients. With that, it will enjoy an expedited review process with closer communications with the FDA. And if everything goes well, the vaccine could win accelerated approval and priority review tags, too, speeding things up even further.

The FDA’s decision was based on data from two studies, Merck said. In both studies, V114 induced an immune response in infants for the two serotypes of S. pneumoniae not targeted by Pfizer’s Prevnar 13 and showed a similar effect in the other 13 serotypes, the company said.

V114’s “breakthrough” tag came about half a year after Pfizer earned the same designation—but in adults—for its 20-valent pneumococcal vaccine candidate, PF-06482077. The two vaccines are in a tight race to be the next big thing in vaccines, with V114 slightly ahead in phase 3.

Prevnar 13 has been hogging that title for some time. In 2018, it grew sales by 4% to reach $5.80 billion, thanks to rollouts in emerging markets. But with the market growing saturated, sales growth has slowed, and Pfizer predicts 2019 sales will be flat year over year. The U.S. adult market may see some decline due a shrinking pool of patients not yet vaccinated, Credit Suisse analyst Vamil Divan wrote in a Tuesday note to clients, referring to a Q&A with Pfizer’s investor relations team.

The company did warn of a potential risk at the upcoming CDC’s Advisory Committee on Immunization Practices (ACIP) meeting on Feb. 28, where experts might remove a recommendation for Prevnar in adults or limit it to high-risk adults only. Currently, the CDC recommends the pneumococcal vaccine for all children younger than 2 years of age and for all adults 65 years or older.

Judging by the Credit Suisse report, the Pfizer team seemed unfazed by Merck’s potential challenger. Merck started phase 3 testing on V114 mid-2018, and one of the two studies is a head-to-head trial against the Pfizer shot. PF-06482077 entered phase 3 a bit later—at the end of 2018. While the two additional serotypes included in the Merck shot are implicated in about 15% of pneumococcal cases, Pfizer’s 20-valent candidate can cover 15% beyond that, Pfizer told Divan.

https://www.fiercepharma.com/vaccines/merck-s-prevnar-challenger-nabs-fda-breakthrough-tag-should-pfizer-be-worried

Teva migraine drug gets sidelined in second PBM’s formulary

Amgen and Eli Lilly’s next-gen migraine drugs just won the prize in another formulary joust. UnitedHealthcare’s pharmacy benefits outfit OptumRx chose their drugs for its preferred coverage list, Reuters reported, citing an OptumRx coverage note.

And that leaves Teva with its second defeat. The company’s CGRP drug Ajovy didn’t make either of OptumRx’s preferred formularies. Patients can still access Teva’s Ajovy, but they would have to pay more.

OptumRx’s selection comes as the drugmakers fight for market share in the new class of migraine prevention drugs known as CGRP inhibitors. Partners Amgen and Novartis won the initial nod in the field with Aimovig last May, and Teva and Eli Lilly each followed with September FDA approvals. Each drug carries a list price of $6,900 per year. Amgen and Novartis set initial pricing, and their rivals followed suit.

Teva estimates payer formularies give more than 60% of U.S. commercial patients access to Ajovy, a company spokeswoman said via email, and the company’s discussion to improve patient access are continuing. Ajovy moved Friday from excluded to nonpreferred on OptumRx’s National Commercial Formularies and continued on the nonpreferred tier for Optum Select and Optum CTRX Select Formularies.

All patients with commercial insurance can use Teva’s copay assistance program to pay “as little as $0” for Ajovy.

“Teva’s Shared Solutions program is also committed to helping patients gain access to AJOVY with a team available to research and understand patients’ coverage and benefits,” she said.

OptumRx’s decision represents the third major coverage selection by a U.S. PBM giant for the drugs. Express Scripts, now part of insurance giant Cigna, made its initial decision on the new drugs back in October—quickly after September approvals for Ajovy and Emgality. The PBM chose to cover Amgen and Lilly drugs on its preferred list and excluded Teva altogether.

CVS Caremark, on the other hand, put Amgen’s Aimovig behind its two rivals in its decision unveiled last week. With the decisions, Eli Lilly’s Emgality has preferred coverage with all three PBM giants, while Amgen’s Emgality scored preferred coverage with UnitedHealthcare’s OptumRx and Express Scripts. Teva’s Ajovy only scored preferred coverage on CVS’ formulary.

Representatives for Optum didn’t immediately respond to a request for comment on the latest coverage decision.

The drugmakers each face different challenges, but the launches are important for all three. Amgen reported Aimovig sales of $119 million in 2018, while Eli Lilly and Teva haven’t yet reported fourth-quarter results.

On a conference call last week, Amgen EVP of global commercial operations Murdo Gordon said Aimovig “reached over 150,000 patients during 2018” and is on a “strong launch trajectory.” Gordon said the company “priced this product for access” and that it’s “been well received by payers for the most part.”

“What’s happened to date has been that we’ve received pretty good coverage with most payers even on a noncontracted basis allowing the product to be reimbursed on the basis of physician attestation alone,” he said on the call.

https://www.fiercepharma.com/pharma/amgen-lilly-cgrp-meds-secure-preferred-coverage-at-unitedhealthcare-while-teva-s-left-out

Gilead reports Q4 adjusted EPS $1.44, consensus $1.71

Reports Q4 revenue $5.795B, consensus $5.49B. Reports Q4 product sales $5.681B. Product sales for the fourth quarter of 2018 were $4.5 billion in the United States, $813 million in Europe and $398 million in other locations. Product sales for the fourth quarter of 2017 were $4.1 billion in the United States, $1.1 billion in Europe and $553 million in other locations.
https://thefly.com/landingPageNews.php?id=2858625

Gilead raises quarterly dividend by 11% to 63c per share

https://thefly.com/landingPageNews.php?id=2858626

UnitedHealth reports selection as one of 4 MCOs to adminster NC Medicaid program

The State of North Carolina, which is partnering with local health plans to improve people’s health and well-being and reduce health care costs, selected UnitedHealthcare Community Plan of North Carolina as one of four managed care organizations to administer its statewide Medicaid program, effective Nov. 1, 2019. “We are honored to work with the State of North Carolina to ensure Medicaid beneficiaries have access to personalized, cost-effective health care. We are committed to improve the overall health of Medicaid plan participants throughout North Carolina,” said Anita Bachmann, CEO, UnitedHealthcare Community Plan of North Carolina.
https://thefly.com/landingPageNews.php?id=2858615

Stephens remains bullish on Abiomed despite ‘Dear Doctor’ letter

Stephens analyst Chris Cooley reiterates an Overweight rating and $415 price target on Abiomed’s shares despite the recent issuance of a “Dear Doctor” letter related to the Impella RP. Specifically, the letter notes the FDA is evaluating post-approval study results for the RP which suggest a higher mortality rate for patients treated with the Impella RP versus what was noted in prior clinical studies, he adds. The analyst’s model estimates sales of the Impella RP will contribute about $48M to FY19 operating results and he points out that the Impella remains on the market and the company is working with the FDA to assess the post approval study data.

https://thefly.com/landingPageNews.php?id=2858619

Medtronic: electromagnetic navigation allows earlier lung cancer diagnoses

A large, yearlong Medtronic study found its electromagnetic navigation system allowed bronchoscopes to better reach difficult areas of the lung and diagnose cancer earlier.

Specifically, the study found that 65% of the patients diagnosed with primary lung cancer were found to be in the earliest stages—with about half of lesions measuring less than 20 mm in diameter—at times when early detection can be critical to improving long-term outcomes.

“These data demonstrate that, for the first time, both academic and community-based care clinicians can safely obtain a diagnosis in small, peripheral lung lesions, and then stage and prepare for future treatment in a single minimally invasive procedure,” said study co-lead investigator Erik Folch, chief of the Complex Chest Disease Center at Massachusetts General Hospital.

While replicating real-world conditions, the study evaluated the diagnostic yield and complication rates of the med-tech giant’s Emprint ablation catheter and its superDimension navigation system for lung procedures and included long-term follow up of negative cases. The study’s results, published in the Journal of Thoracic Oncology, included 12 months of follow-up of 1,215 patients at 29 medical centers in the U.S.

The procedure was successfully completed in 94% of study patients and a navigation-assisted diagnosis was obtained in 73%. In addition, the procedure had lower complication rates.

Specifically, organ wall injuries causing a collapse of the lung, or pneumothorax, occurred in only 4.3% of patients, compared to previously published rates ranging between a fifth and a quarter of transthoracic needle biopsies, Medtronic said.

The superDimension system has received 510(k) clearance from the FDA as well as a CE Mark in Europe and has also been approved in Japan, Korea and China. The Emprint ablation catheter kit has a CE Mark but is not cleared in the U.S.

Medtronic is planning a prospective study in up to 30 patients to evaluate the safety and performance of bronchoscopic thermal ablation using the Emprint catheter when guided by the superDimension system.

https://www.fiercebiotech.com/medtech/medtronic-study-shows-electromagnetic-navigation-allows-earlier-cancer-diagnoses-smaller