Pfizer may trim Prevnar 13 guidance after panel vote – Cantor

Cantor Fitzgerald’s Louise Chen (Overweight/$53) says Pfizer (NYSE:PFE) may cut its sales guidance for pneumonia vaccine Prevnar 13 after the recent vote by the CDC’s Advisory Committee on Immunization Practices (ACIP) backing a revision of vaccination guidelines for adults over the age of 65.

A poll of primary care docs revealed that 41% do not intend to change their usage of Prevnar 13 despite the vote, however.

The vaccine accounted for 11.3% of the company’s Q1 revenues ($1,486M/13,118).

On another note, Ms. Chen believes that sales of Merck’s (NYSE:MRK) HPV vaccine Gardasil 9 could ramp in patients aged 27 – 45 after the ACIP vote, adding that 26% of primary care physicians will “moderately” increase usage. She rates the stock Overweight with a $95 fair value target.

The Quant rating on PFE is Very Bullish while the SA Authors rating is Bullish.

https://seekingalpha.com/news/3475645-pfizer-may-trim-prevnar-13-guidance-acip-vote-cantor

Jazz Pharma to launch Sunosi next week in U.S.

Jazz Pharmaceuticals (NASDAQ:JAZZ) detailed its U.S. commercial launch plan for Sunosi (solriamfetol) yesterday afternoon via a webcast. The FDA approved the dopamine and norepinephrine reuptake inhibitor in March for the treatment of excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Key points:

The product will be available at pharmacies next week. Salesforce will begin calling on healthcare providers next week as well.

61% of the 165K narcolepsy patients in the U.S. are undiagnosed. Most of the diagnosed patients are being treated with stimulants (Schedule II drugs) or wake promoting agents (Schedule IV drugs).

About 12M Americans have been diagnosed with OSA. About 6% are being treated with medications. Almost half with excessive daytime sleepiness fail to respond to medications.

The wholesale price (WAC) is $660 for a 30-day supply of either the 75M mg or 150 mg dose.

Revenue assumptions include an increase in the OSA treatment rate from 6% to mid-teens, low-to-mid-single-digit growth rate in diagnosis and mid-to-high teen market share (all by 2025).

2025 sales target: at least $500M.

https://seekingalpha.com/news/3475673-jazz-pharma-launch-sunosi-next-week-u-s

Annovis Bio readies IPO

Annovis Bio (ANVS) has filed a preliminary prospectus for an $11.5M IPO.

The Berwyn, PA-based company develops treatments for neurodegenerative disorders like Alzheimer’s (AD) and Parkinson’s (PD) diseases.

Lead candidate is orally administered ANVS-401 which, according to the company, inhibits the synthesis of neurotoxic proteins (amyloid beta, tau and a-synuclein) associated with neurodegeneration. A Phase 2a study in AD patients is ongoing. A Phase 2a in PD patients should launch in Q1 2020. By the end of 2024, it expects to have conducted two pivotal trials in AD and PD and to have filed a U.S. marketing application.

2019 Financials (Q1): Operating Expenses: $186.8K (-1.6%); Net Loss: ($190.9K) (-0.5%); Cash Burn: ($228.7K) (-45.8%).

https://seekingalpha.com/news/3475681-annovis-bio-readies-ipo

Drug distributors rally after fresh round of price hikes from makers

Pharmaceutical wholesalers McKesson (MCK +4.2%), Cardinal Health (CAH+3.2%) and AmerisourceBergen (ABC +3.5%) rally after a number of drug makers hiked prices earlier this week, apparently emboldening investors that efforts to corral increases will fizzle.

https://seekingalpha.com/news/3475708-drug-distributors-rally-fresh-round-price-hikes-makers

Puma down on underwhelming neratinib data in biliary tract cancer

Puma Biotechnology (PBYI -2.6%) slips on below-average on the heels of preliminary results from a Phase 2 basket study, SUMMIT, evaluating neratinib in HER2-positive cancers. The data were presented at the ESMO World Congress on Gastrointestinal Cancer in Barcelona.

Investors appear disappointed with the results from the 20-subject biliary cancer cohort that received neratinib alone. The confirmed objective response rate (ORR) was only 10% (n=2/20), both partials, and the clinical benefit rate (responders + stable cancer) was 30% (n=6/20) (two partial responders + four with stable disease that lasted at least 16 weeks). Median progression-free survival (PFS) was only 1.8 months.

No new safety signals were observed.

The estimated primary completion date of the trial is September 2021.

https://seekingalpha.com/news/3475741-puma-3-percent-underwhelming-neratinib-data-biliary-tract-cancer

Alexion Ultomiris OK’d in Europe

The European Commission approves Alexion Pharmaceuticals’ (ALXN -0.5%) ULTOMIRIS (ravulizumab) for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) with hemolysis with clinical symptoms indicative of high disease activity and for adult patients who are clinically stable after at least six months on SOLIRIS (eculizumab).

ULTOMIRIS, a long-acting C5 complement inhibitor, is administered once every eight weeks. SOLIRIS is dosed every two weeks after the lead-in period.

https://seekingalpha.com/news/3475750-alexions-ravulizumab-okd-europe-pnh

FDA Clears Path For Continuing Review Of Lannett New Drug Application

Lannett Company, Inc. (NYSE: LCI) today commented on the U.S. Food and Drug Administration‘s (FDA) denial of a Citizen Petition submitted by Genus Lifesciences requesting that the FDA refuse to accept any submissions related to Lannett’s 505(b)(2) New Drug Application (NDA) for Cocaine Hydrochloride Topical Solution, 4% and 10%.

“We are pleased with the FDA’s decision, which affirmed our belief that the regulatory review of our NDA can continue,” said Tim Crew, chief executive officer of Lannett. “We believe we have addressed and responded to all comments in the FDA Complete Response Letter, including conducting a QT prolongation study, and we believe we will receive approval by early 2020.”

https://www.biospace.com/article/releases/fda-clears-path-for-the-continuing-review-of-lannett-company-s-new-drug-application/