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Friday, May 8, 2020

Trying out LA’s new coronavirus testing regime

FDA publishes first validation results of 12 COVID-19 antibody tests

The FDA published results from the first batch of COVID-19 antibody diagnostics to have their accuracy independently evaluated by federal laboratories—starting with the 12 blood tests the agency has already authorized for emergency use against the pandemic.
The data illustrates each test’s approximate ability to avoid false-positive and false-negative results, known as specificity and sensitivity, as well as their overall predictive value—essentially, how much a clinician could trust the likelihood of a correct reading when discussing the results with a patient, based on the test’s performance as well as the estimated prevalence of the novel coronavirus throughout the community.
The validation work is part of a project launched last month in collaboration with the Centers for Disease Control and Prevention and the National Institutes of Health, and the results come just days after the agency clamped down on the broad marketing of antibody tests across the country.
Conducted by the National Cancer Institute’s Frederick National Laboratory for Cancer Research, the test data was also used by the FDA as it decided whether to grant the products a green light. In addition, the FDA last month issued a broad authorization for antibody tests that are voluntarily submitted and pass review by the program.
It is currently unknown how many people in the U.S. have been exposed to the novel coronavirus and have developed antibodies against the disease. In addition, this percentage varies among the groups of people being tested—healthcare workers, for example, are at greater risk and show higher rates of infections compared to the broader population.
To calculate the tests’ positive and negative predictive values, the FDA assumed a baseline 5% prevalence rate—which, taken nationwide, would amount to over 16.4 million people. However, the agency said that any single antibody test, when put up against a largely asymptomatic general population, “is not likely to be sufficiently accurate to make an informed decision,” and that additional tests focusing on different aspects of the virus would be needed.
The FDA also posted a simple calculator that shows predictive values based on different levels of prevalence, which may change over time or across different locations.
The first COVID-19 serology test granted an Emergency Use Authorization by the FDA—Cellex’s lateral flow rapid test, using drops of blood and a test strip similar to a pregnancy test—showed a combined sensitivity of 93.8% and a specificity of 96.0% when searching for two different antibodies linked to the coronavirus.
At 5% prevalence, that equates to a positive predictive value of 55.2%. At 10% prevalence, that estimate of performance increases to 72.3%, while at 2.5%, it drops to 37.6%. In short, the more likely it is that a person has been exposed to the disease, the more likely the test is giving a correct positive result. Cellex’s test was more accurate at ruling out cases, showing a 99.7% negative predictive value at 5% prevalence.
Other products use different testing technologies and examine larger blood samples—such as the high-throughput ELISA tests developed by Abbott, Roche and other companies.
Roche’s recently authorized Elecsys test showed 100% sensitivity and 99.8% specificity across multiple antibody types, with a positive predictive value of 96.5% and a negative predictive value of 100% at 5% prevalence. Similarly, Abbott’s Architect test for IgG antibodies showed a sensitivity of 100%, specificity of 99.6%, and positive and negative predictive values of 92.9% and 100%, respectively.
Meanwhile, a separate, two-step ELISA test developed by clinical laboratories at the Mount Sinai Health System in New York showed a sensitivity and specificity of 92.5% and 100%, resulting in positive and negative predictive values of 100% and 99.6%.
The full list of test results from all 12 FDA-authorized tests is available here.
https://www.fiercebiotech.com/medtech/fda-publishes-first-validation-results-12-covid-19-antibody-tests

Cadila shutters Indian ingredients plant as workers test positive for COVID-19

Global drugmakers are working overtime to keep supplies coming amid the novel coronavirus pandemic. But in manufacturing facilities packed with workers, COVID-19 presents a particularly difficult challenge—and now one Indian plant has been forced to shutter due to a rash of infections.
Cadila Pharmaceuticals has shut down an active pharmaceutical ingredients (API) plant in Dholka, Ahmedabad, India, after 26 employees tested positive for COVID-19, Reuters reported.
Cadila ordered the facility closed Thursday and required 95 of its employees be quarantined at home. The drugmaker had also begun sanitizing the site, Reuters said.
The shutdown at the Cadila plant comes just weeks after another Indian manufacturing hub was temporarily locked down as a COVID-19 hotspot and underscores the dangers the novel coronavirus has posed for the global supply chain.

In late April, a manufacturing hub in Baddi, India—responsible for 35% to 40% of the nation’s pharmaceutical output—came back online after weeks on lockdown as a COVID-19 containment zone, Business Standard reported.
Some of the world’s biggest generics and API providers have factories in Baddi that were shut down partially or in full as part of the lockdown, including Sun Pharma, Abbott Laboratories and Dr. Reddy’s.
To help keep the facilities running at full capacity, the Indian government allowed a one-time movement of employees from Chandigarh state to Baddi to help staff the plants, according to Business Standard, as well as a resumption of intradistrict movement within Himachal Pradesh, where Baddi resides.

Cadila’s decision to shut down its Dholka facility highlighted concerns Sanofi CEO Paul Hudson raised in early April when he said that one worker with a fever at a drugmaker’s manufacturing site could require “a half dozen” to go into quarantine.
At the time, Sanofi was working to scale production of Plaquenil, a branded version of antimalarial hydroxychloroquine, but had to work at reduced capacity to prevent the spread of COVID-19 infections, Hudson told Reuters.
https://www.fiercepharma.com/manufacturing/cadila-shutters-indian-ingredients-plant-after-26-workers-test-positive-for-covid-19

5 Biopharmas Where BofA Would Put Money To Work



Biopharma shares have outperformed the broader market year-to-date, giving rise to apprehension over whether a pullback is in the offing. An analyst at BofA Securities said Friday that now is the time to go from defensive to offensive in the sector, as quarantines are winding down in several parts of the globe.

The Biopharma Analyst

Analyst Geoff Meacham shortlisted Eli Lilly And Co LLY 0.28%, Vertex Pharmaceuticals Incorporated VRTX 0.5%, Bristol-Myers Squibb Co BMY 0.16%, BioMarin Pharmaceutical Inc. BMRN 3.22% and Amgen, Inc. AMGN 0.14% as biopharma stocks where he would put his money to work.
The analyst has the following ratings and price targets for the shares:
  • Lilly: Buy/$165
  • Vertex: Buy/$300
  • Bristol-Myers Squibb: Buy/raised the price target from $75 to $80
  • BioMarin: Buy/lifted price target from $110 to $120
  • Amgen: Buy/price target increased from $265 to $275

5 Reasons For BofA’s Bullish Disposition

BofA is increasingly bullish on the biopharma group due to the following factors, Meacham said:
  • Expectations for robust revenue growth of 6% in the second half of 2020 compared to the first-half, which is double that of the S&P 500’s revenue growth.
  • Reasonable price-earnings for the stocks in the sector.
  • Many value-creating events lined up for the second half.
  • Lower policy risk stemming from goodwill earned from the COVID-19 pipeline.
  • A consistently positive FDA backdrop.

Q1 Earnings Get ‘A’ Grade

All of the big biotechs and major pharma companies reported both revenue and adjusted EPS beats in the first quarter, with Lilly and Vertex even raising some parts of their 2020 guidance, Meacham said.
Citing slower new starts and forex headwinds, Bristol-Myers Squibb and BioMarin lowered their 2020 revenue guidance, but maintained their EPS guidance, the analyst said.
Meacham expressed surprise at Merck & Co., Inc. MRK 0.99% and Alexion Pharmaceuticals, Inc. ALXN 0.02% lowering their 2020 revenue and adjusted EPS guidance, given his belief that oncology or orphan diseases wouldn’t be as sensitive to COVID-19 disruption.

Lilly One of The Higher Quality Stocks In BofA’s Coverage

Lilly is a source of differentiated growth given its early product cycle and diversified base business, including diabetes, immunology and immunotoxicology and migraine, and an advancing late-stage pipeline of potentially best-in-class or first-in-class therapies, Meacham said.
The analyst said he likes Lily’s potential for additional earnings growth in 2020-2021 and views Lilly as one of the higher quality stocks in his coverage despite its higher valuation.
The prospects for 2021 look attractive, with selpercatinib potentially launching in non-small cell lung cancer and thyroid cancer by year’s end, and tirzepatide approval in 2021 representing a “step change” for the diabetes franchise, he said.

Consensus For Vertex To Move Higher?

Vertex has a richer — though well-deserved — valuation, due to its differentiated growth profile, Meacham said.
Given that Vertex’s commercial execution is largely unaffected by the COVID-19 pandemic, the analyst said investors will begin to look forward to 2021 sooner than for other companies with more commercial risk.
BofA expects consensus estimates to continue to move higher, making Vertex’s valuation even more attractive.

Bristol-Myers Has Highly Differentiated Growth

With an estimated 8% revenue growth and 19% EPS growth in 2021 compared to 5-6% and 12%, respectively, for peers, and with six new launches expected this year, 2020 is shaping up to be a very robust period for Bristol-Myers despite the ongoing COVID-19 headwinds, Meacham said. The analyst said the company’s growth looks highly differentiated.
An increasingly diversified product mix and beatable launch expectations position the company for meaningful upside to consolidated P&L, with improving synergies, he said.

BioMarin’s ‘Game-Changing’ Late-Stage Pipeline

BioMarin’s late-stage pipeline in valrox and vosoritide have improved its growth outlook, Meacham said.
The analyst termed the company’s late-stage pipeline as “game-changing.” The second-half launch of Roctavian is the most important catalyst for the company this year, with the product likely to accelerate the company’s already above-average growth profile, he said.
“We see BioMarin as one of the higher quality names in our coverage universe given its clean growth story and it remains our SMid cap top pick.”

Amgen Looks To New Product Growth To Compensate For Legacy Product Erosion

The long-term outlook for Amgen’s Otezla is improving given the recently announced Phase 3 data for mild-to-moderate psoriasis, Meacham said.
The company rapidly refocused its story from legacy product erosion to new product growth with the acquisition of Otezla from the Bristol/Celgene deal, the analyst said.
“Since then Amgen’s growth profile has only improved, led by an expanded addressable market for Otezla, outperforming Amgen Biosimilars and Evenity franchises, aggressive formulary negotiation for Aimovig, and an exciting pipeline in AMG 510 and tezepelumab looking to contribute as soon as 2021.”
https://www.benzinga.com/analyst-ratings/analyst-color/20/05/15989612/5-biopharmas-where-bofa-would-put-its-money-to-work

Pfizer to review Duchenne gene therapy data May 15

Pfizer (PFE +0.5%) will host a conference call on Friday, May 15, at 10:00 am ET to review its Duchenne muscular dystrophy (DMD) data presentation at the American Society of Gene and Cell Therapy Annual Meeting.
The company’s candidate is gene therapy PF-06939926. In June 2019, it presented initial Phase 1b data on six boys with DMD that underwhelmed investors.
A 99-subject Phase 3 clinical trial is set to begin any time.
Related tickers: Sarepta Therapeutics (SRPT +4.1%), Solid Biosciences (SLDB +4.1%)
https://seekingalpha.com/news/3572233-pfizer-to-review-duchenne-gene-therapy-data-may-15

Malaria drug fails to show benefit in COVID-19 study

An observational study involving COVID-19 patients treated at New York-Presbyterian Hospital-Columbia University Irving Medical Center did not show a treatment benefit from the use of malaria drug hydroxychloroquine. The results were just published in the New England Journal of Medicine.
1,446 patients were treated, 70 were intubated, died or were discharged within 24 hours so they were excluded from the analysis. Of the remaining 1,376, 811 received hydroxychloroquine (600 mg twice on day 1, then 400 mg daily for a median of five days). 45.8% (n=371/811) were treated within 24 hours after presentation to the emergency department and 85.9% (n=697/811) were treated with 48 hours.
Patients receiving the malaria drug were more severely ill at baseline than those who did not (n=565). Overall, 346 patients were either intubated (n=180, of which 66 subsequently died) or died without intubation (n=166).
The main analysis failed to show a relationship between hydroxychloroquine and a reduction in time to intubation or death.
The results dampen hopes that the drug would help COVID-19 patients considering that the U.S. has millions of doses available.
ETFs: THW, BME, GRX, IXJ, GDNA, KMED, XLV
https://seekingalpha.com/news/3572242-malaria-drug-fails-to-show-benefit-in-covidminus-19-study

Arcturus up on new preclinical data on COVID-19 vaccine

Arcturus Therapeutics Holdings (ARCT +6.1%) perks up, albeit on below-average volume, on the heels of new preclinical data supporting its COVID-10 vaccine program LUNAR-COV19.
The company says the new results augment previously reported preclinical results that showed a “strong” antibody response (IgG anti-spike protein) and 100% virus neutralization at a “very low” dose.
Specifically, the data showed a dose-dependent response in CD8+ T cells at all doses tested, increasing from 4% at baseline to 8% with increasing doses of its STARR mRNA.
A single administration of LUNAR-COV19 STARR mRNA induced higher anti-spike protein IgG responses than conventional mRNA at equivalent doses.
LUNAR (Lipid-enabled and Unlocked Nucleomonomer Agent modified RNA) is the company’s proprietary lipid-mediated system for delivery of RNA into cells.
Its STARR (Self-Transcribing And Replicating RNA) technology platform combines self-replicating RNA with LUNAR to produce proteins inside the body.
https://seekingalpha.com/news/3572264-arcturus-up-on-new-preclinical-data-on-covidminus-19-vaccine