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https://www.cbsnews.com/news/covid-vaccine-booster-pfizer-kids-ask-fda/#l1zjwqq620h02q2awc1
WHY??? 99.97 RECOVERY RATE AT THIS AGE
Sierra Oncology (SRRA) – The drug developer agreed to be bought by GlaxoSmithKline (GSK) for $1.9 billion, sending its shares surging by 37.5% in the premarket, while Glaxo shares rose 1.1
Halozyme to Acquire Antares Pharma to Create a Specialty Product and Drug Delivery Leader
April 13 2022 - 06:00AM PR Newswire (US)
Transaction Expected to be Immediately Accretive to Revenue and Non-GAAP Earnings in 2022 with Multiple Drivers to Accelerate Financial Growth Through 2027 and Beyond
Augments Drug Delivery Business with Best-in-Class Auto Injector Platform with Broad Licensing Potential
Diversifies Revenue Mix with Addition of Growing Testosterone Replacement Therapy Product Revenues to Anchor Commercial Opportunity with Key Targeted Audiences
Creates a Leading Drug Delivery Business with Broadly Licensable Opportunities across ENHANZE and Antares Auto Injector Platforms
SAN DIEGO and EWING, N.J., April 13, 2022 /PRNewswire/ .. Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") and Antares Pharma, Inc. (NASDAQ: ATRS) ("Antares") today announced that the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for $5.60 per share in cash. The transaction, which values Antares at approximately $960 million, was unanimously approved by both the Halozyme and Antares Boards of Directors.
Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.) (PRNewsfoto/Halozyme Therapeutics, Inc.)
The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple growth drivers beyond 2027. The combination of Halozyme and Antares will create a leading drug delivery and specialty product company. The Antares business consists of a best-in-class, differentiated, royalty revenue generating auto injector platform business that offers broad licensing opportunity, and a commercial business, with three proprietary commercial products.
"The addition of Antares, particularly with its best-in-class auto injector platform and specialty commercial business, augments Halozyme's strategy, further strengthens our position as a leading drug delivery company and extends our strategy to include specialty products," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The acquisition of Antares fits well with our previously discussed strategic priorities and provides substantial financial growth potential and disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme is well-positioned to leverage Antares' value proposition, driven by a strong balance sheet, established industry relationships and business development experience. We look forward to welcoming Antares' talented team as we embark on our next chapter of accelerating financial growth, maximizing patient benefit, and enhancing value."
Robert F. Apple, president and chief executive officer of Antares, commented, "We are pleased to have reached this agreement with Halozyme, as this transaction showcases the value of Antares' highly complementary business, provides our shareholders with attractive and certain value, and brings together industry-leading expertise and drug delivery platforms to accelerate growth and create new opportunities. As we remain committed to continuing to serve our partners, I would like to thank our employees for their hard work and dedication to this mission. We look forward to working with the Halozyme team to complete the transaction and deliver best-in-class therapies and drug delivery solutions."
Compelling Financial and Strategic Benefits
Immediate Revenue and Non-GAAP Earnings Accretion and Long-Term Financial Upside: The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings, supported by Antares' proprietary product revenues, royalty revenues and profitability. The addition of Antares is also expected to accelerate top- and bottom-line growth and enhance cash flow generation through 2027, increasing Halozyme's flexibility to pursue further growth drivers in the forms of new product and therapy launches, and partnerships.
Business Development to Augment Long-Term Growth, Consistent with Strategic Priorities: The addition of Antares' commercial products and existing auto injector capabilities accelerate Halozyme's strategy to drive long-term, durable revenue growth and value creation through focused external growth. Halozyme expects to build on Antares' core platform technology and capabilities to drive incremental, durable revenue opportunities with additional intellectual property protections for Antares technology in place beyond 2030.
Substantial Market Expansion Opportunity in High Revenue Segments: Antares' successful development and partnership of its technology platforms offers a widely licensable product suite that can be broadly applied across a spectrum of market segments representing multiple tens of billions of dollars1 in estimated peak sales. This includes the potential for conversion to both high-viscosity and high-volume auto injector devices, supported by Halozyme's extensive infrastructure and commercially validated ENHANZE platform technology.
High Growth, Durable Commercial Franchise with Proven Track Record: Antares' suite of FDA-approved, high quality commercial products and partner products utilizing the Antares auto injector technology have already demonstrated commercial success and are positioned for long-term growth. Launch of Tlando™ will leverage existing testosterone commercial infrastructure and capabilities in a growing therapeutic category, building on momentum created by Xyosted®'s success.
Two Highly Complementary Platforms, Each with Meaningful Pipelines: Antares' broadly applicable, differentiated auto injector platform is suitable for use with a broad range of medications. The versatility of this platform enables a highly licensable business with significant revenue upside. The combined entity will be able to leverage its deep industry expertise and existing commercial infrastructure in the U.S. to expand delivery capabilities and pursue growth opportunities within multiple small- and large-molecule products.
Transaction Terms, Financing and Time to Closing
Under the terms of the merger agreement, Halozyme will commence a cash tender offer to acquire all of the outstanding shares of Antares for $5.60 per share in cash. The transaction is not subject to a financing condition. Halozyme intends to finance the transaction using existing cash on hand and new sources of debt. Following completion of the transaction, Halozyme expects to maintain a strong balance sheet with less than 3.5x net debt-to-EBITDA ratio at the time of transaction close. Net debt-to-EBITDA ratio is expected to decline significantly in the quarters post transaction close. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Antares' outstanding shares of common stock, the expiration or termination of the HSR waiting period, and other customary conditions. Following the successful completion of the tender offer, Halozyme will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price. This transaction is expected to close in the first half of 2022.
BofA Securities and Wells Fargo Securities LLC are acting as financial advisors to Halozyme and Weil, Gotshal & Manges LLP is acting as legal advisor. Jefferies LLC is acting as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal advisor.
Business Update
Halozyme reaffirms its 2022 guidance and its commitment to the three year $750 million share repurchase program.
Conference Call
Halozyme will host a conference call and a simultaneous webcast to discuss the transaction today, Wednesday, April 13, 2022 at 8:00 a.m. ET/5:00 a.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a webcast replay will be available following the close of the call. To register for this conference call, please use this link: https://conferencingportals.com/event/QfiVLXsr. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has touched more than 600,000 patient lives in post-marketing use via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed using ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
About Antares Pharma
Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in targeted therapeutic areas. The Company develops, manufactures and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery systems that are designed to provide commercial or functional advantages such as improved safety and efficacy, convenience, improved tolerability, and enhanced patient comfort and adherence. The Company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. The Company has formed partnership arrangements with several different industry leading pharmaceutical companies.
Forward-Looking Statements
This press release contains "forward-looking statements". All statements, other than statements of historical fact, included herein, including without limitation those regarding our future product development and regulatory events and goals, product collaborations, our business intentions and financial estimates and anticipated results, are, or may be deemed to be, forward-looking statements. Words such as "expect," "anticipate," "intend," "plan," "believe," "seek," "estimate," "think," "may," "could," "will," "would," "should," "continue," "potential," "likely," "opportunity," "project" and similar expressions or variations of such words are intended to identify forward-looking statements, but are not the exclusive means of identifying forward-looking statements in this press release. Although Halozyme's and Antares' management each believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Halozyme and Antares, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, risks related to Halozyme's and Antares' ability to complete the proposed acquisition on the proposed terms or on the proposed timeline, including the receipt of required regulatory approvals, the possibility that competing offers will be made, other risks associated with executing proposed acquisition, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the proposed acquisition will not be realized, risks related to future opportunities and plans for the combined company, including uncertainty of the expected financial performance and results of the combined company following completion of the proposed acquisition, disruption from the proposed acquisition making it more difficult to conduct business as usual or to maintain relationships with customers, employees, manufacturers or suppliers, and the possibility that, if the combined company does not achieve the perceived benefits of the proposed acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of Halozyme's shares could decline, as well as other risks related Halozyme's and Antares' respective businesses, including the ability to grow sales and revenues from existing products and to develop, commercialize or market new products, competition, including potential generic competition, the uncertainties inherent in research and development, including future clinical data and analysis, regulatory obligations and oversight by regulatory authorities, such as the U.S. Food and Drug Administration, including decisions of such authorities regarding whether and when to approve any drug, device or biological application that may be filed for any product candidates as well as decisions regarding labelling and other matters that could affect the availability or commercial potential of any product candidates, the absence of a guarantee that any product candidates, if approved, will be commercially successful, Halozyme's ability to execute its share repurchase program according to plan, Halozyme's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with Halozyme's and Antares' intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on Halozyme and on Antares and their respective customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on Halozyme's and Antares' employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact Halozyme and Antares. This situation is changing rapidly and additional impacts may arise of which Halozyme and Antares are not currently aware and may exacerbate other previously identified risks. While the list of factors presented here is representative, no list should be considered a statement of all potential risks, uncertainties or assumptions that could have a material adverse effect on Halozyme's consolidated financial condition or results of operations. The foregoing factors should be read in conjunction with the risks and cautionary statements discussed or identified in the public filings with the U.S. Securities and Exchange Commission (the "SEC") made by Halozyme, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Halozyme's annual report on Form 10-K for the year ended December 31, 2021 and Antares' annual report on Form 10-K for the year ended December 31, 2021. The forward-looking statements speak only as of the date hereof and, other than as required by applicable law, Halozyme and Antares do not undertake any obligation to update or revise any forward-looking information or statements. Investors are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.
About the Offer
The tender offer for the outstanding shares of Antares common stock referenced in this press release has not yet commenced. This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Halozyme and its acquisition subsidiary will file with the SEC, upon the commencement of the tender offer. At the time the tender offer is commenced, Halozyme and its acquisition subsidiary will file a tender offer statement on Schedule TO and thereafter Antares will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer.
THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. ANTARES' STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE (AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME) BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF ANTARES' SHARES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES.
The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of Antares' stock at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC's website at www.sec.gov. Additional copies may be obtained for free by contacting Halozyme or Antares. Copies of the documents filed with the SEC by Antares will be available free of charge on Antares' internet website at https://www.antarespharma.com/investors/sec-filings or by contacting Antares' Investor Relations Department at tbui@antarespharma.com. Copies of the documents filed with the SEC by Halozyme will be available free of charge on Halozyme's internet website at https://ir.halozyme.com or by contacting Halozyme's Investor Relations Department at ir@halozyme.com.
Additional Information
In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Halozyme files annual, quarterly and special reports and other information with the SEC and Antares files annual, quarterly and special reports and other information with the SEC. You may read and copy any reports or other information filed by Halozyme and Antares at the SEC public reference room at 100 F. Street, N.E., Washington D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Halozyme's and Antares' filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.
Halozyme Contacts:
Investors:
Dawn Schottlandt / Claudia Styslinger
Argot Partners
212-600-1902
Halozyme@argotpartners.com
ir@halozyme.com
Media:
Eric Brielmann / Kelly Sullivan / Amy Feng / Caroline Lipe
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449
Antares Contacts:
Investors:
Tram Bui
Vice President, Corporate Communications and Investor Relations
609-359-3016
tbui@antarespharma.com
Media:
Andrew Cole / Jared Levy / Hayley Cook
Sard Verbinnen & Co
212-687-8080
Antares-SVC@sardverb.com
Bipartisan Group's $100B Plan To Prevent Next Pandemic
Quote: The plan includes funding for: creating vaccine candidates for each of the 26 families of viruses known to infect humans; developing antiviral medications that can work against a broad spectrum of viruses; building out manufacturing capacity for vaccines, antivirals, tests, and other countermeasures; deploying genomic sequencing as a way to track outbreaks; developing broadly useful diagnostic technologies and better regulatory processes for approving and disseminating plentiful rapid tests; and improving security in laboratories dealing with dangerous viruses.
https://www.vox.com/23020343/pandemic-prevention-apollo-athena-bipartisan-commision?fbclid=IwAR2C-OspxPzF1D2beJLdqShIVJeDjU9eEFzqjt3UeQeGD1Gdk-G2CRHsyo4
From Dew Diligence: Sabizabulin’s MoA in COVID treatment—(from VERU website):
https://verupharma.com/pipeline/sabizabulin-for-covid-19/
Quote:
Sabizabulin is an orally bioavailable bis-indole that binds to the “colchicine binding site” of a and b tubulin and inhibits tubulin polymerization at low nanomolar concentrations. Sabizabulin disrupts the microtubule filaments similar to nocodazole and colchicine, the central mechanism that contributes to both their antiviral and anti-inflammatory activities.
…The central mechanism of colchicine clinical anti-inflammatory and anti-viral activities is based on its ability to bind the “colchicine binding” sites on alpha and beta tubulin which when incorporated into microtubule block subsequent microtubule polymerization. Inhibition of tubulin polymerization is responsible for the effects of colchicine on cell migration, cytokine release, and intracellular trafficking (antiviral) and disruption of inflammatory cell activities…
Colchicine modulates leucocyte mediated inflammatory activities including inhibition of leucocyte production of superoxides and release of various cytokines and pyrogens. Colchicine-like agents may therefore be useful in treating the “cytokine storm” seen with SARS-CoV-2.
So, according to the company, sabizabulin has a dual anti-inflammatory/antiviral MoA, but I question whether the antiviral MoA is a material contributor to efficacy in already hospitalized patients with severe COVID.
p.s. Colchicine is the standard second-line agent (following NSAIDs) for pericarditis.
Veru (VERU) – The drugmaker’s shares surged 31% in the premarket after it reported “Overwhelming” Evidence of efficacy for its experimental drug for treating hospitalized Covid-19 patients. It will meet with the Food and Drug Administration to seek emergency use authorization for the treatment.
Veru Inc. is an oncology biopharmaceutical company. The Company is focused on developing medicines for the management of breast and prostate cancers. The Company's FC2 segment consists of its commercial product, FC2. The Pharmaceuticals segment includes activities related to multiple drug products under clinical development and ENTADFI, a treatment for benign prostatic hyperplasia. It has a commercial Sexual Health Division, which includes two products, such as ENTADFI, a treatment for benign prostatic hyperplasia (BPH), and the FC2
Female Condom (Internal Condom) (FC2), for the dual protection against unplanned pregnancy and the
transmission of sexually transmitted infections. Its breast cancer drug pipeline has four clinical development programs for two drugs, such as enobosarm, an oral selective androgen receptor targeting agonist, and
sabizabulin, an oral cytoskeleton disruptor. Its prostate cancer drug pipeline includes sabizabulin, VERU-100
and zuclomiphene citrate.
"Alongside the small bleeds, the researchers found severe widespread brain inflammation and neuron damage. Fischer said the neurological damage was NOT linked to the severity of respiratory disease. This means many animals displayed only mild COVID-19 symptoms yet still experienced neurological damage!!" It continues to the conclusion that, " Long-term follow-up studies on long COVID patients will be needed to answer these questions."
https://newatlas.com/science/covid19-brain-damage-bleeding-inflammation-mild/
Quote: Gabriel Hébert-Mild
https://twitter.com/Gab_H_R/status/1511707706096340993
Antibody-mediated SARS-CoV-2 uptake by monocytes/macrophages triggers inflammatory cell death that aborts production of infectious virus BUT causes systemic inflammation that contributes to COVID-19 pathogenesis
https://www.nature.com/articles/s41586-022-04702-4
Quote: Archimedes
Problem👆
— Archimedes (@AlphaTrader00) April 6, 2022
Fix👇
Direct regulation of monocyte-macrophage activity by lenzilumab could provide a more favorable micro-environment where effector T cells could be protected from cytokine-induced apoptosis. This would preserve a non-exhausted Tcell phenotypehttps://t.co/nnuZOeR26y
Omicron BA.2 projected to displace other Covid variants in U.S. in two weeks https://www.cnbc.com/2022/04/04/more-contagious-omicron-bapoint2-on-track-to-displace-other-variants-in-us-in-next-two-weeks.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
Myocarditis risk higher after Covid infection than Pfizer or Moderna vaccination https://www.cnbc.com/2022/04/01/myocarditis-risk-higher-after-covid-infection-than-vaccination-cdc-finds.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
https://www.humanigen.com/
March 24, 2022, Updated NIH COVID-19 Treatment Guidelines
Updated NIH COVID-19 Treatment Guidelines include updated results and interpretation from lenzilumab LIVE-AIR study now published in The Lancet Respiratory Medicine. The updated interpretation of LIVE-AIR concludes “Lenzilumab improved ventilator-free survival in participants with hypoxemia who were not receiving MV, with the greatest benefit among those with lower CRP levels”, based on the increased incidence of ventilator-free survival observed in patients with CRP <150 mg/L (90% vs 79%, HR 2.54; 95% CI, 1.46–4.41; P=0.0009). Currently, lenzilumab is not yet authorized or approved but is available via compassionate use in some countries (U.S., ex-U.S.). Guidelines state that while GM-CSF is believed to be a key driver of lung inflammation in COVID-19 pneumonia, operating upstream of other pro-inflammatory cytokines and chemokines, NIH interpretation of clinical data show that lenzilumab is the only GM-CSF inhibitor to demonstrate a benefit in the treatment of COVID-19. Lenzilumab may mitigate inflammation by inhibiting this signaling axis upstream of IL-6 and IL-1 and thus minimizing downstream production of numerous pro-inflammatory mediators involved in the pathogenesis of COVID-19.
HOW MANY WILL BE ENOUGH PLUS BOOSTERS????
FDA authorizes fourth Pfizer Covid vaccine dose for people age 50 and older https://www.cnbc.com/2022/03/29/fda-authorizes-fourth-pfizer-covid-vaccine-dose-for-people-age-50-and-older-.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
Stimulating severe COVID-19: the potential role of GM-CSF antagonism
https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00539-7/fulltext#%20
One of the key components of the detrimental hyperinflammatory response in COVID-19 is granulocyte-macrophage colony-stimulating factor (GM-CSF), which is an immunomodulatory cytokine that might help to clear respiratory microbes by stimulating alveolar macrophages, but when in excess can cause damage. Its concentrations are low or undetectable in healthy individuals, yet many conditions can cause a rapid increase its concentration.1 Increased circulating concentrations of GM-CSF have been described in patients with COVID-19 compared with healthy controls.2 In the later stages of lung disease in COVID-19, excessive GM-CSF production can contribute to the dysregulated immune response in severe COVID-19,3 in which, upstream of IL-1 and IL-6, activated T cells target neutrophils and macrophages.4 Agents that interfere with its actions have high plausibility for benefit, not just in COVID-19, but in other acute inflammatory conditions, such as acute respiratory distress syndrome or sepsis.5
In The Lancet Respiratory Medicine, Zelalem Temesgen and colleagues6 report on a multicentre, placebo-controlled clinical trial of hospitalised patients with COVID-19, showing that lenzilumab, a neutralising monoclonal antibody against GM-CSF, is associated with improved survival without invasive mechanical ventilation at 28 days. Lenzilumab is a monoclonal antibody that directly binds GM-CSF and is being tested for conditions such as chronic myelomonocytic leukaemia and B-cell lymphoma.
Of 520 randomly assigned patients who were hypoxic or who required oxygen, but who did not require invasive mechanical ventilation, 479 patients were included in the modified intention-to-treat analysis. Patients in the lenzilumab group showed a 6% absolute increase in survival without ventilation at 28 days compared with the placebo group (198 [84%] of 236 patients vs 190 [78%] of 243 patients; hazard ratio [HR] 1·54 [95% CI 1·02–2·32], p=0·040). This difference on the outcome of survival without ventilation was primarily driven by more patients in the placebo group requiring invasive ventilation (49 [20%] patients) than those in the lenzilumab group (26 [11%] patients; HR 0·52 [0·32–0·82], p=0·0059). Key secondary outcomes, such as mortality, ventilator-free days, intensive care unit days, or recovery time, along with adverse events were not significantly different between the two groups.
This study population had lower baseline C-reactive protein (CRP) concentrations than the cohorts in RECOVERY and REMAP-CAP—trials where IL-6-targeted therapy has shown the largest benefit.7, 8 Exploratory sensitivity analyses suggested greater benefit of lenzilumab in patients with CRP concentrations less than the median value of 79 mg/L; further study of a CRP-guided approach, possibly targeting patients with lower CRP concentrations, earlier in their disease course, or of a different disease phenotype, could therefore be warranted. Whether biomarker-driven immunotherapy with stratification of patients can guide individualised use of immunomodulatory treatments in COVID-19 needs to be explored.
Omicron BA.2 subvariant has doubled in the U.S. and will soon dominate https://www.cnbc.com/2022/03/23/covid-omicron-bapoint2-subvariant-will-soon-dominate-in-us-but-fauci-doesnt-expect-another-surge.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
The Illusion of Evidence-Based Medicine
From the British Medical Journal, published March 16, 2022
"Evidence based medicine has been corrupted by corporate interests, failed regulation, and commercialisation of academia, argue these authors"
https://www.bmj.com/content/376/bmj.o702
FDA says current dose of GSK, Vir COVID therapy likely not effective against BA.2 variant … By Reuters Staff
March 25 (Reuters) - The U.S. health regulator has determined that the current authorized dose of GlaxoSmithKline Plc and Vir Biotechnology’s antibody-based COVID-19 treatment is unlikely to be effective against the Omicron BA.2 variant, the companies said on Friday.
The agency updated its emergency use authorization fact sheet on the drug sotrovimab. (Reporting by Manojna Maddipatla in Bengaluru; Editing by Shailesh Kuber)
https://www.reuters.com/article/health-coronavirus-gsk-fda/fda-says-current-dose-of-gsk-vir-covid-therapy-likely-not-effective-against-ba-2-variant-idUSL3N2VS3TX
Drugmakers, scientists begin the hunt for long COVID treatments
https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-scientists-begin-hunt-long-covid-treatments-2022-03-25/
After producing vaccines and treatments for acute COVID-19 in record time, researchers and drugmakers are turning to finding a cure for long COVID, a more elusive target marked by hundreds of different symptoms afflicting millions of people.
Leading drugmakers, including those who have launched antiviral pills and monoclonal antibodies for COVID-19, are having early discussions with researchers about how to target the disease, five scientists in the United States and UK told Reuters.
Companies including GlaxoSmithKline (GSK.L), Vir Biotechnology (VIR.O) and Humanigen (HGEN.O) confirmed they had spoken to researchers on trials using their current treatments against long COVID. Others including Pfizer (PFE.N) and Roche (ROG.S) said they are interested but would not elaborate on plans.
Researchers, biotech companies and public health experts say major pharmaceutical companies are integral to getting a proven treatment for the disease, which currently afflicts more than 100 million people, according to the World Health Organization.
"When you look at the numbers for heart failure, for diabetes, etc, that is the ballpark we are talking about," said Amitava Banerjee, a leading researcher on a long COVID trial.
Long COVID, with some 200 reported afflictions that include fatigue, chest pain and brain fog, is defined by symptoms that last longer than 3 months. It sidelines people who have had both mild and severe COVID-19, including children. In the United States, it is estimated to have affected 1-in-7 working age adults.
Sandi Zack, 53, a former elementary school teacher from the Atlanta area who can no longer work, described symptoms including extreme fatigue, dizziness, pain and heart palpitations since contracting COVID in December 2020.
She has sought help from a range of specialists and tried a variety of drugs to ease her symptoms including steroids and the antidepressant fluvoxamine.
“We’re all still out here,” she said. "Hoping, and waiting.”
There are fewer than 20 clinical trials underway testing drugs, a handful of which have moved beyond early stages, according to interviews with more than a dozen independent and government-backed scientists and a Reuters review of a global clinical trials database.
Scientists hope their research will uncover the causes of long COVID, a major hurdle in finding targets for new drugs or identifying existing medicines that may work as treatments.
“We are getting to the stage where we are getting traction, and for people suffering, we are getting treatments tested,” said David Strain, a University of Exeter Medical School lecturer whose research has informed which treatments will be tested in a major British trial. “Hopefully we will have things we can we offer them to get their lives back to normal in the near future.”
Big pharmaceutical companies are looking for disease-specific biomarkers that would allow them to assess the value of tested medicines, experts say.
“What they’re struggling with is a case definition for long COVID,” said Dr. Amy Proal, an expert in post-viral diseases at the PolyBio Research Foundation in Mercer Island, Washington. She said she has held confidential meetings with two venture capital groups and one major pharmaceutical company.
Possible underlying causes researchers are studying include damage from the original infection, lingering reservoirs of virus in the body, an autoimmune response, in which the immune system attacks its own cells, and a dysregulated immune response causing excess inflammation that damages small blood vessels or nerves. It could be a combination of those or other factors, they say.
SEARCHING FOR A CURE AND FUNDING
One major UK-funded trial led by University College, London, will test four drugs among 4,500 long COVID patients.
They include antihistamines loratadine and famotidine, the gout and heart inflammation treatment colchichine - all available as generics - and Johnson & Johnson's (JNJ.N) blood clot preventer Xarelto (rivaroxaban).
All have data from preliminary studies in people suggesting they could work against some of the possible disease targets for long COVID, such as inflammation and blood clots.
Banerjee, lead researcher on that trial, said the drugs will target several potential underlying mechanisms of long COVID while seeking to understand more about them.
“It’s challenging, because we’re going for a hazy target,” he said in a phone interview. “People on the industry side are trying to figure it out too.”
U.S-based Axcella Therapeutics is working with the University of Oxford in the UK on a drug developed for nonalcoholic steathohepatitis (NASH), a liver disease marked by dysregulated metabolism, inflammation and scarring.
In long COVID, the hope is the drug will restore the normal function of mitochondria - the energy factories of cells. Poorly functioning mitochondria may explain the crushing long-term fatigue so many patients experience.
As lead researcher Dr. Betty Raman put it, if COVID damaged the battery, the drug aims to restore that battery, so cells can perform their normal functions without using up too much energy.
PureTech Health (PRTC.L), another U.S. biotech, is running a midstage trial of an experimental pulmonary fibrosis treatment aimed at preventing long-term lung scarring linked with COVID.
In Seattle, researchers at the University of Washington and the Fred Hutchinson COVID Clinical Research Center are testing Resolve Therapeutics' experimental treatment targeting fatigue in long COVID patients.
The drug works by dissolving certain RNA in the blood that has been linked with increased inflammation in patients with autoimmune diseases such as Lupus and Sjogren's syndrome, said Dr. James Andrews, a rheumatologist at the University of Washington who is leading the trial.
Scientists who believe the root cause of long COVID could be lingering virus are keen to test whether existing COVID-19 treatments or vaccines could have an impact.
Moderna (MRNA.O) is donating its vaccine for early trials in the UK testing whether it can help kickstart the immune system and ease long COVID symptoms, the company said in an emailed statement.
Funding has been a struggle for some companies.
Berlin Cures Holding AG, a German biotech, secured only enough money for the first stage of testing of its autoimmune drug - previously used for heart failure - that has shown promise in a handful of patients when used experimentally.
“People call us and they cry on the phone," Chief Operating Officer Peter Goettel told Reuters. "Some people want to sell their house to give us donations, just to get a shot.”
https://www.globenewswire.com/news-release/2022/03/22/2407640/0/en/Maimonides-Medical-Center-Adopts-Revolutionary-Technology-That-Quickly-Distinguishes-Bacterial-and-Viral-Infections.html
Quote: Today, Maimonides Medical Center announced a landmark agreement with MeMed, an Israel-based medical technology firm, for the adoption of MeMed BV, a new, FDA-approved, cutting-edge test that distinguishes whether a patient is suffering from a bacterial or viral infection within 15 minutes.
…The MeMed BV test analyzes the body’s immune response to infection rather than focusing on detecting the presence of a pathogen, yielding reliable results within 15 minutes.
Macular Degeneration milady, this is probably the best source of a solution over drug "tease-ures", once they improve survivability of cells and control expense.
https://news.usc.edu/196827/usc-discovery-shows-long-term-viability-of-stem-cell-derived-retinal-implant/
MRNA submit FDA-EUA request for FOURTH, 4TH COVID shot:
https://www.accesswire.com/693615/Moderna-Submits-Amendment-to-the-Emergency-Use-Authorization-for-an-Additional-Booster-Dose-of-its-COVID-19-Vaccine-in-the-US
Quote:
The request to include adults over 18 years of age was made to provide flexibility for the U.S. Centers for Disease Control and Prevention (CDC) and healthcare providers to determine the appropriate use of an additional booster dose of mRNA-1273, including for those at higher risk of COVID-19 due to age or comorbidities. This submission is based in part on recently published data generated in the United States and Israel following the emergence of Omicron.
A little history is in order here. For the third shot (i.e. first “booster,”) ACIP. the CDC’s committee on vaccines, recommended an EUA for age 65+ and those at high risk from workplace exposures and/or medical comorbidities. Then, the CDC Director overruled ACIP and recommended the booster for all adults, which is what the Biden administration wanted. I will not be surprised if the fourth-shot EUA requests from PFE/BNTX and MRNA follow the same script. >>>> 4th SHOT, & HOW MANY BOOSTERS??? ....
"NIH Funding Tied to FDA Approval of 210 Drugs Since 2010"
A report published in Proceedings of the National Academy of Sciences found that funding from the National Institutes of Health (NIH) contributed to published research associated with every drug approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2016. This amounts to 210 drug approvals, 84 of which were first-in-class agents. Researchers at Bentley University conducted a literature review for mentions of each new molecular entity, as well as studies of their molecular targets. They then cross-checked to determine which of those studies had received any NIH funding. More than $100 billion in NIH funding went supported research that contributed – directly or indirectly – to the 210 drugs approved in the six-year study period. The R01 grant was the most common source of this funding, and 90 percent of the publications were related to the biological targets of the drugs, rather than the drugs themselves. “This work underscores the breadth and significance of public investment in the development of new therapeutics,” the authors concluded, “and the risk that reduced research funding would slow the pipeline for treating morbid disease.” Source: STAT News, February 12, 2018; Cleary EG, Beierlein JM, Khanuja NS, et al. Contribution of NIH funding to new drug approvals 2010–2016. Proc Nat Acad Sci. 2018 February 6. [Epub ahead of print]."
https://ashpublications.org/ashclinicalnews/news/3819/NIH-Funding-Tied-to-FDA-Approval-of-210-Drugs
Longer version: https://www.pnas.org/doi/10.1073/pnas.1715368115
Tony Butler incorrectly summarized his chat with Tim by stating that our next catalyst will be the NIH ACTIV-5 readout (which is correct), at the end of Q2 (which is incorrect). The topline data readout is projected late Q1 (which ends in two weeks), or early Q2.
See the last minute of the video:
https://wsw.com/webcast/roth43/hgen/1810184
Butler is still projecting a $13 price target. This compares to the $28 - $30 price targets from Wainwright and Cantor Fitzgerald. Our readout can literally be released any day now, and I would not want be the analyst with a $13 price target in front of that data. We're also about 6 weeks out on our Q1 10-K, which could have sells through Clinigen to report, especially with sharp spikes in Covid overseas.
A 30-year-old female founder leading billion-dollar bet on CRISPR gene editing https://www.cnbc.com/2022/03/12/30-year-old-female-founders-billion-dollar-bet-on-crispr-gene-editing.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
"A novel lead variant was identified inside the gene encoding granulocyte-macrophage colony-stimulating factor (GM-CSF), CSF2. GM-CSF was a crucial cytokine in the synthesis and differentiation of myeloid cells such as neutrophils, macrophages, and monocytes.
The authors previously demonstrated that the circulating GM-CSF levels were linked to the severity of COVID-19, indicating its role as a pharmacological target in severe illness."
https://www.news-medical.net/news/20220311/Novel-genetic-relationships-with-severe-SARS-CoV-2.aspx
Covid was declared a pandemic two years ago. Experts warn it's still not over https://www.cnbc.com/2022/03/11/covid-declared-a-pandemic-two-years-ago-health-experts-warn-its-still-not-over.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
AVID BIOSERVICES REPORTS FINANCIAL RESULTS FOR THIRD QUARTER ENDED JANUARY 31, 2022 AND RECENT DEVELOPMENTS
-- Recorded Third Quarter Revenue of $31.5 Million --
-- Myford South and Viral Vector Facilities Construction Continues On Schedule --
-- Signed $52 Million in Net New Business Orders and Ended the Quarter with a Backlog of $140 Million; Highest Backlog To Date --
TUSTIN, Calif., March 08, 2022 (GLOBE NEWSWIRE) -- Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced financial results for the third quarter of fiscal 2022, ended January 31, 2022.
Highlights from the Quarter Ended January 31, 2022, and Other Events:
“I am pleased to report another successful quarter for Avid. Our financial and operational performance were strong, demonstrating year-over-year growth in revenues, gross margin, net income and adjusted EBITDA. This represents our seventh consecutive quarter of operational profitability,” stated Nicholas Green, president and chief executive officer of Avid Bioservices.
“Fueling this growth has been the success of our business development team. They continue to achieve robust
new business signings, as evidenced by our current backlog of $140 million – our highest backlog to date.
We expect this trend to continue as we increase capacity, expand our commercial team and broaden our services, including our recent expansion into the cell and gene therapy sector of the market.
“Finally, to support growth today and in the future, the company continues to execute a strategically phased expansion plan that allows us to align spending with increasing market demand. This is highlighted by our downstream expansion, which came on line this quarter just in time to support our increased backlog, up from $120 million last quarter to $140 million.
“The company expects to launch its new viral vector business in two phases with process and analytical development suites launching in mid calendar 2022 and GMP manufacturing suites coming on line approximately one year later. In addition, we anticipate the completion of the Myford South facility expansion in early calendar 2023. Combined, we expect these expansions to organically increase the company’s total annual revenue
generating capacity from approximately $120 million to in excess of $350 million in a period of three years.”
Financial Highlights and Guidance
The company is reiterating revenue guidance for fiscal 2022 of $115 million to $117 million, a 20-22% increase
over fiscal 2021.
Revenues for the third quarter of fiscal 2022 were $31.5 million, representing a 44% increase compared to $21.8 million recorded in the prior year period. The increase in revenues for the quarter can primarily be attributed to an increase in the scope of in-process and completed manufacturing runs and an increase in process development revenues primarily associated with services provided to new customers as compared to the prior year period. For the first nine months of fiscal 2022, revenues were $88.4 million, a 29% increase compared to $68.3 million in the prior year period. The increase in revenues for the nine months of fiscal 2022 as compared to the prior year period can primarily be attributed to an increase in the number and scope of in-process and completed manufacturing runs, in unutilized reserved capacity fees, and in process development revenues.
As of January 31, 2022, revenue backlog was $140 million, representing a net increase of 17% compared to $120 million at the end of the same quarter last year. The company expects to recognize the majority of this backlog over the next twelve months.
Gross margin for the third quarter of fiscal 2022 was 29%, compared to a gross margin of 28% for the third quarter of fiscal 2021. Gross margin for the first nine months of fiscal 2022 was 34% compared to 31% for the prior year period. The increases in gross margin for the quarter and the first nine months were primarily from higher manufacturing and process development revenues during the periods, partially offset by increases in planned growth costs including compensation and benefits, stock-based compensation, and facility and equipment related costs.
Selling, general and administrative expenses (“SG&A”) for the third quarter of fiscal 2022 were $5.8 million, an increase of 45% compared to $4.0 million recorded for the third quarter of fiscal 2021. The increase in SG&A for the third quarter was primarily due to stock-based compensation, compensation and benefits, and facility and related expenses. For the first nine months of fiscal 2022, SG&A expenses were $15.3 million as compared to $12.0 million for the prior year period. The increase in SG&A during the nine months was primarily due to stock-based compensation, facility and related expenses, advertising costs, compensation and benefits, and legal and accounting fees.
For the third quarter of fiscal 2022, the company recorded net income attributable to common stockholders of $2.2 million or $0.04 per basic and diluted share, as compared to net income attributable to common stockholders of $0.8 million or $0.01 per basic and diluted share, for the third quarter of fiscal 2021. For the first nine months of fiscal 2022, the company recorded net income attributable to common stockholders of $12.1 million or $0.20 per basic and $0.19 per diluted share, compared to net income attributable to common stockholders of $5.6 million or $0.10 per basic and diluted share, for the fiscal 2021 period.
Avid reported $150.0 million in cash and cash equivalents as of January 31, 2022 compared to $169.9 million as of the prior fiscal year ended April 30, 2021.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.
Recent Corporate Developments
Drew Brennan, general manager of Avid’s viral vectors business, has successfully recruited key leadership for the viral vector business to manage process development, quality, operations and facilities. The process of adding additional strength and depth to the team is also well underway, as is the construction of our 53,000 square foot dedicated viral vector facility in Costa Mesa, CA.
The company’s commercial team signed multiple new orders during the third quarter, totaling approximately a net $52 million. These projects span all areas of the business, from process development to commercial manufacturing.
Phase I of the company’s Myford, mammalian facility was completed and is now operational, increasing annual revenue generating capacity from $120 million to $170 million. This expansion was strategically timed to accommodate the company’s growing backlog, which reached $140 million by the end of the third quarter. The company currently expects to complete the second phase of our Myford South expansion, which includes both upstream and downstream GMP manufacturing suites, during the first quarter of calendar 2023. With respect to the viral vectors business, the company expects to bring its process and analytical development capacity on line in mid-calendar 2022 and ultimately the GMP manufacturing suites on line approximately one year later. Please visit the Avid website Facilities page for more information about the company’s expansions and videos documenting progress ( https://avidbio.com/expansion-updates/ ).
Statement Regarding Use of Non-GAAP Financial Measures
HUMANIGEN ROTH PRESENTATION
New Slides from the Roth Presentation
https://s28.q4cdn.com/539885110/files/doc_presentations/2022/HGEN-Roth-Conference-03-13-22.pdf
Are some people more predisposed genetically to severe COVID - specifically to limit the ability of the virus to make copies of itself, or excessive inflammation and blood clotting? This study says yes.
$HGEN are some people more predisposed genetically to severe COVID - specifically to limit the ability of the virus to make copies of itself, or excessive inflammation and blood clotting? This study says yes. https://t.co/pEI95yXXa0
— Jerry Q*👁️🗨️ (@swandivr) March 7, 2022
Among the findings was predisposition to mutation in the CSF2 gene pic.twitter.com/cMCI9NCY8R
— Jerry Q*👁️🗨️ (@swandivr) March 7, 2022
NEWS -- Innovation Pharmaceuticals Reports Additional Findings Based on Review of Brilacidin Phase 2 COVID-19 Trial Results and Compassionate Use Cases
WAKEFIELD, MA / ACCESSWIRE / March 7, 2022 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today reported findings from data review of the Company's Brilacidin Phase 2 COVID-19 study and compassionate use of Brilacidin in critically-ill COVID-19 patients.
"Based on analyses of our Phase 2 trial results, Brilacidin showed promising treatment effects in NEWS2 clinical improvement scores and among patients with the most elevated biomarker levels," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "These results, along with observations on the compassionate use of Brilacidin in COVID-19 related to dosing, as well as data being generated from ongoing scientific collaborations, are informing paths forward for our Brilacidin antiviral program. We believe Brilacidin has merit to help address COVID-19 and can play a role in preparing for future pandemics, given Brilacidin's unique immunomodulatory and antiviral properties. Progress in the Brilacidin antiviral program largely will be dependent upon obtaining government funding for additional clinical development and leveraging external research relationships. Going forward, our business focus will be to advance Brilacidin in other disease areas and to pursue new business opportunities through joint ventures and other investments."
Summary of Brilacidin COVID-19 Trial Design and Results
The Phase 2 trial (see NCT04784897) was a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of Brilacidin treatment in addition to current standard-of-care (SoC) compared to SoC alone, in 120 hospitalized patients with moderate-to-severe COVID-19.
Study treatment, Brilacidin IV or saline IV (placebo), was administered as 3 doses or 5 doses. For efficacy analyses, the main comparison was between the Brilacidin 5-dose group and the pooled placebo group.
Even with randomization--stratified by age (<= 65 yrs, >65 yrs) and severity (moderate, severe)--patients allocated to the Brilacidin treatment groups exhibited a greater degree of disease burden at baseline, as reflected by higher, on average, elevated biomarker levels (e.g., CRP, viral load), in contrast to the pooled placebo group.
As previously released, Brilacidin did not show a difference compared to placebo in reducing Time to Sustained Recovery Through Day 29, the study's primary endpoint based on clinical status. There was also no difference in mortality between active and placebo, with both groups experiencing low mortality rates (7 percent) compared to other studies that evaluated patients with moderate-to-severe COVID-19. Beneficial Brilacidin treatment effects, however, were observed in NEWS2 secondary endpoints, as well as on the primary endpoint in patient subgroups, as summarized below.
Pharmacokinetic (PK) analysis (from measured plasma sample concentrations) provided comparable estimations to those seen previously in the Brilacidin IV program, although exposure was generally greater than observed prior (when comparing patients on similar treatment regimens for the indication of acute bacterial skin and skin structure infections [ABSSSI]). These new PK data will help inform any future Brilacidin IV dosing strategies.
Brilacidin was generally well-tolerated by patients, with an overall safety profile in COVID-19 patients consistent with previous clinical studies. The incidence of patients with at least one treatment-emergent adverse event (TEAE) was higher for Brilacidin treatment compared to placebo. However, the proportion of patients with TEAEs is similar across groups (72 percent on active, 65 percent on placebo) after excluding the Brilacidin-related adverse events of tingling (paresthesia) and hypoesthesia (numbness), which are known, transient, mostly mild, non-serious adverse events related to Brilacidin IV treatment. The incidence of serious adverse events was the same (12 percent on active, 12 percent on placebo), and no serious adverse events were reported as related to study treatment.
Secondary Endpoint Analysis
• NEWS2 Scores (Intent-to-Treat Population)
More patients in the Brilacidin 5-dose group achieved and maintained, for at least 24 hours, a National Early Warning Score 2 (NEWS2) of <=2. By 10 days (from randomization), 97 percent of the Brilacidin 5-dose group had achieved this NEWS2 endpoint compared to 84 percent of patients in the pooled placebo group. A NEWS2 score of 2 or less is clinically meaningful as an aggregate score of 4 or less translates to low clinical risk, per NEWS2 criteria.
The mean change from baseline in NEWS2 was greater for the Brilacidin treatment groups than for the pooled placebo group, at all assessment timepoints (Study Days 3, 5, 8, 11, 15, and 29).
NEWS2 is an ordinal scale developed by the U.K.'s Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention and is considered a valuable tool for management of COVID-19. NEWS2 is based on certain physiological parameters--respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse, level of consciousness, and temperature. NEWS2 has been used as an endpoint for several COVID-19 clinical trials.
Post-Hoc Analysis
• Inflammatory Biomarkers: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
For those patients with baseline values for C-Reactive Protein (CRP) in the highest quartile (4th quartile), all patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29, compared to 77 percent of patients in the pooled placebo subgroup. Time to sustained recovery was on average shorter in the Brilacidin 5-dose subgroup compared to placebo.
Additionally, for those patients with baseline values for Interleukin-6 (IL-6) in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (89 percent compared to 67 percent on placebo). Time to sustained recovery also was on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients.
Both CRP and IL-6 levels, when elevated at baseline, have been shown to predict worse outcomes in COVID-19 patients and our data was consistent with this. These two biomarkers have been used by other pharmaceutical companies as enrollment criteria to target COVID-19 patient populations most likely to benefit from treatment. The NIH-sponsored clinical evaluation of Humanigen's drug, lenzilumab (ACTIV-5/BET-B), was updated to include, as the trial's primary endpoint, survival without ventilation by 28 days in patients with baseline CRP levels under 150mg/l.
• Viral Load Biomarker: Patient Subgroup with Highest Quartile Baseline Values (Per Protocol Population)
For those patients with baseline values for viral load in the highest quartile, more patients in the Brilacidin 5-dose subgroup achieved sustained recovery through Day 29 (92 percent compared to 82 percent on placebo). Time to sustained recovery was also on average shorter in the Brilacidin 5-dose subgroup compared to placebo for this quartile of patients. This is notable given median time from symptom onset to treatment randomization averaged 9.53 days in the Brilacidin COVID-19 trial, and thus likely occurred after peak viral load in most patients.
• Time from Onset of Symptoms to Randomization (Per Protocol Population)
If a patient started study treatment within fewer than 7 days of onset of COVID-19 symptoms, patients in the Brilacidin 5-dose group achieved sustained recovery more quickly compared to the pooled placebo group (p=0.03). For this patient population, early treatment with Brilacidin from onset of symptoms appeared to have a potential positive impact on time to sustained recovery (the study's primary endpoint), suggesting cases that can be treated close to initial onset of disease may be an attractive population to target for Brilacidin treatment.
Multiple monoclonal antibodies targeting COVID-19, as well as the oral COVID-19 antiviral molnupiravir (Lagevrio™), failed in hospitalized patients but later achieved success in treating earlier-stage disease. The antiviral remdesivir (Veklury™) also recently exhibited substantial benefit in non-hospitalized COVID-19 patients, including an 87 percent lower risk of hospitalization or death than placebo after a 3-day intravenous course of the drug.
• Standard-of-Care (SoC)
Review of Brilacidin Phase 2 COVID-19 trial data showed most patients (>87 percent) received treatment with systemic corticosteroids (generally at high doses, and for long durations), and treatment with mucolytics (>82 percent), antivirals (>68 percent), analgesics (>56 percent), immunosuppressants (>45 percent), anti-thrombotic agents (>97 percent), and other supportive medications as SoC for COVID-19.
These seemingly aggressive SoC treatment strategies are likely attributable to the Delta variant of SARS-CoV-2, which became prevalent during trial enrollment and has been associated with significantly higher in-hospital mortality compared to earlier SARS-CoV-2 variants. Such implementation of a more aggressive COVID-19 SOC, as has been reported by other companies evaluating COVID-19 trial results, may have contributed to an overall lessening of observable Brilacidin treatment effects.
Brilacidin Compassionate Use in COVID-19-Observed Treatment Effects
Noticeable treatment effects attributed to the compassionate use of Brilacidin were reported by investigators. Patients receiving compassionate use of Brilacidin were at extremely advanced stages of disease and had exhausted other conventional treatment options. Compassionate use cases comprised Brilacidin being administered to critically-ill COVID-19 patients over a longer duration (up to 10 days of treatment) than in the Phase 2 COVID-19 clinical trial (3 and 5 day dosing), with some patients also receiving higher and more frequent (twice daily) dosing. There appeared to be a potentially favorable treatment response based on increased Brilacidin dosing. For the Brilacidin compassionate use cases, in general, investigators observed more stable disease with initial improvements evident on chest x-rays and in COVID-19 disease biomarkers (e.g., CRP and ferritin). While nearly all of these critically-ill patients ultimately succumbed to severe hypoxic respiratory failure (secondary to COVID-19 viral pneumonia) and expired, survival time for these patients who initially were not expected to live beyond a few days was appreciably extended.
Brilacidin Antiviral Program-Planned Next Steps
Future progress in the broader Brilacidin antiviral program will largely be tied to obtaining government funding for additional clinical development while benefiting from ongoing collaborative research with NIH and other scientists. Brilacidin's broad-spectrum antiviral activity is generating positive data. Publications and conference abstracts related to this research are being prepared.
Given the need for development of new small molecule antivirals and immunomodulators, the Company is planning to submit Brilacidin for possible inclusion in government-sponsored COVID-19 trial platforms, e.g., the NIH ACTIV program. Platform trials, which typically enroll hundreds of patients per treatment arm, can more accurately evaluate the treatment potential of COVID-19 drug candidates. Pursing a biomarker-driven approach, increasing Brilacidin dosing and treatment duration, targeting different patient populations, testing Brilacidin in combination with drugs exhibiting different mechanisms of action (e.g., remdesivir, given strong synergistic in vitro data)--all are possible elements of any future Brilacidin COVID-19 trial design. Compassionate use of Brilacidin also is anticipated to continue, which could further inform Brilacidin's treatment effects in COVID-19. For more details on the Company's Compassionate Use policy, please visit: https://www.ipharminc.com/expanded-access-and-compassionate-use.
The Company also plans to seek additional clinical development support from the NIH Antiviral Program for Pandemics (APP). Brilacidin for prophylactic use, including assessing Brilacidin in pre-clinical animal models, is of particular interest due to Brilacidin's blocking and neutralizing antiviral properties and industry investment in developing intranasal-targeted, direct-acting antivirals. Preliminary Brilacidin formulation work for inhaled delivery has been conducted, with the NIH APP a potential avenue to expand on this work, along with exploring the subcutaneous administration of Brilacidin, which has greater than 70 percent bioavailability via this route of administration.
Pipeline Advancement, Other Business Opportunities
Efforts to advance the Brilacidin Oral Mucositis (OM) program are a key focus. The Company is presently exploring timelines and scenario planning-including the option to seek a meeting with the U.S. Food and Drug Administration towards the initiation of a Phase 3 clinical trial evaluating oral rinse Brilacidin as a new treatment for the prevention of OM in head and neck cancer patients receiving chemoradiation. Brilacidin oral formulation development work for Ulcerative Colitis continues. The Company has also been notified by Alfasigma, its licensing partner, of their intent to initiate this year Phase 2 testing of Brilacidin in Ulcerative Proctitis/Proctosigmoiditis.
In other news, the Company is evaluating a number of potential pipeline additions and other unique business opportunities, including investments in medical-related technologies. In certain instances, management is in advanced discussions for products believed to be accretive to revenue by diversifying Innovation's portfolio. The Company will provide updates on all such matters as appropriate.
About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its potential impact on SARS-CoV-2 (COVID-19) and other viruses. Other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation that the Company's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
mailto://info@ipharminc.com
SOURCE: Innovation Pharmaceuticals Inc.
View source version on accesswire.com:
https://www.accesswire.com/691759/Innovation-Pharmaceuticals-Reports-Additional-Findings-Based-on-Review-of-Brilacidin-Phase-2-COVID-19-Trial-Results-and-Compassionate-Use-Cases
Pfizer, Moderna expect combined vaccine sales of $51 billion this year https://www.cnbc.com/2022/03/03/covid-pfizer-moderna-project-51-billion-in-combined-vaccine-sales-this-year.html?__source=iosappshare%7Ccom.apple.UIKit.activity.CopyToPasteboard
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This board is about medical news, medical and medicine advancements from pharmaceutical and biotech companies, as
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http://biotech-profits.org/
http://www.hardrightedge.com/wheel/tcrules1.htm
http://www.therapeuticsdaily.com/news/channel.cfm?channelID=28
http://www.medicalnewstoday.com/sections/genetics/
http://www.medicalnewstoday.com/sections/biology-biochemistry/
http://content.nejm.org/current.shtml
http://www.sciencedaily.com/
Some T/A sites:
http://www.americanbulls.com/
http://www.askresearch.com/
http://www.stockta.com/
http://www.stockconsultant.com./
http://www.investorshub.com/boards/read_msg.asp?message_id=297509
http://www.ttrader.com/dirttime.php
http://www.otcbb.com/asp/Info_Center.asp
http://bigcharts.marketwatch.com/
Find out if your stock is on the SHO List
http://www.buyins.net/tools/short_list.php?src=1,7,9
Understanding Level 11-http://www.hotstockmarket.com/forums/showthread.php?t=14938
OTCBB Biggest Gainers (%)http://www.stockhouse.com/mostactives/index.asp?type=winners&exchange=OTCBB
OTC Biggest Declinershttp://www.stockhouse.com/mostactives/index.asp?type=losers&exchange=OTCBB
OTC Biggest Volume Gainers http://www.stockhouse.com/mostactives/index.asp?type=mostactives&exchange=OTCBB
Technical Indicators http://stockcharts.com/school/doku.php?id=chart_school:technical_indicators
Screeners:
http://finviz.com/screener.ashx?v=111&f=cap_microover,geo_usa,sh_curvol_o100,sh_insttrans_o20,sh_price_o1,sh_short_u5,ta_rsi_ob70&ft=4&r=21 From Stock Seasonality Site.
http://www.marketscreen.com/c/pcquote/default.asp
http://moneycentral.msn.com/investor/finder/deluxestockscreen.aspx?query=Institutional+Ownership+Up+....
http://www.secform4.com/index.php
http://screen.morningstar.com/StockSelector.html
http://www.stockfetcher.com
http://investorideas.com/
http://www.wallstreettape.com/
http://findarticles.com/p/articles/mi_pwwi/is_200603/ai_n1610669
4
http://find.thestreet.com/cgi-bin/texis/tscsection/?k=Technology&sec=Technology&submenu=news....
Filings Sites:
http://www.pinksheets.com/
http://www.otcbb.com
http://www.gsionline.com/support/formtypes.html
http://www.coordinatedlegal.com/SecretaryOfState.html
http://www.searchsystems.net/list.php?nid=398
SEC FORM EXPLANATIONS
http://www.sec.gov/about/forms/secforms.htm
http://www.briefing.com/GeneralInfo/Features/LearningCenter/edu_SEC_Documents.htm
http://www.sec.gov/index.htm
To see how and about the SEC rules, regulations and cases involving stock manipulators.
SEC REALTIME FILINGS
http://www.nasdaq.com/asp/quotes_sec.asp?mode=&page=&symbol=QQQQ&symbol=&symbol=&....
http://home.businesswire.com/portal/site/home/index.jsp?front_door=true&headlineSearchConfigBO=v....
BOARD RULES:
The main objective for this moderated thread is to keep it free of posts which do not add value to the discussion of the stocks, the latest medical news, and information, while keeping the board balanced, clean, on-topic with due diligence kept up to date.
All posts here should stay focused on medical news and information.
Pro and con debate is encouraged as long as the opinions are kept on a mature level, with the omission of personal attacks,
violations of IHUB rules and basic civility.
Personal attacks, personal issues, political innuendo, spamming, duplicate posts of same subject matter, redundancy, obvious bashing, blatant pumping, irrelevant off topic subject matter, advertising, arguing, feeding and promoting bashers of other IHUB sites will be strictly prohibited.
Posts which the moderators feel violate these rules will be removed without question or debate.
If you are willing to cooperate and co~exist with other posters in this environment within the guidelines laid out, then welcome and have a great time posting and learning.
Please Note: Please add links to websites and information whenever they are available for accuracy and informational purposes.
Plus, I am not an MD, but rather a longtime biotech/pharma investor and former Quant analyst. So, if I can answer any questions relating to medical information, I will, and cede to any medical professionals whom are better equipped to answer those inquiries.
Thank you....PL1
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