Los Angeles, Jan. 23, 2020 (GLOBE NEWSWIRE) -- Hoverink Biotechnologies announced today that CEO Debbie Mae Carter will step down and will be succeeded by Cyrus Sajna as CEO and CFO of the company.
Hoverink Biotechnologies board of directors has appointed Cyrus Sajna, currently the company’s Vice President, to succeed Carter as interim CEO / CFO.
Quote from Cyrus Sajna “It is an honor to succeed Debbie, who has had an extraordinary career with Hoverink,” Cyrus also said. “I am proud and delighted to serve as Hoverink Biotechnologies next Chief Executive Officer.
Cyrus is also a Director at Hoverink Biotechnologies and has been instrumental in accelerating the rotation of the company to focus on biopharma and defense particularly with the development of the Body Globe Body Armor
The Company has two operating segments:
| i) | Biopharmaceuticals | |
| ii) | Defense |
Defense Segment
Our Defense Segment consist of our BODY GLOBE BODY ARMOR® (BGBA) which consist of our customized laminated polycarbonate transparent complete Body Armor dome solutions intended to be used by the military and law enforcement personnel as bullet and blast resistant transparent armor; the BODY GLOBE BODY ARMOR® Uses a laminated polycarbonate molded in a partial dome shape providing protection and dramatically reduces the probability of the military and law enforcement personnel being harmed by a bullet or blast and also provides the ability to safely return fire with a small hole for the barrel of a U.S. Soldiers or Local Law Enforcement officer’s weapon to safely return fire.
Quote from Cyrus Sajna “ The Body Globe Body Armor” is intended to protect American Soldiers and local law enforcement from incoming fire with our polycarbonate domes.”
Our Preclinical Biopharmaceutical Segment (BPS) consist of our lead drug candidates:
LADAVRU®, Pharmaceutical preparations for the treatment of gastrointestinal and oncological diseases and disorders. LADAVRU a non-opioid product. LADAVRU is a proprietary opioid alternative which is deliverable as an IV injectable, OR solid preparation containing; Citric Acid, Mannitol and Dronabinol, a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9- trimethyl-3-pentyl-6Hdibenzo[b,d]pyran-1-ol.
It is estimated that over 11 million people suffer from opioid addiction and over 2 million have used opioids. Physicians desperately seek a non-opioid solution. Our non-opioid product candidate LADAVRU® focuses on chronic pain, nausea and discomfort and may treat chronic pain, nausea and discomfort in the following patient populations including leukemias, lymphomas, and breast, stomach, uterine, ovarian, bladder, and lung cancers.
https://www.hhs.gov/opioids/about-the-epidemic/index.html
KAIYADRU® Pharmaceutical preparations, namely, pharmaceutical preparations for the treatment of diseases and disorders of the alimentary tract and metabolism, and blood and blood forming organs; pharmaceutical preparations for the treatment of diseases and disorders of the cardiovascular system, musculoskeletal system, central nervous system, peripheral nervous system, genitourinary system and respiratory system; and pharmaceutical preparations for the treatment of dermatological, hormonal, infectious, viral and oncological diseases and disorders.
An estimated 30.3 million people in the United States, or 9.4 percent of the population, have diabetes. About one in four people with diabetes don’t know they have the disease. An estimated 84.1 million Americans aged 18 years or older have prediabetes.
Source: https://www.niddk.nih.gov/health-information/diabetes have prediabetes.
MAXKAFLEN ® antibiotic for cattle and swine; antibiotics
With world beef consumption being projected at 60.9 million metric tons in 2018, up 1.3 million metric tons from 2017. The need for reasonably priced antibiotics is ever increasing. Additionally, the nation’s top 10 states help produce over 94 Million heads of cattle all requiring antibiotics. MAXKAFLEN is intended to be a cost effective solution.
The United States is projected to consume 12.59 million metric tons of beef in 2018, up 546K metric tons from 2017. Brazil is projected to consume 7.94 million metric tons of beef in 2018, up 185K metric tons from 2017. http://beef2live.com/story-world-beef-consumption-country-352-106829
Regulatory
The sale of animal health products is governed by the laws and regulations specific to each country in which we intend to sell our products. To maintain compliance with these regulatory requirements, we must establish processes, systems and dedicated resources with end-to-end involvement from product concept to launch and maintenance in the market. Our regulatory milestones require we engage in dialogue with various agencies regarding their policies that relate to animal health products.
United States
United States Food and Drug Administration. The regulatory body that is responsible for the regulation of animal health pharmaceuticals in the United States is the Center for Veterinary Medicine, or the CVM, housed within the FDA. All manufacturers of animal health pharmaceuticals must show their products to be safe, effective and produced by a consistent method of manufacture as defined under the Federal Food, Drug and Cosmetic Act. The Agency’s basis for approving a drug application is documented in a Freedom of Information Summary. Post-approval monitoring of products is required by law, with reports being provided to the CVM’s Surveillance and Compliance group. Reports of product quality defects, adverse events or unexpected results are produced in accordance with the law. Additionally, we are required to submit all new information for a product, regardless of the source.
United States Department of Agriculture. The regulatory body in the United States for veterinary vaccines is the USDA. The USDA’s Center for Veterinary Biologics is responsible for the regulation of animal health vaccines, including immunotherapeutics. All manufacturers of animal health biologicals must show their products to be pure, safe, effective and produced by a consistent method of manufacture as defined under the Virus Serum Toxin Act. Post-approval monitoring of products is required. Reports of product quality defects, adverse events or unexpected results are produced in accordance with the agency requirements.
| ● | We must timely collaborate or in- and out-license opportunities. We intend to collaborate or in- and out-license MAXKAFLEN® KAIYADRU® LADAVRU® to biotechnology or pharmaceutical companies for preclinical and clinical development and commercialization. We may initiate the clinical development of our lead product candidate, ; | |
| ● | seek to obtain regulatory approvals for MAXKAFLEN® KAIYADRU® LADAVRU® | |
| ● | prepare for the clinical trials and potential commercialization of KAIYADRU® LADAVRU® | |
| ● | create manufacturing processes and quantities to prepare for clinical trials and the commercialization of MAXKAFLEN ® KAIYADRU® LADAVRU® for any indications for which we receive regulatory approval; | |
| ● | establish outsourcing of the commercial manufacturing of MAXKAFLEN® KAIYADRU® LADAVRU® for any indications for which we may receive regulatory approval; | |
| ● | establish an infrastructure for the sales, marketing and distribution of MAXKAFLEN ® KAIYADRU® LADAVRU® for any indications for which we may receive regulatory approval; | |
| ● | continue preclinical development of our product candidates MAXKAFLEN® KAIYADRU® LADAVRU®; | |
| ● | expand our research and development activities and advance the discovery and development programs for other product candidates, including novel combination solutions comprised of our own amplifiers, correctors and potentiators; | |
| ● | maintain, expand and protect our intellectual property portfolio; | |
| ● | continue our research and development efforts and seek to discover additional product candidates; and | |
| ● | add operational, financial and management information systems and personnel, including personnel to support our clinical development and commercialization efforts and operations as a public company. |
About Hoverink Biotechnologies
We are an innovative preclinical biopharmaceutical company committed to the discovery development, manufacturing and commercializing our product candidates.
Our website address is in beta at www.hoverinkbiotech.yolasite.com. Our email is info@hoverink.net
This press release contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus, including logos, artwork, and other visual displays, may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Except where the context requires otherwise, in this prospectus “Company,” “Hoverink,” “we,” “us” and “our” refer to “Hoverink Biotechnologies, Inc.”Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company’s expectations for seeking regulatory approval and commercial launch of its products, including any conditional marketing authorization from the EMA, initiation of future clinical trials, data availability from ongoing and future clinical trials, and the company’s expectations for its 2017 financial outlook. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the company may experience delays in the completion of its clinical trial (whether caused by competition, adverse events, patient enrollment rates, regulatory issues or other factors); risks that data from its clinical trials may not be indicative of subsequent clinical trial results; risks.
For Body Armor Sales, Media and Investor Contact:
Cyrus Sajna, Vice President Direct 310-467-2048 or 866-443-4666 EXT 113
Hoverink Biotechnologies, Inc.
1801 Century Park East., 24th Floor
Los Angeles, California 90067
cyrus@hoverink.net