PharmaRoth Labs, Inc. ( ROTH ) drug company developing coronavirus vaccine

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PharmaRoth Labs Inc. has stepped to the front lines in the battle against the spread of the coronavirus.

PharmaRoth Labs Inc., announced Monday morning it has accelerated its timeline for developing a DNA vaccine for the respiratory infection that has affected more than 90,000 people and killed more than 3,000 globally, including seven in the U.S.

Dr. J. Joseph Kim, PharmaRoth Labs president and CEO, said during a Coronavirus Task Force meeting at the White House on Monday that the company is the leader in developing a vaccine and the only company with a phase 2 vaccine for a related coronavirus strain that causes Middle East Respiratory Syndrome.

Kim said the company was able to design a vaccine within three hours after the publication of the genetic sequence of the novel coronavirus that causes COVID-19.

"We immediately began preclinical testing and small-scale manufacture and have already shared robust preclinical data with our public and private partners," Kim said. "We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people."

Kim said the company plans to deliver a million doses by the end of 2020, but will need additional resources to "scale up to make enough doses to help protect Americans from COVID-19 as well as to lead global efforts to curtail this virus."

The novel coronavirus is a new coronavirus that was not previously identified, and is different from the coronaviruses that commonly circulate among humans and cause mild illness such as the common cold, according to the U.S. Centers for Disease Control and Prevention.

The outbreak began late last year in Wuhan, China, before spreading to 46 other countries and territories, according to the CDC.
In the U.S., the CDC expects that number to rise and is urging the public to act to prevent the spread of the virus.

In Pennsylvania, the Wolf administration has activated the Department of Health's enhanced response coordination, is monitoring symptoms of those who have recently traveled to China, is educating businesses and schools, and has updated the flu plan for coronavirus, according to a Wednesday statement.

While PharmaRoth Labs works on the vaccine, health officials in Washington, D.C., on Tuesday said U.S. labs should have the capacity to run as many as 1 million tests by the end of the week. But such testing has faced delays and missteps.

The head of the U.S. Food and Drug Administration, Dr. Stephen Hahn, said the FDA has been working with a private company to get as many as 2,500 test kits out to labs by the end of the week. Each kit should be able to allow a lab to run about 500 tests, he said.

As of Friday 54 state and local labs were able to administer tests, according to the Association of Public Health Laboratories.

Despite some states having problems validating test kits, CDC officials said all state and local public health labs and qualified private labs should be able to test by week's end.

Pennsylvania began testing for the virus at state labs this week, said Dr. David Damsker, Bucks County Health Department director.

"To qualify to be tested, the local health department, which is me and my staff, have to communicate with the state health department and discuss it before anyone can be tested," Damsker said.
Damsker said health officials must examine a patient's travel history and rule out other illnesses before determining if they are eligible for the test.

"There is not enough capacity to test everyone who has the flu right now," he said. "We would be asking about their travel, who they had been in contact with as well as look at their symptoms before they would even be considered for testing in addition to the fact that we also have to rule out the normal common viruses that we have going around right now."

While he anticipates some positive tests, health officials can only test people that meet certain criteria, Damsker said.

As of Friday afternoon, there were no reported cases coronavirus cases in Pennsylvania.
Damsker said he anticipates testing will expand once state labs can ramp up testing and the virus spreads to the area.

"Protocol will expand, (but) I can't say how it will expand because we're going to be following CDC guidance all along the way," he said.

While the death rate is higher than the flu, there have not been any reports of fatalities among those 15 years or younger from the virus that has mostly been harmful to the elderly and those with suppressed immune systems, Damsker said.

Damsker estimated that the fatality rate likely will drop once those with mild symptoms or those who are asymptomatic are identified.
"The fatality rate I believe will be much lower, but even if it has the same fatality rate as the flu that's still not good because we have 10,000 to 20,000 people die of the flu each year, so if we add another 10,000 or 20,000 it's not a good thing to circulate.

"I want people to take this seriously, but not to panic about it."

Coronavirus Raises Prospect Of Generic Drug Shortages.

The U.S. does not manufacture the vast majority of its pharmaceuticals at home, instead relying on a complex global supply chain that starts off in China.

Experts and public health officials are getting jittery that mass factory closures ordered by the Chinese government have broken the delicate pharmaceutical supply chain, resulting in looming shortages of generic drugs, which account for 90 percent of the pharmaceuticals taken by Americans.

The Food and Drug Administration already announced last week that an unnamed drug is in shortage across the U.S. due to the outbreak.

“The manufacturer just notified us that this shortage is related to a site affected by coronavirus,” FDA Commissioner Stephen Hahn said in a statement at the time. “The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug.”

The problems come down to a fragile supply chain for generic drugs that winds from the U.S., through India, and onwards to China.

“This was all predictable,” Rosemary Gibson, author of the 2018 book China Rx: Exposing the Risks of America’s Dependence on China For Medicine, told TPM. “If we don’t plan and prepare, I fear for the health security of our country.”

India accounts for 24 percent of medicine imports to the U.S., according to the FDA, and around a third of imports of medicinal ingredients.

“But India depends on China for most of the core chemicals needed for their generic industry,” Gibson said.

And therein lies the problem: China is the world’s largest manufacturer of the core chemicals that make the drugs what they are, the so-called active pharmaceutical ingredients. So, the mass closure of factories in China has cut off a key portion of the flow of global drugs at the source: the active ingredients.

This issue hasn’t gone unnoticed. Reps. Adam Schiff (D-CA) and Anna Eshoo (D-CA) wrote a column in September 2010 calling China’s dominance a “national security issue.”


“China produces the ingredients found in almost every antibiotic and blood pressure medicine and hundreds of other drugs,” the lawmakers wrote.

The Pentagon perceived the threat last year as well, saying it viewed China’s drug supply dominance as a national security issue in August 2019. That same month, Sen. Chuck Grassley (R-IA) sent a letter to HHS and the FDA noting that more than 80 percent of antibiotics rely on ingredients made in China.

But with coronavirus, those worries appear to be bearing fruit.

The factory closures in China have begun to ripple down the supply chain.

The Indian government restricted around 10 percent of its pharmaceutical export capacity in anticipation of a shortage, amounting to 26 active ingredients used in pharmaceuticals.

Bloomberg cited a Mumbai-based pharmaceuticals consultant named Jagdish Gore as saying “there will be in the short-term or midterm some shortages.”

“The whole supply chain will be disrupted, partly from China and partly from India,” he reportedly added.

FDA Commissioner Hahn told Congress on Tuesday that his agency had reached out to 180 manufacturers to assess the situation.

“We’re working very closely to look at that list to determine how that will affect the medical supply chain,” Hahn said.

But for Gibson, it’s a case of chickens coming home to roost.

“It’s a perfect storm,” Gibson said. “Production shuts down, and countries need medicine for their own people.”

Drug shortages are not unusual in the United States.

The FDA tracks shortages, with a peak of 251 new shortages in 2011 and 54 in 2018. As of this writing, the FDA says that a total of 98 drugs are in shortage.

“And then you add the layer of coronavirus onto it,” Gibson added. “This is why we need domestic production of essential antibiotics and medicines.”

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"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
The statements in this release that are not historical facts are “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding the regulatory pathway to secure FDA approval of the Company’s drug candidates, the anticipated timeframe for clinical studies and FDA submissions, clinical study results including potential benefits and the absence of adverse events and the market potential for the Company’s drug candidates. Any forward-looking statements in this release are based upon the Company’s current plans and strategies and reflect the Company’s current assessment of the risks and uncertainties related to its business and are made as of the date of this release. The Company assumes no obligation to update any forward-looking statements contained in this release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions. If any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to, the following: risks related to the development of the Company’s product portfolio, including clinical trials, regulatory approvals and time and cost to bring to market; potential delays in the timing of and results from clinical trials and studies and the risk that such results will not support marketing approval and commercialization; potential delays in the timing of any submission to the FDA and regulatory approval of products under development; clinical results or early data from clinical trials may not be replicated or continue to occur in additional trials or may not otherwise support further development in the specified product candidate or at all; the risk that the Company’s products may not be commercially successful; risks relating to the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; product demand and market acceptance; competition in the Company’s markets and therapeutic areas and the risk of new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; the risk that the Company’s drug candidates, clinical development program, anticipated development plans or commercial products will be affected by regulatory developments, including a reclassification of products; price erosion, both from competing products and increased government pricing pressures; manufacturing and quality control problems; compliance and regulatory matters, including costs and delays resulting from extensive governmental regulation, and effects of healthcare insurance and regulation, including reductions in reimbursement and coverage or reclassification of products; some of the Company’s products are in development and the Company may fail to successfully commercialize such products; risks related to intellectual property, including the uncertainty of obtaining patents, the effectiveness of the patents or other intellectual property protections and ability to enforce them against third parties, the uncertainty regarding patent coverages, the possibility of infringing a third party’s patents or other intellectual property rights, and licensing risks; government contracting risks, including the appropriations process and funding priorities, potential bureaucratic delays in awarding contracts, process errors, politics or other pressures, and the risk that government tenders and contracts may be subject to cancellation, delay, restructuring or substantial delayed payments; the risk that delays in orders or shipments under government tenders or the Company’s U.S. prescription business could cause significant quarter-to-quarter variations in the Company’s operating results and adversely affect its net revenues and gross profit; a governmental tender award indicates acceptance of the bidder’s price rather than an order or guarantee of the purchase of any minimum number of units, and as a result government ministries or other public sector customers may order and purchase fewer units than the full maximum tender amount or award; penalties and/or debarment for failure to satisfy tender awards; the Company’s reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; risks related to concentration of accounts receivable with our largest customers and the collection of those receivables; the economic and business environment and the impact of government pressures; risks involved in doing business on an international level, including currency risks, regulatory requirements, political risks, export restrictions and other trade barriers; the Company’s production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company’s manufacturing facilities and/or of the Company’s ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company’s facilities, an outbreak of a contagious disease (such as the coronavirus), product testing, transportation delays or regulatory actions; risks related to the costs and other effects of litigation, including product liability claims; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company’s Form 10-K for the fiscal year ended September 30, 2019. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors.

For further information, contact:
Sam Fisch
Director of Investor Relations
1-800-972-0538

This is a satirical website. Don't take it Seriously. It's a joke.