U.S. emergency labs ready to work on Ebola drugs if asked

Reuters

By Sharon Begley and Toni Clarke

NEW YORK/WASHINGTON, Aug 9 (Reuters) - All three U.S. facilities established to quickly make vaccines and therapeutics in the event of a major public health threat say they are standing by to support any U.S. government effort to scale up a treatment for Ebola.

The facilities, called Centers for Innovation in Advanced Development and Manufacturing (ADM), were set up by the U.S. Department of Health and Human Services in partnership with private industry, to respond to pandemics or chemical, biological, radiological, or nuclear threats.

They have the expertise to quickly switch production lines to manufacture, for example, a smallpox vaccine if that scourge were to re-emerge, or an anthrax vaccine, and other life-saving compounds against both natural outbreaks and bioterrorism.

"They know our number and they can call us 24 hours a day," said Brett Giroir, chief executive of Texas A&M Health Science Center, site of one of the facilities. "We are prepared."

Global health agencies are only starting to consider whether to make experimental drugs, most of which have only been tested on monkeys, available to patients in West Africa, which is suffering the worst Ebola outbreak in history.

The World Health Organization is convening a group of bioethicists to consider such as issues as who decides which patients would receive the treatments or vaccines. U.S. officials have repeatedly emphasized the importance of public health measures such as quarantines to stop the spread of the disease.

Among the Ebola treatments that have shown promising results in lab animals is an antibody cocktail from Mapp Biopharmaceutical, a tiny biotechnology company in San Diego; a vaccine from Profectus in Tarrytown, New York; and an RNA-interference drug being developed by Vancouver-based, Tekmira Pharmaceuticals, which late last week got approval from the U.S. Food and Drug Administration to resume safety trials in human volunteers.

The decision to order any of the three advanced labs to begin making Ebola treatments would be made at the highest levels of the Obama administration.

BUS-LENGTH CLEAN ROOMS

The Texas facility consists of a dozen bus-length mobile clean rooms, each supplied with sterile air, nutrient media for growing cells, and other clean-manufacturing requirements.

"We are prepared to make any kind of vaccine," Giroir said, from the traditional kind grown in chicken eggs to newer varieties grown in mammalian or bacterial cells. "The whole idea is to take a process that may exist only on sticky notes at a small biotech company and scale it up as fast as possible"

The three centers are required to have the ability to produce vaccines against pandemic flu but must also dedicate at least six months a year to developing products against other threats, and at sufficient volume to meet a sudden spike in U.S. demand, Giroir said.

The Texas facility collaborates with British drugmaker GlaxoSmithKline Plc. A center led by Emergent Biosolutions in Baltimore, Maryland, collaborates with various universities as does the third center, in Holly Springs, North Carolina, led by Swiss drug company Novartis AG.

Their operations are funded with $400 million from HHS and are overseen by the Biomedical Advanced Research and Development Authority (BARDA), part of HHS's Office of the Assistant Secretary for Preparedness and Response.

Combined, the centers have the capacity to produce and deliver at least 50 million doses of vaccine against pandemic influenza, the most likely source of a health emergency, within 12 weeks.

Any Ebola order would be for much fewer doses, said Giroir. "Even if Ebola were spreading here, it's not an airborne transmissible disease like influenza so you wouldn't need 50 million doses. At most you'd need a few thousand, maybe a million."

SCALING UP

The centers are not set up to invent drugs. They are designed to take what Giroir calls "the scientific substrate" or recipe for the product, either an existing one or, as in the case of Ebola treatments, an experimental one and develop a process for making it.

Of the three, only the Texas lab said it can produce proteins such as human antibodies in plant-based systems, which is how Mapp's Ebola drug has been made in limited quantities, so the government may sub-contract with a company that has additional plant technology.

One candidate is Bryan, Texas-based Caliber Biotherapeutics LLC. Mapp currently works with Kentucky BioProcessing, a unit of tobacco giant Reynolds American to produce its drug. More capacity would be needed to scale up.

Emergent Biosolutions' facility does not have the recipe to develop an Ebola treatment, but Adam Havey, president of the company's biodefense division, said that if the government asked it to produce something against the virus "we would absolutely respond to that."

Novartis said its facility also "stands ready, as with previous public health emergencies, to provide scientific support aimed at halting the current outbreak."

Even with dedicated facilities to hand, getting medicines to Africa quickly and in sufficient quantities will be a challenge.

BARDA does have a network of distributors, including Baxter International Inc, Cook Pharmica LLC and JHP Pharmaceuticals, who would be obliged, if requested, to fill vials and package a BARDA-designated product.

While U.S. legislation intended such production to be for U.S. use, there are provisions for products to be provided to allies and other countries if it is in the interest of national security.

(Reporting by Sharon Begley and Toni Clarke; Editing by Michele Gershberg and Martin Howell)

Rates

View Comments (1)

Recommended for You

  • Tycoon buys 30 Rolls-Royces for Macau hotel

    A Hong Kong tycoon has placed the biggest ever order for Rolls-Royce cars, agreeing to buy 30 Phantoms to chauffeur guests at a luxury resort he's building in the global gambling capital of Macau. Stephen Hung's $20 million purchase surpasses the 14 Phantoms bought by Hong Kong's Peninsula Hotel in…

    Associated Press
  • Looking to Save Money on Home & Auto Insurance?

    Speaking with an insurance agent can help identify your eligibility for insurance discounts. Get a home & auto insurance quote today.

    AdChoicesFarmers InsuranceSponsored
  • Tycoon's arrest sends shock wave through Russia

    Tycoon's arrest sends shock wave through Russia MOSCOW (AP) — The arrest of a Russian telecoms and oil tycoon has sent shock waves through the country's business community, with some fearing a return to the dark days of a decade ago, when the Kremlin asserted its power by imprisoning the country's…

    Associated Press
  • Before You Buy Alibaba, Check Out 4 Top China Stocks

    Before You Buy Alibaba, Check Out 4 Top China Stocks While investors gear up for Alibaba Group 's (BABA) hotly anticipated initial public offering, don't forget about other Chinese stocks that are worth keeping an eye on. Today's Young Guns Screen of

    Investor's Business Daily
  • Costco Stores in Canada to Stop Taking American Express

    “The credit card relationship between American Express and Costco Wholesale Canada will not be renewed when it expires” on Dec. 31, the company said today in an e-mail to Canadian customers. The message was attributed to Lorelle Gilpin, vice president of marketing and membership for Costco…

    Bloomberg
  • "The Retiree Next Door": How successful retirees stretch their savings

    "The Retiree Next Door": How successful retirees stretch their savingsBy the time she hit her late 40s, Toni Eugenia wasn’t sure she would ever be able to retire. Eugenia, 56, a pharmacy technician who lived in Houston, was nearly $200,000 in debt and

    Yahoo Finance
  • As Fed takes baby steps, Cramer's trick for profit

    In turn, Cramer says making money in the market, involves looking at the environment through the lens of the Fed. "The trick is to remember that they speak for the common person," Cramer said. "The Fed wants the common person to make money." With that backdrop always in mind, Cramer says it becomes…

    CNBC
  • Play

    Citi, Bank of America Offer Discounted Mortgages

    Citigroup and Bank of America will offer mortgages at discounted interest rates to help borrowers with low incomes or subprime credit. AnnaMaria Andriotis joins MoneyBeat. Photo: Getty.

    WSJ Live
  • AARP® Auto Insurance Program from The Hartford

    50+? Request a free quote and you could save $404* on Auto Insurance from The Hartford!

    AdChoicesThe HartfordSponsored
  • CNBC Anchor Calls Out Fed-Hater Bill Fleckenstein In Startling Shouting Match

    CNBC Bill Fleckenstein of Fleckenstein Capital appeared on CNBC's Futures Now program on Tuesday. Futures Now host Jackie DeAngelis came out swinging, asking Fleckenstein right at the top if he was willing to admit that he had misunderstood monetary policy. Sounding taken aback, Fleckenstein…

    Business Insider
  • Beanie Babies creator's sentence debated in court

    Beanie Babies creator's sentence debated in court CHICAGO (AP) — Federal prosecutors seeking to put the billionaire creator of Beanie Babies in prison for hiding millions in Swiss bank accounts told appellate court judges Wednesday that the toymaker's sentence of probation threatens to erode the…

    Associated Press
  • Apple to unveil new iPads, operating system on Oct. 21 : report

    The company plans to unveil the sixth generation of its iPad and the third edition of the iPad mini, as well as its operating system OS X Yosemite, which has undergone a complete visual overhaul, the Internet news website said. Trudy Muller, a spokeswoman for Apple, declined to comment. The iPad is…

    Reuters
  • Gilead Stock Is Falling On These Drug Setbacks

    Gilead Stock Is Falling On These Drug Setbacks Gilead Sciences (GILD) shares are backsliding Wednesday on news that the patient drop-out rate for hepatitis C drug Sovaldi is quadruple that of clinical trials. In addition, the biotech's Phase 2 study results

    Investor's Business Daily
  • Here's What Mark Cuban Wishes He Knew About Money In His 20s

    Cuban is the owner of the Dallas Mavericks basketball team. Billionaire investor and entrepreneur Mark Cuban is generous with his advice. When we asked him what he wishes he'd known about money in his 20s, he said:

    Business Insider
  • Margaritaville casino owners seek bankruptcy

    The owner of Biloxi's Margaritaville casino has filed for Chapter 11 bankruptcy protection Tuesday, only hours before a hearing where the landlord aimed to seize the property. The filing by MVB Holding LLC in U.S. Don Dornan, a lawyer for landlord Clay Point LLC, said the company had planned to ask…

    Associated Press
  • Froot Loops® Cereal

    Who Says You Have to be a Kid to Enjoy the Fruity Goodness of Froot Loops? Remember The Sweet Aroma & Fruity Taste with a Bowl of Froot Loops Today!

    AdChoicesKellogg's Froot Loops®Sponsored
  • Embraer to sell 50 E-175 jets to Republic in $2.1 billion deal

    Brazil's Embraer SA, the world's third largest commercial planemaker, said on Wednesday it booked a firm order from U.S. The deal, which will be included in Embraer's order book for the third quarter, is valued at $2.1 billion, the planemaker said in a securities filing. The planes will be operated…

    Reuters
  • SHOE COMPANY: Our CEO Just Disappeared And Most Of The Money Is Gone

    "and like that: he's gone." This is an actual headline from a company press release: "CEO and COO disappeared, most of the company's cash missing." (Via FastFT) In a statement, German-based shoe company Ultrasonic said its CFO,  Chi Kwong Clifford Chan, has been unable to reach the company's CEO,…

    Business Insider
  • Don't buy Alibaba stock: 'Dean of Valuation'

    Investors should steer clear of Alibaba , valuation expert Aswath Damodaran said Wednesday. On CNBC's " Fast Money ," Damodaran, a professor of finance at New York University's Stern School of Business, noted that he was looking at Alibaba stock from the perspective of a long-term investor, not a…

    CNBC
  • Billionaire Investor Says Chinese People Work Harder And Western Companies Could Face Deep Trouble After Alibaba IPO

    Michael Moritz, the chairman of VC firm Sequoia Capital, is a huge fan of Chinese internet companies and reiterated his enthusiasm for the Chinese market in an interview with The Wall Street Journal Wednesday. The billionaire investor described the Alibaba IPO as a “major landmark event” that is as…

    Business Insider
  • Play

    What the Fed Meeting Means for Bonds

    Janet Yellen & Co. are expected to hint at their timetable for raising interest rates. Here's how investors should prepare ahead of the meeting.

    WSJ Live
  • Top Analyst Upgrades and Downgrades: AEP, BHP, GE, Incyte, 3M, Tyco, Under Armour and More

    Top Analyst Upgrades and Downgrades: AEP, BHP, GE, Incyte, 3M, Tyco, Under Armour and More Stocks were firm on Wednesday morning ahead of the FOMC meeting outcome. Tuesday’s rally may have sparked higher interest again, and investors are looking for bargains

    24/7 Wall St.
  • The New 2015 Sonata®: A Step Above the Competition

    There's a Sonata® that's perfect for you, and this is your chance to build it! Visit the Hyundai® Official Site to customize your 2015 Sonata® today!

    AdChoicesHyundaiSponsored
  • 6 Things Debt Collectors Wish You Knew

    The work debt collectors do is not popular, and has become increasingly derided by those who don’t like what we do or simply don’t know the facts about debt collection. Too often, debt collection is painted with a broad brush to create a portrait that isn’t accurate, and doesn’t properly educate…

    Credit.com