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PostPosted: Tue Sep 02, 2014 7:17 pm 
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US HHS has contracted with ZMapp maker to develop drug for Ebola.

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PostPosted: Tue Sep 02, 2014 7:18 pm 
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FOR IMMEDIATE RELEASE
September 2, 2014
Contact: HHS Press Office
202-690-6343
HHS contracts with Mapp Biopharmaceutical to develop Ebola drug
Work will accelerate drug development and testing

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR). This contract supports the government-wide response to the Ebola outbreak in West Africa.

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will provide funding as well as access to subject matter expertise and technical support for manufacturing, regulatory, and nonclinical activities through a $24.9 million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego, California. ASPR can extend the contract up to a total of $42.3 million.

Work under the contract supports the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval.

“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” explained Dr. Nicole Lurie, assistant secretary for preparedness and response. “Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today’s agreement represents an important step forward.”

The Defense Threat Reduction Agency (DTRA) within the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID) of HHS’ National Institutes of Health supported initial work on this product. To speed the development of ZMapp, BARDA will work closely with those agencies. BARDA also will work with the company to optimize and accelerate the manufacturing of ZMapp so testing can be done as soon as possible.

As part of the project funded today, Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug’s safety and efficacy in people. Mapp Biopharmaceuticals also will work with BARDA on the manufacturing process, increasing production yields and the scale of manufacturing.

As an experimental drug, ZMapp currently is available only in very limited quantities and these steps will contribute to increasing the amount of product potentially available to treat patients with Ebola.

ZMapp is a combination of three monoclonal antibodies manufactured in tobacco plants. Monoclonal antibodies bind certain virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient's immune system has to fight. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses.

The project with Mapp Biopharmaceutical is the first BARDA program supporting the development of a product against viruses that cause viral hemorrhagic fever.

Even the most advanced potential therapeutics and vaccines for Ebola are entering early clinical trials. BARDA is working with other federal agencies to accelerate the development of Ebola therapeutics and vaccines and to identify ways to optimize and expand their production. BARDA is exploring whether its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time.

BARDA is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

For more information about advanced research and development of medical countermeasures, visit http://www.medicalcountermeasures.gov. Contract opportunities and awards are announced at http://www.fbo.gov.


###
http://www.hhs.gov/news/press/2014pres/ ... 0902b.html

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PostPosted: Tue Sep 02, 2014 7:23 pm 
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Ebola Scan for Sep 02, 2014
HHS funds for ZMapp; China's Ebola drug approval; 30-minute Ebola test
Filed Under:
Ebola; VHF

HHS contract aims to boost ZMapp development for Ebola

The US Department of Health and Human Services (HHS) will spend up to $42.3 million to help accelerate development of the experimental Ebola drug ZMapp, the agency said in a press release today.

The HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR), through its Biomedical Advanced Research and Development Authority (BARDA), will provide funding as well as access to subject matter experts and technical support, HHS said. The contract covers manufacturing, regulatory, and nonclinical activities for ZMapp through a $24.9-million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego to speed development of the drug, which has been used without known efficacy on several patients with Ebola virus disease (EVD).

If all goes well, ASPR can extend the contract for up to $42.3 million total, HHS said. The goal is to gain Food and Drug Administration approval.

The funds will go toward manufacturing a small amount of ZMapp for early-stage clinical safety studies and nonclinical studies to demonstrate safety and efficacy in people. Mapp Biopharmaceutical will also work with BARDA on increasing production yields and the scale of manufacturing to make more doses.

"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," said Nicole Lurie, MD, MSPH, assistant secretary for preparedness and response, in the news release.

"Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the US government, and today's agreement represents an important step forward," she added.
Sep 2 HHS news release

http://www.cidrap.umn.edu/news-perspect ... ep-02-2014

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PostPosted: Wed Sep 03, 2014 10:45 am 
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U.S. Awards Contract to Develop More Experimental Ebola Drug
Mapp Biopharmaceutical's ZMapp Said to Have Cured Monkeys in a Study

By PETER LOFTUS CONNECT
Sept. 2, 2014 6:12 p.m. ET
The U.S. Department of Health and Human Services said Tuesday it awarded a $25 million contract to Mapp Biopharmaceutical Inc. to fund the manufacture of a small amount of experimental Ebola treatment ZMapp and to speed the drug's development.

The new supply to be funded with the 18-month contract would be used in early-stage clinical studies to test the drug's safety and efficacy, HHS said. The contract can be expanded to a value of up to about $42 million, HHS said.

San Diego-based Mapp Biopharmaceutical last month said a limited supply of ZMapp had been exhausted after it provided doses to several people infected in the current Ebola outbreak in West Africa. The company said then that it only had a small amount for the purposes of conducting animal studies. Last week, researchers said ZMapp was effective in curing monkeys of Ebola in a study.

HHS said the new contract would help accelerate development of ZMapp, with a goal of securing approval by the U.S. Food and Drug Administration. Mapp Biopharmaceutical also will work with HHS on the manufacturing process, increasing production yields and the scale of manufacturing.

A batch of ZMapp is now under production, and a Phase 1 safety study in humans is planned for the end of the year, said Robin Robinson, director of the Biomedical Advanced Research and Development Authority of HHS.

HHS is involved in discussions about when and how to bring experimental drugs to areas affected in the current Ebola outbreak, but the department believes it is critical to complete Phase 1 safety testing first, Dr. Robinson said.

The Christian mission group SIM USA said Tuesday one of its doctors, an American, has tested positive for the Ebola virus after treating obstetrics patients in Monrovia, Liberia. The doctor has been isolated and is "doing well," the group said.

No remaining ZMapp is available to provide a dose to the doctor, according to a person familiar with the matter. Seven people infected with Ebola had received ZMapp before the supply was exhausted, the person said.

ZMapp is a cocktail of three monoclonal antibodies designed to bind to and neutralize Ebola virus.

Write to Peter Loftus at peter.loftus@wsj.com

http://online.wsj.com/articles/u-s-awar ... 1409695957

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PostPosted: Fri Sep 05, 2014 10:50 am 
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Feds Make $42M Bet on Local Biotech to Develop Ebola Drug

Posted by Chris Jennewein on September 3, 2014 in Tech | 1190 Views | 1 Response

San Diego biotech Mapp Biopharmaceutical was awarded a federal contract Tuesday worth up to $42.3 million to develop its promising ZMapp drug for treating patients infected with the deadly Ebola virus.

The contract with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, supports the development and manufacturing of ZMapp with a goal of Food and Drug Administration approval.
Image
Kevin Whaley, CEO of Mapp Biopharmaceutical. Photo by Chris Jennewein


“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” said Dr. Nicole Lurie, assistant secretary for preparedness and response. “Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today’s agreement represents an important step forward.”

The Department of Defense and other federal agencies supported initial work on ZMapp. The drug was apparently successful in treating two Americans stricken with the disease in August amid the outbreak in West Africa.

As part of the new contract, Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug’s safety and efficacy in people. The company will also focus on the manufacturing process, increasing production yields and the scale of manufacturing.

As an experimental drug, ZMapp currently is available only in very limited quantities and these steps will contribute to increasing the amount of product potentially available to treat patients with Ebola, officials said.

ZMapp is a combination of three monoclonal antibodies manufactured in tobacco plants. Monoclonal antibodies bind certain virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient’s immune system has to fight. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses.

BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

An example of one of the data visualizations from San Diego State University's Center for Information Convergence and Strategy.Rep. Peters Hails SDSU Data Center to ‘Reveal Hidden Patterns’→


Dr. Erica Ollmann Saphire of the Scripps Research Institute holds a model of the Ebola virus. Photo by Chris Jennewein Scripps Called Ground Central for Ebola Virus Researchers→


http://timesofsandiego.com/tech/2014/09 ... bola-drug/

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PostPosted: Fri Sep 05, 2014 10:56 am 
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Feds to spend $42M on Ebola drug
By Gary Robbins2:13 P.M.SEPT. 3, 2014 Updated5:25 P.M

The San Diego company that created an experimental drug that may have helped save the lives of two aid workers stricken with Ebola virus will receive up to $42.3 million to speed development of the medication.

Moving with unusual speed, the Department of Health and Human Services said Wednesday it will initially give Mapp Biopharmaceutical of Sorrento Mesa $24.9 million to make the ZMapp serum, and up to $17.4 million more to put it on a path to FDA approval.

The announcement came as American medical missionaries Nancy Writebol and Dr. Kent Brantly were making some of their first extended comments about contracting Ebola in July while working in Liberia. Writebol said that ZMapp was a “booster” for the immune system, but added that she believed “supportive care was just as important as the serum.”

ZMapp had never been used in humans until it was given to Brantly and Writebol in a last-ditch effort to save their lives. Both of them became so ill from the virus they thought they were about to die. Brantly and Writebol were transported to Emory University in Atlanta, where they recovered.

Scientists aren’t able to quantify what role ZMapp played in their recovery; the serum has only been tested in monkeys. ZMapp appeared to be so promising it was given to five other Ebola patients, two of whom have died. Mapp Biopharmaceutical then ran out of the drug, which placed pressure on the U.S. government to provide funding to make more of the serum on an accelerated basis.

The pressure spiked in recent days after scientists released a study that says that 18 monkeys who were given a deadly dose of the Ebola virus survived after they were given ZMapp. Drugs that work in monkeys and other animals do not always work in humans, casting doubt about the true viability of the drug. But government funders quickly came up with money.

Health and Human Services said Wednesday in a statement that, “As part of the project funded today, Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug’s safety and efficacy in people. Mapp Pharmaceutical also will work with (the government) on the manufacturing process, increasing production yields and the scale of manufacturing.”

Mapp Pharmaceutical executives could not be immediately reached for comment.

“It’s unusual that things would happen this fast. But there’s a confluence of events,” said Dr. Michael Gilson, director of the Center for Drug Discovery Innovation at UC San Diego’s Skaggs School of Pharmacy and Pharmaceutical Sciences.

“This is the largest outbreak of Ebola to date and it comes when there is a promising therapy in the wings. You have a chance to act on it.”

The World Health Organization says that more than 1,900 people have died from the current Ebola outbreak in West Africa. That’s larger than the combined number of people killed by all previous outbreaks, WHO says.

Gilson said that Health and Human Services’ rapid investment in ZMapp is reminiscent of the huge effort the government made to produce and distribute penicillin to soldiers during World War II. He also said that he feels it was appropriate to given ZMapp to humans even though it had only been tested in monkeys.

“This is a lot like cancer care,” Gilson said. “Many cancer drugs are toxic. And yet we knowingly give people these medications because they are so ill. It is justifiable as long as you have informed consent.”

Ebola is an insidious disease whose fatality rate can reach 90 percent during outbreaks. The disease is most common in remote areas of Central and West Africa, usually near tropical rainforests, says WHO. Humans typically contract the virus from wild animals. People then spread it through human-to-human contact.

The ZMapp serum is basically a cocktail; it contains three antibodies that attach to the virus and attempt to neutralize it. The serum boosts the immune system, apparently giving humans a better shot at survival.

Mapp has been collaborating with the Scripps Research Institute in La Jolla, where biologist Erica Ollmann Saphire is overseeing a $28 million international research consortium that are trying to develop treatments.

Wednesday’s announcement about ZMapp thrilled Saphire, who told U-T San Diego, “This is terrific news! It will help establish safety and efficacy for a badly needed treatment.”

The Associated Press contributed to this story.

http://www.utsandiego.com/news/2014/sep ... ticle-copy

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PostPosted: Fri Sep 05, 2014 11:01 am 
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Funds To Speed Ebola Drug Development
A $42 million US government contract awarded to an experimental Ebola medicine maker aims to accelerate the process of meeting demand for the therapeutic.

By Kerry Grens | September 4, 2014


WIKIMEDIA, LINDA BARTLETT
Mapp Biopharmaceutical, whose experimental drug ZMapp was given to a few people infected with Ebola virus, has received a government contract worth more than $42 million. The Biomedical Advanced Research and Development Authority, an office within the US Department of Health and Human Services (HHS), agreed to offer an initial $24.9 million for “funding as well as access to subject matter expertise and technical support for manufacturing, regulatory, and nonclinical activities,” according to a press release.

“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” Nicole Lurie, the assistant secretary for preparedness and response, said in the release.

Last week, researchers reported that ZMapp appeared to cure 18 monkeys of Ebola. Although the drug has also been given to a handful of infected humans, it’s not clear yet whether it has helped them. Subsequently, Mapp had exhausted its supply of the drug.

The San Diego Union-Tribune reported that HHS acted “with unusual speed” to get the money moving. “It’s unusual that things would happen this fast. But there’s a confluence of events,” Michael Gilson, director of the Drug Discovery Institute at the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California, San Diego, told the Union-Tribune. “This is the largest outbreak of Ebola to date and it comes when there is a promising therapy in the wings. You have a chance to act on it.”

http://www.the-scientist.com/?articles. ... velopment/

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PostPosted: Fri Sep 05, 2014 11:29 am 
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Liberia: U.S. Expediting Zmapp Production, Contracts Services Drug Producer

By Wade C. L. Williams
Monrovia - US President Barack Obama's Special Assistant and Senior Director at the National Security Council Gayle Smith, has disclosed that the American government has given green-light for more production of the experimental drug Z-Mapp.

Smith announced during a teleconference Wednesday, held alongside the Centers for Disease Control Director for Global Health, Tom Kenyon, from Washington with journalists around Africa reporting on the deadly Ebola virus, that the producer of the drug Mapp Biopharmaceutical, was awarded the contract on September 1, 2014.

"Our department of Health and Human Services announced yesterday the award of a contract to the company that produces it to speed the drug's development," she said. "It is not going to be fully tested already and handed quickly as we would like, but we are expediting to the extent that we can safely do so, progress with respect to this. One thing with this Z-Mapp, the US government does not produce it. There is this company that produces it."

Smith said US President Obama takes the outbreak seriously adding that it should be looked at as a global crisis that every government in the world should be concerned about. "The President is consistently raising the need for a ramped up response to the Ebola outbreak in all of his engagement. He and National Security advisor Susan Rice, Secretary Kerry has been doing the same and they will continue to do so," she said.

"There are multiple opportunities to do that both in terms of bilateral engagements but also a number of multilateral venues. Yes, we will continue at the highest level of government to urge other governments to join us in what must be a very accelerated and expanded response."

Dr. Kenyon also said during the teleconference attended by Liberian journalists at the U.S Embassy that there are also other interventions that are at the research level at this stage with Z-Mapp being one of them. He said the drug a therapeutic of antibodies that helps to bind the virus so that it does not infect the body is very difficult to produce.

"When the outbreak began there were only five doses in the world. Those have all been used," he said.

"It takes a long time to produce the product and the bottom-line is we don't even know if it works. We don't know if it is helpful to the immune response, we don't know really what the outcomes are. Yes, some patients received it; some who received it died, some who received it survived, we really can't say whether it is effective. But I'm sure the research; once production can get up to where it needs to be will take place."

Dr. Kenyon said there is also a vaccine trial getting underway and the National Institute for Health is a key sponsor. He said experts are hoping the vaccine will prevent infections, but he said it would not impact the current outbreak.

"But we're only at the first phase; the first phase would be what's the right dosage and does it produce an antibody response; does it create any side effects that would be problematic in a larger trial," said Dr. Kenyon. "These studies are going to take time, they're not going to help us with this current outbreak, but we remain hopeful that these tools will become available in the not too distant future."

Kevin Whaley, CEO of Mapp Biopharmaceutical. Photo by Chris Jennewein



The company based in San Diego was awarded the federal contract Tuesday that is put at a worth of up to $42.3 million to develop its promising ZMapp drug for treating patients infected with the deadly Ebola virus.

The contract with the Department of Health and Human Services' Biomedical Advanced Research and Development Authority, or BARDA, supports the development and manufacturing of ZMapp with a goal of the Food and Drug Administration approval according to The Times of San Diego.

"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," said Dr. Nicole Lurie, assistant secretary for preparedness and response of the company told The San Diego Times in an interview after the news of the contract broke in the US.

"Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. Government, and today's agreement represent an important step forward." The Department of Defense and other federal agencies supported initial work on ZMapp. The drug seems to have helped in treating two Americans stricken with the disease in August in Liberia.

As part of the new contract, Mapp Biopharmaceutical will manufacture a small amount of the drug for early stage clinical safety studies and nonclinical studies needed to demonstrate the drug's safety and efficacy in people. The company will also focus on the manufacturing process, increasing production yields and the scale of manufacturing according to the San Diego Times.

ZMapp is a combination of three monoclonal antibodies manufactured in tobacco plants. Monoclonal antibodies bind certain virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient's immune system has to fight. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses. BARDA develops and procures medical countermeasures - vaccines, medicines, diagnostics and medical equipment - that address the public health and medical consequences of chemical, biological, radiological, and nuclear accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

Three Liberian Health workers were treated with the experimental drug, one died and the other two survived. Dr. Abraham Borbor, the Chief Medical Doctor then at the Liberia's biggest referral hospital died after receiving the drug after contracting the disease. But Kyndy Kobbah, a Physician Assistant at the C. H. Rennie Hospital in Kakata, Margibi County, who was near death after contracting the virus and a Congolese doctor Dr. Senga Omeonga were administered the drug and they survived afterwards.

Another American infected

The president of a missionary group working in Liberia said third American sickened with the Ebola virus decided to return to Liberia after the other two people became ill. SIM President Bruce Johnson said at a news conference Wednesday that Dr. Rick Sacra returned to Liberia about a month ago after another SIM doctor and a missionary became ill with Ebola the Associated Press is reporting. Both survived after treatment at Emory University in Atlanta.

Johnson says the 51-year-old Sacra lives in the Boston area. He says Sacra wasn't caring for Ebola patients, but was delivering babies in the SIM hospital's obstetrics unit. He says it's not known whether Sacra will return to the U.S. for treatment.

http://allafrica.com/stories/2014090517 ... ?viewall=1

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