Is Mapp BioPharma Winning The Race To Combat Ebola? Five pharmaceutical companies are competing for FDA approval, of a cure for the deadly Ebola epidemic spreading in West Africa. Bidness Etc explores which company is ahead in the competition
Mapp Biopharmaceuticals Inc., Tekmira Pharmaceuticals Inc. (TKMR), Sarepta Therapeutics Inc. (SRPT), Fujifilm Holdings Corp. (ADR) (FUJIY), and BioCryst Pharmaceuticals Inc. (BCRX) are the major players that have been identified as most prominent inthe race for developing a cure for the Ebolaepidemic. Bidness Etc gives a breakdown of where each company stands right now.
Tekmira Pharmaceuticals: TKM-Ebola
TKM-Ebola, also called anti-Ebola viral RNAi Therapeutic, resulted in 100% protection from the Zaire species of Ebola in animals, according to results from Tekmira’s pre-clinical studies conducted earlier. In 2010, Tekmira entered a $140 million contract with the US Department of Defense (DOD) to develop a cure for Ebola. Phase 1 trials for TKM-Ebola began in January, and Tekmira was given a fast-track designation for the development of TKM-Ebola in March. In July, US regulatory bodies placed a ‘full hold’ on TKM-Ebola due to safety concerns. However, the FDA changed the status to ‘partial hold’ because of mounting pressure to rush the approval process for an Ebola cure.
Tekmira stock has soared 207% so far this year, with one of the main reasons for the hike being the change of the regulatory status for its potential cure for Ebola.
Mapp Biopharmaceuticals: ZMapp
San Diego-based and privately held, Mapp Biopharmaceuticals is still planning Phase 1 trials of the drug ZMapp, and has not commenced them yet. However, the drug has worked on two American health workers who contracted the disease while in Africa, and their condition has improved, according to their relatives. However, since ZMapp has not gone through standard trials and tests, it has led to an ethical dilemma in the international health community.
Mapp reported a shortage of the drug after it was shipped to two unidentified West African nations. Since Ebola-affected countries like Liberia are still demanding ZMapp, Mapp Biopharmaceuticals has asked for financial assistance from the US government, to increase production.
NIH's National Institute of Allergy and Infectious Diseases (NIAID), the Department of Defense's Defense Threat Reduction Agency (DTRA), and the HHS' Biomedical Advanced Research and Development Authority (BARDA) are all supporting the development of ZMapp.
Sarepta Therapeutics: AVI-7537
Sarepta’s AVI-7537 is said to have a cure rate of 60-80%, after being tested on monkeys and healthy human individuals (to monitor safety). Nevertheless, it has not been tested on Ebola patients.
Sarepta says it has enough supply of AVI-7537 to treat about 100 Ebola infected patients in the span of a few months. Considering the ‘partial hold’ on TKM-Ebola and the limited supply of ZMapp, Sarepta’s drug could potentially fill the demand-supply gap.
The company has requested US regulators to allow the use of its untested drug in West Africa. In 2010, The DOD provided Sarepta $291 million for the development of a cure for Ebola and the Marburg virus, but due to federal budget constraints the funding was pulled back in 2012.
Fujifilm Holdings Corp.: Favipiravir
Fujifilm Holding Corp.’s US partner, MediVector Inc., is in talks with the FDA regarding approval of Favipiravir. The drug has a comparative advantage because it was previously used as a cure for influenza, in human trials. Also, Favipiravir is a pill, unlike ZMapp, which makes it easier to administer in a place like Africa where health care is not fully developed.
BioCryst Pharmaceuticals Inc: BCX4430
BioCryst’s BCX4430 works by inhibiting virus replication but has still not gone through Phase 1 trials. In September last year, the company entered a contract worth $22 million with the National Institute of Allergy and Infectious Diseases (NIAID) to develop BCX4430, that assisted BioCryst in pre-clinical trials.
Even though the company has been silent about their status of its potential cure for Ebola, its stock has gained about 11% in the past month.
The Winner: ZMapp
Tekmira seemed to have an edge over all other companies, at least until the end of last week. Tekmira stock was soaring after the FDA changed its status on TKM-Ebola. However, Mapp suddenly seems to be the drug of choice , based on the announcement that the demand for ZMapp is increasing, and the US government is expected to help increase ZMapp production.
Tekmira stock soared by about 80% in the past five days, but the wind seems to have gone out of its sails for now, and it is down about 3.5% during pre-market trading, as of 7:37 am EDT.
International Impact
Medical experts have issued a warning that the Ebola outbreak might travel outside of West Africa, putting the international community at unrest.
Hong Kong, US and Canada have already reported that they are taking measures to isolate those individuals who are traveling to and from Africa. Saudi Arabia and The Ivory Coast have banned passenger flights from Guinea, Liberia and Sierra Leone- the centers of the deadly outbreak.
Meanwhile, China has sent aid worth $4.9 million, and medical teams to Liberia, Sierra Leone and Guinea to fight off this epidemic.
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