Aegis Awarded 2nd Patent for Monoclonal Antibody Formulations that Avoid Oxidative Damage Due to Polysorbate Surfactants
SAN DIEGO, CA October 7, 2014/MarketWire-- Aegis Therapeutics LLC announced today that it has been awarded U.S. Patent No. 8,846,044, dramatically broadening its patent franchise to cover all useful alkylsaccharides for stabilizing any or all monoclonal antibody biotherapeutics. The Aegis ProTek® excipients provide reduced immunogenicity while avoiding the oxidative damage caused by contaminating peroxides and reactive aldehydes intrinsic to the polysorbates such as Tween®-20 and 80, a commonly used polysorbate surfactants found in nearly all monoclonal antibody therapeutics. Oxidative damage that can result in protein aggregation and neutralizing antibodies that block drug action is a growing concern throughout the pharma industry and governmental regulatory bodies. The FDA recently issued a “Guidance for Industry” document titled: “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product” highlighting its concerns about immunogenicity in biotherapeutics.
From SCRIP Intelligence: Ebola crisis worsens; caution urged on experimental interventions
Only 30% of people being struck with Ebola are surviving the disease in the current outbreak – meaning the death rate is now at about 70%, said Dr Bruce Aylward, assistant director-general in charge of the operational response at the World Health Organization (WHO).
The virus has now claimed the lives of nearly 4,500 people – including a United Nations worker who died at a German hospital on 14 October – with infections at about 8,900, he said, adding WHO expects the number of cases to surpass 9,000 within the next few days.
Worse, Dr Aylward said, is that if nothing changes over the next 60 days in the response for Ebola, such as additional healthcare workers and medical supplies and equipment, WHO has estimated that between 5,000 to 10,000 people per week could become infected by early December with the virus, which currently is striking about 1,000 people per week.
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From SCRIP INtelligent: Nurse gets Ebola survivor plasma; ZMapp maker ups efforts
In light of the urgent need for medicines to treat Ebola – which has killed more than 4,000 people, infecting about 8,400 – Mapp Biopharmaceutical has stepped up its efforts to produce more ZMapp, focusing on improving the expression of the antibodies in Nicotiana, the plant in which the drug is manufactured, said Larry Zeitlin, the company's president.
ZMapp, a monoclonal antibody cocktail, was used in seven Ebola patients, including survivors Dr Kent Brantly, Nancy Writebol and William Pooley, under compassionate use. But supplies of the product were quickly exhausted (scripintelligence.com, 24 August 2014, 07 August 2014, 05 August 2014).
So Mapp has been struggling to quickly make more of the drug – a medicine Dr Brantly has insisted contributed to saving his life (scripintelligence.com, 22 August 2014).
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Otonomy Appoints Anthony J. Yost Chief Commercial Officer
SAN DIEGO, Oct. 21, 2014 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the appointment of Anthony J. Yost as chief commercial officer. Mr. Yost brings 30 years of experience in pharmaceutical product sales and marketing that includes building and managing commercial teams at multiple companies.
"The addition of Tony to the Otonomy team is an important step in the establishment of our commercial organization as we prepare for the regulatory filing of the New Drug Application for AuriPro™ with the FDA in the first half of 2015," said David A. Weber, Ph.D., president and CEO of Otonomy. "Tony's expertise in building high-performance commercial teams, and his broad pharmaceutical sales and marketing experience, including products sold in the hospital setting, as well as physician-administered drugs, make him well-suited to lead the commercialization efforts for AuriPro and Otonomy's other product candidates."