MOUNTAIN VIEW, Calif., March 2 /PRNewswire/ -- Aviron (Nasdaq: AVIR)
today announced that Louis F. Mocca has been named Vice President, Regulatory
Affairs. He will report to J. Leighton Read, MD, Chairman and CEO. In his
new role, Mr. Mocca will be responsible for all regulatory activities,
including the supervision of regulatory interaction with the U.S. Food and
Drug Administration for all of Aviron's potential products. Initially,
Mr. Mocca will focus on regulatory activities related to FluMist(TM), Aviron's
investigational intranasal influenza vaccine for which Aviron plans to submit
a Biologic License Application in the summer or fall of 1999.
Mr. Mocca joins Aviron from North American Vaccine, Inc., where he most
recently served as Senior Director, Regulatory Affairs. In this role, he was
responsible for the implementation of all regulatory affairs programs,
including CMC (Chemistry, Manufacturing and Controls), clinical and regulatory
operations. He has also served as Director, Worldwide Regulatory Affairs at
Bristol-Myers Squibb.
Prior to joining Bristol-Myers Squibb, Mr. Mocca served as a researcher
and reviewer at the FDA Center for Biologics Evaluation and Research for
twenty years. His responsibilities included review of license applications
for investigational vaccines being considered for approval, including
Poliovirus, Hepatitis B, Diphtheria, Tetanus and Acellular Pertussis and
Haemophilus b. While at FDA, he reviewed manufacturing and clinical data from
hundreds of Investigational New Drug applications, and he was actively
involved in the inspections of pharmaceutical firms to determine maintenance
of Good Manufacturing Practice.
Mr. Mocca earned a bachelors degree in Epidemiology and Environmental
Health in 1972, and a masters degree in Medical Mycology (Microbiology) in
1976, both from George Washington University.
"Mr. Mocca's extensive experience in all aspects of the regulatory
process, as well as his long track record in both the vaccine industry and at
FDA, are important to Aviron's success, especially as Aviron proceeds towards
commercialization of FluMist(TM), and as other vaccine candidates in our
pipeline advance through the clinic," Dr. Read said. "We welcome him to the
Aviron team."
Aviron is a biopharmaceutical company based in Mountain View, Calif.
focused on prevention of disease. The company's goal is to develop products
which offer cost-effective prevention of a wide range of infections that
affect the general population. The majority of Aviron's products under
development are live vaccines against viral infections. These include
intranasal vaccines under development for respiratory infections and their
complications -- influenza, parainfluenza (PIV-3), and respiratory syncytial
virus (RSV), and injectable vaccines to prevent cytomegalovirus (CMV) and
genital herpes (HSV-2). Aviron is also developing, in collaboration with
SmithKline Beecham Biologicals, a subunit vaccine against Epstein-Barr Virus
(EBV) infection, a major cause of infectious mononucleosis.
This press release contains forward-looking statements. Actual results
may differ materially from those suggested here. Factors that could cause
actual results to differ include, but are not limited to, failure in a
clinical trial, failure to demonstrate stability or to validate equipment or
the manufacturing process. Risk factors also include the assessment by the
regulatory agencies that the company's future license applications for its
intranasal influenza vaccine are incomplete or inadequate to approve the
product for marketing to one or more target populations. Additional
information concerning factors that could cause such a difference is contained
in Aviron's Annual Report on Form 10-K for the year ended December 31, 1997.
To receive an index and copies of recent press releases, call Aviron's
News-On-Call toll-free fax service, 800-758-5804, extension 114000.
Additional information about the company can be located at
http://www.aviron.com.
SOURCE Aviron
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http://www.aviron.com
Company News On-Call:
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CONTACT:
investors, Lyn Christenson, 650-919-3716, or
media, Karen Gilbert, 650-919-6578, both of Aviron; or John
Bluth, 415-356-1000, or Louise Leavitt, 212-453-2000, both of
Fleishman-Hillard, for Aviron
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