Peregrine Pharmaceuticals Appoints Former Genentech Senior Executive Dr. Robert Garnick as Head of Regulatory Affairs
October 19 2009 - 9:30AM
PR Newswire (US)
- During a 24-Year Career at Genentech, Dr. Garnick was Responsible
for the Approval of 17 Products Including Rituxan(R), Herceptin(R),
Avastin(R) and Lucentis(R) - - Dr. Garnick to Direct Regulatory
Operations, Strategy and Commercial Development Planning as
Peregrine Advances its Oncology and Infectious Disease Clinical
Programs - TUSTIN, Calif., Oct. 19 /PRNewswire-FirstCall/ --
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHMD) today announced that
Dr. Robert Garnick has joined the company as the head of regulatory
affairs. Dr. Garnick was formerly the senior vice president of
regulatory, quality and compliance at Genentech. During his 24-year
career at Genentech, he was responsible for 17 new product
approvals including most of the company's top selling monoclonal
antibody therapeutics such as Rituxan®, Herceptin®, Avastin® and
Lucentis®. Dr. Garnick will be responsible for overseeing
Peregrine's interactions with the U.S. FDA and regulatory agencies
around the world, and will lead the development of the company's
regulatory strategies for advancing its novel monoclonal
antibody-based treatments for cancer and infectious diseases. "Rob
has an unparalleled track record in the biotechnology and
pharmaceutical industry, having led the regulatory, quality and
compliance strategy for developing many of the most successful
monoclonal antibody therapeutics currently on the market
representing multiple disease areas," said Steven W. King,
president and CEO of Peregrine. "His profound understanding of
every aspect of the regulatory process and how it impacts clinical
design and drug development is already proving invaluable as we
prepare for the next stage of clinical development for our
innovative drug candidates bavituximab and Cotara®. We have made
considerable progress over the past few years in our clinical
programs and bringing Rob's expertise and experience on board at
this critical time is a significant development for the company."
Dr. Garnick has over 30 years of experience in drug and biologic
pharmaceutical development, including 24 years at Genentech helping
to build the biotechnology industry. Dr. Garnick joined Genentech
in 1984 and after a series of promotions, he became vice president
of quality in 1994 and was later promoted to senior vice president
of regulatory, quality and compliance in 2001. In this role, Dr.
Garnick was responsible for all the regulated aspects of
Genentech's business including drug development, commercial
production and promotional and labeling compliance. After leaving
Genentech in 2008, Dr. Garnick founded Lone Mountain Biotechnology
and Medical Devices Inc., a successful company specializing in drug
and device consulting where he remains as president and CEO.
"Peregrine's bavituximab and Cotara products represent the kind of
innovation that made my drug development work so exciting and
fulfilling at Genentech," said Dr. Garnick. "Peregrine's
PS-targeting antibodies such as bavituximab represent an entirely
new mechanism that has already shown considerable promise for the
treatment of cancer and infectious diseases, while Cotara has shown
promising survival benefits in patients suffering from the worst
form of brain cancer. I welcome the opportunity to work with the
Peregrine team to help advance these promising candidates through
the clinical and regulatory process." Dr. Garnick has also been
extensively involved with the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH), a project that brings together
regulatory authorities and pharmaceutical industry experts from
Europe, Japan and the U.S. to discuss scientific and technical
aspects of product registration from a global perspective. He has
extensive experience in analytical methodology, process validation,
and the regulatory review process in the U.S. and Europe. Dr.
Garnick has authored numerous scientific papers and is a frequent
keynote speaker at pharmaceutical Industry conferences and events.
Joseph Shan, vice president of clinical and regulatory affairs at
Peregrine added, "Rob is a welcome addition to the team at
Peregrine, joining at an opportune time as we have just recently
completed enrollment in all three of our ongoing bavituximab Phase
II cancer trials, as well as a bavituximab Phase I cancer trial. He
brings a tremendous amount of enthusiasm and experience across many
different areas that will be very valuable as we continue to
advance our clinical and preclinical programs." About Peregrine
Pharmaceuticals Peregrine Pharmaceuticals, Inc. is a
biopharmaceutical company with a portfolio of innovative product
candidates in clinical trials for the treatment of cancer and
serious virus infections. The company is pursuing three separate
clinical programs in cancer and HCV infection with its lead product
candidates bavituximab and Cotara®. Peregrine also has in-house
manufacturing capabilities through its wholly owned subsidiary Avid
Bioservices, Inc. (http://www.avidbio.com/), which provides
development and bio-manufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be
found at http://www.peregrineinc.com/. Safe Harbor Statement:
Statements in this press release which are not purely historical,
including statements regarding Peregrine Pharmaceuticals'
intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. It is important to note that the company's
actual results could differ materially from those in any such
forward-looking statements. Factors that could cause actual results
to differ materially include, but are not limited to, uncertainties
associated with completing preclinical and clinical trials for our
technologies; the early stage of product development; the
significant costs to develop our products as all of our products
are currently in development, preclinical studies or clinical
trials; obtaining additional financing to support our operations
and the development of our products; obtaining regulatory approval
for our technologies; anticipated timing of regulatory filings and
the potential success in gaining regulatory approval and complying
with governmental regulations applicable to our business. Our
business could be affected by a number of other factors, including
the risk factors listed from time to time in the company's SEC
reports including, but not limited to, the annual report on Form
10-K for the year ended April 30, 2009 and the quarterly report on
Form 10-Q for the quarter ended July 31, 2009. The company cautions
investors not to place undue reliance on the forward-looking
statements contained in this press release. Peregrine
Pharmaceuticals, Inc. disclaims any obligation, and does not
undertake to update or revise any forward-looking statements in
this press release Contacts: GendeLLindheim BioCom Partners
Investors Media Barbara Lindheim (800) 987-8256 (212) 918-4650
DATASOURCE: Peregrine Pharmaceuticals, Inc. CONTACT: Investors,
GendeLLindheim BioCom Partners, 1-800-987-8256, , or Barbara
Lindheim, +1-212-918-4650 Web Site: http://www.peregrineinc.com/
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