Accera, Inc. Appoints Dr. Thomas Werner President & CEO and Announces FDA Acceptance of IND Application for AC-1204 for Mild-to-Moderate Alzheimer's Disease

By Accera Inc., PRNE
Monday, October 4, 2010

BROOMFIELD, Colorado, October 5, 2010 - Accera, Inc., a medical research and development company delivering
breakthrough therapies for serious diseases such as Alzheimer's disease (AD),
announced today that Thomas Werner, Ph.D., has been appointed President and
CEO. Concurrently with Dr. Werner's appointment, the U.S. Food and Drug
Administration (FDA) has accepted Accera's Investigational New Drug (IND)
application to conduct a phase 2-3 clinical study in patients with
mild-to-moderate AD with its product AC-1204.

Dr. Werner was elected to Accera's board of directors in March 2009.
Prior to his election, he was the managing director and senior vice president
of GlaxoSmithKline (GSK) in Germany and had served as CEO of the GSK
Foundation until early 2009. Dr. Werner was instrumental in the development
of successful growth strategies for the German subsidiaries of GSK and
Bristol-Myers Squibb. Under his leadership, the ACE inhibitor Captopril
became the largest selling pharmaceutical product in Germany, and the asthma
drug Viani(TM) grew to become one of the leading pharmaceutical products in
Germany.

Dr. Werner cofounded the Genetic Research Center, a joint venture with
the Max Planck Institute for Psychiatry and the Ludwig-Maximilians-University
, both in Munich. Dr. Werner earned his Ph.D. in chemistry at the University
of Gottingen in Germany.

"We are delighted to appoint Dr. Werner as Accera's president and CEO,"
said Claude H. Nash, Ph.D., Chairman of Accera's Board of Directors. "As
Accera continues expanding its commercialization efforts for Axona(R) and
initiates clinical trials with AC-1204, Dr. Werner's leadership will maximize
Accera's development of therapeutic alternatives for Alzheimer's disease."

Based in part on available clinical data associated with Axona/AC-1202,
Accera will forego conducting the traditional phase 1 dose-escalation trial
of AC-1204 and proceed directly to a phase 2-3 study. Referred to as the
ALERT Protocol (AC-1204 Long-Term Efficacy Response Trial), the planned trial
will be a six month, double-blind, randomized, placebo-controlled,
parallel-group study to investigate the effects of daily administration of
AC-1204 in subjects with mild to moderate AD. Approximately 400 study
subjects are anticipated to enroll in as many as 30 clinical sites within the
U.S. The efficacy of AC-1204 versus placebo will be measured by two primary
outcomes: changes from baseline test scores in the Alzheimer's Disease
Assessment Scale - Cognitive subscale (ADAS-Cog) and the Clinician's
Interview-Based Impression of Change Plus (CIBIC-plus). These tests have been
established as validated measurements of efficacy accepted by FDA for
approval of other medications for AD.

Accera has completed four clinical trials with similar compounds in
elderly normal volunteers and in patients with memory impairment or
mild-to-moderate AD. In these trials, patients with mild-to-moderate AD
receiving Axona (AC-1202) for up to 90 days experienced cognitive improvement
compared with placebo. These treatment effects were notably significant among
patients who were not carriers of the apolipoprotein E4 allele (APOE4), a
genetic risk factor associated with a higher probability of developing AD.
Approximately 50% of individuals diagnosed with probable AD are estimated to
be APOE4 positive. Peer-reviewed results were published in Nutrition &
Metabolism in August 2009 in the article entitled "Study of the ketogenic
agent AC-1202 in mild to moderate Alzheimer's disease: a randomized,
double-blind, placebo-controlled, multicenter trial." Axona (AC-1202) is
currently commercially available in the U.S. as a prescription medical food
product.

Like Axona, AC-1204 increases production of ketone bodies, which can
serve as an alternative fuel for the brain in AD patients suffering from
glucose hypometabolism. Numerous studies have shown that an early feature of
AD is region-specific declines in cerebral glucose metabolism. One strategy
to treat this condition has been to supplement the brain's normal glucose
supply with ketone bodies.

"Accera is in a period of significant growth in both the
commercialization of Axona and development of clinical trials with AC-1204. I
look forward to leading the Company in both efforts," said Dr. Werner. "The
IND acceptance for AC-1204 represents a further validation of Accera's
methods, research and commitment to advancing novel therapeutic alternatives
for Alzheimer's disease. We expect the ALERT study will further demonstrate
the long-term benefits of Accera's approach to Alzheimer's."

About AC-1204

AC-1204 targets the metabolic deficiencies and imbalances associated with
Alzheimer's disease by providing ketone bodies as an alternative energy
source for brain cells that have defective glucose metabolism. This approach
has been shown to safely improve cognitive function and memory in AD patients
and in pre-clinical animal models of dementia.

About Axona(R)

Axona is a prescription-only medical food intended for the clinical
dietary management of the metabolic processes associated with
mild-to-moderate Alzheimer's disease. For more information, visit
www.about-axona.com

About Accera, Inc.

Accera, Inc. is a privately held commercial-stage biotechnology company
that developed and now markets Axona in the U.S. Accera is engaged in the
research, development and commercialization of other clinical applications
for Axona and AC-1204 in acute and chronic neurodegenerative diseases. For
more information about Accera, please visit www.accerapharma.com.

    Company contact:
    Accera, Inc.
    +1-303-999-3705
    Bill Poncy
    VP Commercial Development
    bponcy@accerapharma.com

    Media Contacts:
    Tiberend Strategic Advisors, Inc.
    +1-212-827-0020
    Andrew Mielach
    amielach@tiberendstrategicadvisors.com
    or
    Madeleine Desmond
    mdesmond@tiberendstrategicadvisors.com

Company, Bill Poncy, VP Commercial Development of Accera, Inc., +1-303-999-3705, bponcy at accerapharma.com, or Media, Andrew Mielach, +1-212-827-0020, amielach at tiberendstrategicadvisors.com, or Madeleine Desmond, mdesmond at tiberendstrategicadvisors.com, both of Tiberend Strategic Advisors, Inc., for Accera, Inc.

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