Avigen, Inc. (Nasdaq:AVGN), Alameda, Calif., a biopharmaceutical
company innovating therapeutics for neurological care, has reported
financial results for its second quarter ended June 30, 2008. At June
30, 2008, Avigen had approximately $65 million in financial assets,
including cash, cash equivalents, and available-for-sale securities and
restricted investments, compared with approximately $78 million at
December 31, 2007.
"This quarter we made significant progress toward achieving
our major goal for 2008 -- to report data from our ongoing AV650 Phase
II trial in patients with spasticity associated with multiple
sclerosis," stated Kenneth Chahine, Ph.D., J.D., Avigen's
president and CEO. "We completed enrollment of the planned 150
patients in the trial and remain on track to report top-line data in the
fourth quarter. Looking ahead, our focus remains on having a successful
end-of-Phase II interaction with the FDA in early 2009 and subsequently
initiating our Phase III registration trials.
"Earlier this week, Avigen sponsored a panel of medical
experts who reviewed data from a recent patient survey on spasticity
management. The panel discussion underscored the significant
dissatisfaction of spasticity patients with the quality of current
therapies, particularly due to undesirable side effects like fatigue,
drowsiness and muscle weakness. Noting that approximately 60% of survey
respondents did not feel the various therapies available to them
effectively managed their symptoms, the panel expressed the view that
the spasticity market is likely much larger than current estimates due
to a lack of patient education and the under use of current therapies.
Based on expert feedback like this, we remain optimistic that
AV650's attractive safety profile will offer a significantly better
option for spasticity patients than current therapies, and that with our
patent strategy, the extended exclusivity potential through 2027 gives
Avigen a considerable opportunity to create value for its shareholders
with this product."
Avigen Highlights
* Completed enrollment and randomization of subjects for AV650
Phase II trial in patients with spasticity associated with multiple
sclerosis and expect to report data before year-end 2008
* Disclosed composition-of-mater patents for a purer form of AV650
that complies with the FDA's standard for impurities in chronically
used medicines in the United States (as reported April 30, 2008)
* Expanded agreement with Sanochemia for the development of this
proprietary, purer form of AV650 (as reported July 23, 2008)
* Sponsored a spasticity expert panel live webcast on July 28th,
highlighting the need for a non-sedating treatment for spasticity and
recognizing the potential increase of the market (archived at
www.avigen.com)
* Sponsored a patient survey conducted by WE MOVE on
"Spasticity Management: The Patient's Perspective," which
illustrates the limitations of current therapies and patient interest in
non-sedating treatment
* Completed an AV411 Phase I maximum tolerated dose study, showing
AV411 to be safe and well tolerated at single oral doses of up to 100mg.
Notably, this is three to five times the approved daily dose in Japan
for treatments such as asthma
Financial Results
Avigen reported a net loss of $7.3 million, or $0.25 per share, for
the quarter ended June 30, 2008, compared to a net loss of $5.8 million,
or $0.21 per share, for the quarter ended June 30, 2007. For the six
months ended June 30, 2008 and 2007, Avigen reported a net loss of $14.8
million, or $0.50 per share, and $11.6 million, or $0.44 per share,
respectively.
Second Quarter Results
Research and development expenses for the quarters ended June 30,
2008 and 2007 were $5.9 million and $4.8 million, respectively. Research
and development expenses in the second quarter of 2008 included
approximately $2.6 million in external costs associated with our
clinical trials, primarily related to the two Phase II trials for AV650,
and $1.2 million in external costs for ongoing preclinical activities
across all our programs.
General and administrative expenses for the quarters ended June 30,
2008 and 2007 were $2.3 million and $2.1 million, respectively, and
continue to reflect management's focus on controlling overhead
costs and directing more resources toward research and development
activities.
Net interest income and other expenses were $703,000 and $907,000
for the three-month periods ended June 30, 2008 and 2007, respectively.
This decrease primarily reflects the general decline in market interest
rates that have led to a lower average yield earned on the portfolio in
the 2008 period.
Six-Month Results
Research and development expenses for the six months ended June 30,
2008 and 2007 were $12.2 million and $9.2 million, respectively. During
the first six months of 2008, research and development expenses included
approximately $5.3 million in external costs associated with our
clinical trials and approximately $2.3 million in external costs
associated with ongoing preclinical activities.
General and administrative expenses for the six months ended June
30, 2008 and 2007 were $4.6 million and $4.3 million, respectively.
Net interest income and other expenses for the six months ended
June 30, 2008 and 2007 were $1.5 million and $1.6 million, respectively.
Avigen's operating expenses for the first half of 2008 are in
line with management's expectations. Included in its previous cash
burn projections, in July 2008, Avigen amended its agreement with
Sanochemia to share incremental costs associated with developing a
proprietary, purer form of AV650. Under the terms of the amendment,
Avigen will pay Sanochemia up to $5 million in additional
milestone-based payments, with $2.5 million expected to be paid in the
third-quarter of 2008 and the remainder expected to be paid in the
second half of 2009.
Consistent with previous guidance, management expects the
company's quarterly cash burn to increase from its current level,
primarily to support the needs of the AV650 program as it moves forward
toward pivotal trials, and believes the company's current financial
resources will be able to fund its planned operating expenses for
approximately two years. The company is still on track to end 2008 with
between $40 to $45 million in cash and securities.
About Avigen
Avigen is a biopharmaceutical company focused on developing and
commercializing small molecule therapeutics to treat serious
neurological disorders, including neuropathic pain and neuromuscular
spasm and spasticity. Avigen's strategy is to complete the
requirements of clinical development for each of the candidates in its
product pipeline, and continue to look for opportunities to expand its
pipeline through a combination of internal research, acquisitions, and
in-licensing, with the goal of becoming a fully integrated commercial
biopharmaceutical company that remains committed to its neurology
products. Avigen is currently developing AV650 for spasticity and
neuromuscular spasm and AV411 for neuropathic pain. Additionally, the
company is advancing AV513, a novel therapy for the treatment of
multiple bleeding disorders, including hemophilia A and B, toward
clinical trials.
For more information,visit http://www.avigen.com or call
510/748-7372.
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