(Source: Business Wire)

CombinatoRx, Incorporated (NASDAQ: CRXX) today reported financial
results for the third quarter ended September 30, 2009.
"With a number of recent positive product-related updates, including an
FDA Advisory Committee on Exalgo and its REMS program, Sanofi-Aventis'
acquisition of Prednisporin, a CombinatoRx-derived combination drug
candidate, through its pending acquisition of Fovea Pharmaceuticals, and
the presentation at ACR of positive 12-month knee osteoarthritis
clinical data for Synavive, we are well-positioned to create a
sustainable biotechnology company as we move toward the closing of our
proposed merger with Neuromed" commented Robert Forrester, Interim
President and CEO of CombinatoRx.
Recent Accomplishments and Business Update:
A meeting of CombinatoRx stockholders is scheduled for November 16,
2009 to vote on matters related to the proposed merger with Neuromed
Pharmaceuticals Inc. The merger seeks to create a sustainable
biotechnology company, bringing together the product assets and
financial resources of both organizations, including potential Exalgo
cash milestones and royalty revenue, and Neuromed's proven drug
development expertise, with the CombinatoRx portfolio of product
candidates and our unique drug discovery capabilities. The rights to
Exalgo were recently acquired by Mallinckrodt Inc., a subsidiary of
Covidien plc, for $15 million in upfront payments, additional
development funding of up to $16 million to cover internal and
external costs associated with Exalgo, an approval milestone of $30
million, which could potentially increase up to $40 million, and
tiered royalties on Exalgo net sales after any marketing approval by
the U.S. Food and Drug Administration.
On September 23, 2009, the FDA's Anesthetics and Life Support Advisory
Committee and its Drug Safety and Risk Management Advisory Committee
jointly discussed the new drug application, or NDA, submitted by
Neuromed for Exalgo seeking FDA approval for the management of
moderate to severe pain in opioid tolerant patients requiring
continuous, around the clock opioid analgesia for an extended period
of time. The joint advisory committee provided feedback to the FDA
with regard to the proposed Risk Evaluation Mitigation Strategy (REMS)
program for Exalgo. The FDA has assigned a PDUFA date of November 22,
2009 to complete its review of Exalgo.
A CombinatoRx-derived combination drug candidate, PrednisporinTM
(FOV1101), was recognized as a key asset by Sanofi-Aventis in its
pending acquisition of our collaborator, Fovea Pharmaceuticals. This
acquisition validates our business strategy of leveraging the
CombinatoRx discovery technology platform and products through
strategic alliances. Positive clinical results with Prednisporin in
subjects with persistent allergic conjunctivitis were recently
announced and based on this data; further advanced clinical trials for
Prednisporin both in the United States and in Europe are planned by
Fovea. CombinatoRx also recently enhanced its economic interest in
Prednisporin and the other product candidates licensed to Fovea for
ophthalmic development. Under the amended agreement, CombinatoRx will
be eligible to receive development and regulatory-based milestone
payments for Prednisporin of up to approximately $40 million and
increased tiered royalty payments of up to 12% of net sales.
SynaviveTM was shown to maintain efficacy levels throughout
a 12-month knee osteoarthritis (OA) extension trial. This data was
presented at the American College of Rheumatology (ACR) 2009 Annual
Meeting in Philadelphia on October 20, 2009 and further supports the
core study data, which was presented at EULAR in June 2009, in which
knee OA efficacy was observed early in treatment and sustained
throughout the three month core study in all WOMAC measurement
subscales including pain, stiffness and physical function. In addition
to maintaining efficacy for the Synavive treatment group, placebo
treated subjects in the core study also experienced statistically
significant improvement in all WOMAC measurement subscales upon
crossing over to Synavive in the extension trial. Importantly, no
treatment-related increases in glucocorticoid associated adverse
events were observed in the Synavive-treated subjects.
Third Quarter 2009 Financial Results (Unaudited):
As of September 30, 2009, CombinatoRx had cash, cash equivalents,
restricted cash and short-term investments of $22.2 million compared to
$30.6 million on June 30, 2009 and $43.7 million on December 31, 2008.
This decrease from June 30, 2009 is primarily due to $2.6 million in
restructuring costs and $1.8 million in professional fees associated
with our ongoing strategic realignment and proposed merger with Neuromed.
Total revenue was $2.7 million in the third quarter of 2009 compared to
$3.0 million reported in the third quarter of 2008.
Research and development expenses totaled $4.9 million in the third
quarter of 2009 compared to $13.8 million in the third quarter of 2008.
The decrease was due primarily to reduced clinical program costs related
to Synavive and CRx-401 as well as reduced compensation and benefit
costs as a result of our restructuring initiatives.
General and administrative expenses were $3.6 million in the third
quarter of 2009, compared to $3.8 million in the third quarter of 2008.
The $0.2 million decrease was primarily due to a decrease in overall
general and administrative expenses related to our fourth quarter 2008
and third quarter 2009 restructurings, offset by an increase in
professional fees and consulting expenses associated with our proposed
merger with Neuromed.
Net loss for the quarter ended September 30, 2009 was $8.3 million, or
$0.24 per share, as compared to a net loss of $15.6 million, or $0.45
per share, in the third quarter of 2008 which included a loss from
discontinued operations of $1.2 million. Stock-based compensation
expense was approximately $0.6 million in the third quarter of 2009, as
compared to $1.5 million in the third quarter of 2008.
Financial Implications of Restructurings:
CombinatoRx announced a restructuring initiative in November 2008 to
focus on its core drug discovery strengths by reducing its workforce and
scope of activities. On July 1, 2009, in connection with the entry into
the Agreement and Plan of Merger with Neuromed, CombinatoRx committed to
an additional restructuring plan that resulted in a reduction of an
additional 36% of its workforce. As a result of the July 2009
restructuring plan, CombinatoRx recorded a restructuring charge of
approximately $2.6 million in the quarter ended September 30, 2009,
primarily representing cash payments for severance and other
personnel-related expenses. As a result, CombinatoRx is reducing its
ongoing operating cash expenditures to provide financial viability and
strategic flexibility with current cash reserves without equity
financing to fund its planned operations into 2012.
About CombinatoRx:
CombinatoRx, Incorporated (CRXX) is pioneering the new field of
synergistic combination pharmaceuticals. Going beyond traditional
combinations, CombinatoRx creates product candidates with novel
mechanisms of action, striking at the biological complexities of human
disease. The CombinatoRx proprietary drug discovery technology provides
a renewable and previously untapped source of novel drug candidates. The
Company was founded in 2000 and is located in Cambridge, Massachusetts.
To learn more about CombinatoRx, please visit www.combinatorx.com.
Forward-Looking Statement:
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
concerning CombinatoRx, its planned merger with Neuromed, Neuromed's
product candidate Exalgo and its potential for FDA approval and the
ability to generate future revenues for the combined company, Neuromed's
agreement with Mallinckrodt, the CombinatoRx drug discovery technology,
Fovea's product candidate Prednisporin, its clinical potential and the
amended agreement with Fovea, the potential of the CombinatoRx product
candidate Synavive, CombinatoRx's financial condition, results of
operations, projected expenses, cash positions and business plans.