La Jolla Pharmaceutical Company (OTCBB: LJPC) (the "Company” and "La
Jolla”) today announced that it has acquired global development and
commercialization rights to GCS-100, a novel therapeutic, from privately
held Solana Therapeutics, Inc. ("Solana”). GCS-100 is a first-in-class
inhibitor of galectin-3, a novel molecular target implicated in cancer
and chronic organ failure.
In connection with the acquisition, George F. Tidmarsh, M.D., Ph.D., the
former Chief Executive Officer of Solana, was appointed as the Company’s
President and Chief Executive Officer. "Having been involved in the
clinical development of GCS-100 over the past several years, I am
thrilled to have the opportunity to continue this compound’s development
in the context of La Jolla,” commented Dr. Tidmarsh. "Targeting
galectin-3 holds great promise in the treatment of a broad range of
life-threatening conditions, and, with GCS-100, we have the most
advanced galectin-3-targeting compound in development."
Galectin-3 plays a key role in the immune system’s response to cancer
and tissue injury, making specific inhibitors of galectin-3 attractive
therapeutic candidates for a wide range of life-threatening diseases,
including cancer, heart failure, kidney disease, pulmonary fibrosis and
liver fibrosis. For example, encouraging work conducted by investigators
at the Ludwig Cancer Institute has shown that galectin-3 inhibits the
activity of cancer-killing T-cells, and that pharmacologically blocking
galectin-3 with GCS-100 reactivates these T-cells.
In addition, a number of independent, academic studies have concluded
that galectin-3 is a mediator of fibrosis (scar formation) after heart,
kidney, lung and liver injury. These include studies conducted by
investigators at leading institutions such as Massachusetts General
Hospital and The Cleveland Clinic demonstrating that elevated galectin-3
levels in blood following myocardial infarction (heart attack) represent
a powerful predictor of adverse clinical outcomes for patients.
GCS-100’s ongoing development as an anti-cancer and anti-fibrotic agent
is supported by extensive preclinical and clinical investigation,
including Phase 1 and Phase 2 clinical trials involving more than 140
patients. Experimental results to date indicate that GCS-100:
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Specifically inhibits galectin-3 in immune cells isolated from
patients;
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Confers anti-cancer activity in patients with several tumor types;
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Exhibits effects on the immune system in patients consistent with
its galectin-3 inhibitory mechanism; and
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Is safe and well tolerated at doses that confer clinical activity.
Dr. Tidmarsh's 22 years of experience in biotechnology include the
successful clinical development of three FDA-approved drugs. Up until
his appointment to La Jolla, Dr. Tidmarsh served as the Chief Executive
Officer of Solana Therapeutics, Inc. Previously, he served as the Chief
Executive Officer of Horizon Pharma, Inc. (NASDAQ: HZNP), a company he
founded in 2005. While at Horizon, he led all aspects of development of
Duexa, which was recently approved by the FDA for the treatment of
rheumatoid arthritis. He also founded Threshold Pharmaceuticals, Inc.
(NASDAQ: THLD) and held senior positions at Coulter Pharmaceutical, Inc.
[acquired by GlaxoSmithKline (NYSE: GSK)] and SEQUUS Pharmaceuticals,
Inc. [acquired by Johnson & Johnson (NYSE: JNJ)]. While at Coulter and
SEQUUS, Dr. Tidmarsh led the clinical development of BEXXAR and Doxil,
respectively, two FDA-approved anti-cancer agents. Dr. Tidmarsh received
his M.D. and Ph.D. from Stanford University, where he also completed
fellowship training in Pediatric Oncology and Neonatology and remains a
Consulting Professor of Pediatrics and Neonatology.
In connection with this acquisition, Saiid Zarrabian was appointed as an
independent director of the Company. Mr. Zarrabian has broad operational
experience in the biotechnology and life sciences tools industries. He
currently serves as President and Chief Executive Officer of Cyntellect,
Inc., a life sciences instrumentation provider. Previously, Mr.
Zarrabian was President and Chief Operating Officer of Senomyx, Inc.
(NASDAQ: SNMX), a biotechnology company that develops novel flavor
ingredients. Prior to Senomyx, he was Chief Operating Officer of
Pharmacopeia, Inc., a drug discovery company that was acquired by Ligand
Pharmaceuticals, Inc. (NASDAQ: LGND), and President of Pharmacopeia’s
MSI division, a leading scientific enterprise R&D software provider that
is now part of Accelrys, Inc. (NASDAQ: ACCL). Mr. Zarrabian has served
as a director of two biopharmaceutical companies: Ambit Biosciences
Corporation and Penwest Pharmaceuticals Co. [acquired by Endo
Pharmaceuticals (NASDAQ: ENDP)].
Also in connection with the acquisition, the former members of the
management team, Deirdre Y. Gillespie, M.D., President and Chief
Executive Officer, and Gail A. Sloan, CPA, Chief Financial Officer, and
the former members of the Board of Directors, Robert A. Fildes, Ph.D.,
Chairman, Bertrand C. Liang, M.D., Ph.D., and Deirdre Y. Gillespie,
M.D., have resigned.
The holders of the Company’s preferred stock entered into a consent and
amendment agreement with the Company, whereby such holders approved the
strategic transaction to acquire GCS-100, and certain terms of the
preferred stock were amended. Additionally, the Company will effect a
reverse split of its outstanding common stock, after which the
conversion price for the Company’s preferred stock may be subject to
adjustment. More information regarding the preferred stock consent and
amendment agreement, the reverse stock split, the acquisition of
GCS-100, and changes to the Company’s leadership are provided in a
Current Report on Form 8-K that the Company will file with the
Securities and Exchange Commission on January 20, 2012.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company dedicated
to the development of treatments that significantly improve outcomes in
patients with life-threatening diseases. GCS-100, the Company’s product
candidate, is a first-in-class inhibitor of galectin-3, a novel
molecular target implicated in cancer and chronic organ failure.
Forward Looking Statement Safe Harbor
This document contains forward-looking statements as that term is
defined in the Private Securities Litigation Reform Act of 1995.
These statements relate to future events or our future results of
operations. These statements are only predictions and involve known and
unknown risks, uncertainties and other factors, which may cause actual
results to be materially different from these forward-looking
statements. The Company cautions readers not to place undue reliance on
any such forward-looking statements, which speak only as of the date
they were made. Certain of these risks, uncertainties, and other factors
are described in greater detail in the Company’s filings from time to
time with the U.S. Securities and Exchange Commission (SEC), all of
which are available free of charge on the SEC’s web site at http://www.sec.gov.
These risks include, but are not limited to, risks relating to the
development of GCS-100, the success and timing of future preclinical and
clinical studies of this compound, and potential indications for which
GCS-100 may be developed. Subsequent written and oral forward-looking
statements attributable to the Company or to persons acting on its
behalf are expressly qualified in their entirety by the cautionary
statements set forth in the Company’s reports filed with the SEC. The
Company expressly disclaims any intent to update any forward-looking
statements.
