Overview
DrugAbuse Sciences (DAS; Hayward, CA) was founded in 1994 to improve the
treatment of alcohol and drug addictions/dependence through the discovery,
development, and commercialization of innovative and cost-effective
medications. The company's strategy is to be the leader in technology and
providing products for alcohol and substance abuse treatment. DAS's
clinical portfolio includes five products in development, three of which
have been developed in the company's proprietary extended-release depot
technology (Lactiz™). In April 2001, DAS competed a $24 million
financing, led by Canaan Partners, a new investor, and principally
supported by its existing investors, 3i and Nomura Securities. In December
2002, the company will obtain $5 million in government grants. DAS is
using the proceeds to execute clinical plans, including the filing of an
NDA for Naltrexone Depot for alcohol dependence and development of other
products in human clinical trials.
Lead Candidate--Naltrexone Depot
The lead drug candidate at DAS is Naltrexone Depot, which is in Phase III
clinical trials as a potential treatment for alcohol dependence.
Naltrexone is a pure opioid antagonist that competitively binds two mu
opioid receptors in the brain and has no opioid agonist properties. It is
approved for use in the US for the treatment of alcohol and opiate
dependence and for the blockade of exogenously administered opiates; and
it is contraindicated in patients receiving opioid analgesics, in patients
currently dependent upon opioids, in patients experiencing acute opioid
withdrawal, in anyone who has failed a naloxone challenge test or has a
positive urine-screening test for opioids, in anyone with a history of
sensitivity to naltrexone, or in anyone with acute hepatitis or liver
failure. The precise mechanism of action of naltrexone in the treatment of
alcoholism is unknown; however, when used in combination with a
comprehensive treatment program, the oral form of naltrexone demonstrates
statistically significant reductions in relapse rates in alcoholics.
Naltrexone Depot, a long-acting injectable formulation intended for
once-per-month administration, was developed in the company's LACTIZ
extended-release injectable technology (See Sidebar: "Lactiz:
Extending Release, Increasing Efficacy?").
According to DAS's CEO, Elizabeth M. Greetham, "our six-month data
indicate that Naltrexone Depot impacts the compliance problem with more
patient retention in the Naltrexone Depot arm than the placebo arm, which
is very encouraging." DAS will present data on Naltrexone Depot the
December 2002 Annual Meeting of the American College of
Neuropsychopharmacology. The company is hopeful that Naltrexone Depot will
lead to increased treatment successes and anticipates significant
improvements in the treatment of alcoholism during the next decade through
the combination of pharmacologic management and behavioral therapy
modules. In October 2001, DAS announced that US Patent #6,306,425 had been
issued, covering the company's extended-release injectable technology for
administering naltrexone. The company may find itself in competition with
Alkermes, which is also developing a sustained-release naltrexone
formulation and which has recently entered Phase III clinical trials.
Candidates for Treating Opiate Addiction
DAS is developing two products in its Lactiz delivery system for the
treatment of opiate dependence. The company's second drug candidate,
Naltrel™ (long-acting naltrexone for injection), is in preparation for
Phase III clinical trials for the treatment (i.e., prevention of relapse)
of heroin addiction. It is intended for once-per-month administration.
Naltrexone blocks the euphoric and other effects of opiates such as
heroin. The oral, once-daily form is approved in the US for the treatment
of opiate dependence. When used in combination with a comprehensive
treatment program, oral naltrexone demonstrates statistically significant
reductions in relapse rates. Analysis of a Phase IIb clinical trial with
Naltrel demonstrated its ability to block the effects of the opiate
hydromorphone over the six-week trial period.
DAS is also in development with buprenorphine depot, an
extended-release injectable formulation for the treatment of opiate/heroin
dependence. Buprenorphine is a mixed agonist-antagonist opiate. An NDA for
an oral tablet formulation of buprenorphine for the treatment of opiate
addiction has been submitted to the US Food and Drug Administration (FDA)
by another company, and its approval would support the validity of this
approach. Buprenorphine Depot is in preclinical development and designed
for administration once every four to six weeks
Candidates for Treating Cocaine Addiction and Cognitive Function
The company's third drug candidate, DAS-431™ IV, a dopamine D1 receptor
agonist, is in Phase II evaluation for the treatment of cognitive
impairment in the elderly and cocaine addiction and is in development for
a broad range of CNS diseases, including schizophrenia. Dopamine D1
receptors are thought to play a role in mediating cognitive processes in
the prefrontal cortex, particularly working memory. The number of D1
receptors appears to be decreased in the elderly, chronic addicts,
patients with schizophrenia and, possibly, patients with Parkinson's
disease and those who have experienced a stroke. DAS-431 directly
activates D1 receptors in the prefrontal cortex and may be useful in
treating these conditions.
In two initial human clinical trials, DAS-431 showed potential for the
treatment of cocaine abuse; in animal studies, it showed efficacy on
working/learning memory impairments. A Phase II study in cocaine dependent
patients has been successfully completed. Further studies in chronic
addiction, the elderly, and patients with schizophrenia are underway.
Worldwide development and marketing rights for all human therapeutic
indications of DAS-431 were licensed from Abbott Laboratories in September
2000.
Two additional drug candidates are in preclinical development at DAS
for the treatment of cocaine addiction. COC-AB™, an equine F(ab')2
cocaine antibody, is in development as an emergency antidote for cocaine
overdose (manufactured under an exclusive agreement with Aventis Pasteur).
ITAC™ is a cocaine vaccine in development for prevention of relapse to
cocaine following treatment. ITAC is based on a new platform technology
developed in collaboration with The Scripps Research Institute.
Alcoholism/Addiction Education
DAS is the sponsor of www.AlcoholMD.com, a medical education and
information Web site that currently draws thousands of visitors each month
and provides anonymous, online self-evaluations of potential alcohol
problems using standardized questionnaires.
Licensing--Products, Sales Partners, and Technologies
DAS is a research and development company with a licensing strategy that
includes technology (including drug delivery technology), product
(including preclinical and clinical) and commercial goals. At present, DAS
seeks commercial partners in the US, Europe, and Asia for its near-term
product candidates. Technology licensing at DAS includes deals with:
- Southern Research Institute (Birmingham, AL). In 1997, DAS
in-licensed Southern Research Institute's proprietary
micro-encapsulation technology for the development of a
sustained-release formulation of naltrexone and other products.
- Abbott Laboratories (Abbott Park, IL). In August 2000, DAS obtained
worldwide exclusive license for all therapeutic indications for
DAS-431.
- The Scripps Research Institute (La Jolla, CA). In 1996,
Scripps granted DAS an exclusive license to develop and commercialize
the institute's patents related to cocaine vaccines.
- University Paris V (Paris, France). In 1999, DAS entered into
a research and development agreement with the University of Paris V to
jointly develop DAS's proprietary antibody platform technology. COC-AB,
a polyclonal antibody against cocaine, and MAP-AB, a polyclonal
antibody against methamphetamine, are in development. The contract was
extended to include the development of monoclonal antibodies.
- EON Laboratories (Laurelton, NY). In 2000, DrugAbuse Sciences
was granted the license to market and distribute oral naltrexone
hydrochloride tablets (50 mg) from EON Laboratories.
Management
DAS was founded in 1994 by Philippe Pouletty, MD. He is the founder of
SangStat Medical Corporation and practiced hematology and immunology in
Paris. Elizabeth M. Greetham, Chairman and CEO, previously worked for
nearly ten years as a portfolio manager for Weiss, Peck & Greer, where
she managed the WPG Life Sciences Funds LP, which invests in select
biotechnology stocks. Among the scientific advisors of DAS are Walter
Ling, MD, UCLA, who serves as Chairman; Herve Galons, PhD, University of
Paris; George Koob, PhD, Scripps Research Institute; and Jean-Marc
Rouzioux, MD, PhD, LD, Aventis Pasteur.
Contact Information
DrugAbuse Sciences, Inc.
25954 Eden Landing Road
Hayward, CA 94545-3816 USA
Tel: 510-259-3200
Fax: 510-259-3201
URL: www.drugabusesciences.com
In Europe
DrugAbuse Sciences SAS
30, Boulevard Pasteur
75015 Paris FRANCE
Tel: 33 (1) 53 58 14 84
Fax: 33 (1) 53 28 14 47
