Inc., a privately held biopharmaceutical company, announced that it has
acquired in bankruptcy proceedings two late stage clinical programs: Ramoplanin
from Oscient Pharmaceuticals Corporation and PRX-3140 from EPIX Pharmaceuticals,
Inc. Ramoplanin - an oral antibiotic for the treatment of Clostridium difficile-associated
disease (CDAD) - is entering Phase 3 trials. PRX-3140 - an orally-bioavailable
Alzheimer's treatment - is in Phase 2 clinical studies. Nanotherapeutics also
acquired the U.S. and foreign patent estates covering each clinical program.
CDAD ranges from uncomplicated diarrhea in its mildest form, to fulminant colitis
and death, in its most severe form. The incidence and severity of CDAD has increased
with the emergence of virulent strains creating a growing unmet need. Ramoplanin,
an orally administered drug, represents a potential new method for managing
certain pathogens commonly found in the hospital. Following oral dosing Ramoplanin
exerts its bactericidal activity locally in the GI tract and is not absorbed
systemically. Ramoplanin has been shown to be bactericidal in vitro against
C. difficile and other gram-positive bacteria and has been studied through Phase
2 clinical trials. A Phase 3 non-inferiority trial against vancomycin is planned
pursuant to a Special Protocol Assessment agreed to by the FDA.
CDAD was mainly a concern in older or severely ill patients who were hospital
inpatients or residents of long-term--care facilities. An increase of CDAD cases
has been reported in the U.S., Australia, Canada, and the United Kingdom. Currently,
it is estimated that 400,000 - 500,000 cases of CDAD occur each year in the
U.S., with the incidence apparently doubling from 1996 to 2003, including a
five-fold increase in those 65 and older. In the U.S., the disease generates
in excess of $2.8 billion annually in hospital health care costs.
PRX-3140 is intended to stimulate cognition and memory by selectively activating
the 5-HT4 G-protein coupled receptor in the brain to produce and release acetylcholine,
a neurotransmitter that plays a role in learning and memory. As Alzheimer’s
disease progresses, acetylcholine production declines, and brain levels of this
critical neurotransmitter decline also. PRX-3140 may potentially slow the progression
of the disease with fewer and less severe side effects than certain current
Alzheimer drugs. A randomized, double-blind, placebo-controlled Phase 2a clinical
trial was completed to assess the effects of PRX-3140 following two weeks of
treatment as monotherapy and separately in combination with donepezil (Aricept®)
in patients with mild Alzheimer's disease. In this study, PRX-3140 appeared
to be well tolerated alone and in combination with Aricept® with no serious
drug-related adverse events reported.
In October, 2009, the FDA permitted a Physician-Sponsored IND and continuation
of the fourth six-month open label extension of PRX-3140.
Alzheimer’s disease is the most common form of dementia, affecting more
than five million Americans and over nine million worldwide. The National Institute
of Aging estimates that about five percent of the population aged 65-74 and
as many as 50% of the US population over 85 have the disease. The global market
is projected to grow from $4 billion in 2006 to over $5 billion in 2010. The
disease is currently incurable and manifests as progressive memory loss, confusion,
and ultimately loss of control of physical and mental functions leading to death.
Nanotherapeutics, Inc. is a privately held biopharmaceutical company. Its product
pipeline includes, an FDA-approved injectable biologic product (OrigenTM DBM,
marketing partner Orthofix), an FDA filed product (NanoFUSETM bone graft), and
other products in clinical trials including NanoDOX® and NanoBUPTM. The
Company also has in-house GMP manufacturing to support additional products.
The 10-year old company employs several platform technologies to manipulate
and enhance the properties of drugs, has an experienced management and development
team, and a pipeline of clinical and pre-clinical pharmaceutical and biologic
Posted December 16th, 2009