Transave Enters Into Cooperative Research Agreement With NIH To Study ARIKACE(TM)...

Transave Enters Into Cooperative Research Agreement With NIH To Study
ARIKACE(TM) In Nontuberculous Mycobacteria
Marks Third Lung Disease to be Investigated with ARIKACE

MONMOUTH JUNCTION, N.J., July 30 /PRNewswire/ -- Transave Inc. announced today
that it has entered into a cooperative research and development agreement with
the National Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), to study ARIKACE(TM) (liposomal amikacin
for inhalation) in patients with nontuberculous mycobacteria (NTM) lung
infections.

Transave and NIAID will collaborate on the planning, design and implementation
of a clinical trial to evaluate ARIKACE in patients with NTM lung disease who
have failed to respond to standard, guideline-based treatment regimens. The
study will assess the safety and tolerability of ARIKACE versus placebo
administered once daily for several continuous months using an investigational
eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient and
portable aerosol delivery system. About 35 patients will be enrolled in the
trial to be conducted at the NIH Clinical Center in Bethesda, MD.

"This is the third type of chronic lung infection for which ARIKACE is being
evaluated," said Tim Whitten, chief executive officer of Transave. "The
preliminary success with ARIKACE demonstrating a sustained clinical benefit in
treating cystic fibrosis (CF) patients with Pseudomonas lung infections is
encouraging as we tackle this additional disease state in collaboration with
NIAID."

There is no clear evidence on what triggers NTM disease, but the bacteria are
commonly found in potable water and in soil, and it has been associated with
lung disease in certain patients. Transave estimates that there are at least
30,000 patients suffering with NTM lung disease in the United States. Current
treatment requires lengthy multi-drug regimens that are often poorly tolerated
and not very effective, especially in patients with severe disease or in those
who have failed prior treatments. Few clinical trials are under way to
identify treatment recommendations, and no new drugs have been assessed for
this disease in many years.

"Patients with Mycobacterium avium complex or Mycobacterium abscessus lung
disease have limited options, which is why we welcome the opportunity to
collaborate with NIAID to study this new treatment," said Renu Gupta, MD,
Transave's Executive Vice President for Development and Chief Medical Officer.
"ARIKACE is an excellent candidate to study in these infections based on the
successful Phase II results in treating other chronic lung infections, where
it demonstrated sustained release in the lung with minimal systemic exposure."

About ARIKACE(TM)
ARIKACE is a sustained-release formulation of the antibiotic amikacin, which
encloses the drug in nanocapsules of lipid called liposomes. This advanced
pulmonary liposome technology prolongs the release of amikacin in the lungs
while minimizing systemic exposure. The treatment uses biocompatible lipids
endogenous to the lung that are formulated into small (0.3 micron), neutral
liposomes that enable penetration of the biofilm and are highly efficient,
with a very low lipid-to-drug ratio (0.65). ARIKACE can be delivered through
nebulization, which enables the small aerosol droplet size (1 to 5 microns) to
facilitate more effective distribution in the lungs.

Positive Phase II results were announced in June 2008 from a clinical trial in
European CF patients with Pseudomonas lung infections. The company also
previously announced completion of enrollment in two additional Phase II
trials including a study where ARIKACE is being evaluated in the treatment of
non-CF patients who have bronchiectasis with Pseudomonas lung infections and a
second trial in U.S. CF patients with Pseudomonas lung infections.

ARIKACE has been granted orphan drug status in the United States by the FDA,
and has received an orphan drug designation in Europe by the European
Medicines Agency for the treatment of Pseudomonas infections in patients with
CF.

About PARI Pharma and the Investigational eFlow((R)) Nebulizer System
ARIKACE is delivered by an investigational eFlow Nebulizer System developed by
PARI Pharma GmbH. The investigational eFlow Nebulizer System uses eFlow
Technology to enable highly efficient aerosolization of medication including
liposomal formulations via a vibrating, perforated membrane that includes
thousands of laser drilled holes. Compared to other nebulization technologies,
eFlow Technology produces aerosols with a very high density of active drug, a
precisely defined droplet size, and a high proportion of respirable droplets
delivered in the shortest possible period of time. Combined with its silent
mode of operation, small size (it fits in the palm of the hand), light weight,
and battery use, products incorporating eFlow Technology reduce the burden of
taking daily, inhaled treatments. The investigational eFlow Nebulizer System
and eFlow Technology are proprietary to PARI Pharma and can be optimized to
specific drug formulations.

About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of
innovative inhaled pharmaceuticals for the site-specific treatment of chronic
lung diseases. The company's major focus is on developing antibiotic therapy
delivered via proprietary advanced pulmonary liposome technology in areas of
high unmet need in lung diseases. The Transave team is dedicated to
leveraging its development and commercialization expertise, along with its
intellectual property, to bring life-extending and life-enhancing medicines to
patients. For more information about Transave's technology and development
programs, visit www.transaveinc.com.

SOURCE Transave, Inc.

Jennifer Corrigan, +1-732-382-8898, Jenn.corrigan@comcast.net