2013-02-12 12:14:04 -

Activaero GmbH /
ACTIVAERO INITIATES PROOF OF CONCEPT TRIAL WITH LASAG IN SEVERE INFLUENZA
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Gemünden/Wohra, Germany, February 12, 2013: Activaero GmbH, the therapeutic area
specialist for respiratory diseases, today announced that the first patients
have been enrolled in an international proof of concept trial to treat
hospitalized patients with acute severe, potentially life-threatening influenza.
This multi-center, randomized, double-blind, placebo-controlled trial will
evaluate the safety and efficacy of LASAG (lysine acetylsalicylate glycine),
inhaled three times daily, in comparison to standard therapy; optionally
including oseltamivir (Tamiflu®). LASAG is an antiviral drug, which potentially
slows down the replication of the influenza virus.

The primary endpoint of the trial is the "time to alleviation" of clinical signs
of    acute influenza,  i.e. headache,  aches, feverishness,  fatigue, cough, sore
throat  and nasal congestion. Secondary endpoints include vital signs, avoidance
of intubation and duration of hospitalization.

"This  trial is highly relevant for physicians  and patients. It will be a major
breakthrough  in  the  field  of  influenza  therapy  if  we  can prove that the
mechanism  of action of LASAG, directly delivered to the lungs using Activaero's
FAVORITE  approach, allows  us to  treat patients  already confirmed with severe
influenza,"  commented Gerhard Scheuch,  Founder and Chief  Executive Officer of
Activaero GmbH. "

The  trial is expected to  enroll 175 patients who will  be randomized to one of
three  treatment groups. Each  patient will receive  five days of treatment with
either  inhaled LASAG (high or low dose)  or LASAG placebo inhalation. The trial
will be conducted in 50 centers throughout Europe and South America.

About Severe Influenza
Influenza is an acute viral infection that spreads easily from person to person
and circulates worldwide. Influenza is characterized by a sudden onset of high
fever, cough (usually dry), headache, muscle and joint pain, severe malaise
(feeling unwell), sore throat and runny nose. Influenza can affect anybody in
any age group and is a serious public health problem that causes severe illness
or death in people at high risk: children younger than age two years, adults age
65 years or older, and people of any age with certain medical conditions, such
as chronic heart, lung, kidney, liver, blood or metabolic diseases (such as
diabetes), or weakened immune systems. The standard therapy to treat the illness
is oseltamivir, while this therapy is not efficacious in severe hospitalized
patients. Influenza can cause serious public health and economic problems. While
most people recover from a bout of influenza, there are large numbers of people
who need hospital treatment and die from the disease every year.

About Activaero's influenza treatment with LASAG
Activaero's influenza program addresses the high unmet medical need to treat
severe influenza. Activaero's program combines LASAG with Activaero's
proprietary FAVORITE inhalation approach. LASAG is a pain-relieving, fever-
reducing and anti-inflammatory substance (non-steroidal anti-
inflammatory/analgesics). The active ingredient in LASAG is D,L-
Lysinacetylsalicylat Glycin, a water soluble form of acetylsalicylic acid. LASAG
is used to treat acute moderate to severe aches and migraine and fever. As
opposed to currently available antiviral therapies, inhaled LASAG has a direct
inhibiting effect on the replication of the virus and thus leads to an effective
reduction of the virus load. In order to obtain this effect the drug has to be
delivered into the lungs.

About FAVORITE
FAVORITE is Activaero's proprietary, clinically and commercially proven
inhalation approach to effectively treat severe respiratory diseases. FAVORITE
actively regulates inspiration flow and inhalation volume. By guiding,
controlling and supporting the patient's breathing optimal inhalation patterns
are created. These then match the therapeutic requirements for severe
respiratory diseases and patients' physical conditions. Using FAVORITE, a
therapy can be selectively targeted to pre-defined lung regions and unlock
completely new opportunities for novel aerosol therapies.

About Activaero
Activaero is a therapeutic area specialist developing treatment solutions for
patients suffering from severe respiratory diseases, including Asthma, Chronic
Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Idiopathic Pulmonary
Fibrosis (IPF) and Pulmonary Hypertension. Activaero's clinically proven
treatment approach FAVORITE ensures highly efficient, targeted, and safe drug
deposition in the lungs to fight in particular severe respiratory diseases with
dramatically better therapeutic outcomes. Activaero was founded in 1998 in
Germany and is a privately held company with offices near Frankfurt and Munich
in Germany as well as in Dublin, Ohio, USA.

For further information please visit:

www.activaero.com


Contact

  Activaero GmbH                        Media contact



  Dr. Gerhard Scheuch                   Dr. Lucia Malfent
  Founder and Chief Executive Officer   MC Services AG
  t: +49-6453-64818-16                  t: +49-89-210228-36
  e: info@activaero.de                  e: lucia.malfent@mc-services.eu
  www.activaero.com




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