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2016-02-18

Saniona: Saniona and Medix sign development and commercialisation agreement for tesofensine and Tesomet in Mexico and Argentina

Saniona, a leading biotech company in the field of ion channels, today
announces that it has entered into a drug development and
commercialisation collaboration with Productos Medix, S.A de S.V
(Medix). Medix is granted exclusive rights to develop and
commercialise tesofensine and Tesomet in Mexico and Argentina. Medix
will finance and be responsible for the clinical development and
regulatory filings in the two countries. Medix intends to initiate
Phase 3 clinical studies for tesofensine for obesity later this year.
Saniona retains all rights to tesofensine and Tesomet in the rest of
the world. Medix will pay Saniona an upfront payment of US$ 1.25
million (about SEK 10.5 million), regulatory milestone payments, and
double-digit royalties on product sales.

"We are very excited about the possibility of developing and
introducing tesofensine and Tesomet to the market in Mexico and
Argentina for Saniona. We are planning to initiate Phase 3 clinical
trials for tesofensine, which has shown outstanding efficacy and good
tolerability in Phase 2 clinical trials in obesity, a severe health
problem in Mexico. We also intend to initiate Phase 2 and Phase 3
clinical studies with Tesomet, which is considered to have additional
benefits for certain patients and may potentially expand the market
for obesity and its comorbidities such as type 2 diabetes," says
Carlos López Patán, CEO of Medix.

Jørgen Drejer, CEO of Saniona sees great opportunities in the
collaboration. "This collaboration is completely in line with our
strategy of combining high ambitions with a low burn rate. It brings
us closer to the market and represents a significant leap for
Saniona. Medix has demonstrated a strong commitment to develop and
commercialise novel treatment paradigms for overweight and obesity
where they have been market leaders in Mexico for several years. By
initiating Phase 3 clinical trials for tesofensine in obesity, Medix
may potentially be the first company to introduce one of Saniona's
product candidates to the market, which may lead to a stable income
stream to Saniona through royalties on product sales in Mexico and
Argentina in the medium term. Moreover, Saniona will have the
exclusive rights to use the clinical data developed by Medix in the
rest of world," says Jørgen Drejer, CEO of Saniona.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail:
tf@saniona.com

About Saniona

Saniona is a research and development company focused on drugs for
diseases of the central nervous system, autoimmune diseases,
metabolic diseases and treatment of pain. The company has a
significant portfolio of potential drug candidates at pre-clinical
and clinical stage. The research is focused on ion channels, which
makes up a unique protein class that enables and controls the passage
of charged ions across cell membranes. Saniona has ongoing
collaboration agreements with Upsher-Smith Laboratories, Inc.,
Productos Medix, S.A de S.V and Saniona's Boston based spinout
Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Idec
Inc. Saniona is based in Copenhagen, Denmark, where it has a research
center of high international standard. Saniona is listed at
AktieTorget since April 2014 and has about 3,000 shareholders. The
company's share is traded under the ticker SANION. Read more at
www.saniona.com.

About Productos Medix, S.A de S.V (Medix)

Medix is a Mexican pharmaceutical company established in 1956. Medix
is primarily focused on treatment of overweight and obesity. The
company is the market leader for treatment of overweight and obesity
in Mexico where it offers the most comprehensive product and service
line. Medix's leading product for treatment of overweight and obesity
is among the top ten pharmaceutical products in Mexico overall. Medix
has earned several recognitions for its social responsibility through
its participation in philanthropic programs for the benefit of the
Mexican population and for its educational efforts involving
thousands of doctors in Mexico. The company has subsidiaries in
Argentina and certain other South American countries.

About overweight and obesity in Mexico

Mexico ranks the most obese country in the world. It is estimated that
more than 70% of the 128 million Mexicans are overweight and that
more than 30% are clinical obese. Since the 1990s, fat has become the
principal source of energy in the Mexican diet and it is assumed that
the consumption of highly processed food will continue increasing. As
a consequence, Mexico has seen the same kind of health issues that
other countries with overweight populations have. Standardized
mortality rates (SMR) for diabetes, acute myocardial infarction
(AMI), and hypertension have increased dramatically. As of 2012,
diabetes - associated with obesity - was the largest single killer in
Mexico.

Obesity is characterised by severe excess weight in the form of fat
and is defined on the basis of a measure referred to as Body Mass
Index (BMI). A BMI of more than 30 is referred to as clinical
obesity, while a BMI of 25-30 expresses excess weight. Obesity is a
serious clinical condition that involves a notably increased risk of
cardiovascular diseases and the development of type 2 diabetes.
According to the World Health Organization, obesity has reached
epidemic proportions worldwide with more than one billion overweight
adults of whom at least 300 million are clinically obese. Today,
there is a strong medical need for more effective treatment options
for obesity.

About tesofensine

Tesofensine, a monoamine uptake inhibitor, is focused on obesity.
Tesofensine has been evaluated in Phase 1 and Phase 2 human clinical
studies with the aim of investigating treatment potential with
regards to obesity, Alzheimer's disease and Parkinson's disease.
Tesofensine demonstrated strong weight reducing effects in Phase 2
clinical studies in obese patients. In general, tesofensine has been
administered to more than 1,200 patients and is well tolerated.

Mode of Action - Tesofensine potentiate dopamine

Pathological overeating and obesity can be caused by decreased
dopamine function in the reward centre of the brain. Dopamine
transporter proteins are inhibited by tesofensine, so the dopamine
receptors are stimulated for a longer period of time after activation
and the brain's reward system is amplified. With a similar mechanism
of action tesofensine also increases levels of two other monoamines,
serotonin and noradrenaline.

Each of these transmitters exert an important function on appetite and
metabolism at different locations in the brain. Dopamine acts in the
nucleus accumbens of the forebrain to modulate reward and the
"pleasure"-feeling of food. The two other transmitters act in the
hypothalamus to increase metabolism and reduce appetite.

The unique efficacy of tesofensine in obesity may be explained by
reversal of blunted dopamine response in obese patients. In obese
individuals the brain centre (striatum) controlling consummatory food
reward dopamine receptors are reduced relative to lean individuals.
It has been found that in the relevant brain region more than 70% of
obese individuals have a blunted dopamine response to food intake.

Clinical Programs - Tesofensine has produced superior weight loss
data.

The clinical Phase 2b trial (TIPO-1) reported in The Lancet showed
levels of weight loss over a six month period that were of high
clinical relevance and highly competitive to other approaches.
Patients lost an average of 12.8 kg on a 1 mg dose, 11.3 kg on a 0.5
mg dose and 6.7 kg on a 0.25 mg dose compared with a 2.2 kg loss in
the placebo group. All participants were instructed to follow a diet
with a 300 kcal deficit and to increase their physical activity
gradually to 30-60 minutes of exercise per day. Of the patients
receiving 0.5 mg daily, considered the relevant therapeutic dose, 87%
of the patients (58% versus placebo) achieved more than 5% weight
loss and 53% of the patients (46% versus placebo) achieved a weight
loss of more than 10% after 6 months follow up.

There has also been reported interim results from a 48-week,
open-label extension trial (TIPO-4) in which 140 patients who
completed the 24-week Phase 2b trial (TIPO-1) were re-enrolled after
an average of three months' wash-out. All were then treated with 0.5
mg tesofensine once daily but up-titration to 1 mg once daily was
allowed in the first 24 weeks of the extension study. The 24-week
interim results for those who were previously treated with 0.5 mg
tesofensine in TIPO-1 showed a total mean weight loss of between 13
kg and 14 kg over 48 weeks of treatment. Furthermore, TIPO-4
confirmed the TIPO-1 results since the patients who were previously
treated with placebo lost approximately 9 kg in the first 24 weeks of
the TIPO-4 study.

About Tesomet

Tesomet is a fix-dosed combination of tesofensine and metoprolol,
which Saniona plans to position for treatment of type 2 diabetes. In
addition to obesity, tesofensine has also the potential to reverse
the progression of type 2 diabetes by reducing liver fat. The market
for type 2 diabetes is estimated to grow from US $ 23 billion in 2014
to 43 billion USD 2023 due to the increasing problems with obesity.
Type 2 diabetes is considered as a progressive chronic disease today.
However, recent published research concludes that type 2 diabetes is
reversible and that large patient populations may undergo long-term
remission if they achieve a substantial weight loss through reduced
food consumption.

Saniona believes that tesofensine represents an interesting new
treatment option for type 2 diabetes, which not only may be used in
parallel with existing treatments, but also may offer potentially
long-term remission in many patients by contributing to a substantial
weight loss. In general, tesofensine has been well tolerated in human
clinical studies. However, an increase in heart rate has been
observed at therapeutic relevant doses of tesofensine. Patent
applications have been filed in respect of the combination
tesofensine and a beta blocker. Saniona has received notice of
allowance of a U.S. patent application, which includes a combination
of tesofensine and metoprolol and which can provide protection in the
United States until 2033, if issued. The combination product is
covered by other recent Saniona patent applications with broad
geographic coverage. Saniona has recently published new results from
datamining of previous clinical studies, which show that tesofensine
improved glycaemic parameters in prediabetes individuals
participating in a Phase 2 obesity study and that metoprolol blunts
the increase in heart rate caused by tesofensine in volunteers in a
Phase 1 study. Saniona expects to initiate a Phase 2a study during

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