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Ergonex Pharma: Terguride receives FDA orphan drug designation for the treatment of pulmonary arterial hypertension

Appenzell (ots)

Ergonex Pharma today announced that the United
States Food and Drug Administration (FDA) has granted orphan drug
designation to Terguride for the treatment of pulmonary arterial
hypertension (PAH). Terguride is currently being evaluated for PAH in
a pivotal Phase II trial in Europe.
"The FDA's grant of orphan drug designation to Terguride for PAH
encourages and strengthens our development program by offering
regulatory, clinical development and commercial benefits," said Dr
Rudolf Reiter, CEO of Ergonex Pharma. "We believe that Terguride can
provide a significant therapeutic benefit in PAH by inhibiting excess
serotonin signalling."
The U.S. Orphan Drug Act is intended to assist and encourage
companies to develop safe and effective therapies for the treatment
of rare diseases, which affect 200.000 persons or less in the United
States. Under the Orphan Drug Act, upon marketing authorization, the
FDA does not accept or approve other applications to market the same
medicinal product for the same indication for a seven-year period. In
addition to potential market exclusivity, orphan drug designation
provides protocol assistance, advice on the conduct of clinical
trials, tax credits for clinical research expenses, grant funding for
research of rare disease treatments and waiver of the Prescription
Drug User Fee Act filing fee.
About Terguride
Terguride has strong anti-serotoninergic activity by acting as a
potent antagonist on 5-HT2B and 5-HT2A receptors: It has
anti-proliferative and anti-fibrotic activity and drives reverse
remodelling processes. Serotonin is a signal molecule in the body
with many functions. In the blood vessel walls of the lung it
stimulates proliferation of smooth muscle cells and narrowing of the
blood vessels, which leads to PAH. Excessive proliferative effects of
serotonin on the heart contribute directly to progression towards
heart failure. Terguride is clinically approved in Japan for
hyperprolactinemia acting as partial dopamine agonist on the
pituitary.
About Pulmonary arterial hypertension
Pulmonary arterial hypertension is a disorder of the blood vessels
in the lung, in which the pressure in large blood vessel rises above
normal. Walls of the blood vessels are thickened and hardened,
becoming less elastic and decrease in lumen leading to increases the
pressure. Patients with PAH suffer from extreme shortness of breath
as the heart struggles to pump against these high pressures causing
such patients to ultimately die of heart failure. PAH can occur with
no known underlying cause, or it can occur secondary to diseases such
as connective tissue disease, congenital heart defects, cirrhosis of
the liver and HIV infection.
About Ergonex Pharma
Ergonex Pharma is a pharmaceutical company focussed on developing
and commercialising well-tolerated and effective products for novel
and typically underserved indications. This is being achieved by
forging collaborations with commercial and academic partners with
expertise in the field of interest and through outsourcing activities
to service providers. (For further information see www.ergonex.com)

Contact:

Dr. Rudolf Reiter
Ergonex Pharma GmbH
Ruetistr. 20
9050 Appenzell
Switzerland
Tel.: +41/071/788'40'65
E-Mail: info@ergonex.com