Medical Need announced today that it has entered into an exclusive distribution agreement with German company Hennig Arzneimittel relating to their product Arlevert® in the Nordic countries Sweden, Denmark, Finland, Norway and Iceland.
Arlevert® is a low-dose combination of cinnarizine and dimenhydrinate, two well-known substances in the treatment of vertigo. By combining low doses of two substances with different modes of action, the product has both peripheral and central effects on vertigo. Arlevert® has been extensively documented to have superior efficacy compared to mono-therapy with either of its active substances in higher doses and compared to betahistine. It combines the good efficacy with no risk for causing somnolence and fatigue.
Arlevert® is indicated for the treatment of vertigo of different origin, which includes a broad range of underlying conditions e.g. vestibular neuropathy, otogenic peripheral vertigo, vertebrobasilar insufficiency and Menière’s disease. Arlevert® is the leading treatment for vertigo in Germany for several years, with a market share of over 50%. To date more than 11 million patients have been treated. Regulatory approval was recently expanded across most of the markets of the European Union.
Under the agreement, Medical Need holds the exclusive rights to distribute Arlevert® in the five Nordic countries (Denmark, Finland, Iceland, Norway and Sweden) and will be responsible for the distribution, marketing and sale of the product in this territory. In Norway and Iceland, the product will initially be provided only on request on a named patient basis, with regards to its potential regulatory approval pending.
“We are delighted to be able to offer this well documented, safe and effective treatment to the Nordic vertigo patients, for whom only few treatment alternatives are currently approved and available”, said Kennet Rooth, COO of Medical Need.
Vertigo is a sensation caused by an imbalance in the signals from the body’s sensory balance organs, including the eyes and inner ears, or by the way these signals are interpreted by the brain. It is commonly perceived as dizziness, instability or a feeling of rotation and is often associated with lack of balance, nausea and vomiting. Vertigo is caused by a wide number of underlying causes and conditions, including benign paroxysmal positional vertigo, vestibular neuropathy, vertebrobasilar insufficiency, vestibular migraine and Menière’s disease. Vertigo is a common condition, responsible for approximately 70 000 hospital admissions in Sweden each year. It is estimated that 10% of the population will experience dysfunction of a balance organ or its connection to the brain over their lifetime.
Arlevert® is an oral fixed dose combination tablet containing 20 mg cinnarizine and 40 mg dimenhydrinate, to be taken three times daily. Arlevert® is indicated for the treatment of vertigo of different origin. The product was originally approved in Germany and is currently the leading treatment for vertigo in Germany, with a market share of over 50% and more than 11 million patients treated.. Regulatory approval was recently expanded across most of the markets of the Europe Union, including Sweden, Denmark and Finland. Arlevert® does currently not have regulatory approval in Norway and Iceland.
About Medical Need
Medical Need is a Sweden based pharmaceutical company, focusing on the registration, distribution, marketing and sale of orphan drugs and niche specialty pharmaceuticals for the treatment of unmet medical needs across Europe. More information on Medical Need can be found on www.medicalneed.com
About Hennig Arzneimittel
HENNIG ARZNEIMITTEL is a medium-sized pharmaceutical company with more than 280 employees and own production in Germany. It is family-owned for four generations already and economically independent from shareholders. In Germany, HENNIG ARZNEIMITTEL is market leader with drugs for the treatment of vertigo and continuously promoting the scientific research in the field of vestibular disorders in cooperation with leading universities. More information on HENNIG ARZNEIMITTEL can be found on www.hennig-am.de