Navamedic ASA: Enters into long-term agreement for distribution of GoNitro®* in the Nordics

11/20/2017 8:00:00 AM

Oslo, November 20, 2017 - Navamedic ASA (OSE: NAVA), the Norwegian medtech and pharmaceutical products company, today announced it has entered into a preliminary long-term agreement with G. Pohl-Boskamp GmbH & Co. KG for the Nordic launch and commercialisation of GoNitro®*, a new nitroglycerin sublingual powder formulation for acute relief of an attack or prophylaxis of angina pectoris.

"We are very pleased to announce a planned extension of our partnership with Pohl-Boskamp for distribution of the prescription medicine GoNitro (nitroglycerin) sublingual powder in the Nordic markets. GoNitro is used to treat adults for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease, the most common type of heart disease. A Nordic approval of GoNitro would enhance the treatment options available to the more than 1.2 million Nordic patients suffering from stable angina, as the first and only short-acting nitrate in a stabilized crystal granule form available in single dose packets," says Tom Rönnlund, Chief Executive Officer of Navamedic.

Pohl-Boskamp has developed a new, patented nitroglycerin oral powder formulation for sublingual administration with the proposed brand name GoNitro®. The product has been submitted for regulatory review in the Nordic markets.

"As Pohl-Boskamp recently have submitted the product for regulatory review in the Nordic markets, with expected approval late 2018 or early 2019, we are jointly evaluating the best approach to the market after an approval and we have entered into a preliminary agreement to allow immediate initiation of this work, " says Rönnlund.

Pohl-Boskamp is also the market authorisation holder for Nitrolingual® Pumpspray, a medication already approved in Norway, Sweden and Denmark, as an oral spray of nitroglycerine used for relief or prevention of sudden attacks of chest pain associated with angina pectoris caused by heart disease. Nitrolingual® Pumpspray has been marketed by Navamedic in the Nordic region since early 2016. Clinical data indicate that the sublingual absorption of nitroglycerin is higher following the administration of GoNitro® compared to Nitrolingual® Pumpspray.

"Short-acting nitrates are the current standard of care for acute relief of an angina attack for patients suffering from coronary artery disease, affecting 3-7% of the adult population. If approved, GoNitro would be the first new dosage form in the short-acting nitrate category in nearly 20 years, offering Nordic healthcare providers and patients a new option for management of angina attacks," says Rönnlund.

The GoNitro® agreement is the third recent partnership for original pharmaceutical products scheduled for launches in 2018 and 2019, leveraging on Navamedic's regulatory, sales and marketing capabilities in the hospital and pharmacy sectors. The company is also working on an additional pipeline of exciting pharmaceuticals with launches scheduled for the coming 6-24 months, bringing the company back on a growth track in the medium-term perspective following the discontinuation of the Aspen agreement.

"The planned long-term agreement with Pohl-Boskamp is in line with our strategic approach of further strengthening and expanding our pharmaceutical products portfolio and entering solid, long-term partnerships. We currently have some great new pharmaceuticals in the pre-launch and launch phase and are looking forward to bringing these new treatment options to patients and physicians across the Nordics," says Tom Rönnlund,

For further information, please contact:

Tom Rönnlund, CEO, Navamedic ASA

Telephone: +46 727 320 321

* GoNitro® is the proposed brand name for the nitroglycerin sublingual powder in the regulatory approval application submitted to Nordic authorities.


ABOUT Angina

Angina is the name for pain or discomfort in the chest. It occurs when the heart isn't getting enough oxygen from blood.
Angina is not a disease, but a symptom of another heart condition. Heart disease is a very serious health issue. It is the number one cause of death in the world. Men and women experience angina about equally. Many patients who have angina are not taking medicine to alleviate the pain.

ABOUT GoNitro®

Fast-acting GoNitro® (nitroglycerin) sublingual powder is approved in the U.S. by FDA (U.S. Food & Drug Administration) for the prevention and treatment of angina. GoNitro® is intended to be used as soon as symptoms of angina occurs, or 5 to 10 minutes before such symptoms are anticipated. GoNitro® is provided in small, single-dose packets that are easy to carry for the patient.

ABOUT NAVAMEDIC:

Navamedic ASA is a Norwegian medtech and pharmaceutical products company, delivering products to patients, hospitals and pharmacies in the Nordic and Benelux markets. The Group's Medtech business has developed and is currently introducing the next generation of digital urine meter Sippi®. Navamedic's Pharma and Healthcare business is a distributor of products supplied by a number of pharmaceutical manufacturers. Navamedic is listed on the Oslo Stock Exchange (ticker: NAVA).

ABOUT G. Pohl-Boskamp GmbH & Co. KG

Pohl-Boskamp is a privately owned business active in the international pharmaceutical market for more than 175 years with commercialized products in more than 45 countries. Through close collaboration with its partners abroad, Pohl-Boskamp focuses on developing and marketing products that positively impact patients' quality of life. It operates in numerous healthcare sectors including pneumology, urology, parasitology, cardiovascular diseases, gastroenterology, sleep disorders and dermatology. For more information, visit www.pohl-boskamp.de.