Life sciences in the Nordic region of Denmark, Finland, Iceland, Norway and Sweden are alive and growing. According to the Nordic Life Sciences Database, there are 3,400 life sciences companies there, with pharma and biotech making up over a quarter of these.
At the Nordic Life Science Day held in Sweden last year drugmakers talked up their ambitions over two days of presentations, symposia and one-on-one meetings. The region could also see an uptick in industry contact now that the European Medicines Agency has chosen Amsterdam, which is slightly closer in proximity, as its new home.
Double Bond: Uppsala, Sweden
Double Bond Pharmaceutical International AB, headed up by CEO Igor Lokot, is developing drugs for cancers, infections, autoimmune diseases and other life-threatening disorders. As Lokot explained to BioPharma Dive in an interview, its model is to take existing drugs and repurpose them.
"We want to take approved drugs and make them better, keeping the risk low," said Lokot.
Lokot unabashedly described the company's approach as "opportunist," scouring for "unpolished gems" in Eastern Europe.
"We can sit between two cultures — the East and the West — and see opportunities where big pharma may not see them," said Lokot. "In the East, there is good research and good products, but no one knows about them."
Double Bond's lead product is Temodex (temozolomide gel), which has orphan drug designation in Europe. It's approved in Belarus for glioblastoma, and has been shown to improve survival by nine months. The gel delivery system is placed on the site following surgery to remove the tumor and kills the residual cells over a number of days.
The next step is to move into clinical trials for approval outside Belarus, potentially in the third quarter of 2018. Double Bond is seeking partners for Temodex and SA033, which uses its delivery system BeloGal to direct doxorubicin directly to the liver. A Phase 1 trial of the drug in liver cancer is planned for 2018.
Acesion Pharma: Copenhagen, Denmark
Acesion Pharma ApS, a Danish biotech company founded in 2011 based in Copenhagen, develops drugs to treat atrial fibrillation, the most common type of cardiac arrhythmia. Atrial fibrillation increases the risk of stroke and heart failure, and is generally a progressive disorder.
Current approaches to the management of atrial fibrillation have their downsides, according to the company. DC cardioversion — a procedure to convert an abnormal heart rhythm to a normal one — is effective, but the results are not sustained and the process requires general anesthesia.
Intravenous and oral therapeutics used to induce cardioversion, which are only available in Europe and not in the U.S., have limited success and are associated with safety concerns, as are oral maintenance and prevention approaches.
Acesion is taking an SK channel inhibitor-based approach, which it expects to be rapid-acting, with potential in IV cardioversion, rapid oral cardioversion for home use, and oral maintenance. Clinical trials are planned for the IV form this year.
Oncology Venture: Hørsholm, Denmark
Oncology Venture AB, formed in 2012 by a Danish and U.S. team, is creating a drug response predictor based on a gene-tumor-technology and big data to help determine what drugs will be effective in various patient populations.
The company's business model will be to in-license Phase 2 drug candidates from big pharmas, specialty pharmas, biotechs or CROs, and develop them further. Oncology Venture will then carry out focused trials and gain additional data. After this, the plan is to out-license the product, create a joint venture, or commercialize in-house in specific geographies.
The company has six drugs in its pipeline and one under negotiation. The pipeline includes APO 010, an immuno-oncology drug in a clinical trial in multiple myeloma; LiPlaCis, a liposomal formulation of cisplatin that came from a deal with Cadila Pharmaceuticals Ltd. and is under investigation in a range of solid tumors ; Irofulven, a drug in development in solid tumors; a PARP inhibitor stemming from a collaboration with Eisai Co. Ltd. that is clinical trial-ready; and a deal with Novartis AG.
Klaria Pharma: Stockholm, Sweden
Founded in 2015, Klaria Pharma Holding AB has a focus on rapid relief in severe pain, such as migraine and cancer-related pain. Like Double Bond, it is looking at repurposing drugs as a way to reduce risk, cut the time to market and lower development costs.
The company was a spinout after AstraZeneca plc closed down its neuroscience research. Its business model is to develop oral transmucosal versions of existing agents using its alginate-based mucoadhesive film drug delivery technology. These types of buccal films are already widely used and are well accepted by patients. The aim is to develop a treatment that is easy to use, noninvasive and has a fast onset, while keeping it simple to manufacture.
The company's objective last year and in 2018 is to complete the formulations in all its projects and to start testing priority drugs in clinical trials. KL-00119, a buccal form of sumatriptan, has shown better drug exposure than nasal spray in the clinical setting. Effective levels of sumatriptan were seen in the plasma within 60 minutes for six of 12 patients using the nasal spray and 11 of 12 using the film. Registrational studies are being planned, and discussions are under way with potential partners.
Klaria has signed an exclusive development, licensing and manufacturing agreement with Purdue Pharma for KL-00514, a buccal formulation of naloxone. The deal includes upfront payments, milestone payments of up to $2.3 million, and royalties. The buccal form of naloxone is in development for the acute treatment of intentional or accidental opioid overdose. The ease of use means that it could be administered by patients, healthcare professionals, police and paramedics.
Redwood Pharma: Stockholm, Sweden
Redwood Pharma AB is developing slow release ophthalmic products based around its IntelliGel drug delivery platform technology for the front of the eye. This is a slow release formulation administered as a liquid at room temperature, and then forms a clear and transparent hydrogel when it comes in contact with a warm surface, such as the eye. IntelliGel has potential for the slow release of difficult-to-deliver agents such as water-insoluble and sparingly soluble drugs.
The lead product, RP101, is in development for dry eye and is a repurposed formulation of a naturally-occurring endogenous molecule licensed from Nascent Pharmaceuticals. Dry eye affects over 100 million people globally. In two Phase 2 trials in 138 postmenopausal women, there was a significant or marked improvement in dry eye, with good safety results. The administration of RP101 was once or twice daily, compared with four times daily. In an analysis that focused on the people who responded, the increased convenience of the new formulation improved compliance.
Production of the active pharmaceutical ingredient is under way, and Redwood Pharma has signed an agreement with the Swiss contract research organization CROss Alliance to manage a planned Phase 2 study in Europe in around 100 women with moderate-to-severe dry eye disease.
Redwood Pharma is seeking partners with products for slow release for its platform, as well as partners for the further development of RP101.