Business Archives - NLS https://nordiclifescience.org/category/business/ Tue, 08 Oct 2024 10:20:49 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 https://nordiclifescience.org/wp-content/uploads/2024/08/cropped-favicon-32x32-1-32x32.png Business Archives - NLS https://nordiclifescience.org/category/business/ 32 32 Pharmaceutical export – strong driving force for the Swedish economy https://nordiclifescience.org/pharmaceutical-export-strong-driving-force-for-the-swedish-economy/ https://nordiclifescience.org/pharmaceutical-export-strong-driving-force-for-the-swedish-economy/#respond Fri, 30 Aug 2024 09:19:37 +0000 https://nls.dev8.qte.nu/?p=87425 Swedish pharmaceutical exports continue to develop positively according to new figures from Statistics Sweden (SCB). Sweden’s total exports increased by 4 percent in value and two percent in volume during the second quarter of 2024 compared to the same time period in 2023. Pharmaceutical exports increased during the period by 9 percent in value and […]

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Swedish pharmaceutical exports continue to develop positively according to new figures from Statistics Sweden (SCB).

Sweden’s total exports increased by 4 percent in value and two percent in volume during the second quarter of 2024 compared to the same time period in 2023. Pharmaceutical exports increased during the period by 9 percent in value and 3 percent in volume.

“The fact that we see a steady and significant increase in pharmaceutical exports shows the continuous global demand for Swedish medical innovations. This is not only a sign of the strength of our research pharmaceutical companies, but also shows the importance of the sector for Sweden’s economy and prosperity,” says Frida Lundmark, expert in life science at Lif – the research pharmaceutical companies.

During January to June, pharmaceuticals accounted for 7.7 percent of Sweden’s total export value. During the first half of 2024, Sweden exported medicines worth nearly SEK 82 billion. During the same period, medicines worth SEK 40 billion were imported. This means that pharmaceuticals have a positive trade net of almost SEK 42 billion and strongly contribute to a positive Swedish trade balance.

The importance of ongoing political processes

Frida Lundmark highlights the importance of ongoing political processes to ensure continued success.

“The revision of the Swedish life science strategy and the upcoming research and innovation bill are crucial to strengthen the conditions for our companies to continue developing and exporting vital medicines. It is through long-term political decisions that we can ensure that Sweden’s life science sector remains competitive and continues to contribute to both Swedish welfare and global health,” says Frida Lundmark.

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A paradigm-shift and a narrative change https://nordiclifescience.org/a-paradigm-shift-and-a-narrative-change/ Mon, 29 Jul 2024 11:14:26 +0000 https://nordiclifescience.org/?p=86584 Besides the extraordinary success of GLP-1 agonists, the recent groundbreaking developments within obesity treatment have also led to obesity being viewed as a chronic biological disease. The World Obesity Federation estimates that 1.1 billion people over the age of five are obese today, and 1.6 billion are overweight. The prevalence of obesity in the U.S. […]

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Besides the extraordinary success of GLP-1 agonists, the recent groundbreaking developments within obesity treatment have also led to obesity being viewed as a chronic biological disease.

The World Obesity Federation estimates that 1.1 billion people over the age of five are obese today, and 1.6 billion are overweight. The prevalence of obesity in the U.S. has grown from 30.5% in 1999–2000 to 41.9% in the period of 2017–2020, according to the Centers for Disease Control and Prevention (CDC). Obesity is also on the rise in the Nordic region with Finland in the lead. According to the Finnish Institute for Health and Welfare, of young adults under 30, 19% of women and 17% of men are obese. In the adults-over-30 age group, 28% of women and 26% of men are obese. Almost one in two men and women have abdominal obesity. These extra kilos entail increased risk of severe health conditions like type 2 diabetes, heart diseases, and even certain cancers, and the global cost of treating obesity-related complications is expected to be USD 1.2 trillion by 2025.

According to the Finnish Institute for Health and Welfare, of young adults under 30, 19% of women and 17% of men are obese. In the adults-over-30 age group, 28% of women and 26% of men are obese.”

Up until recently the road to weight-loss for people suffering from obesity was long and hard, and often impossible. The pharmacological management of obesity has included amphetamines, thyroid hormones, dinitrophenol, and various drug combinations that were withdrawn due to serious adverse effects shortly after regulatory approval (Müller et al., Nature Review, 2021). Agents as diverse as mitochondrial uncouplers, sympathomimetics, serotonergic agonists, lipase inhibitors, cannabinoid receptor antagonists, and a growing family of gastrointestinal-derived peptides chemically optimized for pharmaceutical use have also been investigated. Many of these approaches, conclude Müller et al., have had a common inability to achieve placebo-adjusted mean weight loss greater than 10% of initial body weight when chronically administered at tolerable doses. If greater weight loss is achieved, it has typically been accompanied with serious acute or chronic adverse effects.

The discovery

So what is so great about these GLP-1 agonists? Briefly put, they mimic the glucagon-like peptide-1 (GLP-1) satiety hormones in our bodies, which lower blood sugar and curb appetite. GLP-1 was first discovered at the University of Copenhagen in 1986 by professor Jens Juul Holst and his colleagues, and since then scientists and companies have developed treatments for glucose regulation, mainly in diabetes.

This year, the FDA also approved a label expansion for Wegovy for the indication of reducing the risk of major adverse cardiovascular events including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke in adults who are either overweight or obese and have an established cardiovascular disease.”

A once-weekly injection of Novo Nordisk’s semaglutide (brand name Wegovy) was FDA approved in June 2021 after a Phase III trial showed that the participants lost 15% of their body weight after 16 months of treatment. In early 2022 it was approved in the UK and the EU as well. In the 2000s the FDA began approving drugs that mimicked GLP-1 for type 2 diabetes treatments (including Novo Nordisk’s Ozempic, which is the same drug as Wegovy but in a different dose), but scientists had noticed their trial participants also lost weight. So they began to trial these drugs for obesity. Today Wegovy is  an approved weight-loss drug for adults who have obesity, as well as people with a body mass index (BMI) of at least 27 who also have a weight-related condition, such as high blood pressure or high cholesterol. This year, the FDA also approved a label expansion for Wegovy for the indication of reducing the risk of major adverse cardiovascular events including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke in adults who are either overweight or obese and have an established cardiovascular disease.

The new market

The GLP-1 market has so far been dominated by Novo Nordisk’s Ozempic and Wegovy and Eli Lilly and Company’s Zepbound and Mounjaro, and according to Chris Schott, a Senior Analyst at J.P. Morgan, the obesity market will largely be a duopoly between these two companies (The increase in appetite for obesity drugs, J.P. Morgan, 2023). However, J.P. Morgan also predicts the emergence of new biotech firms seeking to enter this drug race, for example exploring how certain medications work in tandem with GLP-1s.

A chronic biological disease

There is no doubt that these new drugs have been a real game-changer within obesity treatment. The newest generations of GLP-1s and combos have led to approximately15–25% weight loss on average, well above prior generations of products. They can obviously save lives and reduce healthcare costs, but they are also changing the narrative on obesity. The condition is starting to be viewed as a chronic biological disease and outside of the patients’ control through lifestyle changes alone.

While demand could continue to outstrip supply for the next several years, we do see these issues resolving in the longer term with more plants coming online and more competitive oral options becoming available.”

However, there are also challenges, including financial and practical ones. For example, patients need to be on these drugs for the long term and often cannot stop taking them. Data from a Novo-funded study in April 2022 showed that patients regained two-thirds of their lost weight one year after discontinuing the use of the drug. Another obstacle is providing access to those who really need them. The drugs have been in short supply at pharmacies worldwide and those who really need injections cannot get them. “While demand could continue to outstrip supply for the next several years, we do see these issues resolving in the longer term with more plants coming online and more competitive oral options becoming available,” predicts Chris Schott in the J.P. Morgan report.

A pill on the way

And now, there is a race towards FDA approval of an equally effective oral medicine. Oral weight loss drugs may signal a more affordable and easier alternative to drugs that require injections. Novo Nordisk’s Rybelsus, a once-daily oral version of semaglutide, was FDA approved in 2019 for type 2 diabetes management. Last year, the company released the results from a 68-week trial with 667 adults who are either obese or overweight with one or more comorbidity. On average, participants lost 15.1% of their body weight after 68 weeks compared to 2.4% of body weight from those on the placebo.

The study acknowledged that the side effects were comparable to the semaglutide injections, with mainly mild to moderate gastrointestinal adverse events (like nausea or diarrhea) being the most common side effect. So it is just a matter of time …

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A treatment shift? Nordic progress beyond GLP-1 https://nordiclifescience.org/a-treatment-shift-nordic-progress-beyond-glp-1/ Mon, 22 Jul 2024 10:43:15 +0000 https://nordiclifescience.org/?p=86577 In the wake of the groundbreaking GLP-1 receptor agonists, a number of new obesity treatments and weight management approaches are emerging  – and a few of them come from the Nordic region. Behavior Lifestyle changes are critical for weight loss, even for patients taking the GLP-1 anti-obesity drugs, and we all know that implementing and […]

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In the wake of the groundbreaking GLP-1 receptor agonists, a number of new obesity treatments and weight management approaches are emerging  – and a few of them come from the Nordic region.

Behavior

Lifestyle changes are critical for weight loss, even for patients taking the GLP-1 anti-obesity drugs, and we all know that implementing and maintaining lifestyle changes can be really hard. Finnish digital health company Onnikka Health has developed a solution to support weight management and this critical lifestyle change. The company originated from the University of Oulu and professor Markku Savolainen’s quest to develop an accessible and cost-effective solution for the obesity epidemic.

While GLP-1 receptor agonists are often very effective in helping with reducing food intake, their impact typically disappears with the ending of the medication, unless the treatment is supported by an efficient lifestyle intervention.”

“Achieving sustained weight loss requires a permanent change in one’s lifestyle and eating behavior. While GLP-1 receptor agonists are often very effective in helping with reducing food intake, their impact typically disappears with the ending of the medication, unless the treatment is supported by an efficient lifestyle intervention. For the majority of obese people, weight-loss drugs are not an option due to cost, availability, or some other reason, whereas efficient lifestyle intervention can be a very good choice for most people,” says Teppo Virkkula, CEO of Onnikka Health.

Savolainen and his team joined forces with Harri Oinas-Kukkonen, a professor of information systems science whose team has developed a Persuasive Systems Design method (PSD) that can influence users to change attitudes and behavior for a sustained period. The two teams combined aspects of behavioral change with PSD.

Teppo Virkkula, CEO, Onnika Health

“Onnikka is all-digital and a cost-effective lifestyle intervention which helps people achieve sustained lifestyle changes and weight loss. It has been systematically developed over more than ten years by using a scientific framework that is proven to impact people’s thinking, attitudes, and behavior,” says Virkkula.

Most users lose 2-5% of their weight with Onnikka and keep it off for many years as proven by clinical studies, according to the company. “Users especially like Onnikka’s gentle and positive approach and non-intrusiveness, as evidenced by very good user feedback and excellent retention rates of over 75% for the one-year program,” says Virkkula.

According to the WHO, one in eight people, or more than one billion people, are now living with obesity, and the problem is forecasted to get even worse, emphasizes Virkkula.

“The economic impact is huge. It is estimated that 10% of all healthcare costs are related to overweight and obesity. The need for efficient, scalable, and cost-efficient solutions to tackle the problem has never been greater,” he concludes.


Prevention

Preventive health is on the rise and Swedish healthtech company Sigrid Therapeutics aims to prevent chronic lifestyle diseases, including obesity, with its new materials platform technology, SiPore.

“Obesity is a global burden affecting billions of people. If nothing is done, obesity could cost the world over USD 4 trillion a year by 2035. It will not be sustainable to treat billions of people with drugs. A healthy lifestyle and early intervention is key for preventing obesity,” emphasizes Sana Alajmovic, CEO and co-founder of Sigrid Therapeutics.

Sigrid Therapeutics is grounded in research conducted at Stockholm University and Karolinska Institutet and co-founder professor Tore Bengtsson’s discovery that undesirable changes in metabolism are normalized after the ingestion of modified silica particles. SiPore consists of precisely engineered micron-sized silica particles with tailored porosity. Inside the gut, these particles work as a molecular sieve by mechanically separating digestive enzymes from undigested food, thereby improving metabolic health through a gentle mode of action, according to the company. The particles pass through the body without being absorbed and are safely eliminated in the same manner as food.

It has a superior safety profile as it acts locally in the gut, which makes it a perfect long-term solution for those who cannot tolerate GLP-1 treatments or would like to sustain their weight loss post GLP-1 treatments.”

“Our SiPore technology is uniquely positioned to help manage weight sustainably. It has a superior safety profile as it acts locally in the gut, which makes it a perfect long-term solution for those who cannot tolerate GLP-1 treatments or would like to sustain their weight loss post GLP-1 treatments,” explains Alajmovic.

Sana Alajmovic, CEO and Co-Founder, Sigrid Therapeutics

The company’s lead product candidate, SiPore21 is an orally-administered medical device for the safe reduction of blood sugar levels in people at risk of developing diabetes, prediabetes, and newly diagnosed type 2 diabetes, but the pipeline of potential products based on the platform also includes obesity and treatment of excessive bile acid levels post bariatric surgery, and weight loss.

“Numerous animal and clinical trials conducted on our breakthrough medical device gel have demonstrated its ability to effectively and safely reduce caloric absorption from meals, as well as to decrease both post-meal and long-term blood sugar levels, all while preserving vital muscle mass,” states Alajmovic.

The company has also recently launched an over-the-counter dietary food supplement, Glucose Stabiliser, designed to control blood sugar and body weight. It is supposed to reduce calorie intake from fat and carbohydrates, and it is taken before the two biggest meals of the day.

“Consumer studies show that 81% of consumers use the product for weight loss. Furthermore, 78% report successful regulation of blood sugar levels, and 77% experience reduced bloating,” says Alajmovic.


Delaying

Beyond the GLP-1 receptor agonists, companies are also looking at other mechanisms of action on weight loss. For example, Swedish Empros Pharma aims to launch its drug candidate EMP16 in 2027.

“EMP16 is an oral drug that is safe and well tolerated. It will also be cost effective,” states Arvid Söderhäll, CEO of Empros Pharma. “It has proven to have a good effect on weight loss, even though it does not entail the very fast weigh loss gained from the GLP-1 drugs. Weigh loss with EMP16 is about 70% fat and 30% muscle mass, which is a very good result. Additionally it has shown to have a good effect on many medical complications that accompany obesity, such as type 2 diabetes, cardiovascular diseases, liver health, and so on.”

EMP16’s main mechanism of action is to delay normal food digestion and absorption processes until the end of the small intestine. It is a fixed-dose combination of two locally active, safe, and established active drugs (orlistat and acarbose). The multiple-unit, modified-release formulation has been designed to maximize the effect of the drugs as well as improve tolerability.

“We have just finished a Phase 2b study and we will have an end-of-Phase-2 meeting with the FDA later in May this year. In total, we have concluded four clinical studies with EMP16 and we plan to initiate Phase 3 studies later this year,” says Söderhäll.

Team Empros Pharma: Mark Quick, Stefan Grudén, Arvid Söderhäll, Halide Shala and Ulf Holmbäck.

Empros Pharma was founded in 2013 by researchers and entrepreneurs at Uppsala University together with the investor Flerie Invest, and Arvid Söderhäll has identified several market opportunities for EMP16.

It is widely known that in practice GLP-1 drugs are not used chronically. About 70% of the patients quit within a year and the patients regain weight as soon as their treatment has finished. EMP16 has a better possibility to function as a chronic treatment.”

“Firstly, as a chronic obesity treatment, perhaps following a treatment with a GLP-1 drug. It is widely known that in practice GLP-1 drugs are not used chronically. About 70% of the patients quit within a year and the patients regain weight as soon as their treatment has finished. EMP16 has a better possibility to function as a chronic treatment,” he states.

“Secondly, EMP16 is very effective for about one third of patients (the responders), in fact, they respond so well that the weight-loss results are comparable with the market leaders. The patient group typically consists of those who have relatively moderate obesity and not too many comorbidities.”

A third market segment for EMP16 is as a combination drug, concludes Söderhäll.

“The mechanism of action is not systemic and can therefore be combined with other obesity drugs. For example, a low dose of EMP16 in combination with a low dose of a GLP-1 drug can achieve a good effect, perhaps completely without side effects.”


Modulating

Danish biopharma company Saniona’s expertise in ion channel drug discovery has also led to the development of a potential new obesity treatment. Tesofensine is a triple-monoamine reuptake inhibitor that modulates brain activity by increasing the levels of three neurotransmitters, dopamine, serotonin, and noradrenaline, which are all intimately involved in regulating appetite, food-seeking behavior, and metabolism. Tesofensine is provided in tablets and will not require titration.

Its weight-reducing effect has been confirmed in a six-month Phase 2 clinical trial in patients with obesity, indicating that tesofensine at the expected recommended dose of 0.50 mg per day provides a weight loss of 10% or more in 24 weeks.

Compared to the subcutaneous GLP-1 analogs, tesofensine is more convenient to use as it is provided in tablets. Furthermore, there is no need for titration.”

“The substantial weight loss and benign safety profile of tesofensine suggest that tesofensine would have a positive impact on cardiovascular outcome like some of the GLP-1 drugs, but unlike several non-GLP-1 medications for treatment of obesity,” says Thomas Feldthus, co-founder and CEO of Saniona. “Compared to the subcutaneous GLP-1 analogs, tesofensine is more convenient to use as it is provided in tablets. Furthermore, there is no need for titration.”

Thomas Feldthus, CEO and Co-Founder, Saniona. Photo: Christoffer Askman

The company’s partner Medix has completed a Phase 3 program with tesofensine in people with obesity, confirming the efficacy and a favorable safety profile. Based on these studies Medix submitted a new drug application to the Mexican food and drug administration, COFEPRIS, in 2019 for approval of tesofensine for the treatment of patients with obesity. The regulatory path was complicated by COVID-19 but in February 2023 the technical committee on new molecules (an advisor to the regulatory agency in Mexico) provided a favorable opinion on tesofensine for the treatment of obesity. Medix subsequently filed a formal application and is currently in close dialog with the regulatory agency in Mexico anticipating a favorable outcome. According to Medix, the current market for prescription medicine for obesity in Mexico is approximately USD 200 million.

“Medix has an inventory of drug substance and a large facility for producing the tablets. Therefore, they should be able to launch the product relative fast following approval, probably within six months,” says Feldthus. “Mexico would be the first country in the world to register tesofensine for obesity. If approved, we may start to introduce it in other territories starting with South America.”

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HiloProbe secures SEK 3 million in funding https://nordiclifescience.org/hiloprobe-secures-sek-3-million-in-funding/ Tue, 25 Jun 2024 09:32:27 +0000 https://nordiclifescience.org/?p=86606 HiloProbe has raised funding from existing owners. “The main focus of this capital injection is to initiate sales, enabling us to attract a larger amount of capital. We anticipate reaching a break-even point after that,” says Lina Olsson, CEO of HiloProbe. HiloProbe describes the interest in its product as “significant” and that the company is close […]

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HiloProbe has raised funding from existing owners.

“The main focus of this capital injection is to initiate sales, enabling us to attract a larger amount of capital. We anticipate reaching a break-even point after that,” says Lina Olsson, CEO of HiloProbe.

HiloProbe describes the interest in its product as “significant” and that the company is close to a breakthrough and the commencement of using ColoNode. This reagent kit utilizes molecular technology, RT-PCR, along with associated web-based software to analyze lymph nodes after surgery of patients with colorectal cancer.

Partnerinvest Norr, an early investor in HiloProbe since 2018, is among the financiers who have recently provided this new capital boost.

“Through several clinical studies, HiloProbe’s ColoNode has been proven to offer more detailed information about colorectal cancer patients’ condition to the treating physicians than current methods allow,” says Mattias Eriksson, investment manager at Partnerinvest Norr. ”We believe that HiloProbe has a good chance of contributing to improved cancer care and becoming commercially successful.”

Photo of Lina Olsson: HiloProbe

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Reshaping the cell therapy sector https://nordiclifescience.org/reshaping-the-cell-therapy-sector/ Tue, 28 Nov 2023 05:39:38 +0000 https://nordiclifescience.org/?p=74387 The previous founder and CEO of BioLamina has gone back to business development, and with his newly founded company he aims to redefine cell therapy development even further. Newly founded Alder Therapeutics is a preclinical phase stem cell therapy development company and, according to Kristian Tryggvason, co-founder and CEO, it is “the next big thing.” […]

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The previous founder and CEO of BioLamina has gone back to business development, and with his newly founded company he aims to redefine cell therapy development even further.

Newly founded Alder Therapeutics is a preclinical phase stem cell therapy development company and, according to Kristian Tryggvason, co-founder and CEO, it is “the next big thing.” The company builds upon data from animal studies that have shown the benefits of the photoreceptor cell differentiation and cardiac cell differentiation methods. These methods have been further developed by Kristian’s father and co-founder of BioLamina, Professor Karl Tryggvason, together with Duke-NUS Medical School and other external parties.

After talking with my two ‘soon to be’ colleagues, I thought this might be the next big thing and sought to start this company myself instead.”

“The idea behind Alder Therapeutics began during my time working with BioLamina. It owned a patent together with Duke-NUS and my job was to license it. We got into a deep due diligence process with one party who really liked the science and dug further in to it. In the end the deal did not go through, but I had a deep insight into the two programs and thought that these might be the best cell therapy programs out there,” he describes.

“After talking with my two ‘soon to be’ colleagues, I thought this might be the next big thing and sought to start this company myself instead.”

Together with Stijn Heessen and Ricardo Baptista, Kristian was able to raise EUR 3 million in seed funding from Flerie and Linc and earlier this year they licensed the technology from Duke-NUS, transferred the manufacturing process to a CDMO, and generated analytical methods that further bolstered the company’s operations. Alder today has two cell therapy candidates – allogeneic stem cell therapies – for diseases with high unmet need, Retinitis Pigmentosa (RP) and chronic heart failure.

“The USP for Alder and our lead program is that we can make excellent photoreceptor cells with a fantastic manufacturing method that treats Retinitis Pigmentosa, an orphan disease, in three different animal models,” says Kristian. “As the manufacturing costs are low and the reimbursement is high, there is also a great commercial opportunity here once the drug is ready to be used. The beauty is that the way we developed this and the cardiac treatment, we can use it for multiple cell therapy programs later on, once we have shown that the lead program works in a human Phase I/IIa trial.”

As founder and CEO of the company Kristian is responsible for driving preclinical development, and managing all PR, marketing and fundraising activities. He hopes that he and his colleagues can announce their next financing round, as well as enter toxicology studies by the end of 2024.

“We should also be finished with the CMC part for Phase I/IIa study within this time period,” he says.

 

 Team Alder Therapeutics: Ricardo Baptista, Chief Technology Officer, Kristian Tryggvason, CEO, and Stijn Heessen, Chief Operations Officer. Photo: Ulf Sirborn

 

Always wanted to start a company

Entrepreneurship is nothing new to Kristian. Fifteen years ago, in 2008, he founded BioLamina together with his father. His father had performed research on extracellular matrix proteins, and had been able to produce full-length, human recombinant laminin proteins, something many research groups had tried but had not been able to do. Karl Tryggvason recognized that this accomplishment was an excellent research tool with the potential to facilitate the development of cell therapies, and he encouraged his son to co-found a company based on it.

Once I had analyzed the idea and the concept, I thought that if I want to start a company, I might never find an idea or concept that is equally good.”

“I was looking for a new opportunity to pop up, and I had always wanted to start a company. Once I had analyzed the idea and the concept, I thought that if I want to start a company, I might never find an idea or concept that is equally good,” says Kristian. “Even if I was afraid that I might fail in building the company and ruining the fantastic idea, I thought I just had to take the chance.”

A good decision as it would turn out. BioLamina is today a profitable EUR 100 million enterprise with more than 70 employees and more than EUR 17 million in annual sales across 35 countries. The company’s products solve many of the technical problems associated with maintaining human pluripotent stem cells in a naive state and pushing these stem cells towards different specialized cell types, such as neurons, heart cells, and liver cells.

“The laminin technology makes culturing any cells on plastic dishes feel like they are safe in the body environment and therefore they are much easier to handle,” explains Kristian.

The toughest challenge was really to convince scientists around the world that they should test and use these (back then) expensive products in their manufacturing by extrapolating data from quite limited scientific data.”

When I asked him about BioLamina’s greatest success factors he stated that firstly their product truly makes it easier to develop cell therapies and in detail handle the manufacturing process. “The success factors were a result of recruiting a fantastic team that was unafraid to try and convince all the key opinion leaders of the benefits that the products from a tiny Swedish company had (most customers were in the US and UK). The team was really dedicated to making sure cell therapies would become a reality with the help of our products,” he says.

“The toughest challenge was really to convince scientists around the world that they should test and use these (back then) expensive products in their manufacturing by extrapolating data from quite limited scientific data,” he adds.

“Once they tested them and used them for years, more and more scientific publications showed that our hypothesis was usually right, and with the help of the products, the scientist could do miracles within their areas. This we did with a fantastic team that travelled around the world talking to scientists. What we learned in one place, we spread to others and the community as a whole benefited from that. It is the great team, persistence, belief and great products that helped here.”

Obtaining key investors is like a dating game

Regardless of running BioLamina or founding Alder, Kristian says that the best part of his job is that he gets to work closely with “fantastically intelligent people that, similar to me, want to develop treatments or want to make the healthcare sector better to save lives or increase the quality of lives of billions of people.”

“Making a difference gives me the kicks,” he says.

Having founded and run BioLamina, Kristian has built a huge network within the cell and regenerative medicine field, enabling him to find the talents in the field, and to understand the field and its competitors. “I believe you learn something from every job you are in, in addition to things that happen outside your job,” he adds.

His advice to other life science entrepreneurs is that obtaining key investors is like a dating game – a similar manner to finding your husband or wife.

“You need to meet a lot of candidates to find someone you really feel comfortable with and for them to feel comfortable with what you do. If you are not looking for institutional funding, the people most likely to invest in you are those that can relate to what you do. If you are trying to build a drug development company, talk with people that have maybe become rich within that space, or at least that have invested a lot in that space,” he advises.

A cell therapy expert

At the beginning of his career, however, he was not sure what he wanted to work with and he has stated that he did not want to work in the same field as his father.

“I was really lost after high school and didn’t really know what to do. I had no idea what I wanted to become. That summer I met the CEO of a small biotech company when they were in their fundraising stage and I spent time with them for a week after they had pitched to VC companies. I thought it sounded like fun and asked him what I needed to do to be able to become good at what he was doing. He said you should get a PhD first,” says Kristian.

“So that’s when I started studying molecular biology [he has a M.Sc in Molecular Biology from the University of Oulu], then a PhD [from the Karolinska Institutet], and then an MBA [from the Copenhagen Business School]. I find the area very rewarding, as we are trying to develop new ways to treat people. I have always been fascinated with that.”

In the beginning it was difficult to make monoclonal antibodies and the technology was not there. Today it is a routine job.”

With more than a decade of experience in the cell therapy field, Kristian Tryggvason believes that in the future there will be a huge development in manufacturing in a similar way that happened with monoclonal antibodies. “In the beginning it was difficult to make monoclonal antibodies and the technology was not there. Today it is a routine job.”

When asked about Nordic life science strengths, he says that the region has been the home of huge pharmaceutical companies, and therefore there is a lot of competence within different areas of drug development.

“Another strong area is proteins and protein technology. Companies like Novo and Cytiva are good examples within this category,” he concludes.

This interview was originally published in NLS magazine No 04 2023, out November 2023

Featured photo of Kristian Tryggvason

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Report: The life science sector is unknown to many in Western Sweden https://nordiclifescience.org/report-the-life-science-sector-is-unknown-to-many-in-western-sweden/ Mon, 13 Nov 2023 10:09:24 +0000 https://nordiclifescience.org/?p=74212 Residents in the Gothenburg area have very little knowledge of the life science sector, shows a new survey from Novus, an analysis and research company. For this reason, six major life science players are marking the start of a joint communicative effort, with the goal of putting the West Swedish life science sector on the […]

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Residents in the Gothenburg area have very little knowledge of the life science sector, shows a new survey from Novus, an analysis and research company.

For this reason, six major life science players are marking the start of a joint communicative effort, with the goal of putting the West Swedish life science sector on the map.

“This survey shows that we have to get better at sharing our fantastic journey. That’s why we want to mark the start of this gathering of forces where together we in the life science sector gear up our work to communicate what we do,” says Matti Ahlqvist, Site manager at AstraZeneca in Gothenburg.

We want to promote good initiatives that lead to increased awareness, new collaborations and attract talent to life science.”

“We want to promote good initiatives that lead to increased awareness, new collaborations and attract talent to life science,” says Marie Uddenmyr, Director Corporate Relations at GoCo Health Innovation City.

Excerpt from the survey

The survey was carried out by Novus on behalf of the Västra Götaland Region, AstraZeneca, Chalmers University of Technology, Business Region Gothenburg, GoCo Health Innovation City and Sahlgrenska Science Park. The survey was carried out as a web-based survey in Novus Sweden panel, between 4-13 October 2023 with 600 people aged 18-84 in Gothenburg and neighboring municipalities.

“The survey shows the importance of communicating both the need and all the positive developments that take place within academia and industry. It affects us all, the future is our joint responsibility to enable healthcare at the forefront,” says Annica Grimberg Lignell, acting CEO of Sahlgrenska Science Park.

The survey shows for example that almost 4 out of 10 state that they hardly know anything about the life science sector in the Gothenburg area, or do not know it at all, and 13 percent have never heard of the sector.

It also shows that together with tech/IT/telecom, life science is the sector that western Swedes know the least about.

The vehicle industry has a figure almost three times as high at 42 percent.”

West Swedes who have deep knowledge of the life science sector, i.e. know it “quite well” or “very well”, make up only 16 percent, the survey shows. Here, too, life science is in the bottom layer. The vehicle industry has a figure almost three times as high at 42 percent.

 

There are also life science arenas in the region, such as Sahlgrenska Science Park and GoCo Health Innovation City. Photo: GoCo

 

The Life Science sector in Western Sweden

The life science sector in Western Sweden employs just over 10,000 people and the life science cluster in Gothenburg is one of the largest in the Nordic region. There are approximately 650 life science companies in the region. Ten of these companies have a turnover of more than one billion SEK.

The broad expertise gathered here creates synergies, and we have great potential to generate even more employment and export revenue.”

There are a large number of important actors in this region, for example on the private side, AstraZeneca, Getinge and Mölnlycke Healthcare, and on the public side, the Västra Götaland region including Sahlgrenska University Hospital, Gothenburg University including Sahlgrenska Academy and Chalmers University of Technology. There are also life science arenas in the region, such as Sahlgrenska Science Park and GoCo Health Innovation City. Many actors are gathered in Health Innovation West, a collaborative organization to build and develop the life science cluster in Western Sweden.

“Gothenburg plays an extremely important role in the life science sector. The broad expertise gathered here creates synergies, and we have great potential to generate even more employment and export revenue. The environment here is fantastic to work in. More people need to know about it, both Gothenburgers and others,” says Patrik Andersson, CEO, Business Region Göteborg.

Read more: New innovation cluster for advanced therapies

Featured photo: GoCo

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AI use is increasing in medicine & life sciences https://nordiclifescience.org/artificial-intelligence-use-is-increasing-in-medicine-life-sciences/ Mon, 06 Nov 2023 05:08:33 +0000 https://nordiclifescience.org/?p=74122 The speed at which artificial intelligence (AI) is becoming part of everyday life has taken much of the world by surprise, but perhaps less so in the Nordic countries where much of the infrastructure already exists to accommodate the new technology.

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Among the areas that are adopting AI the fastest are life sciences and medicine, both in the clinical and research fields, through national efforts and multi-nation collaborations. While each innovation that enters the market seems to take less time to be adopted – as evidenced by how quickly cell phones became indispensable – AI is setting new records.

“The steam engine and electricity took decades to become part of daily life,” says Christian Guttmann, Professor at Karolinska Institutet and Executive Director of the Nordic AI Institute, who focuses his research on AI use in health, medicine and pharmaceuticals. “Generative AI took only two months to reach 100 million users.”

Generative AI took only two months to reach 100 million uses.

An established discipline

For Christian Guttmann, who has studied and applied AI, machine learning and multi-agent systems in healthcare for several decades, the explosion of AI applications is not surprising. A scientist, entrepreneur and businessman, he was named one of the top 100 AI global leaders in 2019. Life science/medical areas with the most opportunities for AI use include drug development, research and diagnoses, he believes.

We can use AI to match molecules to pathogens, manage chronic diseases and in healthcare to look at patterns of certain conditions. It will lead to major advancements in healthcare operations and services, and doctors and hospitals will benefit from better delivery of services.”

“In the Nordic countries, it is an established discipline,” Guttmann says. “In part this is because so much information is already digitized. We can use AI to match molecules to pathogens, manage chronic diseases and in healthcare to look at patterns of certain conditions. It will lead to major advancements in healthcare operations and services, and doctors and hospitals will benefit from better delivery of services.”

AI also has been used to identify additional uses for drugs other than their original purpose and to track the long-term well-being of patients. “There is very accurate data around quality registries and very accurate information about people’s health outcomes,” Guttmann says. “When we combine that knowledge, we aim to use it for real-world evidence.”

Nordic initiatives

Think tanks in different countries continue to study more uses for AI in the life sciences and medical fields. Sweden has invested USD 1 billion in Hagastaden in Stockholm, a city district fostering life science research and entrepreneurship through a collaboration of businesses, healthcare and university professionals. SciLifeLab & Wallenberg National Program for Data-Driven Life Science is a 12-year, SEK 3.1 billion project charged in part with training life scientists to use data more efficiently.

An initiative to improve diagnoses of brain ailments at HUS Helsinki University Hospital in Finland, in conjunction with local corporations, has led to the development of an algorithm that can identify potentially deadly intracerebral hemorrhages by reviewing images. The next goal is to create a formula that can pinpoint all sudden intracerebral hemorrhages.

In other nations, Norway is revamping its healthcare system and looking for ways to apply AI, while Denmark is exploring how AI can help manage its homecare programs, notes Guttmann.

The hope is to position the Nordic countries at the forefront when it comes to ethical AI and responsible use of health data.”

Nordic Innovation initiatives go even deeper into AI uses. A three-year project is underway to create and showcase an ethical algorithm capable of reading digital and analog patient journals, from different countries and health systems, as well as in different languages. Besides the primary goal of simplifying access to records, while maintaining patient privacy, the hope is to position the Nordic countries at the forefront when it comes to ethical AI and responsible use of health data.

Christian Guttmann, Professor, Karolinska Institutet, Executive Director, Nordic AI Institute

Implementation and data protection

One of the challenges of implementing AI in healthcare is the disconnect between technology and medicine. While big technology companies can produce innovations quickly, implementing them in hospitals and medical settings can take much longer.

Privacy and data protection also remain key concerns in AI use, especially when it comes to personal information. Some healthcare professionals worry about a lack of transparency and provenance when AI is applied in healthcare settings. While the results are often superior to those produced by a human, there is concern about the inability to see all the steps that led to the outcome. “They want very accurate traceability,” Guttmann says. “That concern should be balanced against the benefits of using AI.”

Generative AI certainly is the opportunity to identify major trends.”

Christian Guttmann continues to see a strong future for AI.

“We’ll be looking at outcomes of health operations and delivery, to track the journey of a patient,” he says. “Generative AI certainly is the opportunity to identify major trends.”

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Multiple issues need further investigation in SynAct trial https://nordiclifescience.org/multiple-issues-need-further-investigation-in-synact-trial/ Thu, 02 Nov 2023 07:19:42 +0000 https://nordiclifescience.org/?p=74112 SynAct Pharma has announced evaluation of the 4-week RESOLVE Phase 2a clinical trial in moderate to severely active rheumatoid arthritis patients with an incomplete response to methotrexate. During the evaluation of the unblinded study data SynAct Pharma identified multiple issues that need further investigation before any conclusion on the outcome of the study can be […]

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SynAct Pharma has announced evaluation of the 4-week RESOLVE Phase 2a clinical trial in moderate to severely active rheumatoid arthritis patients with an incomplete response to methotrexate.

During the evaluation of the unblinded study data SynAct Pharma identified multiple issues that need further investigation before any conclusion on the outcome of the study can be made, the company states. The RESOLVE study was designed to identify doses of resomelagon (AP1189) to be applied in part B of the trial and as an initial assessment of safety and tolerability in patients with moderate to severely active rheumatoid arthritis with an incomplete response to methotrexate (MTX). The study conducted under an US-IND at sites in the US, Moldova and Bulgaria and tested 3 doses of resomelagon vs placebo; a total of 125 patients were randomized and the study was conducted though a contracted full-service CRO.

“We are disappointed with the issues we have encountered in attempting to assess the RESOLVE study,” stated Torbjörn Bjerke, CEO of SynAct Pharma. “We have informed the clinical CRO that we will be initiating a third-party audit.”

SynAct Pharma has decided to initiate a full third-party investigation into the conduct and quality of the trial including a full study audit. The audit will also include the EXPAND study as the previously announced trial was run by the same CRO with an overlap in clinical sites. SynAct Pharma will further inform the market when the full investigation of the study has been finalized which it anticipates will be available in the beginning of 2024, it states.

Photo of Torbjørn Bjerke: SynAct

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Interview: Jonina Gudmundsdottir, Coripharma https://nordiclifescience.org/interview-jonina-gudmundsdottir-coripharma-2/ Wed, 01 Nov 2023 05:30:07 +0000 https://nordiclifescience.org/?p=74076 In the heart of Iceland’s life sciences industry, Jonina Gudmundsdottir, the CEO of Coripharma, is making her mark. With a deep understanding of the industry’s challenges and a relentless drive for excellence, Gudmundsdottir has steered Coripharma toward transformative success. Iceland’s life sciences industry has thrived in recent years, propelled by its unique strengths. With a […]

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In the heart of Iceland’s life sciences industry, Jonina Gudmundsdottir, the CEO of Coripharma, is making her mark. With a deep understanding of the industry’s challenges and a relentless drive for excellence, Gudmundsdottir has steered Coripharma toward transformative success.

Iceland’s life sciences industry has thrived in recent years, propelled by its unique strengths. With a culture of innovation that has fostered a fertile ground for life sciences, Coripharma, under Chief Executive Officer (CEO) Jonina Gudmundsdottir‘s leadership, has capitalized on these advantages as a new company in name, but not without history or experience.

While the name Coripharma itself is relatively new, the origins of the company actually date back to the 1980s, and a company named Delta hf. Fast forward to the early 2000s and a couple of mergers later, Delta hf. rebranded as Actavis in 2004. Later acquired by Teva Pharmaceuticals in 2016, Coripharma was then founded in 2018 and acquired Actavis from Teva.

“Though it has a slightly confusing history, I would say we are not totally regarded as a newcomer in the business, even though we have a new name,” Gudmundsdottir notes happily.

This fortunately also hasn’t hindered business opportunities for a company like Coripharma explains Gudmundsdottir. “Everyone is looking to reduce the complexity and reduce their number of suppliers. So I’m very happy to say that we have already signed with all of the big players in Europe and we are good partners for our customers, which we can prove again and again,” she says.

The right focus

Jonina Gudmundsdottir’s experience in the pharmaceutical industry has shaped her leadership style. As the CEO of Coripharma, she aims to position the company in a way that suits it, particularly in where to focus their business.

By positioning the company in this area, for a relatively small company there is no danger of competing with larger manufacturers, as this is where we are kind of putting our focus, not competing with large-scale manufacturing.”

“What is typically happening is that pharmaceuticals are becoming more specific, they only affect very specific cells for a specific disease. By positioning the company in this area, for a relatively small company there is no danger of competing with larger manufacturers, as this is where we are kind of putting our focus, not competing with large-scale manufacturing,” she explains.

Yet, like any industry, the life sciences sector faces its fair share of challenges. Gudmundsdottir recognizes the importance of overcoming obstacles and forging with the tools that they have. Having a strong team also helps make Coripharma such a good strategic partner. Gudmundsdottir explains that Coripharma has its own development team and its own portfolio selection and that they select their own products for development.

“Then we also have a list of products that we can offer to European pharmaceutical companies. With that in mind, the vision is basically to be a prominent player in the B2B field,” she says.

 

Jonina Gudmundsdottir’s experience in the pharmaceutical industry has shaped her leadership style. Photo: Heida HB

 

A powerful heritage

Obviously, being a new company means that some things will take more time than others, and drug development is no quick process. Gudmundsdottir is determined to make sure that doesn’t hold the company back.

“The development of a product takes almost five years, through the regulatory process into the market. So next year the first large-scale developed products will go to market,” she says.

Iceland has always been very strong when it comes to generic pharmaceutical development. In the beginning that was because of patent tolls. The patent companies were not applying for patents in Iceland as it is just too small, and that kind of became a growth area for the generics industry.”

After acquiring their R&D facilities in 2019, this speed is quite an achievement and something that Gudmundsdottir is not surprised by. She explains Iceland’s unique place, historically.

“Iceland has always been very strong when it comes to generic pharmaceutical development. In the beginning that was because of patent tolls. The patent companies were not applying for patents in Iceland as it is just too small, and that kind of became a growth area for the generics industry,” she explains.

While this is not the case anymore, what remains is this strong heritage and large talent pool, she continues. “We have people who are really experienced in generic drug development and we are very much building on this powerful heritage.”

 

View of a glacier lagoon under a dramatic sky at glowing red in midnight sun in summer Jokulsárlón, Iceland. Photo: iStock

 

Finding talent

Aside from having the support of the Icelandic government when it comes to R&D, there is the acknowledgement that Coripharma is very lucky to have a huge talent pool within the generic pharmaceuticals sector, says Gudmundsdottir. “But having said that, obviously we also need to attract young people,” she adds.

Attracting young people to the business is also not just about salaries, but there is a business reason for this too.

For anyone wanting to join the company, that is quite an exciting proposition.”

“I think we can safely say that we are really paying very fair and generous salaries compared to many countries around us, which then again affects the higher price. We acknowledge the fact that we will never be competing on these kinds of large-scale in general manufacturing. We are going for more difficult developments because we have such a strong R&D team. For anyone wanting to join the company, that is quite an exciting proposition,” she says.

Taking responsibility

That being said, Gudmundsdottir’s elevation to the CEO position came in 2020 when it was a strange time for many industries. I ask her how the COVID-19 pandemic affected her start in the position.

“Obviously it was a difficult start, but as time went on some changes have been for the better,” she says. “The pharmaceutical business is a very conservative field. It had very much relied on personal contacts. We were transporting agreements back and forth with courier services, and now everyone accepts electronic signatures, which aside from being a much faster way of doing business, also helps the company’s environmental goals.”

We are educating our customers about this because they are also looking for partners with our environmentally friendly conditions.”

Under Gudmundsdottir’s leadership, Coripharma has achieved significant milestones with its commitment to sustainability at the forefront of its operations, and a strong focus on environmental stewardship. “What we have here in Iceland is obviously the perfect spot in a way because our energy is 100% green,” she says. “We are educating our customers about this because they are also looking for partners with our environmentally friendly conditions,” she adds.

Through initiatives such as responsible waste management and a reduced carbon footprint Coripharma aims to continually minimize its environmental impact, and Gudmundsdottir explains that is also good for business. “We have been focusing very much on waste sorting, putting emphasis on that for all of our employees. Last year we published our sustainability report for the first time, which was a good achievement for a young company.”

Coripharma extends its contributions beyond the lab, actively supporting the local community, and this is important to the company, says Gudmundsdottir.

“We feel this is the responsibility of every company to contribute to the local society. As we are not in Reykjavik, we are in a different community and we are supporting the local sports club here, with a lot of emphasis on that,” she says with pride.

Coripharma office in Hafnarfjörður, Iceland

 

Bringing together teams

When I ask Gudmundsdottir about her management style as the CEO she emphasizes that it’s all about bringing together teams. “If I’ve learned anything, it is that you need to have the right people. If you have the right people, and the right teams that are working well together, then you’re doing something right,” she says.

If I’ve learned anything, it is that you need to have the right people. If you have the right people, and the right teams that are working well together, then you’re doing something right.”

Gudmundsdottir’s ambitious goals, commitment to sustainability, and contributions to the local community make her a driving force at the company, but she remains modest throughout, explaining that she sees herself as kind of the selector of the best people. “I’m lucky that a lot of people have wanted to follow me. I’m really grateful to have this new angle to the job because that has been a huge learning curve,” she concludes.

This interview was originally published in NLS magazine No 03 2023, out September 2023

Featured photo: Heida HB

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Aqilion reports positive Phase I results https://nordiclifescience.org/aqilion-reports-positive-phase-i-results/ Tue, 31 Oct 2023 05:46:53 +0000 https://nordiclifescience.org/?p=74073 The company has reported results from its ARIA-1 study in healthy volunteers with the drug candidate AQ280, a selective proprietary JAK1 inhibitor, being developed as a treatment for eosinophilic esophagitis (EoE) within the Regulus program. Healthy subjects were administered single or multiple doses in a sequential escalating dosing schedule until the maximum planned dose of […]

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The company has reported results from its ARIA-1 study in healthy volunteers with the drug candidate AQ280, a selective proprietary JAK1 inhibitor, being developed as a treatment for eosinophilic esophagitis (EoE) within the Regulus program.

Healthy subjects were administered single or multiple doses in a sequential escalating dosing schedule until the maximum planned dose of AQ280 was reached, describes the company in a press release. Data describing the pharmacokinetic profile, safety and pharmacodynamic biomarkers of the drug candidate have now been unblinded and evaluated.

“These results represent the first clinical data with our drug candidate AQ280 and it is a valuable milestone both in the Regulus program and for Aqilion. We are very pleased with the results, and taken together these data encourages us to progress our preparations for Phase 2 in patients with eosinophilic esophagitis,” says Sarah Fredriksson, CEO Aqilion.

Key findings according to the company

Dose: The achieved exposures in the Single Ascending Dose (SAD)- and the Multiple Ascending Dose (MAD) cohorts are in line with estimates of a therapeutically effective range based on preclinical models and will inform the dose selection for the upcoming phase 2 trial.
Safety: There were no serious adverse events and the dose escalations in SAD and MAD were not restricted by adverse events.
Pharmacokinetics: The exposure and half-life for AQ280 were well aligned with the preclinical predictions and supports once daily dosing. Food intake did not influence the pharmacokinetics in any significant way.
Pharmacodynamics: AQ280 inhibited CXCL10 in a dose-dependent manner. CXCL10 is a well-recognized biomarker for JAK inhibition.
Selectivity: The JAK1 on-target effects were evident, and dose related, and there was only minimal effects on reticulocyte values, a marker of JAK2 inhibition.

Photo of Sarah Fredriksson: Aqilion

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