2017, 05, 09 — PILA PHARMA has carried out a fully subscribed new issue of shares

Malmö, Sweden, 9th  May 2017

You can also download the press release as PDF here

PILA PHARMA has carried out a fully subscribed new issue of shares

PILA PHARMA AB, a Swedish pharmaceutical company based in Malmö, is pleased to announce that the company has raised SEK 10 million through a fully subscribed new issue shares.

Both existing shareholders and new investors participated in the new issue. ALMI Invest for the third time defended its position of 15 per cent of the share capital and remains the second largest shareholder in the company behind Dorte X. Gram, the founder and CEO of PILA PHARMA.

PILA PHARMA is developing a novel type of oral anti-diabetic agent: a TRPV1 antagonist for the treatment of diabetes. PILA PHARMA recently received regulatory approval of its first clinical trial application, permitting the company to move its clinical development candidate XEN-D0501 into a safety trial in type 2 diabetic patients. Recruitment of patients to the safety trial is ongoing.

In addition to the safety trial, the proceeds from the new issue will also enable PILA PHARMA to further consolidate it’s internal organisation, to plan for the next clinical efficacy trial and to – earlier than originally planned – initiate internal research activities with the aim of strengthening the company’s IP-portfolio, carry out further asset exploration and to evaluate new licensing opportunities.

Dorte X. Gram, the inventor of the principle of treating diabetes with TRPV1 antagonists and with a background including more than ten years at Novo Nordisk A/S in Denmark, comments: “I am very pleased with the strong interest from both existing shareholders and new investors and particularly that PILA PHARMA now has a strong international shareholder base. My organisation and I are really motivated to enter the next phase in PILA PHARMA’s development where we seem to be on the map of both investors and potential exitpartners as well as of other companies with assets that may complement ours”.

“It is amazing how far Dorte X. Gram has brought PILA PHARMA in less than three years and with limited funds from previous financing rounds. So even if SEK 10 million may look like a small amount in the biotech industry, this financing secures that PILA PHARMA can continue its rapid development”, says Erik Nerpin, Chairman of the Board.

Notes to Editors:

Contact:

PILA PHARMA
Dorte X. Gram, PhD
CEO

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a privately held clinical stage pharmaceutical company based in Malmö, Sweden.
PILA PHARMA is developing a novel type of oral anti-diabetic agent: a TRPV1 antagonist for the treatment of diabetes.
XEN-D0501, the recently purchased, safe clinical development candidate, is entering the first clinical trial in type-2 diabetic patients in 2017.

For further information, please visit: pilapharma.com

About diabetes

Diabetes is a world wide pandemic with a staggering prevalence of 422 m diabetics corresponding to approximately 8-10% of the population.
The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

2017, 03, 06 — PILA PHARMA receives regulatory approval of its first clinical trial application and appoints new Chairman of the Board

Malmö, Sweden, 6th  March 2017

You can also download the press release as PDF here

PILA PHARMA receives regulatory approval of its first clinical trial application and appoints new Chairman of the Board

PILA PHARMA AB, a Swedish pharmaceutical company based in Malmö, Sweden, is pleased to announce that it has received regulatory approval of its first clinical trial application thus permitting the company to move its clinical development candidate, XEN-D0501, into a safety trial in type 2 diabetic patients.

“I am very excited about finally being at the point where we can progress a TRPV1 antagonist into diabetic patients!”, says Dorte X. Gram, founder and CEO of PILA PHARMA and continues: “It is nearly 17 years since I formulated the hypothesis that inhibitors of the TRPV1 (a.k.a. the “chili-receptor”) could be novel pharmacologic tools for the treatment of obesity and obesity-related diseases and disorders. Today, PILA PHARMA has use-patents that give us the exclusive right to treat obesity and diabetes with TRPV1 receptor antagonists and we are now very close to test the first development candidate, XEN-D0501, in diabetic patients.”

The first step will be to assess the safety of the molecule following a single-dose in diabetic patients. If successful, it can progress to multiple-dose efficacy trials to test the effect in diabetics later this year.

In 2003, Dorte X. Gram defended the hypothesis in her PhD thesis “Capsaicin-Sensitive Nerves in Experimental Diabetes” to a dream-team of opponents: professors Henning Beck-Nielsen, Jens Juul Holst and Mads Krogsgaard Thomsen.

During the last year PILA PHARMA has been working closely together with professor Henning Beck-Nielsen’s clinical team at Odense University Hospital in Denmark, to prepare for the clinical trial.

“Henning was the first to suggest that we should test the concept in man, but no clinical-ready TRPV1 antagonists were available at that time. Henning is one of the academic “heavyweights” in diabetes, so I am extremely grateful that Henning still supported the project, when I called to ask for his help more than 10 years later, when antagonists were potentially available”, says Dorte X. Gram.

With Henning Beck-Nielsen back in the project, the plan for moving rapidly towards clinical proof of concept with a clinical ready substance was created and a pilot phase 2 protocol was suggested by Henning Beck-Nielsen.

“We still follow that plan, but due to regulatory requirements, a single-dose safety study was inserted in the plan and is now being initiated. As soon as possible, thereafter, we will conduct the pilot phase 2 originally designed by Henning”, says Dorte X. Gram.

Given PILA PHARMA’s rapid development and predicted future increase in capital need, PILA PHARMA has appointed attorney Erik Nerpin as new Chairman of the Board. He has 25 years of experience in corporate finance and M&A, including high profile transactions such as Pfizer’s acquisition of Pharmacia, where he advised Pfizer. For many years, he has been advisor to the Lundin Group of companies, including Lundin Petroleum and Lundin Mining. He has also long experience of board work in pharmaceutical companies, being currently Chairman of Kancera and Diamyd Medical, both listed on Nasdaq First North in Stockholm, Sweden.

“Over the years, I have advised numerous early stage pharmaceutical companies. Many of them have, as expected in this business, failed but some of them have actually made it, such as Alligator Bioscience, CellaVision and Hansa Medical, today all successful companies listed on Nasdaq in Stockholm, Sweden. It is an honor for me to enter the board as new Chairman and I am convinced that PILA PHAMA will grow into something really big in the near future”, comments Erik Nerpin.

“I am extremely impressed by Dorte X. Gram as founder and CEO”, comments Erik Nerpin further. Being a football fan, he adds “I believe everybody who knows football will understand when I call Dorte X. Gram “The Special One”.

Dorte X. Gram adds: “Erik is super sharp and I believe that he will add real value to me, our Board and the company. I am very, very proud that he has accepted to work with me as Chairman and closest colleague in PILA PHARMA”.

For further information, please contact:

Dorte X. Gram
CEO and Director of the Board

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

Erik Nerpin
Chairman of the Board

M: +46 (0)70 620 7359
E: erik.nerpin@advokatnerpin.com

Please also visit PILA PHARMA’s webb page: pilapharma.com

About PILA PHARMA

PILA PHARMA is a Swedish pharmaceutical company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet based treatment for diabetes. The company owns use patents for treating diabetes and obesity with TRPV1 antagonists and a clinical ready and safe TRPV1 development candidate XEN-D0501.

About diabetes

Diabetes is a world-wide pandemic with a staggering prevalence of 422 m diabetics corresponding to approximately 8-10% of the population. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

In 2014, the global diabetes market was assessed to be 37,5 bn € and is projected to rise to >100 bn € in 2018. Approximately half of this market attributes to oral anti-diabetic agents (tablets) whereas the other half of the market attributes to injectable treatments, like insulin and GLP-1.

2016, 06, 22 — Press release / PILA PHARMA successfully completes new shares emission and strengthens the Board of Directors

Malmö, Sweden, 22 June 2016

You can also download the press release as PDF here

PILA PHARMA successfully completes new shares emission and strengthens
the Board of Directors

PILA PHARMA raises new capital to initiate the clinical assessment of XEN-D0501 as novel anti-diabetic agent

PILA PHARMA AB, Malmö, Sweden announced today it has completed a successful new shares emission which will allow the company to progress its newly acquired clinical development candidate, XEN-D0501, into clinical trials in type 2 diabetic patients.

The new shares emission was directed towards a smaller group of private investors and ALMI Invest Syd AB and was over-signed within 2 weeks.

“It is really highly motivating and I am deeply honored and humble that private people place their trust in me and the company by investing their personal savings in the project” says Dorte X. Gram, founder and CEO of PILA PHARMA.

“Drug discovery projects are normally very costly with high risk of failure” adds Per Antonsson, investment manager at ALMI Invest and Director of the Board of PILA PHARMA. “But the de-risking and cost-reducing approach of PILA PHARMA has made this an attractive investment case for ALMI and we are happy that we were able to defend our stock holding despite great interest from private investors”.

The Chairman of PILA PHARMA, Jan R. Nilsson notes that as a private investor it has been appealing to notice the enormous amount of work that has been laid down in the project so far and the fact that the company has a clear strategy to exit within 3 years as well as the drive by the CEO. “Dorte has a lot of energy, engagement and power” says Jan and Per supplies that “the fantastic energy shown by Dorte is absolutely needed in this kind of virtual drug development projects”.

Approaching clinical trials with the further need of funding whilst preparing for exit, PILA PHARMA is proud to announce the strengthening of its Board of Directors with two significant pharma professionals, Lene Andersen and Fredrik Buch.

“Lene has been on my list of potential Directors of the Board in PILA PHARMA for a long time”, says Dorte X. Gram. “Although we did not know each other then, I noticed Lene already when working at Novo Nordisk, where she was deeply involved in making the insulinanalogue business become a success”. Lene Andersen has worked at Novo Nordisk for more than 18 years with strategy, operations and corporate relations and consolidates PILAs insight into the diabetes market, positioning and marketing of diabetes products as well as licensing.

“Fredrik is a new connection, that I have recently met via private Swedish investors evaluating the PILA business case, says Dorte. “Fredrik was challenging my presentation of the PILA PHARMA clinical development plan including budget in a sophisticated manner, that I thought would be more useful to have inside the company than outside” says Dorte with a smile. Fredrik Buch is a medical doctor and scientist by training and strengthens the Board substantially with clinical, regulatory, financing and board expertise by having a significant track record ranging from academic medical research, clinical development in several pharmaceutical industries, health care fund managing, venture capital, private investor in the biotech segment and last but not least a significant experience from various board of directors.

Notes to Editors:

Contacts:

PILA PHARMA
Dorte X. Gram, PhD
CEO

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

About PILA PHARMA

PILA PHARMA is a “micro-pharma” in the diabetes segment established in Malmö, Sweden. The aim of the company is to develop a novel and superior tablet based treatment for diabetes. The company owns use patents for treating diabetes and obesity with TRPV1 antagonists and has recently acquired a clinical ready TRPV1 asset including the development candidate XEND0501 and will initiate a fast-track clinical development program to demonstrate significant efficacy and safety in type 2 diabetics followed by exit. PILA PHARMA seeks investments for its later stage clinical program. For further information, please visit: pilapharma.com

About diabetes

Diabetes is a world wide pandemic with a staggering prevalence of 415 m diabetics corresponding to approximately 8-10% of the population and it expected to rise to 642 in 2040, according to the International Diabetes Federation. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

In 2014, the global diabetes market was assessed to be 37,5 bn € and is projected to rise to >100 bn € in 2018, according to Reuters. Approximately half of this market attributes to oral anti-diabetic agents (tablets) whereas the other half of the market attributes to injectable treatments, like insulin and GLP-1.

PILA PHARMA CEO explains potential of “chili receptor” as diabetes therapy

Dr. Dorte Gram, CEO of PILA PHARMA AB, one of Sweden’s youngest biotech companies, talks to Mike Ward, global director of content for Informa Pharma Intelligence’s insights portfolio, about PILA’s history, its novel diabetes technology and why we should keep an eye on its lead asset that will be taking off with clinical studies in the near future. PILA owns issued use-patents that give it exclusive rights to treat diabetes and obesity with antagonists of the TRPV1 receptor. The company has recently acquired the TRPV1 antagonist asset previously owned by Ario Pharma Ltd (Cambridge, UK). The TRPV1 target (also called the “chili receptor”) has previously been shown to have applications across pain and inflammatory diseases and is speculated to have a role in diabetes as well.

 

Please find below the link to Dr. Dorte Gram interview with Mike Ward – Global Director of Content, Pharma Intelligence, In Vivo/Pink Sheet/Scrip:
partnering360.com

2016, 03, 30 — Press release / PILA PHARMA Acquires Ario Pharma’s TRPV1Assets

Malmö, Sweden, 30 March 2016

You can also download the press release as PDF here

The clinical assessment of a novel diabetes treatment seems within reach for PILA PHARMA with the acquisition of XEN-D0501, a clinical ready and safe TRPV1 antagonist development candidate

PILA PHARMA AB, the Malmö based “micro-pharma” aiming at developing innovative new approaches to treat diabetes, announced today it has acquired the TRPV1 antagonist asset previously owned by Ario Pharma Ltd (Cambridge, U.K.).

The acquired asset include a series of small molecule TRPV1 antagonists including the clinical ready and safe development candidate XEN-D0501, patents, know-how and data.

The TRPV1 target (also called the “chili-receptor”) has been shown to have applications across pain and inflammatory diseases and is speculated to have a role in diabetes as well.

After oral delivery, “target-interaction” (blockade of the “chili-receptor”) has been demonstrated in man and in vivo  efficacy in regulating blood glucose has been demonstrated in diabetic mice, together suggesting that this compound could have the potential to be effective in human diabetes after oral delivery.

PILA PHARMA is planning to undertake a fast-track clinical development program, assessing the efficacy and safety of XEN-D0501 in treatment of type 2 diabetes.

There is a significant unmet need to provide an orally available therapeutic for diabetes, which not only offers the regulation of blood glucose but that also addresses the co-morbidities of diabetes – elevated blood lipids and increased bodyweight that are associated with an increased risk of cardiovascular disease. In preclinical models of diabetes, TRPV1 antagonists have been shown to correct both insulin secretion as well as insulin sensitivity and be effective regulators of blood glucose and blood lipids.

The target product profile of PILA PHARMAs anti-diabetic TRPV1 antagonists is to effectively reduce blood glucose to near-normal levels via a dual regulation of insulin secretion and insulin sensitivity as well as regulating blood lipids and bodyweight thereby eventually reducing the overall risk of cardio-vascular disease”.

Dorte X. Gram, CEO of PILA PHARMA, commented: “I am very pleased to have reached an agreement with Ario Pharma regarding this valuable asset. The acquisition of especially XEND0501 permits us to move straight to clinical safety and efficacy trials in type 2 diabetic patients. I’m thrilled that we are so close to know if the hypothesis of regulating diabetes with blockers of the “chili-receptor”, TRPV1, that I put forward almost 15 years ago will be valid.

John Ford, CEO of Ario Pharma commented “XEN-D0501 is a highly potent and selective, orally available inhibitor of TRPV1. XEN-D0501 has demonstrated good oral bioavailability and appropriate pharmacodynamics and pharmacokinetics in humans, and has been well tolerated in both healthy volunteers and patients1.

1. Round P, Priestley A, Robinson J. An investigation of the safety and pharmacokinetics of the novel TRPV1 antagonist XEN-D0501 in healthy subjects. Br J Clin Pharmacol. 2011;72(6):921-31.

Notes to Editors:

Contacts:

PILA PHARMA
Dorte X. Gram, PhD
CEO

M: +46 (0)73 903 6969
E: dxg@pilapharma.com

ARIO PHARMA
John Ford, PhD
CEO

M: +44 (0)79 44545 197
E: john.ford@ariopharma.com

About PILA PHARMA

PILA PHARMA is a ‘micro-pharma’ in the diabetes segment established in Malmö, Sweden. The aim of the company is to develop a novel and superior tablet based treatment for diabetes. The company owns use patents for treating diabetes and obesity with TRPV1 antagonists and will combine these with a clinical ready TRPV1 asset and initiate a fast-track clinical development program to demonstrate significant efficacy and safety in type 2 diabetics followed by exit. PILA PHARMA currently seeks investments for its clinical program. For further information, please visit: pilapharma.com

About Ario Pharma

Ario Pharma Ltd focusses on the development of drugs that modulate TRP channels initially focusing on the treatment of respiratory indications. Ario has recently evaluated the antitussive properties of XEN-D0501, a potential best-in-class TRPV1 inhibitor, in two Phase 2 clinical trials. The company is managed by a highly experienced development team and supported by world-renowned KOLs and will now focus on the development of their TRPA1 asset for multiple indications. For more information see ariopharma.com

About diabetes

Diabetes is a world wide pandemic with a staggering prevalence of 415 m diabetics corresponding to approximately 8-10% of the population and it expected to rise to 642 in 2040, according to the International Diabetes Federation. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes.

In 2014, the global diabetes market was assessed to be 37,5 bn € and is projected to rise to >100 bn € in 2018, according to Reuters. Approximately half of this market attributes to oral anti-diabetic agents (tablets) whereas the other half of the market attributes to injectable treatments, like insulin and GLP-1.

2016, 01, 18 — Change in the Board of Directors and Scientific Advisory Board of PILA PHARMA

18 January 2016

The Chairman of Pila Pharma Board of Director, Mogens Vang Rasmussen has decided to resign from his position in PILA PHARMA at the end of 2015 due to an increased workload as co-owner and partner of Vesicon, a newly established company with the ambition to bring new and innovative ultra sound devices to the market.

PILA PHARMA established a Board of Directors in January 2015 with highly skilled pharmaceutical professionals, and Mogens Vang Rasmussen accepted to head up the Board of Directors. He brought a long time experience from the life science industry including the understanding of the diabetes market in addition to insight into strategy, planning and financing.

Mogens Vang Rasmussen has made a tremendous contribution in the start-up period of PILA PHARMA in defining a solid direction for the company’s strategy and development plans, says CEO Dorte X. Gram. I’m grateful that Mogens, with his significant background in biotech and the pharmaceutical industry,
accepted the chairmanship in this initial phase.

PILA PHARMA is now moving to another phase after the start-up period and needs to consolidate further into a small company.
New Chairman of the Board, Jan R. Nilsson, will help in this transition and brings to PILA PHARMA substantial business managerial experience from various positions, e.g. as CEO for Securitas-Direct / Verisure in Norway, Belgium, Holland and Denmark.

We are very proud to have been able to attract Jan R. Nilsson to the Board of Directors of PILA PHARMA, says CEO Dorte X. Gram, and I personally look much forward to working together with Jan in consolidating and further developing the company both on the administrative side as well as on the operational side.

Further, to strengthen the Scientific Advisory Board in terms of Intellectual Property Rights of our future business, we are pleased to welcome Jens Viktor Nørgaard who is a European Patent Attorney and a leading expert in Biotech and Pharma patenting.

Jens Viktor Nørgaard has already played a significant role in PILA PHARMAs history in working with me on the patenting process that eventually led to the issue of the use-patents, says CEO Dorte X. Gram. I am very pleased, that Jens Viktor Nørgaard has accepted to join our Scientific Advisory Board, and I trust that he will ensure that PILA PHARMA will have the right focus on Intellectual Property Rights going forward.

2015, 09, 11 — Change in the PILA PHARMA Board of Directors

11-Sep-2015

Director of the Board, Axel Nemetz, will resign from his position

In January 2015, PILA PHARMA established a Board of Directors, which encompassed highly skilled pharmaceutical professionals. At that time, Axel Nemetz was invited to join the Board of Directors due to his thorough understanding of the diabetes market, including insight into strategy, planning and financing.

“Axel Nemetz has contributed significantly in transforming PILA PHARMA into a professional business unit and we want to thank him a lot for his valuable input to PILA PHARMA’s strategic discussions. We wish him the best of luck in his new endeavours and his role as Head of Market Entry Strategies, Life Sciences & Healthcare at IBM”, says CEO Dorte X. Gram.

PILA PHARMA is moving towards a new investment round and in association with that, a new Director of the Board will be announced.

2015, 02, 18 — New method gives hope of treatment of diabetes

ALMI_Invest

Press release 2015-02-18

Download as PDF

New method gives hope of treatment of diabetes

More and more adults’ get type 2 diabetes. Today, more than 8% of the earths grown-up population have the disease and the negative development increases by 7,5% per year. Today treatment is mainly focused on delaying the time to treatment of the life long disease with insulin. PILA PHARMA, which has been established at Medeon Science Park in Malmø, is dedicated to develop a novel approach of the treatment of type 2 diabetes, and is currently in the process of starting a project, which already has showed promising pre-clinical results. Almi Invest has made an investment in PILA PHARMA.

– PILA PHARMA has concluded pre-clinical trials and demonstrated some very positive and exiting results. For obvious reasons investments in the development of pharmaceutical products is extremely high risk. However, this is exactly the mission for Almi Invest to invest in high-risk projects, and this project needs a decent chance to be seriously examined. So even if it will be a long journey to a safe and efficient pharmaceutical product or treatment method, the need is immense and the market is huge says Per Antonsson, Investment Manager at Almi Invest.

New class of an oral pharmaceutical product for the treatment of type 2 diabetes

The objective of the project is to develop a new class of an oral pharmaceutical product to treat newly diagnosed type 2 diabetic patients in combination with other glucose regulating pharmaceutical products hereby delaying the treatment with insulin to delay and possible avoid the late complications and debilitating diseases associated with diabetes.

The woman behind the Company

Dorte Xenia Gram is the owner of PILA PHARMA.

– The investment from Almi Invest confirms that they believe in our concept, which is extremely important for us. The investment from Almi Invest enable us to continue our development and ultimately investigate how a smaller number of patients will react in an acute glucose tolerance study says Dorte Xenia Gram, CEO at PILA PHARMA.

Dorte X. Gram has an extensive network of experts and diabetes competences linked to her company and bring herself diabetes expertise from her previous position within diabetes at the Danish diabetes company Novo Nordisk. When Novo Nordisk, for strategic reasons, decided to focus their research and development on proteins, Dorte X. Gram had the chance to acquire the use patent for the active ingredient, which is the cornerstone of the development to an active oral pharmaceutical product for the treatment of newly diagnosed type 2 diabetic patients.

Professionalism in the Board of Directors

In association with Almi Invest’s investment, the Board of Directors has been expanded with individuals with a broad-based experience from public life science companies. In addition to Per Antonsson, which represents Almi Invest, Axel Nemetz and Mogens Vang Rasmussen have been added to the company’s Board of Directors. Axel has a background as Global Head of m-health at Vodafone and before that he was European Head of Strategy at Novo Nordisk. Mogens has a background as Finance Director, Planning and Investor Relations, Novo Nordisk of North America, New York, USA and later he served as CEO and CFO/COO at Zealand Pharma, a biotech company with diabetes products.

For further information please contact:

  • Maria Kessling, Head of Communication Almi Invest; +4676-880 88 10, maria@kessling @ almi.se
  • Per Antonsson, Investment Manager Almi Invest; +4670-872 87 17, per.antonsson@almi.se
  • Dorte Xenia Gram, CEO, PILA PHARMA +46 (0) 73 903 6969; dxg@pilapharma.com

About Almi Invest:

Almi Invest invests in Swedish companies with scalable business concepts and prospects for long-term capital growth. Through the support of our experienced investment managers, capital and networks, we create opportunities for businesses to grow and compete in a global market. We invest from the seed phase to the expansion phase. We are located across the whole of Sweden, with regional knowledge and an international perspective. Our portfolio consists of 400 growth companies in many different industries. Almi Invest is a subsidiary of the Almi Group.
Almi.se