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.