Category Archives: Uncategorized

Bone markers as screening strategy for patient adherence to osteoporosis medications

IOF-ECTS Position Paper provides recommendations for the screening of adherence to oral bisphosphonates; proposes assessment using PINP and CTX bone turnover markers (BTMs) at baseline and after three months.

Oral bisphosphonates are common first line treatments for osteoporosis. However, approximately half of patients who begin osteoporosis treatment do not follow their prescribed treatment and/or discontinue treatment within a year. Identifying low adherence to medication – a problem commonly seen with many chronic diseases – is a critical issue as it jeopardizes the efficacy of treatment, leaving osteoporosis patients unprotected against fractures.

For the complete news story, visit the International Osteoporosis Foundation online.

 

 

Lorenzo Bosisio Appointed CEO of EffRx Pharmaceuticals

Freienbach, Switzerland, October 11th, 2016 – EffRx Pharmaceuticals SA announced that the Company has made some changes and additions to its management team.

Lorenzo Bosisio has been appointed as Chief Executive Officer effective July 1st, 2016. Prior to his promotion to CEO, Mr. Bosisio served as Chief Commercial Officer since 2013. During his tenure in EffRx, he has built the commercial infrastructure from the ground, successfully launched the Company’s lead product, Binosto®, enabling the transformation of EffRx from a drug development company to an integrated biopharmaceutical company with an international footprint.

Mr. Bosisio brings significant strategic and operational leadership experience from senior positions at Amgen, Alexion, PwC, and Tissot Medical. He has an excellent track record in building new international operations and brands as well as driving transformational growth in biopharmaceutical companies.

“I am highly satisfied with this appointment. Mr. Bosisio has exactly the right cross-functional experience and the right mindset to lead the expansion of our core franchise and to generate new business development opportunities.” said Mr. Jonas Ekblom, Chairman of EffRx.

Mr. Bosisio commented, “It has been a challenging and rewarding journey to bring EffRx to what it is today. I look forward to seeing further success and to leading EffRx through the next stage of its development”.

The company also announced that Mr. Paolo Agnoluzzi will serve as interim CFO, Dr. Josef Hruska has taken on the role as Medical / Medical Affairs Director and that Mr. Michael Schmid has joined as International Marketing Director.

About EffRx Pharmaceuticals

EffRx Pharmaceuticals is an innovative specialty pharmaceutical company that develops and commercializes novel therapeutic entities for specialty indications by applying its proprietary technology platform. EffRx developments focus at improving the quality of life of patients with unmet medical needs.

About Binosto®

Binosto® – the first and only alendronate buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate1. Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the oesophagus. Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures.

Disclaimer

Please refer to the official Binosto® Prescribing Information and approved indications, contraindications, and warnings in your country.

1Approved SmPC in Europe: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1447998343651.pdf

 

 

EffRx Announces Changes in the Composition of the Board of Directors

Freienbach, June 14th, 2016 — EffRx Pharmaceuticals SA, a specialty pharmaceutical company focused on the development of novel therapeutic entities for orphan and specialty indications, today announced the appointment of Dr. Jonas Ekblom as Chairman and Dr. Alcide Barberis as Member of the Board of Directors.

“I feel elated to join the Board of this exciting company and I look forward to working with the Management team and the Board of Directors as we progress EffRx into its next phase of consolidation, maturation and growth,” commented Dr. Jonas Ekblom, Chairman.

Dr. Ekblom and Dr. Barberis will be replacing Mr. Oscar Ahlgren, Mr. Carl-Gustaf Johansson and Mr. Thomas Mårtensson who have stepped down from their current role as Directors. During their tenure they have successfully managed the transition of EffRx to become an integrated pharmaceutical company with its flagship program, Binosto®, being now commercialized in 10 key countries across Europe, Asia and America. Mr. Anders Wiklund will continue to serve as a Board Director and with his accomplished industry experience will ensure a smooth transition within the Board.

Dr. Jonas Ekblom brings over 20 years of experience from the life science sector, with a focus in pharmacology and drug development. He has managed R&D programs in in several therapeutic areas. Dr. Ekblom has business experience from US, EU and Asia.

Dr. Alcide Barberis is a biotech entrepreneur and manager with over 20 years management experience in the biotechnology industry and scientific experience in the private and public research sectors.

 

Internis launches GI friendly alendronate formulation

PharmaTimes, May 20, 2016 — Internis Pharma Binosto is now widely available across the UK, offering patients with osteoporosis the chance to access the first buffered formulation of alendronate designed to minimise gastrointestinal side effects commonly linked with traditional versions of the drug.

The National Institute for Health and Clinical Excellence recommends alendronate as an option for the prevention of first fractures in a number of groups who have a high risk of fracture, as long-term treatment with the drug is known to improve bone mineral density (from 2.4 percent to 8.8 percent) and cut the risk of fracture (from 12 percent to 49 percent).

However, the side effects of the drug has led to poor compliance rates, with nine out of ten patients who are taking traditional form of alendronate having to drop therapy as a result. Eighty percent of patients come off treatment in the first year and over one in three fail to pick up a second indication, largely because of the gastrointestinal effects associated with bisphosphonates like alendronate.

Osteoporosis is estimated to affect more than three million people in the UK, most of whom are only aware they have it when they break a bone. Addressing poor adherence to treatment has been a key goal for some time, as it is estimated to result in a 37 percent higher risk of hospitalisation and a 17 percent higher risk of fracture, the firm notes.

Binosto’s novel, buffered alendronate formulation dissolves in water, helping to overcome the difficulties in swallowing pills that some patients experience and, crucially, as it increases pH levels in the stomach, thus minimising the gastrointestinal side effects commonly linked to these medicines, it has the potential to boost adherence.

The cost is £22.80 for four once-weekly tablets. This is a higher purchase price than a generic alendronate tablet but is lower than alternative treatments for patients who fail on alendronate (such as denosumab, etc). A spokesperson for the firm told PharmaTimes that Binosto should “save considerably on downstream costs”, given its potential to improve adherence and reduce the incidence of osteoporotic fracture, which costs the NHS around £5 million per day or £2 billion per year.

“I believe that, over time, data will show that Binosto’s novel alendronate formulation helps to improve the longterm tolerability of alendronate and helps to ensure that more women with osteoporosis are properly treated. This could result in fewer fractures, improved patient quality of life and lower overall costs,” said Dr Andrew Pearson, consultant radiologist, NHS Borders, commenting on its potential.

This impact will be more significant as our ageing population grows therefore, it is essential that patients have access to effective treatments that they are able to take over many years,” added Internis’ chief operating officer Paul Tredwell.

www.pharmatimes.com/news/internis_launches_gi_friendly_alendronate_formulation_1025980

Binosto® now available for the effective treatment of postmenopausal osteoporosis

BioPortfolio, May 20, 2016 — The first buffered alendronate designed to minimise gastrointestinal side effects commonly associated with traditional alendronate treatment

Huddersfield, 19 May, 2016, Internis Pharmaceuticals Ltd: Binosto, the first buffered alendronate (alendronate acid 70mg); is now available on prescription as an effervescent tablet. Binosto has been specifically designed to overcome the serious difficulties patients have with gastrointestinal side effects of traditional alendronates and to offer patients an effective alternative, which helps them to remain compliant with their treatment. Binosto dissolves to create a pleasant tasting strawberry-flavoured liquid formulation, taken just once a week, to treat osteoporosis in post-menopausal women.

Referred to as the ‘silent disease’, osteoporosis is estimated to affect more than three million people in the UK, most of whom are only aware they have it when they break a bone. Currently, the National Institute for Health and Clinical Excellence (NICE) recommends alendronate as an option for the prevention of first fractures in a number of groups who have a high risk of fracture. Long-term treatment with alendronate is effective at improving bone mineral density (from 2.4% to 8.8%) and reducing the risk of fracture (from 12% to 49%).

Unfortunately, compliance with alendronate tablets is poor; nine out of ten patients who are taking traditional alendronate are unable to continue taking the tablets due to side effects. Of more concern, poor adherence has been estimated to result in a 37% higher risk of hospitalisation and a 17% higher risk of fracture. Modelling predicts that if adherence to alendronates can be improved this will lead to fewer fractures for patients.

Supplied by Internis, a leading UK bone health company, Binosto’s novel, buffered alendronate formulation completely dissolves in just 120ml of plain water and helps to overcome the difficulties in swallowing pills that some patients experience. Importantly, Binosto’s buffered formulation has been shown to increase the pH of the patient’s stomach, minimising the gastrointestinal side effects that are common with these medicines. Internis believes that patients will find Binosto easier to take than alendronate tablets and therefore be likely to adhere to their medication for longer. This, in turn, could help to reduce the number of fractures seen in patients who cannot tolerate traditional alendronate tablets. Internis will be closely monitoring prescription data to confirm that patients adhere to Binosto for longer.

Dr Andrew Pearson, Consultant Radiologist, NHS Borders, commented:

“I believe that, over time, data will show that Binosto’s novel alendronate formulation helps to improve the longterm tolerability of alendronate and helps to ensure that more women with osteoporosis are properly treated. This could result in fewer fractures, improved patient quality of life and lower overall costs. I am very excited by Binosto’s potential.”

Chief Operating Officer of Internis, Paul Tredwell commented: “Following recent research on over 1.6 million prescriptions, we know that patients don’t comply with their traditional bisphosphonate tablets, with 80% of patients coming off treatment in the first year and over 1 in 3 patients not picking up a second prescription. This compliance issue is, in part, due to the gastrointestinal side effects, which are well known to be associated with bisphosphonates like alendronate. With the launch of Binosto and its novel, buffered formulation, Internis aims to increase this compliance, which, in the long term, will result in fewer fractures and a reduction in associated costs to the NHS. This impact will be more significant as our ageing population grows therefore, it is essential that patients have access to effective treatments that they are able to take over many years.

Adherence hopes for effervescent osteoporosis drug

Pharmaceutical Field, Amy Schofield, May 19, 2016 — Binosto, the first buffered alendronate (alendronate acid 70mg) is now available on prescription as an effervescent tablet.

Binosto has been specifically designed to overcome the serious difficulties patients have with gastrointestinal side effects of traditional alendronates. Supplied by UK bone health company Internis, Binosto offers patients an alternative which helps them to remain compliant with their treatment.

Binosto is taken once a week, dissolved in water, to treat osteoporosis in post-menopausal women and helps to overcome the difficulties in swallowing pills that some patients experience. The National Institute for Health and Clinical Excellence (NICE) currently recommends alendronate as an option for the prevention of first fractures in a number of groups who have a high risk of fracture.

Osteoporosis is estimated to affect more than three million people in the UK, many of whom are not aware that they have the condition until they break a bone.

Long-term treatment with alendronate is effective at improving bone mineral density (from 2.4% to 8.8%) and reducing the risk of fracture (from 12% to 49%). Unfortunately, compliance with alendronate tablets is poor. Modelling predicts that if adherence to alendronates can be improved this will lead to fewer fractures for patients.

Binosto’s buffered formulation increases the pH of the patient’s stomach, minimising the gastrointestinal side effects that are common with these medicines.

Chief Operating Officer of Internis, Paul Tredwell, commented: “Following recent research on over 1.6 million prescriptions, we know that patients don’t comply with their traditional bisphosphonate tablets, with 80% of patients coming off treatment in the first year and over 1 in 3 patients not picking up a second prescription. With the launch of Binosto and its novel, buffered formulation, Internis aims to increase this compliance, which, in the long term, will result in fewer fractures and a reduction in associated costs to the NHS.”

First-in-Class Osteoporosis Treatment Binosto® Launches in South Korea

Freienbach, January 7, 2016 — EffRx Pharmaceuticals SA announced today that its Korean partner has received regulatory clearance from the Korean Ministry of Food and Drug Safety (MFDS) to market Binosto® buffered alendronate for the treatment of osteoporosis in Korea.

Binosto® – the first and only buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the esophagus (in case of reflux) and the stomach to acidified alendronate1.

Binosto is marketed in Korea by Ahn-Gook Pharmaceutical who has a strong local sales presence and expertise. Commercial launch activity in Korea is anticipated early January 2016. Jin Auh, Ahn-Gook President & CEO, said that the Korean market is worth 115M USD, with alendronate accounting for more than 90%. “We expect Binosto® to overcome certain limitations of oral bisphosphonates and to provide improved adherence to therapy for patients suffering from osteoporosis.”

Lorenzo Bosisio, Chief Commercial Officer of EffRx Pharmaceuticals, comments “we are pleased to receive the Korean regulatory approval for Binosto, expanding physician and patient access to our product. Korea is a sizeable and important pharmaceutical market. We expect continued momentum as we launch in new territories around the world.”

Binosto® is currently available by prescription in the United States, Italy, Spain, Portugal, and the UK. The initial uptake in Europe with almost half a million monthly prescriptions in the first year has been very promising. Binosto® is licensed in over 50 countries and in the process of gaining regulatory clearance in several territories, hence further expanding its global footprint.

About EffRx Pharmaceuticals
EffRx Pharmaceuticals is an innovative specialty pharmaceutical company that develops and commercializes novel therapeutic entities for orphan and specialty indications by applying its proprietary technology platform. EffRx developments focus at improving the quality of life of patients with unmet medical needs.

About Ahn-Gook
Ahn-Gook Pharmaceutical Co., Ltd. is a Korean-based pharmaceutical company. The Company’s products include respiratory agents, gastrointestinal agents, anti-inflammatories, analgesics, ophthalmics and circulatory system agents. It also provides antibiotics, antifungal drugs, antihyperlipidemics, antiallergic drugs, anti-diabetic drugs, urinary system drugs and skin disease remedies. Anh-Gook also markets OTC and ethical drugs.

About Binosto
Binosto® – the first and only buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate1. Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the oesophagus. Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures.

Disclaimer
Please refer to the official Binosto® Prescribing Information and approved indications, contraindications, and warnings in your country.

1Approved SmPC in Europe: www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1447998343651.pdf

 

Contact
Pamela Saredi
Communications Manager
+41 44 503 78 64
psaredi@effrx.com

Successful Label Variations Granted to Binosto® in Europe

Freienbach, December 17, 2015 — EffRx Pharmaceuticals SA today announced that the MHRA (UK Medicines & Healthcare products Regulatory Agency) has adopted two positive variations for the labelling of Binosto® – buffered effervescent alendronate for oral solution. These variations will be implemented through the Decentralized Procedure (DCP) in the other European territories where Binosto® is approved.

The label now indicates that the specific Binosto® pharmaceutical formulation “minimises the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate.”

The Binosto® label also includes study data published in the International Journal of Pharmaceutics, “Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate.” The updated label also highlights that Binosto® is a buffered formulation for oral solution and provides the pH of this novel pharmaceutical form.

For anyone with osteoporosis, the best protection against suffering from a life-threatening fracture is taking medications as prescribed.  However, studies show that many patients are not adherent to therapy or have trouble in swallowing pills, and stop taking their medication. The updated label supports the rationale that Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures. The new label will also help to differentiate the hybrid approved Binosto® from generic alendronate formulation in the market.

Aileen Dowling, Head of Regulatory Affairs at EffRx, comments that “this label update reinforces the hybrid nature of the product, a different pharmaceutical form, being easier to swallow and incorporating a buffer system that can address oesophageal tolerability of alendronate tablets.“

Binosto® is currently available by prescription in Europe in the following countries: UK, Italy, Spain, and Portugal. The initial uptake in Europe with almost half a million monthly prescriptions in the first year has been very promising. Binosto® is licensed in over 50 countries and in the process of gaining regulatory clearance in several territories, hence further expanding its global footprint.
About EffRx Pharmaceuticals

EffRx Pharmaceuticals is an innovative specialty pharmaceutical company that develops and commercializes novel therapeutic entities for orphan and specialty indications by applying its proprietary technology platform. EffRx developments focus at improving the quality of life of patients with unmet medical needs.

About Binosto®
Binosto® – the first and only buffered solution for the treatment of osteoporosis – delivers gold standard fracture-risk reduction and offers the potential to improve adherence to therapy. Buffering minimizes the possibility of exposing the oesophagus (in case of reflux) and the stomach to acidified alendronate1. Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the oesophagus. Binosto® has the potential to improve long-term patient adherence to therapy, thereby decreasing the risk of disabling fractures.

Disclaimer
Please refer to the official Binosto® Prescribing Information and approved indications, contraindications, and warnings in your country.

1Approved SmPC in Europe: www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1447998343651.pdf

Contact
Pamela Saredi
Communications Manager
+41 44 503 78 64
psaredi@effrx.com