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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

New Partnership in Russia and CIS Further Expands Footprint for EffRx Proprietary Technologies

Freienbach, Switzerland, January 13, 2015 – EffRx Pharmaceuticals SA, a specialty pharmaceutical company focused on the development of novel therapeutic entities for a variety of orphan and specialty indications, today announced the signing of an agreement with Andrus Ltd. to develop products for commercialization in Russia and CIS countries.

“We are excited to further expand the footprint of our proprietary technologies with the development of novel therapeutic entities for these fast-growing emerging markets” said Christer Rosén, EffRx Chief Executive Officer. “Although our core focus within EffRx is to develop our own un-encumbered orphan products we will still utilize this business segment to generate a steady increasing revenue stream.”

Under the terms of the agreement EffRx will develop novel, tailored therapeutic entities (6 products are presently identified) for commercialization by Andrus in Russia and CIS countries. “We are excited to expand our partnership with Andrus beyond our earlier agreement with Binosto®, our first approved product for osteoporosis, and to bring new products that will address an unmet medical need in these countries” said Christer Rosén.

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

About Andrus Ltd.
Andrus Ltd. is dedicated to creating a novel Russian biopharmaceutical platform by bridging the gap between novel biopharmaceutical technologies and the Russian Healthcare market. Through partnering with leading development companies and leveraging Andrus’ domestic operations, the Company is able to build a healthcare platform based on best in class science and drug development.

EffRx Signs Binosto® Distribution Agreements in Russia and Africa

New Partnerships Significantly Expand Global Footprint for Proprietary Buffered Effervescent Osteoporosis Therapy

Freienbach, Switzerland — EffRx Pharmaceuticals SA, a specialty pharmaceutical company, today announced the signing of two new distribution agreements that will bring its osteoporosis treatment, Binosto®, to strategic markets in Russia, CIS countries and Africa.

“We are excited to expand the global footprint of Binosto® with the addition of these fast-growing emerging markets”

EffRx has partnered with Andrus, Ltd. to distribute Binosto® in Russia, Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Ukraine and Uzbekistan. Through another partnership, with Adcock Ingram Heathcare (Pty) Ltd., Binosto® will be available in South Africa, Namibia, Botswana, Swaziland, Lesotho, Zimbabwe, Kenya and Ghana.

EffRx’s first commercial product, Binosto®, is a buffered, effervescent formulation of alendronate, the most broadly prescribed treatment for osteoporosis. The product was approved by the U.S. Food & Drug Administration in 2012. With these agreements, Binosto® will be commercially available in 53 countries worldwide.

“We are excited to expand the global footprint of Binosto® with the addition of these fast-growing emerging markets,” said Lorenzo Bosisio, EffRx Chief Commercial Officer. “Binosto® is our first approved product and provides an important proof of concept for our development pipeline of novel therapeutic entities, and we look forward to making it available to an increasing population with these two agreements.”

“The continued worldwide adoption of Binosto® is the first of our current out-licensing initiatives and is expected to provide a steady income stream in the future. We continue to focus on the two other, potentially larger, elements of our threefold growth strategy – products in the orphan drug segment, including the ongoing development of our PCOS product, and lifecycle management,” said Christer Rosén, EffRx Chairman and Chief Executive Officer.

EffRx signs distribution agreements for Binosto® in Italy, Spain and Portugal

Freienbach, February 4th 2014 – EffRx Pharmaceuticals S.A. today announced that it has signed exclusive distribution agreements with three leading local pharmaceutical companies in Italy, Spain and Portugal for Binosto® – EffRx’s innovative osteoporosis medication. Under the terms of the agreement, EffRx grants exclusive marketing authorization and distribution rights to Abiogen Pharma SpA. for Italy, Lacer S.A. for Spain, and Laboratorios Atral S.A. for Portugal.

Binosto® is the first and only buffered solution for the treatment of osteoporosis, delivering fracture-risk reduction at the hip & spine. Binosto is administered as an effervescent tablet for oral solution and offers convenience for the patient. Binosto is currently marketed in the United States, and approved in Europe and Australia; approvals in other territories are pending. Binosto® was originally developed by EffRx through an agreement with Merck & Co, Inc. granting EffRx worldwide rights to all Merck effervescent and related patents protecting alendronate.

EffRx expects the launch in these markets beginning in the second quarter 2014. Italy, Spain and Portugal are 3 major markets for osteoporosis treatment in Europe. EffRx is confident that the promise of Binosto® will also become true in other European countries with the appointment of distribution partners that have a sizeable footprint as well as in-depth understanding of their local markets.

Christer Rosén, Chairman and CEO of EffRx Pharmaceuticals said, “We are thrilled to announce the partnerships with Abiogen, Lacer, and Atral.  These partners, with their well-established sales forces, are well positioned to drive Binosto® to a market leadership position.”

EffRx is committed to making Binosto® available to osteoporosis patients around the world and is currently discussing the commercialization of Binosto® with pharmaceutical companies in other key Regions and countries.

About EffRx Pharmaceuticals
EffRx Pharmaceuticals is an innovative specialty pharmaceutical company that exploits its proprietary technology platform to create novel therapeutic entities.

EffRx strives to make existing good medicines better and thereby improve the quality of life of patients. EffRx targets improvements to leading medications, focused on tolerability, absorption, compliance and convenience, thus creating best in class products.

EffRx has established its proprietary pipeline in metabolic bone disease and pediatric medications and is presently aggressively expanding its product portfolio.

Enquiries
Lorenzo Bosisio
lbosisio@effrx.com
+41 44 503 7867

EffRx signs distribution agreement with Ahn-Gook Pharma for Binosto® for Korea

Freienbach, 03 June 2013 – EffRx Pharmaceuticals S.A. today announces the signing of an exclusive distribution agreement with Ahn-Gook Pharmaceutical Co. Ltd for Binosto – EffRx’s innovative osteoporosis medication for the Korean market.

Under the terms of the agreement, EffRx grants exclusive rights to Ahn-Gook to register, market and distribute Binosto® in South Korea. This agreement will leverage Ahn-Gook’s strong local presence and expertise in Korea.

Binosto® is the first and only buffered solution for the treatment of osteoporosis, delivering fracture-risk reduction at the hip & spine and offering the potential to improve adherence to therapy. Binosto® is taken with a small amount of water and lowers gastric acidity in the first 30 minutes after administration, a time when the patient must not eat or drink anything other than plain water.

Christer Rosen, EffRx Chairman and CEO said at the signing ceremony “We are pleased to initiate a partnership with Ahn-Gook who has a dynamic and outstanding sales force, and we are convinced that Ahn-Gook becomes a new strong player in the Korean osteoporosis market.

Jin Auh, Ahn-Gook President & CEO said that the Korean market is worth 140M USD, and bisphosphonates account for more than 90%. “We highly expect Binosto® to overcome limitations of current bisphosphonates”

Binosto is expected to be registered in Korea in 2014 and launched within the same year.

 

Enquiries
Lorenzo Bosisio
+41 44 503 7867
 

About Binosto®
Binosto® (buffered alendronate sodium 70mg) is an effervescent tablet for oral solution and has been approved in the United States, Europe and Australia for the treatment of osteoporosis. It has been marketed since October 2012 in the United States by Mission Pharmacal, and is expected to be launched in other territories in 2014.

Binosto has been developed with EffRx innovative patented effervescent technology. EffRx is operating under exclusive worldwide rights to all effervescent and related patents of alendronate licensed from Merck & Co, Inc.

About EffRx
EffRx Pharmaceuticals SA is an innovative specialty pharmaceutical company that exploits its proprietary technology platform to improve the efficacy, tolerability and convenience of medicines, thereby generating better products and improving quality of life for patients.  The primary focus is on metabolic bone disease, pediatric medications and supporting larger companies in Life Cycle Management. 

About Ahn-Gook
Ahn-Gook Pharmaceutical Co., Ltd. is a Korea-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.

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

Agreement with Hikma Pharmaceuticals

EffRx signs a distribution agreement with Hikma Pharmaceuticals for Binosto® in MENA

Freienbach, 4 February 2013 – EffRx Pharmaceuticals SA today announces the signing of a distribution agreement with Hikma Pharmaceuticals for Binosto®, EffRx’s innovative osteoporosis medication, for the Middle East and North Africa (“MENA”) region.  Binosto® is the first and only buffered solution for the treatment of osteoporosis, delivering fracture-risk reduction and offering the potential to improve adherence to therapy.  

Under the terms of the agreement, EffRx grants the exclusive rights to Hikma to register, market and distribute Binosto® in 19 countries across MENA.  The agreement will leverage Hikma’s strong local presence and regulatory expertise in MENA, with over 1,600 sales and marketing representatives across the region. 

Binosto® was developed by EffRx through an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of alendronate.   Patents have been granted to EffRx providing exclusivity for Binosto® through February 2023.  Additional patents are pending.   Binosto (buffered alendronate sodium 70mg) is an effervescent tablet for oral solution and has recently been approved in the United States, Europe and Australia[1] for the treatment of osteoporosis in postmenopausal women.  In the United States it is also approved for the treatment of men with osteoporosis to increase bone mass.  Approvals in other territories are pending.

Mazen Darwazah, Hikma’s Vice Chairman and CEO of MENA said, “We are pleased to be licensing this excellent product from EffRx.  The agreement supports our strategy to continue working with global partners to strengthen our product portfolio in growing therapeutic categories, including women’s health.  Hikma is committed to bringing a broad range of high quality, pharmaceutical products to patients in MENA.”  

Christer Rosén, Chairman and CEO of EffRx Pharmaceuticals said, “We are thrilled to announce this partnership with Hikma, a company who we believe to be an ideal partner for EffRx in MENA.  We believe Hikma’s well-established sales force across the region can drive Binosto® to a market leadership position and we are extremely proud to have Hikma as a partner.”

EffRx is currently discussing the commercialization of Binosto with pharmaceutical companies in other key Regions. Lorenzo Bosisio, VP Business Development said, “This agreement is an important milestone for EffRx. It comes just after the recently announced reacquisition of rights to Binosto from Takeda. We are very excited about the strong interest for Binosto from partners in the remaining territories, such as Europe, Asia, and Latin America. We are committed to fulfil the promise of Binosto for patients around the world.”