Category Archives: Uncategorized

EffRx to Attend the Medical Meeting: Bisphosphonates2019 – Celebrating 50 Years from 15-17th July 2019 in Sheffield, UK

EffRx Pharmaceuticals SA is proud to announce that it will attend the upcoming medical meeting bisphosphonates2019 – Celebrating 50 years, taking place 15-17th of July 2019 in Sheffield, UK. The year 2019 marks 50 years since the first publication on the biological effects of the bisphosphonates. The meeting which focuses 100% on bisphosphonates will review developments over the past 50 years, discuss our current understanding and look at what the future may hold.

EffRx Pharmaceuticals SA is also pleased to inform that new safety data on Binosto® will be presented at the Bisphosphonates2019 medical meeting. The data will be presented as a poster and oral snap presentation titled “Upper Gastrointestinal Safety with the Buffered Solution of Alendronate 70 mg: 6 Years of Post-Marketing Experience” authored by B. Cortet, P. Fardellone, L. Zakin, E. Fink Eriksen on Monday, 15th of July 2019, at 12:55 pm (poster #40).

The authors of the new Binosto® safety data conclude that Binosto® is associated with a lower frequency of upper gastrointestinal adverse reactions than reported for alendronate tablets and that it is a well-tolerated oral bisphosphonate for the management of osteoporosis.

“The safety data, after 6 years of post-marketing experience, reinforce that Binosto® is a well-tolerated oral bisphosphonate for the management of osteoporosis,” says Dr Lorraine Zakin, Medical Affairs Director at EffRx Pharmaceuticals.

EffRx looks forward to seeing you at the Bisphosphonates2019 in Sheffield!

About EffRx Pharmaceuticals SA

EffRx Pharmaceuticals SA is a commercial-stage functionally integrated pharmaceutical company, based in Switzerland, that develops and commercializes niche & orphan medicines in Europe. EffRx aims to be the preferred accelerator for late clinical & regulatory development, approval, valorization of niche & orphan medicines in Europe and Switzerland.

About Binosto®/Steovess®

Our lead commercialized product, Binosto® is indicated for the treatment of osteoporosis. Binosto® (alendronate 70 mg effervescent tablets) is the first and only buffered solution for the treatment of postmenopausal osteoporosis. It reduces the risk of hip, spine, and non-spine fractures.1 The buffered solution with high acid-neutralizing capacity minimizes the risk of exposing the esophagus (in case of reflux) and the stomach to acidified alendronate.2,3 Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the esophagus. Binosto® has the potential to improve adherence to therapy4, thereby decreasing the risk of disabling fractures.

Disclaimer

Statements made here are according the approved Binosto Summary of Product Characteristics in Europe. Please refer to the Binosto®/Steovess® prescribing information and approved indications, contraindications, and warnings in your country.

References:

  1. Black DM et al. Fracture Risk Reduction with Alendronate in Women with Osteoporosis: The Fracture Intervention Trial. J Clin Endocrinol Metab 2000;85:4118-4124.
  2. Binosto Summary of Product Characteristics. 2017.
  3. Hodges LA et al. Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate. Int J Pharm 2012;432:57-62.
  4. Giusti A et al. Persistence with the buffered solution of alendronate 70 mg: prospective observational study. Osteoporos Int 2018;29(S1):S431.

Media Contact: Pamela Saredi, psaredi@effrx.com

EffRx Pharmaceuticals Signs Exclusive License Agreement with Pharmaxis for the Registration and Commercialization of Bronchitol® in Switzerland

FREIENBACH, Switzerland (BUSINESS WIRE) – EffRx Pharmaceuticals SA, a commercial-stage company that commercializes niche and orphan medicines in Switzerland and Europe, today announced it has entered into an exclusive license agreement with Pharmaxis Ltd, a listed pharmaceutical research company in Australia, for the registration and commercialization of Bronchitol® (mannitol) for cystic fibrosis in Switzerland.

Under the terms of the agreement, EffRx will take responsibility for registering, obtaining pricing and reimbursement as well as commercializing Bronchitol® in Switzerland. Bronchitol® works by rehydrating the airway/lung surface and promoting a productive cough, hence improving mucus clearance and lung function. The product is inhaled as dry powder twice daily using a small handheld device and it is expected to be available on the Swiss market by 2021.

Cystic fibrosis is a hereditary rare disorder affecting the exocrine glands. It causes the production of abnormally thick mucus, leading to disease manifestations primarily in the lungs, but also in pancreas, intestines, liver and kidneys. Cystic fibrosis patients often suffer from frequent respiratory tract infections. According to the Swiss Society for Cystic Fibrosis (CFCH), there are about 1,000 people affected by cystic fibrosis in Switzerland. While there is no cure for the disease, thanks to medical advances, a majority of cystic fibrosis sufferers today reach adulthood.

“We are extremely pleased to announce this exclusive licensing agreement for Bronchitol®. We look forward to making this novel therapeutic option accessible to Swiss patients suffering from cystic fibrosis”, commented Lorenzo Bosisio, CEO of EffRx Pharmaceuticals. “We are encouraged by the clinical data and experience with Bronchitol® which show that this convenient treatment is well-tolerated and can lead to improvements in lung function.”

Gary Phillips, CEO of Pharmaxis said, “Our team is delighted to have entered this collaboration with EffRx. We are keen to leverage the go-to-market expertise of EffRx to bring Bronchitol® to the Swiss market and are pleased to secure in EffRx an experienced commercial partner.”

This licensing agreement underpins EffRx strategy to expand its portfolio through licensing collaborations in Europe and Switzerland with innovative biopharmaceutical companies developing promising niche and orphan medicines.

Bronchitol® has been the subject of three large-scale, global clinical trials conducted by Pharmaxis. It is approved and marketed in Europe, Russia, Australia and several other countries. In the United States, Bronchitol® has recently received a positive recommendation from a Committee advising the US Food and Drug Administration (FDA) on the use of Bronchitol® for adult cystic fibrosis patients; with the FDA expected to advise its decision within the next few weeks.

About EffRx Pharmaceuticals

EffRx Pharmaceuticals is a commercial-stage pharmaceutical company focused on the late-stage development and commercialization of prescription medications for niche and orphan indications. The business model is centered around providing superior clinical and commercial value propositions for physicians, payers and patients. EffRx aims to be the preferred accelerator for late clinical and regulatory development, approval, valorization of niche and orphan medicines in Switzerland and Europe.

EffRx pro-actively seeks in-licensing opportunities for Europe in niche therapeutic areas, with a primary interest for rare diseases, where EffRx has received an orphan drug designation (ODD) from FDA for a pipeline asset.

EffRx’s go-to-market competence is proven by the development, launch and lucrative expansion of Binosto® in a highly competitive European market.  Our lead commercialized product, Binosto® for the treatment of osteoporosis, is licensed in 50+ countries and marketed in the US, Europe, selected MENA and Asian countries.

About Pharmaxis

Pharmaxis (ACN  082  811  630)  is  an  Australian  pharmaceutical  research  company  focused  on  inflammation and fibrosis with a portfolio of products at various stages of development and approval.  Its product Bronchitol® for cystic fibrosis is marketed in Europe, Russia and Australia. Its product Aridol® for the assessment of asthma is sold in the United States, Europe, Australia and Asia. The company’s development pipeline is centered on its expertise in amine oxidase chemistry and includes a series of Lysyl Oxidase Inhibitors under clinical development targeting fibrotic diseases of the heart, kidney, liver and lung. Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). The company’s head office, manufacturing and research facilities are located in Sydney, Australia. For more information about Pharmaxis, please see www.pharmaxis.com.au

Media contact: Pamela Saredi, psaredi@effrx.com

 

EffRx to Showcase Binosto® at the WCO-IOF-ESCEO 2019 in Paris

FREIENBACH, Switzerland–(BUSINESS WIRE)– EffRx Pharmaceuticals SA is proud to announce that it will participate in the 19th Edition of the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases, taking place April 4-7, 2019 in Paris. The WCO-IOF-ESCEO Congress is the world’s leading clinical conference on bone, joint and muscle health and therefore the ideal venue for EffRx to showcase its flagship product Binosto®, the only buffered soluble alendronate for the treatment of postmenopausal osteoporosis.

EffRx Pharmaceuticals SA is also pleased to inform that new safety data on Binosto® will be presented at the WCO-IOF-ESCEO Congress. The data will be presented as a poster titled “Upper Gastrointestinal Safety with the Buffered Solution of Alendronate 70 mg: 6 Years of Post-Marketing Experience” authored by P. Fardellone, B. Boëzennec and B. Cortet on Saturday, 6th of April 2019, from 14:00 to 15:00 (poster #579).

The authors of the new Binosto® safety data conclude that Binosto® is associated with a lower frequency of upper gastrointestinal adverse reactions than reported for alendronate tablets and that it is a well-tolerated oral bisphosphonate for the management of osteoporosis.

“These updated data reinforce the safety profile of Binosto® after 6 years of post-marketing experience,” says Dr Lorraine Zakin, Medical Affairs Director at EffRx Pharmaceuticals.

Medical professionals from around the world will be able to learn more about Binosto® and its exciting properties at the Binosto® booths 20 and 21 in the exhibition area of the Palais des Congrès de Paris.

EffRx looks forward to welcoming you to the Binosto® booth at the WCO-IOF-ESCEO Congress in Paris!

About EffRx Pharmaceuticals SA

EffRx Pharmaceuticals SA is a commercial-stage functionally integrated pharmaceutical company, based in Switzerland, that develops and commercializes niche & orphan medicines in Europe. EffRx aims to be the preferred accelerator for late clinical & regulatory development, approval, valorization of niche & orphan medicines in Europe and Switzerland.

About Binosto®/Steovess®

Our lead commercialized product, Binosto® is indicated for the treatment of osteoporosis and marketed in US, Europe and Asia. Binosto® (alendronate 70 mg effervescent tablets) is the first and only buffered solution for the treatment of postmenopausal osteoporosis. It reduces the risk of hip, spine, and non-spine fractures.1 The buffered solution with high acid-neutralizing capacity minimizes the risk of exposing the esophagus (in case of reflux) and the stomach to acidified alendronate.2,3 Binosto® is taken once a week as an easy-to-swallow, buffered solution with no risk of a tablet getting lodged in the esophagus. Binosto® has the potential to improve adherence to therapy4, thereby decreasing the risk of disabling fractures.

Disclaimer

Please refer to the official Binosto®/Steovess® prescribing information and approved indications, contraindications, and warnings in your country.

References:

  1. Black DM et al. Fracture Risk Reduction with Alendronate in Women with Osteoporosis: The Fracture Intervention Trial. J Clin Endocrinol Metab 2000;85:4118-4124.
  2. Binosto Summary of Product Characteristics. 2017.
  3. Hodges LA et al. Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate. Int J Pharm 2012;432:57-62.
  4. Giusti A et al. Persistence with the buffered solution of alendronate 70 mg: prospective observational study. Osteoporos Int 2018;29(S1):S431.

Media Contact: Pamela Saredi, psaredi@effrx.com

Rare Disease Day is on February 28, 2019 – Help Raise Awareness

The main objective of Rare Disease Day is to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives.

The campaign targets primarily the general public and also seeks to raise awareness amongst policy makers, public authorities, industry representatives, researchers, health professionals and anyone who has a genuine interest in rare diseases.

Rare Disease Day was launched by EURORDIS-Rare Diseases Europe and its Council of National Alliances in 2008.

Learn more

EffRx Announces Expansion of the Executive Team

FREIENBACH, Switzerland–(BUSINESS WIRE)–EffRx Pharmaceuticals SA, a commercial-stage pharmaceutical company focused on niche therapeutics in Europe today announced the recent expansion of the Executive Team with Lorraine Zakin, MD, as Director, Medical Affairs, Peter Lichtlen, MD, PhD as Chief Medical Advisor, Christiane Sievert as Director, Regulatory Affairs and Victor Papavasileiou as Vice President, Business Development.

read more on Business Wire

EffRx Pharmaceuticals: Osteoporosis Patients in Southeast Asia Get Access to Binosto®

EffRx launches Binosto® – buffered soluble alendronate – in Malaysia and Singapore

FREIENBACH, Switzerland–(BUSINESS WIRE)–EffRx Pharmaceuticals SA today announced that physicians in Malaysia and Singapore treating patients with postmenopausal osteoporosis have a new therapeutic option: buffered soluble alendronate (Binosto®). This novel therapeutic option, which is already available in fifteen countries worldwide, provides gold-standard fracture risk reduction and offers better upper gastrointestinal safety profile than reported for alendronate tablets.1-3

go to the full article on BUSINESS WIRE

World Osteoporosis Day – WOD on October 20th: Help Spread the Word

World Osteoporosis Day – WOD, marked on October 20th each year, is year-long campaign dedicated to raising global awareness of the prevention, diagnosis and treatment of osteoporosis and related musculoskeletal disease.

It aims to put bone health and fracture prevention on the global health agenda and reaches out to health-care professionals, the media, policy makers, patients, and the public at large.

Some Facts About Osteoporosis:

  • By 2050, the worldwide incidence of hip fracture in men is projected to increase by 310% and by 240% in women.
  • Osteoporosis accounts for more days in the hospital than breast cancer, heart attack, diabetes & other diseases.
  • Loss of independence after a hip fracture, approximately 60% require assistance a year later and 20% will require long-term nursing care.
  • Fracture risk up to 27% higher than prostate cancer risk.
  • Aged 50+ 1/3 women 1/5 men: will suffer an osteoporotic fracture worldwide.

Knowing your risk factors

Take the IOF One-Minute Osteoporosis Risk Test to find out whether you may have specific factors which place you at higher risk of osteoporosis and fractures.

www.iofbonehealth.org/iof-one-minute-osteoporosis-risk-test

EffRx commitment to bone health:

Although a small-scale company, EffRx’s employees have made personal efforts to make some noise on behalf of the WOD. Each employee has asked relatives, friends and acquaintances throughout October to support the IOF Global Patient Charter (https://www.iofbonehealth.org/iof-global-patient-charter)

Additionally, in honor of World Osteoporosis Day, EffRx organized a company bone-healthy-brunch on October 16th. Although bone-healthy nutrition is important – particularly to build maximum peak bone mass in adolescents -, drug therapies are critical for fracture prevention in people at high risk of fracture. Today, there are many proven and effective treatments which have been shown to reduce the risk of osteoporotic fracture by between 30–50%.

 

Binosto® Persistence and Efficacy Safety Data to be Presented at the ASBMR 2018 Congress in Montréal, Canada

FREIENBACH, Switzerland–(BUSINESS WIRE)–EffRx Pharmaceuticals SA is proud to announce that recent data from a standardized clinical database suggest an improved safety and tolerability profile of Binosto® (alendronate effervescent tablets) over conventional alendronate tablets in postmenopausal women with osteoporosis, translating into higher treatment persistence of patients. Binosto was also found to be as effective as traditional alendronate tablets based on assessment of bone mineral density scores and bone turnover markers. read more

https://www.businesswire.com/news/home/20180926005351/en/Binosto®-Persistence-Efficacy-Safety-Data-Presented-ASBMR