Category Archives: Uncategorized

EffRx Pharmaceuticals Statement on COVID-19

The globe has literally gone into quarantine due to the COVID-19 outbreak. This is an unprecedented crisis situation in terms of breadth and scale, from a global health, social and economic standpoint.

While committed to keep our core activities unaffected, EffRx has implemented measures aimed at guaranteeing business operation continuity, with particular focus on the supply of Binosto® to our customers. EffRx has engaged with its suppliers and clients to ensure continuity of the business and will continue to monitor the situation as it evolves with the aim to minimize the impact of this crisis on our business.

EffRx has further taken internal measures to reduce the contamination risk for employees and business partners. The health of our staff and partners is our number one priority. The entire staff is working remotely from home with effective equipment & systems. We have also cancelled all travels, replaced face-to-face meetings/trainings by virtual meetings and are pursuing digital collaboration with all our stakeholders.

We thank for your loyalty, flexibility and understanding for the unforeseen consequences of this global pandemic. We are in this together.

Wishing you all good health.

EffRx Pharmaceuticals
Lorenzo Bosisio
CEO

The 13th international Rare Disease Day coordinated by EURORDIS will be on February 29, 2020

Rare Disease Day takes place on the last day of February each year. 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.

Building awareness of rare diseases is so important because 1 in 20 people will live with a rare disease at some point in their life. Despite this, there is no cure for the majority of rare diseases and many go undiagnosed. Rare Disease Day improves knowledge amongst the general public of rare diseases while encouraging researchers and decision makers to address the needs of those living with rare diseases.

Learn more about Rare Disease Day here.

Meet the EffRx Team at the 25th Annual BIO-Europe International Conference from November 11-13, 2019 in Hamburg

EffRx will be attending Europe’s largest life science partnering conference, BIO-Europe, which offers countless opportunities to engage with global life science partners. This year´s BIO-Europe partnering event will again draw over 4,000 industry attendees from over 60 countries, representing more than 2,000 companies for three days of high-level networking.

To set up a meeting, please contact us via the partnering platform or at info@effrx.com.

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