Category Archives: Uncategorized

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.

Lorenzo Bosisio, CEO of EffRx, commented, “We are thrilled to have attracted such talent and experience to drive the further growth of our company. Over the last few years, I feel proud to have been part of the transformation of EffRx into an integrated specialty pharmaceutical company with strong competence in accessing and harnessing the European market. With the addition of this experienced team we are advancing on our path to become an accelerator for late-stage development, valorization and commercialization of niche & orphan medicines in Europe.”

Lorraine Zakin, MD, Director Medical Affairs, is an experienced Medical Affairs and Clinical Development expert. She began by specializing in general surgery and had 7 years of international hospital practice before entering the pharmaceutical industry. During her decade-long tenure in the biopharmaceutical industry, Dr. Zakin has led Medical Affairs and Clinical Development initiatives at regional and global levels across several therapeutic areas, including cardiology, oncology and women’s health.

Peter Lichtlen, MD, PhD, Chief Medical Advisor, has 20 years of biotech and pharma experience both with listed and private companies. Acting as Chief Medical Officer and Head of clinical R&D in his prior career Dr. Lichtlen has led global clinical development programs across different therapeutic areas and was responsible for international medical affairs and pharmacovigilance teams. Dr. Lichtlen has an extensive industry network and concurrently serves in board-, advisory- and leadership-roles in several EU- and US-based innovation companies.

Christiane Sievert, Director Regulatory Affairs, brings over 30 years of experience in Regulatory Affairs ranging from early to last stage development projects in orphan, specialty as well as generic indications for the EU, US and ROW.  Ms. Sievert has proven, in-depth knowledge in Regulatory Affairs across international markets, first-hand experience in interacting with health authorities, as well as expertise in setting up, leading & optimizing Regulatory Affairs processes and infrastructures.

Victor Papavasileiou has more than 10 years of Business Development experience in the global pharmaceutical and biotech industry. With a background in science and engineering he moved on to Business Development and strategy, where he has worked for both start-ups and mature companies. He brings extensive experience in leading all aspects of the transactional phase. In his career he has successfully contributed to the build-up of profitable product portfolios in several therapeutic areas through M&A and strategic licensing transactions.

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. Our vision is to be the preferred and dedicated partner in Europe for the late clinical development, approval and valorization of emerging niche biopharmaceuticals.

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.

Contacts

EffRx Pharmaceuticals SA
Pamela Saredi
psaredi@effrx.com

 

 

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

In both Malaysia and Singapore, Binosto® is marketed by Zuellig Pharma. For EffRx Pharmaceuticals SA, who has developed Binosto®, the launch in Southeast Asia marks another important milestone. “With the addition of Malaysia and Singapore, our geographic footprint grows significantly,” says EffRx Commercial Director Michael Schmid. “We are happy to have selected a strong and renowned local partner. While growth of Binosto® in our existing markets remains high, geographic expansion through strong local partnerships continues to be a key priority for Binosto® to bring the its promise to patients worldwide.”

The launch of Binosto® in Malaysia and Singapore will be followed in 2019 by launches in other Southeast Asian markets. For Zuellig Pharma, who holds the marketing rights in these countries, Binosto® presents a very exciting opportunity to add a unique flavor to the management of osteoporosis. “With its innovative properties and compelling efficacy and safety evidence, it can be part of many physicians’ toolkit for thousands of osteoporotic patients across Asia”, says Frederick Fong, Director Marketing Excellence (Asia) at Zuellig Pharma.

Data presented at this year’s WCO-IOF-ESCEO Congress and published in Osteoporosis International suggest that Binosto® is associated with higher persistence, i.e. better treatment adherence, than alendronate tablets.4 The same data also showed significantly fewer patients discontinuing Binosto® due to gastrointestinal adverse events – confirming the favorable GI safety profile of Binosto®.

About EffRx Pharmaceuticals

EffRx Pharmaceuticals is a commercial-stage pharmaceutical company, which focuses on developing and commercializing prescription medications for specialty and orphan indications. EffRx actively seeks collaboration opportunities with U.S. bio-pharmaceutical companies, which are looking to commercialize their products in Europe. EffRx can act as accelerator of EU go-to-market strategies and be a spring board for an initial international set-up in Switzerland.

About Zuellig Pharma

Zuellig Pharma is one of the largest healthcare services group in Asia. We provide world-class distribution, digital and commercial services to support the growing healthcare needs in this region. The company was started almost a hundred years ago and has grown to become a US$10 billion business covering 13 markets in Asia with over 10,000 employees. Our purpose is to make healthcare more accessible. Our people serve over 320,000 medical facilities in Asia and we work with over 1000 clients including the top 10 pharmaceutical companies in the world. More recently, we launched our Zuellig Health Solutions Innovation center to develop new services and address some pressing healthcare needs in Asia. Since then, our teams have been focused on creating data, digital and disease management solutions, supporting patients with chronic conditions and helping payers manage healthcare costs. We are also making headway in using big data to inform our decisions and those of our clients, on how to optimize for greater operational accuracy and efficiency.

About Binosto®

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.2,5 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® 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. 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.
  3. Hruska J et al. Upper Gastrointestinal Safety with the Buffered Solution of Alendronate 70mg: Postmarketing Experience. J Bone Miner Res 2017;32 (Suppl 1):S269. Available at http://www.asbmr.org/education/AbstractDetail?aid=e14d6b16-9338-4e96-b070-d744f2d208da. Accessed October 16, 2018.
  4. Giusti A et al. Persistence with the buffered solution of alendronate 70 mg: prospective observational study. Osteoporos Int 2018;29(S1):P853.
  5. Binosto 70mg SPC. mhra.gov.uk; accessed 16.10.2018.

Contacts
EffRx Pharmaceuticals SA
Pamela Saredi
psaredi@effrx.com

 

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.

The data will be presented as posters at the ASBMR 2018, the American Society for Bone and Mineral Research, held from the 28th of September until 01th October – 2018 at the Palais des Congrès de Montréal, in Montréal QC, Canada.

The poster entitled, “Persistence with Buffered Solution of Alendronate 70mg: Prospective Observational Study,” authored by Giusti et al. presentation number SAT-0322, will be presented at the Congress in the ASBMR Discovery Hall – Room 220 B-E on Saturday, 29th of September from 12:30-2:30 pm.

The second Binosto® safety data poster, “Effect of Buffered Solution of Alendronate 70mg on Bone Mineral Density and Bone ALP: Prospective Observational Study,” authored by Giusti et al. presentation number SUN-0697, will be presented by Prof. Dennis Black a day later at the Congress in the ASBMR Discovery Hall – Room 220 B-E on Sunday, 30th of September from 12:30-2:30 pm.

Binosto®, the world’s first and only buffered soluble alendronate for the treatment of osteoporosis, was developed with the aim to capitalize on the excellent efficacy profile of alendronate sodium while improving gastrointestinal tolerability. Upper gastrointestinal side effects are known to be problematic with tablet forms of alendronate sodium as well as of other bisphosphonates.

“Poor adherence and persistence with oral bisphosphonates can result in patients being at increased risk of osteoporotic fractures,” states Lorraine Zakin, MD, Director Medical Affairs at EffRx Pharmaceuticals. She further states, “the data presented therefore strongly suggest that alendronate effervescent tablets have substantial potential by increasing treatment persistence to improve the long-term outcome of patients with osteoporosis.”

The American Society for Bone and Mineral Research (ASBMR) is a professional, scientific and medical society established to bring together clinical and experimental scientists who are involved in the study of bone and mineral metabolism. The conference attracts nearly 4’000 expert attendees from around the globe.

About EffRx Pharmaceuticals

EffRx Pharmaceuticals is a commercial-stage pharmaceutical company, which focuses on developing and commercializing prescription medications for specialty and orphan indications. EffRx actively seeks collaboration opportunities with U.S. bio-pharmaceutical companies, which are looking to commercialize their products in Europe. EffRx can act as accelerator of EU go-to-market strategies and be a spring board for an initial international set-up in Switzerland.

About Binosto®

Binosto® (alendronate 70 mg effervescent tablets) is the first and only buffered solution for the treatment of osteoporosis with proven antifracture efficacy. The buffered solution minimizes the possibility of exposing the esophagus (in case of reflux) and the stomach to acidified alendronate and thus reducing the risk of upper gastrointestinal toxicity1,2. It 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 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.

References:

  1. Hodges LA et al. Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate. International Journal of Pharmaceutics 2012;432:57-62.
  2. Binosto 70mg SPC. mhra.gov.uk; accessed 25.09.2018

 

 

 

Binosto Data to be Presented at the WCO-IOF-ESCEO Congress in Krakow, Poland, Held from April 19th to 22nd, 2018

EffRx Pharmaceuticals SA is proud to announce that it will participate in the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases in Krakow, Poland, from 19 to 22 April 2018. The WCO-IOF-ESCEO Congress, as it is also known, 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 world’s first and only buffered soluble alendronate for the treatment of postmenopausal osteoporosis. Medical professionals from around the world will be able to learn more about Binosto and its exciting properties at the Binosto booth in the exhibition area of the ICE Krakow congress center (booth #21).

EffRx Pharmaceuticals SA is equally thrilled to inform that new Binosto data pertaining to its efficacy and persistence will be presented at the WCO-IOF-ESCEO Congress. The data will be presented in the poster area on Saturday, 21 April 2018, from 14:00 to 15:00 (posters #853 and #857).

Binosto®, the world’s first and only buffered soluble alendronate for the treatment of osteoporosis, was developed with the aim to capitalize on the excellent efficacy profile of alendronate sodium while improving gastrointestinal tolerability. Upper gastrointestinal side effects are known to be problematic with tablet forms of alendronate sodium as well as of other bisphosphonates.

Please join EffRx at the WCO-IOF-ESCEO Congress in Krakow!

EffRx to Showcase Binosto® at WCO-IOF-ESCEO 2018 in Krakow, Poland

FREIENBACH, Switzerland–(BUSINESS WIRE)–EffRx Pharmaceuticals SA is proud to announce that it will participate in the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases in Krakow, Poland, from 19 to 22 April 2018. 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 thrilled to inform that data on Binosto® persistence and efficacy will be presented at the WCO-IOF-ESCEO Congress. The data will be presented in the poster area on Saturday, 21 April 2018, from 14:00 to 15:00 (posters #853 and #857).

The authors of the Binosto® persistence and efficacy studies concluded that Binosto® is associated with higher persistence than alendronate tablets and as efficacious as alendronate tablets on surrogate endpoints for anti-fracture efficacy.

“Last year we presented post-marketing safety data which supported our hypothesis that the unique Binosto® properties have a positive impact on reducing the incidence of upper gastrointestinal side effects1,” says Dr. Josef Hruska, Executive Medical Director at EffRx Pharmaceuticals. “This year we are strengthening the available evidence with very exciting, new Binosto® data, indicating that patient persistence is significantly higher than with alendronate tablets. Furthermore, and as expected, there was no difference in efficacy between Binosto® and alendronate tablets.”

Medical professionals from around the world will be able to learn more about Binosto® and its exciting properties at the Binosto® booth in the exhibition area of the ICE Krakow Congress Center (booth #21).

Please join EffRx at the WCO-IOF-ESCEO Congress in Krakow!

About EffRx Pharmaceuticals SA

EffRx Pharmaceuticals SA is a Swiss-based commercial-stage pharmaceutical company developing and commercializing prescription medications for specialty indications. Our lead commercialized product, Binosto® is indicated for the treatment of osteoporosis and marketed in US, Europe and Asia. We strive to address true unmet medical needs and provide improved outcomes to patients with musculoskeletal, genitourinary and rare disorders.

About Binosto®/Steovess®

Binosto® (alendronate 70 mg effervescent tablets) is the first and only buffered solution for the treatment of osteoporosis with proven anti-fracture efficacy. The buffered solution minimizes the possibility of exposing the esophagus (in case of reflux) and the stomach to acidified alendronate and thus reducing the risk of upper gastrointestinal toxicity.2,3 In the EU, Binosto® is approved for the treatment of postmenopausal osteoporosis. It 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 long-term patient adherence to therapy, 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. Hruska J et al. Upper Gastrointestinal Safety with the Buffered Solution of Alendronate 70mg: Postmarketing Experience. J Bone Miner Res 2017;32(S1):S269. Available at http://www.asbmr.org/education/AbstractDetail?aid=e14d6b16-9338-4e96-b070-d744f2d208da. Accessed March 22, 2018.
  2. Hodges LA et al. Modulation of gastric pH by a buffered soluble effervescent formulation: A possible means of improving gastric tolerability of alendronate. International Journal of Pharmaceutics 2012;432:57-62.
  3. Binosto® 70mg SPC. mhra.gov.uk; accessed 16.4.2018

Media Contact: Pamela Saredi, psaredi@effrx.com

 

 

European Market-Entry Strategy for Biopharma Companies

The European pharmaceutical market offers many opportunities for U.S. biopharmaceutical companies. An early engagement as well as a visceral understanding of the heterogeneity of the European market are key to succeed. Partnering with EffRx Pharmaceuticals, a commercial-stage pharmaceutical company offers various advantages. Because of its diversity and non-bureaucratic access to a talented workforce, EffRx an ideal partner to kick off your international go-to-market strategy.

For the entire article please go to the Greater Zürich Area.

Meet the EffRx Team at the 23rd Annual BIO-Europe International Conference from 6-8 November 2017 in Berlin

The 23rd Annual BIO-Europe International Conference is the “must-attend” event and Europe’s largest life science partnering conference. And EffRx will be there.

The conference brings together hundreds of the world’s most innovative leaders across biotech, finance and pharma for high-level networking, pre-scheduled partnering meetings, strategic panel discussions and more.

To arrange for a meeting, please contact us via the BIO-Europe partnering platform.