New agreement expands collaboration between OnDosis and TIEFENBACHER GROUP

Swedish Life science company OnDosis and German B2B pharmaceutical company TIEFENBACHER GROUP initiate four new innovative development projects targeting ADHD, rare diseases, and transplantation medicine. The idea is to improve the health and everyday lives of millions of patients by giving them access to finely tuned and individualized medicine.

TIEFENBACHER GROUP is a pioneering healthcare company with innovative and best-in-class solutions along the entire pharmaceutical development value chain. The company’s vision is to improve patients’ lives by making a difference in tomorrow’s health. An idea that corresponds well with how OnDosis wants to revolutionize how patients take their medicines. “It feels fantastic to expand our existing collaboration with several new projects,” says Dr. Kristian Ruepp, Joint Managing Director, TIEFENBACHER GROUP.

Last year, the two companies began cooperating on an ADHD treatment that has already received attention in the USA. As an example, the OnDosis drug/device for ADHD was highlighted during APSARD, the annual general meeting of The American Professional Society of ADHD and Related Disorders.

“Whilst our first ADHD project fast approaches final stages of development, we are thrilled to partner up with TIEFENBACHER for no less than four more projects that will greatly expand our portfolio,” says Martin Olovsson, CEO OnDosis. “Some of the critical and heart-warming targets include helping those with serious rare diseases, and patients that have undergone an organ transplant. Two patient groups where finely tuned and individualized doses of the prescribed medications are critical to outcomes and necessary to for patients to live a better everyday life.”

The partnership aims to develop and commercialize products in the intersection between traditional drug-based medicine and digital therapeutics. The five products developed are planned for launch 2023 and onwards. The team at OnDosis consists of experts in developing and designing proprietary solutions, including intuitive, user-friendly, and connected devices that deliver medicine and enables digital solutions to be integrated. As a result, each patient’s specific needs can be met with individualized doses that the patient or the doctor can adjust should the need arise. The collection of data on dosing linked to outcomes open up a new field of a closed loop disease management. Ultimately, the goal is to achieve algorithm-based
dosing through predictive modeling leading to personalized treatments.

Another novelty is to dispense the drugs as pellets instead of pills or capsules, making them easier to consume.

TIEFENBACHER GROUP has significant expertise and experience in developing pharmaceuticals across all stages of development. Their expertise guarantees efficient development of medicines in a form that allows individual dosing whilst meeting the most rigorous quality and safety standards. Also, TIEFENBACHER’s leading competence within supply chain and B2B commercialization will be instrumental when the first products developed by Tiefenbacher and OnDosis reach the market in 2023-2024.

“One of our key focus areas is what we call ‘Beyond Imagination’, and OnDosis is the right partner when going there. Together, we will make a real difference when it comes to optimizing the effects of the medicine people take,” says Kristian Ruepp. “We want to give people a chance to live the life they deserve. For many, this is only possible with the right dose of their prescribed medication. In collaboration with Tiefenbacher, we have every chance to fulfill this vision,” Martin Olovsson concludes.

For further information around pharmaceuticals or other worldwide health solutions please contact TIEFENBACHER PHARMACEUTICALS: info@aet.eu

TIEFENBACHER GROUP plays an active role in the fast changing and innovative ecosystem of the pharmaceutical industry and healthcare. Please visit us on: www.tiefenbachergroup.com


Spreading of Post COVID-19 Disease „Black Fungus“ in India – TIEFENBACHER GROUP supports with Posaconazole Tablets

Black Fungus (Mucormycosis) is dramatically spreading in India connected to the extensive 2nd COVID-19 wave. The highly life-threatening disease usually occurs as a rare disease in immunocompromised patients. However, many patients who have survived their COVID-19 infection with the help of external oxygen support are now affected by black fungus. Physicians in India believe that an inadequate oxygen supply of COVID-19 patients may be the reason for this dangerous development.

With Posaconazole tablets Tiefenbacher produces one of the most effective treatments against Black Fungus and is now supporting India to push back this disease fast. “When we heard about the problems with Black Fungus in India we directly decided to change our production plans and produce as fast as possible Posaconazole tablets for India. We hope to be able to help as many Black Fungus patients as fast as possible.” says Oliver Schrader, Joint Managing Director of Tiefenbacher Group.


TIEFENBACHER GROUP announces global launch of TIEFENBACHER MEDICAL DEVICES

After more than five years in operation, TIEFENBACHER GROUP will transfer its medical device business into a new stand-alone company: TIEFENBACHER MEDICAL DEVICES.

The launch follows TIEFENBACHER GROUP´s strategy to offer better patient therapies by combining established drug-based medicines with medical devices & digital health. TIEFENBACHER MEDICAL DEVICES is focused on medical devices for respiratory treatments and multiple other innovative drug-device combination products for individualized treatments in globally relevant disease areas.

Please have a look at our Website: www.tiefenbachergroup.com/medical-device/

About TIEFENBACHER MEDICAL DEVICES
TIEFENBACHER MEDICAL DEVICES is developing medical devices as part of combination products and offering eHealth solutions where relevant. We leverage the full potential during drug-device combination product developments and keep people safe and healthy by maximizing treatment outcomes while minimizing healthcare spends. Driven by patient demands, we are managing the entire innovative process from concept to market entry and create healthcare opportunities across the globe as well as accelerating routes to market.

For further information around medical devices or other worldwide eHealth solutions please contact TIEFENBACHER MEDICAL DEVICES: info@aet.eu

TIEFENBACHER GROUP plays an active role in the fast changing and innovative ecosystem of the pharmaceutical industry and healthcare. Please visit us on: www.tiefenbachergroup.com


TIEFENBACHER PHARMACEUTICALS announces global launch of Teriflunomide making multiple sclerosis therapy more affordable and better available worldwide

TIEFENBACHER PHARMACEUTICALS, part of TIEFENBACHER GROUP, has successfully developed a global dossier for a generic version of Teriflunomide 7 mg and 14 mg film-coated tablets.  

 Teriflunomide is an important part of the therapy of multiple sclerosis and the global roll-out of the product in more than 40 countries will make this therapy more affordable and better available for the over 2,8 million patients worldwide.  

 The product was developed and is commercially produced at our Indian manufacturing site TIEFENBACHER LABORATORIES in Hyderabad and at Combino Pharm Ltd.   

The formulation has successfully passed four bioequivalence studies against reference products from three different markets. The product is already approved in Australia, Canada, New Zealand, and the US. Additional filings in Europe, South America and South Africa are under preparation and will take place this year in line with data exclusivity expiry.  

For further information please contact TIEFENBACHER PHARMACEUTICALSinfo@aet.eu 

Disclaimer: Teriflunomide, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force. 


AET Pharma US Inc. Announces Successful approval of generic Posaconazole by the Food and Drug Administration (FDA)

On 1st February 2021, AET Pharma US Inc, part of TIEFENBACHER GROUP, received FDA approval of the Abbreviated New Drug Application (ANDA) for Posaconazole 100 mg Delayed-Release Tablets. This is another milestone for TIEFENBACHER GROUP in further strengthening its product portfolio in the United States. The US launch of Posaconazole will proceed in close cooperation with our experienced distribution partner, Lupin Pharmaceuticals Inc. With the market entry of Posaconazole, we look forward to increasing availability and ensuring affordability of this treatment for American patients.

The product has been developed by and is manufactured at TIEFENBACHER LABORATORIES in Hyderabad, India, and has already been successfully launched in the European Union and in Australia. The registration dossier is currently under filing in several additional international markets.

For more information, please contact TIEFENBACHER PHARMACEUTICALS: info@aet.eu


TIEFENBACHER PHARMACEUTICALS Announces Global Launch Of Rivaroxaban

TIEFENBACHER PHARMACEUTICALS, part of Tiefenbacher Group, is pleased to announce the availability of a registration dossier for the generic of Rivaroxaban 2.5 mg, 10 mg, 15 mg and 20 mg film-coated tablets.
The product was developed at TIEFENBACHER LABORATORIES, Hyderabad. Commercial production for early markets is conducted outside of Europe. For European markets, the product will be manufactured at TIEFENBACHER GROUP facility on Cyprus.

The formulation has successfully passed fifteen global bioequivalence studies and six additional pivotal studies are currently under preparation. The registration dossier is currently approved in several EU markets via DCP and via national applications in CIS countries and in Canada.

The product has already been successfully launched in early markets and further markets will follow during the course of this year. The registration dossier is under filing in several additional international markets with a global roll out to follow in more than sixty markets throughout the world.

The market exclusivity and basic patent have already expired, while the SPC will expire in September 2023 in Europe.

For more information, please contact TIEFENBACHER PHARMACEUTICALS: info@aet.eu

Disclaimer: Rivaroxaban, which is subject to patent prosecution, is currently not offered or made available in countries where patents are in force.


International Brand Relaunch of TIEFENBACHER GROUP

“We are very excited to launch our new AET website, representing the pharmaceutical FDF business of TIEFENBACHER GROUP. It is an important milestone within the international brand relaunch of our whole company group (www.tiefenbachergroup.com) and represents the fundamental changes which we have started in the recent years. We are on the move to drive important efficiencies in our supply chain and become a more and more innovative, patient-centered enterprise with a global pharmaceutical footprint.”

Oliver Schrader and Dr. Kristian Ruepp, Managing Directors AET

“We are very excited to launch our new AET website, representing the pharmaceutical FDF business of TIEFENBACHER GROUP. It is an important milestone within the international brand relaunch of our whole company group (www.tiefenbachergroup.com) and represents the fundamental changes which we have started in the recent years. We are on the move to drive important efficiencies in our supply chain and become a more and more innovative, patient-centered enterprise with a global pharmaceutical footprint.”

Oliver Schrader and Dr. Kristian Ruepp, Managing Directors AET


Tiefenbacher Group and OnDosis enter a strategic partnership for game-changing integration of medicines and digital health

Tiefenbacher Group and OnDosis today announced the signing of an extensive co-development agreement for multiple products in the upcoming years. This collaboration strengthens both companies’ commitment to further develop and commercialize innovative products within individualized treatments and digital health, combining traditional drug-based medicines with digital therapeutics and intelligent dosing.