Bioventus to Co-Develop Placenta-based Tissue Products with MTF Biologics – A Closer Look
The long awaited announcement related to an agreement for a placental-based tissue product is complete. But what does that mean for Bioventus and when will we have a product on the market? We spoke with Alessandra Pavesio for answers to those questions and more.
Q: Why are we excited about placental tissues? How will a biologic product add to our portfolio?
A: We are excited by the prospect of adding an injectable formulation of placental tissues to our portfolio of non-surgical treatments of osteoarthritis as patients and caregivers are seeking safe and effective solutions that will manage pain but also either delay or possibly even eliminate the need for total knee replacements. Placental tissues hold great promise in this regard because they are naturally rich in a wide array of growth factors and regulatory molecules that can beneficially impact OA symptoms (such as pain and limited mobility) while potentially delaying the progression of the disease. Placental tissues are donated by mothers following healthy c-section delivery of their baby and are a wonderful gift of tissue that contains many growth factors (in the past this tissue was just discarded). In the treatment of knee OA a biologic product is unique in that it contains molecules that can work together and naturally affect the imbalance of OA by reducing joint inflammation and promoting the formation of healthier and more durable cartilage.
Q: The press release said the initial focus is on knee osteoarthritis, what other indications might we consider and what other development opportunities could we pursue with these placental tissues?
A: Placental tissues are very safe and well tolerated and are being used in a variety of clinical indications ranging from wound healing, to ocular surgery, to post-surgical adhesion prevention, and as dural substitutes. In orthopedics, injectable placental formulations have been reported to be effective in management of tendinopathy and plantar fasciitis, and more recently are being evaluated as treatments for degenerative disc disease. Our agreement with MTF includes the broad field of musculoskeletal painful conditions so we will think strategically at our development options beyond OA while realizing that approval for each of these indications would require significant clinical investments.
Q: Who from Bioventus is on the development team and is some of the work being conducted in the new lab space in Durham?
A: Many individuals outside of R&D have contributed to bringing this deal to completion- amongst them Sarah Caley and Jeff Welch from BD, David Campagnari from Manufacturing, Patricia Howard from Sales, Mark Harbaugh and Robin White from Marketing, Tom Brady from legal and Julia Taurus from Finance. The core RD team that’s been in the forefront of the formulation development work with MTF and that will continue to develop and test it in the new lab space in Durham until its ready for clinical studies is led by Carl Flannery and includes Scott Seaman, Jason Siegfried, MK Kottke and Neill Pounder. As the program develops over the next few months more team members from marketing, clinical operations and medical affairs will become more actively involved
Q: What makes MTF Biologics a good partner for this program?
A: In our search for the right partner we evaluated dozens of companies and multiple tissue banks. In the end we found MTF offered the best partnering characteristics. Not only is MTF the largest tissue bank in the world, they also have over 30 years of experience bringing safe tissue products to the market to help patients heal. Furthermore, we chose them based-upon their experience and network for sourcing tissues effectively (engaging with donors and harvesting tissue during healthy c-section births), and their track record developing/manufacturing a range of quality tissue allograft products. These traits, combined with a mutual commitment to this long-term partnership made MTF the right choice for Bioventus.
Q; When would the first product be available for a commercial launch? Will we get updates on the progress of the program?
A: Our intention is to bring a product to market that is backed by clinical data and in compliance with FDA guidelines, we will conduct all preclinical and clinical testing required for a Biologic License Application (BLA) – BLA approval is presently estimated in 2024, which would then offer the ability to gain reimbursement of the product and open its use up to the millions of patients with knee OA who have health insurance or similar coverage. Our BLA plans and timelines will become more accurate after our first interactions with FDA, which are expected to occur later this year and in the first quarter of 2021.
That said, today there are other tissue-based products on the market and there is a possibility that we could introduce our product in the cash pay market in late 2020. If this occurs the product would be used by clinicians where similar to platelet rich plasma (PRP) and Bone Marrow Aspirate Concentrate (BMAC) patients pay out-of-pocket for knee OA treatment.
As data becomes available and milestones are reached on this program, we will be sure to share – you should expect a first update in late Q3 of 2019.
Q: Will these products be launched globally or just in the US?
A: We plan to evaluate opportunities for international distribution of these products based on local regulatory and market considerations.
Readers, pay attention to Bionet and Bioventus News and we will share results with you as the project progresses and milestones are met.