Showing all posts written by Casey Donahoe
BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration
BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The medical device is said to be a component of BioArctic’s SC0806 product for treatment of complete spinal cord injury. The allowed claims are directed toward “selecting a spinal cord device” having certain geometric characteristics, “positioning peripheral autologous nerves in … through channels,” and implanting the device in an injured spinal cord. The device is said to be soakable in a solution of FGF1 growth factor prior to implantation. BioArctic reports to have received corresponding patents in China and Australia.
According to BioArctic, despite considerable research into bridging spinal cord gaps, no product is yet available on the market. BioArctic states that the SC0806 spinal cord product is currently undergoing Phase 1/2 clinical trials in Sweden and was granted orphan drug status in the European Union and the United States, qualifying the product for 10 and 7 years of market exclusivity, respectively. The product received funding from the European Union’s Horizon 2020 Research and Innovation Program, the EU’s largest public investment program for research and innovation, comprising an €80 billon investment over 7 years, culminating in 2020.
According to BioArctic, in addition to developing treatments for complete spinal cord injury, its research focuses on disease modifying treatments and reliable biomarkers and diagnostics for neurodegenerative diseases, such as Alzheimer’s disease and Parkinson’s disease, for which AbbVie has agreed to develop and commercialize BioArctic’s Parkinson’s antibody portfolio. European Biotechnology rated BioArctic’s €71.8 million IPO as one of Europe’s most successful in 2017.
Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the treatment of gastrointestinal (GI) diseases. According to the announcement, Takeda will contribute its GI expertise to the development of medical devices to be designed by BioSurfaces using BioSurface’s biomaterial nanotechnology. Takeda’s GI drug Entyvio has recently been predicted by gastroenterologists to see significant growth. Fittingly, BioSurfaces touts its nano-fibrous materials, said to be formed by electrospinning FDA-approved polymers, as superior platforms for drug-delivery. Vincent Ling, Ph.D., senior director of the Materials and Innovation, Takeda Pharmaceutical Sciences, commented:
Our research collaboration will lead to the development of cutting-edge use of biopolymers and device fabrication technology. Application of developed technology has the potential to help prevent strictures and promote healing of fistulas, which are common manifestations of GI diseases.
The partnership continues a trend for Takeda, which has entered into at least 50 other new partnerships over the past 20 months, according to Life Science Leader. A little over a year ago, the 236-year old pharmaceutical company announced its plans to restructure the R&D organization by focusing on three therapeutic areas – Oncology, Gastroenterology (GI), and Central Nervous System (CNS) – as well as on Vaccines. As reported by Life Science Leader, the partnerships reflect the “restructuring of the R&D organization around the idea of increasing external collaboration on a global scale.” BioSpace notes that Takeda’s new strategy also includes splitting-off several assets outside of its new R&D focus as well as investing in strategic acquisitions, with the Financial Times reporting in 2016 that Takeda had allocated $15 billion for U.S. acquisitions.
Takeda’s partnership with BioSurfaces is not the first time it has teamed up with a nanotech partner to complement its drug discovery with drug delivery modalities. “Takeda is devoting itself to the idea of spinning off companies based on new technologies, including those discovered outside. As a pharma designed for drug discovery, at times it’s best to fund an alternate modality, so it can grow externally, before integrating it into our pipeline. I think that’s a view of nanotechnology we can entertain for the future” said Ling in 2016.
Codman Neuro, part of Johnson & Johnson’s DePuy Synthes business unit, recently announced its acquisition of Neuravi Ltd., a privately-held Irish medical device company, for an undisclosed amount. The Irish Times reported that the acquisition is the largest price paid for a European venture-backed medtech company since Medtronic’s $700 million buyout of CoreValve in 2009. According to its website, Neuravi focuses on neurointervention therapies for acute stroke treatment.
Neuravi’s sale to Codman Neuro comes after several rounds of fundraising, in which Neuravi secured tens of millions of dollars for the development and commercializing of its EmboTrap Revascularization Device. Neuravi explains that the EmboTrap Revascularization Device is a thrombectomy system designed to restore blood flow to the brain by capturing and removing blood clots. In a 2016 press release, Neuravi CEO Eamon Brady quoted the most recent investment of $16.7 million as important for building a commercial presence in the U.S. and cited the “opportunity due to the under-developed stroke treatment ‘toolbox’ available to stroke clinicians today.” The EmboTrap devices are now commercially available in Europe and are currently undergoing clinical trials in the U.S. Speaking to the Irish Times regarding Neuravi’s acquisition, Justin Lynch, a partner of one of Neuravi’s early institutional investors, said:
This is a company that has knocked the ball out of the park. They have beaten every milestone, earlier and with less money that budgeted, which is almost unheard of in this business.
Neuravi’s revascularization devices appear to have successfully caught the attention of Codman Neuro. Shlomi Nachman, Company Group Chairman of Johnson & Johnson Medical Devices Cardiovascular & Specialty Solutions recently stated:
Rapid restoration of flow is of utmost importance when treating stroke patients . . . . The EmboTrap platform was designed to address this critical need and we are excited to combine Neuravi’s expertise in clot research with Codman Neuro’s global resources to accelerate innovation in acute ischemic stroke treatment.
Codman Neuro describes its portfolio as including medical devices for hydrocephalus management, neuro intensive care and cranial surgery, and endovascular treatment of cerebral aneurysms and stroke, including aneurysm coils and vascular reconstruction devices.
Shortly before Codman Neuro’s acquisition of Neuravi, Integra Lifesciences announced that it plans to purchase Codman from Johnson & Johnson for $1.05 billion. Integra explained that it intends the acquisition to expand Integra’s international presence. Integra markets products in orthopedic extremity surgery, neurosurgery, and reconstructive and general surgery, including wound repair. According to Integra’s press release, Codman Neuros’ neurosurgery business generated $370 million in 2016 from the sale of neuro-critical care and electrosurgery devices. Johnson & Johnson reported to Reuters that the deal with Integra excludes its neurovascular and drug delivery businesses.