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Pharma Tech Outlook | Thursday, December 10, 2020
Subject to all obligatory regulatory approvals, the products under progress can treat a series of central nervous system diseases, including epilepsy, autism spectrum disorder, and general severe pain and anxiety experienced as part of conditions like palliative care diabetic neuropathy.
FREMONT, CA: Kindeva Drug Delivery (Kindeva) and Breath of Life International (BOL Pharma or BOL) signed an agreement to study the probability of multiple inhaled cannabinoid products. Under the contract, Kindeva will develop novel formulations of BOL Pharma’s cannabinoid-based drug products delivered by Kindeva’s Metered-Dose Inhaler (MDI) technology.
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Subject to all obligatory regulatory approvals, the products under progress can treat a series of central nervous system diseases, including epilepsy, autism spectrum disorder, and general severe pain and anxiety experienced as part of conditions like palliative care diabetic neuropathy. If effective, this early-stage activity can lead to the long-term commercial supply of regulated inhaled cannabinoid products, leveraging Kindeva’s commercial manufacturing competencies and BOL’s accumulated knowledge and innovation in the field of medical cannabis.
“We are thrilled to launch this partnership with BOL Pharma,” said Aaron Mann, CEO, Kindeva Drug Delivery. “This is a partnership between two highly innovative and growing companies. BOL Pharma is an acknowledged leader in medical cannabis, and I’m excited that Kindeva has the opportunity to support their progress in this space. Kindeva’s formulation and development expertise, built on more than 20 successful customer launches, enables us to be a strategic partner to BOL Pharma throughout the development lifecycle. Most importantly, the successful development of these products would ultimately offer patients a new and valuable tool for treating truly debilitating conditions.”
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Kindeva, a leading Contract Development and Manufacturing Organization (CDMO), has a historical inheritance of solving complex drug delivery challenges in the biotechnology, biotechnology, and life sciences sectors. The firm has over six decades of development-driven innovation across several drug delivery technologies, including transdermal, inhalation, and microneedles. In inhalation, Kindeva’s list of novel achievements comprises the invention of the MDI and Chlorofluorocarbon (CFC) free MDI.
“We are excited to form a partnership with Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, a recognized global leader in the development of complex drugs, to develop a best-in-class inhaler,” said Kfir Avraham, CEO, BOL Pharma. “By entering into this collaboration, BOL Pharma reaffirms its commitment to developing pharmaceutical-based cannabinoid products to address serious medical needs. This partnership, bringing together two leading companies, will provide a patient-centric solution to those at need.”
This announcement highlights the budding opportunity for inhalation to expand into adjacent therapy areas and indications. In recent years, Kindeva has been actively recognizing and progressing new development prospects in inhalation that go beyond COPD and asthma. “The BOL partnership demonstrates how broad and effective inhaled drug delivery can be,” Mann said. “Applications for inhaled therapies go beyond respiratory diseases. In this case, we’re looking at the systemic delivery of drugs via the lungs. Due to heightened bioavailability compared to oral delivery, inhaled cannabinoids have the possibility to significantly reduce the dosage and reduce the variability currently observed with cannabinoid treatment, with the potential to also enhance the overall accuracy, safety and efficacy.”
The products are being developed for several markets worldwide, including the United States, the United Kingdom, and the European Union. “With Kindeva as our partner, BOL pharma is committed to testing this best-in-class inhaler in clinical trials to establish the safety and efficacy in several unmet medical conditions in consultation with the FDA and EMA”, said Boaz Hirshberg MD, CMO, BOL Pharma. “This partnership will allow us to develop a platform that will deliver an accurate and consistent dose to patients. Furthermore, the rapid onset of action will provide an advantage, especially when dealing with severe pain.”
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