Orion Biotechnology Successfully accomplishes Phase 1 Clinical Trial of a First-in-Class Precision Engineered Ligand Analog for HIV Prevention

Orion Biotechnology Canada Ltd | October 16, 2020

Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering GPCR-targeted therapeutics, today announced the results of their Phase 1 study of OB-002H which is an investigational candidate microbicide for HIV prevention. The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel. OB-002, a highly potent chemokine analog of CCL5 (a ligand for the CCR5 HIV co-receptor), has previously been shown to be completely protective in a non-human primate model of vaginal HIV transmission (Veazey R et al. JID 2009). The Phase 1 study design included open-label single-dose (vaginal and rectal) and multi-dose product (vaginal) administration of OB-002H gel to study participants followed by a randomised, double-blind, placebo-controlled multi-dose (vaginal) phase of product administration. During the multi-dose phase of the study, participants received study product once daily for five days. The study enrolled a total of 30 healthy volunteers in Warsaw, Poland at the BioVirtus Phase 1 Research Site. The product was well tolerated, and product-related genital adverse events were mild (Grade 1) or moderate (Grade 2) and transient.

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Pharma Tech Holdings SA Obtains a Capital Commitment Agreement of CHF 30 million from Global Investor LDA Capital

Pharma Tech | August 09, 2022

Pharma Tech Holding SA announced it has secured a CHF 30 million investment to support its portfolio investments from LDA Capital Ltd, a global investment group with expertise in cross border transactions including the agriculture, Agri-tech, and CBD industries. Established in 2019, PTH is a Swiss based holding company, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. This investment will allow PTH to mainly invest and support its portfolio company Blue Sky Swisse SA a JV between PTH and listed company IGEA PHARMA NV IGPH - ISIN NL0012768675. BSS focuses on the extraction of natural active principles from vegetable matrices, vegetable waste, and renewable sources to deliver B2B products under the form of CBD oil, Terpenes and Waxes. The factory located in Biasca, will be built to the state of art of extraction technology by super critical CO2 and will be energy self-sufficient through the use of solar photovoltaic panels and district heating. BSS will grant for highest CBD quality also due to a proprietary extraction process, starting from the farming performed under strict control and culminating with the immediate freezing of the flowers after harvest, with the target to also sell “all natural” formulations to increase bioavailability thus enhancing the possible applications. Last, but not least, BSS will invest in the agricultural raw material chain and will create an aeroponic green house in Ticino, to deliver a high quality GMP Pharmaceutical CBD oil. LDA Capital agreed to commit an amount of up to CHF 30 million in cash within a maximum of three years. This Capital Commitment will be released based on drawdowns by PTH, that PTH has the right to exercise at its sole discretion. “We’re thrilled with this partnership and are so glad that LDA Capital recognizes the value of PTH and its portfolio company, with the aim of creating one of the most innovative hub for health-tech, agri-tech and functional food,” Sabina Del Nigro, CEO at PTH About Pharma Tech Holding Pharma Tech Holding SA is a holding company based in Lugano, Switzerland, which invests into innovative businesses with high technological value and scalability potential, mainly in Switzerland and Europe, with a focus on the health-tech, Agri-tech, and functional food. About LDA Capital LDA Capital is a global alternative investment group with expertise in cross border transactions worldwide. Our team has dedicated their careers to international & cross border opportunities having collectively executed over 250 transactions in both the public and private middle markets across 43 countries with aggregate transaction values of over US$11 billion.

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PHARMA TECH

Gerresheimer and Zollner enter into a strategic partnership for electronically controlled medtech systems from a single source

Gerresheimer AG | August 18, 2022

Gerresheimer AG and Zollner Elektronik AG are pooling their market-leading pharmaceutical and medical technology expertise under a strategic partnership. Starting immediately, they will offer pharmaceutical, healthcare and biotech companies their conceptual design, development and manufacturing capacities for drug delivery and medical technology systems, including complete electronics, from one single source. Gerresheimer serves as the central point of contact for customers. The market-leading partners combine the expertise of Gerresheimer in innovative devices for the administration of medicines and medical technology systems with the globally established electronics expertise of Zollner. Together they want to further develop their expertise in the healthcare sector and open up new markets. With this strategic partnership, Gerresheimer and Zollner are counting on the global trend toward electronic, digitally controllable and connected drug delivery and diagnostic systems. These include insulin pens, inhalators, like for people suffering with asthma, Point-of-Care systems and medicine pumps. The demand for medical and pharmaceutical devices with electronic components mostly for the treatment of chronic illnesses will significantly increase in coming years. According to studies, the market for digital and connected solutions for the treatment of diabetes alone is expected to grow to around EUR 11bn by 2025. Zollner Elektronik AG is one of the world's largest manufacturing service providers for electronic and mechatronic components (Electronic Manufacturing Services or EMS). It generated revenues of around 1.9 billion Euros with just over 12,000 employees at 23 locations in Germany and abroad, 18.3% of that in the area of Healthcare & Life Sciences. "The future belongs to digital treatment support with electronic systems and connected platforms. The partnership with Zollner helps us provide our pharma customers with innovative one-stop medtech solutions. For patients, using these solutions means better treatment and enhanced quality of life. At the same time, the healthcare system also benefits by way of permanently reduced treatment costs." Dietmar Siemssen, CEO of Gerresheimer AG "Digitalization of medical devices is advancing at a very fast tempo. At Zollner, we are happy to have found an ideal partner in Gerresheimer for the expansion of our successful Healthcare & Life Sciences efforts," says Markus Aschenbrenner, Managing Board Member at Zollner. "Together we will expand access to existing markets, exploit new growth markets and support our mutual customers along the entire life cycle of the products." Zollner and Gerresheimer have collected much cooperation experience in numerous projects. The electronics specialist in Zandt already supplies Duesseldorf-based Gerresheimer with components and assemblies for medicine pumps in Parkinson's therapy. Gerresheimer and Zollner are now further developing this cooperation and will act as equal partners for the healthcare system of the future. Through the integration of concept design, development and manufacturing, the products of both sides can be brought to market faster and more efficiently. Also gained is permanent, secure access to electronic components. The cooperation initially covers the development of inhalers for chronic lung disease sufferers, autoinjectors, ophthalmology systems and drug pumps, as well as contract manufacturing for these and similar devices.

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BUSINESS INSIGHTS

MediPharm Labs Enters into $6.2M Purchase Agreement for the Sale of Australian Facility

MediPharm Labs Corp. | July 12, 2022

MediPharm Labs Corp. a pharmaceutical company specialized in precision-based cannabinoids, has entered into a Share Purchase Agreement with OneLife Botanicals PTY for the sale of MediPharm Labs Australia Pty Ltd a wholly-owned subsidiary of the Company, for a minimum value of $6.9M AUD. The Agreement is subject to routine conditions and is anticipated to close within 90 days. The Agreement includes the assets of MPLA, specialized licensing, operational knowledge, and Australian and New Zealand customers currently served from that facility. All international contracts outside of Australia and New Zealand will remain with MediPharm Labs and be serviced from our Barrie GMP facility. In July 2021, MediPharm Labs was the first purpose-built cannabis facility to receive a pharmaceutical Drug Establishment License. Awarded by Health Canada, this license is recognized in over 50 countries as part of the Pharmaceutical Inspection Co-operation Scheme. At this time, the Company has completed a review of its international manufacturing platform and identified significant potential savings in moving all domestic and international manufacturing to the Canadian facility. After an extensive sale process, the Agreement with OneLife Botanicals was identified as a strategic fit for both parties. OneLife Botanicals is an emerging leader in Australia region for cannabis-based wellness and medical products, with plans to launch OTC CBD products across Australia. Purchasing the MPLA facility expedites OneLife Botanicals' timing to commercialization. The Company and OneLife Botanicals will also enter into a transition services agreement to allow for the two companies to smoothly transition products and services produced in the facility, and to work together on future commercial opportunities. David Pidduck, CEO of MediPharm Labs commented, "This sale represents a major milestone for MediPharm Labs as it continues to focus on rightsizing the business to achieve profitability. As we look to maintain our strong cash balance, this transaction paired with corporate restructuring completed in June 2022 should allow us to reduce our quarterly burn rate as we improve sales. I want to personally thank our Australian team. This group of professionals are trailblazers in the Australian and international medical cannabis market, achieving major milestones such as multiple customer product launches and our first deliveries to Germany. OneLife Botanicals is gaining one of the most capable medical cannabis manufacturing teams in Australia." "This purchase aligns and expedites the strategic aim of our organization to produce high quality medicinal cannabis products by integrating manufacturing into the end-to-end supply chain. The integration of a fully operational facility brings forward our objectives to take our products and brand to the market. OneLife Botanicals CEO Andrew Grant Our company undertook extensive research in considering this important acquisition and is highly confident about the capabilities and capacity of the operation to manufacture products in accordance with all compliance and quality standards. The integration of this business with our existing cultivation facility facilitates savings in capital investment, access to operational efficiencies and establishes us as a significant supplier in the Australian medicinal cannabis industry. We intend to build on the existing customer base and develop additional product distribution opportunities to become a formidable participant in the market." About MediPharm Labs Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment Licence from Health Canada, becoming the only company in North America to hold a domestic Good Manufacturing Licence for the extraction of natural cannabinoids. The Company carries out its operations in compliance with all applicable laws in the countries in which it operates. About OneLife Botanicals Onelife Botanicals is a niche producer of medicinal cannabis in Melbourne, Australia. The company has a passion for developing and producing products that provide a range of health benefits and assist in treating a range of specific health conditions. The company operates an existing cultivation site with extensive Infrastructure, including fit for purpose glasshouses for growing Medicinal Cannabis in a controlled environment. The glasshouses facilitate the optimum growing environment through temperature and climate control, allowing natural sunlight to be maximized in a protected and secure environment. The Directors and stakeholders are focused on identifying and exploring market opportunities, along with embracing innovation in the production processes. The success of the business is able to be achieved with an extensive Research and Development program, aimed at staying ahead of changes in growing methods, technological solutions and product applications, along with advanced automation ensuring that we minimize operating expenditure and maximise quality control.

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