Former Insys sales exec to shell out $9.5M in opioid spray kickback scheme

Insys | April 03, 2019

Insys’ former VP of sales has settled and turned state's evidence in an Arizona kickback suit alleging an executive-driven scheme to buy scripts for the company’s powerful opioid spray, Subsys. Alec Burkaloff, who pleaded guilty in a Boston courthouse in November on federal racketeering charges, agreed Wednesday to forfeit $9.5 million and admit his role in a plan to induce physicians to write scripts for the company’s under-the-tongue fentanyl spray as part of a paid speaker program he personally managed. “Individuals like Alec Burkaloff used unlawful business practices to earn millions of dollars and to fan the flames of opioid addiction," said Arizona Attorney General Mark Brnovich in a release. "This ‘profits-over-patients’ attitude has had a devastating impact on individuals and families throughout this state.”

Spotlight

Global sales of oncology medicines were widely reported to have exceeded $100 billion for the first time in 2014, with the U.S. and European markets generating the majority of sales. This trajectory is expected to continue: Decision Resources Group (DRG) analysis suggests sales of oncology medicines will exceed sales of medicines in every other therapeutic area, growing at a nearly double-digit compound annual growth rate through 2021 to reach $170 billion (Figure 1). This surge will be driven by the approval and uptake of targeted small molecules and biologic therapies, reflecting the industry’s shift towards personalized treatments and a wide array of molecular and immunological targets.


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BUSINESS INSIGHTS

Element Materials Technology Announces Completion of its Acquisition by Temasek

Element and Temasek | July 08, 2022

Element Materials Technology a global leader in testing, inspection, and certification services, has completed its acquisition by Temasek, a global investor headquartered in Singapore. Temasek has been a minority shareholder in Element since 2019. Temasek has acquired Element from Bridgepoint, whose successful ownership has been an important part of a more than ten-fold increase in Element’s turnover over the past decade. The acquisition, which was subject to regulatory approvals, was previously announced on 25th January 2022. As a highly differentiated TIC leader with a track record of technical expertise, Element is a trusted partner to customers, supporting them from early R&D, through complex government approvals, and into production, with a focus on laboratory-based testing. Its 7,000+ scientists, engineers, and technologists, based across a global network of more than 200 laboratories in 30 countries, serve technically demanding and highly regulated sectors, ensuring products are safe and sustainable. Element works with customers across a wide spectrum, from developing the next generation of aircraft, spacecraft, and autonomous vehicles, to vaccine component testing in its US pharmaceutical laboratories; and from the certification of smartphones and wearable technologies, to providing 5G carrier approvals and developing connected robots. The Group generates annual revenues of more than $1 billion and has grown at over 20% a year over the last ten years. It is well-positioned to accelerate this growth as it builds deeper leadership positions in critical end-markets including life sciences and connected technologies. Element also benefits from strong global ESG tailwinds - with over 60% of its work directly supporting customers on their sustainability journeys, it will continue to play a critical role in the decarbonization of the global economy. “We are delighted to complete this landmark transaction with Temasek, and to begin work on the next chapter of Element’s story. Their partnership over the last three years has been hugely beneficial to our growth. Today, Element is the partner of choice to companies at the forefront of innovation, from advanced medical science to autonomous cars, and has one of the most talented and highly qualified teams in the TIC space. Jo Wetz, CEO of Element We are excited to build upon that legacy of success and drive Element forward by scaling our business further through strategic investments and acquisitions, with a focus on high growth end-markets such as life sciences and connected technologies. Element will continue to play a crucial role in supporting our customers on their sustainability journeys, and in making tomorrow safer than today.” Allan Leighton, Non-Executive Chairman of Element, said: “Element is a true success story – a talented management team leading an exceptional group of experts across offices and laboratories in more than 30 countries around the world. We’re now entering another exciting chapter of purpose-driven growth, together with our customers and our new owners”. Chris Busby, partner at Bridgepoint, said: “Element has been bold in its ambition, delivered impressive organic growth, and implemented a targeted acquisition strategy. As a result, it has significantly expanded its expertise for over 50,000 customers worldwide and become an undisputed heavyweight in TIC. We are proud of what Element has achieved and wish them continued success in the future.” Element was advised by Bank of America Securities, Goldman Sachs and Rothschild & Co A&O EY BCG DLA, Jamieson and PwC. About Element The Element Materials Technology Group is one of the world’s leading global providers of testing, inspection, and certification services for a diverse range of products, materials, and technologies in advanced industrial supply chains where failure in use is not an option. Headquartered in London, UK, Element’s c.7,000 scientists, engineers, and technologists, working in our global network of over 200+ laboratories, support customers from early R&D, through complex regulatory approvals, and into production ensuring their products are safe and sustainable, and achieve market access. In 2021, Element set out its new, industry leading environmental commitments, adopting science-based targets and committing to net zero emissions across its entire global business by 2035. These environmental commitments follow Element’s achievement of the highest ESG ranking in the testing, inspection and certification industry from Sustainalytics, a global leader in ESG research and data. About Temasek Temasek is a global investment company with a net portfolio value of S$381 billion as at 31 March 2021. Headquartered in Singapore, it has 13 offices in nine countries around the world. The Temasek Charter defines Temasek’s three roles as an Investor, Institution, and Steward, which shape its ethos to do well, do right, and do good. As a provider of catalytic capital, it seeks to enable solutions to key global challenges. With sustainability at the core of all Temasek does, it actively seeks sustainable solutions to address present and future challenges, as it captures investible opportunities to bring about a sustainable future for all.

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BUSINESS INSIGHTS

ClinChoice Raises $150 mm Series E Round Financing, Further Strengthening its Global Services Capabilities

ClinChoice | July 05, 2022

Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot Capital. Proceeds of the financing will be used to fund the Company's continued business expansion and innovative service offering worldwide. As a full service clinical-stage CRO, ClinChoice serves the global market by providing integrated one-stop clinical development services to emerging biopharmaceutical, medical device and consumer health clients around the world. ClinChoice has over 3000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. With over 25 years of high-quality services, ClinChoice has completed more than 1,000 Phase I-IV full-service clinical projects and supported over 100 innovative drug registrations, clinical design and development. ClinChoice strictly adheres to GCP and ICH standards and has developed robust SOPs recognized by more than 50 large multinational companies, all of which have passed multiple inspections and audits by major regulatory agencies around the world. "We thank the investors for their trust in ClinChoice. This round of capital investment fully validates ClinChoice's rapid growth and future potential in the field of clinical CRO. With the new round of financing, we will further enhance our innovative service offering and continue business expansion by organic growth and M&A, in order to better serve our clients worldwide." Global Chairman and CEO of ClinChoice, Mr. Ling ZHEN Dr. Hongbin ZHOU, Co-Chief Investment Officer of Legend Capital, said, "We would like to express our gratitude for trusting in Legend Capital and we are excited to be part of ClinChoice, together with the Management Team and the existing shareholders, including Lilly Asia Ventures, Goldman Sachs. We are very positive on the growth outlook of the CRO industry. As a rapidly growing CRO, ClinChoice has built an excellent platform combining global expertise with deep knowhow across key local markets, to support innovation. Going forward, we will work closely with the management team to improve its existing business, attract industry talent and launch new strategic initiatives." About ClinChoice ClinChoice is a global clinical CRO, providing high-quality Integrated One-stop Service Offerings for new bio-pharmaceutical and medical device clients worldwide. Our Service Offerings cover Clinical Operation, Project Management, Biostatistics, Data Management, Biostatistical Programming, Regulatory Affairs, Medical Affairs, Feasibility Research, HGRAC Submission, Clinical Safety Management, Site Management Organization, Nature Medicine/Traditional Chinese Medicine and Phase I Clinical Research, etc. Now, ClinChoice has over 3,000 employees worldwide covering most of drug development hotbeds in US, China, multiple countries in Europe and Southeast Asia. Since its inception, ClinChoice has completed multiple rounds of financing, with investments from renowned institutional investors including Goldman Sachs, Lilly Asia Ventures, and DFJ Dragon Fund. About Legend Capital In April 2001, Legend Capital was established as a fund manager under Legend Holdings, focusing on the early-stage VC and growth-stage PE investment. Since its establishment, Legend Capital has been adhereing to internationally accepted standards to create best practices in fund management and operation. With a proven track record of more than 20 years, it now has full experience in fund management and operation and has built an extensive partner ecosystem across the entire investment chain.

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PHARMACY MARKET

Standigm Signs MOU with Merck Korea for AI drug Discovery Research

Standigm | June 02, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the signing of a Memorandum of Understanding (MOU) with Merck Korea, for AI-based drug discovery research. The MOU signing took place on May 30 at the headquarters of Standigm, attended by Sojeong Yun, CEO of Standigm, and Stephen Namkoo Lee, the Head of Science and Lab Solutions, Life Science business sector of Merck Korea. Under the MOU, Standigm will accelerate its drug discovery research by adopting Merck's AI software SYNTHIA™. which can help Standigm's novel compound synthesis. SYNTHIA™ is a computer-aided retrosynthetic design tool and unites network theory, modern high-power computing, and expert chemical knowledge to rapidly design synthetic pathways. "Applying AI to the drug discovery process can dramatically reduce time in discovering novel drug candidates and finding optimized synthesis paths. By pooling know-how in AI synthesis of Merck and Standigm's AI technology together, we expect better results in drug discovery faster, compared to the traditional AI drug discovery method," Sojeong Yun, co-founder and CEO of Standigm "Candidate chemical discovery using AI technology for new drug development is playing a crucial role in the growth of local bioindustry," said Stephen Nam-Koo Lee, Head of Science and Lab Solutions for South Korea, Life Science business sector, Merck Korea. As a leading workflow AI drug discovery company, Standigm has actively conducted research on AI technology in organic synthesis at its own Synthetic Research Center, established last year. About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and Standigm has expanded its operations across the world, recently opening offices in the U.S. and UK. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation. About Merck Merck a leading science and technology company, operates across life science, healthcare and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

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BUSINESS INSIGHTS

ALR Technologies Completes Definitive Manufacturing Agreement with Infinovo Medical for the GluCurve Pet CGM Hardware

ALR Technologies | June 30, 2022

ALR Technologies SG Pte. Ltd the diabetes management company, announces the completion of a definitive manufacturing agreement with Infinovo Medical Co. Ltd to manufacture and supply the Continuous Glucose Monitor hardware that will be utilized as part of the ALRT GluCurve Pet CGM. The Manufacturing Agreement gives ALRT the exclusive global rights to distribute the Infinovo CGM hardware for the animal health market, providing long-term production and supply. Subject to the satisfaction of all closing conditions it is expected that initial deliveries of product by Infinovo will be made during Q4 of 2022 “Executing the Manufacturing Agreement with Infinovo marks another major milestone in our path to commercialization and profitability. Our next targeted milestone is securing distribution for the ALRT GluCurve Pet CGM. We have been working with many of the largest global distributors and pharmaceutical companies in animal health, evaluating different distribution opportunities ranging from joint venture partnerships to sales and distribution agreements. We believe we have narrowed in on the right company and right deal structure to best bring value to our shareholders and to those who care for diabetic pets. We hope to announce the details of this pivotal next step in the near future.” Sidney Chan, Chairman and CEO of ALRT The Manufacturing Agreement is subject to certain closing conditions including the completion of a distribution agreement with a third party by July 31, 2022. About Infinovo Medical Co. Ltd Founded in 2016, Infinovo is an innovative medical technology company, focusing on developing an accurate and affordable CGM for patients which will be available for both Type 1 and Type 2 Diabetics. ALR Technologies SG Pte. Ltd. ALRT is a data management company that developed the ALRT Diabetes Solution, a comprehensive approach to diabetes care that includes an FDA-cleared and HIPAA compliant diabetes management system that collects data directly from blood glucose meters and continuous glucose monitoring devices, and a patent pending Predictive A1C algorithm to track treatment success between lab reports and an FDA-cleared Insulin Dosing Adjustment program. ALRT also offers an algorithm to provide prescribers support for timely non-insulin medication advancements. The overall goal is to optimize diabetes drug therapies to drive improved patient outcomes. The program tracks performance of all clinical activities to ensure best practices are followed. The ALRT Diabetes Solution gives healthcare providers a platform for remote diabetes care, helping to minimize patient exposure to potential infections in clinical settings. Currently, the Company is focused on diabetes and intends to expand its services to cover other chronic diseases anchored on verifiable data. In addition, the animal health division of ALRT has identified an unmet need in diabetes care and has developed GluCurve; a solution to assist Veterinarian Doctors to determine the efficacy of insulin and to help to identify the appropriate dose and frequency of administration of insulin for companion animals, thereby delivering the same optimization of diabetic drug therapies to pets as to humans. ALR Technologies SG Pte. Ltd. is controlled by ALR Technologies Inc., a Company with its shares traded on the OTC:QB under the symbol “ALRT”. On May 17, 2022, ALR Technologies Inc. announced an Agreement and Plan of Merger and Reorganization for the sole purpose of changing the Company’s jurisdiction of incorporation from Nevada to Singapore (the “Redomicile Merger Agreement”). The Redomicile Merger Agreement is subject to the required approval of the Company’s stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 filed by ALRT related to the Redomicile Merger, and other customary closing conditions. The Redomicile Merger is expected to be completed during the third quarter of 2022. See the Form 8-K filed May 20, 2022, by ALR Technologies Inc. for further information about the Redomicile Merger Agreement.

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Spotlight

Global sales of oncology medicines were widely reported to have exceeded $100 billion for the first time in 2014, with the U.S. and European markets generating the majority of sales. This trajectory is expected to continue: Decision Resources Group (DRG) analysis suggests sales of oncology medicines will exceed sales of medicines in every other therapeutic area, growing at a nearly double-digit compound annual growth rate through 2021 to reach $170 billion (Figure 1). This surge will be driven by the approval and uptake of targeted small molecules and biologic therapies, reflecting the industry’s shift towards personalized treatments and a wide array of molecular and immunological targets.

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