Teva expands blood pressure drug recall in the US amid cancer fears

Pharmaphorum | June 14, 2019

Teva has expanded a recall of losartan potassium tablets after tests revealed a potential human carcinogen in the blood pressure drug. The Israeli pharma earlier this week recalled six lots of the drug containing unacceptable levels of a nitrosamine impurity. This builds on a decision in April when Teva withdrew 35 lots after detecting the same impurity known as NMBA (N-Nitroso-N-methyl-4-aminobutyric acid). According to a recall notice shared by the FDA, Teva had sold bulk lots of the drug to California-based Golden State Medical Supply. The bottles were in sizes containing 30, 90 or 100 tablets. People affected by the recall should continue taking their drugs and ask a doctor or pharmacist about alternatives or replacements, the FDA said. This is because stopping the medication without replacement could cause more harm than continuing with the treatment course. Teva needs to maximise its revenues to pay off huge debts it incurred when it acquired Allergan’s generics business in 2016 for $40.5 billion. The company posted a loss for the first quarter of the year of $97 million, compared with a $1.1 billion profit in the first quarter of 2018.

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Dharlene Tundo obtained her Bachelor of Science in Molecular Biology from Montclair State University and has over ten years of diverse experience in research and pharmaceutical industry. Dharlene contributed to the successful launch of two oncology drugs, Cyramza and Portrazza, at Lilly Pharmaceutical. Her research interest is focused on the study of Lactobacillus and Bifidobacterium species. She is dedicated to develop a method to analyze and obtain cell count differentiation on viable and non-viable bacterial cells for the manufacture of probiotic supplements, using the flow cytometric approach.


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Tasly Pharmaceuticals and Mauna Kea Technologies Announce Joint Venture and Licensing Agreements

Mauna Kea Technologies | July 12, 2022

Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy platform, and Tasly Pharmaceuticals announced the execution of an agreement to form a Joint Venture. Under terms of the agreement, Tasly and Mauna Kea will form a Joint Venture that will (i) commercialize selected Cellvizio indications in China, (ii) develop and commercialize Cellvizio globally in the fields of Neurology and Neurosurgery, and (iii) manufacture Cellvizio units for the Chinese market. The JV will utilize both existing distribution partners and its own network of China-based marketing professionals to accelerate market adoption. In exchange for contributing licenses and other intellectual property to the JV, Mauna Kea will receive cash payments totaling $10 million, a 44.1% equity interest in the JV, and a 5-year commitment to purchase minimum quantities of Cellvizio systems and probes. Mauna Kea’s equity holdings are net of shares issued to Cenponts Tech Limited in consideration for strategic advisory services provided in connection to the transaction. The Joint Venture will be majority owned and funded by Tasly and jointly managed by Tasly and Mauna Kea. The Joint Venture will be in an immediate position to leverage Mauna Kea’s position as global leader in probe and needle-based confocal laser endomicroscopy, with its FDA clearance for neurosurgery applications, its broad regulatory clearances in the Chinese market as well as its significant installed based in leading hospitals in China. “We are delighted to partner with Tasly Pharmaceuticals, a life sciences leader in Asia-Pacific with a global presence. This transaction both expands the addressable market for Cellvizio and increases Mauna Kea’s capacity to invest further in product and clinical development, including molecular imaging and artificial intelligence. This announcement builds on the strategic repositioning we announced in December 2021 and our emphasis on forming capital-efficient partnerships that leverage the commercial reach of global biopharma and medtech firms while increasing patient access to Cellvizio.” Sacha Loiseau, Ph.D., founder and Chairman of Mauna Kea Technologies Kaijing Yan, Chairman of Tasly Pharmaceuticals Group, commented: “The field of biomedical engineering is an important part of Tasly Pharmaceuticals’ second growth curve strategy. The cooperation with Mauna Kea Technologies will enable us to quickly access large markets in China addressed by the multiple clinical applications of Confocal Laser Endomicroscopy. The recent advances in molecular imaging with Cellvizio are also of great interest to us since Tasly Pharmaceuticals could assist the Joint Venture in developing new combinations of Cellvizio with novel molecular markers, aligned with our vision of providing integrated solutions from diagnosis to treatment. We very much look forward to a fruitful and rich collaboration with Mauna Kea Technologies.” About Tasly Pharmaceuticals Group Adhering to the business mission of "To share the joy of health with all", Tasly has always been promoting the integrative development of traditional Chinese medicine and modern medicine. Tasly continuously focuses on the three disease fields of cardio-cerebro-vascular diseases, digestive and metabolic diseases and tumors, which have the largest market share and the fastest development in China. It is committed to providing drug R&D that is urgently needed for clinical use and even addresses the unmet needs in China's clinical market. By leveraging the coordinated development advantages of modern TCM, biological medicine and chemical medicine, it carries out the strategic layout of innovative drugs and continues to maintain its leading position in the industry and the development momentum of R&D and innovation. About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions.

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Titan Pharmaceuticals Announces Board Expansion and Management Changes

Titan Pharmaceuticals, Inc. | August 22, 2022

Titan Pharmaceuticals, Inc. announced that it has expanded its Board of Directors from five to eleven and appointed six new directors following their election at its special meeting of stockholders held on August 15, 2022. The new directors, which were on a nominee slate proposed by Activist Investing LLC are Avraham Ben-Tzvi, Peter L. Chasey, Eric Greenberg, David E. Lazar, Matthew C. McMurdo and David Natan. In addition, following the Special Meeting, Mr. Lazar was appointed interim Chairman and Chief Executive Officer, with a mandate to lead Titan's continuing review of strategic alternatives. Mr. Lazar succeeds Marc Rubin, M.D., who will no longer serve as Executive Chairman, but will remain on the Board. "As one of the largest investors in Titan, Activist Investing's goal is to help the Company unlock value for both ourselves and our fellow shareholders through a strategic transaction. I believe the reconstituted Board, which collectively possess decades of experience in pharmaceutical executive leadership, clinical research, strategic turnarounds, deal structuring, corporate governance, investment management, accounting, finance and corporate law, will be a tremendous asset in this endeavor." Mr. Lazar Biographies of Newly Elected Directors Avraham Ben-Tzvi is the Founder of ABZ Law Office, a boutique Israeli law firm specializing in outsourced general counsel services for publicly traded as well as private companies and corporations, Investments & Securities Laws, Commercial Law & Contracts and various civil law matters, which he established in January 2017. Mr. Ben-Tzvi served as Chief Legal Officer and General Counsel of Purple Biotech Ltd. (formerly Kitov Pharma Ltd.), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, from November 2015 until April 2020. Prior to that, Mr. Ben-Tzvi served as General Counsel and secretary at Medigus Ltd., a minimally invasive endosurgical tools medical device and miniaturized imaging equipment company, from April 2014 until November 2015. Mr. Ben-Tzvi is a member of the Israel Bar Association, and is also licensed as a Notary by the Israeli Ministry of Justice. Prior to that he served as an attorney at one of Israel's leading international law fi rms where, amongst other corporate and commercial work, he advised companies and underwriters on various offerings by Israeli companies listing in US and on various SEC related filings. Prior to becoming a lawyer, Mr. Ben-Tzvi worked in a number of business development, corporate finance and banking roles at companies in the financial services, lithium battery manufacturing and software development industries. Mr. Ben-Tzvi holds a B.A., magna cum laude, in Economics from Yeshiva University in New York and an LLB, magna cum laude with Honors, in from Sha'arei Mishpat College of Law in Hod HaSharon, Israel. Peter L. Chasey serves as the Owner of Chasey Law Offices, a law practice specializing in personal litigation, business litigation and commercial law, since founding the practice in 2005. Earlier in his career, Mr. Chasey served as staff counsel for one of the largest insurance companies in the world defending general claims against insured businesses and also served as a land surveyor. Mr. Chasey holds a B.S. in Political Science and Government from the University of San Diego and a J.D. from the University of San Diego School of Law. Eric Greenberg has over 40 years of capital markets experience. As a trader and portfolio manager at hedge funds, his areas of expertise included the development of trading strategies, portfolio management and deal structuring. Mr. Greenberg was Co-Founder of Blink Charging Co., a leader in the EV charging infrastructure industry. In addition, Mr. Greenberg provides investor relation and digital marketing services for companies across a variety of industries, such as life sciences, fintech, internet platforms and others. Mr. Greenberg holds a B.B.A in Finance from Baruch College and an M.B.A. in Finance from Baruch College Zicklin School of Business. David E. Lazar has served as the Chief Executive Officer of Custodian Ventures LLC, a company which specializes in assisting distressed public companies through custodianship, since February 2018, and Activist Investing LLC, an actively managed investment fund, since March 2018. Previously, Mr. Lazar served as Managing Partner at Zenith Partners International Inc., a boutique consulting firm, from July 2012 to April 2018. In his role as Chief Executive Officer of Custodian Ventures LLC, Mr. Lazar has successfully served as a custodian to numerous public companies across a wide range of industries. Mr. Lazar currently serves as an Advisor to PROMAX Investments LLC, a position he has held since July 2022, and as an Ambassador at Large for the Arab African Council for Integration and Development, since March 2022. Matthew C. McMurdo currently serves as Managing Member of McMurdo Law Group, LLC, a corporate and securities law practice, since 2010. Previously, Mr. McMurdo was a Partner at Nannarone & McMurdo, LLP, a boutique law firm, from 2008 to 2010. In addition, Mr. McMurdo served as General Counsel of Berkley Asset Management LLC, the general partner of a real estate fund focused on opportunistic and distressed real estate assets, from 2011 to 2013. Mr. McMurdo holds a B.S. in Finance from Lehigh University and a J.D., cum laude, from Benjamin N. Cardozo School of Law. David Natan currently serves as President and Chief Executive Officer of Natan & Associates, LLC, a consulting firm offering chief financial officer services to public and private companies in a variety of industries, since 2007. In addition, Mr. Natan currently serves as Executive Vice President and Chief Financial Officer for Airborne Motorworks, Inc., a privately-held aerospace transportation company, since April 2020. From February 2010 to May 2020, Mr. Natan served as Chief Executive Officer of ForceField Energy, Inc., a company focused on the solar industry and LED lighting products. From February 2002 to November 2007, Mr. Natan served as Executive Vice President of Reporting and Chief Financial Officer of PharmaNet Development Group, Inc., a drug development services company, and, from June 1995 to February 2002, as Chief Financial Officer and Vice President of Global Technovations, Inc., a manufacturer and marketer of oil analysis instruments and speakers and speaker components. Prior to that, Mr. Na tan served in various roles of increasing responsibility with Deloitte & Touche LLP, a global consulting firm. Mr. Natan currently serves as a member of the Board of Directors and Chair of the Audit Committee of Global Diversified Marketing Group, Inc., a manufacturer, marketer and distributor of food and snack products, since February 2021 and serves as a member of the Board of Directors and Chair of the Audit Committee of Sunshine Biopharma, Inc., a pharmaceutical and nutritional supplement company, since February 2022. Previously, Mr. Natan served as Chairman of the Board of Directors of ForceField Energy, Inc., from April 2015 to May 2020, and as a member of the Board of Directors of Global Technovations, Inc., from December 1999 to December 2001. Mr. Natan holds a B.A. in Economics from Boston University. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. In December 2021, Titan commenced a process to explore and evaluate strategic alternatives to enhance shareholder value.

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Asahi Kasei Bioprocess to Showcase Award-winning MOTIV™ Buffer Management Technology for Pharmaceutical Manufacturing at ACHEMA 2022

Asahi Kasei Bioprocess | August 01, 2022

Asahi Kasei Bioprocess America, subsidiary of diversified Japanese multinational company Asahi Kasei, will be featuring their MOTIV™ Buffer Management Technology at ACHEMA 2022 in Frankfurt this August. Winner of “Best in Show” at Interphex in 2017, “Technology of the Decade” from Bioprocess international in 2012 and originator of the concept for inline buffer formulation (IBF™), Asahi Kasei Bioprocess is a market leader that keeps pharmaceutical production moving efficiently and precisely through solutions like MOTIV with built-in automation software so that medicine can get to patients sooner and safer. Buffers are used for the vast majority of processes in pharmaceutical development, which has traditionally required storage in extremely large tank farms to be utilized as necessary. MOTIV can blend buffers from concentrates in small, single-use bags and is controlled with sensors to maintain and assure precision. It is also able to blend buffers to exact specifications as needed during a downstream development process and can handle a wide variety of buffer formulations. In addition, it is automated by the integrated OCELOT™1 System Control software to be repeatable and also helps to reduce waste created in the development process, so it is a more sustainable means of pharmaceutical manufacturing. “We have been working to ‘standardize’ system designs as much as we can, to make them more readily available with shorter lead times; but are also very capable at building custom systems to meet the specific needs of customers,” says Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America. “One of our strengths is not only having an innovative product, but also an extensive family of MOTIV systems to choose from. Buffer is the lifeblood of pharma manufacturing and with the R&D opportunities of being a part of the Asahi Kasei Group we have been able to develop MOTIV to be the most reliable and efficient IBF technology in the market today. Not to mention, Operation Warp Speed helped push capacity to expand globally and billions of dollars are being invested by manufacturers to ramp up production as quickly as possible. This drives a new sense of value for systems like our MOTIV family that can streamline processes.” 1 The OCELOT System Control is an Asahi Kasei Bioprocess proprietary technology that integrates and/or interfaces with plant-wide control systems in a universally compatible format, allowing for far-reaching data collection and analysis. About Asahi Kasei Bioprocess The Fluid Management Business Unit of Asahi Kasei Bioprocess is devoted to solving therapeutic product safety, efficiency and purity challenges within the pharmaceutical and bioprocessing industries. With technology platforms for virus filtration, chromatography, inline buffer formulation and oligonucleotide synthesis, our bioprocessing systems, columns, and automation solutions advance GMP manufacturing of critical drug substances around the world. Built with pride, built with quality, built to exceed your high expectations. “Built for You.” About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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Enable Injections Enhances Board with Addition of John DeFord, Ph.D.

Enable Injections, Inc. | August 12, 2022

Enable Injections, Inc. a company developing and manufacturing the enFuse® platform of investigational wearable drug delivery systems, is pleased to announce the appointment of John DeFord, Ph.D. to the company's Board of Directors, effective July 29, 2022. Enable Injections' enFuse is an innovative drug delivery technology designed to subcutaneously (SC) deliver large volumes of up to 50mL for a wide range of therapies and diseases, dedicated to improving the patient experience. Dr. DeFord brings over three decades of expertise as a global medical technology executive, most recently the executive vice president and chief technology officer for Becton, Dickinson and Company (BD) (BDX), a global medical technology company. Prior to BD, Dr. DeFord served in senior science, technology and leadership roles of increasing responsibility at organizations such as C.R. Bard and Cook Incorporated, with additional experience in venture capital as managing director of Early Stage Partners venture capital fund. He is currently also a member of the board of directors at Nordson Corporation (NDSN), NuVasive (NUVA), and Blue Spark, Inc. DeFord graduated from Purdue University with a bachelor's degree and master's degree in electrical engineering, and a Ph.D. in electrical/biomedical engineering, dedicating his career to innovative medical technologies to save lives, enhance quality of life and improve the patient experience. "Enable Injections is at the forefront of both simplifying the therapeutic delivery of critical medications and enhancing quality of life for the patient. I am excited to join the Board of Directors at this important time in the company's growth and development; and I look forward to working with the management team and Board to help accelerate translation of this important technology to the clinical setting." Dr. DeFord "We are pleased to welcome Dr. DeFord as a new director to Enable's Board," said Mike Hooven, President and CEO of Enable Injections. "We believe adding depth of experience in the global medical technology space such as Dr. DeFord's is key to the strong growth of our business." About Enable Injections Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

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Dharlene Tundo obtained her Bachelor of Science in Molecular Biology from Montclair State University and has over ten years of diverse experience in research and pharmaceutical industry. Dharlene contributed to the successful launch of two oncology drugs, Cyramza and Portrazza, at Lilly Pharmaceutical. Her research interest is focused on the study of Lactobacillus and Bifidobacterium species. She is dedicated to develop a method to analyze and obtain cell count differentiation on viable and non-viable bacterial cells for the manufacture of probiotic supplements, using the flow cytometric approach.

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