Whos toughest on drug prices. Watch Trump and his 2020 challengers wrestle for the title

fiercepharma | July 16, 2019

One year away from the next presidential election, the rising cost of prescription drugs is once again at the forefront of American politics, with action plans from two Democratic candidates in two days. And brace yourselves, drugmakers: Analysts figure the target on your backs will only get bigger. After former VP Joe Biden unveiled a price-hike-limiting plan Monday, Sen. Kamala Harris has now unfurled her own proposals to combat rising drug costs—and they'd be a major blow for drugmakers. The escalation from Democratic candidates could lead to a contest for the most punitive pricing plan with President Donald Trump, who's made big promises to rein in pharma that haven't yet paid off. Harris’ “People Over Profit” plan would require the Department of Health and Human Services (HHS) to put a hard cap on select prescription drug prices at the average price in other developed nations, she said in a statement Tuesday. The government’s price cap would be updated annually, according to the plan, and account for inflation. The plan, set with an action date from Congress within 100 days of her inauguration, would levy a 100% tax on sales that exceed the HHS cap, which would “go back directly to consumers” through rebates, she said. Harris also floated the idea of using aggressive litigation and the 1980 Bayh-Dole Act’s “march-in” provision as punitive measures for drugmakers who don’t follow the new rules, allowing her administration to license out patents for rogue prescription drugs to keep companies in line.

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Athira Pharma Announces Topline Results from ACT-AD Phase 2 Proof of Concept Study of Fosgonimeton in Mild-to-Moderate Alzheimer’s Disease

Athira Pharma, Inc. | June 27, 2022

Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced topline results from its exploratory ACT-AD Phase 2 study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. Fosgonimeton is a small molecule designed to enhance the activity of Hepatocyte Growth Factor and its receptor, MET, which are expressed in the central nervous system to promote brain health and function. “Following compelling ERP P300 latency biomarker data from a small Phase 1b trial over eight days in Alzheimer’s patients on fosgonimeton monotherapy, this Phase 2 trial provides valuable insights into the nature of this novel intervention over 26 weeks. ACT-AD was designed as a learning study to further investigate the ERP P300 biomarker signal over 6 months, assess safety in a patient population more representative of the real world, by allowing the use of add-on standard-of-care acetylcholinesterase inhibitors (AChEIs, e.g., donepezil), and explore fosgonimeton’s effect on psychometric outcomes, including ADAS-Cog11, to inform the ongoing Phase 3 LIFT-AD study. To that end, this study achieved its goal,” said Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira. “The study was intended to show differences on the biomarker ERP P300 latency. This primary endpoint was not met by protocoled analysis, however a pre-specified subgroup analysis indicated a potential diminished effect of fosgonimeton when given in combination with AChEIs. A subsequent post hoc analysis of the data from patients on fosgonimeton monotherapy showed a meaningful improvement in both ERP P300 latency and cognitive performance compared to placebo at 26 weeks. “These data points are very encouraging as they indicate the expected pharmacological activity of fosgonimeton by parallel improvement on ERP P300 latency and ADAS-Cog11 and show a favorable safety profile over six months. This is the first time monotherapy fosgonimeton has shown an effect on ADAS-Cog11, suggesting a potential cognitive benefit. We will use these insights for a rational optimization of the ongoing LIFT-AD trial. We plan to seek advice from our scientific advisors, investigators, and ultimately regulators on how to expeditiously analyze and potentially adapt the LIFT-AD study,” Dr. Moebius “The data from the fosgonimeton monotherapy analysis are encouraging and show biologic activity that may support the potential role of the HGF/MET pathway in neurodegenerative diseases,” said Marwan Sabbagh, M.D., FAAN, professor of neurology at Barrow Neurological Institute, Phoenix, AZ. “ACT-AD adds to the body of literature suggesting ERP P300 latency as an important biomarker for cognitive status.”

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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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Innocoll Announces Publication of Positive Results from Pivotal Clinical Trial of POSIMIR in Arthroscopic Subacromial Decompression

Innocoll Pharmaceuticals | July 07, 2022

Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, announced the publication of the results of Study BU-002-IM evaluating the safety and efficacy of POSIMIR® for infiltration use in 107 patients undergoing arthroscopic subacromial decompression. The peer-reviewed paper, entitled “SABER-Bupivacaine Reduces Postoperative Pain and Opioid Consumption After Arthroscopic Subacromial Decompression: A Randomized, Placebo-Controlled Trial,” was published online on May 17, 2022 in the Journal of the American Academy of Orthopedic Surgeons Global Research & Reviews. According to the report, POSIMIR 5 mL administered into the subacromial space at the end of arthroscopic subacromial decompression surgery in this double-blind, randomized, controlled, multicenter study, reduced mean postoperative pain on movement over 72 hours by 1.3 points on a 0-10 scale compared with vehicle control, a relative reduction of 20%. Simultaneous improvements in postoperative opioid use during the same 72-hour period provided evidence that the observed pain reduction was clinically meaningful. The median time to first request for opioid rescue medication was 12.4 hours among patients treated with POSIMIR compared with 1.2 hours in patients who received vehicle control. The median total opioid consumption in intravenous (IV) morphine milligram equivalents over 72 hours was 4.0 mg in the POSIMIR group vs 12.0 mg in the vehicle control group. The proportion of patients who were opioid free at 72 hours was 40% in the POSIMIR group vs 16% in the vehicle control group. As reported in the paper, the most common treatment-emergent adverse events were headache, nausea, musculoskeletal pain, cardiac disorders, skin and subcutaneous tissue disorders, injury and procedural complications, general disorders and administration site conditions and respiratory, thoracic, and mediastinal disorders. Of 2 serious adverse events reported among patients in these treatment groups, only 1 occurred during the immediate 2-week postsurgical follow-up period, and none was considered related to treatment. There were no TEAEs leading to study discontinuation. “These very compelling results, demonstrating up to three days of local analgesia after a single intra-operative injection, make POSIMIR an important new tool in treating postoperative pain from arthroscopic subacromial decompression,” said Sten Rasmussen, MD PhD, Professor and Head of Department of Clinical Medicine, Aalborg University, Denmark, the senior author and a principal investigator in the POSIMIR study. “We are excited to publish the positive results of this pivotal clinical trial of POSIMIR, the second approved product in our portfolio of nonopioid, extended-duration, locally-acting analgesics for postsurgical pain control. As the only company with two non-opioid extended release bupivacaine products on the market, we look forward to bringing POSIMIR to the orthopedic community,” Louis Pascarella, Innocoll President and Chief Executive Officer About POSIMIR POSIMIR for infiltration use contains more bupivacaine in a single dose than any other approved, sustained-release bupivacaine product. It employs a proprietary extended-release technology that enables the continuous release of bupivacaine, a non-opioid local anesthetic, directly to the surgical site for 3 days after administration. POSIMIR was approved in February, 2021 by the US Food and Drug Administration. POSIMIR is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Use in any other surgical procedure is investigational. POSIMIR is a registered trademark of Innocoll Pharmaceuticals Limited. About Subacromial Decompression Shoulder Surgery Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally performed as outpatient surgery, and most patients go home within a few hours of surgery. The most intense pain typically occurs during the first 3 days and is often managed with a combination of nerve block and oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S. About Innocoll Pharmaceuticals Limited Innocoll Pharmaceuticals Limited is a global biotech pharmaceutical company headquartered in Athlone, Ireland and is a subsidiary of Innocoll Biotherapeutics Holding Limited. The Innocoll group of companies is focused on the development and commercialization of pharmaceutical technologies to meet some of today’s most important healthcare challenges. About Gurnet Point Capital Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion Group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, Gurnet is able to deliver differentiated results for its investors and partners.

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Protect Pharmaceutical Corporation has acquired top notch software development company.

PROTECT PHARMACEUTICAL Corp | June 28, 2022

Protect Pharmaceutical Corporation has acquired the 100% of the shares of CJSC “Inaiapp”, a Belarusian developer of corporate software for business digitalization. With 8 years of blockchain development experience and list of long term clients, Inaiapp will bring its qualification and management processes to a new level. “Robotic process automation, AI systems and machine learning systems, blockchain-based solutions, Data Science tools for business growth - we closely follow global trends in IT technology and are now ready to create the most profitable solution for your business.” Nick Greb, President of PRTT PRTT offers range of services and software products, to solve painful problems. The company is using time-tested practices in the field of robotics, artificial intelligence, machine learning and blockchain, creating first-class solutions that meet current business needs. “Now we will combine the US market presence with extensive technical expertise that enable us to develop products that accelerate and streamline business processes through autonomy, transparency and security.” - Nick adds. About PRTT Protect Pharmaceutical Corporation is a full-cycle software development and delivery company that produces, releases, and supports digital products for the business-to-business and business-to-consumer markets. The company’s expertise lies in custom software development and consulting services in Business automation, Artificial Intelligence, Machine Learning, Data Science, Big Data, Image recognition, Blockchain development, and cloud services. Its domain focus includes Supply chain, Logistics, Healthcare, Finance, Real estate, Legal, Insurance, Advertising, and more.

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