Roche, Merck, Novartis and others hike prices on 83 meds starting in July

fiercepharma | July 09, 2019

Roche, Merck, Novartis and others hike prices on 83 meds starting in July
Its not uncommon for drugmakers to raise prices on big-selling meds to start each year and at each years halfway point. So as the calendar turned to July, many companies marked the occasion with price increases in an indication that political pressure against pharma's price hikes may be waning. So far in July, drugmakers including AbbVie, Roche’s Genentech, Eli Lilly, GlaxoSmithKline and Sanofi have raised prices on at least 83 medicines, Wells Fargo analyst David Maris wrote in a note. He cited MediSpan PriceRx data in his reporting and only tracked price hikes from a group of big and specialty pharma companies. The figure compares with eight price hikes for the same group last year. Market watchers may remember Pfizer’s mid-year price hikes in 2018 that caused a headache for the industry. After the company raised dozens of prices, President Donald Trump tweeted that the pharma giant and others “should be ashamed” of their moves. After a call between Pfizer’s then-CEO Ian Read, Trump and HHS secretary Alex Azar, the company agreed to defer the increases. Now, price hikes seem to be attracting less attention, Maris wrote. “To us it appears now that the criticism from politicians and the president has quieted down, companies are more aggressively and broadly pursuing drug price increases again,” he wrote. “We are not so confident that the lull in criticism will continue and could foresee more negative headlines in the coming months." In July, Novartis’ Sandoz raised prices on six products by 9.9%; AbbVie raised prices on blood cancer treatment Venclexta by 5%; Genentech raised prices on a range of products by 1.5% to 3%; Amneal instituted its own set of 9.9% price hikes; Eli Lilly raised prices for cancer drugs Cyramza, Alimta and Erbitux by 2.5%; and Merck raised prices on HIV therapy Insentress by 5%.

Spotlight

The objective of this round table was to highlight Veolia's most promising development markets and the Group's new growth horizons - in addition to its spent sulphuric acid from the petroleum industry is being regenerated for use in the production processes of the electronics, pharmaceutical and cosmetics industries.


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RESEARCH

DisperSol Technologies Announces Collaboration with Ajax Therapeutics to Develop Enhanced KinetiSol Drug Formulations

DisperSol Technologies | December 18, 2021

DisperSol Technologies LLC announced that it is has entered into a research collaboration with Ajax Therapeutics, Inc. to apply its KinetiSol technology to enhance the bioavailability of an Ajax drug candidate in development for the treatment of hematologic malignancies. “Ajax is taking an innovative approach to developing a pipeline of selectively targeted small molecules and we look forward to applying our proprietary KinetiSol technology to help enhance the bioavailability of one of these promising drug candidates. This collaboration is another example of our partnering strategy with our KinetiSol technology platform to help improve the bioavailability of next generation targeted therapies to provide new treatments for patients in need.” Dr. Edward Rudnic, CEO of DisperSol Technologies About DisperSol Technologies DisperSol is a clinical-stage drug development company focused on developing new treatments for patients utilizing its proprietary KinetiSol® technology platform. KinetiSol has proven capable of creating novel therapeutics from poorly bioavailable drugs to deliver unique clinical benefits to patients. The platform enables a drug development path forward to patients when other options fail to make a difference. DisperSol’s active programs include, DST-0509 about to enter Phase 3 for iron overload disorder and DST-2970 in Phase 2 for refractory metastatic prostate cancer. Additional earlier-stage programs include DST-5407 for non-squamous non-small cell lung cancer. About Ajax Therapeutics Ajax Therapeutics, Inc. is pursuing uniquely selective approaches to develop novel therapies targeting key cytokine signaling pathways that drive hematologic malignancies. By combining the deep cancer and structural biology insights of our founding scientists with the industry’s most advanced computational drug discovery and protein structure platforms from our founding partner, Schrödinger, Inc., we aim to discover and develop more precisely designed therapies to address significant unmet needs for patients with hematologic malignancies.

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BUSINESS INSIGHTS

Deargen Annonuces Patent Application for a TNBC Target Novel Drug Candidate Using AI

Deargen Inc. | December 23, 2021

Deargen, a company specializing in the development of novel NCE drugs using artificial intelligence, announced on the 22rd that it had discovered and synthesized a new anticancer target compound using its own AI platform and had already applied for a patent for it. Deargen has the technology to predict candidates for a novel drug without the 3D structure data of proteins. Deargen's technology, which uses amino acid sequence data rather than the structure information of proteins, possesses global-level differentiated artificial intelligence technology that enables the rapid development of novel drugs even for proteins whose 3D structure has not yet been identified. "The new compound for which we have applied for a patent this time is a first-in-class candidate, and we plan to develop a therapeutic agent targeting triple-negative breast cancer. TNBC is an area where there are few novel drugs available and it is difficult to find innovative targets, so it is a disease with a high demand for new therapeutics…Deargen confirmed the efficacy of the new compound discovered through in-vitro experiments." An official from Deargen Also, the substance that Deargen discovered through this study is an NCE. An NCE refers to a new chemically synthesized drug, which requires a great deal of time and money because it is difficult to develop such a drug that has not been previously approved by the FDA. However, it is within an area with high needs by many global pharmaceutical companies as it has the advantage of being able to receive market monopoly rights for 5 years in the U.S. and 10 years in Europe after product approval. In particular, Deargen's achievements are significant in that it discovered the new compound in a shorter time than the existing novel drug discovery process through its collaboration of advanced AI and in-house experts for novel drug development. The target discovery and substance design process, which usually takes about 3 to 4 years in the existing traditional drug development process, was carried out in just 10 weeks, and it took merely 2 weeks for target discovery and 8 weeks for substance design and synthesis. Currently, Deargen is establishing a large-scale R&D center. With this R&D center, the plan is to further shorten the period of the discovery of candidates by efficiently managing the time required for designing and synthesizing substances. The R&D center will be in charge of fast verification of substances by conducting the design and synthesis verification of substances under joint research with Deargen's internal pipeline, along with the production of high-quality data. Daniel Bae, Chief Business Officer of Deargen said : "We plan to continuously derive new substances with patentability through our synthesis research center, which will be established in the first half of next year. We plan to not only build our own pipeline centered on anticancer drugs, but also to introduce various business models with our partners that go beyond the existing joint research contracts." He also said, "Deargen plans to establish its position among global AI drug developers as a company specializing in NCE drug development, from target discovery to compound design and synthesis." About Deargen Inc. Established in December 2016, Deargen is an AI-based drug discovery and development company. In February 2020, the company released study results on predicting the development of COVID-19 treatments. Candidate compounds for treating COVID-19 predicted by Deargen include remdesivir, which was first approved as an emergency therapy. The company conducts research on and owns core AI technologies in-silico, such as 'prediction of bio-markers', 'selection of disease targets', and 'extraction of candidate substances for new drugs', utilizing techniques of meta analysis of genome big data and its unique AI technologies. Building on these outcomes, the company is developing new drugs in collaboration with multiple pharmaceutical companies and research institutions, demonstrating its outstanding technology capabilities as being named as top awardees at the ILSVRC, a world-prominent deep-learning competition, and Dream Challenge, an international AI-based new drug development competition.

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PHARMACY MARKET

Virpax Pharmaceuticals Recaps Milestones and Highlights Product Portfolio

Virpax® Pharmaceuticals, Inc. | December 29, 2021

Virpax® Pharmaceuticals, Inc. "Company" achieved significant milestones relating to its pipeline of product candidates as of the end of 2021, which are summarized below. “I believe that Virpax has made significant progress this past year toward our stated goalsThese accomplishments include accelerated development of our existing product candidates, broadening our pipeline of product candidates, and utilizing grants where appropriate. We recently announced that we anticipate commencing our initial human trial for Epoladerm™ in the second quarter of 2022. Anthony P. Mack, Chairman and CEO of Virpax “Virpax initially focused strictly on pain product candidates. However, our unique Molecular Envelope Technology delivery platform licensed from Nanomerics, Ltd. has enabled the development of product candidates for central nervous system and anti-viral indications. In the second half of 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter anti-viral product candidate formulated to prevent the spread of respiratory infections like influenza, SARS-CoV-2 and rhinovirus. We added VRP324 which is an intranasally delivered cannabidiol formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences as a part of our Cooperative Research and Development Agreement, determined that the MET intranasal delivery formulation bypasses the liver which we believe reduces drug-to-drug interaction concerns for treatments using this technology. “On the corporate front, we strengthened our Board by appointing two new members adding expertise in commercialization and financial strategy. Additionally, in 2021 we raised approximately $58 million in aggregate gross proceeds from our initial public offering and an underwritten follow-on public offering. These funds are being used for research and development activities of our product candidates. We are on track to add accomplishments in 2022 and I remain confident that we have the significant financial strength to continue advancing our pipeline,” concluded Mr. Mack. Epoladerm™ Epoladerm is a diclofenac topical spray film product candidate that is being developed for pain associated with osteoarthritis of the knee. Virpax recently reported successful results of a Charles River Laboratories single dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. 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Additional pre-clinical trials are being conducted with Lipocure, the product developer, to improve the formulation to potentially enhance manufacturing efficiencies, prolong duration and extend patent protection. Once completed, we plan to perform seven preclinical animal studies as part of required FDA IND enabling trials. Envelta™ Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. This product leverages Nanomeric’s MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal delivery enabling the enkephalin to permeate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS. Virpax recently announced that under this CRADA, the National Institutes of Health has awarded multiple contracts to support the research, development and manufacturing of Envelta. These contracts are to support Good Manufacturing Practices production of drug substance and drug product, as well as to support Good Laboratory Practices toxicology, safety studies and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and has procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to manufacture Leu-enkephalin, the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to promptly suppress pain. AnQlar™ AnQlar is a high-density intranasal molecular masking spray in development as an anti-viral OTC product for protection against respiratory infections, such as SARS-CoV-2 and influenza, that Virpax anticipates will be used as an adjuvant to barrier-based personal protective equipment. Virpax recently announced a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar. Additionally, Virpax engaged Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in early 2022. VRP324 Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children and adults. Under this agreement, Virpax has the global rights to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare CNS diseases considered serious epileptic encephalopathies that cause epileptic seizures, as well as cognitive and behavioral changes, and are generally resistant to treatment. Preclinical studies of VRP324 have been initiated by Nanomerics which it anticipates will be completed in the first quarter of 2022. Upon completion, Virpax will collaborate with RRD International, a clinical drug development company which Virpax has engaged, to prepare the pre-IND briefing documents for the FDA. About Virpax Pharmaceuticals Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.

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Intent Data in the Age of Data Regulation

DECK 7 | March 23, 2020

Since the implementation of Data Protection Act in 2018, the approach behind the use of data has changed dramatically. Our clients and customers don’t just want a great experience, they also want to make sure they can trust us. Tweet This! And it makes perfect sense in the present time and space. But as data is considered a key factor in positive customer experience, the U.S. brands and agencies have found it to be increasingly complicated to earn customer trust while remaining compliant. In an article by John Snyder, CEO at Grapeshot, for Adexchanger, he says that the GDPR will remove 75% of third-party data and what’s left will be more expensive. This has caused the power dynamic between brands and agencies to evolve over time.

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Spotlight

The objective of this round table was to highlight Veolia's most promising development markets and the Group's new growth horizons - in addition to its spent sulphuric acid from the petroleum industry is being regenerated for use in the production processes of the electronics, pharmaceutical and cosmetics industries.

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