Why did Teva ink an $85M deal to sidestep the Oklahoma opioid trial?

fiercepharma | May 28, 2019

Less than 48 hours before the first major opioid trial began, Teva struck an $85 million deal with Oklahoma officials, about one-third what painkiller giant Purdue Pharma paid to settle similar claims. That leaves Johnson & Johnson as the only remaining drugmaker facing trial Tuesday, while Teva can breathe a sigh of relief at least until a much bigger legal fight plays out this fall. Teva's $85 million settlement resolves claims that its painkillers and their marketing fed an opioid addiction crisis in Oklahoma. Together with the $270 million Purdue agreed in March, that's $355 million. Oklahoma had asked for $10 billion in damages. Teva didn't admit any wrongdoing with its settlement.The state's trial is the first among a raft of lawsuits claiming opioid makers aggressively promoted their meds, misled patients and doctors about their safety, and cost governments billions of dollars in the process. With more than 1,000 lawsuits queued up after it, analysts are watching for hints about what drugmakers might eventually pay to resolve the legal battle. The company chose to settle because it thought there "was a bad set-up in Oklahoma, a traditionally plaintiff-friendly jurisdiction," Bernstein analyst Ronny Gal wrote in a note to clients on Tuesday."Given the national media attention, Teva wanted to avoid this being their first verdict in opioid litigation," Gal added. "They believe odds will be better in other, more balanced jurisdictions."Teva's weekend news may come as a surprise to some industry watchers, given CEO Kåre Schultz’s comments on a recent conference call. Earlier this month, Schultz said plaintiff’s lawyers are focused on where they can get money in the opioid litigation. But Teva has a lot of debt and not a lot of money, so those lawyers will have “to find somebody else if they want big settlements," he said."It won’t be with us," Schultz added.And compared with Purdue's painkiller business, Teva's isn't all that significant, as Wells Fargo analyst David Maris pointed out in an investor note. "We were surprised that Teva's settlement is so large relative to the Purdue settlement, Maris wrote, adding, "Purdue marketed OxyContin and is considered to be at the center of the opioid crisis, while Teva's involvement was minor in comparison."

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Harrow Launches VIGAMOX® in the U.S.

Businesswire | August 01, 2023

Harrow a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The U.S. commercial rights to VIGAMOX werepurchasedby Harrow in January of 2023, and VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name. “Having now completed the NDA transfer of VIGAMOX, we are excited to begin the implementation of the market access, marketing, inventory management, national sales detailing, and other brand‑leveraging strategies that we have developed during this transfer period,” said Mark L. Baum, Chief Executive Officer of Harrow. “With an exceptional record of safety and efficacy, VIGAMOX is a well-known, reliable, and trusted product by U.S. eyecare professionals, many of whom regard VIGAMOX as the preferred broad-spectrum topical antibiotic to treat patients for bacterial conjunctivitis (sometimes referred to as 'pink eye') as well as many other common bacterial-based infections.” Product orders for VIGAMOX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen. About VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5%: INDICATIONS AND USAGE VIGAMOX® is a topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Corynebacterium species*, Micrococcus luteus*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri*, Streptococcus pneumoniae, Streptococcus viridans group, Acinetobacter lwoffii*, Haemophilus influenzae, Haemophilus parainfluenzae*, and Chlamydia trachomatis. Efficacy for this organism was studied in fewer than 10 infections. IMPORTANT SAFETY INFORMATION Contraindications VIGAMOX® is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication. Warnings and Precautions Hypersensitivity Reactions –Hypersensitivity and anaphylaxis have been reported with systemic use of moxifloxacin. Prolonged Use –May result in overgrowth of non-susceptible organisms, including fungi. Avoid Contact Lens Wear –Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse events were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, subconjunctival hemorrhage, and tearing. These events occurred in approximately 1%-6% of patients. Nonocular adverse events reported at a rate of 1%-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis. About Harrow Harrow Health, Inc. is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.

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PAN-TB Collaboration Announces the Start of a Phase 2 Clinical Trial to Evaluate Two Novel Tuberculosis Treatment Regimens

PRNewswire | August 10, 2023

The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) collaboration announced today the start of a phase 2b/c clinical trial, sponsored by the Bill & Melinda Gates Medical Research Institute (Gates MRI). The trial will evaluate whether novel regimens that combine registered products and new chemical entities have the potential to effectively treat drug-sensitive TB (DS-TB) and inform the development of a "pan-TB" regimen capable of treating all forms of active pulmonary TB. The regimens under evaluation are designed to explore shorter treatment durations compared to existing drug regimens, without the need for accompanying drug-resistance testing for individuals. The goal is to identify a candidate regimen suitable for phase 3 development. Trial sites are being hosted in countries with a high burden of TB. The trial has started in South Africa with the first participant screened in the last week of July. Subsequent trial sites are expected to launch in the Philippines in August and in Peru in 2024, pending national approvals. The collaboration is evaluating two novel drug regimens comprising five antibacterial agents—bedaquiline, delamanid, pretomanid, quabodepistat (formerly known as OPC-167832), and sutezolid DBQS – delamanid, bedaquiline, quabodepistat and sutezolid PBQS – pretomanid, bedaquiline, quabodepistat and sutezolid The trial employs an innovative design that consists of two stages to assess the efficacy of the regimens and evaluate the potential to shorten treatment duration. In the initial stage, the trial will enroll approximately 129 participants. The safety, tolerability, efficacy, and pharmacokinetics of the complete DBQS and PBQS regimens, with each drug administered daily for four months (17 weeks), will be evaluated in participants 18 to 65 years old with DS pulmonary TB. Approximately 43 participants will receive the six-month (26 weeks) standard-of-care treatment for DS-TB1 in the countries where trial sites are located.2 If successful, the second stage will enroll approximately 400 participants to test the selected regimen at shorter treatment durations, ranging from two to four months, across five arms. An additional 30-40 participants will be enrolled in the standard-of-care arm for the second stage of this trial. To support participants during their treatment, the trial integrates a Stop Treatment and Watch (STrAW) Concilium, a group made up of expert clinical consultants that will evaluate trial participants' treatment response, blinded to the specific regimen they receive, and advise trial investigators on patient management. The trial will utilize the best available tools including regular engagement with treatment support workers, direct observation of therapy with video technology, and medication reminder monitors. A novel Biomarkers Strategy will inform promising new biomarkers with the aim of enabling faster access to data to monitor treatment outcomes for future trials. The need for novel TB treatment regimens Despite the introduction of new medicines in recent years, treatment remains a long, complex, and demanding process for people diagnosed with TB and can place significant costs on households and the health system. The most used drug regimen for the treatment of DS-TB requires people to take multiple drugs for at least six months, often with routine monitoring. TB treatment can place unmanageable financial strain on individuals and their households. The World Health Organization (WHO) estimates that nearly half of TB-affected households face catastrophic total costs associated with treatment, including costs of travel to clinics, loss of income during treatment, and more, fueling cycles of poverty in vulnerable communities. Further, accurate, rapid drug resistance testing is essential for early diagnosis of both drug-sensitive and drug-resistant TB, but access to testing can be limited due to high costs, technical challenges, and other barriers. Emilio Emini, PhD, CEO, the Bill & Melinda Gates Medical Research Institute, said: "The Bill & Melinda Gates Medical Research Institute is committed to developing biomedical interventions that address global health concerns for those in the greatest need. The team at the Gates MRI looks forward to working with our partners across the PAN-TB collaboration, to evaluate the potential of these novel TB treatment regimens, in the hope that it may offer a potentially easier pathway for all people diagnosed with pulmonary TB by offering well-tolerated, shorter and simpler treatment options." Masanori Kawasaki, Global TB Project Leader, Otsuka Pharmaceutical Co. Ltd, said: "We are immensely proud to be part of this remarkable, trailblazing, collaboration which is now launching a clinical trial for a new, and shorter, pan-TB treatment regimen. We are excited too to be working closely with key partners to bring new treatment options to patients. Otsuka is dedicated to life-saving research and development as demonstrated by our sustained hard work and investment in developing a new chemical entity called quabodepistat. We are most grateful to the Bill & Melinda Gates Medical Research Institute for bringing together leaders in the field of TB, towards the goal of ending TB for good." Ruxandra Draghia-Akli, MD, PhD, Global Head of Global Public Health R&D, Janssen Research & Development, LLC, said: "Our medicine for multidrug-resistant TB has reshaped TB treatment regimens over the past decade, but more must be done to develop the even shorter, simpler regimens needed to treat all forms of the disease and end TB once and for all. Today's milestone is another step in this direction, and we look forward to seeing the results of this important study." Mel Spigelman, MD, President and CEO of TB Alliance, said: "Sincere thanks and congratulations to all who have made this innovative and exciting new journey a reality. Bringing revolutionary, highly impactful new treatments to all TB patients around the world is a goal that deserves and requires all our concerted dedicated efforts." About the Project to Accelerate New Treatments for Tuberculosis The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) is a first-of-its-kind collaboration among philanthropic, non-profit and private sectors that aims to accelerate the development of an investigational drug regimen capable of treating all forms of tuberculosis. The PAN-TB collaboration leverages members' collective assets, resources and scientific expertise to identify and evaluate new drug regimens with an acceptable safety profile, that have the potential to treat both drug-sensitive and drug-resistant TB and are well-tolerated, shorter in duration and simpler to use than existing options. The collaboration focuses on advancing research through phase 2 clinical efficacy studies to identify promising regimens for further development. The PAN-TB collaboration plans to work closely and transparently with the European Regimen Accelerator for Tuberculosis (ERA4TB), which was launched in January 2020. New molecular entities identified by ERA4TB that show promise in initial human studies could later be incorporated into the PAN-TB collaboration's later-stage, clinical research. Several organizations, including Evotec, GSK, TB Alliance and Janssen Pharmaceutica NV, are members of both projects, which will help to ensure coordination across collaborations toward the common goal of advancing TB drug and regimen development. The members of the PAN-TB collaboration are Evotec, GSK, Janssen Pharmaceutica NV, Otsuka Pharmaceutical Co., Ltd., based in Japan, TB Alliance, the Bill & Melinda Gates Medical Research Institute and the Bill & Melinda Gates Foundation. Additional members may be announced in the future. About Evotec SE Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this "Data-driven R&D Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g., neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 4,900 highly qualified people.

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European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® 0.1% for the Treatment of Dry Eye Disease

businesswire | August 25, 2023

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU). Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved. CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity. “Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED. CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® the worldwide first water-free ophthalmic technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.

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