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Would Trumps new drug-imports plan do much to prices, or to pharma?

The Pharma industry cheered when the Trump administration introduced a proposal putting drug pricing rebates in the crosshairs. But like so many other drug pricing ideas over the years, the measure didnt go anywhere. Now, the administration is switching gears to importation. HHS on Wednesday presented a plan for bringing in cheaper drugs from Canada, an approach the industry staunchly opposes. It marks a major shift from previous policies on imports, but the plan itself might not do much to lower prices—or hurt pharma, according to one industry watcher. The plan would allow imports through two pathways. The first would let states, wholesalers or pharmacists launch pilot projects to import drugs from Canada that are approved in the U.S. and “manufactured consistent with the FDA approval.” Under the second, the FDA could allow manufacturers to import drugs under new national drug codes, potentially allowing for lower prices than those stipulated by existing contracts. The drugs would have to be identical to their U.S. counterparts and have appropriate labeling. HHS says the pathway could work for insulins, rheumatoid arthritis drugs, cardiovascular meds and more. While the news may have sent concerns around the halls at top drugmakers, one analyst quickly responded that he isn’t worried. In a note to clients titled “SNOOZE?”, Evercore ISI’s Umer Raffat dug into the plan’s details and outlined some shortfalls—or positives from a pharma industry perspective. Digging into the first pathway, Raffat pointed out that many of pharma's most costly products—biologics such as AbbVie's Humira; IV drugs, a category that would include many pricey cancer treatments; and inhaled products, such as respiratory therapies from GlaxoSmithKline and AstraZeneca, are all excluded. So are meds that require Risk Evaluation and Mitigation Strategies at the FDA—a group that comprises many expensive and newer drugs, such as multiple sclerosis treatments.

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TailorMed Partners with Eagle Pharmaceuticals to Streamline Patient Financial Assistance Enrollment

Business Wire | October 25, 2023

TailorMed, a leading technology company offering the nation’s largest network of patients, providers, pharmacies, life science companies, and other partners dedicated to improving healthcare affordability, announced Eagle Pharmaceuticals, Inc. will be implementing TailorMed’s Express Enroll solution. This partnership will introduce new efficiencies in seeking to secure financial assistance for patients prescribed Eagle’s Pemfexy to manage and treat lung cancer. With Express Enroll, providers and pharmacies within the TailorMed network can now complete Pemfexy Copay Assistance Program enrollments through a fully digital process, without leaving the TailorMed platform. Nearly half of cancer patients with high out-of-pocket costs have abandoned or delayed filling a prescription. Cost-related prescription abandonment and nonadherence lead to poor patient experiences and outcomes. TailorMed’s network-driven, technology-powered approach offers a comprehensive solution by uniting all impacted parties with the same goal: helping ensure that every patient, across all medical conditions, can afford care. TailorMed’s solutions have now been implemented across more than 700 hospitals, 1,200-plus clinics, and over 600 pharmacies. Without the use of technology, the process of identifying and enrolling patients in financial assistance is typically manual, cumbersome, and reactive, resulting in missed opportunities to maximize available resources. The TailorMed platform enables users—who include financial navigators, medication assistance coordinators, pharmacy technicians, and other healthcare professionals—to proactively match patients with the right resources at the right time. Its Express Enroll solution uses automatic data mapping, real-time API connections, and embedded e-signature workflows to facilitate seamless, in-platform enrollment in assistance offered by pharmaceutical companies. These capabilities will empower TailorMed users to complete Pemfexy Copay Assistance Program enrollments quickly and efficiently, supporting stronger patient experiences and medication adherence. “This partnership with TailorMed underscores our commitment to supporting patient access to Pemfexy,” said William Kim, VP of Market Access, Oncology at Eagle Pharmaceuticals. “A technology-driven enrollment approach will make enrollment in the Pemfexy Copay Assistance Program more efficient, which benefits patients and healthcare provider offices.” “The impact of healthcare affordability is far-reaching and requires a network approach, uniting stakeholders across the entire ecosystem,” said Srulik Dvorsky, Co-founder and CEO of TailorMed. “Trailblazers in the life sciences industry stand to strengthen this network considerably by providing direct access to financial assistance for lifesaving medications. We’re proud to partner with Eagle Pharmaceuticals to help further patient enrollment and improve access to Pemfexy.” About TailorMed TailorMed offers the nation’s largest network of patients, providers, pharmacies, partners, and life science companies focused on ensuring all patients across all medical conditions can afford treatment. Driven by TailorMed's best-in-class platform, network constituents can proactively identify, match, and enroll patients in financial assistance programs to deliver a world-class patient financial experience while reducing the cost of care delivery and increasing revenues. TailorMed’s secure, web-based financial assistance solutions are deployed across more than 1,000 sites of care, including Providence Health, UnityPoint Health, Yale-New Haven Health, and Advocate Aurora Health. About Eagle Pharmaceuticals, Inc. Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and Byfavo® and Barhemsys® through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states, and the company is focused on developing medicines with the potential to become part of the personalized medicine paradigm in cancer care.

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GoodRx and MedImpact Announce Program to Ensure Seamless Access to Affordable Prescriptions

Business Wire | September 14, 2023

GoodRx a leading resource for healthcare savings and information, and MedImpact, the independent pharmacy benefit manager (PBM) and health solutions company, announced a new savings solution designed to integrate GoodRx’s prescription pricing in a seamless experience at the pharmacy counter. Now, when an eligible MedImpact member fills a prescription for a generic medication, it will automatically compare their benefit and the GoodRx price and then deliver the lowest one. The amount paid will be applied to the member’s deductible. “This solution allows us to meet Americans where they are by providing them with low prices on their prescriptions without the need for them to compare costs on their own,” said Cynthia Meiners, Strategic Program Development Officer at GoodRx. “We are bringing together the best of what GoodRx does with the best of what MedImpact does to make it incredibly convenient for MedImpact’s members to start and stay on their prescribed treatments, and to fully integrate their clinical data. We truly feel the future of healthcare lies in these types of integrations.” The collaboration achieved by integrating GoodRx’s price comparison technology with MedImpact’s advanced technology platform allows both companies to deliver more savings without any additional work on the part of the consumer. In addition, members will benefit from the seamless data integration this program provides. Through MedImpact’s rigorous drug safety review, which includes thousands of health and safety checks, patients will be alerted about any negative drug interactions. “We are delivering to clients a full portfolio of health, wellness and savings solutions and we see this program as an important part of it,” Marcus Sredzinski, Pharm D, General Manager and MedImpact Senior Vice President. “This delivers hassle-free savings to members, while helping payers capture clinical and adherence data they may have otherwise missed.” GoodRx is actively working to access new lives by expanding its prescription savings reach by partnering with pharmacy benefit managers and their plan sponsors to collaboratively integrate into the insurance benefit market. Through these programs with CVS Caremark, Express Scripts, and MedImpact, GoodRx savings are seamlessly integrated at point-of-sale with three major PBMs that reach over 60% of insured lives. This new program will become available to eligible MedImpact members starting January 1, 2024. About GoodRx GoodRx is a leading resource for healthcare savings and information that makes healthcare affordable and convenient for all Americans. We offer consumers free access to transparent and lower prices for brand and generic medications, affordable and convenient medical provider consultations via telehealth, and comprehensive healthcare research and information. Since 2011, we have helped consumers save over $60 billion and are one of the most downloaded medical apps over the past decade. GoodRx periodically posts information that may be important to investors on its investor relations website at https://investors.goodrx.com. We intend to use our website as a means of disclosing material nonpublic information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult GoodRx’s website regularly for important information, in addition to following GoodRx’s press releases, filings with the Securities and Exchange Commission (the “SEC”) and public conference calls and webcasts. The information contained on, or that may be accessed through, GoodRx’s website is not incorporated by reference into, and is not a part of, this press release. About MedImpact For more than 30 years, MedImpact has been building, delivering, and reimagining pharmacy benefit solutions for healthcare payers who face complex and dynamic challenges. As the leading independent PBM, we offer clients the clarity they need to make care and cost decisions; control over a powerful suite of solutions that manage pharmacy spend; and confidence that comes from a proven PBM partner who is fully aligned with their goals and invested in their future.

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PHARMACY MARKET

Indivior Enters an Exclusive Licensing Agreement with Alar Pharmaceuticals

PR Newswire | October 12, 2023

Indivior PLC a leading addiction treatment company, announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable ("LAI") candidate, ALA-1000. ALA-1000 is a sustained-release LAI prodrug of buprenorphine. With dosage intervals of potentially up to four times per year, ALA-1000 could address unmet opioid use disorder ("OUD") patient needs with a longer duration of treatment, which could provide an option for patients seeking a less frequent maintenance therapy regimen, for patients living in remote areas without easy access to care, and for high-risk patients, such as those transitioning from the Justice system. Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates. The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in Q1. Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved. "Alar provides Indivior with a unique opportunity to further address unmet patient needs in the treatment of OUD with potentially the first three-month buprenorphine LAI," said Christian Heidbreder, Chief Scientific Officer. "By providing a therapeutic option for patients who might benefit from less frequent dosing, ALA-1000 has the potential to broaden the spectrum of care for OUD treatment as well as enhance the addressable patient population." ALA-1000 is an investigational drug and is positioned to be the first three-month buprenorphine administered subcutaneously entering the clinical stage. Results from a single-ascending dose ("SAD") study, announced by Alar in January 2022, demonstrated the safety, tolerability and sustained release profile of ALA-1000 over 12 weeks in patients with OUD2. Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039. Based in Taichung, Taiwan, Alar is a drug development company which focuses on developing long-acting drug products for central nervous system ("CNS") disorders and chronic diseases, utilizing its proprietary depot technology. Compared with other long-acting subcutaneous injection technologies, its proprietary platform has been associated with distinctive characteristics such as low viscosity solution, small injection volume and sustained drug release profile. The transaction is not expected to have a material impact on the Group's FY 2023 adjusted results. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder (SUD). Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in 39 countries worldwide.

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PHARMACY MARKET

TailorMed Partners with Eagle Pharmaceuticals to Streamline Patient Financial Assistance Enrollment

Business Wire | October 25, 2023

TailorMed, a leading technology company offering the nation’s largest network of patients, providers, pharmacies, life science companies, and other partners dedicated to improving healthcare affordability, announced Eagle Pharmaceuticals, Inc. will be implementing TailorMed’s Express Enroll solution. This partnership will introduce new efficiencies in seeking to secure financial assistance for patients prescribed Eagle’s Pemfexy to manage and treat lung cancer. With Express Enroll, providers and pharmacies within the TailorMed network can now complete Pemfexy Copay Assistance Program enrollments through a fully digital process, without leaving the TailorMed platform. Nearly half of cancer patients with high out-of-pocket costs have abandoned or delayed filling a prescription. Cost-related prescription abandonment and nonadherence lead to poor patient experiences and outcomes. TailorMed’s network-driven, technology-powered approach offers a comprehensive solution by uniting all impacted parties with the same goal: helping ensure that every patient, across all medical conditions, can afford care. TailorMed’s solutions have now been implemented across more than 700 hospitals, 1,200-plus clinics, and over 600 pharmacies. Without the use of technology, the process of identifying and enrolling patients in financial assistance is typically manual, cumbersome, and reactive, resulting in missed opportunities to maximize available resources. The TailorMed platform enables users—who include financial navigators, medication assistance coordinators, pharmacy technicians, and other healthcare professionals—to proactively match patients with the right resources at the right time. Its Express Enroll solution uses automatic data mapping, real-time API connections, and embedded e-signature workflows to facilitate seamless, in-platform enrollment in assistance offered by pharmaceutical companies. These capabilities will empower TailorMed users to complete Pemfexy Copay Assistance Program enrollments quickly and efficiently, supporting stronger patient experiences and medication adherence. “This partnership with TailorMed underscores our commitment to supporting patient access to Pemfexy,” said William Kim, VP of Market Access, Oncology at Eagle Pharmaceuticals. “A technology-driven enrollment approach will make enrollment in the Pemfexy Copay Assistance Program more efficient, which benefits patients and healthcare provider offices.” “The impact of healthcare affordability is far-reaching and requires a network approach, uniting stakeholders across the entire ecosystem,” said Srulik Dvorsky, Co-founder and CEO of TailorMed. “Trailblazers in the life sciences industry stand to strengthen this network considerably by providing direct access to financial assistance for lifesaving medications. We’re proud to partner with Eagle Pharmaceuticals to help further patient enrollment and improve access to Pemfexy.” About TailorMed TailorMed offers the nation’s largest network of patients, providers, pharmacies, partners, and life science companies focused on ensuring all patients across all medical conditions can afford treatment. Driven by TailorMed's best-in-class platform, network constituents can proactively identify, match, and enroll patients in financial assistance programs to deliver a world-class patient financial experience while reducing the cost of care delivery and increasing revenues. TailorMed’s secure, web-based financial assistance solutions are deployed across more than 1,000 sites of care, including Providence Health, UnityPoint Health, Yale-New Haven Health, and Advocate Aurora Health. About Eagle Pharmaceuticals, Inc. Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and Byfavo® and Barhemsys® through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states, and the company is focused on developing medicines with the potential to become part of the personalized medicine paradigm in cancer care.

Read More

PHARMA TECH

GoodRx and MedImpact Announce Program to Ensure Seamless Access to Affordable Prescriptions

Business Wire | September 14, 2023

GoodRx a leading resource for healthcare savings and information, and MedImpact, the independent pharmacy benefit manager (PBM) and health solutions company, announced a new savings solution designed to integrate GoodRx’s prescription pricing in a seamless experience at the pharmacy counter. Now, when an eligible MedImpact member fills a prescription for a generic medication, it will automatically compare their benefit and the GoodRx price and then deliver the lowest one. The amount paid will be applied to the member’s deductible. “This solution allows us to meet Americans where they are by providing them with low prices on their prescriptions without the need for them to compare costs on their own,” said Cynthia Meiners, Strategic Program Development Officer at GoodRx. “We are bringing together the best of what GoodRx does with the best of what MedImpact does to make it incredibly convenient for MedImpact’s members to start and stay on their prescribed treatments, and to fully integrate their clinical data. We truly feel the future of healthcare lies in these types of integrations.” The collaboration achieved by integrating GoodRx’s price comparison technology with MedImpact’s advanced technology platform allows both companies to deliver more savings without any additional work on the part of the consumer. In addition, members will benefit from the seamless data integration this program provides. Through MedImpact’s rigorous drug safety review, which includes thousands of health and safety checks, patients will be alerted about any negative drug interactions. “We are delivering to clients a full portfolio of health, wellness and savings solutions and we see this program as an important part of it,” Marcus Sredzinski, Pharm D, General Manager and MedImpact Senior Vice President. “This delivers hassle-free savings to members, while helping payers capture clinical and adherence data they may have otherwise missed.” GoodRx is actively working to access new lives by expanding its prescription savings reach by partnering with pharmacy benefit managers and their plan sponsors to collaboratively integrate into the insurance benefit market. Through these programs with CVS Caremark, Express Scripts, and MedImpact, GoodRx savings are seamlessly integrated at point-of-sale with three major PBMs that reach over 60% of insured lives. This new program will become available to eligible MedImpact members starting January 1, 2024. About GoodRx GoodRx is a leading resource for healthcare savings and information that makes healthcare affordable and convenient for all Americans. We offer consumers free access to transparent and lower prices for brand and generic medications, affordable and convenient medical provider consultations via telehealth, and comprehensive healthcare research and information. Since 2011, we have helped consumers save over $60 billion and are one of the most downloaded medical apps over the past decade. GoodRx periodically posts information that may be important to investors on its investor relations website at https://investors.goodrx.com. We intend to use our website as a means of disclosing material nonpublic information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors and potential investors are encouraged to consult GoodRx’s website regularly for important information, in addition to following GoodRx’s press releases, filings with the Securities and Exchange Commission (the “SEC”) and public conference calls and webcasts. The information contained on, or that may be accessed through, GoodRx’s website is not incorporated by reference into, and is not a part of, this press release. About MedImpact For more than 30 years, MedImpact has been building, delivering, and reimagining pharmacy benefit solutions for healthcare payers who face complex and dynamic challenges. As the leading independent PBM, we offer clients the clarity they need to make care and cost decisions; control over a powerful suite of solutions that manage pharmacy spend; and confidence that comes from a proven PBM partner who is fully aligned with their goals and invested in their future.

Read More

PHARMACY MARKET

Indivior Enters an Exclusive Licensing Agreement with Alar Pharmaceuticals

PR Newswire | October 12, 2023

Indivior PLC a leading addiction treatment company, announced that it has gained exclusive global rights to develop, manufacture, and commercialize Alar Pharmaceuticals Inc.'s ("Alar") portfolio of long-acting injectable formulations that release a prodrug1 of buprenorphine at varying durations, including its lead long-acting injectable ("LAI") candidate, ALA-1000. ALA-1000 is a sustained-release LAI prodrug of buprenorphine. With dosage intervals of potentially up to four times per year, ALA-1000 could address unmet opioid use disorder ("OUD") patient needs with a longer duration of treatment, which could provide an option for patients seeking a less frequent maintenance therapy regimen, for patients living in remote areas without easy access to care, and for high-risk patients, such as those transitioning from the Justice system. Under the agreement with Alar, Indivior will pay $10 million to secure exclusive global rights to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates. The $10 million payment is in addition to an initial $5 million option payment made by Indivior to Alar in Q1. Alar is entitled to potential milestone payments if various developmental, regulatory, and commercial goals are achieved. "Alar provides Indivior with a unique opportunity to further address unmet patient needs in the treatment of OUD with potentially the first three-month buprenorphine LAI," said Christian Heidbreder, Chief Scientific Officer. "By providing a therapeutic option for patients who might benefit from less frequent dosing, ALA-1000 has the potential to broaden the spectrum of care for OUD treatment as well as enhance the addressable patient population." ALA-1000 is an investigational drug and is positioned to be the first three-month buprenorphine administered subcutaneously entering the clinical stage. Results from a single-ascending dose ("SAD") study, announced by Alar in January 2022, demonstrated the safety, tolerability and sustained release profile of ALA-1000 over 12 weeks in patients with OUD2. Alar has been granted composition of matter and formulation patents for ALA-1000 covering sustained-release buprenorphine formulations with expiry in 2037 and 2039. Based in Taichung, Taiwan, Alar is a drug development company which focuses on developing long-acting drug products for central nervous system ("CNS") disorders and chronic diseases, utilizing its proprietary depot technology. Compared with other long-acting subcutaneous injection technologies, its proprietary platform has been associated with distinctive characteristics such as low viscosity solution, small injection volume and sustained drug release profile. The transaction is not expected to have a material impact on the Group's FY 2023 adjusted results. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat addiction and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of substance use disorder (SUD). Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in 39 countries worldwide.

Read More

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