Medicaid misclassification bill inspired by EpiPen snafu passes Congress

FiercePharma | April 03, 2019

How long does it take Congress to reach an agreement on drug prices? On the topic of drug misclassifications in Medicaid, about two and a half years. That’s the time that’s passed since Mylan’s famous EpiPen saga and the Justice Department settlement that followed. Finally, lawmakers have passed the Right Rebate Act, hoping to crack down on drug misclassifications that lower drugmaker rebates and cost taxpayers. And now the bill is headed to the president's desk. The legislation allows the Department of Health and Human Services to closely monitor the Medicaid Drug Rebate Program for misclassifications and requires regular reports to make sure it keeps an eye out. Under the bill, the HHS secretary could require drug companies to reclassify medications and impose penalties for drugs that are “knowingly misclassified.”

Spotlight

The Prescription Drug User Fee Act (PDUFA) program is the cornerstone of modern FDA drug review. User fees currently fund about half of new drug review costs. By providing needed funds, PDUFA ended slow and unpredictable review and approval of new drug applications, while keeping FDA’s high standards.

Spotlight

The Prescription Drug User Fee Act (PDUFA) program is the cornerstone of modern FDA drug review. User fees currently fund about half of new drug review costs. By providing needed funds, PDUFA ended slow and unpredictable review and approval of new drug applications, while keeping FDA’s high standards.

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PHARMA TECH

Advaxis and Ayala Pharmaceuticals Enter into Merger Agreement

Advaxis and Ayala Pharmaceuticals | October 20, 2022

Ayala Pharmaceuticals, Inc. a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers and Advaxis, Inc. a biotechnology company devoted to the discovery, development and commercialization of immunotherapies based on a technology which uses engineered Listeria monocytogenes, today announced that they have entered into a definitive merger agreement. The merger would result in a combined company that will focus predominantly on the development and commercialization of Ayala’s lead program AL102 for the treatment of desmoid tumors and Advaxis’s candidate ADXS-504 in development for prostate cancer. Kenneth A. Berlin, President and Chief Executive Officer of Advaxis, said, “Advaxis took a thorough approach in our quest to find the right partner with the right products. This merger is expected to enhance Advaxis’s portfolio of clinical assets, with Ayala’s proprietary gamma secretase inhibitors that are being developed as targeted therapies for rare and aggressive tumors. Ayala’s lead candidate, AL102, is currently being investigated in the Phase 2/3 RINGSIDE study in desmoid tumors, which we believe will accelerate the stage of product development for the combined company dramatically. We are particularly excited about very promising interim data from RINGSIDE, which showed that AL102 monotherapy had meaningful anti-tumor activity with tumor shrinkage in the majority of patients that appeared to be deepening over time. The combined management team has extensive commercial and R&D experience, and we believe we have the cash to advance the combined portfolio through key milestones in 2023, including longerterm data from Part A of RINGSIDE, clarity on the registration path for AL101 in recurrent/metastatic adenoid cystic carcinoma (ACC) and initial clinical and PSA data from the Phase 1 trial of ADXS-504 in prostate cancer. We believe that this transaction will also help drive our efforts to return to a Nasdaq listing and enhance our ability to access capital.” “We are pleased to announce the proposed merger with Advaxis, which is expected to provide our pipeline and AL102 with additional financial resources as well as additional infrastructure in the U.S. The two companies have a shared mission to develop innovative therapies to improve the lives of patients with cancer and I believe we have found a good partner to advance our pipeline and create value for our stakeholders.” Roni Mamluk, Ph.D., President and Chief Executive Officer of Ayala Consummation of the merger is subject to certain closing conditions, including, among other things, approval by the stockholders of Ayala. At the closing of the merger, Ayala will be delisted from The Nasdaq Global Market. The combined company’s common stock is expected to begin trading on the OTCQX at the effective time of the merger, subject to Advaxis’ planned efforts to have the stock of the combined company listed on Nasdaq, as to which no assurances can be made. About Ayala Pharmaceuticals, Inc. Ayala Pharmaceuticals, Inc. is a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare tumors and aggressive cancers. Ayala’s approach is focused on predicting, identifying and addressing tumorigenic drivers of cancer through a combination of its bioinformatics platform and next-generation sequencing to deliver targeted therapies to underserved patient populations. The company has two product candidates under development, AL101 and AL102, targeting the aberrant activation of the Notch pathway with gamma secretase inhibitors to treat a variety of tumors, including adenoid cystic carcinoma and desmoid tumors. AL102 has received Fast Track Designation from the U.S. FDA and is currently in the Phase 3 portion of a pivotal study for patients with desmoid tumors. AL101 has received Fast Track Designation and Orphan Drug Designation from the U.S. FDA and is currently in a Phase 2 clinical trial for patients with ACC bearing Notch activating mutations. About Advaxis, Inc. Advaxis, Inc. is a clinical-stage biotechnology company focused on the development and commercialization of proprietary Lm-based antigen delivery products. These off-the-shelf immunotherapies are a significant advancement in immunotherapy as they integrate multiple functions into a single therapy by directing antigen presenting cells to stimulate T-cells and other components of the immune system, while reducing tumor protection in the tumor microenvironment, facilitating the elimination of tumors. The company has two programs in the clinic: ADXS-503 for late-stage lung cancer and ADXS-504 for early-stage prostate cancer.

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PHARMACY MARKET

Walgreens Boots Alliance Completes Majority Share Acquisition of CareCentrix

Walgreens Boots Alliance and CareCentrix | September 01, 2022

Walgreens Boots Alliance, Inc. announced it has completed its previously announced majority share acquisition of CareCentrix, Inc.—the leading independent home-centered platform that coordinates care to the home for health plans, patients and providers. The majority investment in CareCentrix accelerates Walgreens Health’s capabilities in delivering quality healthcare across a spectrum of settings including primary care, specialty pharmacy care, post-acute care and home care. By bringing together Walgreens trusted health services and community presence with CareCentrix’s technology-enabled, care-at-home solutions, the partnership better addresses the needs of people with complex or chronic conditions as they transition out of the hospital. CareCentrix’s advanced data analytics capabilities enable highly personalized care plans to help people transition to the right site of care, prioritizing care in the home when appropriate. This approach supports both care quality and value by reducing hospital readmissions and improving patient satisfaction and outcomes. “We created Walgreens Health to reimagine local healthcare and wellbeing for all. This partnership advances our ability to address the needs of people across care settings immediately following hospital discharge. Our collaboration with CareCentrix is one of the many ways we are expanding on our pharmacy and patient expertise to surround individuals with care when and how they need it.” Roz Brewer, CEO, WBA Healthcare services delivered after discharge, including care delivered in the home, are one of the fastest growing segments in healthcare today. Caring for patients from the hospital to the home represents more than $75 billion in annual healthcare costs for payers, providers and patients. “The most challenging part of the healthcare journey is the last mile – extending healthcare delivery into people’s homes,” said John Driscoll, CEO, CareCentrix. “Together with Walgreens Health, CareCentrix is able to combine Walgreens trusted community presence with our powerful technology-enabled care to better address patients’ unique health needs in their homes.” In addition to home-based care, CareCentrix connects patients to appropriate providers and sites of care post-discharge, utilizing a predictive analytics platform, HomeFirst Analytics. This level of customization also includes pairing patients with care transition teams that support patient engagement for 90 days post-discharge to improve quality metrics. Walgreens Health will continue to advance capabilities that integrate CareCentrix data analytics and home care expertise with WBA’s portfolio of health solutions to identify and close care gaps, as well as coordinate patient care across conditions, settings and provider networks. These capabilities will enable Walgreens to support medication reconciliation for CareCentrix patients transitioning from hospital to home and provide primary care options to patients when needed, including Village Medical physicians and advanced practice providers. CareCentrix will also play a critical role in Walgreens Health integrated offerings to manage population level risk for benefits management and post-acute spend and outcomes. CareCentrix manages care for 19 million members through approximately 7,400 provider locations, and empowers more people to live, heal and age at home. By partnering with health plans and health systems, CareCentrix has reduced total cost of care for members by 20 percent, including a greater than 11 percent reduction in emergency department usage and a 23 percent reduction in skilled nursing costs. This investment gives WBA majority ownership of CareCentrix, investing approximately $330 million for 55 percent of the company at an $800 million valuation, net of debt, with the option to acquire the remaining equity interests in the future. In WBA’s fiscal year 2021, CareCentrix delivered pro forma sales of $1.5 billion. Following the completion of the investment, CareCentrix will continue to operate as an independent company under its current executive leadership. Sidley Austin LLP acted as lead legal advisor for WBA, along with Weil, Gotshal & Manges LLP. Citi acted as financial advisor for CareCentrix, Inc., and Cleary Gottlieb Steen & Hamilton LLP acted as lead legal advisor. About Walgreens Boots Alliance Walgreens Boots Alliance is an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 170-year heritage of caring for communities. A trusted, global innovator in retail pharmacy with approximately 13,000 locations across the U.S., Europe and Latin America, WBA plays a critical role in the healthcare ecosystem. The company is reimagining local healthcare and well-being for all as part of its purpose – to create more joyful lives through better health. Through dispensing medicines, improving access to a wide range of health services, providing high quality health and beauty products and offering anytime, anywhere convenience across its digital platforms, WBA is shaping the future of healthcare. WBA has more than 315,000 team members and a presence in nine countries through its portfolio of consumer brands: Walgreens, Boots, Duane Reade, the No7 Beauty Company, Benavides in Mexico and Ahumada in Chile. Additionally, WBA has a portfolio of healthcare-focused investments located in several countries, including China and the U.S. About CareCentrix CareCentrix offers value-based home solutions to payors and health systems to help more of their members access the home care they need, when they need it. Through a single platform, CareCentrix coordinates multiple, complex home care needs for over 19 million members through a national network of approximately 7,400 provider locations, resulting in a simplified patient and physician experience. For over 25 years, CareCentrix’s focus on the whole person has improved continuity of care, reduced unnecessary readmissions and unnecessary emergency department utilization, and has delivered positive financial results for health plans. With proprietary HomeFirst Analytics to stratify risk and optimize care delivery, CareCentrix takes on the complexities of care coordination and management of care in the home to provide our clients with essential insights into care at home. CareCentrix has been named one of Fierce Healthcare’s 2022 “Fierce 15” companies and FORTUNE’s Best Workplaces for Aging Services.

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BUSINESS INSIGHTS

Indivior To Acquire Opiant Pharmaceuticals

Indivior | November 21, 2022

Indivior PLC and Opiant Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Indivior will acquire Opiant for an upfront consideration of $20.00 per share, in cash plus up to $8.00 per share in contingent value rights that may become payable in the event that certain net revenue milestones are achieved during the relevant seven-year period by OPNT003 after its approval and launch. The transaction has been unanimously approved by the boards of directors of each company. "Our work in combatting addiction has never been more critical, with overdose deaths in the United States occurring at near record numbers1," said Mark Crossley, Chief Executive Officer of Indivior. "Opiant's portfolio of product candidates is an excellent strategic fit that diversifies and strengthens our offerings, while Indivior's strong commercial capabilities are expected to propel a combined product pipeline with the potential to help patients along a continuum from substance use disorder and rescue to recovery. The combination with Opiant will provide Indivior with one of the most comprehensive and relevant treatment platforms to address the ongoing U.S. opioid and overdose epidemic and extends our leadership position in addiction treatments. We look forward to working with Opiant's talented team as we undertake our shared mission of changing patients' lives through access to life-transforming treatment for substance use disorders." Acquisition Strengthens and Extends Indivior's Position as a Leader in Addiction Treatment "We are pleased to have reached an agreement that reflects the great potential Opiant has created with OPNT003 and our pipeline of medicines. This transaction combines Opiant with an organization that shares our patient-focused mindset, and we believe creates immediate value for patients, our employees and our stockholders. It will enable us to leverage Indivior's global scale, commercial strength and scientific expertise to accelerate our mission to create best-in-class medicines for the treatment of substance use disorders and drug overdose." Roger Crystal, M.D., Opiant's President and Chief Executive Officer Opiant is a biopharmaceutical company developing treatments for addiction and drug overdose leveraging intranasal and injectable delivery technologies. Opiant contributed to the development of the formulation of NARCAN® Nasal Spray, a treatment to reverse opioid overdose. In addition to OPNT003, nasal nalmefene, the pipeline includes OPNT002, nasal naltrexone, which is currently in a Phase II trial to assess its potential as a treatment for alcohol drinking and cravings, and OPNT004, a CB-1 antagonist in preclinical development as a potential injectable treatment for acute cannabinoid overdose ("ACO"). OPNT003 is an investigational opioid overdose reversal agent that Opiant has been developing alongside a worsening opioid crisis, driven by the increased prevalence of synthetic opioids, such as illicit fentanyl. These powerful drugs are responsible for the surge of overdose deaths in the United States (103,000-plus overdose deaths reported in the latest annual period, of which over 75% were driven by opioids, mainly fentanyl and synthetic opioids1). OPNT003 is designed to be used by non-healthcare individuals and delivered intranasally. Observations from multiple clinical studies reinforce its potential rapid onset and long duration of action. Opiant received FDA Fast Track Designation for OPNT003 in November 2021 and is expected to complete its New Drug Application submission for OPNT003 with the FDA in the fourth quarter of 2022. Subject to approval by the FDA, anticipated approval for a fast-track application is third quarter 2023, with launch in the United States expected in the ensuing months. 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. 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.

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