Jazz, Alexion and Lundbeck to pay $122m to settle kickback probe

Jazz Pharmaceuticals | April 08, 2019

Drugmakers Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals have agreed to pay a total of $122.6m to settle allegations of paying kickbacks via copay assistance foundations. The US Department of Justice (DOJ) said that the companies violated the False Claims Act by paying patients under Medicare and the Civilian Health and Medical Program (ChampVA) through purportedly charitable organisations. These charitable foundations allegedly subsidised the copays with financing from the companies. The Anti-Kickback Statute restricts drugmakers from offering or paying, directly or indirectly, in the form of money or any other thing of value to motivate Medicare or VA patients to buy their medicines.

Spotlight

Kristy Grimm talks about the expansion of the Medical Affairs team at Vertex.

Spotlight

Kristy Grimm talks about the expansion of the Medical Affairs team at Vertex.

Related News

BUSINESS INSIGHTS

Kyowa Kirin Expands License Agreement with Synaffix and Takes Exclusive Target Rights Based on Latest Positive ADC Data

Synaffix | July 01, 2022

Synaffix B.V. a biotechnology company focused on commercializing its clinical-stage platform technology for the development of antibody-drug conjugates with best-in-class therapeutic index, today announces that Kyowa Kirin Co., Ltd.a global specialty pharmaceutical company that strives to create new value through the pursuit of advances in life sciences and technologies, has expanded the license agreement with Synaffix by adding a third ADC target to its research evaluation and development efforts under this deal. In addition it exercised its option to take exclusive development and commercialization rights for an undisclosed ADC target under the terms of this agreement. This follows a successful initial research collaboration between the companies whereby Kyowa Kirin has demonstrated a highly competitive preclinical therapeutic index for its lead program under this collaboration, prepared from a Kyowa Kirin antibody using Synaffix's ADC technology. The technology licensed from Synaffix include GlycoConnect™, HydraSpace™, and multiple toxSYN™ linker-payloads, which allow for the drug-to-antibody ratio to be tailored to 1, 2 or 4 to optimize the therapeutic index of the ADC. Under the terms of the amended license agreement, Synaffix will receive an immediate payment of $5 million and is eligible to receive total potential payments for the first ADC program alone of up to $171m plus royalties on commercial sales. "We are thrilled with the successful ADC data, expansion of this license agreement and to see a leading global pharmaceutical company like Kyowa Kirin deploying Synaffix ADC technology in order to fulfill its mission of improving the lives of patients with cancer worldwide." Floris van Delft, Ph.D., Chief Scientific Officer of Synaffix About Synaffix B.V. Synaffix B.V. is a biotechnology company that enables ADC product candidates using its clinical-stage, site-specific ADC technology platform. In addition to GlycoConnect™ and HydraSpace™ technology, the toxSYN™ linker-payload platform rounds out a fully complementary technology platform that enables any company with an antibody to develop proprietary best-in-class ADC products under a single license from Synaffix. The Synaffix platform enables a rapid timeline to clinic due to the established supply chain of technology components. Granted patents covering Synaffix' technology provide end-to-end protection of the manufacturing technology as well as the resulting products through at least 2039. The business model of Synaffix is target-specific technology out-licensing, as exemplified through its existing deals with ADC Therapeutics, Mersana Therapeutics, Shanghai Miracogen, Innovent Biologics, ProfoundBio, Kyowa Kirin, Genmab and Macrogenics. About The Synaffix ADC Platform Technology Synaffix' proprietary ADC technology platform consists of GlycoConnect™, HydraSpace™ and toxSYN™ technologies. Both GlycoConnect™ and HydraSpace™ are clinical-stage technologies that enable best-in-class ADCs with significantly enhanced efficacy and tolerability. GlycoConnect™ is a conjugation technology that exploits the native antibody glycan for site-specific and stable payload attachment and is tunable to DAR1, DAR2 or DAR4 formats. HydraSpace™ is a compact and highly polar spacer technology that is designed to further enhance therapeutic index, particularly with hydrophobic payloads. toxSYN™ is a linker-payload platform that spans key, validated MOAs for ADC product development, including SYNtecan E™ and SYNeamicin G™, among other linker-payloads. The combination of these three technologies provides developers with a "one stop" and easy-to-use ADC technology platform, allowing any antibody developer to develop its own proprietary ADC and any ADC developer to expand its pipeline further and increase its competitive position.

Read More

BUSINESS INSIGHTS

EditForce and Mitsubishi Tanabe Pharma Enter into License Agreement

EditForce, Inc. | July 06, 2022

EditForce, Inc. has entered into a License Agreement with Mitsubishi Tanabe Pharma Corporation to research, develop and commercialize potential gene therapy products for a specific target disease in the field of CNS by utilizing EditForce's proprietary PPR protein platform technology. In this alliance, MTPC and EditForce aim to create potential novel pharmaceuticals for the specific CNS disease by utilizing the drug R&D know-how and global business experience of MTPC and the novel biotechnology of EditForce. MTPC will acquire the exclusive right to conduct the selection of drug candidate molecules, preclinical and clinical development, manufacturing, and commercialization worldwide. Under the terms of the Agreement, EditForce will receive an upfront payment and milestone payments amounting to over 20 billion yen depending on the development stage and commercialization progress, and royalties based on worldwide sales after the launch. "I am so delighted to reach the agreement with MTPC, which has an interest in our proprietary PPR protein platform technology. We look forward to working closely with MTPC to develop and deliver breakthrough pharmaceutical products with our technology to patients suffering from diseases." Takashi Ono, President and CEO of EditForce About EditForce, Inc. EditForce, Inc., a Kyushu University-originated venture company developing a unique DNA/RNA editing technology (PPR platform technology (*)), was established in May 2015 by KISCO Ltd. and Prof. Takahiro Nakamura of Kyushu University (former president of EditForce and currently its scientific advisor) and funded by companies and funds that have track records of investing in life sciences and biotechnology. EditForce aims for drug discovery that applies the PPR technology through joint research with universities and private companies. Pentatricopeptide repeat protein platform technology PPR is a protein discovered in plants that regulates gene expression by binding to DNA and RNA in a sequence-specific manner. The PPR proteins are also found in humans and yeasts, and they have similar functions. Prof. Takahiro Nakamura and Dr. Yusuke Yagi, CTO of EditForce, have focused on the PPR proteins and elucidated the mechanism that determines sequence specificity, and established a technology for creating various PPR proteins, each of which binds to a specific target DNA or RNA sequence. Furthermore, it is possible to manipulate and modify the target genome and RNA both inside and outside the cell by fusion with effector proteins. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation the pharma arm of Mitsubishi Chemical Group is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future." MTPC sets the MISSION of "Creating hope for all facing illness." To that end, MTPC is prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of the central nervous system and immuno-inflammation. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis.

Read More

PHARMA TECH

House Rx to Launch Specialty Drug Dispensing Inside Rheumatology Clinics By Partnering with Three Leading Practices

House Rx | August 04, 2022

House Rx, the platform for medically integrated dispensing of specialty medications, announced it has partnered with three new rheumatology clinics to integrate in-house specialty drug dispensing – also known as medically integrated dispensing (MID) – into the clinics' operations. The three practices are: Arizona Arthritis & Rheumatology Associates (AARA), Arthritis & Osteoporosis Consultants of the Carolinas (AOCC), and Arthritis Associates of Tennessee and represent an additional 68 providers that will dispense specialty medications through the House Rx platform, bringing the total number of providers on House Rx's platform to 137. While MID has grown in oncology, House Rx's partnership with these practices is one of the first to bring the model to rheumatology care. "It's very exciting to partner with key thought leaders in rheumatology to bring medically integrated dispensing to this specialty. Each one of these practices is a leader in their region, and we look forward to partnering very closely with them to define a new standard for a better patient experience and improved outcomes for patients living with rheumatic diseases." Ogi Kavazovic, Co-Founder and CEO of House Rx By bringing specialty dispensing into the physician's office, the partnership with House Rx aims to dramatically improve the specialty medication experience for patients. The MID care model provides a seamless and efficient way for patients to receive prescribed therapies directly from their doctor – which research has demonstrated improves outcomes, including quality of life and increased survivability, when contrasted with the Pharmacy Benefit Manager-controlled specialty pharmacy approach. "This partnership will increase patient satisfaction by providing prescription medication in-house, and House Rx's technology and expertise will help us achieve this," said Prakash Viswanathan, CFO of AARA. "It is motivating to help trailblaze a new path in rheumatology and be one of the first practices to bring specialty medication dispensing under our roof, making it far easier and quicker for patients to get the medications they need." "We couldn't be more excited about this partnership, which will bring immediate benefits for our patients," said Scott Gilomen, CEO of AOCC. "Having managed an oncology practice earlier in my career, I've seen first-hand the advantages of the MID model and look forward to how House Rx's approach to MID will propel the rheumatology field forward – with our practice at the forefront." "The House Rx model will transform how rheumatology care is delivered, making it more coordinated and improving our patients' experience," said Beth Simpson, DO and managing physician partner at AATN. "We look forward to our patients not being on hold for hours on end waiting to speak with a specialty pharmacy. Instead, they'll speak immediately with House Rx's integrated team of pharmacy experts who understand their rheumatologic conditions." While the concept of dispensing specialty medications in rheumatology is not new — a handful of clinics attempted dispensing in the past but ultimately were unsuccessful due to a lack of technological and operational support — House Rx's model approaches in-office dispensing in a new way. By providing clinics with specialized technology and operational support from pharmacists and pharmacy technicians who work integrated with the clinic, practices can keep the service under their roof while reducing the heavy lifting of implementing and maintaining a successful MID program. In addition, clinics can repurpose staff resources normally spent on prior authorizations and financial assistance for patients to focus on direct patient care or other activities critical to the viability and financial independence of community rheumatology clinics. About House Rx House Rx is a healthcare technology and services company focused on making specialty medication more accessible and affordable. The company partners with specialty clinics across the country to help these community clinics offer medically integrated dispensing, bringing together clinical and pharmacy expertise to better serve patients, lower the cost of care, and create a better experience for patients and their caregivers. Learn more at www.houserx.com. About Arizona Arthritis & Rheumatology Associates With 19 physicians, 30 advanced practice providers, and 10 clinics around the state of Arizona, AARA is one of the largest rheumatology practices in the country bringing world-class expertise to patients managing autoimmune conditions. A member of the American Rheumatology Network, and always at the forefront of rheumatology care, AARA has led the way in addressing the rheumatologist workforce shortage by integrating advanced practice providers into their practice, which has allowed the practice to scale clinical operations and meet the demand of a growing patient population. About Arthritis & Osteoporosis Consultants of the Carolinas Based in Charlotte, North Carolina, AOCC has 10 physicians and 5 advanced practice providers caring for patients across two clinics. Combining years of experience in private practice, academic teaching and clinical research, the clinic staff provides highly individualized and state-of-the-art care. About Arthritis Associates Founded in 1975, Arthritis Associates has been at the forefront of rheumatological care in Chattanooga, TN and is the only practice in the area treating both adult and pediatric patients. Arthritis Associates has an excellent, experienced and knowledgeable team including skilled nurses who can administer intravenous treatments onsite, supervised by a board-certified rheumatologist.

Read More