AbbVie wins hep C contract with Washington state in latest 'Netflix' deal

biopharmadive | April 26, 2019

Subscription-based contracts for pharmaceuticals is a relatively new concept. But it's one quickly moving into practice, with Louisiana and Washington both expecting to start these programs this summer.

One industry analyst predicts these programs could spread.

"We fully expect other states to step in and take advantage of these contracts," Ronny Gal, an analyst at Bernstein wrote in an email to BioPharma Dive. "The public health value is compelling."

Gal added that these types of deals also make sense for the companies, as long as the final discounts they concede are relatively modest. "The predictability of earnings is worth a lot," he added.

That's particularly the case in the hepatitis C market, where declining patient starts have made revenue growth a more uncertain prospect.

Washington hopes to finalize the contract and begin the program by July 1, Judy Zerzan, chief medical officer for the Washington State Health Care Authority, said in an interview with BioPharma Dive. That will coincide with the state completing the drafting of its broader plan to eliminate hep C in a decade.

Spotlight

Lots of genetic diseases come down to a small change in a single gene, but how do you treat those diseases when the cells involved don’t have any DNA?

Spotlight

Lots of genetic diseases come down to a small change in a single gene, but how do you treat those diseases when the cells involved don’t have any DNA?

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MEDICAL

Agilent Announces Collaboration with APC on Real-Time Process Monitoring

Agilent Technologies | May 31, 2022

Agilent Technologies Inc. (NYSE: A) today announced a collaboration agreement with APC Ltd., in which the companies commit to working towards combining their technologies to provide unique workflows to customers that support automated process analysis via liquid chromatography (LC). Agilent has selected to partner with APC, a provider of innovative small molecule and large molecule process design and process development solutions. Both APC and Agilent pursue similar goals, which are focused on helping customers in the biopharmaceutical and pharmaceutical industry to improve the human condition and to delivering life-changing drugs to market faster and more efficiently. The collaboration between the companies leverages their complementary strengths to develop specific workflows, which bridge the gap between the analytical and process solutions. We are delighted to be collaborating with APC on a solution for real-time/automated process monitoring, Adapting our analytical capabilities to support online process monitoring requirements reflects the current trend within the pharma and biopharma industry towards continuous manufacturing and helps our mutual customers to develop higher quality drugs faster.” Stefan Schuette, vice president and general manager of Agilent’s Liquid Phase Separations Division. Agilent is a leader in the analytical lab with a comprehensive portfolio of analytical equipment for the biopharma and pharma industry, This collaboration leverages our complementary strengths and ultimately provides even better services and technologies to our customers by giving them greater insights into, and control of, their processes.” Damian Connolly, Analytical Lead at APC. The results obtained during the collaboration will be shared with customers via applications notes and joint webinars, which will also showcase the recently launched InfinityLab Online LC and InfinityLab Bio LC portfolio from Agilent. These new product offerings and the collaboration with APC ensure a leading position in the trend towards continuous manufacturing, process analytical technology (PAT), and real-time release testing (RTRT) in the biopharmaceutical and pharmaceutical industry. About Agilent Technologies Agilent Technologies Inc. (NYSE: A) is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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CELL AND GENE THERAPY

CSL Plasma Reimagines Donor Experience With First Donations Completed on Innovative Plasma Collection Technology

CSL Plasma | August 08, 2022

CSL Plasma, the plasma collection business of global biotherapeutics leader CSL Behring, began a new era in plasma donations, collecting its first plasma donations using leading-edge plasma collection technology that is expected to significantly reduce average collection time – by approximately one-third – and improve the donor experience. The Rika Plasma Donation System, only available at CSL Plasma and developed by Terumo Blood and Cell Technologies, is designed to reduce collection time, and improve the donor and operator experience. When considering prior average CSL Plasma donation procedure times, this could represent about a 30% reduction in average donation time for donors. The new plasmapheresis system first launched today in the Aurora, Colorado, CSL Plasma location, as part of a phased rollout to CSL Plasma U.S. collection centers. Plasma collected at CSL Plasma facilities is used in the manufacturing of lifesaving plasma-derived therapies. "Today marks a threshold moment for plasma donors following years of dedication, innovation and collaboration – demonstrating how we are driven by our promise in delivering lifesaving and life-extending therapies to patients around the world. We look forward to the positive impact this new technology brings and are thankful for plasma donors who continue to do the amazing every day when they donate at CSL Plasma." CSL Chief Operating Officer Paul McKenzie CSL Plasma believes features of the new Rika system can enable the collection of more plasma, in shorter periods of time, supporting quality and safety, and, ultimately, better serving patients who rely on plasma-based therapies. One of the first plasma donors to experience the Rika system, Kelly Geiser is a resident of the Denver area. She has donated plasma since 2017, and is a Platinum level donor as part of CSL Plasma's donor loyalty program, iGive Rewards®. Geiser appreciated that she was able to complete the donation procedure with the new technology in under 35 minutes and in the fastest donation time she has experienced, while every plasma donor's experience will vary. Donating plasma is also personal for Geiser, who says that therapies made from plasma have helped her and her family, including a parent who recently underwent emergency surgery. "It feels good knowing I'm helping people and, who knows, I might've helped somebody I know," said Geiser. According to Terumo BCT, benefits of the Rika Plasma Donation System include Rika completes one plasma collection in 35 minutes or less on average. The proprietary design of the system's centrifuge maximizes the plasma yield per cycle. The Rika Plasma Donation System was designed to allow no more than 200 milliliters of blood cells outside the donor's body, resulting in a low extracorporeal volume, which may contribute to a more comfortable donor experience. With less than 200 milliliters of blood cells outside the donor's body at any given time, should the initial procedure not be completed, the donor can return and donate without being deferred. The device is designed with an advanced user interface to guide CSL Plasma front-line employees. Operators can quickly and confidently resolve alarms, thanks to guidance provided on the Rika system's touchscreen, which also alerts operators about situations that require attention and provides suggested actions to resolve the situation. The system allows for real-time data analytics to drive device maintenance and repairs. CSL Plasma is implementing the new devices at Colorado centers and then expanding to other U.S. locations, providing donors more opportunities to "do the amazing" and be rewarded for their generosity. "As a long-time leader in our industry, CSL Plasma looks forward to this new plasmapheresis technology to delight our plasma donors and attract new donors while supporting a better operating experience for our employees," said Walter Charles, CSL Plasma Senior Vice President and General Manager. "As we complete the implementation of new technology at U.S. centers, we continue to address the critical and ongoing need for human plasma to produce life-saving medicines for people with serious and rare diseases." About CSL Plasma CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with more than 300 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics company and a member of the CSL Group of companies. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL Limited headquartered in Melbourne, Australia, employs more than 25,000 people. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

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INDUSTRIAL IMPACT

iNtRON Confirms Efficacy of CDL200 Against CDI Clinical Isolates

iNtRON Biotechnology | July 12, 2022

iNtRON Biotechnology announced that CDL200, a novel biological drug candidate under the development of the world's first enteric colon-targeted capsule formulation for the treatment of intractable and recurrent CDI confirmed the strong efficacy against clinical isolates from CDI patients. A company official explained that the antibacterial activity of CDL200 was evaluated for 20 clinical isolates from patients in Europe and Korea, and rapid lysis effect within few minutes after treatment was confirmed from all of the tested strains. In particular, even though majority of the tested strains are resistant strains to the commonly used antibiotics such as Metronidazole, Vancomycin, and Rifaximin, CDL200 showed very potent and rapid bactericidal activity. CDL200 is an endolysin-based novel biological drug candidate for the treatment of Clostridioides difficile infection, a hard-to-treat and recurrent bowel diseases. CDL200 has innovative drug properties that can eradicate bacteria much faster than the conventional antibiotics in the market, and also can be used for the infection caused by antibiotic-resistant bacteria and/or highly virulent bacteria. CDI patient population has been increasing globally and resulting in high mortality rate due to resistance to the existing antibiotics and serious complications such as toxic megacolon, sepsis, and intestinal perforation. Although there is growing interest in refractory CDI that does not respond well to primary treatment, there are only few studies on effective treatment yet. The more serious problem is the frequency of recurrent CDI is increasing, since the risk of subsequent recurrence is over 45% in patients who have had at least one recurrence. The conventional treatment based on Metronidazole and Vancomycin is not effective for CDI with severe intractability and repeating recurrence. And the recently attempted FMT (fecal microbiota transplantation), that is, the treatment of administering donor feces to the patient's intestinal tract, has advantages such as not suppressing the intestinal flora and not creating resistant strains, but the treatment brings objection to the general public and is limited in that there is a possibility that other pathogens from the donor may be transmitted. The mortality rate of CDI was about 3-4% in the past, but due to intensification of antibiotic-resistant bacteria and the emergence of highly virulent strain (NAP1/027), the recent mortality rate has been rapidly increased to over 10%, which makes global awareness growing. Dr. KANG, Sang Hyeon, CTO of iNtRON, said, "We have a number of new endolysin pipelines under the development utilizing our unique itLysin® technology for the serious infection that the development of effective therapeutic agents are urgently needed." "Based on the development experience of SAL200, we will strive to enhance the value of our rich itLysin® pipelines and will continue to secure global competitiveness in the endolysin field." Mr. YOON, Kyung Won, CEO of iNtRON About CDL200 CDL200 is a novel endolysin-based anti- Clostridioides difficile causes an infection of the large intestine which is often referred to as C. difficile or C. diff. CDL200 showed potent and rapid activity against 100% clinical isolates from multi-nation and has no disturbance of the normal flora in human's gut. The potential clinical usage and indications are CDI and IBD (Inflammatory Bowel Disease), and the targeted administration route of CDL200 is oral in capsule formulation. CDL200 is under non-clinical stage development and IND enabling studies will be conducted throughout the year. About iNtRON Biotechnology, Inc. iNtRON is a leader in bacteriophage-based technology with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development investments since their foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area. About iNtODEWORLD, Inc. iNtRON has established its wholly owned US subsidiary, iNtODEWORLD, Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news, updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US.

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