Industry News
NORTH CHICAGO, IL - AbbVie Inc. (NYSE: ABBV) and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, today announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.
OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils.
"This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "By leveraging our expertise in immunology drug development, we look forward to advancing OSE-230, which offers a novel mechanism-of-action to treat chronic inflammation."
"We are very pleased to collaborate with AbbVie, a global leader in the development and commercialization of innovative medicines, to drive our OSE-230 program forward," said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics. "This partnership represents a major milestone in our company's progress and recognizes the value of our innovative R&D capabilities. I would like to thank all our employees who helped us reach this milestone through dedication and hard work."
Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize OSE-230. OSE Immunotherapeutics will receive a $48 million upfront payment and will be eligible to receive up to an additional $665 million in clinical development, regulatory and commercial milestones. In addition, OSE Immunotherapeutics will be eligible to receive potential tiered royalties on global net sales of OSE-230.
The transaction is subject to the satisfaction of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
LEBANON, TN – Health Connect Partners, a leading organization for bringing hospital providers and suppliers together through industry-specific conferences, recently held its signature Online Reverse Expo with overwhelming success to kick off the 2024 conference season.
Over three days, February 6-8, Health Connect Partners was able to facilitate a total of 2,328 connections between providers and suppliers in the markets of Pharmacy, Radiology, Supply Chain, and OR/Surgical. With each meeting extended to 14-minutes this year, over 543 hours of one-on-one meetings were held within less than three business days (~24 hours in total).
“In today's crucial healthcare landscape, fostering connections is paramount, and our Health Connect Partners Online Reverse Expo platform facilitated just that,” said Jason Green, Partner & Chief Sales Officer. “A huge thank you to all the Hospital Leaders who actively participated, ensuring continued collaboration and innovation. Additionally, I would like to extend my gratitude to our HCP team who continue to masterfully orchestrate meaningful connections between the right people at the right time.”
Since 2020, HCP’s online platform has offered Suppliers the ease and access to key decision-makers they may not otherwise connect with given the fast-paced nature of healthcare. Michael Gitomer with Azurity Pharmaceuticals shared, “Thanks to HCP for what you have created in bringing Hospital Providers and Industry together to have meaningful discussions. The HCP team is always thinking of ways to improve its product and increasing the time from 9 to 14-minutes really helped to create opportunities to schedule follow-up meetings on our own. Companies are crazy if they do not see the value in Health Connect Partners meetings and conferences.”
Dr. Mark Cohen, President and Founder at the National Recall Alert Center added, “The Online Reverse Expo provides the most amazing opportunity we ever had in such a concentrated period. Imagine, where else could we ever spend 14 unadulterated minutes - audio and video - one-on-one - with the full attention of a potential hospital buyer? And then, within one full minute later, be in front of another hospital-confirmed buyer for another full 14 minutes? This repeated itself 20 plus times over three days. Although it is too early to determine the financial results, it might have been the best marketing spend with the greatest impact we've ever had with Health Connect Partners, and we strongly suggest others consider this amazing opportunity.”
Next for Health Connect Partners is its In-Person events scheduled for this spring in Dallas, Texas. With a full schedule of educational and networking opportunities, HCP will welcome the Hospital Pharmacy Industry to the Hilton Anatole, April 8-10 followed a month later by the Radiology, Supply Chain, OR/Surgical, and Nursing Home markets May 20-22, 2024. For more information regarding participation in or sponsorship of HCP in-person or online conferences, please visit www.hlthcp.com.
LEBANON, TN - In a significant blow to healthcare systems across the United States, Change Healthcare, a leading provider of healthcare technology solutions, has fallen victim to a cyberattack, resulting in widespread disruption to hospital pharmacies nationwide. The breach, which occurred last week, has sparked concerns over patient safety, prescription processing delays, and data security vulnerabilities.
The cyberattack targeted Change Healthcare's network infrastructure, compromising vital systems responsible for processing prescription orders, managing inventory, and facilitating communication between healthcare providers and pharmacies. As a result, hospitals relying on Change Healthcare's services have faced severe operational challenges, with many struggling to fulfill critical medication orders and maintain essential pharmacy services.
Amidst the chaos, hospital administrators and pharmacists have been forced to resort to manual methods for prescription processing and inventory management, leading to significant delays and disruptions in patient care. Moreover, the breach has raised serious concerns regarding the security of sensitive patient data, prompting healthcare organizations to reassess their cybersecurity protocols and safeguards.
The ramifications of the cyberattack extend far beyond individual hospital pharmacies, as healthcare providers grapple with the broader implications of compromised data security and operational integrity. With patient safety hanging in the balance, hospitals are under immense pressure to swiftly address the fallout from the breach and implement robust measures to prevent similar incidents in the future.
As hospitals work tirelessly to restore normalcy to their pharmacy operations, the incident serves as a stark reminder of the evolving threat landscape facing the healthcare sector. With cyberattacks becoming increasingly sophisticated and pervasive, healthcare organizations must remain vigilant and proactive in safeguarding their systems and protecting patient data.
In response to the breach, Change Healthcare has issued a statement acknowledging the incident and affirming its commitment to resolving the issue swiftly and transparently. The company has reassured its clients and partners of ongoing efforts to strengthen cybersecurity defenses and mitigate any further disruptions to services.
As investigations into the cyberattack continue, hospitals are left grappling with the aftermath, striving to balance the imperative of providing quality patient care with the pressing need to fortify their defenses against future cyber threats. The incident serves as a sobering wake-up call for the healthcare industry, highlighting the critical importance of cybersecurity in an increasingly digitized world.
NORTH CHICAGO, IL & SAN DIEGO, CA - AbbVie Inc. (NYSE: ABBV) and Tentarix Biotherapeutics today announced a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology. The collaboration will integrate AbbVie's expertise in oncology and immunology with Tentarix's proprietary Tentacles™ platform.
Tentacles™ are multi-functional, conditionally-active antibody-based biologics that are designed specifically to activate immune cells that can modulate disease pathways, while potentially mitigating safety concerns associated with non-specific targeting of other immune cells.
"Oncology and immunology are two of our key strategic growth areas where we are pursuing novel technologies that aim to deliver transformative therapies, which address unmet patient needs," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "This strategic partnership complements our ongoing efforts in developing novel biologics, potentially to expand our oncology and immunology portfolios with conditionally-active multi-specific molecules."
"We are excited to join forces with AbbVie to help accelerate cutting-edge, conditionally-active therapeutic programs towards clinical applications for patients in need," said Don Santel, interim chief executive officer, Tentarix Biotherapeutics. "This collaboration adds to our portfolio of internal and external pipeline programs and is a strong validation of our approach in understanding and targeting complex immune interactions that drive cancers and inflammatory diseases."
Under the terms of the agreements, Tentarix will receive upfront option payments, totaling $64 million from AbbVie, for the two programs. AbbVie will receive an exclusive option to fully acquire the programs following candidate nomination, for an additional undisclosed payment for each program.
SILVER SPRING, MD & RESEARCH TRIANGLE PARK, NC - United Therapeutics Corporation (Nasdaq: UTHR) announced today the commencement of litigation with the United States Food and Drug Administration (FDA). In the litigation, United Therapeutics alleges that the FDA mistakenly permitted Liquidia Corporation (Liquidia) to skirt longstanding FDA rules, precedents, and procedures on how pending drug approval applications are handled by the agency. In doing so, the FDA inappropriately denied United Therapeutics its right to obtain a stay of Liquidia’s final approval until United Therapeutics’ pending patent infringement claim against Liquidia can be resolved.
This litigation addresses the FDA’s handling of Liquidia’s unlawful amendment to a pending new drug application (NDA) seeking to add a second indication, pulmonary hypertension associated with interstitial lung disease (PH-ILD), to the label of its proposed inhaled dry powder treprostinil product. United Therapeutics alleges in the litigation that the FDA’s rules, precedents, and procedures require that Liquidia seek approval for this second indication by filing a new NDA rather than filing an amendment to a pending NDA. United Therapeutics believes this distinction is critical to ensure the proper review and approval of new drug applications in a fair, equitable manner consistent with the FDA’s prior practices with which industry has complied for decades.
Before 2021, every clinical trial of drugs approved for the treatment of pulmonary hypertension that were studied for the treatment of PH-ILD failed. Some approved PH therapies worsened patients’ pulmonary hypertension, and PH-ILD remained a disease for which there were no approved therapies.
Notwithstanding this clear record of failure by others in PH-ILD, United Therapeutics took the bold step at considerable expense to conduct an innovative pivotal trial of Tyvaso® (treprostinil) Inhalation Solution for the treatment of PH-ILD. This trial, called INCREASE, was the largest and most comprehensive completed study of patients with PH-ILD, and its successful results led the FDA to approve Tyvaso as the first ever treatment for PH-ILD in March 2021. The results of the INCREASE study were published in The New England Journal of Medicine in January 2021.
Under the Hatch-Waxman Act, when a company like Liquidia seeks approval of an application that relies on another drug’s prior approval and may infringe patents listed for that drug, a timely filed action for patent infringement prevents the FDA from approving an NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. By filing an amendment to its existing NDA rather than a new NDA, Liquidia avoided a 30-month stay of approval for PH-ILD despite Liquidia’s decision to rely on United Therapeutics’ prior approval for Tyvaso. By filing this litigation, United Therapeutics seeks to protect the equity afforded true pharmaceutical and biotech innovators through the correct and consistent interpretation of the FDA’s rules, precedents, and procedures. If United Therapeutics is successful in its litigation with FDA, a stay of up to 30 months could prevent final approval for Liquidia’s PH-ILD indication to allow separate patent litigation to be resolved.
“The FDA is a global leader among public health agencies, but sometimes legal and regulatory precedents are missed,” said Dean Bunce, Executive Vice President, Global Regulatory Affairs at United Therapeutics. “We are simply asking that the FDA apply its own rules and precedents consistently to honor the Hatch-Waxman balance struck by Congress between innovators and imitators: Liquidia can rely on United Therapeutics’ innovation to speed its path to market, but the cost of that shortcut is that Liquidia must address the infringement claim against it before rushing to market.”
United Therapeutics previously sued Liquidia alleging infringement of U.S. Patent No. 11,826,327 (the ’327 patent) based on Liquidia’s efforts to obtain approval for the PH-ILD indication. The claims of the ’327 patent generally cover improving exercise capacity in patients suffering from PH-ILD by inhaling treprostinil at specific dosages. The patent infringement case is currently pending in U.S. District Court for the District of Delaware.
About PH-ILD
Interstitial lung disease (ILD) is a group of lung diseases that are characterized by marked scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with activity, labored breathing, and fatigue.
Group 3 Pulmonary hypertension (PH) frequently complicates the course of patients with interstitial lung disease and is associated with worse functional status measured by exercise capacity, greater supplemental oxygen needs, decreased quality of life, and worse outcomes. PH is estimated to affect at least 15% of patients with early-stage ILD (approximately 30,000 PH-ILD patients in the United States) and may affect up to 86% of patients with more severe ILD.
About TYVASO® (treprostinil) Inhalation Solution
INDICATION
TYVASO (treprostinil) is a prostacyclin mimetic indicated for the treatment of:
- Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%).
The effects diminish over the minimum recommended dosing interval of 4 hours; treatment timing can be adjusted for planned activities.
While there are long-term data on use of treprostinil by other routes of administration, nearly all controlled clinical experience with inhaled treprostinil has been on a background of bosentan (an endothelin receptor antagonist) or sildenafil (a phosphodiesterase type 5 inhibitor). The controlled clinical experience was limited to 12 weeks in duration. - Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- TYVASO is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, TYVASO may produce symptomatic hypotension.
- TYVASO inhibits platelet aggregation and increases the risk of bleeding.
- Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both Cmax and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness.
DRUG INTERACTIONS/SPECIFIC POPULATIONS
- The concomitant use of TYVASO with diuretics, antihypertensives, or other vasodilators may increase the risk of symptomatic hypotension.
- Human pharmacokinetic studies with an oral formulation of treprostinil (treprostinil diolamine) indicated that co-administration of the cytochrome P450 (CYP) 2C8 enzyme inhibitor, gemfibrozil, increases exposure (both Cmax and AUC) to treprostinil. Co-administration of the CYP2C8 enzyme inducer, rifampin, decreases exposure to treprostinil. It is unclear if the safety and efficacy of treprostinil by the inhalation route are altered by inhibitors or inducers of CYP2C8.
- Limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. However, pulmonary arterial hypertension is associated with an increased risk of maternal and fetal mortality. There are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production.
- Safety and effectiveness in pediatric patients have not been established.
- Across clinical studies used to establish the effectiveness of TYVASO in patients with PAH and PH ILD, 268 (47.8%) patients aged 65 years and over were enrolled. The treatment effects and safety profile observed in geriatric patients were similar to younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of hepatic, renal, or cardiac dysfunction, and of concomitant diseases or other drug therapy.
ADVERSE REACTIONS
- Pulmonary Arterial Hypertension (WHO Group 1)
In a 12-week, placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most common adverse reactions seen with TYVASO in ≥4% of PAH patients and more than 3% greater than placebo in the placebo-controlled study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%). In addition, adverse reactions occurring in ≥4% of patients were dizziness and diarrhea. - Pulmonary Hypertension Associated with ILD (WHO Group 3)
In a 16-week, placebo-controlled study (INCREASE) of 326 patients with PH-ILD (WHO Group 3), adverse reactions were similar to the experience in studies of PAH.
Please see Full Prescribing Information, the TD-100 and TD-300 TYVASO® Inhalation System Instructions for Use manuals, and other additional information at www.tyvaso.com or call 1 877 UNITHER (1-877-864-8437).
United Therapeutics: Enabling Inspiration
At United Therapeutics, our vision and mission are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs.
You can learn more about what it means to be a PBC here: unither.com/pbc.
NORTH CHICAGO, IL - AbbVie (NYSE: ABBV) today announced that its board of directors has unanimously selected Robert A. Michael, AbbVie's current president and chief operating officer, to succeed Richard A. Gonzalez as the company's chief executive officer (CEO). Mr. Gonzalez, who has served as CEO since the company's formation in 2013, will retire from the role of CEO and become executive chairman of the board of directors, effective July 1, 2024. Additionally, the board has appointed Mr. Michael as a member of the board of directors effective July 1, 2024.
"On behalf of AbbVie's board, I am extremely excited that Rob has agreed to serve as AbbVie's next CEO," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "As a key member of the Executive Leadership Team, he has had a tremendous impact on AbbVie. From establishing our financial planning organization, to the development of our diversified business strategy, to successfully navigating the end of exclusivity for Humira in the U.S., Rob has been integral to AbbVie's impact since inception. Rob has also played an important role in key business development opportunities that have been critical to delivering on our long-term growth strategy, including the acquisitions of Allergan and ImmunoGen and the pending Cerevel Therapeutics transaction. I have known and worked with Rob for many years, and he has the experience, leadership capabilities and strategic vision to accelerate AbbVie's success well into the future."
"The board and I have been planning for a seamless CEO succession for some time. Now is the opportune time to hand the CEO role over to Rob," continued Mr. Gonzalez. "The business is performing very well and is in a strong position for the long term. Our pipeline contains multiple promising candidates to sustain our future strong growth. It has been a privilege and immensely gratifying to serve with all my AbbVie colleagues for the past 11 years growing AbbVie into what it is today, and I look forward to continuing to work with Rob as executive chairman of the board."
"The AbbVie board recognizes that CEO succession planning is one of our most important responsibilities," said Glenn Tilton, lead independent director, AbbVie's board of directors. "The company has been planning for the eventual succession for a long time and has been thoughtful and deliberate to ensure the right plan was in place for a potential successor. The board conducted a thorough process to identify the right leader for AbbVie's next chapter. It is a testament to the strength and depth of AbbVie's management team that we have the ideal internal candidate in Rob to assume the CEO position. The board has the highest confidence in Rob and looks forward to working with him to create meaningful value for our shareholders and all our stakeholders."
"All of us at AbbVie owe Rick an enormous debt of gratitude for his remarkable leadership over the past 11 years," continued Mr. Tilton. "Under his stewardship, AbbVie has generated a total return to shareholders of more than 700%, created over $250 billion in market valuation, grown our annual patient base to more than 60 million people in 175 countries, invested over $60 billion in R&D and nearly tripled annual revenue. We are thrilled that we will continue to benefit from Rick's experience, intellect and integrity on AbbVie's board of directors."
"I am honored to assume the CEO role for AbbVie, and I am excited about our company's bright future," said Robert A. Michael, president and chief operating officer, AbbVie. "Rick has been a tremendous leader for AbbVie and mentor to me personally. His legacy at AbbVie will be felt for years to come. I would like to thank the board for expressing its confidence in me, and I look forward to working with Rick and the entire board to deliver results for our patients, our employees, our shareholders and our communities."
About Robert A. Michael
Robert A. Michael is president and chief operating officer of AbbVie. A member of AbbVie's Executive Leadership Team, Mr. Michael is responsible for global commercial operations, finance, corporate human resources, global operations, business development and corporate strategy for the company. Previously, he served as vice chairman and president.
Mr. Michael has 31 years of experience including leadership roles across multiple businesses, including pharmaceuticals, aesthetics, diagnostics, diabetes care and nutrition. He began his career with Abbott as a member of the financial development program and ultimately served as division controller, nutrition supply chain and division controller, molecular diagnostics, among other roles.
Upon AbbVie's separation from Abbott in 2013, Mr. Michael established and led the company's first financial planning organization as vice president, AbbVie financial planning and analysis. He then held a series of leadership roles of increasing responsibility including vice president, controller for commercial operations; vice president, treasurer; and vice president, corporate controller. He was appointed chief financial officer in 2018, vice chairman, finance and commercial operations in 2021, vice chairman and president in 2022 and president and chief operating officer in 2023.
About Richard A. Gonzalez
Richard A. Gonzalez is chairman of the board and CEO of AbbVie. Mr. Gonzalez is AbbVie's founding CEO, having led the company since its inception in 2013. During his tenure as CEO, AbbVie market capitalization has increased from $54 billion in 2013 to more than $300 billion today, revenue has nearly tripled and adjusted, diluted EPS has grown from $2.93 to $11.11.1 In that time, AbbVie has grown to more than 50,000 employees and serves patients in more than 175 countries with its portfolio of innovative medicines.
Prior to AbbVie's separation from Abbott in January 2013, Mr. Gonzalez was a 30-year Abbott veteran. He served as president and chief operating officer of Abbott. He also held various senior leadership positions in Abbott's Medical Products businesses, including president and chief operating officer of the Medical Products Group; senior vice president and president of the former Hospital Products Division; vice president and president of the Health Systems Division; and divisional vice president and general manager for Diagnostics Operations in the United States and Canada.
Mr. Gonzalez has been a long-standing leader in the greater Chicago community where he serves on the University of Chicago Board of Trustees and as a member of the Commercial Club of Chicago.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter) and YouTube.
IRVING, TX - Vizient, Inc. announced it has released trends providers should strategize for in 2024. These include payer strategy, ambulatory design considerations, an approach to primary care access and the importance of targeted technology adoption. View 2024: A Year for Bold Bets.
"Where and how healthcare providers invest their resources is a crucial question," said Bill Woodson, senior principal, Intelligence at Sg2, a Vizient company. "Those decisions will ultimately impact financial performance, market position, and in the end, patient care delivery."
The trends are projected based on market research and data analysis, including proprietary Sg2 all-payer claims data. Based on the data and in-house expertise, Vizient is advising providers to:
- Revisit their payer strategy: Medicare Advantage now represents two-thirds of the total Medicare population in some markets and the number of Medicaid enrollees continues to grow. With a high proportion of Medicare and Medicaid enrollees in managed care, providers should have a strategy that proactively addresses total cost of care as a market play.
- Re-evaluate their ambulatory business model: As the shift from inpatient to outpatient care continues to accelerate, an ambulatory strategy must be designed to meet consumer expectations. Providers should also work to understand their consumer purchasing patterns and get ahead of forthcoming price transparency mandates.
- Change the game in primary care: Primary care in traditional office settings will shrink to less than 50% of market share by 2030, according to Sg2, as payer-owned and retail healthcare models surge. Analytics can help pinpoint key growth segments. Providers should keep an eye on new-market entrants and use analytics to determine gaps those entrants address before deciding whether to partner or compete.
- Differentiate through targeted technology adoption: Technology adoption is crucial to effectively managing accelerating consumer needs. Evolving AI tools, home DNA testing, new cellular-based therapies, telehealth visits and use of digital devices that capture real-time health trends all show exponential growth.
"2024 must be a year of inside-out focus for healthcare organizations. Investing time, talent and capital in areas that better meet patient need today and address what tomorrow's patients will demand is essential," said Woodson. "A focus on these vital areas will help providers on their journey to cost, quality and market performance alignment."
In December 2020, Pharmacolog AB and Codonics Inc. entered into a partnership agreement for sales and marketing of WasteLog™ for the North American market, which over time has been expanded to include sales of DrugLog™ and several regions, such as China, the Middle East region, the GCC countries and Jordan, Mexico and Canada. This agreement established minimum sales targets for the DrugLog™ and WasteLog™ products, which were not closely met for either product last year. As a result, Codonics was informed today that the existing contract will be terminated in its entirety. This means that Pharmacolog will in the future have the exclusive right to distribute the company's products in these regions.
Furthermore, it is the board and management's assessment that this strengthens the conditions for successfully executing the company's strategy and divesting the remaining assets, which mainly consist of WasteLog™ and which has a larger installed base than DrugLog™.
Lars Gusch, CEO of Pharmacolog comments: "Unfortunately, we have repeatedly been disappointed by Codonic's lack of sales results in the past. This has had a serious negative impact on our business and thus Pharmacolog's financial stability. The cancellation of the contract is therefore an unavoidable step that at the same time increases the conditions to fully execute on the company's set strategy."
Construction is currently underway on a new and improved pharmacy at Mercy Health – Urbana Hospital. The current pharmacy space will move from a smaller hallway space near the emergency room to a full-scale, state-of-the-art operation located inside the previous McAuley Senior Living Center.
The expanded pharmacy is the first phase in support of major plans to increase oncology access for the Urbana community later in 2024. Those plans include infusion services including six infusion chairs and a private infusion suite as well as a medical oncology practice featuring four exam rooms.
“It is extremely exciting to see progress happening in the McAuley space and know we are taking necessary steps to fill a major gap in our community to offer cancer care close to home for our residents of Champaign County,” said Jamie Houseman, president of Mercy Health – Urbana Hospital.
The new pharmacy will include United States Pharmacopeia (USP)-compliant clean rooms that are required to bring oncology services to the Urbana campus. These rooms will enable the pharmacy to prepare compounds in advance of a need, which reduce the burden on nursing staff to compound medications at the bedside.
“It all adds up to a great service enhancement for our patients and associates,” said Josh Walker, PharmD, MHA, director of pharmacy for the Mercy Health – Springfield market. “This advance compounding will improve patient safety and nurse efficiency. The additional space will also allow the pharmacy to organize, prepare and plan for the challenges we are facing in health care today, such as medication shortages.”
Construction on the new pharmacy space is expected to be complete later this year. In the meantime, the pharmacy will remain open in its current space near the emergency room.
NEW HAVEN, CT - BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that it has terminated its proposed public offering of $60.0 million of shares of its common stock or, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock, previously announced on February 8, 2024. As a result of such termination, no securities of the Company are being sold pursuant to the offering.
The termination results from an assessment by the Company's management that current market conditions are not conducive for an offering on terms that would be in the best interests of the Company's stockholders. In addition, the Company intends to focus on its upcoming meeting with the FDA on February 20, 2024 for its Phase 3 TRANQUILITY At Home trial. The trial will evaluate BXCL501 as a potential acute treatment of agitation associated with dementia due to probable Alzheimer’s disease in the at-home setting. The data readout from this trial is expected in Q1 2025.
The offering was being made by the Company pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (the “SEC”) on November 2, 2023 and which became effective on November 13, 2023 and a preliminary prospectus supplement filed with the SEC on February 8, 2024.