PHARMACY MARKET, PHARMA TECH
prnewswire | March 31, 2023
PANTHERx® Rare, one of the largest and fastest growing rare pharmacies in the United States, is pleased to announce the launch of Joenja® (leniolisib), an oral selective small-molecule PI3K delta inhibitor indicated for the treatment of APDS in adult and pediatric patients ages 12 or older.
"Our patients living with rare and devastating diseases deserve the best that medicine can offer. Through innovation and technology, we continue to make a positive impact on the quality of life of those living with rare diseases. We are pleased to add Joenja® to the list of medications in PANTHERx® portfolio," said Rob Snyder, president of PANTHERx® Rare.
Activated Phosphoinositide 3-Kinase-Delta Syndrome, or APDS, is a rare primary immunodeficiency affecting approximately one to two people per million with disease onset occurring as early as infancy. This condition results from a variant in the genes PIK3CD or PIK3R1 with both genes playing a role in the regulation of white blood cell maturation. The presence of a mutation in these genes lead to hyperactivity of the PI3Kδ pathway resulting in a failure for the immune cells (B and T cells) to mature and properly function. Imbalance in the PI3Kδ pathway results in immunodeficiency and dysregulation. Those with APDS may develop recurrent respiratory tract infections, bronchiectasis, lymphoproliferation as well as neurodevelopment delay and failure to thrive. Clinical presentation is highly variable ranging from asymptomatic adults to those suffering from lymphoproliferation or development of profound immunodeficiency.
Snyder explained Joenja® exerts its effects by blocking the active binding sites of PI3Kδ inhibiting the signaling pathway hyperactivity that leads to dysfunction and dysregulation of B and T cells. In clinical trials, Joenja® achieved both co-primary efficacy measures of reduction in lymph node size and correction of immunodeficiency in the target population. The most common adverse reactions (>10%) were headache, sinusitis, and atrophic dermatitis.
About PANTHERx Rare
PANTHERx Rare is one of the largest and fastest growing rare pharmacies in the United States. PANTHERx transforms lives by delivering medicine breakthroughs, clinical excellence, and access solutions to people living with rare and devastating conditions. Although the overall incidence of rare diseases is as common as diabetes, less than 7% of the 7,000 known rare and devastating disorders have an FDA-approved therapy. Changes in federal policy and advances in science have led to a surge in FDA orphan drug approvals, providing tremendous hope to the rare disease community.
PANTHERx was recently awarded Specialty Pharmacy of the Year by the National Association of Specialty Pharmacy and earned the inaugural Accredited Distinction in Rare Diseases and Orphan Drugs from the Accreditation Commission for Health Care. PANTHERx is now a five-time winner of the prestigious MMIT Patient Choice Award, including the 2022 honor. PANTHERx is headquartered in Pittsburgh, licensed in all 50 states, and holds accreditations from URAC, NABP, and ACHC.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | May 02, 2023
COEUS, a leading healthcare communications, technology, talent, and consulting firm delivering a variety of services and platforms to all stakeholders in the healthcare ecosystem, announced today that it has completed a major rebranding. Following nearly 14 years of both organic growth and acquisitions, all business units have been combined to form one entity: COEUS.
Since the company’s inception in 2009, the company sought to build a suite of services capable of providing end-to-end solutions for drug and therapy manufacturers ranging from preapproval, through launch, and eventual loss of exclusivity.
“A little over 13 years ago, we started this company with just one employee. After a series of acquisitions, the hiring of more than 140 people, and the creation of numerous distinct business units all coming online at different times, we felt it was a necessary part of our evolution to consolidate the business units to one entity capable of servicing all clients,” stated Marc Hixson, CEO, COEUS. “Our clients have routinely told us that our experts, our strategic vision of what healthcare should be, and our commitment to leveraging — and building — technologies that improve the biotech, pharmaceutical, and payer audiences truly sets COEUS apart. It’s time to let the rest of the industry in on it.”
Through the rebranding, the company has redesigned its logo, launched an entirely new website and reinvented all its marketing collateral to reflect the company’s new identity.
As part of the consolidation, COEUS has appointed Jodie McVan to the position of Chief Commercial Officer. In her new role, Jodie will oversee the day-to-day operations, staffing, and the management of existing offerings, as well as drive the creation of new services and products for the consulting and agency business.
“With the combination of end-to-end service offerings for manufacturers, our technology platforms and services for manufacturers and payers alike, and industry leading talent and deep subject matter expertise, COEUS is well-positioned to efficiently deliver world-class service to our clients,” stated Jodie McVan, Chief Commercial Officer, COEUS. Visit 1COEUS.com to explore the new website and brand.
Established in 2009, COEUS is a leading healthcare consulting, communications, technology, and talent firm. The company offers clients a variety of services, as well as SaaS technology platforms, for various stakeholders throughout the healthcare ecosystem including all payers and emerging or more established drug manufacturers. Leveraging the deep knowledge and experience of the company’s many subject matter experts, COEUS works on all drug types with a particular focus on cell and gene therapies, rare diseases, and oncology. The company also has unique expertise in the creation and management of value-based agreements by leveraging COEBRA™, the company’s evidence and outcomes adjudication platform. In its 13-year history, the company has supported the launch of more than 120 pharmaceutical brands and has worked with more than 300 pharma clients including many top global pharmaceutical manufacturers.
Globenewswire | May 16, 2023
Athenex, Inc. a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that, following an ongoing strategic review, it has reached agreement with its lenders to move forward with an expedited sales process of the Company’s assets across its primary businesses: Athenex Pharmaceutical Division (“APD”), Orascovery, and Cell Therapy.
To best facilitate this process, Athenex and certain of its subsidiaries filed voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas. This will enable the Company to divest its assets and wind down the Athenex platform in an orderly fashion, while seeking to maximize value for its stakeholders. The Company anticipates concluding the expedited sales process by July 1, 2023, with the Chapter 11 cases continuing thereafter to resolve claims.
Athenex has also reached an agreement with its secured lenders, subject to court approval, for the consensual use of cash collateral, which will enable the Company to, among other things, satisfy certain obligations to its vendors for authorized goods received and services rendered after the filing. Athenex Pharma Solutions (“APS”), which includes the Company’s manufacturing facility in Clarence, New York, is expected to continue its operations for at least the next 90 days, to provide commercial supply of tirbanibulin ointment. In addition, APD is continuing to operate in the ordinary course and fill customer orders with the ample inventory it has on hand.
Dr. Johnson Lau, Chief Executive Officer of Athenex, on behalf of the management team and the Athenex Board of Directors, said, “Throughout our history, we have sought to become a leader in bringing innovative cancer treatments to the market and improving patient health outcomes. Our team was successful in bringing tirbanibulin, through regulatory approvals, to the U.S. market and a number of EU countries, as well as Taiwan. Unfortunately, our oral paclitaxel product candidate received a complete response letter from the U.S. Food and Drug Administration, and this significant regulatory setback, coupled with challenging biotech markets and the difficult economic environment, put tremendous pressure on our ability to continue to fund our businesses.
“Over the past two years, we made considerable progress in refocusing our business around our promising NKT cell therapy platform, monetizing non-core assets to improve our balance sheet and extending our cash runway, paying down $108 million of debt, and undertaking a comprehensive review of strategic alternatives to create value for our stakeholders. While we explored every viable avenue to avoid this outcome, an orderly sales process represents the best path forward at this time.
“Our goal remains to identify purchasers who will continue development of the important drug candidates for which we have established a good foundation, and to bring them to market on behalf of medical practitioners and, most importantly, for patients. We are incredibly thankful to our team for their dedication to Athenex and will look to support our colleagues through this transition period.”
Pachulski Stang Ziehl & Jones LLP is acting as Athenex's legal counsel. MERU is serving as its financial advisor and Cassel Salpeter & Co., LLC as its investment banker.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next-generation cell therapy products for the treatment of cancer. The Company’s mission is to become a leader in bringing innovative cancer treatments to the market and to improve patient health outcomes. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company is focused on its innovative Cell Therapy platform, based on natural killer T (“NKT”) cells.