BUSINESS INSIGHTS, PHARMACY MARKET
EVERSANA | February 24, 2023
On February 23, 2023, Xspray Pharma AB announced that it has signed an agreement with EVERSANA to aid the launch and commercialization of its innovative cancer therapy Dasynoc for treating chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL) in the United States. Xspray Pharma will maintain financial and strategic control while granting EVERSANA exclusive commercialization access to support the second-half 2023 launch of Dasynoc. Dasynoc, if FDA approved, will be a new treatment option for CML and ALL patients that will enter the $3.5 billion commercial market for Tyrosine Kinase Inhibitors in the United States.
Under the agreement, EVERSANA will provide Xspray with a dedicated commercialization team with expertise in the successful commercialization of cancer drugs, including TKI products, and offer support in areas such as agency services, market access, clinical and commercial field teams, patient services, medical science liaisons, and compliance. In addition, this agreement gives Xspray access to EVERSANA's experienced commercial leaders and enables a quick launch while optimizing the launch budget.
Dasynoc is expected to bring significant benefits to CML patients as it is bioequivalent to Sprycel® at a 30% lower dose with significantly better variability, enabling better precision and predictability of dosing. Dasynoc is granted ODD by FDA for the treatment of CML and ALL.
The product offers an important improvement for CML patients, as retrospective registry data presented at ASH 2022 show that patients on concomitant tyrosine kinase inhibitor (TKI) and proton pump inhibitor (PPI) treatment (e.g., omeprazole) of 79% have low 5-year overall survival rates compared to 94% for patients on TKI only. Dasynoc uptake is unaffected by PPIs, hence offering an essential benefit to CML patients.
Xspray plans to launch the product in the second half of 2023, subject to FDA approval and ongoing litigation processes pertaining to patents for crystalline dasatinib forms that Xspray believes are not present in its product.
EVERSANA is a prominent global services provider to the life sciences industry, offering integrated solutions that focus on the patient experience and cover all stages of the product life cycle. The company aims to create long-term, sustainable value for patients, prescribers, channel partners, and payers. It works with over 670 organizations, including established pharmaceutical companies and start-ups, to advance life sciences solutions and contribute to creating a healthier world.
BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | March 23, 2023
Hovione and Laxxon Medical announced a strategic collaboration to advance the use of 3D screen printing technologies for the pharmaceutical industry. This partnership combines Laxxon´s expertise in 3D screen printing, based on their SPID®-Technology, with Hovione's product & process development, engineering and manufacturing expertise in pharmaceutical applications. Under the terms of the agreement, Hovione will establish the Laxxon Medical 3D screen printing technology at Hovione's cGMP production sites first in Portugal and later in the USA.
The 3D technology displays numerous advantages including the potential to produce unique or customized dosage forms with characteristics that cannot be achieved with conventional dosage forms, the ability to create tablets of any shape and size, the option to easily adjust the number of active substances and individual components in the composition of the tablet and even to set the dosage individually for each patient for personalized medicines.
"Laxxon is thrilled to establish a long-term partnership with Hovione." said Klaus Kuehne, COO of Laxxon Medical. "This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry thus accelerating our ability to serve our customers." "Hovione has a global reputation for their pharmaceutical innovation services, expertise and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts." said Helmut Kerschbaumer, Laxxon's CEO. "We are looking forward to collaborating with Hovione to promote innovation through 3D screen printing."
"We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics but it also has the potential to reduce the time and cost of drug development" says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds "Hovione has a track record of turning emerging pharmaceutical production technologies into reliable and scalable offerings at both developmental and commercial scales. We are excited at the prospect of supporting Laxxon in industrializing its 3D printing technology and make it accessible to a greater number of pharmaceutical and medical device companies."
With this partnership the platform will be available from early development phases to routine commercial manufacturing.
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) Hovione has a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
BUSINESS INSIGHTS, PHARMACY MARKET
VERO Biotech | February 03, 2023
On February 2, 2023, VERO Biotech Inc., a commercial-stage biotechnology company focused on neonatal intensive care and the acute care hospital community, announced that FDA has approved its innovative second-generation GENOSYL® Inhaled Nitric Oxide (iNO) delivery system for use in the operating room with rebreathing anesthesia. The second generation GENOSYL® DS is now the first and only iNO delivery device approved for use in both rebreathing and non-rebreathing anesthesia procedures, enhancing patient care, saving money for the hospital, and minimizing waste anesthetic gas pollution.
GENOSYL® DS is the first tankless inhaled nitric oxide delivery system. Nitric oxide, when inhaled, dilates the pulmonary blood vessels and can improve oxygenation in neonates suffering from hypoxic respiratory failure and pulmonary hypertension. GENOSYL® DS, unlike tank-based systems, generates and delivers iNO at the bedside via a small disposable cassette. This helps eliminate the need for hospitals to manage large, cumbersome tanks while also aiding in the simplification of clinical workflow.
The following are the expected advantages of the second generation GENOSYL® DS
Ability to employ rebreathing anesthesia: Rebreathing allows reduced gas flows, resulting in less usage of expensive anesthetic drugs, thereby reducing hospital costs; enhanced patient comfort (by preserving patient body temperature and moisture).
Smoother care process: seamless iNO delivery from the ICU to surgery and post-operative care leads to process and workflow enhancements for the healthcare organization, thus lowering the hospital's overall cost.
Set and forget: It allows anesthesiologists to continue using rebreathing anesthesia, thereby preventing potentially dangerous, time-consuming and cumbersome workarounds.
Reduced ecological consequences of anesthesia delivery: less anesthetic is released into the environment.
It is important to note that FDA has only approved the second generation GENOSYL® DS for use with rebreathing anesthesia in the surgical suite. The third generation GENOSYL® DS, which was recently approved, has not been tested with rebreathing anesthesia. VERO Biotech is currently conducting similar validations and expects to have data available in the first quarter of 2023.
About VERO Biotech
Headquartered in Atlanta, GA, VERO Biotech is an emerging biotechnology firm that focuses on designing, developing, and commercializing next-generation inhaled nitric oxide (NO) delivery systems to tackle unmet medical needs in patients with cardiopulmonary conditions. The company's mission is to improve patients' lives by pioneering innovative technologies for inhaled NO delivery in acute care hospitals and beyond, wherever nitric oxide treatment is required. By focusing on the science, development, and commercialization of its innovations, it aims to exceed customer expectations regarding safety, efficacy, and growth.