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
Harrow | February 16, 2023
On February 15, 2023, Harrow, a renowned pharmaceutical firm specializing in eyecare in the United States, announced the launch of its next-generation, patent-pending compounded Atropine formulations. These formulations are now accessible through ImprimisRx, a mail-order pharmacy subsidiary wholly owned by Harrow.
The following are the key features of ImprimisRx's next-generation Atropine formulations
Thoroughly validated analytical tests are conducted to ensure potency, consistency, and stability.
The formulations are free of preservatives and boric acid.
They possess a physiologic pH of 5.5.
They can be stored at room temperature for up to 180 days.
Eyecare professionals can purchase these compounded Atropine formulations for as less as $39 per 5mL bottle through various channels, such as online via atropine.com or by contacting ImprimisRx Customer Service at 615-437-4690 via call or text.
Compounded formulations are recommended for patients with clinical requirements that are not met by FDA-approved medications. It is essential to note that compounded medications are not reviewed by FDA for their safety and effectiveness. ImprimisRx does not manufacture copies of products that are already available in the market.
Harrow's Chairman and Chief Executive Officer, Mark L. Baum, commented, "Our mission has always been to help our eyecare professionals address their patients' unmet needs and to make ophthalmic medications both accessible and affordable. The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer."
(Source – Business Wire)
Founded in 2012, Harrow is a leading ophthalmic pharmaceutical firm in the United States focused on discovering, developing, and introducing accessible, innovative, and affordable prescription therapies. It holds commercial rights for ten FDA-approved eyecare pharmaceutical products. In addition, the company also operates ImprimisRx, a leading U.S. compounding business that specializes in ophthalmic medications and is licensed to ship prescription drugs in all 50 states. The success of its efforts is reflected in its remarkable financial performance, with a 72% compound annual growth rate achieved during our first eight years in operation. This phenomenal growth rate has established Harrow as one of the fastest-growing ophthalmic pharmaceutical companies in the United States.
BUSINESS INSIGHTS, PHARMA TECH
CONTINUUS Pharmaceuticals | March 15, 2023
On March 14, 2023, ValGenesis, Inc., a leading enterprise validation lifecycle management solutions provider, announced that CONTINUUS Pharmaceuticals has successfully implemented the ValGenesis Validation Lifecycle Management System (VLMS) for efficient management of validation processes across the company in a 100% digital format.
CONTINUUS Pharmaceuticals is a rapidly growing small business specializing in end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals. As a spin-out company resulting from a long-term collaboration between MIT and Novartis, CONTINUUS Pharmaceuticals is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of raw materials and APIs to final dosage forms.
Due to the immense validation requirements involved in the production of different drug products, CONTINUUS Pharmaceuticals needed an electronic solution that determines the disposition of their assets while switching amongst product lines. By leveraging the ValGenesis VLMS, CONTINUUS Pharmaceuticals has successfully implemented facilities, equipment validation, computer system and utility validation.
The ValGenesis VLMS is the system of record for CONTINUUS Pharmaceuticals' engineering team and will be expanded to other teams in the future. The highly automated, real-time, and compliant system provided by ValGenesis minimizes the potential for Good Manufacturing Practice (GMP) non-compliance while accelerating time to market.
About CONTINUUS Pharmaceuticals
CONTINUUS Pharmaceuticals is an end-to-end integrated continuous manufacturing (ICM) company specializing in pharmaceutical production. The company is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of APIs and raw materials to final dosage forms. It leverages a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through a $65 million joint research project between Novartis and MIT. With ICM, it aims to transform and streamline the supply chain of pharmaceuticals by delivering high-quality, lower-cost drugs "on-demand."