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.
About EVERSANA
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.
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BUSINESS INSIGHTS, PHARMA TECH
West Pharmaceutical Services | February 13, 2023
West Pharmaceutical Services, Inc., a leading global innovative injectable drug administration solutions provider, recently announced the expansion of its remarkable collaboration with Corning Incorporated, which now includes exclusive distribution rights for Corning Valor® Glass vials as well as the launch of its first product, West Ready Pack™ with Corning Valor® RTU Vials employing SG EZ-fill® technology.
The West Ready Pack™ with Corning Valor® RTU Vials integrates West's highest quality NovaPure® stoppers, Flip-Off® CCS (Certified, Clean, Sterilized) seals and Corning's best-in-class Valor® RTU Vials with SG EZ-fill® technology into a complete containment solution to assist in the introduction of parenteral drugs and diagnostics to the market.
West announced its agreement with Corning in January 2022, which includes a multimillion-dollar investment to develop Corning's Valor® Glass technology to improve patient safety and increase access to life-saving therapies. This strategic alliance provides premier elastomer-glass system solutions for injectable drug storage and delivery. In addition, West and Corning intend to collaborate to develop the next generation of integrated packaging and delivery system solutions.
Valor® RTU Vials with SG EZ-fill® technology improve medication storage and distribution, enable more reliable access to important medicines for public health, and maximize production efficiency. This pharmaceutical glass was explicitly created to handle the problems of modern industrial procedures.
The Ready Pack™ mixture of NovaPure® stoppers, Flip-Off® CCS seals, and Valor® RTU Vials with SG EZ-fill® technology offers drug developers the following advantages
Proven Container Closure Integrity (CCI), which includes the ability to sustain cold storage CCI when cooled to and kept at -80 degrees Celsius;
Ready-to-use sterile format that may be introduced immediately into filling operations, avoiding the requirement for component preparation;
Premium components with the most stringent particle requirements available from West; and
Availability in volumes appropriate for small-scale filling operations with continuity to quantity alternatives for large-scale commercial operations.
About West Pharmaceutical Services
Founded in 1923, West Pharmaceutical Services, Inc. is a leading high-quality, innovative injectable solutions and services provider. It is a trusted partner to both established and emergent drug producers and contributes to the safe, effective containment and delivery of life-enhancing and life-saving medications to patients. West supports its clients by supplying over 45 billion components and devices each year, with a team of approximately 10000 members spread across 50 facilities globally. Headquartered in Exton, Pennsylvania, the company has been operating for over a century and achieved $2.83 billion in net sales in the fiscal year 2021.
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PHARMA TECH
BioMarin Pharmaceutical Inc. | March 08, 2023
On March 7, 2023, BioMarin Pharmaceutical Inc., a global biotech company focused on improving lives via genetic discovery, announced that the US FDA has accepted its supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for injection to expand the treatment of achondroplasia in children under the age of 5.
Achondroplasia is a common form of disproportionate short stature. The FDA has set an action date of October 21, 2023, for the sNDA. The sNDA is supported by data from a Phase 2 double-blind, randomized, placebo-controlled clinical trial, which showed similar safety and efficacy profiles in children under five years of age compared to those aged five years and older.
The European Medicines Agency (EMA) also validated BioMarin's application for VOXZOGO in January to treat children under the age of 2. If approved, VOXZOGO could be prescribed for over 1,000 additional children from birth for achondroplasia.
VOXZOGO is the first EMA and FDA-approved treatment for achondroplasia with open bone growth plates. The treatment uses a new class of therapy, C-type natriuretic peptide (CNP) analog, which promotes bone growth by acting as a positive regulator of the signaling pathway downstream of the fibroblast growth factor receptor 3 gene (FGFR3).
The drug is approved in the EU, Brazil, and Australia for children aged two years and above with epiphyses (bone growth plates) and in Japan for children from birth who have achondroplasia with open growth plates. BioMarin has enrolled 250 children with achondroplasia in seven clinical studies in eight countries to evaluate the safety and efficacy of VOXZOGO.
About BioMarin Pharmaceutical Inc.
BioMarin is a leading biotechnology firm established in 1997 with a mission to transform people's lives by using genetic discovery. The company creates targeted therapies that address the underlying cause of genetic disorders to improve the quality of life for individuals with rare genetic diseases. It has developed eight first or best-in-class treatments and has a range of product candidates to address various genetic disorders using the same science-based approach. As BioMarin continues to create new and innovative solutions, it has the potential to impact the lives of even more people. The company is committed to prioritizing patients and their needs in its approach to drug development.
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