RESEARCH, PHARMACY MARKET
Impel Pharmaceuticals | February 23, 2023
On February 22, 2023, Impel Pharmaceuticals, a pharmaceutical firm that develops innovative treatments for diseases with high unmet medical needs, announced that it will execute an operational streamlining plan to reduce employee and non-employee expenses, primarily affecting the research and development division. The company intends to divert resources to benefit from the successful response of payors and prescribers to Trudhesa® (dihydroergotamine mesylate) nasal spray (0.725 mg per spray).
Impel Pharmaceuticals will stop research and development activities on INP105, a drug to treat agitation and aggression in autism spectrum disorder. The reduction in expenses is expected to come from lower non-employee-related general and administrative and research and development expenses, as well as a reduction of 16 percent in headcount.
Additionally, the company announced that its Chief Medical Officer, Stephen Shrewsbury, M.D., will leave the company on March 31, 2023.
The company projects that these measures, along with others, will provide sufficient capital to fund operations through Q3 2023, allowing it to focus on maximizing the commercial opportunity and positive momentum of Trudhesa® in the huge and rapidly expanding acute migraine market.
Trudhesa® has experienced a strong launch trajectory, with 58,424 prescriptions at the end of 2022, accounting for 4.3% of branded acute migraine prescriptions (nTRx) among prescribers after a full-year launch. Impel expanded its sales force by 50%, from 60 to 90 sales professionals, in July 2022 to capitalize on this positive momentum, resulting in a 58% increase in new quarterly prescriptions from Q2 to Q4 2022. Reimbursement of all shipments finished the year at over 60%, and refill rates remained high, with an average of 63% at the end of 2022.
The company plans to increase its efforts to commercialize Trudhesa® while also exploring strategic and financing initiatives and opportunities to fully leverage the potential of its proprietary Precision Olfactory Delivery (POD®) technology and expertise with small and large molecules in various disease areas.
About Impel Pharmaceuticals
Impel Pharmaceuticals is a commercial-stage pharmaceutical firm that focuses on developing and providing treatments for patients suffering from diseases with high unmet needs. The company employs a novel approach to drug delivery by utilizing its proprietary Precision Olfactory Delivery (POD®) technology in conjunction with established therapeutics to develop and offer treatments. In September 2021, it received approval from the U.S. FDA for its first product, Trudhesa® nasal spray, which is used to treat acute migraine with or without aura in adults. Along with Trudhesa, the company continues to address patient needs through licensing and partnerships.
BUSINESS INSIGHTS, PHARMA TECH
Sumitovant Biopharma, Inc. | January 20, 2023
On January 19, 2023, Neochromosome, Inc., announced a partnership with Sumitovant Biopharma, Inc., a technology-driven biopharmaceutical firm expediting the discovery and commercialization of novel therapeutics.
This collaboration blends Neochromosome's neoYeast™ platform with Sumitovant's DrugOME™ computational ecosystem to identify new proteins that would benefit from non-canonical amino acid chemistries that are unavailable in nature.
As part of the collaboration, Sumitovant used a combination of natural language processing (NLP), artificial intelligence (AI), machine learning (ML), and computational algorithms to identify opportunities for Neochromosome to enhance the discovery and production of proteins limited by evolution and traditional fabrication processes. For example, non-canonical amino acid inclusion allows new-to-nature proteins with improved structures and functions but often requires chemical synthesis, which is expensive, size- and complexity-restricted, and environmentally damaging.
neoYeast™, based on Neochromosome's world-leading genome-scale cell engineering technology stack, enables the highly efficient and environmentally friendly integration of non-canonical amino acids into proteins, with both discovery and manufacturing possible in a single genome-engineered yeast strain. Sumitovant used DrugOME to explore libraries of traditional and non-traditional sources of data to recommend targeted protein development candidates for neoYeast.
Co-Founder and CEO of Neochromosome, Leslie Mitchell, commented, "The combination of Sumitovant's technology platform and life-sciences expertise with Neochromosome's ability to both discover and biomanufacture novel proteins in a single system enables Neochromosome to accelerate and streamline the delivery of better therapies for patients." She added, "We are excited to partner with the world-class team at Sumitovant to identify opportunities to create better versions of existing drugs, along with new-to-nature compounds, and to manufacture them efficiently at scale."
(Source – Business Wire)
Sumitovant Biopharma, Inc.
The firm has supported the development of multiple FDA-approved products and a strong pipeline of early-through late-stage investigational assets addressing unmet needs in pediatrics, oncology, urology, women's health, specialty respiratory, and infectious diseases through its proprietary computing and data platforms, scientific expertise, and diverse company portfolio. It is a wholly-owned subsidiary of Sumitomo Pharma.
BUSINESS INSIGHTS, PHARMACY MARKET
Cellworks Group | January 13, 2023
Cellworks Group Inc., a pioneer in personalized therapy biosimulation, announced the introduction of its precision drug development business units.
These units will use predictive biosimulation to shorten drug development time-to-market and revive previously researched but disapproved pharmaceutical assets.
The two new business units will use Cellworks' computational biology model (CBM) and biosimulation platform to predict responses to pharmaceutical interventions in silico, streamlining the clinical trial by identifying suitable patients more quickly, thereby reducing the time and cost of developing successful pharmaceutical agents.
Cellworks precision drug development: Pre-clinical stage
Companion molecule development: The Cellworks platform can augment a drug's usability by finding companion molecules that improve performance when combined with the investigational agent.
Biomarker development: Cellworks utilizes cell lines and historical patient data to uncover novel biomarkers for investigational agents. This may increase drug success rates by proactively identifying individuals who will respond to an agent.
Indication expansion: By utilizing the Cellworks patient database of 100,000+ omics patient profiles and 1,800 oncology cell lines to examine the agent's effectiveness in different indications, the Cellworks platform can identify additional indications where an experimental treatment may be successful.
Cellworks precision drug development: Clinical stage
Drug revival and repurposing: The platform seeks to anticipate whether certain drugs cause a response, which may be used to identify whether shelved assets can be resurrected via suitable patient selection or the discovery of non-obvious reasons.
Clinical trial biosimulation: Through biosimulation clinical trials, the Cellworks platform may anticipate humans' clinical response to pharmaceutical agents in weeks, yielding critical insight years ahead of a traditional clinical practice.
Cellworks Platform and Computational Biology Model (CBM)
The Cellworks platform biosimulates the impact of specific pharmacological molecules on a given patient or class of patients using the patient's genetic profile. To generate a customized or cohort-specific disease model, multi-omic data from a cohort or patient is fed into the Cellworks computational biology model (CBM).
About Cellworks Group
Cellworks is one of the leaders in precision medicine. The organization assists physicians and payers in navigating the most efficacious, cost-effective therapies for patients. Its primary therapeutic areas are oncology, immunology, dermatology, and infectious diseases. Its one-of-a-kind biosimulation platform is a unified representation of biological information gathered from disparate databases and used to find cures. The company has the world's strongest trans-disciplinary team of molecular biologists, cellular pathway modelers, and internet software technologists working towards a common goal, i.e., taking on significant diseases to improve patients' lives.