BUSINESS INSIGHTS, PHARMA TECH
US Pharmacopeia | January 04, 2023
The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience.
The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines.
PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility.
USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience.
Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design.
About The U.S. Pharmacopeia (USP)
USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.
BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
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.