BUSINESS INSIGHTS, PHARMA TECH

Arrowhead Pharmaceuticals Announces $25 Million Milestone Payment from Amgen

Arrowhead and Amgen | December 21, 2022 | Read time : 01:00 min

Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals Inc. announced a $25M milestone payment from Amgen. This milestone was triggered by the first subject enrolled in Amgen’s Phase 3 trial of olpasiran. Arrowhead is further eligible to receive up to an additional $535 million in aggregate development, regulatory, and sales milestone payments from Amgen and Royalty Pharma plc.

We are pleased with the great progress on the clinical development of olpasiran, which was developed using Arrowhead’s proprietary TRiMTM technology. This is an important milestone for the program and for Arrowhead, as this is the second TRiMTM-enabled candidate to enter Phase 3 studies. Importantly, as our pipeline continues to advance expeditiously, we anticipate multiple Arrowhead therapies will also reach Phase 3 trials over the coming year.”

Christopher Anzalone, Ph.D., Arrowhead’s president and CEO

Olpasiran is a small interfering RNA originally developed by Arrowhead using its proprietary Targeted RNAi Molecule, or TRiM, platform and licensed to Amgen in 2016. It is designed to lower levels of lipoprotein(a) (Lp(a)), a genetically determined risk factor for cardiovascular disease. Phase 2 study results from the OCEAN(a)-DOSE study were presented at the American Heart Association Scientific Sessions 2022, where olpasiran demonstrated a significant and sustained reduction in Lp(a) levels over 36 weeks. These data were simultaneously published in the New England Journal of Medicine on November 6, 2022.

About Lp(a)
Lp(a) is genetically determined1-3 and a presumed independent risk factor for cardiovascular disease. Although an agreed upon threshold for elevated Lp(a) is not firmly established, approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).1 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.3

About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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Xtalpi Partners with Singapore's Drug Discovery Platform to Find Better Cancer Treatments

XtalPi Inc. | December 29, 2022

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Impel Pharmaceuticals Prioritizes Trudhesa Commercial Opportunity

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.

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ClinChoice Announces Acquisition of CROMSOURCE

ClinChoice | March 03, 2023

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