BUSINESS INSIGHTS, PHARMACY MARKET
Visiox Pharma LLC | December 09, 2022
Visiox Pharma, LLC., a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic drugs to address highly prevalent diseases in need of new treatment options, today announced that it has received notification from the U.S. Food and Drug Administration that the agency has completed its filing review and accepted for filing the New Drug Application for PDP-716 for the treatment of glaucoma.
The FDA has assigned a Prescription Drug User Fee Act target action date of August 4, 2023.
"The NDA acceptance for filing is an exciting milestone and an important next step towards the planned approval and commercial launch of PDP-716. If approved, Visiox has the potential to bring the first once-daily brimonidine to market for the treatment of glaucoma to patients and eye care professionals."
Ryan Bleeks, Chief Executive Officer
Visiox is a privately funded biopharmaceutical company focused on the development and commercialization of ophthalmic therapeutic candidates to address highly prevalent diseases in need of new treatment options. Each day is an opportunity for us to disrupt and revolutionize the current market to maximize patient and physician satisfaction. As an agile business partner, we will achieve this through a high level of collaboration with all eye care professionals.
Visiox plans to soon submit a second New Drug Application for SDN-037 to the U.S. FDA to address an unmet need for cataract surgery. SDN-037 is a twice daily topical difluprednate corticosteroid utilizing patented TJMTM proprietary formulation. The novel technology provides powerful post-surgical control of inflammation in a clear solution enabling convenient dosing with a proven active ingredient. Cataract extraction is the most frequently performed eye surgery in the U.S. It accounts for 70% of all ocular surgeries. 50 million people are projected to have cataracts in the U.S. by 20501.
PDP-716, SDN-037, and TearActTM delivery technology were licensed by Visiox from Sun Pharma Advanced Research Company Ltd.
BUSINESS INSIGHTS, PHARMA TECH
Arrowhead and Amgen | December 21, 2022
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.
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.
Citius Pharmaceuticals, Inc. | November 22, 2022
Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority. Citius expects to receive the funds by late 2022 or early 2023.
"This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application for I/ONTAK,"
Jaime Bartushak, Chief Financial Officer of Citius
About the Technology Business Tax Certificate Transfer Program
The NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash. The NJEDA and the New Jersey Department of Treasury's Division of Taxation jointly administer the NOL Program, which has routinely been hailed as a "lifeline" by entrepreneurs seeking capital for their companies. The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million. Thirty-six percent of program applicants are private businesses, while the remaining 64 percent are publicly traded companies. To date, more than $1.17 billion in funding has been distributed to over 570 technology and life sciences companies since the program's inception in the late 1990s.
About the New Jersey Economic Development Authority
The New Jersey Economic Development Authority serves as the State's principal agency for driving economic growth. The NJEDA is committed to making New Jersey a national model for inclusive and sustainable economic development by focusing on key strategies to help build strong and dynamic communities, create good jobs for New Jersey residents, and provide pathways to a stronger and fairer economy. Through partnerships with a diverse range of stakeholders, the NJEDA creates and implements initiatives to enhance the economic vitality and quality of life in the State and strengthen New Jersey's long-term economic competitiveness.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma for which a BLA has been submitted. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.