VIEWS AND ANALYSIS
Businesswire | May 05, 2023
Harrow a leading U.S. eyecare pharmaceutical company, announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for ILEVRO® (nepafenac ophthalmic suspension) 0.3%, NEVANAC® (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%. These three FDA-approved ophthalmic medicines, which are now commercially available under the Harrow umbrella, were among the five products that Harrow purchased in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process. Harrow expects to complete the transfer of the NDAs for the two remaining products, VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% and TRIESENCE® 40 mg/ml, by year-end.
“We are delighted to have completed the NDA transfer process for ILEVRO, NEVANAC, and MAXIDEX earlier than our originally estimated six-month period,” said Mark L. Baum, Chief Executive Officer of Harrow. “We can now implement our market access, marketing, inventory management, and national sales detailing strategies for each of these three products, and we expect to extend those efforts when the NDAs for the remaining two products, VIGAMOX and TRIESENCE, are transferred later this year.
“Our market research has shown that the market need for all five of these products continues to increase with U.S. demographic growth and that there are few, if any, new competitive threats, particularly in the NSAID market. These products are used during procedures and within markets in which Harrow already has a strong foothold, and we look forward to making these well-known and valuable ophthalmic medicines available to the eyecare professionals that we serve nationwide as we continue to execute our branded ophthalmic pharmaceuticals market strategy.”
Product orders for ILEVRO, NEVANAC, and MAXIDEX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
Harrow is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | April 10, 2023
Enanta Pharmaceuticals, Inc. a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for EDP-323, Enanta’s L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV).
"Receiving Fast Track designation from the FDA underscores EDP-323’s potential as a once-daily, oral therapeutic for the treatment of this deadly virus and reflects the pressing need for a highly potent, direct antiviral to treat RSV, particularly for high-risk populations,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “Given that EDP-323 has shown sub-nanomolar potency against several RSV-A and RSV-B strains in vitro and is not expected to have cross-resistance to other classes of inhibitors, we believe it could be used as a monotherapy or in combination with other RSV mechanisms to potentially broaden the addressable RSV patient populations or the treatment window. We believe this designation will be a valuable component of our clinical and regulatory strategy as we progress EDP-323 in development.”
The Fast Track program is designed to accelerate the development and review of products such as EDP-323, which are intended to treat serious diseases and for which there is an unmet medical need. Fast Track designation enables more frequent communication with the FDA and eligibility for FDA programs such as priority review and rolling review, if relevant criteria are met.
EDP-323 is being evaluated in a Phase 1 double-blind, placebo-controlled study designed to assess its safety, tolerability, and pharmacokinetics (PK). Enanta plans to present new preclinical PK data at the European Congress of Clinical Microbiology and Infectious Diseases in April and expects to report topline data from the Phase 1 study this quarter.
EDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily, oral dosing in humans. These data indicate that EDP-323 is a potent inhibitor of RSV replication and has the potential to be a best-in-class, once daily, oral antiviral treatment for RSV.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 and hepatitis B virus. Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus.
BUSINESS INSIGHTS, PHARMACY MARKET
Shields Health Solutions | March 17, 2023
Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced that it has partnered with Nemours Children’s Health, Delaware, to collaborate in developing a specialty pharmacy program that will provide patients with complex, chronic conditions access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.
Shields will provide Nemours Children’s Health new support services through its partnership to meet the unique needs of patients with complex chronic conditions. Now, specialty pharmacy liaisons will work with patients on-site in clinics, offices, and pharmacies, among other locations, guiding patients who fill their prescriptions with Nemours Children’s. These liaisons work with teams of experts to assist patients and families with a multitude of tasks, including health insurance prior authorizations or securing financial assistance to help overcome one of the significant barriers to care.
These expanded patient support services, combined with access to recently approved and newly available drugs, will give Nemours’ patients greater availability for onsite treatment options. Shields currently partners with nearly 80 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery, often within two days, and improved medication adherence greater than 90 percent on average.
Nemours Children’s Health is one of the largest multistate pediatric health systems in the country and provides award-winning care to more than 38,000 specialty patients. The complete health system includes two free-standing children's hospitals and a network of more than 70 primary, specialty and urgent care practices. US News & World Report ranked Nemours Children’s Hospital, Delaware among the 10 best children’s hospitals in the Mid-Atlantic region and recognized Nemours Children’s Hospital, Florida for excellence in orthopedics and endocrinology.
“Nemours’ commitment to outstanding care for children with chronic diseases aligns with Shields core mission,” said Stephen Davis, Senior Director of Health System Strategy. “Specialty pharmacy services provide challenges for all patient populations, but pediatric patients have unique needs that require tremendous support. We are proud to provide that support for patients at Nemours Children’s Health and help them achieve the best possible health outcomes.”
“As Nemours Children’s Health works toward creating the healthiest generations of children, it is imperative to address social determinants of health including access to medications that are affordable, said,” said Robert J. Mullen, BS, PharmD, RPh, Vice President, Patient Operations, Delaware Valley, at Nemours Children’s Health, Delaware. “Specialty pharmacy services can cause many challenges for the complex patients that Nemours Children’s cares for on a daily basis. We are proud to be partnering with Shields Health Solutions to help ease the burden for families acquiring prescription medication for their children and in turn achieve better health outcomes.”
About Shields Health Solutions
Shields Health Solutions (Shields) is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.