PharmTech AI Pulse Check panelists explain why attribution, audit trails, and sign-off matter more than AI watermark detection for GxP quality teams.
News|Articles|February 28, 2020
Hikma, Glenmark Pharmaceuticals Enter Exclusive Licensing Agreement
Author(s)Pharmaceutical Technology Editors
Generic pharmaceutical company, Hikma Pharmaceuticals, and the Swiss subsidiary of Glenmark Pharmaceuticals, Glenmark Specialty, have signed an exclusive license agreement for the commercialization of Ryaltris in the United States.
Advertisement
Generic pharmaceutical company, Hikma Pharmaceuticals, and the Swiss subsidiary of Glenmark Pharmaceuticals, Glenmark Specialty, have signed an exclusive license agreement for the commercialization of Ryaltris in the United States.
Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) is an investigational fixed-dose combination nasal spray that has been designed for the treatment of seasonal allergic rhinitis (SAR). Under the terms of the exclusive agreement, Glenmark will take responsibility for the development and FDA regulatory approval of Ryaltris, and Hikma will be responsible for the commercialization of the nasal spray in the US post-approval.
“We are pleased to form this partnership with Glenmark, which builds on our market-leading position in nasal allergy sprays and advances our objective of growing our specialty business in the US,” said Brian Hoffmann, president of Hikma Generics, in a Feb. 27, 2020 press release. “Hikma is the largest supplier of generic nasal sprays in the US. Adding Ryaltris is a significant step forward in expanding our US nasal spray leadership into branded medicines. Importantly, it will allow us to leverage our strong, existing specialty salesforce already calling on doctors with our specialty portfolio, and to potentially leverage our nasal spray manufacturing capabilities in Columbus, Ohio. We look forward to bringing this important new treatment option to millions of US patients.”
“We are happy to partner with Hikma in the US as Ryaltris is a perfect strategic fit in their near-term plan to build a branded nasal spray portfolio. This partnership gives us an opportunity to tap into the largest pharmaceutical market in the world. This step is aligned with our vision to make Ryaltris the first global brand of Glenmark by launching it in several markets across the globe,” added Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, in the press release.
Source:
Advertisement
Related to this article
Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Advertisement
Advertisement