Welcome to our dedicated page for Hikma Pharmaceuticals Plc news (Ticker: HKMPY), a resource for investors and traders seeking the latest updates and insights on Hikma Pharmaceuticals Plc stock.
Hikma Pharmaceuticals PLC (HKMPY) generates a steady flow of news related to its role as a multinational pharmaceutical company focused on branded and non-branded generic medicines, sterile injectables and complex technologies such as nasal sprays. The company’s announcements highlight new product launches, regulatory milestones, manufacturing investments and strategic partnerships across North America, the Middle East and North Africa (MENA), and Europe.
Recent news has included US Food and Drug Administration (FDA) approvals and launches of hospital-focused therapies such as TYZAVAN (vancomycin injection, USP), a ready-to-use or ready-to-infuse glycopeptide antibacterial indicated for septicemia, infective endocarditis, skin and skin structure infections, bone infections and lower respiratory tract infections in appropriate adult and pediatric patients. Hikma has also announced the US launch of COMBOGESIC IV (acetaminophen and ibuprofen) injection, an opioid-free intravenous pain management option for adults where IV administration is clinically necessary.
Other updates cover Hikma’s role in addressing the opioid overdose crisis through KLOXXADO (naloxone HCl) nasal spray 8 mg, including a shelf-life extension and an exclusive commercial partnership with Emergent BioSolutions for sales in the US and Canada. Oncology and biosimilar developments feature in news about the FDA approval of STARJEMZA (ustekinumab-hmny) Injection, a biosimilar referencing Stelara, under a commercialization agreement with Bio-Thera Solutions, and the acquisition of an FDA-approved ANDA for trametinib tablets from Novugen.
Investors and healthcare professionals following HKMPY news can also expect coverage of Hikma’s manufacturing and R&D investments in the US, partnerships to expand access to next-generation sequencing cancer diagnostics in MENA, and venture-backed digital health initiatives through Hikma Ventures. This news page provides a centralized view of these developments, helping readers understand how Hikma’s product pipeline, partnerships and regional activities are evolving over time.
Hikma Pharmaceuticals PLC has signed an exclusive license and distribution agreement with AFT Pharmaceuticals for Combogesic® IV, a non-opioid intravenous pain relief medication. This agreement grants Hikma exclusive rights to market and distribute the product in the US, which is designed for post-operative use. AFT plans to file for FDA approval in the upcoming months. Hikma aims to expand its portfolio in non-opioid pain management, enhancing access to high-quality medicines for patients and healthcare providers in the US.
Hikma Pharmaceuticals has resumed the launch of its generic Advair Diskus in the US after receiving FDA approval for an amendment to its Abbreviated New Drug Application. The amendment was necessary to enhance packaging controls in compliance with new industry standards. The generic product is available in 100mcg/50mcg and 250mcg/50mcg doses, aimed at improving access to this critical medication for patients and healthcare providers in the US.
Hikma Pharmaceuticals announced a $4.06 million donation in medicines in 2020, up from $3.1 million in 2019. This includes immediate support to the Lebanese Ministry of Health after the Beirut explosion. The company established new partnerships with Dispensary of Hope, Direct Relief, Americares, Brother's Brother Foundation, and the National Children's Cancer Society. These collaborations aim to expand medicine donations to underprivileged communities affected by the COVID-19 pandemic.
Hikma Pharmaceuticals and Arecor Limited have expanded their collaboration with a new exclusive agreement to co-develop a ready-to-administer injectable medicine in the US. This builds on their previous partnership from January 2020. The product will utilize Arecor's Arestat™ technology and is expected to seek FDA approval via the 505(b)(2) pathway in 2023. The agreement includes royalty-based terms, with Hikma responsible for manufacturing and commercialization, while Arecor will receive upfront and milestone payments.
Hikma Pharmaceuticals announced that the US Court of Appeals upheld a ruling favoring its generic version of Vascepa, indicating no infringement on six Amarin patents. This decision follows FDA approval received in May 2020, setting the stage for the product's launch. Vascepa generated approximately $1.1 billion in US sales over the last year. Hikma aims to provide affordable access to this critical medication, reinforcing its commitment to improving health for patients in the US.
Hikma Pharmaceuticals has announced its participation in a CAD4.0 million Series A financing round for SeamlessMD, increasing the company's total funding to CAD7.4 million. SeamlessMD specializes in digital patient engagement and is utilized by several prominent health systems. Hikma Ventures aims to support the expansion of SeamlessMD's digital health solutions, particularly in the wake of increased demand due to COVID-19. SeamlessMD's platform is backed by significant clinical validation, demonstrating cost reductions and shorter hospital stays.