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Overview of Hikma Pharmaceuticals Plc
Hikma Pharmaceuticals Plc (OTC: HKMPY) is a leading global pharmaceutical company committed to improving healthcare access by delivering high-quality, affordable medicines. Headquartered in the United Kingdom, Hikma operates across North America, the Middle East and North Africa (MENA), and Europe, leveraging its extensive expertise to address critical health challenges. With over 45 years of experience, the company has built a diverse portfolio of branded and non-branded generic medicines, specialty pharmaceuticals, and injectables, serving millions of patients worldwide.
Core Business Areas
Hikma's operations are organized into three primary business segments:
- Generics: This segment focuses on producing affordable, high-quality generic medicines, including treatments for chronic and acute conditions. Notable products include naloxone-based solutions for opioid overdose reversal, such as KLOXXADO®.
- Injectables: Hikma is a major player in the sterile injectables market, manufacturing critical care medications for hospitals, including antibiotics, oncology drugs, and anesthetics.
- Branded Pharmaceuticals: Primarily targeting the MENA region, this segment offers a range of branded medicines tailored to local healthcare needs, ensuring accessibility and affordability.
Competitive Positioning
Hikma operates in a competitive pharmaceutical landscape, facing rivals such as Teva Pharmaceuticals, Sandoz (a Novartis division), and Viatris. However, it distinguishes itself through its strong presence in the MENA region, where it is a market leader, and its ability to manufacture complex products like naloxone nasal sprays and sterile injectables. Its vertically integrated supply chain and focus on operational efficiency further enhance its competitive edge.
Industry Significance
Hikma plays a crucial role in addressing global healthcare challenges. Its naloxone-based products, such as KLOXXADO®, are vital in combating the opioid overdose epidemic, particularly in the United States. The company's commitment to innovation and strategic partnerships, such as its collaboration with Emergent BioSolutions, underscores its dedication to expanding access to life-saving treatments. Additionally, Hikma's strong regulatory compliance and manufacturing capabilities position it as a trusted partner for governments, healthcare providers, and patients worldwide.
Operational Excellence
Hikma's global footprint includes state-of-the-art manufacturing facilities in North America, Europe, and the MENA region. These facilities adhere to stringent regulatory standards, ensuring the production of safe and effective medicines. The company's vertically integrated model allows it to control every aspect of the supply chain, from raw material sourcing to final product distribution, ensuring quality and cost efficiency.
Commitment to Healthcare
Beyond its commercial operations, Hikma actively collaborates with governments, non-profits, and community organizations to improve healthcare outcomes. Through initiatives like the Hikma Community Health program, the company works to expand access to essential medicines, particularly in underserved regions.
Conclusion
Hikma Pharmaceuticals Plc is a cornerstone of the global pharmaceutical industry, renowned for its high-quality medicines and commitment to healthcare accessibility. By balancing innovation with operational efficiency, the company continues to meet the evolving needs of patients and healthcare providers, solidifying its position as a trusted partner in the fight against global health challenges.
Hikma Pharmaceuticals PLC has announced an exclusive US license agreement with FAES Farma S.A. to commercialize Bilastine tablets, an antihistamine for allergic rhinitis and urticaria. Hikma will obtain FDA regulatory approval and handle commercialization upon approval, providing upfront and milestone payments along with royalties to FAES. This partnership builds on an existing collaboration in the Middle East and North Africa, where Hikma is the exclusive licensee for Bilastine in 15 countries, aiming to enhance its presence in the US allergy market.
Bio-Thera Solutions and Hikma Pharmaceuticals have entered a commercialization agreement for BAT2206, a proposed biosimilar to Stelara in the US. Bio-Thera will handle development and manufacturing, while Hikma gains exclusive rights to commercialization. The deal includes a $20 million upfront payment and potential milestones of up to $130 million. BAT2206 is currently in a Phase III clinical trial, focusing on treating autoimmune diseases. This partnership allows Hikma to expand into the biosimilar market in the US, leveraging Bio-Thera's strong technical capabilities.
Hikma Pharmaceuticals PLC announced the US launch of KLOXXADO™ (naloxone HCl) nasal spray 8mg, approved by the FDA in April 2021 for emergency opioid overdose treatment. KLOXXADO™ delivers twice the naloxone per spray compared to Narcan® 4mg, addressing the rising opioid overdose crisis, which has surged nearly 30% due to the COVID-19 pandemic. With approximately 93,000 overdose deaths last year, KLOXXADO™ aims to enhance emergency response efforts. Hikma aims for broad accessibility to this critical treatment tool.
On April 30, 2021, Hikma Pharmaceuticals announced FDA approval for KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg. This new treatment is designed for emergency use against opioid overdoses, featuring double the naloxone of Narcan® (4mg). The rising opioid crisis necessitates innovative solutions, as overdose incidents surged, especially during the COVID-19 pandemic. Community surveys indicate a significant demand for higher naloxone doses, with 34% of Narcan reversals utilizing multiple doses. KLOXXADOTM is expected to hit the market in late 2021.
Melinta Therapeutics and Hikma Pharmaceuticals have signed an exclusive licensing agreement for Vabomere® and Orbactiv® in the MENA region. Vabomere® is for complicated urinary tract infections, while Orbactiv® is used for acute bacterial skin infections. Hikma will manage the registration and commercialization across 18 markets, expanding their existing partnership. This agreement enhances Hikma's hospital anti-infective portfolio, providing more treatment options for healthcare professionals.
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.
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