Mylan NV

LONDON, April 17, 2025 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, today announces it has acquired the FDA-approved Abbreviated New Drug Application (ANDA) for trametinib tablets from Novugen. Hikma also announces it has entered into a commercial agreement with Novugen where Hikma will be responsible for all US sales and marketing of this product, which Novugen will manufacture and supply to Hikma. Trametinib is an orally administered kinase inhibitor medication used to treat certain cancers. When launched, Hikma will have 180 days of US generic market sales exclusivity for this product. "Hikma's Generics business is accelerating its efforts to expand its pipeline by developing and acquiring important medicines in growing therapeutic areas most needed by US patients and healthcare providers," said Dr. Hafrun Fridriksdottir, president of Hikma Generics. "Our acquisition of this cancer treatment strengthens our broad US pipeline of essential medicines and will further our ability to put better health within reach every day for millions of Americans." "As cancer treatment remains a critical healthcare challenge, our partnership with Hikma reflects a shared commitment to ensuring the availability of effective, cost-efficient, and high-quality oncology treatments in the US," said Rahil Mahmood, Chief Executive Officer of Novugen. "This exclusive first-to-file molecule is a testament to Novugen's innovation, regulatory excellence, and dedication to expanding access to high-barrier, niche products with limited alternatives—ensuring life-changing treatments reach more US patients. With Hikma's strong market presence and commercial capabilities, this collaboration represents an excellent strategic synergy." According to IQVIA, US sales of trametinib, sold under the brand name Mekinist® (trametinib) Tablets, were approximately $436 million in the 12 months ending December 2024. Hikma's Generics business supplies a range of oral, inhalation and other generic and specialty products in the North American market, and has expertise in complex technologies, such as nasal sprays, where we are the largest supplier by volume in the US1. 1IQVIA MAT December 2024, volumes by eaches Mekinist® is a registered trademark of Novartis Pharma AG This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States. Enquiries Hikma Pharmaceuticals PLC About Hikma (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch) Hikma helps put better health within reach every day for millions of people around the world. For more than 45 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 9,500 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: About Novugen Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of expertise in the healthcare industry. The company has successfully ventured into strategic healthcare businesses and developed world-class healthcare facilities worldwide. Driven by a passion for science and a bold global strategy, Novugen specializes in niche, difficult-to-formulate generics across various therapeutic areas, including general and oncology pharmaceuticals, while adhering to stringent global quality standards. With vertical integration from research and development to manufacturing in Malaysia, Novugen maintains full control over its supply chain. Its state-of-the-art manufacturing facilities, comply with USFDA, EMA, PIC/S, and WHO regulatory requirements. Novugen is also the first in Malaysia and the only in Southeast Asia with USFDA-approved pharmaceutical manufacturing facilities dedicated to oral solid dosage forms for general medicines and highly potent oncology drugs. This accreditation positions Novugen as the first in Malaysia to manufacture and export high-quality medicines for the U.S. market. Novugen is committed to expanding early access to complex pharmaceutical products that often lack robust generic alternatives. Through continuous innovation, we strive to lead the way in delivering high-quality, technology-driven pharmaceuticals globally. SOURCE Hikma Pharmaceuticals USA Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MAHWAH, N.J., April 16, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce the upcoming launch[1] of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg. Glenmark's Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is bioequivalent and therapeutically equivalent to the reference listed drug, Adderall®[2] Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women's Health, Inc. and the company will begin distribution in May 2025. According to IQVIA™ sales data for the 12-month period ending February 2025, the Adderall® Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market[3] achieved annual sales of approximately $421.7 million*. Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is a highly prescribed medication in the United States. Glenmark is very pleased to be able to help alleviate the shortage this country has been facing with this upcoming launch." About Glenmark Pharmaceuticals Ltd. Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of cardio-metabolic, respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions. For more information, visit . You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma). References: 1. Glenmark's Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is only approved for the indication(s) listed in Glenmark's approved label. 2. All brand names and trademarks are the property of their respective owners. 3. Market includes brand and all available therapeutic equivalents. Note: IQVIA data obtained by Glenmark is only available for all approved RLD indications. Glenmark's product is only approved for the indications listed in Glenmark's approved label and is not marketed for all RLD indications. *IQVIA™ National Sales Perspectives: Retail & Non-Retail, February 2025. Logo: For more information, please contact: Udaykumar Murthy [email protected] +91 9960377617 SOURCE Glenmark Pharmaceuticals Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Findings from a Section 232 investigation could offer President Donald Trump justification to impose tariffs on pharmaceuticals over a long-term horizon. An investigation into the national security implications of pharma imports has been underway for two weeks, the Trump administration disclosed Monday.The Department of Commerce initiated what’s known as a Section 232 investigation targeting pharmaceuticals and related products April 1, according to a Federal Register filing (PDF). A separate probe into semiconductors was launched at the same time.A Section 232 investigation, enabled by the Trade Expansion Act of 1962, looks into the effects of certain imports on U.S. national security. If a threat is identified, the president can then impose trade restrictions, such as tariffs, to correct the situation or take other non-trade-related actions as deemed necessary, according to an explanation from the Commerce Department.The new probe targets “both finished generic and non-generic drug products, medical countermeasures, critical inputs such as active pharmaceutical ingredients and key starting materials, and derivative products of those items,” according to the filing.The Commerce Department will examine topics such as the demand for pharmaceuticals in the U.S., the role of foreign supply chains, the concentration of drug imports from a small number of producers and the potential for foreign countries to weaponize their control over pharma supplies.After the probe’s scheduled official publication April 16, public comments on the issue will be open for 21 days. An investigation report to President Donald Trump is due in 270 days.Still, the Trump administration may aim to dramatically beat that deadline. Over the weekend, Commerce Secretary Howard Lutnick said tariffs on the pharma and semiconductor industries will come “in the next month or two.”Sectoral tariffs on pharmaceuticals, semiconductors and autos are “not available for negotiation” with other countries, Lutnick said Sunday on ABC News.“They are just going to be part of making sure we reshore the core national security items that need to be made in this country,” he said. An ongoing 232 investigation doesn’t prevent the Trump administration from imposing tariffs on pharmaceuticals on an emergency basis. Instead, a conclusive Section 232 investigation provides the president justification to add tariffs over longer timelines and to potentially take further actions as he tries to onshore domestic manufacturing. Trump has used findings from previous Section 232 investigations to justify his recent 25% tariffs on steel, aluminum and the auto industry.In recent months, Trump has threatened 25% or higher tariffs on pharmaceuticals as well. Pharma companies are lobbying the White House for a better deal, including a phase-in approach with a gradual implementation. But, based on the president’s recent comments, industry watchers fear that the tax rate may reach even higher, Jefferies analysts said in a Monday note.“When the pharmaceutical companies started to go to Ireland, I would have said, 'that’s OK, if you want to go to Ireland. I think that’s great.' But if you want to sell anything into the United States, I’m going to put a 200% tariff on you so you’re never going to be able to sell anything into the United States,” Trump said during a March meeting with Ireland’s leader, Micheál Martin, at the White House.A 25% tariff would be painful to the pharma industry’s profits, Jefferies analysts concluded. But, overall, the impact is “surmountable for most innovative companies given reasonable gross margins and global manufacturing footprints,” William Blair analysts said in a Monday note.As the William Blair team sees it, the greatest risk falls on generic drug supplies, which make up 90% of prescriptions in the U.S.In a statement, the CEO of the Association for Accessible Medicines (AAM), John Murphy, said tariffs will “exacerbate current shortages that hinder patient access” if they are are not joined by “substantive regulatory and reimbursement changes.”The AAM urges the administration “to work with us on a suite of reforms that prioritize patients, national security, and ultimately will lead to more resilient and reliable access here in the U.S.,” he added. Generics account for 1.2% of total U.S. healthcare costs despite representing 90% of all prescriptions in the country. Manufacturers of these drugs are already operating under “razor-thin margins” and can’t tolerate large tariffs, Kathleen Jaeger, U.S. spokesperson for the Indian Pharmaceutical Alliance, said in a statement.“Adding tariffs on America’s affordable medicine partners in India would make it even worse—for patients, the healthcare system and for America’s national security,” she said.