Ampicillin

New Delhi: Experts in the pharma industry have raised their concerns over the government's move to notify a minimum import price (MIP) for certain key pharmaceutical inputs to combat aggressive undercutting and dumping from Chinese manufacturers . Experts said a chain-wide MIP on Pen-G, 6-APA and amoxicillin would raise costs across essential medicines, disrupt government tenders and concentrate supply-without clear evidence of dumping or import-led injury. "The country must protect and build its local infrastructure. However, the approach must be measured, so as to not destroy an entire network of MSMEs and significantly increase the cost for life saving antibiotics for the nation's poorest and most vulnerable," said an expert on the condition of anonymity. The government has proposed to impose MIP on Penicillin-G (Pen-G), with possible extension to 6-aminopenicillanic acid (6-APA) and amoxicillin. Penicillin-G is not a standalone product. It is the upstream 'mother molecule' for a wide range of essential antibiotics, feeding into intermediates such as 6-APA, GCLE and 7-ADCA, and into high-volume formulations including amoxicillin, ampicillin, multiple cephalosporins and widely used combinations. "Because of this structure, an MIP at Pen-G-or worse, across Pen-G, 6-APA, amoxicillin-acts as a cost floor across dozens of price-controlled formulations used extensively in primary care and public procurement," he said. The National Pharmaceutical Pricing Authority had earlier in 2019 and 2024 invoked Paragraph 19 of DPCO-to raise ceiling prices for penicillin-family antibiotics after manufacturers reported non-viable economics. "This confirms that essential anti-infectives operate on extremely thin margins even without trade restrictions," another expert said. An analysis of tenders shows that the state government procurement for amoxicillin and key combinations totals about ₹1,012.6 crore at current prices. "If API costs double to the MIP levels under discussion, suppliers face losses of approximately ₹350 crore, rendering multiple contracts non-viable. Past tender data already shows that similar input-cost shocks led to sharp price increases, bidder exits and re-tendering across states," said another expert. He said that data suggested that Pen-G prices have reverted to pre-Covid levels of about $13.5 per kg. Over the last twelve months, India imported approximately 8000 tonnes of Pen-G. In the same period, the country imported around 11,250 tonnes of 6-APA, compared with reported domestic capacity of roughly 3,600 tonnes per annum. "Even after adjusting for exports, domestic requirements materially exceed available capacity. Notably, there has been no meaningful open-market domestic supply of Pen-G or 6-APA in the current financial year, and significant volumes have been transacted with related parties," he added. In 2020, the government launched a production-linked incentive (PLI) scheme to draw investments in the manufacturing of critical raw material from domestic players, as part of efforts to reduce the country's dependence on China and bring pricing stability. However, the Chinese started cutting the prices even further, putting at risk huge investments made by the PLI beneficiaries. "Layering a high MIP on top of PLI risks converting it into permanent protection, weakening efficiency incentives and transferring costs to patients and public budgets. Where a PLI beneficiary shows low-capacity utilisation, high fixed costs and reliance on inter-company financing, the corrective tools should be operational restructuring and scale-up-not a nationwide price floor on essential inputs". By Teena Thacker ,

NEW YORK, June 11, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced seven presentations, including two featured oral plenary sessions, on AXS-12 and solriamfetol, at SLEEP 2025, the 39th annual meeting of the Associated Professional Sleep Societies (APSS), being held June 8-11, 2025, in Seattle, Washington. Details for the presentations are as follows: AXS-12 Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 405 Title: Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Oral Presentation Date and Time: Wednesday, June 11, 3:45 - 4 p.m. PT Oral Session: O-24 Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 390 Title: Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the CRESCENDO Survey Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY Oral Presentation Date and Time: Wednesday, June 11, 4 - 4:15 p.m. PT Oral Session: O-24 Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-51 Poster Number: 391 Solriamfetol Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-50 Poster Number: 366 Title: Real-World Use of Solriamfetol for Excessive Daytime Sleepiness in Patients with Obstructive Sleep Apnea in the US Lead Author: Yang Zhao, PhD, Axsome Therapeutics Poster Presentation Date and Time: Wednesday, June 11, 10 - 11:45 a.m. PT Poster Session: P-50 Poster Number: 369 About AXS-12 AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for the treatment of narcolepsy. AXS-12 is thought to modulate noradrenergic activity to promote maintain tone during wakefulness, and noradrenergic and cortical dopamine signaling to promote wakefulness and enhance cognition. AXS-12 has been granted U.S. Food and Drug Administration (FDA) Orphan Drug Designation for the treatment of narcolepsy. AXS-12 is covered by issued patents providing protection to at least 2039. AXS-12 is an investigational drug product not approved by the FDA. About Solriamfetol Solriamfetol is a dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist, and 5-HT1A agonist being developed for the treatment of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), binge eating disorder (BED), and excessive sleepiness associated with shift work disorder (SWD). About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI®, AUVELITY®, and SYMBRAVO® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com Source: Axsome Therapeutics, Inc.