Pickings by Pharma Veterans Newsletter #6 – September 29, 2024

This newsletter is the offering from Asrar Qureshi, Founder of Pharma Veterans. It will bring to you a selection of Pharma Industry news and developments from Pakistan, region, and the world. It will be published bi-weekly on alternate Sundays. For queries and sending information, please send email to [email protected].

PAKISTAN

·????? 7th Pharma Summit was held at Islamabad on September 25. Industry leaders, government officials, and international experts gathered to discuss the future of Pakistan’s pharmaceutical sector.

o?? Chairman PPMA, Mian Khalid Misbah lamented on low export volume of $300 million only. He announced a target of $3 billion within 5 years. [Comment -Commendable goal, but it is not the first time such slogans have been raised. While these make good rhetoric, these are not based on any working and are not achieved.]

o?? Dr. Kaiser Waheed Sheikh, Conference Chairman, underscored the need for digital transformation to remain competitive particularly against regional rivals, India and BD. He also criticized the oversight of controlled substances by narcotics office who lack medical expertise.

o?? Top 50 exporting companies were given Pharma Export Summit Awards 2024.

·????? Federal Commerce Minister, Jam Kamal, announced plans to reactivate 16 sectoral councils to bolster trade and investment. This initiative aims to develop comprehensive plans and policies for industrial growth and trade promotion in the country. Speaking at the 7th Pharma Export Summit and Award 2024, Jam said that recommendations from these councils would be submitted to the export development board, chaired by the prime minister, for prompt implementation. Each council will have its own secretariat to identify strategies and enhance trade and industrial activities, benefiting the local pharmaceutical sector. [Comment – by the time the sectoral councils will present their recommendation, the government will be completing its term]

·????? Excerpts from the minutes of 339th meeting

o?? From January to December 2023, 6,202 new registrations were issued.

o?? From January to July 2024, 2,657 new registrations were issued.

o?? Renewals and post-registration variations are not included in above numbers.

[Comment – Registration Board should only handle new molecules applications. Generics, renewals, PRV cases should be handled by a permanent team, working full time at DRAP]

India

·????? The Central Drugs Standards Control Organization (CDSCO) has released a list of 59 drug samples declared as ‘Not of Standard Quality’ during the month of August, with samples of drugs labelled as manufactured by some of the major companies.

·????? Alembic Pharmaceuticals receives USFDA approval for paliperidone extended-release tablets, and albendazole tablets USP, 200mg.

·????? Lupin gets USFDA approval for bumetanide injection, USP. Lupin also gets Health Canada approval for biosimilar pegfilgrastim.

·????? Strides Pharma Global secures USFDA approval for fluoxetine tablets 60mg, and for theophylline extended-release tablets 300mg and 450mg.

·????? Zydus gains USFDA approval for amantadine extended-release capsules 68.5mg, and for scopolamine transdermal system.

·????? Granules India receives USFDA approval in ANDA category for glycopyrrolate oral solution.

·????? Granules India scolded over truckloads of torn manufacturing documents after recent USFDA inspection. Earlier this month, the company was slapped with a Form 483 from the FDA, following the inspection of its Telangana facility; the inspection ran from Aug 26 to Sep 6. The FDA noted that on the first day of its inspection, investigators witnessed three trucks “full of scrap materials” attempting to depart Granules’ plant. Upon digging into these scraps, the FDA found remnants of signed and dated manufacturing documents such as analytical balance printouts, handwritten worksheets and a “large number” of “uncontrolled papers” that had been “torn into pieces and crumpled.” When the FDA was doing a walk-through of Granules’ quality control laboratory, inspectors noticed cleaning personnel removing a large black “scrap bag” from the area. The bag, like the trucks, contained a “large number of torn and a few intact pieces of analytical balance printouts, pH meter printouts” and more, the FDA said in its write-up.

·????? Biocon Biologics was handed down Form 483 as the company failed to back up and overwrote manufacturing data. The FDA further chided Biocon for its failure to properly investigate batch discrepancies.

·????? ?

Bangladesh

·????? The pharmaceutical market of BD is expected to surpass US$ 6 billion by 2025, reports Dublin-based market and research firm, ‘Research and Markets’.

o?? CAGR is expected to be around 12 percent between 2019 – 2025.

o?? 200, out of 280 local companies, occupy 90% market. A very healthy competitive situation.

o?? Share of generic drugs is 75%.

o?? Products are exported to 144 countries.

·????? The top 50 companies are setting up their facilities at the Active Pharmaceutical Ingredient Industrial Park in Munshiganj for local production of APIs.

·????? EUROPE – European Medicines Agency – EMA (CHMP meets every month for review.

·????? Some Drugs Under Review

o?? Denosumab – mAb for bone disease

o?? Miradametinib – Anti cancer

o?? Olezarsan – Lipid modifying drug

o?? Pridopidine – Nervous system

o?? Zuranolone – Psychiatry

o?? Belantamab – mAb for cancer

·????? Positive Recommendations – for Biosimilars & New Generics

o?? None published yet.

·????? Negative Recommendations

o?? None published yet.

United States – Food & Drug Administration – USFDA

·????? Drug Withdrawal from Market

o?? Pfizer is withdrawing its drug OXBRYTA (voxelotor), treatment for sickle cell disease, from the market due to safety concerns. Healthcare professionals have been asked not to prescribe it, and patients have been asked to contact their HCP for starting other treatment option.

·????? Drug Developments

o?? TC BioPharm PLC, a clinical stage company, has announced that the first patient in the ACHIEVE Phase 2b trial ongoing in the UK has completed the full dose regimen with no drug related adverse events. The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of trial drug TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.

o?? Insilico Medicine, a clinical stage, generative AI-driven drug discovery company, has announced positive preliminary results from Phase IIa clinical trial evaluating ISM001-055, a first-in-class small molecule treatment for idiopathic pulmonary fibrosis.

o?? Ascletis Pharma Inc. has announced completion of initial dosing in its two recently initiated clinical trials for ASC30, the first and only small molecule GLP-1 receptor agonist that can be used once monthly subcutaneously and once-daily orally for the treatment of obesity.

o?? Trishula Therapeutics Inc., a clinical stage biotechnology company has reported final results from a Phase I trial of TTX-030, a potential, first-in-class drug for patients with first-line metastatic pancreatic cancer.

·????? New Drug Approvals

o?? COBENFY (xanomeline and trospium) – formerly KarXT. Karuna Therapeutics Inc. Treatment for Schizophrenia in adults.

o?? AQNEURSA (levacetylleucine) – IntraBio Inc. Treatment for Niemann-Pick Disease Type C. [Niemann-Pick disease is a group of rare conditions passed down in families. The conditions affect the body's ability to break down and use fats, such as cholesterol and lipids, inside cells. Because of the buildup of fats, these cells don't work as they should, and, over time, the cells die. Niemann-Pick disease can affect the brain, nerves, liver, spleen and bone marrow. Sometimes it can affect the lungs. Symptoms of Niemann-Pick disease relate to worsening function of the nerves, brain and other organs over time. Niemann-Pick disease can happen at different ages but mainly affects children. The condition has no known cure and is sometimes fatal. Treatment is focused on helping people live with their symptoms.

o?? MIPLYFFA (arimocolol) capsules – Zevra Thearpeutics Inc. Treatment for Niemann-Pick disease in combination with miglustat.

o?? EBGLYSS (lebrikizumab-lbkz) – Eli Lilly & Co. Targeted IL-3 inhibitor for the treatment of atopic dermatitis in adults and children 12 years and older who weigh at least 40kg.

Concluded.

Disclaimer: I research through multiple resources for this newsletter and gratefully acknowledge their contribution. It may not be possible to give all references here for reasons of space, and I sincerely regret it.