Pickings by Pharma Veterans Newsletter #4 – September 01, 2024

This newsletter is the latest 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

·????? Pharma Industry achieved sales of Rs. 916 billion in FY 2023-24, with a 22% YoY increase. The growth is higher than the last five years CAGR of 17%. The last quarter was the highest – Rs. 237 billion, and 25% YoY jump. Price deregulation contributed to higher-than-normal sales during last quarter. It is estimated that 20% is due to price increase and 5% due to volume increase.

·????? Pharmaceutical exports witnessed a significant increase of 29.66% in July 2024, compared to the same period last year. According to Pakistan Bureau of Statistics, the country exported pharmaceutical goods worth $33.97 million in July 2024, up from $26.20 in July 2023. Quantity increase was 10.59%; 7,098 metric tons in July 24, compared to 7,151 metric tons in July 23. On month-on-month basis, exports increased by 16.63%, from 29.13 million in June 2024.

·????? The Drug Regulatory Authority Pakistan is aspiring to get membership of the Pharmaceutical Inspection Cooperation Scheme – PIC/S for its inspectorates in the field of Good Manufacturing Practices (GMP). To raise awareness about PIC/S theme and GMP guidelines, DRAP shall hold two virtual sessions for pharmaceutical manufacturers, on 4th and 6th September 2024.

·????? DRAP has successfully switched from Online Import Export System (OIES) to Pakistan Single Window 9PSW), effective August 15, 2024. PSW is an electronic portal enabling cross-border trade using standardized information and documents through a single-entry point for all import, export, and transit-related regulatory requirements.

·????? Karachi Tax Bar Association has formally requested FBR to include the pharmaceutical sector under Rule 18A of the Sales Tax Rules 2006. KTBA argued that since pharma manufacturers pay sales tax for the entire supply chain, the requirement for vendors to submit returns was redundant. If approved, it will streamline tax processes for the industry and reduce administrative burden.

India

·????? Political unrest in Bangladesh has affected Indian Pharma companies exports of drugs and ingredients to the neighboring country due to stranded payments. Financial losses are feared to increase. India supplies about 30% of APIs and other related raw materials’ requirement of BD. India’s export of pharmaceutical products to BD was about US$50 million in 2023. Several Indian companies, who have manufacturing units in BD for filling the BD market demand, may find it difficult to sustain.

·????? Lupin launches Doxorubicin HCl Liposome injection in the US market.

·????? Zydus Lifesciences gets USFDA approval to market Amantadine ER (68.5mg) capsules, and tentative approval for Gocovri (137mg) for treating Parkinson’s disease.

·????? Biocon Biologics sign a pact with JJ and Janssen to market its Bmab 1200 (bUstekinumab) in Europe, Canada, and Japan.

·????? Fairfax Group and Bain Capital are competing to buy out Farmson Basic Drugs, a leading API maker in India, valued at INR 4,000 crore. Farmson is a major producer of paracetamol with a revenue of INR 1,750 crore in FY24. Farmson, founded in 1969 is among the largest makers of API paracetamol globally. Due diligence has been done by both private equity firms. The final bids are expected shortly.

·????? Aurobindo, Glenmark, and FDC recall products in the US market due to manufacturing issues. USFDA also pulled up Eugia Pharma, a subsidiary of Aurobindo, citing significant manufacturing issues at its Telangana plant.

·????? The Pharma industry associations have once again urged the Department of Pharmaceuticals to implement price changes from the next batches, and not the current one. At present, once ceiling prices are notified by the National Pharmaceutical Pricing Authority, the revised ceiling price is mandatorily made applicable with immediate effect. This is impossible, considering the logistics involved, but it leads to show-cause notices and litigations.

Bangladesh

·????? Renata Limited has successfully synthesized the active pharmaceutical ingredient (API), Sorafenib, which is used to treat various cancers, particularly liver cancer.

·????? Bristol-Myers Squibb and Medicines Patent Pool have granted sub-license to Beximco Pharma for producing hepatitis C drug Daclatasvir locally, so that patients can ger relief in price.

·????? Beacon Pharmaceuticals Limited, announced the launch of first global generic of Crizotinib. The drug is used for the treatment of Non-Small Cell Lung Cancer.

·????? The country is grappling to normalize after forced departure of pervious government.

EUROPE – European Medicines Agency – EMA (CHMP meets every month for review. August 2024 meeting minutes not published yet. Some more information from July meeting)

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

o?? Rituximab – for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, and Rheumatoid Arthritis – approved for Reddy Holding GmbH.

o?? Ustekinumab – for the treatment of Crohn’s disease, Ulcerative Colitis – approved for Fresenius Kabi Deutschland GmbH, Formycon AG, Samsung Bioepis NL B.V.

o?? Trastuzumab – for the treatment of adult patients with HER2 positive metastatic breast cancer and HER2 positive early breast cancer – approved for Prestige Biopharma, Belgium.

o?? Axitinib – for the treatment of adult patients with advanced renal cell carcinoma – generic approved for Accord Healthcare S.L.U.

·????? Negative Recommendations

o?? None reported.

United States – Food & Drug Administration – USFDA

·????? Important Developments

o?? Eli Lilly announced on 27 August that it was making ZEPBOUND? (tirzepatide) 2.5 and 5mg single-dose vials availble for self-pay patients with an on-label prescription. These vials are priced at 50% or more discount compared to other drugs in this category (GLP-1). The program will benefit obese patients looking to reduce weight, but it will discourage users looking for cosmetic weight loss.

o?? Eli Lilly and Company announced positive topline results from the SURMOUNT-1 three-year study (176-week treatment period) evaluating the efficacy and safety of?tirzepatide?(Zepbound?and?Mounjaro) once weekly for long-term weight management and delay in progression to?diabetes?in adults with pre-diabetes and obesity or overweight. Weekly tirzepatide injections (5 mg, 10 mg, 15 mg) significantly reduced the risk of progression to type 2 diabetes by 94%?among adults with pre-diabetes and obesity or overweight compared to placebo.

o?? Data published in?The Journal of the American Medical Association (JAMA)?from the pivotal Phase III studies OASIS 1 and 2, evaluating the efficacy and safety of the investigational compound elinzanetant, has shown consistent results across both studies and are in line with the Phase II SWITCH study. This data reinforces the strong evidence of efficacy and safety of the compound.?Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, administered orally once daily.

·????? New Drug Approvals

o?? LAZCLUZE – Lazertinib – Johnson & Johnson Innovative Medicine – for the treatment of certain patients with epidermal growth factor (EGFR)-mutated, Non-Small Cell Lung Cancer.

o?? NIKTIMVO – axatilimab-csfr injection – Incyte and Syndax Pharmaceuticals – for the treatment of chronic graft-versus-host disease.

o?? LIVDELZI – seladelpar – Gilead Sciences, Inc. – for the treatment of Primary Biliary Cholangitis.

o?? NEMLUVIO – nemolizumab – Galderma Laboratories, L.P. – for the treatment of adult patients with Prurigo Nodularis.

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.