Pickings by Pharma Veterans Newsletter #8 – October 27, 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].

OCTOBER IS THE MONTH OF PINK RIBBON TO MARK BREST CANCER

PAKISTAN

·?????? Pakistan’s harsh operating environment will continue to burden its pharmaceutical sector despite the country’s plan to establish a Pharmaceutical Economic Zone to improve the market. According to reports, the health ministry has announced plans for a Pharmaceutical Economic Zone with the CPEC and Special Investment Facilitation Council to attract foreign investment to country.

·?????? The Competition Commission of Pakistan on Friday approved the acquisition of trademarks for the pharmaceutical product CLAFORAN by Hoechst Pakistan Ltd from Sanofi Aventis Deutschland GmbH through a trademark assignment agreement.

·????? Pakistan has commenced the commercial export of cardiac stents in limited quantities to Iran, Afghanistan, and different African countries after their successful utilization at local hospitals, it has been learned.?Speaking exclusively to ProPakistani at the 21st Health Asia International Exhibition and Conferences, Samane Shifa Foundation Chairman Dr Syed Shahid Noor said the manufacturing facility in Pakistan is limited as it currently produces stents in a single shift.?Once the capacity is scaled up from different potential investors, it should gradually increase to three shifts. Pakistani-made cardiac stents are being utilized at leading local hospitals such as NICVD and Combined Military Hospitals, making treatment accessible and affordable for patients.?The cost of local cardiac stents is Rs. 25,000, as against the imported brand that costs up to Rs. 150,000. The federal government provided funding of Rs. 331 million to NUST (Islamabad) for the development of Medical Devices Development Center in 2020. The stents have been approved by Pakistani and European authorities and the institute received a manufacturing license from DRAP recently. Besides Bare Metal Stents (BMS), the facility also has the capacity to manufacture Drug Eluting Stents (DES) and Percutaneous Transluminal Coronary Angioplasty Balloon Catheters (PTCA balloon catheters).?Noor mentioned that local companies have manufactured ten medical devices in collaboration with leading universities, and more than 20 devices are in the development stage.

India

·?????? Mankind Pharma said it had completed the acquisition of Bharat Serums and Vaccines Limited for INR 13,768 crore. The acquisition will position Mankind as a market leader in the Indian women’s health and fertility drug market, alongside high entry barrier products in critical care segment.

·?????? The Income Tax Appellate Tribunal in Ahmedabad has disallowed more than 12 crore INR incurred by Sun Pharma on doctors’ promotional activities. Sun Pharma had incurred various amounts on accommodation, business promotion expenses, conference fees, freebies, and gifts to doctors.

·?????? The Enforcement Directorate’s Mumbai wing on Friday conducted searches in Mumbai and Haryana in connection with a probe into a bank loan fraud case against Sharon Bio Medicine Limited and others. The pharma company allegedly caused losses to the banks to the tune of INR 220 crore.

·?????? Torrent Pharma reported its net profit increase 17.35% to INR453 crore in Q2 FY25.

·?????? Strides Pharma Science Ltd. reported consolidated revenue of INR12,011 million, marking a 17% YoY increase.

Bangladesh

·????? Synovia Pharma plc authorities have sought government help for the atrocities at their headquarters by ex-employees forcibly entering headquarters, vandalizing property, and harming innocent staff. The organization said that former employees of the company illegally occupied company office and took position. On 21 October, when current employees asked them to vacate the premises, the ex-employees physically assaulted the staff. Synovia is the name of the organization after Sanofi group left the country.

·????? Square Pharma plc has declared a record 110% cash dividend to its shareholders for the fiscal year 2023-24 and decided to invest Tk500 crore to boost its production. After last fiscal, company paid 105% cash dividend to its shareholders.

·????? Workers of Nipro JMI Pharma Limited and JMI Syringe and Medical Devices have blocked the Dhaka-Chittagong Highway in Gajaria, Mishiganj, demanding increase in wages across the board.

·????? The pharmaceutical exporters are keenly awaiting government response to their call for an exemption from the stringent payment conditions under Income Tax Act. The relevant Section mandates that the payments for goods or services must be cleared within 45 days of acceptance.

EUROPE – European Medicines Agency – EMA

EMA approved following drugs in September and October 2024.

·????? Positive Recommendations

o?? ALHEMO (concizumab) – for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors.

o?? KORJUNY (catumaxomab) – for the intraperitoneal treatment of malignant ascites in cancer patients.

o?? FLUAD – an influenza vaccine for adults aged 50 and older.

o?? ELAHERE (mirvetuximab) – for the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

o?? HETRONIFLY (serpulimab) – for the treatment of extensive-stage small cell lung cancer.

o?? POMALIDOMIDE - generic version for the treatment of multiple myeloma.

·????? Negative Recommendations

o?? None published yet.

United States – Food & Drug Administration – USFDA

·????? Drug Developments

o?? Grünenthal annoinced that first participants have been enrolled in a first-in-human Phase I clinical trail for a nociceptin (NOP) receptor agonist. Grünenthal pioneered the research into this treatment modality to deliver a unique and transformative first-in-class therapy option to millions of patients suffering from chronic pain.

o?? Merck (MSD) announced positive results from Phase 2b/III clinical trial of clesrovimab, an investigational RSV, Preventative mAb. The drug candidate significantly reduced incidence and RSV disease hospitalization in healthy preterm and full-term infants.

o?? Gilead Sciences Inc. and Merck (MSD) announced new results from a Phase 2 clinical study evaluating the investigational combination of islatravir and lenacapavir for HIV treatment. Results are promising as viral load suppression was maintained at 48 weeks.

·????? New Drug Approvals

o?? VYLOY (zolbetuximab-clzb) injection – Astellas Pharma US, Inc. for the treatment of advanced gastic and GEJ cancer.

o?? VYALEV (foscarbidopa and foslevodopa) injection – AbbVie Inc. for adults living with advanced Parkinson’s disease.

o?? HYMPAVZI (marstacimab-hncq) – Pfizer Inc. for the treatment of adults and adolescents with hemophilia A or B without inhibitors.

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.