Pickings by Pharma Veterans

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

·????? The Competition Commission of Pakistan has approved the acquisition of two pharmaceutical products, Methycobal and Myonal, including their trademarks, know-how, and record in terms of assets consequent to an Asset Purchase Agreement between Hilton Pharma Pakistan and Eisai Pharma Japan.

·????? Earnings of Pakistan’s listed pharmaceutical sector was down 42% YoY. Thus, decline is primarily attributed to decrease in gross margins and increase in finance cost.

·????? Pakistan Pharmaceutical Manufacturers Association – PPMA Chairman has shown serious concern over drug pricing policies and essential drugs list. Government has capped price increase for essential drugs at 7% which falls short given significant inflation, currency depreciation, and cost of utilities. He added that Pakistan’s essential drugs list has 494 medicines, which is the biggest in the region. India has 384, Bangladesh 117, and Sri Lanka has only 60 medicines on the list.

·????? Pakistan has been facing continuous shortage of Insulin due to uncertain policies of the government. The patients face unnecessary distress, loss of control, and additional costs due to this factor.

Excerpts from a research article published in July 2024:

• The domestic pharmaceutical industry, despite its substantial size, has not demonstrated the expected growth and dynamism of a thriving industry and has remained uncompetitive on the global stage, with minimal exports. Domestic pharmaceutical exports have been valued at merely around US$200 million, tremendously lower than the India’s pharmaceutical exports worth US$24 billion, and even Jordan’s US$800 million exports, despite having a much smaller population of only 9 million. Moreover, India has 201 US-FDA-certified plants which is an impressive number, while Jordan has 4 certified plants, enabling the above both countries to export to the US, accounting for 60% of the global market. In contrast, Pakistan’s low exports and lack of US-FDA-approved firms, the international standard requirement demonstrate the country’s inadequate competitiveness and substandard products
• The market share, within the industry has become top-heavy, with the top 100 firms out of approximately 759 (IQVIA figure) controlling 97% of the market, leaving only 3% of the market for the remaining 650 firms. This skewed structure, coupled with the lack of competitiveness, indicates the sector’s inability to positively impact national economic growth and public health
• Recently, 6 bioequivalence centers, licensed by the DRAP, inclusive of a provincial government-owned facility, the Pakistan Drug Testing & Research Center in Lahore have been established and are also being expanding in number [38]. However, none of these centers hold accreditation from international bodies. Their performance in facilitating exports and their compliance with regulatory requirements for generic drug registration or international standards remain uncertain
• On utilization of CRF by DRAP the industrial experts viewed there is zero utilization so far while a huge amount was collected with DRAP. The Drug Act 1976, since its enactment mandates pharmaceutical companies to allocate 1% of their gross profits to the government to conduct. There is no data available to demonstrate the total amount collected and utilized over time and what impact it has had on the drug-related domestic R&D
• DRAP should ensure compliance of industrial manufacturing to the latest standards
• DRAP should issue NOCs only to those premises which are located in industrial areas for the long-term growth of industry and to avoid exposure of the population to the wastes of the industry.
• DRAP should get the PICS membership to represent the country with good regulatory control to improve the image of national pharmaceuticals.

India

·????? The Maharashtra State Pharmacy Council has made a proposal to the Pharmacy Council of India that, similar to the prefix, ‘Dr.’ used by medical professionals like physicians etc. a prefix like ‘Pr.’ Or ‘Ph’ for registered pharmacists should be considered to distinguish them from non-pharmacists.

·????? Exports of drugs and pharmaceuticals from the country registered a 9.3 per cent growth in the first three months of the fiscal year from April to June 2024. The exports during the three months stood at $7.20 billion, as against $6.59 billion in the same period of previous fiscal year. During the month of June, the exports registered a 10 per cent growth at $2.47 billion as compared to $2.25 billion reported in the same month of last year.

·????? Indian pharmaceutical industry aims to achieve a market size of US$ 130 billion by 2023 and US$ 450 billion by 2047.

·????? Gennova BioPharma introduces pediatric pack size of Pegaspargase to treat ALL in children

·????? Lupin launches the world’s first triple combination drug, containing Vilanterol, Fluticasons furoate, and Glycopyrronium bromide, for COPD patients.

·????? Glenmark introduces triple drug combination of DPP-4 inhibitor Teneligliptin, SGLT2 inhibitor Dapagliflozin, and Metformin, for Type 2 diabetes patients.

·????? Glenmark receives USFDA approval for generic Topiramate capsules 15 and 25mg in the US market.

·????? Lupin receives USFDA approval for generic Topiramate Extended-Release capsules in the US market.

·????? Zydus gets final approval from USFDA for marketing Sacubitril and Valsartan combination in the US market.

Dr. Reddy’s Laboratories signs licensing pact with Takeda Pharmaceuticals Japan to market their GI drug Vonoprazan tablets India.

Bangladesh

·????? Bangladesh has 284 registered pharma companies. The market size is US$3.2 billion. BD companies are now exporting to 150 countries.

·????? Beximco Pharma was the first Bangladeshi company that was audited and approved by the USFDA in June 2015. They are now exporting drugs to the US market regularly.

·????? Four Bangladesh companies are now USFDA approved: Beximco, Square, Eskayef, and Renata

·????? Incepta Vaccines has launched its vaccine bulk manufacturing facility in Dhaka.

·????? 17 companies are now manufacturing a large range of anti-cancer drugs in Bangladesh including mAbs. Some of these are being imported in Pakistan also.

EUROPE – European Medicines Agency – EMA

EMA’s human medicine committee has concluded its review of OCALIVA (obeticholic acid) has recommended that its marketing authorization be revoked, because its benefits are no longer considered to outweigh its risks. OCALIVA is used to treat adults with primary biliary cholangitis, an autoimmune condition that causes gradual destruction of the bile ducts in the liver, which can lead to liver failure and increase the risk of liver cancer.

Committee reviewed the following applications in its June 2024 meeting.

o?? BALVERSA (erdafitinib) – for adult patients with unresectable or metastatic urothelial cancer. Approved.

o?? EURNEFFY (epinephrine), the emergency treatment against allergic reactions. Approved.

o?? mRESVIA (RSV mRNA vaccine) – for adults 60 years of age and older for lower respiratory disease caused by Respiratory Syncytial Virus.

o?? ORDSPONO (odronextamab) – conditional authorization for treatment of follicular lymphoma and diffuse large B-cell lymphoma. Approved.

o?? PIASKY (crovalimab) – treatment of nocturnal paroxysmal hemoglobinuria. Approved.

o?? TAUVID (flortaucipir) for PET imaging of brain. Approved.

o?? WINREVAIR (sotatercept) – for adult patients with pulmonary arterial hypertension. Approved.

o?? Two generic drugs: Enzalutamide for prostate cancer; and Nilotinib for chronic myeloid leukemia. Approved.

·????? Committee refused Masitinib for amyotrophic lateral sclerosis of nervous system, and Pegcetacoplan for geographic atrophy secondary to age-related macular degeneration.

·????? Teva withdrew its application of Dabigatran etexilate for prevention of venous thromboembolic events.

United States – Food & Drug Administration – USFDA

Recalls

o?? BluePoint recalls 21 batches of Potassium Chloride Extended-Release 750mg due to failed dissolution.

o?? Glenmark USA recalls 114 batches of Potassium Chloride Extended-Release 750mg due to failed dissolution.

o?? Integrity Products recalls two male enhancement supplements, found to be tainted with sildenafil and tadalafil.

o?? Sagent recalls two lots of Docetaxel injection due to presence of particulate matter.

Latest New Drug Approvals

o?? KISUNLA (donanemab-azbt) – for Alzheimer’s disease.

o?? PYZCHIVA (ustekinumab-ttwe) – for plaque psoriasis, Crohn’s disease, ulcerative colitis

o?? AHZANTIVE (aflibercept-mrbb) – for macular degeneration.

o?? NYPOZI (filgrastim-txid) – for neutropenia.

o?? OHTUVAYRE (ensifentrine) – dual inhibitor of enzymes phosphodiesterase 3 & 4 for COPD.

o?? TEPYLUTE (thiotepa) – for breast cancer, ovarian cancer

Concluded.

Disclaimer: I have researched 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.