SL12102-SL2011-Lecture 3 Medicine & Dosage PDF

Fundamentals of Pharmacy & Pharmacology: The Science of Medicines SL12102 / SL12011 Lecture 3: Concept of medicine and dosage forms, brands and generics Dr C POURZAND  Intended learning outcomes By the end of the lecture you will be able to:- Understand the nome...

Fundamentals of Pharmacy & Pharmacology: The Science of Medicines SL12102 / SL12011 Lecture 3: Concept of medicine and dosage forms, brands and generics Dr C POURZAND  Intended learning outcomes By the end of the lecture you will be able to:- Understand the nomenclature of medicinal products Explain why medicines are protected Understand research and development strategy in Pharma Industry Explain the difference between branded and generic drugs Describe the benefits and potential drawbacks of generic medicines  What is a medicine? A medicine is any product used to diagnose, cure, mitigate, treat or prevent a disease The medicinal product is the presentation of a drug in a dosage form suitable for administration to the public i.e... a formulation Drug: Also known as Active Pharmaceutical Ingredient (API) Excipient: All the other components of a formulation other than the active drug Formulation: The process in which APIs and excipients are combined to produce a medicinal product  Medicinal product nomenclature Every branded medication has 2 names: 1. The Brand name: Given by the pharmaceutical R&D company and is a registered ® name. 2. Chemical name – name for the active pharmaceutical ingredient, which is decided by an expert committee. A medication is often known by a registered brand name provided by the innovator (e.g. Zantac®, Prozac®) Medical devices and Packaging are typically trademarked (™) Marketing and Branding is critically important in the US – the brand name can be different between EU and US (e.g. Advair® (US), Seretide® (EU)). The chemical and brand name appear on the medication label and product literature. Captain Zantac™ Shape and colour of Viagra was trademarked A trademark is any word, name, symbol, or design, or any combination thereof, used in commerce to identify and distinguish the goods of one manufacturer or seller from those of another and to indicate the source of the goods." Trademark generally lasts as long as the trademark is used in commerce and defended against infringement. Pantone 2567C Pantone Pantone 2587C 2573C  Branded Drugs New medicines are marketed as a branded product. Companies take out patents on each new drug they discover to regain money spent on R&D and make a profit. A standard patent last 20 years but can be extended by an additional 5 years. It takes approx. 10-15years of this period to develop, file a new drug application and obtain a marketing authorization (MA). Only the company can produce and sell the medicine to recover costs during the remaining years.  Patent vs. Marketing Life ed Approv y nt it Pate te Toxic 100% Acu olog y mac Phar it y % of Patent Life Remaining Toxic als hroni c n C linic icals C a e I Hum man Clin i nica ls 75% h as II Hu C l P an P hase I I I Hum l i cation e p Phas p Discovery & D rug A New Pre-clinical 50% Studies et Mark Clinical Development 25% & Regulatory Marketing Patent Expiry 0% 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Year Since Patent Approval Need to recover costs before the patent expires!  Pharmaceutical Research & Development (R&D) Industry The objective of pharmaceutical research and development is to “convert synthesised chemical compounds into candidate drugs for development” Product development involves  Pharmaceutical R&D Industry To be successful, research-based pharmaceutical companies must ensure that new discoveries are frequently being brought to the market. Required for market growth/shareholders and to fund Astra Zeneca Pipeline (2014)  Pharmaceutical R&D companies have a mixed portfolio of products Global Distribution of Pharmaceutical Sales Medicines expenditure per person  Qvar’s generic name: Beclometasone Dipropionate Augmentin’s generic name: amoxicillin/clavulanate potassium  Blockbuster drug model A blockbuster drug is where sales reach over US $1 billion per annum. > 1/3 of the pharma market is accounted by blockbusters Search for a blockbuster is the foundation of R&D strategy.  Avatar Lipitor (Pfizer) Budget $237 Launched in 1998 million Patent protection until 2011 International gross earning Cost to Market: $0.5 - 1 billion $3.02 billion International gross earning $13.7 billion per annum $ROI = $2.78 Billion $ROI ~ $100 billion ROI : Return on investment  Blockbuster drug model There were only 4 blockbuster drugs in 1992. In late 90’s blockbuster pharmaceuticals were on the verge of patent expirations while late-stage product pipelines scarce, thus shaking the foundations of an industry that was once the favorites of Wall Street. – Increased to 29 in 1998, 35 in 1999 and 44 in 2000. From 2000 to 2022, the number increased 5-fold, with a slowing of growth from 2018. However massive demand for Covid vaccines and therapeutics during pandemic accelerated the growth. Since 2000, annually ca 14 drugs became blockbusters for the first time and ca 8 lost their rank with their annual revenues falling back below $1Billion  Examples of top Blockbusters in 2023 Comirnat y Keytruda Humira Company: Pfizer and BioNTech 2023 sales: $11.2-15.3 billion Company: AbbVie Company: Merck & Co. Disease: COVID-19 2023 sales: $14.4 billion Before COVID, AbbVie’s Humira was top- 2023 sales: $25 billion Disease: Rheumatoid selling for 9 consecutive years. Diseases: Melanoma, non- arthritis, juvenile idiopathic In 2021, Comirnaty sales reached small cell lung cancer, head arthritis, psoriatic arthritis, $36.8 billion, being unprecedented in a and neck cancer, classical ankylosing spondylitis, single year for a pharmaceutical Hodgkin lymphoma, primary Crohn’s disease, ulcerative product. mediastinal large B-cell In 2022, the annual sales reached colitis, plaque psoriasis, lymphoma, bladder cancer, $37.8 billion by Pfizer and BioNTech hidradenitis suppurativa and which was more than double of the microsatellite instability-high uveitis. sales of their lone serious competitor or mismatch repair deficient Moderna, which sold $36 billion of its cancer, gastric cancer, Spikevax vaccine. esophageal cancer, cervical cancer, liver cancer, biliary Ozempic In 2023, by transition of pandemic into the endemic stage, sales decreased. tract cancer, Merkel cell Company: Novo Nordisk In October, Pfizer cut $9 billion from its carcinoma, kidney cancer, 2023 sales: 95.7 billion annual revenue projection Danish kroner ($14 billion) For 2024, Pfizer projects Comirnaty endometrial cancer, tumor sales reached $5 billion, being short of mutational burden-high Disease: Type 2 diabetes, Wall Street’s estimate as well as the cancer, cutaneous squamous cardiovascular risk reduction company’s own prediction that vaccine cell carcinoma, triple-negative in diabetes patients. sales would be in line with what they breast cancer were in 2023.  30 years of novel FDA approvals Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). https://www.nature.com/articles/d41573-024-00001-x  Generic Drug Companies Generic business kicks in when a leading brand finally loses patent protection. Usually, a multiple of generic drug companies launch copycat versions of the original. Profits are much lower. 90’s - 00’s: The era of the Generics Population all over the World are getting older Increase in the size of the middle class Government promoting the use of generic drugs in efforts to slow down increase in health spending Increased acceptance of generic drugs by doctors, pharmacists and patients A number of blockbusters in major diseases states have lost patent protection (e.g. cardiovascular, respiratory)  What is a Generic Drug? A drug which is bioequivalent (PK and PD properties) to a leading brand name Generic medicines must be identical in dose, route of administration, safety and efficacy as the “innovator”  Major saving to the NHS e.g. 90-94% saving on Atorvastatin The growth of generics in the UK Number of Generic prescriptions in UK GP practices (median 83%) Worldwide Levels of Generic Penetration  Prescribing generic medicines Prescribers are encouraged to prescribe medicines by their generic name. Generic medicines are equally effective and can save up to 80% on the cost of a branded product Allow pharmacist the widest choice of products to dispense. Important if there is a shortage of a particular product.  Word of Caution In rare cases, a patient may need to stay on a branded medicine. Some examples may include: – Epilepsy medicines – slight differences in rate of absorption may cause a big difference in therapeutic effect. – Modified-release preparations – Generic equivalents may absorb differently. – Lithium – different brands may vary widely in the absorption and how the medicine becomes active. – Biological medicines – Copies of these complex medicines (called biosimilars) may not be automatically used as a substitute. Doctors need to reference the specific manufacturer.  Further resources https://www.uspharmacist.com/article/drug-patent-expirations-and-the-pate nt-cliff. European Medicines Agency guidance document on generic medicines and bioequivalence. https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-guideli nes/clinical-pharmacology-pharmacokinetics/product-specific-bioequivalence-guidance Comparator products in Bioequivalence/Therapeutic Equivalence studies https://www.gov.uk/guidance/comparator-products-in-bioequivalencetherapeutic-equivale nce-studies Legal battle over Lipitor (atorvastatin) sales in UK. http://www.pharmatimes.com/news/pfizer_settles_with_teva_over_lipitor_in_uk_98026 9. NHS guidance on the prescribing of generic medicines in specific diseases. http://www.nhs.uk/Conditions/Medicinesinfo/Pages/Brandnamesandgenerics.aspx. Top 20 drugs by worldwide sales in 2023.