ACELEX capsule 2mg - Tissue Selective COX-2 inhibitor CrystalGenomics Acelex NC Jan2016. Acelex® (polmacoxib) is a non-steroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, for the treatment of symptoms associated with arthritis. Suffering from joints pain which might have been due to age or other reason. Acelex capsule 2 mg is one of new drug in the market for joints pain relief.
This prsentation explains the use of biomarker with reference to an article: Accelerating Drug Develeopment using Biomarkers-Sitagliptin.
It was presented my my 2 friends and me. Hope it helps you guys.
This Presentation Give You A brief Information About DPP4 And New Recommendations .This Presentation Guide You How To Treat Patients With Safety.
For Further Contact:03354999496
Olmesartan medoxomil is an angiotensin II receptor antagonist which is used for the treatment of high blood pressure. An ester prodrug, it is completely and rapidly hydrolyzed to the active acid form. It is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents
this is just powerpoint of the report on a pharma company this was to present in the class and for the ease to understand the research of principle of marketing in institute of business management IoBM
Dapagliflozin is an AstraZeneca patented medication. In India, Sun Pharma and Abbott serve as licensed partners for dapagliflozin's distribution. While the primary patent for dapagliflozin expired in October 2020, a specific (species) patent safeguards AstraZeneca's dapagliflozin in India until May 15, 2023.
Under the brand name "Oxra®," Sun Pharma will undertake the promotion and distribution of dapagliflozin. This medication is approved for use in the United States as a monotherapy and in combination therapy to enhance glycemic control in patients with type 2 diabetes.
In China, the National Medical Products Administration (NMPA) approved dapagliflozin, both in combination with metformin and as a standalone treatment, for inadequately-controlled type-2 diabetes mellitus. It was introduced for the treatment of type 2 diabetes in China in 2018.
Japan has authorized Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
The Shanghai Shenkang Hospital Development Center has outlined a three-year plan to promote clinical skills and innovations in municipal hospitals, reflecting a commitment to healthcare advancements.
Efforts are being made to expand distribution channels across diverse geographical regions. AstraZeneca is closely monitoring the Indian market to secure a significant share and prevent the infringement of dapagliflozin by generic manufacturers.
Regulatory bodies are actively assessing dapagliflozin's drug and approval processes, ensuring compliance with appropriate dose and indication guidelines. For further inquiries, please contact pranayraju66@gmail.com.
This prsentation explains the use of biomarker with reference to an article: Accelerating Drug Develeopment using Biomarkers-Sitagliptin.
It was presented my my 2 friends and me. Hope it helps you guys.
This Presentation Give You A brief Information About DPP4 And New Recommendations .This Presentation Guide You How To Treat Patients With Safety.
For Further Contact:03354999496
Olmesartan medoxomil is an angiotensin II receptor antagonist which is used for the treatment of high blood pressure. An ester prodrug, it is completely and rapidly hydrolyzed to the active acid form. It is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents
this is just powerpoint of the report on a pharma company this was to present in the class and for the ease to understand the research of principle of marketing in institute of business management IoBM
Dapagliflozin is an AstraZeneca patented medication. In India, Sun Pharma and Abbott serve as licensed partners for dapagliflozin's distribution. While the primary patent for dapagliflozin expired in October 2020, a specific (species) patent safeguards AstraZeneca's dapagliflozin in India until May 15, 2023.
Under the brand name "Oxra®," Sun Pharma will undertake the promotion and distribution of dapagliflozin. This medication is approved for use in the United States as a monotherapy and in combination therapy to enhance glycemic control in patients with type 2 diabetes.
In China, the National Medical Products Administration (NMPA) approved dapagliflozin, both in combination with metformin and as a standalone treatment, for inadequately-controlled type-2 diabetes mellitus. It was introduced for the treatment of type 2 diabetes in China in 2018.
Japan has authorized Forxiga (dapagliflozin) as an oral adjunct treatment to insulin for adults with type-1 diabetes (T1D).
The Shanghai Shenkang Hospital Development Center has outlined a three-year plan to promote clinical skills and innovations in municipal hospitals, reflecting a commitment to healthcare advancements.
Efforts are being made to expand distribution channels across diverse geographical regions. AstraZeneca is closely monitoring the Indian market to secure a significant share and prevent the infringement of dapagliflozin by generic manufacturers.
Regulatory bodies are actively assessing dapagliflozin's drug and approval processes, ensuring compliance with appropriate dose and indication guidelines. For further inquiries, please contact pranayraju66@gmail.com.
Pearls about NSAIDs and their usage in the managaement of chronic pain, considering safety profile of both selective cox-2 or non selective cox-2 inhibitors
Safety and Efficacy of BMAC and Adipose-Derived MSCs Treatment in Combination...semualkaira
Knee osteoarthritis (KOA) is one of the most
widespread degenerative diseases that lead to pain and disability.
Oral NSAIDs and Intra-articular corticosteroid injections are usually used to relieve symptoms in patients with knee osteoarthritis.
In this study, we assessed the safety and efficacy of the combination of autologous adipose-derived mesenchymal stem cells (ADMSC) that is mechanically treated with a stromal vascular fraction
(SVF) and bone marrow aspirate concentrate (BMAC) injections
on pain reduction and improvement of functioning in patients with
KOA. The aim was to gain more information as there is a lack of
research on combinational orthobiologic treatment.
Safety and Efficacy of BMAC and Adipose-Derived MSCs Treatment in Combination...semualkaira
Knee osteoarthritis (KOA) is one of the most
widespread degenerative diseases that lead to pain and disability.
Oral NSAIDs and Intra-articular corticosteroid injections are usually used to relieve symptoms in patients with knee osteoarthritis.
In this study, we assessed the safety and efficacy of the combination of autologous adipose-derived mesenchymal stem cells (ADMSC) that is mechanically treated with a stromal vascular fraction
(SVF) and bone marrow aspirate concentrate (BMAC) injections
on pain reduction and improvement of functioning in patients with
KOA. The aim was to gain more information as there is a lack of
research on combinational orthobiologic treatment.
Pharma leader series top stem cell technology companies 2015 2025Visiongain
For an Executive Summary of this report please contact ben.suntivarakom@visiongain.com
(+44 (0)20 7549 9976)
or refer to our website: http://goo.gl/bhNICQ
Annovis Bio is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (AD-DS). Annovis is believed to be the only company developing a drug for AD, PD and AD-DS that inhibits
more than one neurotoxic protein and improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. The company expects its treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. Annovis has an ongoing
Phase 2a study in AD patients and a second Phase 2a study in early PD and early AD patients.
In recent years, the approval of nucleic acid therapeutics for listing has been accelerating. Numerous nucleic acid therapeutics that have the potential to become blockbuster drugs have released clinical data covering cardiovascular and metabolic diseases, liver diseases, and a variety of rare diseases. Especially after the approval of the two mRNA COVID-19 vaccines, nucleic acid therapeutics have received more and more attention from the world.
International Journal of Pharmaceutical Science Invention (IJPSI) is an international journal intended for professionals and researchers in all fields of Pahrmaceutical Science. IJPSI publishes research articles and reviews within the whole field Pharmacy and Pharmaceutical Science, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
Annovis Bio is a clinical-stage, drug platform company addressing
neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease
(PD) and Alzheimer’s in Down Syndrome (AD-DS). Annovis is believed to
be the only company developing a drug for AD, PD and AD-DS that inhibits
more than one neurotoxic protein and improves the information highway of
the nerve cell, known as axonal transport. When this information flow is
impaired, the nerve cell gets sick and dies. The company expects its
treatment to improve memory loss and dementia associated with AD and
AD-DS, as well as body and brain function in PD. Annovis has an ongoing
Phase 2a study in AD patients and a second Phase 2a study in early PD
and early AD patients.
2020 OA Vision: Emerging Therapeutics on the OA landscapeOARSI
Philip Conaghan MBBS PhD FRACP FRCP
Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds
Deputy Director, NIHR Leeds Biomedical Research Centre
SciTech Development pitch deck including company overview, proprietary technology, lead drug ST-001 nanoFenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, cancer indications and drug mechanism of action (MOA).
RETINA COMPANY SHOWCASE- Aerie PharmaceuticalsHealthegy
Panel Discussion by Aerie Pharmaceuticals at OIS@ASRS 2016.
Participant:
Casey Kopczynski, Chief Scientific Officer- Aerie Pharmaceuticals
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Similar to Acelex capsule 2mg - tissue selective cox-2 inhibitor crystal genomics acelex nc jan2016 (20)
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
2. To become a fully integrated biopharmaceutical company in Korea and expand
internationally through collaborations and partnerships
To become a fully integrated biopharmaceutical company in Korea and expand
internationally through collaborations and partnershipsVisionVision
2000.07 Founded
2003.09 Publication in Nature (article and cover based on platform technology)
2006.01 IPO on KOSDAQ
2006.10 Established US subsidiary, CG Pharmaceuticals, Inc. for clinical development
2012.06 Designated by the Korean government as one of the ‘KIPC’ certified companies
2014.07 Designated by the Korean government as one of the ‘K-BrainPower’ companies
2015.02 Obtained the NDA approval from MFDS for Acelex®
in Korea (osteoarthritis)
2015.09 Launch of Acelex®
in Korea
2000.07 Founded
2003.09 Publication in Nature (article and cover based on platform technology)
2006.01 IPO on KOSDAQ
2006.10 Established US subsidiary, CG Pharmaceuticals, Inc. for clinical development
2012.06 Designated by the Korean government as one of the ‘KIPC’ certified companies
2014.07 Designated by the Korean government as one of the ‘K-BrainPower’ companies
2015.02 Obtained the NDA approval from MFDS for Acelex®
in Korea (osteoarthritis)
2015.09 Launch of Acelex®
in Korea
HistoryHistory
Next generation NSAID, Acelex®
for osteoarthritis (first-in-class)
Novel antibiotic candidate for MRSA infection, CG400549 (first-in-class)
Molecular-targeted cancer therapeutic, CG200745 (best-in-class)
Next generation NSAID, Acelex®
for osteoarthritis (first-in-class)
Novel antibiotic candidate for MRSA infection, CG400549 (first-in-class)
Molecular-targeted cancer therapeutic, CG200745 (best-in-class)
Key ProgramsKey Programs
CrystalGenomics is a commercial stage biopharmaceutical company with
innovative platform technologies dedicated in the discovery and
development of novel pharmaceuticals in unmet medical need areas.
Corporate Overview
3. Platform Technology : Overview
Integration of in vitro experiments and in silico technology enables the company to streamline
the drug discovery process from gene to drug.
Lead Discovery ( SCPTM
)
SCPTM
NMR
Virtual
Screening
In vitro Assay
SCPTM
Library
SCPTM
Screening
Synchrotron, NMR
Structure Determination ( SPSTM
)
AGTC
TCAG
Target
Selection
Lead Optimization and Candidate Selection ( SDFTM
)
In vivo
Evaluation
DMPK
Toxicology
Pharmacology
Biological
Evaluations
Target Assays
Cellular Assays
In vitro DMPK
Drug Design &
MediChem
SDFTM
X-ray
SDFTM
Informatics
Parallel Synthesis
Pre-clinical
Candidate
Lead / Target
Complex
O
R2
R3
O
N
R1
IND-enabling Tox
(CRO in EU,USA)
4. CG Has Global Standard Drug Discovery Capabilities
Viagra®
(sildenafil)
Cialis®
(tadalafil)
Levitra ®
(vardenafil)
CrystalGenomics was the first group to solve the complex crystal structure of PDE5 using
SPS™ technology: Nature 425, 98-102 (2003).
6. R&D Pipeline
Disease Target
Candidat
e
Indication Phase I Ph II Ph III
1
Infectious Disease MRSA
2
Cancer MDS
Area Product Indication Current Status Partners
2
Cancer Pancreatic cancer
1
Cancer AML
1
CNS Alzheimer’s Disease
2
Metabolic Anemia
1. First-in-class , 2. Best-in-class
Novel Therapeutics Pipeline
Inflammation 1
Acelex®
Osteoarthritis
• Approved by the MFDS (Feb. 2015),
• Launched in Korea (Sep. 2015)
• Partnered with TR-Pharm for Turkey & MENA (Jan. 2016)
Area Indication Discovery Preclinical Ph I Ph II Ph III NDA
8. Acelex® 2mg Capsule
Novel NSAID for the relief of signs and symptoms of osteoarthritis
▪ Global market for arthritis drugs was USD 50B, of which
$17.5B consisted of COX-2 drugs & NSAIDs but existing
therapies have CV and GI safety issues and there is a great
unmet medical need for a safer drug1
▪ 16,344 deaths and 545,452 hospital admissions from GI
bleeding in 2006 and heavy NSAID usage partially to blame2
▪ Celebrex®
(Pfizer) - 2012 global sales was USD 2.7B and
USD 51M+ sales in Korea with double digit CAGR (2012)
▪ Approved by the MFDS of Korea (Feb. 5, 2015)
▪ Launched in September 2015 (marketed and sold by
Dong-A ST)
▪ Partnered with TR-Pharm for commercialization of
Acelex in Turkey & MENA region, covering 19 countries
(Jan. 2016)
1
IMS Top Line Industry Data (2009)
2
Statistical Brief #65 Healthcare Cost and Utilization Project Jan. 2009 Agency for Healthcare Research & Quality, Rockville, MD
Acelex Target Market
Acelex®
, A Novel NSAID for Osteoarthritis
9. Acelex®
, Tissue Selective NSAID for Osteoarthritis
Category Projected Advantages of Acelex
Efficacy
• Quicker onset of relief from the signs and symptoms of OA over celecoxib.
• Achieved superior PGA (Physicians Global Assessment) scores compared to celecoxib.
Dose • Only 2 mg/day dose, the lowest daily dose among all known NSAIDs.
Administration
Frequency
• Convenient once-a-day dosing regimen unlike most other NSAIDs.
Gastrointestinal
Side Effects
• Significantly improved GI safety in comparison with traditional NSAIDs on the market.
Cardiovascular
Side Effects
• Acelex’s tissue-selective-COX2-inhibition mechanism is projected to provide a meaningful
enhancement of cardiovascular safety over currently available NSAIDs.
< Acelex® 2mg Capsule >
Tissue-Selective NSAID for the Relief of Signs Symptoms of Osteoarthritis (OA)
• Approved by the MFDS (Feb. 2015),
• Launched in Korea by Dong-A ST (Sep. 2015)
• Partnered with TR-Pharm for Turkey & MENA (Jan. 2016)
11. 1
Positioning of A Novel NSAID, Acelex®
for Osteoarthritis
• Acelexwould be the first, tissue-selective and once-a-day osteoarthritis drug with a novel
mode of action that specifically targets affected joints to relieve pain and restores
mobility
• Acelex 2 mg once-a-day could provide more rapid onset of relief from the signs and
symptoms of osteoarthritis in comparison with Celebrex 200 mg once-a-day without
added safety risk.
12. 1
Product Profiles of Marketed NSAIDs and COX-2 Inhibitors
Classification Drug Products Characteristics GI Risk CV Risk
Traditional
NSAIDs
Traditional NSAIDs:
naproxen,
ibuprofen,
diclofenac
- Low selectivity
- 2–4 times/day (75–2,400 mg/day)
Very high
Moderate or
high
Vimovo (Pozen,
AstraZeneca)
- Naproxen + Esomeprazole
-Twice/day
- FDA warning for long-term use
- Sales volume is small.
Moderate Moderate
COX-2
Inhibitors
Celebrex®
(Celecoxib: Pfizer)
- Sales in 2010 was $2,374M
- Once or twice/day (200–400
mg/day)
Low Moderate
Arcoxia®
(Etoricoxib: Merck)
- Sales in 2010 was $398M in EU
- Not approved in the US
- Once/day (30–120 mg/day)
Low High
Tissue
Selective
COX-2 Inhibitor
Acelex®
(Polmacoxib: CG)
- ‘Tissue selective’ COX-2 inhibitor
- Once/day (2 mg/day)
Low
None
observed
to date
13. 1
Whole Blood, Blood
Vessels, CV Tissues
Inflamed Joints (OA, RA)
Limited side effects Good efficacy
Polmacoxib
COX-2
CA
CA >> COX-2
Preferred binding to CA
CA << COX-2
Preferred binding to COX-2
Polmacoxib, a dual inhibitor of COX-2 and human CA (carbonic anhydrase), does
not inhibit COX-2 in CA-rich tissues (e.g. CV system), but it fully inhibits COX-2 in
CA-deficient tissues (inflamed joints).
Mechanism of Polmacoxib
14. 1
Summary of Clinical Studies for Acelex
Phase Type
ClinicalTrials.gov
Identifier
Trial
Size
Status Location
1
First-in-human study
Single ascending dose (SAD) study
- 24 Completed UK
Multiple ascending dose (MAD) study
Safety and Pharmacokinetic (PK) Study
- 16 Completed UK
MAD study
Safety and pharmacokinetic study
- 48 Completed US
Pilot biomarker study NCT00780325 24 Completed US (Univ. of Penn)
Drug-drug interaction (DDI) study NCT01154764 26 Completed Seoul, Korea
Supra-therapeutic MAD study
safety and PK study
NCT01154790 48 Completed Seoul, Korea
2
Placebo controlled proof-of-concept study NCT00530452 248 Completed EU
Celecoxib controlled dose finding study NCT01341405 125 Completed Seoul, Korea
3
Placebo and Celecoxib controlled pivotal
Ph 3 efficacy & safety for approval
and extended safety study
NCT01765296 362 Completed Seoul, Korea
15. 1
Compiled Summary of Completed Studies
Clinical Studies Summary
Phase 1 studies
• Dose dependent exposure observed.
• No significant PK differences among different ethnic and gender groups.
• Clearly differentiated whole blood vs. plasma distribution of polmacoxib – Proof of
polmacoxib-CA binding (75 80x higher conc. in whole blood vs. plasma).∼
• No drug-drug interaction observed.
• Stable blood pressure maintained throughout entire duration of clinical studies
• Absence of significant side effects even in the supra-therapeutic MAD Study
• Cardiovascular safety – Various measurements including ECG, Holter monitoring, vital
signs, and blood chemistry lab tests did not indicate signs of CV adverse events.
• Gastrointestinal safety – Absence of significant GI adverse events
Phase 2a study
• Clinically significant efficacious dose = 1.2 mg per day
• No drop outs due to lack of efficacy
• Maintenance of stable blood pressure throughout entire study
16. 1
Compiled Summary of Completed Studies
Clinical Studies Summary
Phase 2b study
• Non-inferiority tests: polmacoxib 2 mg/day and 4 mg/day vs. celecoxib 200 mg/day
• Uniform dosing on Days 1-28 (no loading dose)
• Very high study drug compliance rates (81-85% in all groups)
• Few dropouts (93-95% completion rate among all 3 treatment arms)
• Polmacoxib 2 mg and 4 mg were non-inferior to celecoxib 200 mg for all efficacy
measures
• Polmacoxib 2 mg dose produced higher efficacy than celecoxib 200 mg, though not
statistically significant (study was not powered for superiority)
• No drop outs due to lack of efficacy
• Polmacoxib 2 mg has a favorable adverse effect profile (comparable to celecoxib 200 mg)
• Polmacoxib 2 mg dose selected for Phase 3 clinical studies
Phase 3 study
• Effficacy (6 week study)
Superiority of polmacoxib 2 mg once-daily vs. placebo
Non-inferiority of polmacoxib 2 mg once-daily vs. celecoxib 200 mg once-daily
• Long Term Safety (6 month study)
No drug-related serious adverse events in either of the polmacoxib or celecoxib groups.
Most of the adverse events were mild to moderate and were expected to happen in this
type of trial.
18. 1
Phase III Study: Study Title & The Objectives
Study Title:
A Double-blind, Randomized, Multicenter, Active- and Placebo-Controlled Phase III
Study to Evaluate the Efficacy and Safety of CG100649 in Osteoarthritis Patients
Objectives:
The objective of the 6-week Efficacy Study was to evaluate the safety and
non-inferiority of the analgesic efficacy of polmacoxib (formerly CG100649) 2 mg
vs. celecoxib 200 mg, and the analgesic superiority of polmacoxib 2 mg vs.
placebo, when administered once daily in subjects with osteoarthritis of
the hip or knee over the 6 week treatment period.
The objective of the Extension Study was to collect a total of 24 weeks of
safety data for those subjects who agreed to continue into the extension.
Study Title and the Objectives of the Study
19. 1
Acelex®
, Phase III Study Results
71.9% of subjects taking Acelex experienced improvement in
signs and symptoms of osteoarthritis
*PGA (Physician’s Global Assessment ): Evaluation of the test subjects by the investigators (physicians)
Acelex showed SUPERIOR EFFICACY over celecoxib with statistical significance (p = 0.005)
Overall improvement of signs and symptoms of osteoarthritis in terms of PGA* scores at week 3
20. 2
Acelex®
, Phase III Study Results
Acelex showed QUICKER ONSET OF RELIEF from osteoarthritis symptoms over celecoxib
Acelex showed statistically significant superiority over placebo at
Week 3 (p=0.003), but celecoxib did NOT show statistically
significant differentiation from placebo at Week 3 (p=0.069)
WOMAC Physical Function scores at Week 3
Acelex demonstrated non-inferior or better efficacy against celecoxib in all other efficacy endpoints
including WOMAC-pain and –stiffness subscales at week-3 and week-6
21. 2
Safety Results from the 6-week Efficacy Study
There were no drug-related serious adverse events in either of the polmacoxib or
celecoxib treatment groups.
Most of the adverse events were mild to moderate and were expected to happen
in this type of trial.
There were no statistically significant differences in all three groups.
Phase III Study: Safety (6-week Treatment Period)
22. 2
Polmacoxib has successfully met the clinical study endpoints as the 2 mg dose of
polmacoxib was tolerated well and based on the results of the 6 week treatment period,‑
polmacoxib 2 mg demonstrated analgesic efficacy and safety similar to that of celecoxib
200 mg, and analgesic superiority over that of placebo.
However, based on the secondary endpoints of WOMAC-Physical function at Week 3 and
PGA at Week 3, the efficacy profile of polmacoxib was superior in comparison with
celecoxib. This suggests that polmacoxib 2 mg achieves a quicker onset of relief from the
signs and symptoms of osteoarthritis compared to celecoxib 200 mg.
The Treatment Emergent Adverse Events (TEAEs) were reported in this study were
generally mild and of the type expected for COX-2 inhibitor drugs.
There were no clinically meaningful or statistically significant differences in the number of
TEAEs among the groups treated with polmacoxib 2 mg, celecoxib 200 mg or placebo.
Phase III Study: Conclusions (6-week Treatment Period)
Conclusions
23. 2
Phase III Study: Extended Safety Study
Safety Conclusions from Safety Extension Study (24 weeks)
• Only polmacoxib 2mg administered (open-label, single arm)
There were no drug-related serious adverse events.
During the safety extension study, the 2mg dose of polmacoxib was tolerated well
and TEAEs were generally mild.
There were no notable increases in the incidence of any TEAEs during the 18-week
safety extension period, or the combined 24-week extended safety period.
There were no clinically relevant findings in the analysis of clinical laboratory tests,
vital signs, ECGs, or physical examination results.
24. 2
Category Projected Advantages of Acelex
Efficacy
• Demonstrated quicker onset of relief from the signs and symptoms of OA over Celebrex.
• Achieved superior PGA (Physicians Global Assessment) scores, than Celebrex with
statistically significance, an efficacy endpoint for measuring the physicians’ perception of
patient improvement in terms of the OA signs and symptoms.
Dose
• Able to achieve therapeutic efficacy (OA) with only 2 mg/day dose, the lowest dose
among all known NSAIDs (both non-selective and selective COX-2 inhibitors).
Administration
Frequency
• Convenient once-a-day dosing regimen
→ The administration frequencies of most commercially available traditional NSAIDs and
incrementally modified NSAID containing products for OA range between b.i.d (twice
daily) through t.i.d (three times daily).
Gastrointestinal
Side Effects
• Acelex has significantly improved GI safety profile in comparison with other commercially
available NSAIDs.
• The GI safety profile of Acelex eliminates the need for concomitant administration of GI
protectant agents.
Cardiovascular
Side Effects
• Acelex’s unique mode of action is projected to provide a meaningful enhancement of
cardiovascular safety from currently available NSAID products.
Product Profile of Acelex
25. 2
Launch of 2 mg
Capsule 2015
Generic Entry Block
2026~2034
• Launch in Korea
• Export or Out-Licensing
• Expansion of Acelex portfolio through development of combination products,
incrementally modified products, new dosage forms, and additional indications.
• Goal is to maintain exclusive position up to 2026~2034 and maximize revenues.
Acelex®
, Lifecycle Management Strategy
Strengthening of the Acelex brand name through launch of multiple products
26. 2
CrystalGenomics, Inc.
5th
F. Bldg.A, Korea Bio Park
700 Daewangpangyo-ro, Bundang-gu,
Seongnam-si, Gyeonggi-do 463-400
Korea
CG Pharmaceuticals, Inc.
5980 Horton Street, Suite 610
Emeryville, CA 94608
U.S.A.