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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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Niche play, alliances hold promise for Biocon
DR KIRAN SHAW MAXUMDAR
MD BIOCON
Niche play, alliances hold promise for Biocon
While biosimilar opportunity in the regulated markets is likely to play out in the medium term, its existing biopharma and branded portfolio will ensure growth in the short term
Niche play, alliances hold promise for Biocon
Business Standard
Innovator sales for these two drugs are pegged at $10 billion which is slightly over half of the worldwide insulin market of $19 billion.On the monoclonal antibody front, the company is in phase III for the cancer drug Trastuzumab which has a market …
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HIV/AIDS vaccine passes Phase 1 clinical trial in humans
HIV/AIDS vaccine passes Phase 1 clinical trial in humans
DVICE
While other HIV/AIDS vaccines that haven’t used killed whole viruses (relying instead on targeting specific components of HIV) have failed in Phase 3 trials, Sumagen is optimistic about their drug because other successful vaccines (including polio …read all at
http://www.dvice.com/2013-9-4/hivaids-vaccine-passes-phase-1-clinical-trial-humans
European Approval for Glaxos Tafinlar
European Approval for Glaxos Tafinlar
Zacks.com
GlaxoSmithKline (GSK – Analyst Report) recently announced that its melanoma drug, Tafinlar, has been cleared by the European Commission (EC). Tafinlar is indicated as a monotherapy for treating adults suffering from unresectable or metastatic melanoma with a BRAF V600 mutation
The approval came on the basis of encouraging data from several multi-center global trials including the phase III BREAK-3 study. We remind investors that … Currently approved melanoma drugs include Zelboraf and Yervoy. Glaxo carries a Zacks Rank #3 …http://www.zacks.com/stock/news/108341/european-approval-for-glaxos-tafinlar
Cytokinetics: Clinical Investigators’ Opinions On ATOMIC-AHF Trial Results
omecamtiv mecarbil
Cytokinetics, Inc. (CYTK): Cytokinetics: Clinical Investigators’ Opinions On …
Seeking Alpha
Pending the results of the ongoing COSMIC-HF trial in 1H, 2014, I believe that the ATOMIC-AHF results support moving omecamtiv mecarbil into Phase III. With success in the Phase III, omecamtiv mecarbil would likely be a several billion drug. I regard …http://seekingalpha.com/article/1672892-cytokinetics-clinical-investigators-opinions-on-atomic-ahf-trial-results?source=google_news
Omecamtiv mecarbil (INN), previously codenamed CK-1827452, is a cardiac specific myosin activator. It is clinically tested for its role in the treatment of left ventricular systolic heart failure.[1] Systolic heart failure is characterised as a decreased cardiac output (<40% ejection fraction), due to decreased stroke volume, resulting in the inability to meet the metabolic demands of the body.[2] The loss of contraction is caused by a reduced number of effective actin-myosin cross bridges in the left ventricular myocytes. One possible underlying mechanism is altered signal transduction that interferes with excitation-contraction coupling.[3] A decreased cardiac output causes peripheral hypotension and activation of the sympathetic nervous system.[2] This in turn stimulates the cardiac myocytes excessively, eventually leading to left ventricular hypertrophy, characteristic of chronic heart failure. Some symptoms of systolic heart failure are fatigue, peripheral oedema, dyspnoea, exercise intolerance and breathlessness.[2] Current inotropic drug therapies such as dobutamine, are palliative and not a cure. They also cause many adverse effects including arrhythmias related to increased myocardical oxygen consumption, desensitization of adrenergic receptors and altering intracellular calcium levels.[4] Thus systolic heart failure is considered malignant, however the novel mechanism of Omecamtiv Mecarbil is a hopeful long-term resolution.
Mechanism of action
Cardiac myocytes contract through a cross-bridge cycle between the myofilaments, actin and myosin. Chemical energy in the form of ATP is converted into mechanical energy which allows myosin to strongly bind to actin and produce a power stroke resulting in sarcomere shortening/contraction.[3] Omecamtiv Mecarbil specifically targets and activates myocardial ATPase and improves energy utilization. This enhances effective myosin cross-bridge formation and duration, while the velocity of contraction remains the same.[5] It also increases the rate of phosphate release from myosin, thereby accelerating the rate-determining step of the cross-bridge cycle, which is the transition of the actin-myosin complex from the weakly bound to the strongly bound state.[1] The overall result of Omecamtiv Mecarbil is an increase in left ventricular systolic ejection time, sarcomere shortening and stroke volume, while the systolic pressure remains the same.[5] This causes a decrease in heart rate while myocardial oxygen consumption is unaffected. The increased cardiac output is independent of intracellular calcium and cAMP levels.[4][6] Thus Omecamtiv Mecarbil improves systolic function by increasing the systolic ejection duration/stroke volume, without consuming more ATP energy, oxygen or altering intracellular calcium levels causing an overall improvement in cardiac efficiency.[5]
Clinical trials
Experimental studies on rats and dogs, proved the efficacy and mechanism of action of Omecamtiv Mecarbil.[4] Current clinical studies on humans have shown there is a direct linear relationship between dose and systolic ejection time.[1][7][8] The dose-dependent effects persisted throughout the entire trial, suggesting that desensitization does not occur. The maximum tolerated dose was observed to be an infusion of 0.5 mg/kg/h. Adverse effects, such as ischemia, were only seen at doses beyond this level, due to extreme lengthening of systolic ejection time.[1] Thus due to the unique cardiac myosin activation mechanism, Omecamtiv Mecarbil could safely improve cardiac function within tolerated doses. Omecamtiv Mecarbil effectively relieves symptoms and enhances the quality of life of systolic heart failure patients. It drastically improves cardiac performance in the short term, however the hopeful long term effects of reduced mortality have yet to be studied.[2][1]
- ^ a b c d e Teerlink, JR (2009). “A novel approach to improve cardiac performance: cardiac myosin activators”. Heart Fail Rev 14 (4): 289–298. doi:10.1007/s10741-009-9135-0. ISSN 1382-4147.
- ^ a b c d Dyke D, Koelling T (2008). “Heart failure due to left ventricular systolic dysfunction”. In Eagle KA, Baliga RR. Practical Cardiology. Philadelphia: Lippincott Williams & Wilkins. pp. 246–285. ISBN 978-0-7817-7294-5.
- ^ a b Bers, DM (Jan 2002). “Cardiac excitation-contraction coupling”. Nature 415 (6868): 198–205. doi:10.1038/415198a. PMID 11805843.
- ^ a b c Shen YT, Malik FI, Zhao X, Depre C, Dhar SK, Abarzúa P, Morgans DJ, Vatner SF (Jul 2010). “Improvement of cardiac function by a cardiac myosin activator in conscious dogs with systolic heart failure”. Circ Heart Fail 3 (4): 522–7. doi:10.1161/CIRCHEARTFAILURE.109.930321. PMID 20498236.
- ^ a b c Malik F, Teerlink J, Escandon R, Clake C, Wolff A (2006). “The Selective Cardiac Myosin Activator, CK-1827452, a Calcium-Independent Inotrope, Increases Left Ventricular Systolic Function by Increasing Ejection Time Rather than the Velocity of Contraction”. Circulation 114 (18 Suppl): 441.
- ^ Teerlink JR, Metra M, Zacà V, Sabbah HN, Cotter G, Gheorghiade M, Cas LD (Dec 2009). “Agents with inotropic properties for the management of acute heart failure syndromes. Traditional agents and beyond”. Heart Fail Rev 14 (4): 243–53. doi:10.1007/s10741-009-9153-y. PMID 19876734.
- ^ Teerlink JR, Clarke CP, Saikali KG, Lee JH, Chen MM, Escandon RD, Elliott L, Bee R, Habibzadeh MR, Goldman JH, Schiller NB, Malik FI, Wolff AA (Aug 2011). “Dose-dependent augmentation of cardiac systolic function with the selective cardiac myosin activator, omecamtiv mecarbil: a first-in-man study.”. Lancet 378 (9792): 667–75. doi:10.1016/S0140-6736(11)61219-1. PMID 21856480.
- ^ Cleland JG, Teerlink JR, Senior R, Nifontov EM, Mc Murray JJ, Lang CC, Tsyrlin VA, Greenberg BH, Mayet J, Francis DP, Shaburishvili T, Monaghan M, Saltzberg M, Neyses L, Wasserman SM, Lee JH, Saikali KG, Clarke CP, Goldman JH, Wolff AA, Malik FI (Aug 2011). “The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial”. Lancet 378 (9792): 676–83. doi:10.1016/S0140-6736(11)61126-4. PMID 21856481.
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Prof. Dr. Rafael Boritzer
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we are marketers of non-branded recombinant proteins with a primary mission of high quality, low priced material for encouraging biopharma research and development outside of North America. We try to integrate our supply services with education of our clients’ with industry videos and information.
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Antibody lipid treatments enter final furlong
A tiny pain-free jab every two weeks could be the future of cholesterol-lowering for high-risk patients, according to clinical researchers gathered in Amsterdam for the European Society of Cardiology congress.
Eli Roth at the University of Cincinnati said that two companies are currently neck and neck in the race to bring the first PCSK9 antibody to market. Partners Sanofi and Regeneron may have the edge, with Phase III data on their fully human monoclonal antibody alirocumab slated to be presented before the end of the year, while the chief competition comes from Amgen with its antibody AMG 145, said Dr Roth. Both antibodies can be delivered via subcutaneous auto-injectors, which many patients say they prefer to taking daily pills, he added.
http://www.pharmatimes.com/Article/13-09-02/Antibody_lipid_treatments_enter_final_furlong.aspx
Alirocumab is a human monoclonal antibody designed for the treatment ofhypercholesterolemia.[1]
This drug was discovered by Regeneron Pharmaceuticals and is being co-developed by Regeron and Sanofi.
THERAPEUTIC CLAIM Treatment of hypercholesterolemia
CHEMICAL NAMES
1. Immunoglobulin G1, anti-(human neural apoptosis-regulated proteinase 1) (human
REGN727 heavy chain), disulfide with human REGN727 κ-chain, dimer
2. Immunoglobulin G1, anti-(human proprotein convertase subtilisin/kexin type 9
(EC=3.4.21.-, neural apoptosis-regulated convertase 1, proprotein convertase 9,
subtilisin/kexin-like protease PC9)); human monoclonal REGN727 des-448-
lysine(CH3-K107)-1 heavy chain (221-220′)-disulfide with human monoclonal
REGN727 light chain dimer (227-227”:230-230”)-bisdisulfide
MOLECULAR FORMULA C6472H9996N1736O2032S42
MOLECULAR WEIGHT 146.0 kDa
SPONSOR Regeneron Pharmaceuticals
CODE DESIGNATION REGN727, SAR236553
CAS REGISTRY NUMBER 1245916-14-6
Drug Developers Need to More Fully Identify And Address Root Causes Of R&D Inefficiency, According To Tufts Center For The Study Of Drug Development
Boston, MA–(Marketwire) – While patent expirations on many top selling medicines are spurring the research-based drug industry to embrace new development paradigms to replenish sparse R&D pipelines, drug developers need to more fully identify and address root causes of R&D inefficiency, according to the Tufts Center for the Study of Drug Development.
read all at
The Cost Of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change
Susan Desmond-Hellmann
There’s one factor that, as much as anything else, determines how many medicines are invented, what diseases they treat, and, to an extent, what price patients must pay for them: the cost of inventing and developing a new drug, a cost driven by the uncomfortable fact than 95% of the experimental medicines that are studied in humans fail to be both effective and safe.
A new analysis conducted at Forbes puts grim numbers on these costs. A company hoping to get a single drug to market can expect to have spent $350 million before the medicine is available for sale. In part because so many drugs fail, large pharmaceutical companies that are working on dozens of drug projects at once spend $5 billion per new medicine.
read all at
How Much They Cost: R&D Spending Per New Drug
| Company | Number of new drugs | 10 year R&D spending ($MIL) | R&D per drug ($MIL) | |
| 1 | Abbott | 1 | 13183 | 13183 |
| 2 | Sanofi | 6 | 60768 | 10128 |
| 3 | AstraZeneca | 4 | 38245 | 9561 |
| 4 | Hoffmann-La Roche | 8 | 70928 | 8866 |
| 5 | Pfizer | 10 | 77786 | 7779 |
| 6 | Wyeth | 3 | 22702 | 7567 |
| 7 | Eli Lilly | 4 | 26710 | 6678 |
| 8 | Bayer | 5 | 33118 | 6624 |
| 9 | Schering-Plough | 3 | 18845 | 6282 |
| 10 | Novartis | 10 | 60727 | 6073 |
| 11 | Takeda | 4 | 24132 | 6033 |
| 12 | Merck&Co | 9 | 49133 | 5459 |
| 13 | GlaxoSmithKline | 11 | 57595 | 5236 |
| 14 | J&J | 13 | 67624 | 5202 |
| 15 | Novo Nordisk | 2 | 9251 | 4625 |
| 16 | UCB | 1 | 4325 | 4325 |
| 17 | Yamanouchi | 1 | 4321 | 4321 |
| 18 | Fujisawa | 1 | 4286 | 4286 |
| 19 | Amgen | 5 | 21350 | 4270 |
| 20 | Astellas | 3 | 12582 | 4194 |
| 21 | Shionogi | 1 | 3854 | 3854 |
| 22 | Celgene | 2 | 7193 | 3596 |
| 23 | Bristol-Myers Squibb | 9 | 30352 | 3372 |
| 24 | Eisai | 4 | 11534 | 2883 |
| 25 | Teva | 2 | 5763 | 2881 |
| 26 | Biogen Idec | 4 | 9470 | 2368 |
| 27 | Vertex | 2 | 4140 | 2070 |
| 28 | Sunovion | 1 | 1967 | 1967 |
| 29 | Human Genome Sciences | 1 | 1954 | 1954 |
| 30 | Elan | 1 | 1903 | 1903 |
| 31 | Gilead | 3 | 5527 | 1842 |
| 32 | Exelixis | 1 | 1789 | 1789 |
| 33 | Lundbeck | 2 | 3527 | 1763 |
| 34 | Millennium | 1 | 1593 | 1593 |
| 35 | Genentech | 4 | 6277 | 1569 |
| 36 | Allergan | 1 | 1559 | 1559 |
| 37 | Baxter | 3 | 4627 | 1542 |
| 38 | Ipsen | 1 | 1459 | 1459 |
| 39 | Forest | 4 | 5184 | 1296 |
| 40 | Cephalon | 1 | 1221 | 1221 |
| 41 | Onyx | 1 | 1219 | 1219 |
| 42 | Sepracor | 1 | 1170 | 1170 |
| 43 | Alcon | 1 | 1133 | 1133 |
| 44 | Theravance | 1 | 1010 | 1010 |
| 45 | Genzyme | 5 | 4814 | 963 |
| 46 | Shire | 4 | 3827 | 957 |
| 47 | Arena | 1 | 934 | 934 |
| 48 | Watson | 1 | 930 | 930 |
| 49 | Adolor | 1 | 877 | 877 |
| 50 | Valeant | 1 | 844 | 844 |
| 51 | Schwarz | 2 | 1545 | 772 |
| 52 | NPS | 1 | 756 | 756 |
| 53 | Regeneron | 3 | 2149 | 716 |
| 54 | Affymax | 1 | 660 | 660 |
| 55 | Seattle Genetics | 1 | 610 | 610 |
| 56 | CV Therapeutics | 1 | 599 | 599 |
| 57 | ImClone | 1 | 517 | 517 |
| 58 | Dendreon | 1 | 509 | 509 |
| 59 | Alexion | 1 | 490 | 490 |
| 60 | The Medicines Company | 1 | 455 | 455 |
| 61 | Ariad | 1 | 444 | 444 |
| 62 | OSI | 1 | 402 | 402 |
| 63 | Talecris | 1 | 396 | 396 |
| 64 | Progenics | 1 | 356 | 356 |
| 65 | Actelion | 1 | 346 | 346 |
| 66 | Savient | 1 | 339 | 339 |
| 67 | Praecis | 1 | 311 | 311 |
| 68 | Vivus | 1 | 309 | 309 |
| 69 | MGI | 1 | 294 | 294 |
| 70 | Vicuron | 1 | 286 | 286 |
| 71 | Salix | 2 | 560 | 280 |
| 72 | Idenix | 1 | 280 | 280 |
| 73 | Mylan | 3 | 762 | 254 |
| 74 | Discovery Laboratories | 1 | 228 | 228 |
| 75 | Indevus | 1 | 222 | 222 |
| 76 | Cubist | 1 | 220 | 220 |
| 77 | Acorda | 1 | 185 | 185 |
| 78 | Ista | 1 | 171 | 171 |
| 79 | Optimer | 1 | 171 | 171 |
| 80 | Theratechnologies | 1 | 164 | 164 |
| 81 | MediGene | 1 | 155 | 155 |
| 82 | Vanda | 1 | 150 | 150 |
| 83 | Eyetech | 1 | 144 | 144 |
| 84 | ThromboGenics | 1 | 137 | 137 |
| 85 | BioMarin | 3 | 403 | 134 |
| 86 | Protalix | 1 | 125 | 125 |
| 87 | Amarin | 1 | 122 | 122 |
| 88 | Insmed | 1 | 118 | 118 |
| 89 | NeurogesX | 1 | 89 | 89 |
| 90 | Hyperion | 1 | 87 | 87 |
| 91 | Cypress Bioscience | 1 | 82 | 82 |
| 92 | New River | 1 | 79 | 79 |
| 93 | Aegerion | 1 | 74 | 74 |
| 94 | Sucampo | 1 | 62 | 62 |
| 95 | Fibrocell | 1 | 62 | 62 |
| 96 | Tercica | 1 | 49 | 49 |
| 97 | Pharmion | 1 | 47 | 47 |
| 98 | Kamada | 1 | 37 | 37 |
| 99 | Lev | 1 | 26 | 26 |
| 100 | OMRIX | 1 | 15 | 15 |
Hope In A Pill- A crop of small-molecule drugs in development could double the treatment options for people with multiple sclerosis in coming years
EMD Serono
Otsuka Receives Complete Response Letter From U.S. Food And Drug Administration For Tolvaptan For Use In Patients With Autosomal Dominant Polycystic Kidney Disease
Otsuka Pharmaceutical Submits New Drug Application in Japan for Tolvaptan for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
TOLVAPTAN
may 30 2013
- Tolvaptan was discovered by Otsuka in Japan, and its primary results from a global clinical trial involving 1,400 ADPKD patients from 15 countries, which demonstrated a statistically significant reduction in the rate of total kidney volume, were published in New England Journal of Medicine in 2012. It is also currently under a fast track review in the US, following our announcement of FDA accepting to review the application in April 2013.
- ADPKD is a hereditary and often physically and mentally burdensome disease characterized by the development of multiple cysts in the kidneys. ADPKD is often associated with pain, hypertension, decreased kidney function and ultimately, kidney failure that may result in hemodialysis or kidney transplantation.
- There are estimated to be approximately 31,000 ADPKD patients in Japan, and the diagnosed prevalence is estimated to be between 1:1000 and 1:4000 globally.
(Tokyo, Japan, May 30, 2013) – Otsuka Pharmaceutical Co., Ltd. Today announced it filed an application with the Pharmaceutical and Medical Devices Agency in Japan (PMDA) to market its novel compound tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Phase III clinical trial results that form the basis of the regulatory filing were published in the New England Journal of Medicine in November 2012. The MHLW has designated tolvaptan as an Orphan Drug.http://www.otsuka.co.jp/en/release/2013/0603_02.html
Tolvaptan (INN), also known as OPC-41061, is a selective, competitive vasopressin receptor 2 antagonist used to treat hyponatremia (low blood sodium levels) associated withcongestive heart failure, cirrhosis, and the syndrome of inappropriate antidiuretic hormone(SIADH). Tolvaptan was approved by the U.S. Food and Drug Administration (FDA) on May 19, 2009, and is sold by Otsuka Pharmaceutical Co. under the trade name Samsca and in India is manufactured & sold by MSN laboratories Ltd. under the trade name Tolvat & Tolsama.
Tolvaptan is also in fast-track clinical trials[2] for polycystic kidney disease. In a 2004 trial, tolvaptan, when administered with traditional diuretics, was noted to increase excretion of excess fluids and improve blood sodium levels in patients with heart failure without producing side effects such as hypotension (low blood pressure) or hypokalemia(decreased blood levels of potassium) and without having an adverse effect on kidney function.[3] In a recently published trial (TEMPO 3:4 ClinicalTrials.gov number, NCT00428948) the study met its primary and secondary end points. Tolvaptan, when given at an average dose of 95 mg per day over a 3-year period, slowed the usual increase in kidney volume by 50% compared to placebo (2.80% per year versus 5.51% per year, respectively, p<0.001) and reduced the decline in kidney function when compared with that of placebo-treated patients by approximately 30% (reciprocal serum creatinine, -2.61 versus -3.81 (mg/mL)-1 per year, p <0.001)[4]
Chemical synthesis:[5] 
- Shoaf S, Elizari M, Wang Z, et al. (2005). “Tolvaptan administration does not affect steady state amiodarone concentrations in patients with cardiac arrhythmias”. J Cardiovasc Pharmacol Ther 10 (3): 165–71. doi:10.1177/107424840501000304. PMID 16211205.
- Otsuka Maryland Research Institute, Inc.
- Gheorghiade M, Gattis W, O’Connor C, et al. (2004). “Effects of tolvaptan, a vasopressin antagonist, in patients hospitalized with worsening heart failure: a randomized controlled trial”. JAMA 291 (16): 1963–71. doi:10.1001/jama.291.16.1963. PMID 15113814.
- (2012) Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease
- Kondo, K.; Ogawa, H.; Yamashita, H.; Miyamoto, H.; Tanaka, M.; Nakaya, K.; Kitano, K.; Yamamura, Y.; Nakamura, S.; Onogawa, T.; et al.; Bioor. Med. Chem. 1999, 7, 1743.
- http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm350185.htm?source=govdelivery
- Gheorghiade M, Niazi I, Ouyang J et al. (2003). “Vasopressin V2-receptor blockade with tolvaptan in patients with chronic heart failure: results from a double-blind, randomized trial”. Circulation 107 (21): 2690–6. doi:10.1161/01.CIR.0000070422.41439.04.PMID 12742979.
New Drug Approvals 