DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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PHASE 1- MGL-3196 (VIA-3196)Madrigal Pharmaceuticals, to treat high cholesterol/high triglycerides
MGL-3196 (VIA-3196) photo credit The haystack http://cenblog.org/the-haystack/tag/mgl-3196/
Madrigal Pharmaceuticals, acquired from VIA Pharmaceuticals, licensed from Roche to treat high cholesterol/high triglycerides , it mimics thyroid hormone, targeted to thyroid hormone receptor beta in the liver
Specifically, MGL-3196 is a thyroid hormone analog, designed to target a thyroid hormone receptor in the liver. These receptors regulate genes involved in cholesterol regulation and metabolism.
MGL-3196 is an orally administered, small-molecule liver-directed ß-selective THR agonist designed to specifically target receptors in the liver involved in metabolism and cholesterol regulation, and avoid side effects associated with thyroid hormone receptor activation outside the liver, including those mediated by THR-α receptors. MGL-3196 has currently completed Phase I single and multiple dose trials in healthy volunteers. MGL-3196 is being developed for dyslipidemia/hypercholesterolemia to lower LDL cholesterol, triglyceride levels and Lp(a), and was inlicensed from Roche Pharmaceuticals. MGL-3196 has excellent safety in comparative studies with other THR agonists tested previously because of MGL-3196’s high liver uptake and high ß-selectivity and nearly complete lack of THR-α activity.
MGL-3196 has completed a single ascending dose study in healthy volunteers in which the compound appeared safe at all doses tested. The multiple ascending dose study in healthy volunteers with mildly elevated LDL cholesterol was completed in October 2012 and provided additional safety and pharmacodynamic information. The Phase I multiple dose, proof of concept study enrolled 48 healthy volunteers with mildly elevated LDL cholesterol to evaluate the safety, pharmacokinetics and pharmacodynamics of MGL-3196 after two weeks of daily dosing. Results showed that MGL-3196 was well tolerated and appeared safe at all doses tested. Daily doses of 50-200 mg showed highly statistically significant reductions relative to placebo of up to 30% LDL-cholesterol (p=.05-<.0001; 28%, non-HDL cholesterol (p=.027-.0001); 24% Apolipoprotein B (p=.008-.0004); and strong trends and up to 60% reduction of triglycerides (range, p=.13-.016).
phase 2-LGX818, Novartis Research Foundation to treat melanoma with a specific mutation in B-RAF kinase V600E
LGX818
Methyl [(2S)-1-{[4-(3-{5-chloro-2-fluoro-3-[(methylsulfonyl)amino]phenyl}-1-isopropyl-1H-pyrazol-4-yl)-2-pyrimidinyl]amino}-2-propanyl]carbamate
Novartis Institutes for Biomedical Research and Genomics Institute of the Novartis Research Foundation to treat melanoma with a specific mutation in B-RAF kinase V600E, selective mutant B-RAF kinase inhibitor
LGX818 is currently in Phase Ib/II clinical trials. Patients with colon cancer or melanoma with the BRAF mutation, including patients resistant to other BRAF-targeted drugs, are receiving LGX818 pills alone or as part of drug cocktails to determine whether the drug is safe and efficacious
A phase Ib/II drug structure by Novartis disclosed at the spring 2013 American Chemical Society meeting in New Orleans to treat melanoma with a V600E mutation in the B-RAF kinase which it inhibits.[1][2][3]
Several clinical trials of LGX818 , either alone or in combinations with the MEK inhibitorMEK162[4], CDK4 inhibitor LEE011[5] are being run. The initial results are encouraging [6].
- C. Drahl, Liveblogging First-Time Disclosures of Drug Structures from #ACSNOLA, 2013, http://cenblog.org/the-haystack/2013/04/liveblogging-first-time-disclosures-of-drug-structures-from-acsnola/
- http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2011023773
- http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2011025927
- http://www.cancer.gov/clinicaltrials/search/view?cdrid=728588&version=HealthProfessional&protocolsearchid=11645832
- http://www.cancer.gov/clinicaltrials/search/view?cdrid=745927&version=HealthProfessional&protocolsearchid=11645832
- http://www.novartis.com/downloads/investors/event-calendar/2012/6-bridging-science-and-patients.pdf
PHASE 1-BMS-906024 by Bristol-Myers Squibb to treat breast, lung, and colon cancers and leukemia
BMS-906024 is in Phase I clinical trials, both alone and in combination with other agents. Patients with colon, lung, breast, and other cancers are receiving intravenous doses of the compound to determine its safety and optimum dose ranges
New Phase I drug structure by Bristol-Myers Squibb disclosed at the spring 2013American Chemical Society meeting in New Orleans to treat breast, lung, and colon cancers and leukemia.[1] The drug works as an pan-Notch inhibitor. The structure is one of a set patented in 2012,[2] and it currently being studied in clinical trials.[3][4]
- C. Drahl, Liveblogging First-Time Disclosures of Drug Structures from #ACSNOLA, 2013, http://cenblog.org/the-haystack/2013/04/liveblogging-first-time-disclosures-of-drug-structures-from-acsnola/
- http://patentscope.wipo.int/search/en/detail.jsf?docId=WO2012129353
- http://clinicaltrials.gov/show/NCT01653470
- http://clinicaltrials.gov/show/NCT01292655
Phase 2, AZD5423 BY ASTRAZENECA FOR COPD
AZD5423
The compound is now in a Phase II study in patients with COPD, where its efficacy and safety are being measured against that of a typical steroid or a placebo
A phase II drug structure by AstraZeneca disclosed at the spring 2013 American Chemical Society meeting in New Orleans to treat respiratory diseases and in particular the chronic obstructive pulmonary disease.[1][2][3][4]
- C. Drahl, Liveblogging First-Time Disclosures of Drug Structures from #ACSNOLA, 2013, http://cenblog.org/the-haystack/2013/04/liveblogging-first-time-disclosures-of-drug-structures-from-acsnola/
- GB2010051905 COMBINATIONS COMPRISING A GLUCOCORTICOID RECEPTOR MODULATOR FOR THE TREATMENT OF RESPIRATORY DISEASES
- SE2009050900 A COMBINATION OF (A) GLUCOCORTICOID RECEPTOR MODULATOR AND (B) A MUSCARINIC ANTAGONIST
- SE2009000264 COMBINATION OF (A) GLUCOCORTICOID RECEPTOR MODULATOR AND (B) A B2-AGONIST
EU OKs Sanofi’s 6 in 1 Pediatric Vaccine
Hexyon/ Hexyon/Hexyon/Hexyon/ Hexacima Hexacima Hexacima 6-in -1 Pediatric Vaccine 1 Pediatric Vaccine 1 Pediatric Vaccine1 Pediatric Vaccine 1 Pediatric Vaccine Approved in Europe
Hexyon/Hexacima is the only fully liquid, ready-to-use, 6-in-1 pediatric vaccine –
Lyon, France – April 22, 2013 – Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the European Commission approved Sanofi Pasteur’s 6-in-1 pediatric vaccine HexyonTM/Hexacima® (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age.
HexyonTM/Hexacima® is the only fully liquid, ready-to-use, 6-in-1 vaccine to protect infants against diphtheria, tetanus, pertussis (whooping cough), Hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b…………………….read more at pharmalive
http://www.pharmalive.com/eu-oks-sanofis-6-in-1-pediatric-vaccine
also read at
AstraZeneca inks cancer deals with Bind and Horizon
AstraZeneca has signed a nanomedicines pact with Bind Therapeutics in a deal which could be worth $200 million to the privately-held US biopharma firm.
The firms will work together to develop what Bind calls an “Accurin”, a targeted and programmable cancer nanomedicine, based on a kinase inhibitor owned by the Anglo-Swedish drugmaker……………………..READ MORE AT PHARMATIMES
http://www.pharmatimes.com/Article/13-04-22/AstraZeneca_inks_cancer_deals_with_Bind_and_Horizon.aspx
NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events
NICE has given a provisional green light for Bayer’s blood thinner Xarelto for help patients with thrombotic events
NICE IS
National Institute for Health and Care Excellence
Developing a series of national clinical guidelines to secure consistent, high quality, evidence based care for patients using the National Health Service in
April 22, 2013
READ MORE AT PHARMATIMES
http://www.pharmatimes.com/Article/13-04-22/Xarelto_gains_NICE_thumbs_up_for_DVT_licence.aspx
RIVAROXABAN
Rivaroxaban (BAY 59-7939) is an oral anticoagulant invented and manufactured by Bayer; in a number of countries it is marketed as Xarelto. In the United States, it is marketed by Janssen Pharmaceutica. It is the first available orally active direct factor Xa inhibitor. Rivaroxaban is well absorbed from the gut and maximum inhibition of factor Xa occurs four hours after a dose. The effects lasts 8–12 hours, but factor Xa activity does not return to normal within 24 hours so once-daily dosing is possible. There is no specific way to reverse the anticoagulant effect of rivaroxaban in the event of a major bleeding event, unlike warfarin
In September 2008, Health Canada granted marketing authorization for rivaroxaban as one 10 mg tablet taken once daily for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery.
In September 2008, the European Commission granted marketing authorization of rivaroxaban for the prevention of venous thromboembolism in adult patients undergoing elective hip and knee replacement surgery. In December 2011 rivaroxaban has been approved by the European Commission for use in two new indications: prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors and treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults.
On July 1, 2011, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adults undergoing hip and knee replacement surgery. On November 4, 2011, the U.S. FDA approved rivaroxaban for stroke prophylaxis in patients with non-valvular atrial fibrillation. On November 2, 2012, the U.S. Food and Drug Administration (FDA) approved rivaroxaban for the treatment of patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) and for long-term treatment to prevent recurrence.
Cipla launches first Biosimilar of Etanercept in India under brand name ‘ETACEPT’
Etanercept
is made from the combination of two naturally occurring soluble human 75-kilodalton TNF receptors linked to an Fc portion of an IgG1. The effect is an artificially engineered dimeric fusion protein.
| Wed, Apr 17 2013 |
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Cipla, the fifth largest pharma company in India with consolidated net sales of Rs.6,800 crore plus, has launched the first biosimilar of Etanercept in India; under the brand name ‘ETACEPT’ for the treatment of rheumatic disorders. Formed through a partnership alliance, ETACEPT is manufactured by a China-based company Shanghai CP Guojian Pharmaceutical Co. Ltd., which will be marketed by Cipla in India. The introduction of Etacept now signals Cipla’s entry into the Biologic segment offering an option to the patients suffering from rheumatic disorders at a lower cost. Etacept is available as a lyophilized powder to be given by subcutaneous injection. It is available with stockists across the country at Rs.6,150 and the recommended dose for adults is 25mg twice weekly by subcutaneous injection. READ MORE AT PHARMABIZ http://www.pharmabiz.com/NewsDetails.aspx?aid=74842&sid=2
Etanercept (trade name Enbrel) is a biopharmaceutical that treats autoimmune diseases by interfering with tumor necrosis factor (TNF; a soluble inflammatory cytokine) by acting as a TNF inhibitor. It has U.S. F.D.A. approval to treat rheumatoid, juvenile rheumatoid andpsoriatic arthritis, plaque psoriasis and ankylosing spondylitis. TNF-alpha is the “master regulator” of the inflammatory (immune) response in many organ systems. Autoimmune diseases are caused by an overactive immune response. Etanercept has the potential to treat these diseases by inhibiting TNF-alpha. Etanercept is a fusion protein produced by recombinant DNA. It fuses the TNF receptor to the constant end of the IgG1 antibody. First, the developers isolated the DNA sequence that codes the human gene for soluble TNF receptor 2, which is a receptor that binds to tumor necrosis factor-alpha. Second, they isolated the DNA sequence that codes the human gene for the Fc end of immunoglobulin G1 (IgG1). Third, they linked the DNA for TNF receptor 2 to the DNA for IgG1 Fc. Finally, they expressed the linked DNA to produce a protein that links the protein for TNF receptor 2 to the protein for IgG1 Fc. The prototypic fusion protein was first synthesized and shown to be highly active and unusually stable as a modality for blockade of TNF in vivo in the early 1990s by Bruce A. Beutler, an academic researcher then at the University of Texas Southwestern Medical Center at Dallas, and his colleagues.[2][3][4] These investigators also patented the protein, selling all rights to its use to Immunex, a biotechnology company that was acquired by Amgen in 2002. It is a large molecule, with a molecular weight of 150 kDa., that binds to TNFα and decreases its role in disorders involving excess inflammation in humans and other animals, including autoimmune diseases such as ankylosing spondylitis, juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis, rheumatoid arthritis, and, potentially, in a variety of other disorders mediated by excess TNFα. In North America, etanercept is co-marketed by Amgen and Pfizer under the trade name Enbrel in two separate formulations, one in powder form, the other as a pre-mixed liquid. Wyeth is the sole marketer of Enbrel outside North America excluding Japan whereTakeda Pharmaceuticals markets the drug. Etanercept is an example of a protein-based drug created using the tools of biotechnologyand conceived through an understanding afforded by modern cell biology. |
FDA OKs Sun Pharma for Generic Januvia, Glumetza
Sun Pharma announces tentative USFDA approvals for generic Januvia® and generic Glumetza®
SUNPHARMA, BSE: 524715) announced that the US FDA has granted its subsidiary, two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia®, Sitagliptin Tablets and generic version of Glumetza®, Metformin HCl Extended-release tablets.
read more at pharmalive
http://www.pharmalive.com/fda-oks-sun-pharma-for-generic-januvia-glumetza
Ceregene announces top-line data from CERE-120 Phase 2b clinical study for Parkinson’s disease
Ceregene, Inc. today announced the top-line data from its double-blind, randomized, controlled Phase 2b clinical study of CERE-120 (AAV-neurturin), a gene therapy product designed to deliver the neurotrophic factor neurturin, for Parkinson’s disease……………read more at
New Drug Approvals 