WORLD DRUG TRACKER – Page 16

Celgene arthritis drug maintains efficacy at 52 weeks-study

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Jun 132013

apremilast

Celgene arthritis drug maintains efficacy at 52 weeks-study
Reuters
The U.S. biotechnology company had previously released positive data from the 500-patient Phase III trial called Palace-1 that compared its drug, apremilast, to a placebo through 16 weeks of treatment. The data being presented at the European League …

http://in.reuters.com/article/2013/06/11/celgene-arthritis-idINL2N0EN21P20130611

Apremilast is an orally available small molecule inhibitor of PDE4 being developed by Celgene for ankylosing spondylitis, psoriasis, and psoriatic arthritis.The drug is currently in phase III trials for the three indications. Apremilast, an anti-inflammatory drug, specifically inhibits phosphodiesterase 4. In general the drug works on an intra-cellular basis to moderate proinflammatory and anti-inflammatory mediator production.

Medical Use [Apremilast is being tested for its efficacy in treating “psoriasis, psoriatic arthritis and other chronic inflammatory diseases such as ankylosing spondylitis, Behcet’s disease, and rheutmatoid arthritis.”

Apremilast is being tested for its efficacy in treating “psoriasis, psoriatic arthritis and other chronic inflammatory diseases such as ankylosing spondylitis, Behcet’s disease, and rheutmatoid arthritis.”

Generic Licensing News, Featured product, Bosentan

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Jun 122013

Generic Licensing News

http://www.leadformix.com/ef1/preview_campaign.php?lf1=900485181e199412625317a3906967

Click here to contact Zack Systems SpA about this product.

BOSENTAN

Bosentan is a dual endothelin receptor antagonist important in the treatment of pulmonary artery hypertension (PAH).

Bosentan belongs to a class of drugs known as endothelin receptor antagonists (ERAs). Patients with PAH have elevated levels of endothelin, a potent blood vessel constrictor, in their plasma and lung tissue. Bosentan blocks the binding of endothelin to its receptors, thereby negating endothelin’s deleterious effects.

bosentan

Bosentan is a dual endothelin receptor antagonist used in the treatment of pulmonary artery hypertension (PAH). It is licensed in the United States, the European Union and other countries by Actelion Pharmaceuticals for the management of PAH under the trade name Tracleer.

Bosentan is indicated mainly for the treatment of pulmonary hypertension. In 2007, bosentan was approved in the European Union also for reducing the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.Bosentan is a competitive antagonist of endothelin-1 at the endothelin-A (ET-A) and endothelin-B (ET-B) receptors. Under normal conditions, endothelin-1 binding of ET-A or ET-B receptors causes pulmonary vasoconstriction. By blocking this interaction, bosentan decreases pulmonary vascular resistance. Bosentan has a slightly higher affinity for ET-A than ET-B.

In the United States, bosentan is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO Class II-IV symptoms, to improve exercise capacity and decrease the rate of clinical worsening.^[1]

Warnings

Due to potential hepatotoxicity, the FDA requires monthly monitoring of liver function tests while taking Bosentan.

Bosentan use requires hematocrit monitoring due to potential onset of anemia. ^[2]

Hormone-based contraception is not possible in women taking Bosentan, due to a pharmacokinetic interaction. ^[3]

Bosentan is absolutely contraindicated in pregnancy because of its teratogenicity. Category X.

volleyball

ViroPharma Receives Orphan Drug Designation For Maribavir In Europe

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Jun 122013

Maribavir

ViroPharma Receives Orphan Drug Designation For Maribavir In Europe
The Herald | HeraldOnline.com
We commend the European Commission for providing incentives such as this for the development of drugs for rare and life threatening diseases.” ViroPharma is currently conducting two Phase 2 dose ranging studies of oral maribavir at one of three doses …

read all at

http://www.heraldonline.com/2013/06/11/4934867/viropharma-receives-orphan-drug.html

Maribavir (originally named 1263W94) is an experimental oral antiviral drug candidate licensed by ViroPharma from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus (HCMV) disease in hematopoietic stem cell/bone marrow transplant patients. The mechanism by which maribavir inhibits HCMV replication is by inhibition of an HCMV encoded protein kinase enzyme called UL97 or pUL97. Maribavir showed promise in Phase II clinical trials and was granted fast track status, but failed to meet study goals in a Phase III trial. However, the dosage used in the Phase III trial may have been too low to be efficacious.

A Phase II study with maribavir demonstrated that prophylaxis with maribavir displayed strong antiviral activity, as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell/bone marrow transplants. In an intent-to-treat analysis of the first 100 days after the transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced with maribavir compared to placebo.

ViroPharma conducted a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplant patients. In February 2009, ViroPharma announced that the Phase III study failed to achieve its goal, showing no significant difference between maribavir and a placebo at reducing the rate at which CMV DNA levels were detected in patients.

Promising Results in Clinical Study for Acne Drug Candidate

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Jun 122013

Promising Results in Clinical Study for Acne Drug Candidate
SkinInc.com
Novan Therapeutics,announced results from a recent clinical trial demonstrating that nitric oxide releasing drug candidate SB204 reduces colonization of the acne causing bacteria Propionibacterium acnes (P. acnes) in the skin of healthy volunteers. This study in combination with Novan’s earlier findings regarding sebum production, suggests the formulation may be capable of targeting multiple factors in acne.

read all at

http://www.skininc.com/skinscience/ingredients/Promising-Results-in-Clinical-Study-for-Acne-Drug-Candidate-211007471.html

Ariad begins Phase 2 trial of Iclusig to treat GI tumors

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Jun 122013

Ponatinib

Ariad begins Phase 2 trial of Iclusig to treat GI tumors

Boston Business Journal (blog)

Ariad Pharmaceuticals, Inc. has launched a Phase 2 trial to test its approved leukemia drug Iclusig as a potential treatment for gastrointestinal stromal tumors (GIST).

The Cambridge, Mass-based company’s drug was approved by the U.S. Food and Drug Administration in December 2012. It’s approved to treat certain patients chronic myeloid leukemia (CML) that is resistant or intolerant to other drugs and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

read all at

http://www.bizjournals.com/boston/blog/bioflash/2013/06/ariad-trial-cancer-drug.html

Dr. Reddy’s Laboratories–An Efficient and Telescopic Process for Valsartan, an Angiotensin II Receptor Blocker

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Jun 042013

An efficient, telescopic, and scalable process for an antihypertensive drug substance, valsartan with an overall yield of 58%, and 99.9% purity is described. A simple, and safe process is developed for the recovery of tributyltin chloride from the tributyltin hydroxide, byproduct formed in the tetrazole ring construction, and reused in the synthesis of valsartan.

Dr. Reddy’s Laboratories

Org. Process Res. Dev., 2012, 16 (4), pp 682–686

DOI: 10.1021/op3000306

Publication Date (Web): March 5, 2012

http://pubs.acs.org/doi/abs/10.1021/op3000306

Clovis Oncology Shares Double on Trial Data for Cancer Drug,CO-1686

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Jun 042013

Colorado-based Clovis said in a statement today. The drug, CO-1686, is in the first of three phases of testing typically required before U.S. regulatory approval.

http://www.businessweek.com/news/2013-06-03/clovis-oncology-shares-almost-double-on-ovarian-drug-trial-data

by WORLD DRUG TRACKER

DR ANTHONY CRASTO

Isis Pharmaceuticals, Inc.announced that data from the Phase 1 study of ISIS-STAT3Rx in patients with cancer were presented today at the American Society of Clinical Oncology in Chicago

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Jun 042013

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced that data from the Phase 1 study of ISIS-STAT3Rx in patients with cancer were presented today at the American Society of Clinical Oncology in Chicago. Results of the initial dose escalation study in patients with metastatic cancer showed that ISIS-STAT3Rx treatment resulted in partial responses that were durable and prolonged in two out of three patients with diffuse large B-cell lymphoma (DLBCL) who were refractory to prior chemotherapy treatments. Isis and AstraZeneca are currently evaluating ISIS-STAT3Rx, in two clinical studies in patients with advanced lymphoma and metastatic liver cancer.

Selumetinib is the first drug ever to show significant benefit for patients with advanced uveal melanoma

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Jun 042013

Two Array Invented MEK Inhibitors Showcased At ASCO
Sacramento Bee
AstraZeneca began a pivotal trial with selumetinib (an Array-invented drug) in thyroid cancer in May 2013 and expects to begin a Phase 3 trial in non-small cell lung cancer during the second half of 2013.

http://www.sacbee.com/2013/06/03/5466446/two-array-invented-mek-inhibitors.html

Two Array BioPharma-invented MEK inhibitors, selumetinib and MEK162, were showcased at the 49th annual meeting of the American Society of Clinical Oncology (ASCO).

by WORLD DRUG TRACKER

DR ANTHONY CRASTO

Experimental Drug Shows Benefits Against Melanoma in Early Study, Lambrolizumab activates body’s immune system to kill cancerous cells, researchers say

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Jun 032013

Experimental Drug Shows Benefits Against Melanoma in Early Study
U.S. News & World Report
SUNDAY, June 2 (HealthDay News) — A new drug called lambrolizumab appears to improve outcomes in patients with advanced melanoma, according to the results of a phase 1 trial. Lambrolizumab is an antibody that works by revealing the cancer to the immune system so it can mount a response and kill the cancer cells with few serious side effects, the researchers said.

read all at

http://health.usnews.com/health-news/news/articles/2013/06/02/experimental-drug-shows-benefits-against-melanoma-in-early-study

by WORLD DRUG TRACKER

DR ANTHONY CRASTO