Archive for the ‘Therapeutic Classification’ Category

Positive Study Results for Aripiprazole Will Lead to NDA

Friday, April 18th, 2014

Aripiprazole-129722-12-9Alkermes excitedly announced extremely positive study data from a Phase 3 trial of Aripiprazole. This randomized, placebo-controlled and double-blind study gleaned better than expected results, leading pharmaceutical executives at Alkermes to set a plan in motion for an NDA by the third quarter of 2014. As a long acting and injectable antipsychotic treatment Aripiprazole Lauroxil is now available as a once a month dosage in either 441 milligrams or 882 milligrams.

Geared for patients with Schizophrenia, Bipolar Disorder and Major Depressive Disorder Aripiprazole is also known as the brand name Abilify, which is marketed by Bristol-Myers Squibb and Otsuka. Once injected the novel antipsychotic Aripiprazole Lauroxil converts to the molecule Aripiprazole, safely alleviating symptoms of mental illness for roughly one month. The Aripiprazole injectable dose has also proven to be efficacious for sufferers of Bipolar Disorder, as it works to help patients control the highs and lows of manic episodes. Complete Phase 3 study data revealed that not only were primary efficacy endpoints met for the patients who were administered the once a month injection of Aripiprazole, but also this unique form of delivery proved to be as effectual and tolerable as the oral dosage. Side effects from the injectable Aripiprazole were similar to those of the oral form of this drug, and included complaints of mainly headache and fatigue.

Schizophrenia is a severe form of mental illness which affects roughly seven of every thousand adults worldwide, with the vast majority of patients being between the ages of 15 and 35 years of age. One percent of Americans are diagnosed with Schizophrenia and both males and females are affected equally. Schizophrenia occurs across racial boundaries and is currently becoming more commonly diagnosed in children. With WHO estimating 24 million people to have a diagnosis of Schizophrenia worldwide the need for research and development of safe and effective drugs is urgent. The World Health Organization clearly states that Schizophrenia is a treatable condition, but has recently voiced concerns that over half of all patients diagnosed with this serious mental illness do not receive appropriate pharmaceutical care.

LGM Pharma provides the API Aripiprazole CAS# 129722-12-9 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

EU Approves Cabozantinib for Metastatic Medullary Thyroid Carcinoma

Thursday, April 17th, 2014

Cabozantinib CAS# 849217-68-1The end of March 2014 brought exciting news from the EU with the announcement of their approval of Cabozantinib for unresectable medullary thyroid carcinoma. Known as the brand name Cometriq and marketed by Exelixis, Cabozantinib works by inhibiting the activity of MET, RET and VEGFR tyrosine kinases. Cases of medullary thyroid carcinoma are virulent and affect roughly one out of every twenty five patients with thyroid cancer. MTC is considered an uncommon form of thyroid cancer and is believed to be genetic in origin for some patients. Oftentimes medullary thyroid cancer quickly spreads to the lungs, bones and lymph nodes. The National Cancer Institute estimates that a little over 56,000 people will be diagnosed with a form of thyroid cancer this year, and almost 2000 of these patients will not survive their diagnosis. The use of Cabozantinib to treat the patient population with MTC is crucial as this specialty drug is indicated specifically for patients in whom an RET mutation status is negative or unknown. The advent of a treatment opportunity with Cabozantinib offers this group of patients with metastatic MTC new hope.

Cabozantinib (Cometriq) was approved in the United States for the treatment of advanced and unresectable MTC in November 2012. Both the U.S. and the EU based their approvals on positive data from a Phase 3 clinical trial coined EXAM. The EXAM trial was international and multi center and included 330 patients with metastatic medullary thyroid carcinoma. This randomized and double- blinded trial showed that the use of Cabozantinib in patients significantly improved progression-free survival as compared to a placebo. Cabozantinib, as Cometriq, is available in 20 milligram and 80 milligram capsules. The capsules should be swallowed whole on an empty stomach, with a full glass of water. Serious side effects may occur, but many patients found Cabozantinib to be safe and tolerable.

LGM Pharma provides the API Cabozantinib for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Trelagliptin Succinate NDA in Japan Captures Global Attention of Pharmaceutical World

Wednesday, April 9th, 2014

Trelagliptin SuccinateRecently, the Trelagliptin Succinate NDA has captured pharmaceutical headlines as it was accepted by the Japanese Ministry of Health, Labour and Welfare. As a unique once weekly treatment for type 2 diabetes, Trelagliptin Succinate is an effectual dipeptidyl peptidase-IV inhibitor. As one of the few providers in the world of Trelagliptin Succinate, LGM Pharma offers this API product for research and development purposes. Takeda Pharmaceuticals, alongside Furiex Pharmaceuticals announced their excitement over a possible marketing of this much needed drug to fight type 2 diabetes in Japan. Trelagliptin Succinate not only offers patients an easy to adhere to treatment for regulating their glucose levels, but it also has proven in a multitude of studies to provide constant and consistent blood sugar control.

The global impact of type 2 diabetes is vast and daunting in nature, with the Worldwide Health Organization predicting type 2 diabetes to be the seventh leading cause of death by the year 2030. India, America and China are currently leading in the number of cases of type 2 diabetes, but other nations are following close behind. Japan, Brazil, Russia, Indonesia, Pakistan and Italy have all shown great increases of patients with type 2 diabetes, and the numbers are not expected to decline.

Clinical trials of Trelagliptin Succinate have proven to be efficacious, with Phase III studies having started in September of 2011. The Phase III trials focused on roughly 600 patients in Japan with type 2 diabetes, and followed these patients for a full year. Trelagliptin clearly offered greater viability as compared to both Sitagliptin Phosphate and a placebo, with the majority of patients who were administered Trelagliptin gleaning a significant decrease in their HbA(1c) levels. Trelagliptin Succinate is also thus far the only “gliptin” that is documented safe in terms of cardiovascular risks.

LGM Pharma supplies the API Trelagliptin Succinate CAS# 1029877-94-8 for research and development purposes.  Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

EU Approves Albiglutide for Type 2 Diabetes

Monday, April 7th, 2014

GlaxoSmithKline LogoOn March 27, 2014, the EU announced their approval of Albiglutide for patients diagnosed with Type 2 Diabetes. This approval was expected by GlaxoSmithKline, as Albiglutide, known as their brand name drug Eperzan, received a positive opinion from the EU at the commencement of 2014. The unique ability of Albiglutide to act as an effectual monotherapy anti-diabetic treatment makes this GLP-1 receptor agonist ideal for many patients. A sizable patient population with Type 2 Diabetes are unable to take certain first line treatments alongside Metformin, which is a typical, add on drug. This group of patients who are unable to tolerate Metformin have proven to benefit greatly from Albiglutide as their only source of glucose regulation. The EU has officially approved Albiglutide for monotherapy in patients who have not found adequate control of their glucose levels through diet and exercise, and who cannot tolerate Metformin. Albiglutide has also been approved as an add-on medication to be used in combination with other glucose-lowering treatments, such as basal insulin for patients who need additional glycemic control.

European Medicines AgencyOffered as a prefilled injectable pen, Albiglutide comes in either 30 milligram or 50 milligram doses. The use of a prefilled pen makes it easy for patients to not only administer their dose, but also to adhere to a regular schedule of just one medication to treat their Type 2 Diabetes. Roughly 5000 patients were enrolled in eight phase 3 trails, which gleaned positive results. The vast majority of patients in these trials were evaluated for almost three years’ time, and trial goals were met in five of the trials. These results are extremely encouraging as almost fifty percent of patients with Type 2 Diabetes fail to adequately control their glucose levels on a regular basis. Albiglutide has a U.S. Prescription Drug User Fee Act (PDUFA) target date of April 15th by the FDA.

LGM Pharma provides Albiglutide CAS# 782500-75-8, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Metronidazole 1.3% Gel Approved by the FDA for BV

Wednesday, April 2nd, 2014

Metronidazole 1.3% Gel Approved by the FDA as an Antibiotic Treatment for Bacterial Vaginosis On March 25, 2014 Actavis and Valeant Pharmaceuticals announced the FDA approval of Metronidazole 1.3% gel for the antibiotic treatment of Bacterial Vaginosis. Bacterial Vaginosis, or BV, is an extremely common vaginal infection which commonly affects women between the ages of 15 and 44. An imbalance of normal bacteria in the vagina is the leading cause of BV. The approval of Metronidazole 1.3% gel is a financial boon for Actavis and Valeant Pharmaceuticals, as the Bacterial Vaginosis treatment market is valued at $140 million annually.

Metronidazole 1.3% gel is now available to women as an easy to use pre-filled disposable applicator. The convenience, as well as efficacy and tolerability of Metronidazole 1.3% gel makes this newly approved treatment for BV significant for the pharmaceutical industry. The safety profile of Metronidazole 1.3% gel was apparent, with very few patients experiencing negative side effects during trials. Common complaints included minor vulvovaginal candidiasis, nausea and headache. Untreated Bacterial Vaginosis can lead to fertility issues, a heightened risk for sexually transmitted diseases and a serious pelvic infection or pelvic inflammatory disease. Antibiotic medications, such as an efficacious gel like Metronidazole, will help ensure that women affected with this regularly diagnosed condition will have proper and timely treatment.

The approval of the 1.3% gel was based on the successful results from a Phase III double-blind, placebo-controlled, randomized and multicenter trial. The higher dosage of Metronidazole proved to be well tolerated and a more effective option for some cases of BV when compared to MetroGel-Vaginal, also known as Metronidazole 0.75% gel. Certain cases of Bacterial Vaginosis require a higher strength treatment with Metronidazole, and the 1.3% gel offers this option.

LGM Pharma provides the API Metronidazole CAS# 443-48-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.