Posts Tagged ‘Japan’

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.

FDA Accepts Peramivir NDA for Influenza Virus Treatment

Monday, March 24th, 2014

Peramivir 330600-85-6BioCryst Pharmaceuticals recently announced that the Peramivir NDA has been accepted for review by the FDA. The exciting news about the antiviral comes on the heels of a deadly flu season around the world, with the H1N1 virus being most commonly found. Widespread flu activity around the United States has caused alarm for practitioners and patients who were in great need of antiviral remedies in a timely manner. The Peramivir NDA will hopefully lead to an approval from the FDA, as this Neuraminidase Inhibitor will offer a novel and effectual treatment option to treat the influenza virus.

Almost twenty percent of Americans is plagued with the influenza virus annually, leading to thousands of deaths due to complications from the flu. Peramivir is already approved in both Korea and Japan, and is administered as an intravenous remedy. The ability of Peramivir to offer a large plasma concentration to the influenza infection sites of patients, as well as being a rapid antiviral agent makes this unique drug a potential boon in the future fight of influenza worldwide.

InfluenzaPeramivir is also efficacious at treating both strains A and B of the influenza virus, and particularly those strains that have proven to be resistant to current best in care neuraminidase inhibitors. A contract from the Biomedical Advanced Research and Development Authority, which is part of the United States Department of Health and Human Services has led to the development of Peramivir, in addition to approximately $234.8 million dollars in financial support. The FDA has declared a standard review time for Peramivir and an action date of December 23, 2014 for a Prescription Drug User Fee Act. BioCryst executives are looking forward to a successful turnout of Peramivir in time for the 2014-2015 flu seasons. Results from roughly 27 successful clinical trials which included 2,700 participants have led to a clear path to FDA approval in the near future. Laboratory tests revealed that Peramivir was a powerful opponent against several strains of the influenza virus, including H1N1, known also as the “swine flu” and the H7N9 strain.

LGM Pharma provides the Peramivir CAS# 330600-85-6 API 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.

Aflibercept Forecasted to Report Blockbuster Status from 2013

Wednesday, January 8th, 2014

afliberceptAflibercept, also known as brand name Eyelea, has been recently touted as a 2013 blockbuster drug. With sales of Aflibercept in the United States thought to have surpassed 1.3 billion dollars in the 2013 calendar year, the pharmaceutical community has been optimistically awaiting final year end data. Marketed by Regeneron in the U.S., Eyelea {Aflibercept} has achieved an anticipated “blockbuster” status as an injectable treatment targeting patients with wet macular degeneration. The ideal every other month dosing schedule makes using Aflibercept easier and more tolerable for patients, as compared to the competitor Lucentis, which requires a monthly injection. In addition to being an effective treatment for age-related wet macular degeneration, Aflibercept was also approved in the United States in September 2012 for the treatment of macular edema following central retinal vein occlusion.

The United States is not the only country to embrace this efficacious product. The final quarter of 2013 brought the approval of Aflibercept in Japan for the treatment of macular edema after central retinal vein occlusion (CRVO).  Prior approval of Eyelea {Aflibercept} has been made by the European Commission, Asia and many Latin American countries for patients with post CRVO macular edema as well. Both wet age-related macular degeneration (AMD) and macular edema following CRVO are estimated to affect almost 70,000 citizens in the EU, 140,000 patients in Japan and more than two million Americans. The majority of patients suffering from these life altering vision conditions are over the age of forty. Most often treatment with Aflibercept is critical for helping these patient populations avoid a significant loss of vision as they age or to avoid total blindness.

Regeneron filed for a new indication approval for Aflibercept in the third quarter of 2013, seeking an approval of Eyelea for the treatment of vision loss related to diabetic macular edema. A decision regarding this request has yet to be rendered by the FDA. Dosing with Aflibercept commonly commences with a two milligram injection given in a healthcare setting every month (four weeks approximately) for the initial three months. After the first three month period the majority of patients continue on a dosing schedule of every other month, or every eight weeks. The two milligram dose remains the same. Adverse effects of Aflibercept are uncommon, and the majority of patients exhibit minimal side effects. The most common complaints from patients being dosed with Aflibercept include eye pain, floaters, cataract development and increased intraocular pressure. As a recombinant fusion protein Aflibercept is an ideal treatment for the vast number of patients suffering from vision impairment from eye related diseases like AMD and CRVO.

LGM Pharma provides Aflibercept CAS# 862111-32-8 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.

Trelagliptin Succinate – a Potential Once a Week Type 2 Diabetes Drug

Monday, November 5th, 2012

Trelagliptin-succinate-1029877-94-8Cases of Diabetes, particularly type 2 Diabetes have skyrocketed worldwide and in the United States. According to the National Diabetes Information Clearinghouse Diabetes affects 25.8 million people of all ages, or roughly 8.3 percent of the U.S. population. The majority of these cases in the United States, upwards of 90 percent, are of the type 2 origin. With medical analysts predicting a significant climb in cases of type 2 diabetes worldwide over the next several decades, as well as the World Health Organization predicting that there will be 366 million people worldwide affected by diabetes by 2030, innovative and effective treatments are necessary.

Trelagliptin succinate, a unique once weekly medication for patients with type 2 Diabetes is currently at the forefront of pharmaceutical studies. As a long acting dipeptidyl peptidase-4 (DPP-4) inhibitor, trelagliptin succinate is in comprehensive clinical trials which are sponsored by Takeda. All of the available DPP-4 inhibitors for type 2 diabetes are currently offered as a once-daily dose only, so the novel once a week dosing of trelagliptin stands to be a sought after product. This alternative for patients having an option for an easy once a week dose, versus having to remember a daily dose, is enticing to many people.  In addition to the easier administration, trelagliptin has the potential to greatly improve treatment compliance.

Results from Phase III clinical trials commenced in September 2011, with approximately 600 patients with type 2 Diabetes documented as participating in this 52 week, open-label study in Japan.  Estimated to be completed by the second half of 2013, this study is poised to reveal never seen before results, leading to a game changing treatment for patients with type 2 diabetes.  Earlier studies of trelagliptin were completed worldwide in 2008. One of these successful studies compared trelagliptin to a placebo, and also to sitagliptin, which is currently marketed as Januvia.  The doses of trelagliptin were 3.125 mg, 12.5 mg, 50 mg and 100 mg. Exact results have yet to be revealed, however, the study goals appear to be met. These goals, which were a decrease in the HbA(1c) levels of patients at the 12 week mark, have been documented on Takeda’s website. This encouraging news, plus current recruiting for the Phase lll and beyond studies suggest that the prior studies have been successful.

Research and development teams are currently looking at not only the prevention and precursors to type 2 Diabetes, but also at the safest, simplest and best long-term treatment solutions. Due to it’s main advantages of the once-weekly treatment, it’s superior efficacy, and it’s cardiovascular safety test results that are demanded by the FDA and in future by other global regulatory authorities, Trelagliptin Succinate will probably supersede all other ‘gliptins’.

LGM Pharma is one of the few providers of the API Trelagliptin Succinate CAS# 1029877-94-8 in the world, as well as many other reliable and hard to find pharmaceutical products. We are currently offering samples of trelagliptin succinate, and continue to offer complete support to clients throughout the research and development 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.

LGM Pharma responds to soaring Potassium Iodide demands in the US amidst fears of radiation contamination in Japan and West Coast

Tuesday, May 17th, 2011
Fukushima-daiichi

Photograph courtesy Tokyo Electric Power Company via Kyodo/AP

For several years now, LGM Pharma has been a leading supplier of active pharmaceutical ingredients (APIs) to various global pharmaceutical firms involved in the research and development of old and new therapeutic chemical entities. In its commitment to improving health opportunities all over the world, the company has forged a longstanding partnership with GlaxoSmithKline, Eli Lilly and Merck, just to name a few of the biggest names in the pharmaceutical industry. Currently, the company supplies over 2,500 active pharmaceutical ingredients to its global clients. Among these is Potassium Iodide CAS# 7681-11-0.

The latest national earthquake and consequent nuclear reactor leaks in Japan brought potassium iodide sales to the ceiling. From Fukushima, Japan to Los Angeles, USA, concerned residents wasted no time in grabbing their own supply of potassium iodide which is available in the U.S. as over the counter (OTC) pills.  The pills are available as 65 mg and 130 mg doses for child and adult, respectively. These pills have been shown to exhibit protective thyroid properties by blocking the formation of tumors caused by high radiation levels.

Though unanticipated, the sudden surge in the demand for potassium iodide pills after a nuclear disaster has not been surprising to the medical and pharmaceutical community. The UN Scientific Committee has named thyroid cancer as the Chernobyl nuclear disaster’s biggest negative health impact to the immediate community residents. In its February 2011 report, more than 6,000 residents from Belarus, Ukraine and Russia have been diagnosed with thyroid cancer as of 2006 since acquiring dangerous levels of radiation in their bodies during the time of the incident.

Though the extent of the Fukushima incident is nothing like the Chernobyl disaster, that hasn’t stopped a lot of the West Coast residents from being prepared for the worst. Quick to respond to the world’s health demands is LGM Pharma. The Japan quake has firmly reiterated the company’s commitment to filling in the gaps in the supply chain of the active pharmaceutical ingredient, Potassium Iodide CAS# 7681-11-0 to it’s pharmaceutical clients involved in its research, development and global distribution.

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.