Carbapenems API’s for Antibiotic Resistance

A new publication is out called “May 19, 2016 – Tackling Drug-Resistant Infections Globally: final report and recommendations” and it highlights the antibiotic-resistant infections which are being seen for the 1st time in the U.S.

The review says “superbugs” could kill 10 million people each year and cost the world $100 trillion in lost economic output by 2050.

For the first time, a 49-year-old woman in Pennsylvania was infected with an E. coli which carried a gene for resistance against the drug colistin. She was successfully treated with an antibiotic. But, the Centers for Disease Control and Prevention, says “Antibiotic resistance is exploding in numbers as well as severity and the trends are alarming”. Read Article

Exenatide Capsule Gleans Patent in Israel

Exenatide AcetateKnown as the brand name Byetta in the United States, which is marketed by AstraZeneca, Exenatide is a GLP-1 analog that is currently offered as an injectable treatment for type 2 diabetes. In mid-January 2015 Oramed Pharmaceuticals was granted a patent in Israel for the oral administration of Exenatide. As an effectual therapy for patients with type 2 diabetes, the advent of this Exenatide capsule is exciting for both patients and practitioners. Exenatide works by producing insulin release at increased glucose levels, which creates a feeling of satiety in patients, subsequently causing a reduction in food intake. This extra bonus of eliciting a reduction in dietary consumption makes Exenatide an ideal treatment for weight loss and weight control, as well as for insulin control. The injectable form of Exenatide has been helpful for patients, but challenging in terms of medication adherence. Many patients dislike using an injectable form of medication daily, so the novel Exenatide capsule is sure to create an optimal form of administration.

Exenatide is also being examined as a potential therapy for patients with Parkinson’s disease. In May 2014 a “Proof of Concept” trial was shared from the Sobell Department of Motor Neuroscience at the UCL Institute of Neurology in London. Basing patient results on a year’s worth of sound data from patients with Parkinson’s disease who had been administered Exenatide for a full year (May 2013-May 2014), an analysis of data showed noteworthy improvements in patients who received Exenatide. Researchers involved in this study cite the neuroprotective benefits of Exenatide, particularly for neuroplasticity. The side effect profile of Exenatide is also a plus for patients, with a small minority of trial participants experiencing mild nausea. The aforementioned study involved 44 patients with moderate to severe Parkinson’s disease. Approximately 20 of the patients received Exenatide in addition to their usual best in care treatment program, and 24 patients were given the placebo alongside best in care therapy. At the one year mark significantly clinical differences were apparent between the groups, with meaningful motor and cognitive differences gleaned from the patients group who received Exenatide. Even at the 14 month mark, when patients who had received Exenatide were taking a holiday from this medication the differences were still widely apparent between both the groups. Researchers utilized the Mattis Dementia Rating scale, as well as a blinded MDS-UPDRS motor subscale evaluation for the patients. The participants who were administered Exenatide had advantages of 5.6 on the blinded MDS-UPDRS motor subscale and 5.3 points on the Mattis Dementia Rating scale as compared to the placebo group. This information is hopeful for the future use of Exenatide for the treatment of not only type 2 diabetes, but also potentially for patients with Parkinson’s disease.

Whether it is injectable or oral Exenatide, LGM Pharma is available to assist clients as a supplier/distributor of the Exenatide CAS# 141758-74-9 API or the Exenatide Acetate CAS# 141732-76-5 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.

Micafungin Remains a Viable Treatment for Candida Infections

Micafungin CAS 235114-32-6As the fourth most common cause of hospital-acquired bloodstream infections in the United States, Invasive Candidiasis is a concern for any patient battling a fungal infection. Micafungin, also known as the brand name Mycamine, which is marketed by Astellas, is an effective antifungal agent. By inhibiting the synthesis of 1,3-beta-D-glucan, Micafungin proves to be a viable member of the echinocandin class of antifungaI therapies. Micafungin is classified as an antiinfective, antibiotic and antifungal drug. Concerns by medical professional worldwide for a rising number of systemic fungal infections over the past two decades are prevalent, with an increasing urgency for continued R&D to meet the needs of tomorrow’s patients. While the candida species are most commonly found in patients who are immunocompromised, the Candida organism is responsible for an overwhelming 80 percent of all major systemic fungal infections.

Micafungin is an approved treatment for patients with esophageal candidiasis, as well as for the prophylaxis of Candida infections in patients who are undergoing hematopoietic stem cell transplantations. Micafungin is determined to be effectual for treating the susceptible organisms C. tropicalis, C. albicans, C. glabrata, C. krusei, C. parapsilosis, and C. krusei. Off-label treatment with Micafungin is also used for patients with pulmonary Aspergillus infection. Micafungin is a successful therapy for treating and preventing a wide variety of fungal infections, with few adverse effects occurring. A minor number of patients experience injection site irritation, diarrhea, vomiting and headache.

As an injectable medication Micafungin is administered via an intravenous solution, typically given once daily for a set period of time. The injection is administered slowly, over at least a one hour period. Patients with Candidiasis usually receive a daily dose based on weight for between ten and thirty days’ time. Patients who are administered Micafungin as a prophylaxis prior to a hematopoietic stem cell transfer will typically receive 50 milligrams daily for between six and fifty days. Those patients who are diagnosed with Candidemia, Candida Peritonitis and Abscesses or Disseminated Candidiasis will likely be administered 100 milligrams daily for between ten and forty-seven days.

Clinical trials of Micafungin have proven to be valuable and successful. In June 2013 the FDA approved Micafungin, as Mycamine, for the treatment of fungal infections in pediatric patients ages four months and older. With Candida infections being a serious concern for the pediatric patient population due to limited treatment options, this approval was welcomed by the medical and pharmaceutical community. Two double-blind and randomized trials of Micafungin (Mycamine) demonstrated the safety and tolerability for pediatric patients who received this antifungal therapy for either the treatment of invasive Candidiasis and Candidemia or the prophylaxis of Candida infections. Of the 479 patients assessed, ages three days through 16 years old, the average once daily treatment regimen was 24.8 days. Every patient received at least one dosage of Micafungin. The most commonly reported adverse effects was vomiting, followed by diarrhea. The FDA did not evaluate or approve the use of Micafungin in patients younger than 4 months old, however.

LGM Pharma can assist clients as a supplier/distributor of the API Micafungin, CAS # 235114-32-6 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.

Data from Loteprednol Study to be Presented to Ophthalmic Congress in the Second Half of 2015

Loteprednol EtabonateWith primary endpoints of a phase 3 trial of Loteprednol Etabonate being met in the fall of 2014, researchers are anxiously awaiting additional data to present in late 2015. The success of Loteprednol for treating both inflammation and pain in post-cataract surgical patients has led trial leaders to anticipate continued positive results to present to the Opthamolic Congress later this year. As an effectual, safe and tolerable opthamolic gel Loteprednol has proven in recent studies to be statistically superior when compared to a placebo gel. Bausch + Lomb/ Valeant Pharmaceuticals, the company that markets Loteprednol Etabonate as the brand name Lotemax, has perfected this anti-inflammatory eye drop, creating a gel with enhanced penetration to allow for swift relief. The first Phase 3 study gleaned encouraging results, which were highlighted by the action of this novel sub-micron particle size gel.

cataractsThe initial Phase 3 study data included approximately 514 patients who were studied at 47 clinical sites around the United States. This randomized study was both a double-masked and parallel group study. Patients who were post cataract surgery were dosed with either Loteprednol Etabonate gel 0.38% or a vehicle gel. There were four groups of patients, receiving either the vehicle dose or the Loteprednol, two or three times a day. The main efficacy endpoint was a total resolution of anterior chamber cells, showing zero cells, indicating no ocular inflammation. This primary endpoint was evaluated at day eight of the study. Additionally, patients were evaluated for pain, with subjects expected to have rated their pain Grade 0 at the eight day mark after surgery. A statistically sizable difference was found in both the primary and secondary study results, with patients who received Loteprednol achieving complete resolution of eye pain by the eighth post-surgical day. An absence in eye inflammation was also noted in a statistically superior number of participants who were given Loteprednol as compared to a placebo, or the vehicle eye drop. Patients in the vehicle arm also displayed a great uptick in the use of rescue medication, even at days 15 and 18 post surgery. With pain and inflammation being serious issues for patients after cataract surgery, the advent of Loteprednol is reassuring for patients who wish to ensure optimal post-operative recovery. Loteprednol has proven and continues to show itself to be an efficacious steroid ophthalmologic gel for patients after cataract surgery. Minor side effects have been noted by patients, which have included complaints of dry, itchy or red eyes and a light burning sensation when the gel/drops are fist applied. No patients withdrew from the aforementioned trials due to adverse effects.

Projections for Cataract (2010-2030-2050)A startling 20 million American adults ages forty and older have cataracts, with 50 percent of adults in the U.S. over age 80 being diagnosed with this unfortunate condition. When untreated, cataracts can lead quickly to blindness. Medicare covers cataract surgery, and the United States government spends roughly 3.4 billion dollars annual on these procedures.

LGM Pharma can assist clients as a supplier/distributor of the API Loteprednol Etabonate, CAS # 82034-46-6 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.

Alemtuzumab is a Formidable Therapy for Cancer and Multiple Sclerosis

alemtuzumabKnown as the brand name Campath, which is marketed by Genzyme, Alemtuzumab is a proven therapy for leukemias, lymphomas and recently, multiple sclerosis. As a monoclonal antibody Alemtuzumab effectively binds to the CD52 protein which occurs on cancerous B and T cell lymphocytes. After attaching to the protein on the cells Alemtuzumab elicits other immune cells to help destroy the cancer cells. An intravenous infusion, administered over roughly two hours is how Alemtuzumab is dispensed. Some patients experience much longer infusion periods, such as five or six hours, particularly if it is their first treatment with Alemtuzumab. Dosing is dependent on weight and condition, with most patients receiving daily infusions in a titrated fashion. After a standard best in care dose is reached many patients are administered infusions of Alemtuzumab three times a week for roughly twelve weeks. Adverse effects may occur, and include reports of low platelet counts, fever, nausea and vomiting. The FDA approved Alemtuzumab in 2001 for the treatment of chronic leukemias and lymphoma.

A new FDA approval for Alemtuzumab was announced in November 2014, with a nod given to Genzyme’s Lemtrada, for the treatment of multiple sclerosis (MS). Indicated specifically for patients with relapsing forms of MS, Lemtrada (Alemtuzumab) is reserved for patients who have had inadequate responses to at least two current therapies for MS. Two successful trials of Alemtuzumab, which compared Lemtrada to Rebif in patients with relapsing MS, showed Alemtuzumab was more effective. This duo of randomized trials involved just about 1,500 patients with refractory multiple sclerosis and included over 6,400 patient-years of follow-up safety studies. While Alemtuzumab does include a boxed warning as the MS drug Lemtrada, the risk of fatal autoimmune conditions is uncommon. However, as of now Lemtrada is only available via a restricted distribution program in the United States. The dosing schedule of Alemtuzumab as Lemtrada for patients with remitting MS is unique, with two treatments dispensed annually. The first administration is given for five consecutive days through an intravenous infusion. The second dosage does not occur until roughly twelve months later, and is dispensed for three consecutive days. Side effects noted from study participants who received Lemtrada included nausea, dizziness, rash, fatigue and flushing. Lemtrada (Alemtuzumab) was approved in the EU in September of 2013 to treat multiple sclerosis.

The potential for Alemtuzumab for treating a wide swath of life threatening illnesses is great. The latest indication for this formidable drug will be a viable option for the 2.3 million people suffering from multiple sclerosis around the globe. In the United States there are approximately 400,000 people who have been diagnosed with MS. LGM Pharma can assist clients as a supplier/distributor of the Alemtuzumab API, CAS # 216503-57-0 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.