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.

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.

Rizatriptan Gets FDA Nod as New Generic for Migraine Therapy

Rizatriptan Gets FDA Nod as New Generic for Migraine TherapyOn January 5, 2015 Jubilant Life Sciences received an FDA nod for their Rizatriptan generic formulation, paving the way for more generic forms of Merck’s blockbuster migraine medication Maxalt. The strengths approved for generic production are both 5 milligrams and 10 milligrams, which makes up an estimated 70 million dollar market. Rizatriptan is an efficacious treatment for patients suffering from migraines, as well as adverse effects which stem from migraines including sensitivity to light and sound, nausea and vomiting. Belonging to a class of drugs known as triptans, Rizatriptan works by affecting serotonin, which causes a narrowing of the blood vessels in the brain. While Rizatriptan does not prevent future migraines it does rapidly alleviate symptoms of a migraine headache, enabling patients to get back to their normal routine as soon as possible.

Rizatriptan is usually prescribed to be taken at the onset of a migraine. Taking Rizatriptan on an empty stomach helps it to work more quickly. Both children and adults can safely be prescribed Rizatriptan, with children being advised not to exceed 5 milligrams daily. Adults should take no more than 30 milligrams in a 24 hour period. Adverse effects from this drug are uncommon. Some patients have reported mild side effects, including dry mouth, dizziness and a tired feeling. An updated report titled “The Prevalence and Burden of Migraine and Severe Headache in the United States: Updated Statistics from Government Health Surveillance Studies” reveals that approximately 14.2 percent of American adults ages 18 and older report experiencing either a migraine or a severe headache in 2012. The prevalence of migraine headaches was highest in females between ages 18 and 44. Migraine headaches are often reported from females who are in their reproductive years, which often coincide with reproductive issues.

MigraineHeadache was documented as the fourth leading cause for patient visits to the emergency room in 2009-2010, with triptans being dispensed in almost 2 percent of patients as treatment. As a whole figures have remained consistent for the major part of the last decade, with migraine headaches affecting 1 out of every 7 Americans annually. Continued research and development of FDA approved generic Rizatriptan is on the forefront of pharmaceutical studies. LGM Pharma can assist clients as a supplier/distributor of the API Rizatriptan, CAS # 145202-66-0 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.