Archive for the ‘Therapeutic Classification’ Category

EU Approves Apixaban for DVT and PE Treatment and Prevention

Monday, August 25th, 2014

apixabanBristol-Myers Squibb and Pfizer has announced that the European Commission has approved Apixaban (Eliquis) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults.

There is an estimated 600,000 people affected by DVT/PE each year in the U.S., and almost 100,000 of those people die from the terrible condition. A shocking 10 to 30% of those people will die within their first month of diagnosis. Even those who are living with DVT will have long-term complications such as post-thrombotic syndrome, which includes swelling, pain, discoloration, and scaling in the affected limb. Approximately 5 to 8% of the U.S. population has one of several genetic risk factors, also known as inherited thrombophilias in which a genetic defect can be identified that increases the risk for thrombosis.

Deep Vein Thrombosis (DVT)

The marketing authorization for Apixaban follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by two pivotal Phase 3 clinical trials, AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) and AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended treatment).

The European Commission approval applies to all European Union (EU) member states as well as Iceland and Norway. Apixaban is also approved in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip or knee replacement surgery, and for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.

“Every year, approximately one million patients in the EU are diagnosed with VTE,” said Dr. Elliott Levy, senior vice president, head of Specialty Development, Bristol-Myers Squibb. “Once a VTE has occurred, approximately 33 percent of patients may experience a recurrence within 10 years.”

“The European Commission’s approval of Eliquis for the treatment of DVT and PE and the prevention of recurrence is an important milestone and demonstrates Bristol-Myers Squibb and Pfizer’s ongoing commitment to bringing innovative medicines to patients who need them,” said Steve Romano, senior vice president, head of Medicines Development Group for Global Innovative Pharmaceuticals, Pfizer Inc.

LGM Pharma is supplier/distributor of the Antithrombotic API Apixaban CAS# 503612-47-3 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.

Amoxicillin Effective When Timed Optimally Before Surgery

Monday, August 18th, 2014

Prophylactic Antibiotics Effective When Timed Optimally Before Surgery

Antibiotics, such as Amoxicillin, are extremely effectual when used appropriately prior to surgical procedures. The expiration of the potent antimicrobial drug Moxatag, also known as Amoxicillin, on October 13, 2020, paves the way for additional development of this generic powerhouse. Study results recently released in Infection Control and Hospital Epidemiology reveal that timing is crucial for the proper use of prophylactic antibiotic treatment. Patients who receive antibiotic prophylaxis approximately two hours before a surgical procedure have a significantly reduced risk of surgical site infections. This data, released by the Rambam Medical Center in Israel on January 15, 2014 indicates that post-surgical patients can absolutely benefit from antibiotic prophylaxis if timed perfectly. Patients who receive antibiotic doses either before the optimal two hour timeframe, or once incisions are made have proven to have notably diminished benefits for infection control.

The aforementioned ten year study in Israel involved 2,537 patients who were in need of preoperative antibiotic prophylaxis, specifically prior to cardiac surgery. Patients involved were given antibiotics at different times, including three hours before surgery, two hours prior to their procedure, one hour before surgery and after surgery was concluded. Data gleaned from this large and randomized study revealed that surgical site infections were least common among the patients who were given antibiotics approximately two hours prior to their surgery. Exactly 8.3 percent of the patient group that received preoperative antibiotic treatment exactly two hours before surgery developed a surgical site infection. This small number of patients is compared with 13.9 percent of patients who developed a surgical site infection, which included patients dosed with prophylactic antibiotics at different times, and not during two hour window prior to surgery. Antibiotics, specifically Amoxicillin are regularly dispensed to patients with heart conditions, such as a heart murmur, prior to both simple and complicated surgical procedures.

LGM Pharma is an Amoxicillin API supplier/distributor for research and development purposes, as well as the sole supplier/distributor of Amoxicillin TEVA API for compounding in the U.S.. 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

Progression Free Survival Goal Met With Cobimetinib

Monday, August 11th, 2014

Vemurafenib and Cobimetinib- a Dynamic Duo in the Fight Against MelanomaImpressive news was revealed from Roche and Exelixis on June 14, 2014 with successful Phase III study results from their melanoma trial. This comprehensive trial involved Exelixis’s Cobimetinib and Zelboraf, which is marketed by Roche, for treating patients with advanced cases of melanoma. All of the 495 patients had specific mutations of the BRAF gene and many were considered to have unresectable cases of this deadly skin cancer. The surprise for clinical trial investigators came when they found the concomitant use of these two drugs led to a longer progression free survival for patients in comparison to their treatment with Zelboraf alone. These top line results are exciting for the medical and pharmaceutical community as this data clears the way for an upcoming FDA application. The Phase III study, coined coBRIM not only met its primary goal of progression free survival, thanks to the addition of Cobimetinib, but it also proved to be safe and tolerable.

Cobimetinib is a highly selective inhibitor of mitogen-activated protein kinase MEK, and has demonstrated efficacious ability sustain the inhibition of MEK in both mutant RAS and BRAF tumor models. The development of Cobimetinib is currently under Roche and Genentech, with a collaboration agreement with Exelixis. A successful Phase 1b dose escalation study of Cobimetinib, called BRIM7, proved this potent drug was effectual when used adjunctively with the BRAF inhibitor Vemurafenib. The BRIM7 study involved patients with metastatic cases of melanoma who had the BRAFV600 mutation, with the results being presented at the 10th European Association of Dermato-Oncology Congress in May 2014.

Clinical trials are ongoing for Cobimetinib alongside other anti-cancer agents, and many of the patients accepted in these trials are chosen specifically for their genetic mutations. Current studies include combining Cobimetinib with: GDC-0068, an AKT inhibitor; Onartuzumab, a MET targeting antibody; MEHD7945A, a biotherapeutic targeting EGFR and HER3; and GDC-0941, a PI3K inhibitor. This patient population is facing a critical need for new and innovative treatment, and Cobimetinib looks like it may be the agent to meet this need.

LGM Pharma is a provider of the API Cobimetinib, CAS # 934660-93-2 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.

 

Pyrazinamide is a Triple Threat to TB in HIV Patients

Friday, August 8th, 2014

PA-824 + Moxifloxacin + PyrazinamideMidstage trial data of a Pyrazinamide cocktail to treat TB has offered encouraging news for patients with the HIV infection. Coined PaMZ, this drug trio includes Pyrazinamide and two antibacterial drugs, with results going into the Phase III trial looking promising. The antibacterial drugs are PA-824, which was initially developed by the Novartis and the potent antibiotic Moxifloxacin, also known as Bayer’s brand name Avelox. The 200 patient Phase II data touted exemplary results, with a 71 percent cure rate for patients as compared to standard single treatment therapy, which had a 38 percent cure rate. Additional good news regarding the Pyrazinamide cocktail is that this effectual treatment does not interfere with the antiviral medications taken by patients with the HIV infection. Statistically patients with the HIV virus are 30 times more likely to develop Tuberculosis {TB}, with this virulent disease killing one in every five patients worldwide. Several of the crucial antiviral treatments used to fight the HIV virus in patients are not compatible with many drugs to remedy TB, so the recent news regarding the Pyrazinamide trio was very encouraging.

Information from the PaMZ trial was recently revealed at the International AIDS Conference which was held in Melbourne. Study investigators are hopeful for the completion of the Phase III study, which is partially funded by the Bill & Melinda Gates Foundation. The Phase III trial is called STAND {Shortening Treatments by Advancing Novel Drugs}, and it will involve 1,500 patients in fifty sites and on four continents. Patients enrolled in this comprehensive study will receive the PaMZ triple trio and then be assessed for a speedy and reliable cure for TB. Patients will also be evaluated to ensure that there is no additional need for injections to treat Tuberculosis and be certain that patient’s HIV treatment regimen is not disrupted. Providing this efficacious drug treatment is approved patients, practitioners and the pharmaceutical companies will be overjoyed, as this triple treatment is 90 percent less expensive than existing treatments for drug-resistant forms of TB. Patients in underprivileged parts of the world where TB is both rampant and deadly will also benefit greatly from this Pyrazinamide cocktail. Upset stomach and fatigue are the most commonly reported side effects, and this Pyrazinamide cocktail is generally safe and well tolerated.

Pyrazinamide CAS 98-96-4As a first line drug in antituberculosis medications Pyrazinamide is a synthetic pyrazine analogue of nicotinamine which has powerful activity against mycobacterium tuberculosis. Roughly one third of the world’s population is infected with tuberculosis bacteria, but only a small number of those infected will become sick with TB.

LGM Pharma is a provider of Pyrazinamide, CAS # 98-96-4, 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.

 

Ivacaftor and Lumacaftor Create Positive Results for Common CF Mutation

Thursday, August 7th, 2014

Recently revealed results from a successful Phase 3 study combining Ivacaftor {Kalydeco} and Lumacaftor {VX-809} are extremely positive for patients with a common Cystic Fibrosis {CF} mutation. Patients who have the mutation of Cystic Fibrosis, which entails two copies of the F508del, have demonstrated in Phase 3 clinical trials an effective response to treatment with the Ivacaftor and Lumacaftor drug combo. Patients with CF who were administered with the dynamic duo Ivacaftor and Lumacaftor displayed significant improvements in their lung function and a sizable reduction in their rate of pulmonary exacerbations. This encouraging study data has led Vertex, the company who markets these potent agents, to prepare a New Drug Application {NDA} for the FDA by the close of 2014.

Ivacaftor and Lumacaftor CF Mutation

CFF chartThe Phase 3 study of Ivacaftor and Lumacaftor was comprehensive and included two 24 week trials which were conducted at 200 sites in Australia, Europe and North America. Over 1,100 people, ages twelve and older, who held two copies of the F508del mutation participated in these Phase 3 trials. There were two dosages of Ivacaftor and Lumacaftor administered to the participating patients, which were compared to a placebo arm of the study. The participants who received either of the Ivacaftor and Lumacaftor combination doses showed tangible improvement in lung function, as well as a lowered rate of pulmonary exacerbations as compared to the placebo group. Patients dosed with the Ivacaftor and Lumacaftor duo also experienced healthier outcomes and even weight gain as compared to the patients who were given a placebo. Both Ivacaftor and Lumacaftor have proven to work like a well-oiled machine together, as Lumacaftor works by moving the F508del CFTR protein to the cell surface and Ivacaftor improves its function and helps to increase the regular flow of fluids and salt in and out of the cell.

The innovations in research and development of drugs to treat patients with Cystic Fibrosis has been monumental, and the life expectancy for a child diagnosed with CF has more than doubled over the past three decades. Continued research and development is clearly needed, and Ivacaftor and Lumacaftor look to be at the forefront of these R&D projects. LGM Pharma is a provider of Ivacaftor, CAS# 873054-44-5 and Lumacaftor, CAS# 936727-05-8 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.