Archive for the ‘Therapeutic Classification’ Category

FDA Approves Efficacious and Long-Acting MS Drug Alemtuzumab

Wednesday, November 19th, 2014

FDA Approves Efficacious and Long-Acting MS Drug AlemtuzumabAlemtuzumab, also known as the brand name MS drug Lemtrada, has recently gained a long awaited FDA approval. Genzyme spent over a decade developing this long-acting agent designed to effectively treat patients with relapsing Multiple Sclerosis. The unique method of dispensing Alemtuzumab is a significant plus for patients who do not tolerate current medication regimens which involve monthly, weekly and even daily injections. Administration of Alemtuzumab is given via two infusion treatment courses, one for five days in a row and another course approximately twelve months later for three days straight. With sixty percent of the global market for MS in the United States the advent of this novel and innovative treatment option for patients is encouraging.

Two successful randomized Phase III trials led to the FDA nod of approval on November 14, 2014. These open-label studies compared Lemtrada to Rebif, which is a subcutaneous interferon beta-1a treatment, considered as high dose. The patients enrolled in these pivotal studies were all diagnosed with refractory MS, having had previously unsuccessful treatments, or patients who were new to any type of biologic treatments. The patient population with no prior medication regimen was deemed the CARE-MS I group and the study participants who had relapsed despite past medical interventions was coined CARE-MS II.

In the CARE-MS I study group the use of Alemtuzumab proved to work with much greater efficacy as compared to the clinical trial participants who were dosed with interferon beta-1a (Rebif). Positive findings in the group of patients who received Alemtuzumab included a notable reduction in yearly relapse rates and a statistically insignificant number of disability relapse rates.  Alemtuzumab was efficacious for the patients in the CARE-MS II study group as well, with participants experiencing a sizable reduction in relapse rates annually, as well as a slowed accumulation in disability overall. A total of 1,500 patients were involved in both studies, with over 6,400 years of patient assessment and follow-up. Alemtuzumab, or Lemtrada will be marketed with a warning for patients that include risks such as potential life-threatening infusion reactions, autoimmune conditions and a higher risk of cancers like thyroid cancer and melanoma. Initial access to this potent therapy will be reserved strictly for patients with relapsed and refractory MS. Sanofi representatives have indicated the current pricing for Lemtrada will be approximately $158,000 for a two treatment regimen.

Astounding figures have been revealed regarding the noted efficacy of Alemtuzumab, with roughly 70 percent of patients displaying no need for further treatments after the initial two for over three years’ time. Study analysts believe that the ability of Alemtuzumab to elicit relapse free results of up to five years’ time is clearly possible, if not probable. Side effects of Alemtuzumab include headache, nausea, rash, diarrhea, back pain, dizziness and insomnia. Serious adverse effects are rare, and may include thyroid disease and pneumonitis. Lemtrada was approved by the EU in September of 2013 and is currently approved in over forty countries worldwide. LGM Pharma can assist clients as a supplier/distributor of Alemtuzumab, 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.

Xigduo FDA Approved for Once Daily Type 2 Diabetes Treatment

Monday, November 3rd, 2014

Xigduo FDA Approved for Once-Daily Type 2 Diabetes TreatmentBritish-Swedish drugmaker AstraZeneca has been approved by the FDA for its once-a-day Xigduo XR extended-release tablet to treat adults with type 2 diabetes mellitus in the United States. AstraZeneca’s once-daily tablet is indicated as an adjunct therapy to diet and exercise to improve glycaemic control. Xigduo XR is already approved in Australia, and Xigduo is approved in the European Union.

The Xigduo FDA approval gives the two anti-hyperglycaemic agents, dapagliflozin and metformin, a green light to be used as a once-daily oral tablet. Dapagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2) and metformin hydrochloride is a biguanide, which decreases glucose production and improves the body’s response to insulin.

SGLT2 inhibitors are a new class of medicines that remove glucose from the body through the kidneys. In 2013, Johnson & Johnson’s canagliflozin/metformin combo was the first to win an FDA approval for the SGLT2 class of drugs. Then after a long battle, Eli Lilly and Boehringer Ingelheim finally won approval for empagliflozin. Meanwhile, Pfizer and Merck are still working through late-stage trials with the competing ertugliflozin.

However, safety worries have thus far limited uptake for the SGLT2 class, as the treatments have been linked to increased rates of genital and urinary tract infections, plus kidney damage and cardiovascular issues. As a result, peak sales estimates for the class of drugs have been erratic, with some pegging their potential north of $5 billion and others expecting cumulative revenue more in line with $2 billion a year.

LGM Pharma provides the two anti-hyperglycaemic agents dapagliflozin and metformin hydrochloride for research and development purposes, and offers clients continued support throughout the R&D process. Type 2 diabetes is the most common form of diabetes affecting patients globally, and the United States alone has over 23 million people suffering from this condition. Continued research and development of new and innovative treatments to combat this ever growing patient population is not only prudent, but also extremely necessary.

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.

Irinotecan and Temozolomide Shows Promise in Breast Cancer Study

Friday, October 24th, 2014

Irinotecan and Temozolomide Shows Promise in Breast Cancer StudyEwing sarcoma tumors disappeared and did not return in more than 70% of mice treated with combination therapy that included Irinotecan and Temozolomide, which are experimental agents developed to fight breast cancer, reported St. Jude Children’s Research Hospital scientists. The study will appear in the November 6 edition of the scientific journal Cell Reports. The treatment paired two chemotherapy drugs currently used to treat Ewing sarcoma (EWS) with experimental drugs called poly-ADP ribose polymerase (PARP) inhibitors that interfere with DNA repair. PARP inhibitors are currently in clinical trials for the treatment of certain breast and ovarian cancers as well as other solid tumors. EWS is a cancer of the bone and soft tissue that strikes primarily adolescents and young adults.

A clinical trial using the three-drug combination therapy detailed in this research is expected to open later this year for adolescents and young adults with EWS whose tumors have not disappeared with standard therapy or have returned after treatment. The trial is a collaboration of researchers at St. Jude and the Dana-Farber/Harvard Cancer Center in Boston. The therapy will pair the PARP inhibitor Olaparib with the chemotherapy drugs Irinotecan and Temozolomide. The study is one of two clinical trials St. Jude plans to open soon combining Irinotecan and Temozolomide with PARP inhibitors for the treatment for EWS. The tumor is diagnosed in about 250 U.S. residents each year, making it the second most common bone tumor in children and adolescents. Long-term survival for EWS patients whose disease has not spread remains stalled at about 75 to 80 percent, and the outcome for patients with metastatic disease is dismal. “During the past 20 years there has been no significant improvement in the cure rate for Ewing sarcoma, and survival is just 15 to 20 percent for patients whose disease has spread or comes back after treatment,” said co-corresponding author Michael Dyer, Ph.D., a Howard Hughes Medical Institute (HHMI) investigator and a member of the St. Jude Department of Developmental Neurobiology. The other corresponding author is Anang Shelat, Ph.D., an assistant member of the St. Jude Department of Chemical Biology and Therapeutics.

This study builds on earlier research from other investigators who reported that EWS cells growing in the laboratory were sensitive to the PARP inhibitor Olaparib. A clinical trial of Olaparib for treatment of adults with EWS that had spread or returned opened a short time later. The latest report includes the St. Jude discovery that EWS cells have a defect in DNA damage repair. DNA is the molecule contained in nearly every cell that carries the instructions needed to assemble and sustain life.

Working with EWS cells grown in the laboratory and mice, investigators showed the EWS defect could be exploited to help patients by combining DNA-damaging chemotherapy with a PARP inhibitor. PARP inhibitors work by interfering with activity of an important DNA-repair enzyme. St. Jude researchers conducted a series of mouse experiments designed to mirror the human phase I, II and III studies that gauge the safety and effectiveness of experimental treatment in humans. The research showed that PARP inhibitors work synergistically with Irinotecan and Temozolomide to kill EWS. The Phase III study included 274 mice with EWS treated in a double-blind, placebo controlled, randomized study. The study included 15 different treatment groups using different combinations and doses of Irinotecan, Temozolomide and three PARP inhibitors currently in development for pediatric cancer treatment. EWS disappeared and had not returned in more than four months in 71 percent of mice treated with Irinotecan, Temozolomide and the PARP inhibitor Olaparib. The results were even better when Irinotecan and Temozolomide were combined with the PARP inhibitor talazoparib. The combination led to a durable, complete remission in 88 percent of the 16 mice treated. “Our preclinical results suggest Ewing sarcoma is particularly sensitive to this combination therapy, a possible indication that the tumor’s DNA repair defect provides us with a much needed advantage to knock out tumor cells,” Shelat said. “There is some evidence that this type of defect is present in other pediatric tumors, and we are actively investigating drug sensitivity in those cancers.”

Researchers used the low-dose, protracted Irinotecan treatment schedule pioneered at St. Jude to reduce Irinotecan toxicity. Adult cancer patients receive fewer, but higher doses of Irinotecan. The adult treatment regimen led to higher toxicity in mice. “The only way to move forward was using the irinotecan approach proven in earlier St. Jude solid tumor clinical research,” Dyer said. One of the planned St. Jude-led clinical trials will combine talazoparib and Irinotecan for the treatment of patients age 1 and older. The other will involve triple drug therapy for treatment of patients age 16 and older.

LGM Pharma is a supplier / distributor of the APIs Irinotecan CAS# 100286-90-6 and Temozolomide CAS# 85622-93-1 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.

Early EU Approval for Ibrutinib

Tuesday, October 21st, 2014

IbrutinibThe early EU approval for Ibrutinib was granted by the European Commission (EC), for Ibrutinib to be sold in the 28 European Union (EU) member states.

Ibrutinib is a first-in-class, oral, once-daily, non-chemotherapy treatment option, and will be used to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

This likely new cancer blockbuster is marketed as the trade name Imbruvica, and is being jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech, Inc. (Janssen). Janssen affiliates will sell Imbruvica in EMEA (Europe, Middle East, Africa), as well as the rest of the world, outside the U.S. In addition to EU markets, a worldwide regulatory filing program for ibrutinib is currently underway.

In the US, Imbruvica obtained approval to treat patients with MCL and CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p), including treatment-naive and previously treated del 17p CLL patients.

The EC approval was based on data from the Phase 2 study (PCYC-1104) in MCL, the Phase 3 RESONATE™ study (PCYC-1112-CA) in CLL and small lymphocytic lymphoma (SLL) and the Phase Ib/II study (PCYC-1102) in CLL/SLL. This approval is based on the Imbruvica Marketing Authorization Application (MAA) submitted to the European Medicines Agency (EMA) last year.

In 2013 the NDA for Ibrutinib was placed on a priority basis by the FDA after a Phase 2 multicenter study of Ibrutinib was presented, and it identified a staggering 70% response rate from MCL patients with 68% of patients demonstrating an overall response rate after roughly nine months.

In June 2014, study results revealed Ibrutinib elicited a significant improvement for patients with either CLL or SLL in both overall survival and progression free survival in a study comparing it with Ofatumumab.

LGM Pharma is a provider of the APIs Ibrutinib, CAS # 936563-96-1 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.

Tavaborole Approved as Antifungal Toenail Treatment

Monday, October 20th, 2014

Tavaborole CAS 174671-46-6 Onychomycosis TreatmentAnacor Pharmaceuticals, Inc. ANAC, announced on Jul 08, 2014 that the FDA has approved the New Drug Application for Tavaborole, which is marketed as KERYDIN™ topical solution, 5%. Tavaborole was designed to be convenient for patients to use and it’s the first oxaborole antifungal approved for the topical treatment of onychomycosis of the toenails.

Onychomycosis is a progressive, recurring fungal infection of the nail and nail bed that affects approximately 35 million people in the United States, according to Podiatry Today.

Tavaborole is a broad-spectrum oxaborole antifungal agent with low molecular weight, permitting optimal nail plate penetration. Tavaborole is a clear, colorless, alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks. Debridement of the nail is not required during the treatment period. Due to its topical application, KERYDIN has low systemic absorption and has not demonstrated systemic side effects.

Studies have demonstrated the superior nail-penetrating properties of tavaborole compared to existing topical antifungal medications approved for the treatment of onychomycosis.

Onychomycosis is one of the most common diseases diagnosed causing approximately one-half of all nail disorders, and it’s prevalence has been steadily increasing. It is difficult to treat, partly due to the subungual location and the inability of both oral and topical antifungals to reach the site of infection. Historically, a large number of patients with onychomycosis would choose not to treat their infection. With the approval of Tavaborole, physicians can now offer patients a safe, effective and easy-to-use topical treatment for their onychomycosis of the toenail.

LGM Pharma can assist clients as a supplier/distributor of Tavaborole CAS No: 174671-46-6, 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.