Prepare for the Future Exaction of Oncology Products


U.S. ShortagesThe Oncology segment of the pharmaceutical industry is not only a fast growing one, but it is also an area where shortages are anticipated. A decrease in availability of sterile injectable oncology drugs have been reported since 2007.  Furthermore, many of the sterile injectable oncology drugs that experienced shortages in 2010 and 2011 had a similar issue in both 2008 and 2009. This data, coupled with the predicted growth of oncology products through 2018, make the need for research and development of these drugs a crucial one. The publication Evaluate Pharma projected that oncology drugs would experience the most growth through the year 2018. This projection, offered in their May 2012, issue indicates a relevant need for oncology products to be produced at a rapid rate to meet the demands of the next decade. The need for both sterile injectable and oral oncology medications are sure to be in demand, and LGM Pharma is a proud provider of these API products.

lenalidomideLenalidomide, CAS# 191732-72-6, is also known as the brand name Revlimid, which is marketed by Celgene. As an oral capsule, lenalidomide is used to treat myelodysplastic syndrome, as well as in conjunction with dexamethasone to treat patients with multiple myeloma. Classified as immunomodulatory agents, lenalidomide is effectual at assisting the bone marrow to produce normal blood cells, and also killing abnormal cells in the bone marrow. Lenalidomide is usually taken once daily with water for 21 days consecutively, and then patients take a 7 day break. Side effects include loss of appetite, nausea, diarrhea, vomiting, exhaustion and weakness. Capsules are available in doses of 5,10,15 and 25 milligrams.

everolimusEverolimus, CAS# 159351-69-6, is also recognized as the brand name Afinitor, marketed by Novartis Pharmaceuticals. Approved on May 25, 2011, everolimus is FDA endorsed for progressive neuroendocrine tumors of pancreatic origin, specifically in patients with metastatic disease. Everolimus may also be used to treat patients with advanced renal cell carcinoma. Side effects include nausea, diarrhea, itching, nosebleeds, and pain in the extremities. Oral tablets are dosed in 2.5, 5, 7.5 and 10 milligrams each.

nilotinibNilotinib, CAS# 641571-10-0, is thought of as a “second-generation” tyrosine kinase inhibitor, created to follow it’s prolific successor, Imatinib Mesylate, CAS# 220127-57-1. Efficacious for the treatment of chronic myeloid leukemia, nilotinib is crucial as many patients develop a resistance to imatinib. In addition, nilotinib has been shown to have an amazing 20-fold increase in both the potency of kinase and proliferation assays when compared to imatinib. Known as the brand name Tasigna, which is marketed by Novartis, nilotinib ellicits side effects such as vomiting, dizziness, hair loss, diarrhea and rashes. Offered in both 150 and 200 milligram capsules, nilotinib is a novel choice for patients who no longer receive effective treatment from imatinib. Recognized as the brand name Gleevec, and also marketed by Novartis, imatinib is approved to treat a wide variety of cancers, including: acute lymphoblastic leukemia (refractory), chronic eosinophilic leukemia or hypereosinophilic syndrome, dermatofibrosarcoma protuberans, chronic myelogenous leukemia (Philadelphia chromosome positive), gastrointestinal stromal tumors, myelodysplastic and myeloproliferative disorders, and systemic mastocytosis. Imatinib is particularly effectual for treatment of patients with BCR-ABL, also known as the Philadelphia chromosome, KIT, and PDGFR gene rearrangements. Adverse effects are similar to those incurred by patients taking nilotinib, but may also include muscle cramps, weight gain due to fluid buildup, and edema. Imatinib is available in 100 or 400 milligram tablets, and the patent for Gleevec is set to expire in mid January of 2015.

pemetrexed disodiumPemetrexed Disodium, CAS# 150399-23-8, is known as the brand name Alimta, and is marketed by Eli Lilly. Patients suffering from advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) will find pemetrexed to be a life prolonging treatment. As a sterile injection given via a slow infusion into a vein, this injection typically takes 10 minutes to administer. Normally given every 21 days, side effects may include nausea, vomiting, diarrhea, low blood cell counts and mouth sores. Patients taking pemetrexed should be dosed with folic acid and vitamin B-12 to protect their stomach, blood cells, and bone marrow from the side effects of this potent drug.

bortezomibBortezomib, CAS# 179324-69-7, is another sterile injectable medication, used to treat both multiple myeloma and mantle cell lymphoma. This formidable treatment is administered as either an injection into the vein or under the skin (subcutaneously). Known by the brand name Velcade, which is marketed by Millennium Pharmaceuticals, bortezomib may cause side effects such as peripheral neuropathy, low blood pressure, pyrexia and neutropenia.

With over 20 million new cases of cancer predicted in 2025 worldwide, the World Health Organization is urging researchers to continue to develop new products to combat this future onslaught of patients. An impressive market of growth has been demonstrated in both the U.S. and worldwide. Anti-cancer drug sales exceeded 50 billion dollars worldwide in 2009 alone. According to the Oncology Market Leaders – Analyses and Outlook – 2010-2025 report, the aging of the population around the world, as well as lifestyle and medical therapies in developing nations has only strengthened the need for more oncologic research,  medications, treatments and development. LGM Pharma is a provider of all of your oncology products, and offers complete assistance to clients 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.

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