This weekend in Monaco the Only Watch 2013 charity auction event put over 30 watch lots on the block as bidders from all over the world fought for a slew of completely unique new watches. In support of the Duchenne Muscular Dystrophy medical charity, the Only Watch auction event occurs every two years and donates 100% of its proceeds to the charity. Now operated by well-known timepiece auctioneer Antiquorum, the Only Watch auction is a novel event because it not only asks brands to donate watches, but that they must offer completely novel ��iece unique��watches, or ones that are the very first piece in a limited edition.
An amazing press opportunity for the participating brands, Only Watch sees some of the world�� top watch makers present offer up extremely desirable pieces. For 2013 the far-and-away winner of the auction was famous Swiss watch brand Patek Philippe. The Only Watch 2013 auction event yielded a total of 5,066,000 Euros. An impressive figure, but it is important to note that 2,950,000 Euros of that (about 58%) amount is due to just one watch ��a Patek Philippe.
Hot Medical Stocks For 2015: Antares Pharma Inc (ATRS)
Antares Pharma, Inc. (Antares) is a pharma company that focuses on self-injection pharmaceutical products and technologies and topical gel-based products. The Company�� subcutaneous and intramuscular injection technology platforms include Vibex disposable pressure-assisted auto injectors, Vision reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, it has licensed its reusable needle-free injection device for use with human growth hormone (hGH) to Teva, Ferring Pharmaceuticals BV (Ferring) and JCR Pharmaceuticals Co., Ltd. (JCR), with Teva and Ferring being its two primary customers. The Company has also licensed both disposable auto and pen injection devices to Teva for use in certain fields and territories and is engaged in product development activities for Teva utilizing these devices.
In the gel-based area, it received Food and Drug Administration (FDA) approval in December 2011 for its oxybutynin gel 3% product, Anturol, for the treatment of overactive bladder. Antares also has a licensing agreement with Watson Watson Pharmaceuticals, Inc. (Watson) under which Watson will commercialize its topical oxybutynin gel 3% product in the United States and Canada. Its gel portfolio also includes Elestrin (estradiol gel) in the United States for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Antares has designed disposable, pressure assisted auto injector devices to address acute medical needs, such as allergic reactions, migraine headaches, acute pain, emesis and other daily therapies.
Pressure Assisted Injection Devices
The Company�� Pressure Assisted Injection Devices consists of three products: reusable needle-free injectors, disposable pressure assisted auto injectors and disposable pen injectors. Reusable needle-free injectors deliver precise medication doses through high-speed, pressurized liquid penetration of the skin without a needle. The injector employs a disposable pl! astic needle-free syringe, which offers liquid medication delivery through an opening that is approximately half the diameter of a standard, 30-gauge needle.
Disposable pressure assisted auto injectors is a technology of controlled pressure delivery of drugs into the body utilizing a spring power source. The Vibex is designed to provide fast subcutaneous or intramuscular injections of up to 0.5ml with minimal discomfort and improved convenience in conjunction with the enhanced safety of a shielded needle. Disposable pen injectors are needle-based devices designed to deliver multiple injections from multi-dose drug cartridges. The devices contain mechanisms that specify the dose to be delivered by defining the amount of movement by the stopper in the cartridge with each device actuation.
The Vision/Tjet has been sold for use in more than 30 countries to deliver either insulin or hGH. The product features a reusable, spring-based power source and disposable needle-free syringe, which acts as the pathway for the injectable drug through the skin and allows for viewing of the medication dose prior to injection. The product is also reusable, with each device designed to last for approximately 3,000 injections (or approximately two years) while the needle-free syringe, when used with insulin or hGH, is disposable after approximately one week when used by a single patient for injecting from multi-dose vials. The Vision/Tjet administers injectables by using a spring to push the active ingredient in solution or suspension through a micro-fine opening in the needle-free syringe. The opening is approximately half the diameter of a 30-gauge needle. The Vision/Tjet is primarily used in the United States, Europe, Asia and Japan.
Antares has designed disposable, pressure assisted auto injector devices to address acute medical needs, such as allergic reactions, migraine headaches, acute pain, emesis and other daily therapies. Its Vibex disposable product combines a low-energy, spr! ing-based! power source with a hidden needle, which delivers up to 0.5ml of the needed drug solution subcutaneously or intramuscularly. Antares is also developing a Vibex MTX auto injector for delivery of methotrexate for treatment of rheumatoid arthritis. The Company�� multi use, disposable pen injector complements its portfolio of single-use pressure assisted auto injector devices. The disposable pen injector device is designed to deliver drugs by injection through needles from multi- dose cartridges. The disposable pen is in the stage of development where devices are being used in clinical evaluations.
Transdermal Products
The Company�� ATD system penetrates the skin to deliver a variety of treatments. The gels consist of a hydro-alcoholic base, including a combination of permeation enhancers. Products being developed/ commercialized include Anturol, Elestrin and Nestragel. Elestrin is a transdermal estradiol gel for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Its other injectable drugs that are presently self-administered and may be suitable for injection with its systems include therapies for the prevention of blood clots and treatments for multiple sclerosis, migraine headaches, inflammatory diseases, impotence, infertility, acquired immune deficiency symdrome (AIDS) and hepatitis.
The Company competes with Ypsomed AG, SHL Group AB, OwenMumford Ltd., West Pharmaceuticals, Becton Dickinson, Haselmeir GmbH, Elcam Medical, Vetter Pharma, Bioject Medical Technologies Inc., The Medical House PLC, Watson, Abbott, Eli Lilly, Auxillium, Inc., Endo Pharmaceuticals, Teva, Mylan, Roxane, Bedford Labs, APP Pharmaceuticals, Hospira, Pfizer, GSK/Astellas, Warner Chilcott and Allergan.
Advisors' Opinion:- [By Luke Jacobi]
Antares Pharma (NASDAQ: ATRS) added 6.65 percent to close at $4.33 following the announcement that an FDA decision is expected on its drug on October 14. Equities
- [By Keith Speights]
Antares Pharma (NASDAQ: ATRS ) announced its first-quarter results �Wednesday morning but failed to impress the market. Shares were down around 3% in midday trading. Here are the highlights from the company's results.
Hot Medical Stocks For 2015: Clovis Oncology Inc (CLVS)
Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.
CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine
CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hENT1 levels.
CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor
CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.
The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line treatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.
CO-338-a PARP Inhibitor
CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the oral formulation, to determine an appropriate dose and schedule.!
The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.
Advisors' Opinion:- [By Keith Speights]
Give me a double
The Motley Fool's David Williamson summed up the great week for Clovis Oncology (NASDAQ: CLVS ) perfectly in his headline a few days ago: "1 Biotech + 2 Cancer Drugs = 100% Pop." While that 100% pop drifted down to 96% by the end of the week, Dave hit the nail on the head. - [By John Udovich]
Bubble talk, biotech IPO setbacks plus news�about small cap biotechs like Intrexon Corp (NYSE: XON) and TNI BioTech (OTCMKTS: TNIB) have dominated biotech news this week or in recent weeks. Just consider the following news:
Why There is No Biotech Bubble & Where to Look for Value in Biotech. Marshall Gordon, the Director and senior health-care analyst of ClearBridge Investments, was recently interviewed by Barron�� where he stated his belief that there is no biotech bubble because biotech stocks have delivered new drugs and have shown an ability to innovate. With that said, he added that the sector got ahead of itself while some biotechs suffered setbacks plus hedge funds decided to trim risk from their portfolios. Nevertheless, Marshall likes or is watching mid cap biotechs BioMarin Pharmaceutical Inc (NASDAQ: BMRN) and Pharmacyclics, Inc (NASDAQ: PCYC) along with small cap biotechs�Pacira Pharmaceuticals Inc (NASDAQ: PCRX) and Clovis Oncology Inc (NASDAQ: CLVS). He also added that recent biotech IPOs have been lesser quality names than earlier offerings. A Trio of Biotech�IPO Setbacks. FierceBiotech has�summarized how a trio of biotech IPO have suffered setbacks. Specifically, Relypsa (NASDAQ: RLYP), a late-stage biotech developing a treatment for hyperkalemia,�slashed its asking price on 6.9 million shares to $12 a share to raise $82 million�from a range of $16 to $19 a share while�Xencor (NASDAQ: XNCR), a biotech developing antibodies for severe autoimmune/allergic diseases and cancer,�has dropped its IPO price to $7 a share to raise $75 million from a range of $14 to $16. Meanwhile, Celladon, which is developing a first-in-class gene therapy for patients with systolic heart failure, has postponed its IPO citing poor market conditions. Coming�Biotech IPOs. Nevertheless, FierceBiotech has noted that GeNO Healthcare (NASDAQ: GNO) is looking to raise $50 million for its�new, patient-friendly approach for delivering inhaled nitric oxide on the
10 Best Shipping Stocks To Invest In Right Now: Cerus Corporation(CERS)
Cerus Corporation, a biomedical products company, engages in the development and commercialization of the INTERCEPT Blood System. The company?s INTERCEPT system is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. It markets the INTERCEPT system for platelets and plasma primarily in Europe, the Russian Federation, and the Middle East. The company is also developing INTERCEPT Blood System for red blood cells or red blood cell system, which is designed to inactivate blood-borne pathogens in donated red blood cells for transfusion. Cerus Corporation has collaboration agreements with Baxter International, Inc.; and BioOne Corporation, as well as the United States Armed Forces. The company was founded in 1991 and is based in Concord, California.
Advisors' Opinion:- [By Seth Jayson]
Cerus (Nasdaq: CERS ) is expected to report Q1 earnings on April 30. Here's what Wall Street wants to see:
The 10-second takeaway
Comparing the upcoming quarter to the prior-year quarter, average analyst estimates predict Cerus's revenues will expand 15.0% and EPS will remain in the red.
Hot Medical Stocks For 2015: Clovis Oncology Inc (CLVS.O)
Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.
CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine
CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hE NT1 levels.
CO-1686-an Oral EGFR Mutant-Select! i! ve Inhibitor
CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.
The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line t reatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.
CO-338-a PARP Inhibitor
CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the o ral formulation, to determine an appropriate dose and s! chedu! le! .
The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.
Hot Medical Stocks For 2015: Inergetics Inc (NRTI.PK)
Inergetics, Inc., formerly Millennium Biotechnologies Group, Inc., incorporated on November 9, 2000, is a holding company for its sole operating subsidiary, Millennium Biotechnologies, Inc. (Millennium). The Company through its subsidiary Millennium, engages in the research, development, and marketing of specialized nutritional supplements as an adjunct to medical treatments for select medical conditions, as well as for athletes seeking improved recovery and advanced performance. The Company markets products, which are targeted toward immuno-compromised individuals undergoing medical treatment for diseases, such as cancer, as well as wound healing and post-surgical healing and geriatric patients in long-term care facilities among other conditions. In January 2013, the Company acquired Bikini Ready and SlimTrim brands from Whole Products Group.
The Company�� product portfolio include, Resurgex Select, Ready-To Drink Resurgex Essential and Ready-To-Drink Re surgex Essential Plus. Resurgex Select is a whole foods-based, calorically dense, high-protein powdered nutritional formula developed for cancer patients undergoing chemotherapy or radiation treatments. Resurgex Essential and Resurgex Essential Plus represent Millennium�� Ready-to-Drink product line and are being sold into the Long-Term Care geriatric markets.
Resurgex Select
Resurgex Select is a whole foods-based nutritional product that is designed to be used throughout the course of cancer treatment (chemotherapy, radiation, etc.), as many times patients lose weight and cannot consume adequate nutrition. This product combines dietary fiber (3 g), low sugar (5 g), and high protein (15 g) with no added antioxidants to be a high-calorie (350 calorie) supplement. It is available in three flavors (Vanilla Bean, Chocolate Fudge, and Fruit Smoothie) and each can be mixed with water, milk, juices, or in soft cold foods, such as yogurt, apple sauce or p udding.
Surgex
Surgex (www.surge! xs! ports.com), is a nutritional support formula that aims to address the concerns of many elite athletes who suffer from symptoms, such as fatigue, lean muscle loss, lactic acid buildup, oxidative stress, and stressed immune systems. This formula is designed to improve recovery parameters in efforts to enhance the performance of professional and collegiate athletes.
Resurgex Essential
The Essential line is a ready-to-drink alternative to Ensure and Boost designed to be marketed into the long-term care channel. Resurgex Essential has 250 whole food calories containing no corn syrup or corn oil. The product also contains fruit and vegetable extracts, and FOS Fiber to provide calories and taste.
The Company competes with Nestle and Abbott Laboratories Inc.
Hot Medical Stocks For 2015: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company�� primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquired Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufacturing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatment of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THALOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin's T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to Novartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company�� pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company�� oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company�� new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis and a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company�� research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn's disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to develop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
Advisors' Opinion:- [By Sean Williams]
Take lung cancer, for instance, which currently has 29 compounds approved by the FDA -- including Celgene's (NASDAQ: CELG ) Abraxane, which was approved as a first-line treatment for non-small-cell lung cancer in October. Abraxane was able to boost the overall response rate by 8% relative to placebo and, along with a handful of other NSCLC treatments, will be tough to unseat even if reolysin works effectively in treating NSCLC.
- [By David Williamson]
Bluebird doesn't have any products in late stage trials, but its three drug-development programs are extremely intriguing. Is the hype for its shares justified, or is this another sign of a biotech bubble? And would investors possibly be better served taking a look at Bluebird's partner Celgene (NASDAQ: CELG ) ?
Hot Medical Stocks For 2015: Fuse Science Inc (DROP.PK)
Fuse Science, Inc. ( Fuse Science), incorporated on September 21, 1988, is a consumer products holding company. The Company maintains the rights to sublingual and transdermal delivery systems for bioactive agents that can effectively encapsulate and charge many varying molecules in order to produce complete product formulations which can be consumed orally, applied topically or delivered otherwise sublingually or transdermally, thereby bypassing the gastrointestinal tract and entering the blood stream directly. The Fuse Science technology is designed to accelerate conveyance of medicines or nutrients relative to traditional pills and liquids and can enhance how consumers receive these products. In December 2012, the Company launched its initial DROP products, PowerFuse, an energy formulation in a concentrated drop and ElectroFuse, an electrolyte formula in a concentrated drop, online, with the expansion into targeted retail distribution channels.
The Compan y is developing formulations and devices, which are compatible with alternative delivery systems for energy, medicines, vitamins and minerals, among other bioactives. These alternative systems include, but are not limited to, sublingual, transdermal and buccal drug delivery methods. use Science has developed and continues to advance, in conjunction with its scientific team, sublingual and transdermal delivery systems for bioactives that can effectively encapsulate and charge varying molecules in order to produce product formulations which can be consumed orally, applied topically or otherwise delivered sublingually or transdermally, thereby bypassing the gastrointestinal tract and entering the blood stream directly. The delivery technology is consists of encapsulation vesicles and ion exchange permeation enhancers. This technology utilizes a gradient across the mucosa membrane to help deliver the bioactive more efficiently through the mucosa.
The Company
Hot Medical Stocks For 2015: AmbiCom Holdings Inc (ABHI)
AmbiCom Holdings, Inc. (AmbiCom Holdings), formerly Med Control, Inc., incorporated on July 1, 2008, through its subsidiaries, is engaged in design and development of wireless products focusing on the wireless medical industry. The Company was a development-stage company organized to sell a product called Med Time, an electronic and portable device aimed to control the doses and schedules of medications taken by elderly individuals. On January 15, 2010, the Company completed the acquisition of AmbiCom Acquisition Corp. (AmbiCom). AmbiCom is a holding company whose operating company, AmbiCom, Inc., is a designer and developer of wireless products focusing on the wireless medical industry. AmbiCom purchases standard wireless products and designs and develops features and packaging to customize these products to their target original equipment manufacturer (OEM) markets. AmbiCom�� wireless device solutions and applications include infusion pumps, heart monitoring machines, and glucose meters.
AmbiCom sells its products through multi-channel distribution and original equipment manufacturer (OEM) channels. The Company delivers its medical device modules to OEM companies, such as Cardinal Health/Carefusion, and Roche. It outsources production of its products to manufacturers in Asia. The Company derives revenue from sales of its wireless device products. These products consist of routers, compact flash adapters/modules, universal serial bus (USB) adapters/modules, mini peripheral component interconnect (PCI) modules, PCI Express mini modules and mobile wireless products. It provides optimized wireless products to the medical industry, which has concentrated on using wireless solutions as a way to reduce healthcare costs as a whole.
Hot Medical Stocks For 2015: Bio-Matrix Scientific Group Inc (BMSN)
Bio-Matrix Scientific Group, Inc., incorporated on October 6, 1998, is a development stage company. The Company, through its wholly-owned subsidiary Regen BioPharma ,Inc., is engaged in the development of regenerative medical applications which it focuses to license from other entities up to the point of completion of Phase I and or Phase II clinical trials after which it would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
The Company has begun development of HemaXellerate, a cellular drug designed to heal damaged bone marrow. HemaXellerate I (TM) is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies.
Advisors' Opinion:- [By Bryan Murphy]
If you're a small cap enthusiast looking for some budding ideas, you may not need to look any further than China GengSheng Minerals, Inc. (NYSEMKT:CHGS), Bio Matrix Scientific Group Inc. (OTCMKTS:BMSN), and MER Telemanagement Solutions Ltd. (NASDAQ:MTSL). All three have either pushed themselves to the brink of a breakout, if they haven't started one already. Here's a closer technical look at MTSL, BMSN, and CHGS, and what it's going to take to get them going if they're not going already.
Hot Medical Stocks For 2015: Autoimmune Inc (AIMM.PK)
AutoImmune Inc., incorporated in September 1988, is a healthcare company. The Company�� products are based on the principles of mucosal tolerance. The Company�� product is sold by Colloral LLC, the Company�� joint venture with Deseret, under the brand name Colloral, The Collagen Solution and Vital 3, and by Futurebiotics LLC under the brand name Vital 3. The other products which are in the development stage include MBP8298 (dirucotide), Oral Copaxone and AI 401.
The Company completed ten human clinical trials involving over 1,900 patients to investigate the use of Colloral as a pharmaceutical for treating symptoms of rheumatoid arthritis. The Company holds a joint venture with Deseret by forming Colloral LLC to manufacture market and sell Colloral as a dietary supplement. Colloral LLC holds a distributing agreement with Futurebiotics LLC for Colloral. Futurebiotics LLC markets the product under the brand name Vital 3. Colloral LLC also markets the pro duct under the Vital 3 brand through The Shopping Channel of Canada via on air segments and their Website.
The Company�� other products in the development stage include MBP8298 (dirucotide) for multiple sclerosis, which is in Phase III trials for secondary progressive multiple sclerosis; Oral Copaxone is in the research stage for multiple sclerosis, and AI 401 is in Phase III trials for Type 1 diabetes. The development of MBP8298 (dirucotide) is conducted by BioMS Medical Corporation (BioMS). In August 2000, BioMS tested patients in a Phase II/III (MAESTRO-01) clinical trial of its MBP8298 treatment for secondary progressive multiple sclerosis. It was conducted at 47 sites across Canada and Europe. In November 2006, BioMS enrolled in a Phase II clinical trial (MINDSET-01) of MBP8298 for treatment of relapsing remitting multiple sclerosis. It enrolled 218 patients at 24 sites in six countries for a 15 month trial.
The Company collaborated with Eli Lilly, which supports clinical testing of orally administer! e! d autoimmune-mediated (Type 1) diabetes product, AI 401. Eli Lilly completed three different Phase II clinical trials to demonstrate human proof of principle for AI 401. The United States study was a one-year, double-blind, placebo-controlled trial with more than 200 patients, designed to measure immunological changes, preservation of pancreatic function and time to insulin dependence. Its second Phase II trial, involving approximately 150 patients, was conducted in France. The third trial was conducted in Italy with approximately 80 patients. In addition, Eli Lilly provided AI 401 for the Diabetes Prevention Trial (DPT-1) conducted by the National Institutes of Health (NIH). During the year ended December 31, 2008, the clinical trial of intranasal insulin to delay or prevent the clinical onset of Type I diabetes, called the Diabetes Prediction and Prevention Project was conducted in Finland. As of January 1, 2009, 115 had been enrolled in this trial.
No comments:
Post a Comment