Monday, January 20, 2014

10 Best Biotech Stocks To Buy Right Now

As we've learned over the past few years, getting a drug approved by the Food and Drug Administration is just half the battle in the biotech sector. Too many biotech companies have relied on the past to dictate the present and have simply assumed that a drug approval would equal success. As we've witnessed firsthand, that's not been the case.

Yesterday I pointed out the failure of KV Pharmaceuticals, whose pre-term-birth drug Makena was priced nearly 100 times higher than the previous combination of drugs given to treat pre-term birth. Just a year later, KV Pharmaceuticals was forced to declare bankruptcy.

This is why, over a three-day period, I'm looking at biotech companies that could really use a helping hand to get their lead drug off the ground. Yesterday, I examined VIVUS, looking at how its chronic weight-management drug Qsymia has failed to take off, and why now is the time to find a marketing partner.

Today, I'd like to add a familiar name to the list and discuss why Dendreon (NASDAQ: DNDN  ) should be raising the white flag and looking for marketing assistance.

10 Best Biotech Stocks To Buy Right Now: AMAG Pharmaceuticals Inc.(AMAG)

AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Its principal product includes Feraheme (ferumoxytol) injection for intravenous (IV) use, which was approved for marketing in the United States in June 2009 by the U.S. Food and Drug Administration, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). The company is pursuing marketing applications in the European Union, Canada, and Switzerland for Feraheme for the treatment of IDA in CKD patients. AMAG Pharmaceuticals was founded in 1981 and is based in Lexington, Massachusetts.

10 Best Biotech Stocks To Buy Right Now: Telik Inc (TELK)

Telik, Inc. (Telik), incorporated in 1988, is a clinical-stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The Company discovers its product candidates using the Company�� drug discovery technology, Target-Related Affinity Profiling (TRAP). TELINTRA, its principal drug product candidate in clinical development, is a small molecule glutathione analog inhibitor of the enzyme glutathione S-transferase P1-1 (GST P1-1). TELCYTA, its other product candidate, is a small molecule cancer drug product candidate designed to be activated in cancer cells.

Clinical Product Development

TELINTRA is the Company�� lead small molecule product candidate in clinical development for the treatment of blood disorders, including cancer. It has a mechanism of action and acts by inhibiting GST P1-1, an enzyme that is involved in the control of cellular growth and differentiation. Inhibition of GST P1-1 results in the activation of the signaling molecule Jun kinase, a regulator of the function of blood precursor cells. Preclinical tests show that TELINTRA is capable of causing the death or apoptosis of leukemic or malignant blood cells, while stimulating the growth and development of normal blood precursor cells. TELINTRA has been studied in Myelodysplastic Syndrome (MDS) using two formulations. A liposomal formulation was developed for intravenous administration of TELINTRA and was used in Phase I and Phase II studies in MDS patients. The results from the Phase II intravenous liposomal TELINTRA clinical trials demonstrated that TELINTRA treatment was associated with improvement in all three types of blood cell levels in patients with all types of MDS, including those in intermediate and high-risk groups. An oral dosage formulation (tablet) was subsequently developed and results from a Phase I study with TELINTRA tablets showed clinical activity and the formulation to be well tolerated. In June 2011, the Company initiated a Phase II clinical ! trial to evaluate TELINTRA tablets. In October 2011, the Company initiated an additional Phase IIb clinical trial to evaluate TELINTRA tablets. '

The activity and safety profile of tablet formulation allowed the Company to complete a Phase II trial of TELINTRA tablets in MDS. The primary objective of the Phase II TELINTRA tablet study was to determine the efficacy of TELINTRA. A multivariate logistic regression analysis was conducted to identify MDS disease prognostic factors associated with erythroid improvement response rates, including prior MDS treatment, age, gender, the international prognostic scoring system (IPSS), risk, Eastern Cooperative Group performance status, years from MDS diagnosis, MDS World Health Organization subtypes, anemia only versus anemia plus other cytopenias, dose schedule and starting dose. Results from this study show that TELINTRA is the first GSTP1-1 enzyme inhibitor shown to cause clinically reductions in red blood cell transfusions, including transfusion independence in low to intermediate-1 risk MDS patients, as well as improvement in platelet count and white blood cell levels in certain patients. TELINTRA, administered orally twice daily, appeared to be convenient and flexible for chronic treatment administration.

TELCYTA is a small molecule drug product candidate that the Company is developed for the treatment of cancer. TELCYTA binds to GST. TELCYTA has been evaluated in multiple Phase II and Phase III clinical trials, including trials using TELCYTA as monotherapy and in combination regimens in ovarian, non-small cell lung, breast and colorectal cancer. Results from these clinical trials indicate that TELCYTA monotherapy was generally well-tolerated, with mostly mild to moderate side effects, particularly when compared to the side effects and toxicities of standard chemotherapeutic drugs. When TELCYTA was evaluated in combination with standard chemotherapeutic drugs, the tolerability of the combinations was similar to that expected of each! drug alo! ne.

Clinical activity including objective tumor responses and/or disease stabilization was reported in the TELCYTA Phase II trials; however, TELCYTA did not meet its primary endpoints in the Phase III studies. Positive results from a Phase I-IIa multicenter, dose-ranging study of TELCYTA in combination with carboplatin and paclitaxel as first-line therapy for patients with non-small cell lung cancer, or NSCLC, were published in a peer reviewed publication. Clinical data demonstrated positive results of TELCYTA in combination with carboplatin and paclitaxel in the treatment of first-line lung cancer followed by TELCYTA maintenance therapy. As of December 31, 2011, the Company had an on-going investigator-led study at a single site of TELCYTA in patients with refractory or relapsed mantle cell lymphoma, diffuse B cell lymphoma, and multiple myeloma.

Preclinical Drug Product Development

The Company has a small molecule compound, TLK60404, in preclinical development that inhibits both Aurora kinase and VEGFR kinase. Aurora kinase is a signaling enzyme whose function is required for cancer cell division, while VEGF plays a key role in tumor blood vessel formation, ensuring an adequate supply of nutrients to support tumor growth. These lead compounds prevented tumor growth in preclinical models of human colon cancer and human leukemia by inhibiting both Aurora kinase and VEGFR kinase. A development drug product candidate, TLK60404, has been selected.

The Company, using its TRAP technology has discovered TLK60357, a novel, potent small molecule inhibitor of cell division. TLK60357 inhibits the formation of microtubules that are necessary for cancer cell growth leading to persistent G2/M cancer cell cycle block and subsequent cell death. This compound demonstrates potent broad-spectrum anticancer activity against a number of human cancer cells. This compound also displays oral efficacy in multiple, standard preclinical models of cancer. TLK60596, a potent VG! FR kinase! inhibitor, blocks the formation of new blood vessels in tumors. Oral administration of TLK60596 to animal models of human colon cancer reduced tumor growth.

Top Medical Stocks To Invest In Right Now: Amgen Inc.(AMGN)

Amgen Inc., a biotechnology medicines company, discovers, develops, manufactures, and markets human therapeutics based on advances in cellular and molecular biology for grievous illnesses primarily in the United States, Europe, and Canada. The company markets recombinant protein therapeutics in supportive cancer care, nephrology, and inflammation. Its principal products include Aranesp and EPOGEN erythropoietic-stimulating agents that stimulate the production of red blood cells; Neulasta and NEUPOGEN to stimulate the production of neutrophils, which is a type of white blood cell that helps the body to fight infections; and Enbrel, an inhibitor of tumor necrosis factor that plays a role in the body?s response to inflammatory diseases. The company also markets other products comprising Sensipar/Mimpara, a small molecule calcimimetic that lowers serum calcium levels; Vectibix, a monoclonal antibody that binds specifically to the epidermal growth factor receptor; and Nplate, a thrombopoietin (TPO) receptor agonist that mimics endogenous TPO, the primary driver of platelet production. In addition, it provides Denosumab, a human monoclonal antibody that targets RANKL, an essential regulator of osteoclasts. Further, the company offers product candidates in mid-to-late stage development in a variety of therapeutic areas, including oncology, hematology, inflammation, bone, nephrology, cardiovascular, and general medicine consisting of neurology. It markets its products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies; consumers; and wholesale distributors of pharmaceutical products. The company has various collaborative arrangements with Pfizer Inc.; GlaxoSmithKline plc; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; Array BioPharma Inc.; Kyowa Hakko Kirin Co. Ltd.; and Cytokinetics, Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.

Advisors' Opinion:
  • [By Seth Robey]

    Another option emerges
    In last week's edition, I teased that one addition to the stalwart section of our virtual portfolio was a glaring omission from the big biotech segment. That company, Amgen (NASDAQ: AMGN  ) , isn't traditionally considered a stalwart, but with a valuation more reminiscent of big pharma than big biotech, a 1.6% dividend yield, and acquisition clout, Amgen could provide stability to any portfolio. But then Abbott Labs (NYSE: ABT  ) reported its quarterly earnings and its post-restructuring narrative presented a more clear companion to Johnson & Johnson.

  • [By Keith Speights]

    A double-digit drop for Amgen (NASDAQ: AMGN  ) stock over the past couple of months has likely left a bad taste in the mouths of shareholders. Is this venerable biotech ready to mount a comeback?�

  • [By Keith Speights]

    Currently, the top 10 stocks in which the ETF is invested comprise more than 55% of total assets. Sure, there are some speculative names included in the full list of holdings. However, the largest stakes are in big biotechs with long track records, like Gilead Sciences (NASDAQ: GILD  ) , Celgene (NASDAQ: CELG  ) , Amgen (NASDAQ: AMGN  ) , and Biogen Idec (NASDAQ: BIIB  ) . These top four holdings make up almost one-third of the ETF's total assets.

10 Best Biotech Stocks To Buy Right Now: Inergetics Inc (NRTI)

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 Resurgex 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 pudding.

Surgex

Surgex (www.surgexspor! ts.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.

10 Best Biotech Stocks To Buy Right Now: Johnson & Johnson(JNJ)

Johnson & Johnson engages in the research and development, manufacture, and sale of various products in the health care field worldwide. The company operates in three segments: Consumer, Pharmaceutical, and Medical Devices and Diagnostics. The Consumer segment provides products used in baby care, skin care, oral care, wound care, and women?s health care fields, as well as nutritional, over-the-counter pharmaceutical products, and wellness and prevention platforms under the brands of JOHNSON?S, AVEENO, CLEAN & CLEAR, JOHNSON?S Adult, NEUTROGENA, RoC, LUBRIDERM, DABAO, LISTERINE, REACH, BAND-AID, CAREFREE, STAYFREE, SPLENDA, TYLENOL, SUDAFED, ZYRTEC, MOTRIN IB, and PEPCID AC. The Pharmaceutical segment offers products in various therapeutic areas, such as anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management, and virology. Its principal products include REMICADE for the treatment of immune me diated inflammatory diseases; STELARA for the treatment of moderate to severe plaque psoriasis; SIMPONI, a treatment for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis; VELCADE for the treatment of multiple myeloma; PREZISTA and INTELENCE for treating HIV/AIDS patients; NUCYNTA for moderate to severe acute pain; INVEGA SUSTENNAtm for the acute and maintenance treatment of schizophrenia in adults; RISPERDAL CONSTA for the management of bipolar I disorder and schizophrenia; and PROCRIT to stimulate red blood cell production. The Medical Devices and Diagnostics segment primarily offers circulatory disease management products; orthopaedic joint reconstruction, spinal care, and sports medicine products; surgical care, aesthetics, and women?s health products; blood glucose monitoring and insulin delivery products; professional diagnostic products; and disposable contact lenses. The company was founded in 1886 and is based in Ne w Brunswick, New Jersey.

Advisors' Opinion:
  • [By James Well]

    Pfizer (PFE) is one of the biopharmaceutical companies hardest hit by drugs losing patent exclusivity. Other big pharmaceutical companies affected by loss of patent protection include Merck (MRK), Johnson & Johnson (JNJ), Novartis (NVS) and Sanofi (SNY). Apart from battling with the loss of revenue due to loss of marketing exclusivity of their drugs, these companies are also packing drug pipelines to offset imminent patent expirations.

  • [By Brian Orelli]

    Axial spondyloarthritis is a precursor to ankylosing spondylitis, which all four TNF inhibitors --�Amgen (NASDAQ: AMGN  ) and Pfizer's (NYSE: PFE  ) Enbrel, Johnson & Johnson's (NYSE: JNJ  ) Remicade and Simponi, and AbbVie's Humira -- are all approved for. But none of them are approved for axial spondyloarthritis, and it doesn't look like Humira will get the nod on this go with the FDA.

  • [By Brian Orelli]

    The FDA generally requires at least two successful phase 3 trials, but will accept a single trial in certain instances when there's an unmet need. There aren't any drugs approved to treat Parkinson's disease psychosis, although atypical antipsychotics such as Johnson & Johnson's (NYSE: JNJ  ) Risperdal, Eli Lilly's (NYSE: LLY  ) Zyprexa, Bristol-Myers Squibb's (NYSE: BMY  ) Abilify, and Pfizer's (NYSE: PFE  ) Geodon are used off label to treat Parkinson's patients experiencing psychotic symptoms, which affects up to 60% of Parkinson's patients.

10 Best Biotech Stocks To Buy Right Now: Autoimmune Inc (AIMM)

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 product 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 administered a! utoimmune-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.

10 Best Biotech Stocks To Buy Right Now: Dendreon Corporation(DNDN)

Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of therapeutics to enhance cancer treatment options for patients. The company offers active cellular immunotherapy and small molecule product candidates to treat various cancers. Its product candidates comprise Provenge (sipuleucel-T), an active cellular immunotherapy for the treatment of metastatic, castrate-resistant prostate cancer; DN24-02, an investigational active immunotherapy for the treatment of patients with bladder, breast, ovarian, and other solid tumors expressing HER2/neu; and TRPM8, a small molecule agonist to transient receptor potential ion channel, for multiple cancers. The company also has a range of products in preclinical studies, which include Carcinoembryonic antigen for the treatment of lung, colon, and breast cancer; and Carbonic AnhydraseIX for the treatment of kidney cancer. Dendreon Corporation was founded in 1992 and is headquartered in S eattle, Washington.

Advisors' Opinion:
  • [By WALLSTCHEATSHEET.COM]

    Dendreon is suffering from lower product sales, which is due to increased competition. Costs are too high, and the company culture is awful. On the other hand, Dendreon narrowed its loss in Q1 on a year-over-year basis, and it expects conditions to improve. While that�� an expected statement from any company that�� performing poorly, and while Dendreon currently relies heavily on Provenge,�Dendreon isn�� a one-trick pony.�It still has several other drugs in the pipeline. It should also be noted that Dendreon has been on the brink of disaster many times throughout its history. It has clawed its way back to life in every instance. Perhaps it has nine lives. If that�� the case, it has used up four of them so far.

  • [By Debra Fiakas]

    Earlier this month biotech Dendreon (DNDN) announced the approval in the European Union of its only commercial product Provenge. Aimed at prostate cancer, Provenge is a novel therapeutic based on Dendreon's proprietary cellular immunotherapy technology. The good news could not have come at a better time. Dendreon has had Provenge on the market in the U.S. since spring 2010. While sales have ramped impressively to $304.3 million in the most recently reported twelve months, the top-line has failed to cover costs and expenses.

10 Best Biotech Stocks To Buy Right Now: Scancell Holdings PLC (SCLP)

Scancell Holdings PLC is a United Kingdom-based company. The Company�� principal activity of the consists of the discovery and development of monoclonal antibodies and vaccines for the treatment of cancer. In April 2012, the Company completed recruitment to the Phase 1 clinical trial of SCIBI. In May 2012, the Company commenced recruitment and treatment of the first patient in the second part of it Phase 1/2 clinical trial of SCIBI. The Phase 2 part of the trial is conducted in five United Kingdom centers in Nottingham, Manchester, Newcastle, Leeds, and Southampton. On August 15, 2012, the Company announced the development of a platform technology, Moditope.

10 Best Biotech Stocks To Buy Right Now: Neoprobe Corporation(NEOP)

Neoprobe Corporation, a biomedical company, engages in the development and commercialization of precision diagnostics that enhance patient care and improve patient benefit. The company is developing and commercializing targeted agents aimed at the identification of occult (undetected) disease. Neoprobe?s two lead radiopharmaceutical agent platforms, Lymphoseek and RIGScan are intended to help surgeons better identify and treat certain types of cancer. Lymphoseek is a diagnostic imaging agent intended for radiolabeling and administration in radiodetection and visualization of the lymphatic system draining the region of injection for delineation of the lymphatic tissue; and RIGScan is an intraoperative biologic targeting agent consisting of a radiolabeled murine monoclonal antibody. The company has a biopharmaceutical development and supply agreement with Laureate Biopharmaceutical Services, Inc. to support the initial evaluation of the viability of the CC49 master working c ell bank, as well as the initial steps in re-validating the commercial production process for the biologic agent used in RIGScan CR. The company was founded in 1983 and is based in Dublin, Ohio.

10 Best Biotech Stocks To Buy Right Now: Prima BioMed Ltd (PBMD.W)

Prima BioMed Ltd is a biotechnology company is engaged in the development and commercialization of medical therapies with a focus on oncology. Its product candidates in development include Cvac, an autologous dendritic cell vaccine for ovarian cancer, monoclonal antibodies for multiple tumour types, and an oral formulation for the human papilloma virus (HPV), vaccine. Its product candidate Cvac is a dendritic cell therapy, for which it is conducting a Phase IIb trial for the treatment of ovarian cancer. Cvac is designed to target the tumour antigen mucin-1, which is expressed at high levels on different tumour types. It also has two preclinical product development programs. In May 2011, Prima BioMed GmbH, a 100 % owned subsidiary of Prima BioMed Ltd, was incorporated in Germany. In May 2011, Prima BioMed Middle East FZLLC, a 100 % owned subsidiary of Prima BioMed Ltd, was incorporated in the United Arab Emirates.

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