Tuesday, November 5, 2013

Top 5 Biotech Stocks To Invest In 2014

Polydex Pharmaceuticals (POLXF.PK) Limited, through its subsidiaries, engages in the development, manufacture, and marketing of biotechnology-based products for the human pharmaceutical market. It is also involved with manufacture of bulk pharmaceutical intermediates for the veterinary pharmaceutical industry worldwide. It primarily offers Dextran and Dextran derivative products.

On The Cusp of a New Period of Growth

Shares of POLXF have risen sharply in recent months. In early June 2013 shares were trading around $0.30. Today shares are trading at around $1.10. The answer to what fueled this sharp rise in share price is simple. After several years of lackluster bottom-line growth on a quarterly and annual basis, the company posted substantial EPS growth during its fiscal 2014 first and second quarters.

POLXF Sales, Income and adjusted EPS - First Half Fiscal 2014 vs. 2013 (Year Ends January 31)


(Click to enlarge)

Top 5 Biotech Stocks To Invest In 2014: 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 5 Biotech Stocks To Invest In 2014: Regeneron Pharmaceuticals Inc.(REGN)

Regeneron Pharmaceuticals, Inc., a biopharmaceutical company, discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions in the United States. The company?s commercial product includes ARCALYST (rilonacept) injection for subcutaneous use for the treatment of cryopyrin-associated periodic syndromes, including familial cold auto-inflammatory syndrome and muckle-wells syndrome in adults and children. Its products under Phase III clinical development stage consist of VEGF Trap-Eye, an aflibercept ophthalmic solution developed using intraocular delivery for the treatment of serious eye diseases; ARCALYST for the prevention of gout flares in patients initiating uric acid-lowering treatment; and Aflibercept (VEGF Trap), which is developed in oncology. The company?s earlier stage clinical programs include various human antibodies, such as REGN727 for low-density lipoprotein cholesterol reduction, REGN88 for rheumatoid arthritis and ankylosing spondylitis; REGN668 for atopic dermatitis and asthma; REGN421 and REGN910 for oncology; REGN475 for the treatment of pain; and REGN728 and REGN846. It also conducts preclinical research programs in the areas of oncology and angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain, cardiovascular diseases, and infectious diseases. The company distributes its products through third party service providers. It has strategic collaboration with sanofi-aventis Group to discover, develop, and commercialize human monoclonal antibodies; and Bayer HealthCare LLC to develop and commercialize VEGF Trap. Regeneron Pharmaceuticals, Inc. was founded in 1988 and is based in Tarrytown, New York.

Advisors' Opinion:
  • [By Ben Levisohn]

    On the downside, Halliburton (HAL) fell 3.5% to $50.66 after beating earnings but underperforming competitors, while Regeneron Pharmaceuticals (REGN) fell 2.4% to $294.89 after it reported positive trial data on Eylea and that it will file an application with the FDA in a few months. And our big loser of the day: PetMed Express (PETS), which plunged 9.8% to $15.21, the biggest drop in the S&P 1500. It reported a profit of 21 cents a share, missing forecasts for a profit of 22 cents.

  • [By John Divine]

    Lastly, shares of Regeneron Pharmaceuticals (NASDAQ: REGN  ) shed 4.1% Friday. Shares in the biopharmaceutical company have more than doubled in the last year, and have been an absolute dream for longer-term shareholders, having been a 10-bagger in the past three years, and trading at more than 15 times their value five years ago. Right now, Wall Street is wondering whether Regeneron's still a bargain at 37 times forward earnings, and today's ruling was decisively negative on a day the health-care sector ended was the second-worst performing area of the markets.

Top 5 Value Companies To Watch For 2014: 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.

Top 5 Biotech Stocks To Invest In 2014: Celsion Corporation(CLSN)

Celsion Corporation, an oncology drug development company, develops and commercializes targeted chemotherapeutic oncology drugs based on its proprietary heat-activated liposomal technology. The company is developing its lead product, ThermoDox that is in Phase III clinical trial for primary liver cancer; and in phase II clinical trial for treatment of recurrent chest wall breast cancer. It has a license agreement with Yakult Honsha to commercialize and market ThermoDox for the Japanese market. The company also has a license agreement with Duke University under which it received exclusive rights to commercialize and use Duke's thermo-liposome technology. In addition, Celsion Corporation has a joint research agreement with Royal Phillips Electronics to evaluate the combination of Phillips' high intensity focused ultrasound with its ThermoDox to determine the potential of this combination to treat a range of cancers. The company was founded in 1982 and is based in Columbia, M aryland.

Advisors' Opinion:
  • [By EquityOptionsGuru]

    The Prolieve Thermodilatation System was actually developed by the current management of Medifocus while employed at Celsion Corporation (NASDAQ:CLSN). The system was also jointly developed with Boston Scientific (NYSE:BSX) before being acquired by Medifocus in July 2012. Prolieve has already received FDA approval, is currently generating revenue, and is the only in office alternative to drug therapy. The system essentially uses microwave energy to treat Benign Prostatic Hyperplasia (BPH), which is a non-cancerous enlargement of the prostate gland that typically affects men over the age of 50. The Prolieve device works by compressing and heating prostatic tissue that may be blocking the flow of urine. This particular treatment option offers patients several benefits including the following:

  • [By Paul Ausick]

    Stocks on the Move: NQ Mobile Inc. (NYSE: NQ) is up 26% at $11.09 as the company fights back against a short-seller report. Celsion Corp. (NASDAQ: CLSN) is up 339.3% at $5.14 following a reverse 1:4.5 stock split. Micron Technology Inc. (NASDAQ: MU) is up 4.7% at $17.50.

Top 5 Biotech Stocks To Invest In 2014: Bioanalytical Systems Inc.(BASI)

Bioanalytical Systems, Inc. provides drug discovery and development services for pharmaceutical, biotechnology, academic, and government organizations primarily in North America, the Pacific Rim, and Europe. The company operates in two segments, Contract Research Services and Research Products. The Contract Research Services segment offers various services, including product characterization, method development, and validation; bioanalytical testing to measure drug and metabolite concentrations in complex biological matrices; stability testing to establish and confirm product purity, potency, and shelf life; in vivo sampling services for the continuous monitoring of chemical changes in life; and pharmacokinetic and safety testing services, as well as provides screening and pharmacological testing, preclinical safety testing, formulation development, regulatory compliance, and quality control testing services. The Research Products segment offers analytical products compris ing liquid chromatographic and electrochemical instruments with associated accessories; in vivo sampling products, such as Culex family of automated in vivo sampling and dosing instruments; and Vetronics? products consisting of instruments and related software to monitor and diagnose cardiac function, and measure other vital physiological parameters in cats and dogs. The company was founded in 1974 and is headquartered in West Lafayette, Indiana.

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