Thursday, November 21, 2013

Top Biotech Companies To Invest In 2014

NEW YORK (TheStreet) -- The broader market was essentially unchanged on a slow Monday of trading. 

Regarding the market entering "bubble territory," Tim Seymour, managing partner of Triogem Asset Management, said on CNBC's "Fast Money," that the market isn't necessarily in a "bubble" yet, but that it is starting to become a bit worrisome. 

He added that the amount of IPOs flooding the market could be a cause for concern. 

Josh Brown, a financial adviser at Ritholtz Wealth Management, reminded investors that the retail "mom and pop" players haven't been in the market for a while, so the rush to get in isn't that surprising. 

Guy Adami, managing director of stockmonster.com, said there are still a few solid secular trends playing out and he liked Visa (V) and Mastercard (MA). He warned investors to be careful with biotech stocks.  Seymour said the valuation for consumer staples is getting stretched, especially compared to their growth rates. He likes companies with exposure to emerging markets, like Pepsico (PEP) and Mondelez (MDLZ), and would be a seller of Doctor Pepper Snapple (DPS) and General Mills (GIS).  Brown called consumer staples the "ultimate irony" because it is considered the "safe-haven" of equities, but will likely feel a lot of pain when interest rates rise and money starts to flow out the stocks.  Liz Dunn, associate director of Macquarie Capital, was a guest on the show who said J.C. Penney (JCP) has enough liquidity to make it though most of 2014 and needs to maintain positive comp-sales. She added that she's cautious on Kohl's (KSS) and preferred more luxurious brands like Polo Ralph Lauren (RL), Coach (COH), and Nordstrom (JWN). 

Top Biotech Companies To Invest In 2014: Navidea Biopharmaceuticals Inc (NAVB)

Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company�� radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson�� disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.

Lymphoseek

Navidea�� pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body�� immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea�� Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-center Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.

AZD4694

AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.

RadioImmunoGuided Surgery

As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.

The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.

Advisors' Opinion:
  • [By Keith Speights]

    3. Navidea Biopharmaceuticals (NYSEMKT: NAVB  )
    Some investors were likely befuddled by Navidea's stock action earlier this year. The company received FDA approval in March for Lymphoseek, its radiopharmaceutical agent used for imaging lymph nodes in patients with breast cancer or melanoma. That was great news, but shares dropped quickly and still haven't returned to previous levels.

  • [By Sean Williams]

    Diagnostics can also play an important role in early and late-stage breast cancer diagnoses. Navidea Biopharmaceuticals (NYSEMKT: NAVB  ) had Lymphoseek, its external lymph-node imaging and intra-operative lymphatic mapping diagnostic device, approved by the Food and Drug Administration earlier this year to help doctors stage cancer. Discovering whether breast cancer has invaded adjacent lymph nodes has never been easier or safer thanks to Lymphoseek, and it can dramatically aid physicians in determining the best course of action for breast cancer patients.

  • [By Sean Williams]

    Another prime example here would be Navidea Biopharmaceuticals' (NYSEMKT: NAVB  ) Lymphoseek which is an injectable agent used in external lymph-node imaging and intra-operative lymphatic mapping. In English this means it will dramatically improve the staging and treatment options for patients with breast cancer. Being that breast cancer was also listed as a commonly misdiagnosed cancer, this is a big step in the right direction for patient care.

Top Biotech Companies To Invest In 2014: Merck & Company Inc.(MRK)

Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. The company?s Pharmaceutical segment provides human health pharmaceutical products, such as therapeutic and preventive agents for the treatment of human disorders in the areas of bone, respiratory, immunology, dermatology, cardiovascular, diabetes and obesity, infectious diseases, neurosciences and ophthalmology, oncology, vaccines, and women's health and endocrine. This segment also offers human health vaccines, such as preventive pediatric, adolescent, and adult vaccines. Its Animal Health segment discovers, develops, manufactures, and markets animal health products. This segment offers antibiotics, anti-inflammatory products, vaccines, products for the treatment of fertility disorders, and parasiticides for cattle, swine, horses, poultry, dogs, cats, salmons, and fish. The Consumer Care segment develops, manufac tures, and markets over-the-counter, foot care, and sun care products. Its over-the-counter product line includes non-drowsy antihistamines; treatment for occasional constipation; decongestant-free cold/flu medicine for people with high blood pressure; nasal decongestant spray; and treatment for frequent heartburn. This segment?s foot care products comprise topical antifungal, and foot and sneaker odor/wetness products; and sun care products include sun care lotions, sprays and dry oils; and sunburn relief products. The company serves drug wholesalers and retailers, hospitals, government agencies, physicians, physician distributors, veterinarians, animal producers, and managed health care providers, as well as food chain and mass merchandiser outlets in the United States and Canada. Merck & Co., Inc. was founded in 1891 and is headquartered in Whitehouse Station, New Jersey.

Advisors' Opinion:
  • [By Dividend]

    Merck (MRK) has a market capitalization of $138.39 billion. The company employs 81,000 people, generates revenue of $47.267 billion and has a net income of $6.299 billion. Merck�� earnings before interest, taxes, depreciation and amortization (EBITDA) amounts to $22.343 billion. The EBITDA margin is 47.27 percent (the operating margin is 18.49 percent and the net profit margin 13.33 percent).

Top 10 Performing 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 Biotech Companies To Invest In 2014: Biogen Idec Inc(BIIB)

Biogen Idec Inc. discovers, develops, manufactures, and markets therapies for the treatment of neurodegenerative diseases, hemophilia, and autoimmune disorders in the United States and internationally. Its marketed products include the AVONEX for the treatment of relapsing multiple sclerosis (MS); RITUXAN for treating relapsed or refractory, CD20-positive, and B-cell Non-Hodgkin?s lymphoma (NHL); TYSABRI to treat relapsing MS; FUMADERM for the treatment of severe plaque psoriasis in adult patients; and FAMPYRA, an oral compound for the improvement of walking in adult patients with MS with walking disability. Biogen Idec Inc.?s products under Phase III consist of PEGylated interferon beta-1a designed to prolong the effects and reduce the dosing frequency of interferon beta-1a; BG-12 for the treatment of MS; Daclizumab, a monoclonal antibody in relapsing MS; Long-lasting factor IX and VIII fusion protein for the treatment of hemophilia B; GA101, a monoclonal antibody for t he treatment of chronic lymphocytic leukemia and NHL; and Dexpramipexole, an orally administered small molecule for the treatment of amyotrophic lateral sclerosis. The company?s Phase I clinical trial products include Anti-LINGO for use in multiple sclerosis, Neublastin for use in neuropathic pain, CD40L for use in systemic lupus erythematosus, ANTI-TWAEK humanized monoclonal antibody for TWEAK, and BIIB037 for use in Alzheimer's disease; and Phase II clinical trial product comprises OCRELIZUMAB, a humanized monoclonal antibody for treating CD20. It has collaboration agreements with Genentech, Inc.; Elan Pharma International, Ltd; Acorda Therapeutics, Inc.; Portola Pharmaceuticals, Inc.; Swedish Orphan Biovitrum AB; Abbott Biotherapeutics Corp; and Vernalis plc. The company was formerly known as IDEC Pharmaceuticals Corporation and changed its name to Biogen Idec Inc. in November 2003. Biogen Idec Inc. was founded in 1985 and is headquartered in Weston, Massachusetts.

Advisors' Opinion:
  • [By James E. Brumley]

    When investors think of companies fighting the good fight in the multiple sclerosis space, Biogen Idec (NASDAQ:BIIB) or Novartis (NYSE:NVS) almost always come to mind. And well they should. Gilenya, an MS therapy from Novartis, generated revenues of $1.2 billion last year, while multiple sclerosis drugs Tysabri, Avonex, and most-recently, Tecfidera, from Biogen Idec are all current or future blockbusters. Tysabri generated sales of $1.6 billion in 2012, and the recently-approved Tecfidera saw sales of nearly $200 million in Q2 (and it's still gaining steam). There's always something bigger and better than those MS drugs in the works, however, and TNI Biotech Inc. (OTCMKTS:TNIB) is one of the names NVS and BIIB need to be proverbially watching over their shoulders.

Top Biotech Companies To Invest In 2014: Amarantus Bioscience Holdings Inc (AMBS)

Amarantus BioScience Holdings, Inc., formerly Amarantus BioSciences, Inc., incorporated on March 22, 2013, is focuses on developing intellectual property and proprietary technology in order to develop drug candidates and diagnostic blood tests to diagnose and treat human diseases. The Company owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF), owns the intellectual property rights to biomarkers related to oncology and neurodegeneration named BC-SeraPro and NuroPro respectively, has a license to an Alzheimer�� disease blood test named LymPro, and owns a number of proprietary cell lines called PhenoGuard. MANF was the first therapeutic protein discovered from a PhenoGuard Cell Line. In December 2012, the Company acquired neurodegenerative diagnostic portfolio from Power3 Medical Products. On March 22, 2013, the Company was merged with into Amarantus Bioscience Inc.

The Company also owns an inventory of 88 cell lines that Amarantus refers to as PhenoGuard Cell Lines. MANF is a protein that corrects protein misfolding. The Company�� MANF product development effort is centered on a therapy for Parkinson�� disease.

Advisors' Opinion:
  • [By Bryan Murphy]

    I've taken bullish swings on - and been wrong to do so - Amarantus BioScience, Inc. (OTC:AMBS) before. My most recent bullish call on the budding biotech name was in April... a rally that fizzled shortly after I said it was just getting started. Somehow though, I find myself coming back to AMBS as a breakout candidate. This time, however, it's for a slightly different reason.

  • [By Bryan Murphy]

    Two weeks ago I penned some bullish thoughts on Amarantus BioScience, Inc. (OTC:AMBS). In simplest terms, I liked the way the stock had spent some time in consolidation mode, and looked like was testing the upper boundary of that zone - I figured a breakout from AMBS was imminent. So I waited... and waited.... and waited. Nothing. A week and a half later, I let the stock fall off my mental radar. As it turns out, I should have been a little more patient. Amarantus BioScience finally did the deed yesterday, and is following through today.

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