Wednesday, August 13, 2014

Top 10 Biotech Companies To Watch In Right Now

Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Shares of Cubist Pharmaceuticals (NASDAQ: CBST  ) , a biopharmaceutical company devoted to developing acute care therapies, added 12% following the announcement of its second-quarter earnings results.

So what: For the quarter, Cubist reported 12.2% revenue growth over the year-ago period, to $258.8 million, as its lead product Cubicin saw revenue jump 13.5%, to $227.1 million. Profit for the quarter decreased to $0.42 per share, from $0.56 per share last year. Still, this was certainly more than enough to excite investors, because Wall Street had been expecting just $254 million in sales and a profit of $0.40 per share. Also fueling today's gains was an update on the advancement of ceftolozane/tazobactam (previously CXA-201) in late-stage trials.

Now what: This was another solid quarter for Cubist. As always, I'm a bit leery when a biotech stock gets a massive chunk of revenue from just a single drug -- in this case, Cubicin is responsible for nearly 88% of total revenue -- as it leaves the company exposed should a sales or safety problem arise with that drug. However, I'm also seeing the beginnings of a diverse pipeline. Ceftolozane/tazobactam, should it be approved for all three tested indications, including the treatment of ventilator-associated bacterial pneumonia, could have peak sales potential of anywhere from $1 billion to $1.3 billion according to varying estimates. If I were you, I'd be adding Cubist Pharmaceuticals to your Watchlist.

Top 10 Building Product Companies To Invest In 2015: Taro Pharmaceutical Industries Ltd (TARO)

Taro Pharmaceutical Industries Ltd., incorporated in 1959, is a science-based pharmaceutical company. The Company develops manufactures, and markets prescription and over-the-counter (OTC) pharmaceutical products, primarily in the United States, Canada and Israel. The Company also develops and manufactures active pharmaceutical ingredients (APIs), primarily for use in its finished dosage form products. The Company�� primary areas of focus include pediatric creams and ointments, liquids, capsules and tablets, mainly in the dermatological and topical, cardiovascular, neuropsychiatric and anti-inflammatory therapeutic categories. The Company operates through three companies: Taro Pharmaceutical Industries Ltd. (Taro Israel), and two of its subsidiaries (including indirect), Taro Pharmaceuticals Inc. (Taro Canada) and Taro U.S.A. The Company markets more than 180 pharmaceutical products in over 25 countries.

Taro Israel manufactures more than 160 finished dosage form pharmaceutical products for sale in Israel and for export. It produces APIs used in the manufacture of finished dosage form pharmaceutical products. It markets and distributes generic products in the local Israeli market. Taro Israel�� primary product lines include dermatology, prescription and OTC semi-solid products (creams, ointments and gels) and liquids; cardiology and neurology, prescription oral dosage products; oral analgesics, both prescription and OTC, and OTC oral and nasal sprays and ophthalmic products.

Taro Canada manufactures more than 70 finished dosage form pharmaceutical products for sale in Canada and for export. It markets and distributes generic products in the local Canadian market. Its product line includes dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology, oncology, gastrointestinal and neurology: prescription oral and injects able dosage products, and allergy (antihistamine): OTC oral dosage products.

Taro U.S.A markets! and distributes generic products in the United States market. Its primary product lines include dermatology: prescription and OTC semi-solid products (creams, ointments and gels) and liquids, cardiology and neurology: prescription oral dosage products, and other prescription and OTC products.

The Company competes with Bristol-Myers Squibb, GlaxoSmithKline, Merck, Novartis, Pfizer/Wyeth, Valeant, Galderma, Merck/Schering-Plough, Teva Pharmaceuticals U.S.A., Mylan Laboratories, Perrigo Company, Ranbaxy Pharmaceuticals Inc., Sandoz Pharmaceuticals, Merck Canada Inc., Pfizer Canada Inc., Janssen Inc., Schering-Plough Canada, Novartis Pharmaceuticals Canada Inc., GlaxoSmithKline Inc., Bayer Inc., Bristol-Myers Squibb Canada, Apotex Inc., Teva Canada Limited, Mylan Pharmaceuticals ULC, Sandoz Canada Incorporated, Pharmascience Inc., Teva Pharmaceutical Industries Ltd., Perrigo Israel Pharmaceuticals Ltd., Dexxon Ltd., Rafa Laboratories Ltd., Bayer AG, Eli Lilly and Company, Merck & Co., Inc. and Pfizer Inc.

Advisors' Opinion:
  • [By Rich Smith]

    Israeli drugmaker Taro Pharmaceutical Industries (NYSE: TARO  ) has a new CEO -- and a new Chairman of the Board, as well.

    On Thursday, Taro announced the imminent retirement of Interim Chief Executive Officer Mr. James Kedrowsk, who will be replaced August 1 by new permanent CEO Mr. Kalyanasundaram Subramanian ("Kal Sundaram"). Additionally, the company said that Dilip Shanghvi�has been appointed Chairman of its Board of Directors.

Top 10 Biotech Companies To Watch In Right Now: 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 Ben Levisohn]

    Shares of Regeneron Pharmaceuticals (REGN) have fallen 4.4% to $323.62 at 3:23 p.m., while�Biogen�(BIIB) has dropped 4% to $327.04 and�Gilead Sciences (GILD) has dipped 0.4% to $79.58. The iShares Nasdaq Biotechnology Index ETF�(IBB), meanwhile, has dropped 0.9% to $258.85 and the SPDR S&P Biotech ETF�(XBI) has declined 0.6% to $160.69. Suffice it to say, biotech investors don’t appear to be enjoying zero-G nearly as much as Kate Upton.

  • [By Anora Mahmudova]

    Heavy losses among biotech stocks dragged the Nasdaq Composite down. The Nasdaq Biotechnology index fell 2.8%. Biogen Idec, Inc. (BIIB) � and Gilead Sciences, Inc. (GILD) � were among the top five losers on the S&P 500, falling 5% and 4.9% respectively.

Top 10 Biotech Companies To Watch In Right Now: bluebird bio Inc (BLUE)

bluebird bio, Inc., incorporated on April 16, 1992, is a clinical-stage biotechnology company, the Company is focused on transforming the lives of patients with severe genetic and orphan diseases using gene therapy. Gene therapy seeks to introduce a functional copy of the defective gene into a patient�� own cells, a process called gene transfer. Through gene transfer, a functional copy of the mutated gene is delivered to the patient�� cells, thereby correcting the underlying genetic defect that causes aberrant gene expression. As of December 31, 2012, the Company is conducting a Phase I/II clinical study in France evaluating an earlier generation of its LentiGlobin vector for the treatment of �-thalassemia major and SCD. Initial proof-of-concept data from this study were published in Nature. During the year ended December 31, 2013, the Company plans to initiate an extension of this study under a revised protocol for LentiGlobin, which the Company refers to as the HGB-205 Study. The Company also plans o initiate a second Phase I/II clinical program in the United States for LentiGlobin, which the Company refers to as the HGB-204 Study, for �-thalassemia major. In March 2013, the Company entered into a strategic collaboration with Celgene Corporation, or Celgene, to discover, develop and commercialize, disease-altering gene therapies in oncology.

Its gene therapy platform is based on viral vectors that utilize a modified, non-replicating version of the Human Immunodeficiency Virus Type 1 (HIV-1) virus, that has been stripped of all of the components required for it to self-replicate and infect additional cells. The HIV-1 virus is part of the lentivirus family of viruses, as a result of which the Company refer to its vectors as lentiviral vectors. Its lentiviral vectors are used to introduce a functional copy of a gene to the patient�� own isolated blood stem cells, called hematopoietic stem cells (HSCs), which reside in a patient�� bone marrow and are capable of differentiating int! o a wide range of cell types. HSCs are dividing cells, thus its approach allows for sustained expression of the modified gene as the Company is able to take advantage of a lifetime of replication of the gene-modified HSCs. Additionally, the Company has developed a cell-based vector manufacturing process that is both reproducible and scalable.

Adrenoleukodystrophy

Adrenoleukodystrophy is a rare X-linked, inherited, neurological disorder that is often fatal. ALD is caused by mutations in the ABCD1 gene which encodes for a protein called the ALD protein (ALDP), which plays a critical role in the breakdown and metabolism of long-chain fatty acids (VLCFA). Without functional ALDP, VLCFA accumulate in cells including neural cells in which they cause damage to the myelin sheath, a protective and insulating membrane that surrounds nerve cells in the brain. This damage can result in decreased motor coordination and function, visual and hearing disturbances, the loss of cognitive function, dementia, seizures, adrenal dysfunction and other complications, including death. ALD is divided into various sub-segments with three main phenotypes that impact brain function: CCALD (Childhood cerebral adrenoleukodystrophy, AMN (Adrenomyeloneuropathy) and ACALD (Adult Cerebral ALD).

�-thalassemia

�-thalassemia is a rare hereditary blood disorder caused by a genetic abnormality of the �-globin gene resulting in defective red blood cells (RBCs). Genetic mutations cause the absence or reduced production of the beta chains of hemoglobin, or �-globin, thereby preventing the proper formation of hemoglobin A, which normally accounts for greater than 95% of the hemoglobin in the blood of adults. Hemoglobin is an iron-containing protein in the blood that carries oxygen from the respiratory organs to the rest of the body. Hemoglobin A consists of four chains-two chains each of a-globin and �-globin. Normally existing at an approximate 1:1 ratio, genetic mutations that impair t! he produc! tion of �-globin can lead to a relative excess of a-globin, premature death of red blood cells. The clinical implications of the a-globin/�-globin imbalance are two-fold: first, patients lack sufficient RBCs and hemoglobin to effectively transport oxygen throughout the body and can become severely anemic; and second, the shortened life span and ineffective production of RBCs can lead to other complications such as splenomegaly, marrow expansion, bone deformities, and iron overload in organs.

Sickle cell disease

Sickle cell disease (SCD) is a hereditary blood disorder resulting from a mutation in the �-globin gene that causes polymerization of hemoglobin proteins and abnormal red blood cell function. The disease is characterized by anemia, vaso-occlusive pain crisis (a common complication of SCD in which there is severe pain due to obstructed blood flow in the bones, joints, lungs, liver, spleen, kidney, eye, or central nervous system), infections, stroke, overall poor life and early death in a subset of patients. Under low-oxygen conditions, which are exacerbated by the red blood cell abnormalities, the mutant hemoglobin aggregates causing the RBCs to take on a sickle shape (sickle cells), which causes them to aggregate and obstruct small blood vessels, thereby restricting blood flow to organs resulting in pain, cell death and organ damage. If oxygen levels are restored, the hemoglobin can disaggregate and the RBCs return to their normal shape, but over time, the sickling damages the cell membrane and the cells fail to return to the normal shape even in high-oxygen conditions.

Advisors' Opinion:
  • [By Garrett Cook]

    Bluebird Bio (NASDAQ: BLUE) shares shot up 34.74 percent to $35.15 following the presentation of positive data on LentiGlobin BB305 at the European Hematology Association (EHA).

  • [By Garrett Cook]

    Bluebird Bio (NASDAQ: BLUE) shares shot up 33.61 percent to $34.86 following the presentation of positive data on LentiGlobin BB305 at the European Hematology Association (EHA).

Top 10 Biotech Companies To Watch In Right Now: 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 Cynthia Andrade]

    Looking at the portfolio, 55% of assets are in large-caps, 25% in mid-caps and the remainder in small firms. The fund has 56% of assets in its top ten holdings, which include Biogen (BIIB), Gilead (GILD), Amgen (AMGN), Regeneron (REGN), and Celgene (CELG).

  • [By Keith Speights]

    Sanofi (NYSE: SNY  ) and Regeneron Pharmaceuticals (NASDAQ: REGN  ) have developed a new drug that could lower LDL even more effectively than popular statin drugs. In November, the two companies announced enrollment in a large late-stage clinical trial to study the effects of an antibody that could lower LDL levels by inhibiting an enzyme called PCSK9 that is involved in the production of cholesterol.

  • [By Ben Levisohn]

    The Nasdaq Composite, however, rose just 0.7% to $4,276.79 this week, as the once surging index was hit hard when biotech stocks tumbled. The reason: Three Democrats sent a letter to Gilead Sciencs (GILD) expressing their bewilderment that the company could charge so much for its hepatitis C drug Sovaldi. Gilead fell 4% to $72.07 this week, while Biogen Idec (BIIB), which was added to the S&P 100, dropped 4.2% to $318.53 and Regeneron Pharmaceuticals (REGN) declined 5.5% to $310.79.

Top 10 Biotech Companies To Watch In Right Now: Epizyme Inc (EPZM)

Epizyme, Inc., incorporated on November 1, 2007, is a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize personalized therapeutics for patients with genetically defined cancers. The Company systematically identify the genetic alterations that create cancer causing genes, called oncogenes, select patients in whom the identified genetic alteration is found and then design small molecule therapeutics to inhibit the oncogene. The clinical development plan for each of its product candidates is directed towards patients with a particular genetically defined cancer.The Company is conducting a Phase I clinical trial of its advanced product candidate, EPZ-5676, an inhibitor targeting the DOT1L HMT, for the treatment of mixed lineage leukemia (MLL-r). The Company has identified its two lead product candidates using its product platform.

EPZ-5676-DOT1L Inhibitor

EPZ-5676 is an intravenously administered small molecule inhibitor of DOT1L. The Company is developing EPZ-5676 for the treatment of MLL-r, an aggressive subtype of the two most common forms of acute leukemia, ALL and AML. Patients with MLL-r are routinely diagnosed with existing technologies that are commonly used in clinical setting. The Company�� Phase 1 clinical trial of EPZ-5676 is an open label, multicenter trial that has two phases.

EPZ-6438-EZH2 Inhibitor

The Company is developing EPZ-6438 as an orally available small molecule inhibitor of EZH2 for the treatment of non-Hodgkin lymphoma patients who have an oncogenic point mutation in EZH2. EZH2 is an HMT that can become oncogenic and cause non-Hodgkin lymphoma and a range of other solid tumors. Two types of non-Hodgkin lymphoma, diffuse large B-cell lymphoma of germinal-center origin, or DLBCL, and follicular lymphoma, or FL, are particularly associated with an EZH2 point mutation. There are no therapies approved specifically for the treatment of cancer associated with an EZH2 point mutation.

Advisors' Opinion:
  • [By Dan Caplinger]

    Outside the Dow, there were a few winners. Guess? (NYSE: GES  ) climbed 8% after a better-than-expected earnings performance, despite the fact that profits fell from year-ago levels. The retailer repeated what we've heard from its peers about bad weather conditions having a negative impact on the company, and its European operations also struggled. Meanwhile, biotech IPO Epizyme (NASDAQ: EPZM  ) soared more than 50% after coming public at $15 this morning. The company has a promising technology in treating cancer caused by carcinogenic genes, and it has collaborations with several major drug companies that should help it push some of its potential treatments through the pipeline.

  • [By John Udovich]

    It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:

  • [By John Udovich]

    On Tuesday, small cap biopharmaceutical company Epizyme Inc (NASDAQ: EPZM) surged 75.56% after the company announced that its�EPZ-5676, a DOT1L inhibitor for acute leukemias, had reached its proof-of-concept milestone, meaning its worth taking a closer look at the stock as well as look at the share performance of cancer stocks like large cap Celgene Corporation (NASDAQ: CELG) and small caps�Dendreon Corporation (NASDAQ: DNDN) and Geron Corporation (NASDAQ: GERN).

  • [By John Udovich]

    Follow-on Stock Offerings From Small Cap Biotech Stocks. Thanks to the boom in biotech IPOs along with the sector�� overall performance, already listed biotechs have the option to ask investors for more cash in the form of a follow-on offering. Recently, FierceBiotech.com noted how four small cap biotechs raised $276 million from follow-on offerings in just one day last week. These small caps�included Epizyme Inc (NASDAQ: EPZM) which raised $88 million, Halozyme Therapeutics, Inc (NASDAQ: HALO) which raised $100 million, Agenus Inc (NASDAQ: AGEN) which raised $52 million and Idera Pharmaceuticals Inc (NASDAQ: IDRA) which raised $36 million. FierceBiotech.com noted that the�steady flow of about $4.5 billion a year in venture cash�along with�more than $3.5 billion from IPOs last year plus all of the�follow-ons are helping to foster both company growth and�accelerate drug�development programs. Mixed Bag for Biotech IPOs. Last Wednesday also saw two small cap biotech IPOs fizzle in one day�with small cap T cell vaccine developer�Genocea Biosciences Inc (NASDAQ: GNCA) raising $60 million but then ending the day down 8.3% to close at $11 while Dutch drug developer uniQure NV (QURE) raised $81.9 million but fell more than 14% to $14.61. However, orphan drug stock Auspex Pharmaceuticals Inc (NASDAQ: ASPX), which is developing�drugs to treat orphan diseases like Tourette syndrome, saw a 30.5% gain to close at $15.66 and raise $84 million. The Boston Globe quoted Michael Ringel, a partner and managing director at Boston Consulting Group who focuses on health care business, as saying:

    ��he mood is incredibly positive. Capital is flowing. [The biotech IPOs]��have been burning hot. I think it�� too early to suggest that is changing. I can�� predict the overall economy any better than anyone else, but I would expect a pretty good year for IPOs.��/p>

Top 10 Biotech Companies To Watch In Right Now: TESARO Inc (TSRO)

TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company�� marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.

Rolapitant

Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.

TSR-011

TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.

The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.

Advisors' Opinion:
  • [By Brian Orelli]

    Tesaro (NASDAQ: TSRO  ) is also up today after announcing that it established a partnership with clinicians to run the phase 3 development of its PARP inhibitor, niraparib. The trial will enroll about 300 breast cancer patients with BRCA mutations, comparing niraparib to investigators' choice of other breast cancer treatments.

  • [By Keith Speights]

    Positive response
    Clovis wasn't the only company to bring good news about an ovarian cancer drug to ASCO. TESARO� (NASDAQ: TSRO  ) announced phase 1 results for�niraparib. Shares of the biotech jumped 16% for the week.

  • [By Brian Pacampara]

    Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool's free investing community, biopharmaceutical company TESARO (NASDAQ: TSRO  ) has received the dreaded one-star ranking.

Top 10 Biotech Companies To Watch In Right Now: NanoViricides Inc (NNVC)

NanoViricides, Inc., incorporated on April 1, 2005, is a development-stage company. The Company is a nano-biopharmaceutical (nanomedicine) company whose business goals are to discover, develop and commercialize therapeutics to advance the care of patients suffering from life-threatening viral infections. The Company has several drugs in various stages of early development. The Company�� drugs are based on several patents, patent applications, provisional patent applications, and other property held by TheraCour Pharma, Inc. (TheraCou), to which the Company has exclusive licenses in perpetuity for the treatment of human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Influenza including Asian Bird Flu Virus (INF), Herpes Simplex Virus (HSV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Rabies. As of June 30, 2012, the Company had six drug development programs: Oral FluCideTM, against all Influenzas; a Piggy-back version of Flucide for hospitalized patients; nanoviricide eye drops against adenoviral EKC and herpes keratitis; HIVCide - I against HIV/AIDS; HerpeCide - I skin cream formulation for herpes cold sores and genital warts, and DengueCide, a broad spectrum nanoviricide designed to attack all types of dengue viruses and expected to be effective in the Severe Dengue Disease syndromes including Dengue Hemorrhagic Fever (DHS) and Dengue Shock Syndrome (DSS). As of June 30, 2012, it had engaged in organizational activities, sourcing compounds and materials, developing novel compounds and nanomaterials, and experimentation with studies on cell cultures and animals. In September 2011, NanoViricides Inc's Inno-Haven LLC acquired a light industrial building.

The Company's product development programs are divided into three sectors: commercially important diseases, neglected tropical diseases (NTD��) and biosecurity/biodefense, and advanced technologies. The Company has collaborations with KARD Scientific, Inc., MA. and Southern Research Institute, AL for influenza viruse! s; National (Central) Institute of Hygiene and Epidemiology (NIHE) (Vietnam), for H5N1 avian flu; The Long Island Jewish Medical System, Feinstein Institute of Medical Research (LIJMS), NY and TheVac, LLC. for viral diseases of the eye (adenoviruses, herpesviruses - epidemic kerato-conjunctivitis (EKC), Herpes Keratitis); TheVac, LLC and Northeastern Ohio Medical University (NEOMED) for herpes virus infections; University of California at Berkeley for dengue hemorrhagic fever viruses; Center for Disease Control and Prevention (CDC) and National (Central) Institute of Hygiene and Epidemiology for rabies virus. The Company has developed lead drug candidates against a number of viral diseases.

The Company had consolidated all of its influenza drug programs into a single pan-influenza FluCide program. It is developing a single drug for all influenzas, whether pandemic, epidemic, seasonal, novel, emerging, human, swine, or avian. It is developing a nanoviricide against adenoviral EKC. The nanoviricide eye drug candidate is formulated as simple eye drops. It is developing an anti-HSV nanoviricide skin cream formulation for direct application to the lesions. It has designed the anti-HIV nanoviricides using rational drug design principles. The ligands it has designed in the case of HIV-1 are thought to be broadly neutralizing. In-silico modeling indicates that its ligands dock to the conserved CD4 binding site of gp120 of HIV-1. The Company is working on developing anti-Dengue therapeutics. Dengue is an important NTD. Its RabiCide program has resulted in candidates that have enabled survival of 20% to 30% of infected animals after disease has set in, using a particular animal model.

The Company competes with Roche, Glaxo SmithKline, BioCryst Pharmaceuticals, Inc., Gilead, Bristol-Myers Squibb Company (BMS), Roche, Boehringer Ingelheim, Merck & Co., Inc. (Merck), Valeant, Schering, Pharmassett, Vertex, Intermune, Achillion and Novartis.

Advisors' Opinion:
  • [By Roberto Pedone]


    One under-$10 nano-biopharmaceutical player that's starting to trend within range of triggering a big breakout trade is Nanoviricides (NNVC), which engages in the discovery, development and commercialization of anti-viral therapeutics primarily in the U.S. This stock has been ripping to the upside so far in 2013, with share up big by 198%.

    If you take a look at the chart for Nanoviricides, you'll notice that this stock has recently formed a double bottom chart pattern at $4.55 to $4.52 a share. Following that bottom, shares of NNVC have now started to uptrend and move within range of triggering a big breakout trade. That trade will hit if NNVC manages to take out the upper-end of its recent sideways trading chart pattern, which has seen NNVC trend between $4.55 and $5.74 a share.

    Traders should now look for long-biased trades in NNVC if it manages to break out above some near-term overhead resistance levels at Friday's high of $4.94 a share to its 50-day moving average of $5.28 a share, and then once it takes out some more key overhead resistance levels at $5.72 to $5.74 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average volume of 234,994 shares. If that breakout triggers soon, then NNVC will set up to re-test or possibly take out its next major overhead resistance levels at $6.50 to its 52-week high at $7.59 a share.

    Traders can look to buy NNVC off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $4.55 to $4.52 a share. One can also buy NNVC off strength once it starts to clear those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.

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