Thursday, July 10, 2014

Best Biotech Stocks To Watch For 2014

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Today, I want to focus on some of my favorite low-priced stocks. While the financial media may not always give $5 or $10 stocks their due, some of my best investments have been in overlooked low-priced stocks. And I know many new investors don’t like putting down $10,000 or $15,000 for only 100 shares of stock. If you count yourself among these ranks, I don’t blame you, and I have some good news to share with you.

Top 5 Energy Companies To Own In Right Now: Medivation Inc.(MDVN)

Medivation, Inc., a biopharmaceutical company, focuses on the development of small molecule drugs for the treatment of castration-resistant prostate cancer, Alzheimer?s disease, and Huntington disease. The company?s product candidates under clinical development include MDV3100, which is in Phase 3 development for the treatment of castration-resistant prostate cancer; and dimebon, which is in Phase 3 clinical trial for the treatment of Alzheimer?s disease and Huntington disease. It has collaboration agreements with Pfizer Inc. to develop and commercialize dimebon; and Astellas Pharma Inc. to develop and commercialize MDV3100. The company was founded in 2003 and is based in San Francisco, California.

Advisors' Opinion:
  • [By Dan Carroll]

    Medivation (NASDAQ: MDVN  ) shares also were hit hard this week, falling 7.8% over the past five days. Shares fell 8% alone on Monday, after Johnson & Johnson (NYSE: JNJ  ) agreed to purchase Aragon Pharmaceuticals in a $1 billion deal. It wasn't a game-changer for J&J, considering Aragon's developmental prostate cancer therapy ARN-509 is in phase 2 trials, although if the company can advance the drug to a regulatory victory down the road, it could one day fill in for J&J's current blockbuster oncology drug Zytiga after its patent expires.

  • [By Sean Williams]

    A slew of competitors
    We've had two treatments recently approved by the FDA a full three months ahead of their PDUFA date: Medivation (NASDAQ: MDVN  ) and Astella Pharma's Xtandi, and Bayer and Algeta's Xofigo. Xtandi improved median overall survival to 18.4 months, compared with just 13.6 months for the placebo in trials while Xofigo's median overall survival tallied 14 months, compared with 11.2 months for the control arm.

Best Biotech Stocks To Watch For 2014: Genomic Health Inc (GHDX)

Genomic Health, Inc. (Genomic Health), incorporated in August 2000, is a molecular diagnostics company focused on the global development and commercialization of genomic-based clinical laboratory services that analyze the underlying biology of cancer allowing physicians and patients to make individualized treatment decisions. Its Oncotype DX platform utilizes quantitative genomic analysis known as reverse transcription polymerase chain reaction (RT-PCR), in standard tumor pathology specimens to provide tumor-specific information, or the oncotype of a tumor. As of February 2012, Oncotype DX was evaluated in invasive breast cancer in 13 clinical studies involving more than 4,000 breast cancer patients worldwide. Genomic Health offers its Oncotype DX tests as a clinical service, where it analyzes the expression levels of genes in tumor tissue samples and provide physicians with a quantitative gene expression profile expressed as a single quantitative score, which it calls a Recurrence Score, for invasive breast cancer and colon cancer and a DCIS Score for DCIS. Its Oncotype DX breast cancer test analyzes the expression levels of 21 genes and Oncotype DX colon cancer test analyzes the expression levels of 12 genes. In March 2012, the Company established a wholly owned subsidiary, InVitae Corporation.

Oncotype DX Platform

The Company�� Oncotype DX platform uses its RT-PCR approach to improve cancer treatment decisions. Its diagnostic approach correlates gene expression to clinical outcomes and provides an individualized analysis of each patient's tumor. The Company has built a diagnostic infrastructure that allows it to move from research into development through to processing actual patient samples in its clinical reference laboratory. The Company offers Oncotype DX tests as clinical laboratory services. Its technology allows the Company to analyze tumor tissue samples in its clinical reference laboratory and provide physicians with genomic information specific to the patient'! s tumor. It analyzes tissues that are handled, processed and stored under routine clinical pathology laboratory practices.

Oncotype DX Breast Cancer Test

To develop its Oncotype DX breast cancer test, the Company evaluated 250 genes in three independent clinical studies, which identified a 21-gene panel whose composite gene expression profile can be represented by a breast cancer Recurrence Score. The Company conducted studies of its Oncotype DX breast cancer test with clinical samples from postmenopausal women with invasive breast cancer who were treated with aromatase inhibitors. In March 2010, the Journal of Clinical Oncology published results from a European study using its test to analyze tumor samples from over 1,200 patients in the ATAC (Arimedix, Tamoxifen, Alone or in Combination) trial, which established the use of aromatase inhibitors for adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer. The study demonstrated that, along with other standard measures, such as tumor size, its Oncotype DX breast cancer test contributes independently to provide a more complete picture of prognosis for N- and N+ patients treated with aromatase inhibitors.

In December 2011, the Company presented positive results from the ECOG E5194 DCIS clinical validation study at SABCS. The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score can predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast. In December 2011, the Company made Oncotype DX available for patients with ductal carcinoma in situ (DCIS), of the breast, a pre-invasive form of breast cancer. The launch of Oncotype DX for DCIS patients was based on positive results presented from a clinical validation study of Oncotype DX breast cancer test in patients with DCIS, conducted by the Eastern Cooperative Oncology Group (ECOG), a clinical trials cooperative! group su! pported by the National Cancer Institute.

Oncotype DX Colon Cancer Test

The Company developed its gene panel by identifying 761 cancer-related genes through review of existing research literature and computer analysis of genomic databases. The 761 candidate genes were also examined to determine whether they would be useful beyond other key variables including tumor stage, tumor grade, lymph nodes examined and MMR/MSI. It selected a final set of 12 genes, which were then independently evaluated in a validation study of over 1,400 stage II colon cancer patients from the Quick and Simple and Reliable (QUASAR), randomized study of adjuvant chemotherapy in the United Kingdom. This international, multi-center randomized trial examined the recurrence risk and the benefit associated with 5-fluorouracil/leucovorin, or 5FU/LV, adjuvant chemotherapy. Gene expression was quantified by RT-PCR from manually microdissected FPE primary colon cancer tissue, and recurrence-free interval, disease-free survival and overall survival were analyzed. In January 2012, the Company presented positive results of the first clinical decision making study of the Oncotype DX colon cancer test that shows that Recurrence Score result has a significant impact on treatment recommendations for stage II colon cancer patients.

The Company competes with General Electric Company, Hologic, Inc., Novartis AG, Myriad Genetics, Inc., Qiagen N.V., Response Genetics, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Roche Holding, Ltd, Siemens AG and Johnson & Johnson.

Advisors' Opinion:
  • [By Keith Speights]

    Genetic testing stands out as one current example of how scientific advances can help reduce medical costs. Genomic Health (NASDAQ: GHDX  ) makes genetic diagnostic tests for�breast, colon, and prostate cancer. Half of the patients diagnosed with prostate cancer each year actually have a very low risk of the cancer progressing. However, 90% of these low-risk patients still undergo surgery or radiation -- at a cost of tens of thousands of dollars per patient. Genomic Health's genetic test helps identify which patients really need more extensive treatment and holds the potential to reduce overall costs.

Best Biotech Stocks To Watch For 2014: 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.

  • [By Ben Levisohn]

    Teva has dropped 7.7% to $37.85 today at 3:23 p.m. but doesn’t seem to be spreading though the generic drug space. Taro Pharmaceuticals (TARO) ha gained 1.1% to $79, while Actavis (ACT) has gained 1.2% to $156.25 and Dr. Reddy’s Laboratories (RDY) has advanced 1% to $40.24. Mylan (MYL) has dropped 0.7% to $38.40.

Best Biotech Stocks To Watch For 2014: Protalix Biotherapeutics Inc (PLX)

Protalix BioTherapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins based on its ProCellEx protein expression system, ProCellEx. Using its ProCellEx system, the Company is developing a pipeline of biosimilar or generic versions of recombinant therapeutic proteins based on its plant cell-based expression technology, which focuses pharmaceutical markets and that rely upon known biological mechanisms of action. ProCellEx protein expression system consists of a set of technologies and capabilities for the development of recombinant proteins, including advanced genetic engineering technology and plant cell-based protein expression methods. Its ProCellEx protein expression system is built on flexible custom-designed bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures. In June 2010, it had completed the preliminary phase I clinical trial of PRX-105.

Taliglucerase Alfa

Taliglucerase alfa is a plant cell expressed recombinant glucocerebrosidase enzyme (GCD) for the treatment of Gaucher disease. The Company has commenced pre-clinical studies of an oral form of taliglucerase alfa. Its oral taliglucerase alfa is a plant cell expressed form of GCD that is naturally encapsulated within carrot cells genetically engineered to express the GCD enzyme. Pre-clinical studies of oral taliglucerase alfa demonstrate the stability of the enzyme in the cell and the capacity of the cell�� cellulose wall to protect the enzyme against degradation in the digestive tract in an in-vitro model of the stomach and intestines. Additionally, rats fed with lyophilized carrot cells expressing GCD have accumulated the active enzyme in the target organs; the spleen and liver. As of December 31, 2010, the Company had completed Phase III Clinical Trial.

PRX-102

The Company is developing PRX-102, its plant cell expressed modified version of the recombinant ! alpha-GAL-A protein, a therapeutic enzyme for the treatment of Fabry disease. Fabry disease is a rare, hereditary, genetic lysosomal storage disorder in humans caused by an X-lined deficiency of the alpha-GAL-A enzyme. The Company is in the animal evaluation testing phase of the development of PRX-102, which tests are based on a mouse model for Fabry disease.

Acetylcholinesterase

Protalix Ltd. is a wholly owned subsidiary of the Company is licensed the rights to certain technology under a research and license agreement with Yissum Research and Development Company (Yissum) and the Boyce Thompson Institute, Inc. Pursuant to the agreement, the Company is developing PRX-105, a plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in several therapeutic and prophylactic indications, as well as in a biodefense program and an organophosphate-based pesticide treatment program.

As of December 31, 2010, its in-vitro experiments of PRX-105 have shown that the acetylcholinesterase enzyme in its ProCellEx protein expression system demonstrates biological activity on biochemical and cellular levels. In addition, early animal studies demonstrated that the acetylcholinesterase expressed in its ProCellEx protein expression system was able to treat animals exposed to the nerve gas agent analogues, both when injected with its acetylcholinesterase product candidate immediately before exposure or when injected after exposure. In March 2010, it initiated a preliminary phase I clinical trial of PRX-105, which the Company completed in June 2010.

pr-antiTNF

pr-antiTNF is a candidate for the treatment of certain autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing, spondylitis, psoriatic arthritis and plaque psoriasis. The Company has designed the antiTNF as pr-antiTNF. pr-antiTNF is a plant cell-expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), f! used to t! he Fc component of a human antibody domain. pr-antiTNF has an identical amino acid sequence to Enbrel and its in-vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner.

The Company competes with Genzyme, Actelion, Crucell N.V., Biolex, Inc., Chlorogen, Inc., Greenovation Biotech GmbH, Symbiosys, Novartis AG/Sandoz Pharmaceuticals, BioGeneriX AG, Stada Arzneimittel AG, BioPartners GmbH and Teva.

Advisors' Opinion:
  • [By Keith Speights]

    Other investors might wish that Pfizer would use some of its cash to acquire a few smaller companies. Protalix BioTherapeutics (NYSEMKT: PLX  ) has been mentioned as one possible candidate. The two companies already partner together on Gaucher disease drug Elelyso. In February, Protalix spurred rumors that Pfizer could be interested in buying the company after it announced that it had engaged Citigroup to pursue a "broad array of strategic alternatives."

  • [By Maxx Chatsko]

    Industrial biotech isn't the only industry headed to Brazil. Protalix (NYSEMKT: PLX  ) entered into a technology transfer agreement with Brazil's Ministry of Health last week that will pay the company $280 million. The deal is big news for Protalix's first product, Elelyso/Uplyso, which was developed with partner Pfizer (NYSE: PFE  ) . The treatment is approved as an enzyme replacement therapy, or ERT, for adults with type 1 Gaucher disease, and it marks a huge step forward for the future of biomanufacturing. In the following video, Fool contributor Maxx Chatsko explains what this means for the product's commercialization and the adoption of Protalix's novel plant cell-based expression system for therapeutic proteins.

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