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)
5 Best Biotech Stocks To Buy For 2014: StemCells Inc (STEM.W)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal hum an neural stem cells. Its HuCNS-SC cells can be directly tr! a! nsplanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenanc e and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of tr ue, germline competent rat embryonic stem cells without! the ! ad! dition ! of cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
5 Best Biotech Stocks To Buy For 2014: Provectus Pharmaceuticals Inc (PVCT)
Provectus Pharmaceuticals, Inc., incorporated on May 1, 1978, is a development-stage pharmaceutical company that is primarily engaged in developing ethical pharmaceuticals for oncology and dermatology indications. The Company develops and focuses to license or market and sells its two prescription drug candidates, PV-10 and PH-10. The Company has transferred all its intellectual property related to over the counter (OTC) products and non-core technologies to its subsidiaries and designated, such subsidiaries as non-core to its primary business of developing its oncology and dermatology prescription drug candidates. The Company focuses on developing its prescription drug candidates PV-10 and PH-10. The Company is developing PV-10 for treatment of several life threatening cancers, including metastatic melanoma, liver cancer, and breast cancer. The Company is developing PH-10 to provide minimally invasive treatment of chronic severe skin afflictions such as psoriasis and atopic dermatitis, a type of eczema. All of the Company's prescription drug candidates are in either the pre-clinical or clinical trial stage.
PV-10
As of December 31, 2011, the Company is developing PV-10, a sterile injectible form of rose bengal disodium (Rose Bengal), for direct injection into tumors. Its PV-10 is retained in diseased or damaged tissue but dissipates from healthy tissue. The Company had conducted Phase I and Phase IIstudies of PV-10 for the treatment of metastatic melanoma, and Phase I studies of PV-10 for the treatment of liver and breast cancers.
PH-10
The Company�� prescription drug candidate PH-10 is an aqueous hydrogel formulation of Rose Bengal for topical administration to the skin. The Company is developing PH-10 for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. In August 2011, the Company completed follow-up of all Phase IIc patients.
Over-the-Counter Pharmaceuticals
The Company had desi! gnated its subsidiary that holds its OTC products, GloveAid and Pure-ific, Pure-Stick, Pure N Clear as non-core. The Company�� GloveAid is a hand cream with both antiperspirant and antibacterial properties, for the comfort of users��hands during and after the wearing of disposable gloves. Its Pure-ific line of products includes two quick-drying sprays, Pure-ific and Pure-ific Kids, that immediately kill up to 99.9% of germs on skin and prevent regrowth for six hours. Pure-ific products prevent the spread of germs and thus complement its other OTC products designed to treat irritated skin or skin conditions, such as acne, eczema, dandruff and fungal infections. Its Pure-ific sprays have been designed with convenience in mind and are targeted towards mothers, travelers, and anyone concerned about the spread of sickness-causing germs.
The Company�� acne products Pure-Stick and Pure N Clear work by decreasing the production of fats, oils and sweat that create an environment conducive to unchecked growth of bacteria. Secondly, the products also act to reduce the number bacteria already present. The Pure-Stick and Pure N Clear are applied topically to affected areas there are no safety concerns with healthy skin.
Top Cheap Stocks To Watch For 2014: Cellular Dynamics International Inc (ICEL)
Cellular Dynamics International, Inc., incorporated on November 16, 2007, develops and manufactures fully functioning human cells in industrial quantities to precise specifications. The Company�� iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products). Customers use its iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics. The Company�� iCell product line includes four different cell types: cardiomyocytes, neurons, hepatocytes and endothelial cells. The Company is actively developing an additional seven different cell types. iCell products are a consumable designed to be used once and then reordered.
The Company manufactures its iCell products from its iPSCs. An iPSC is a cell that has the ability both to replicate indefinitely and to be transformed into any cell type in the human body. The Company�� iCell O/S consists of six products, which include iCell Cardiomyocytes, iCell Neurons, iCell Endothelial Cells, iCell Hepatocytes and MyCell.
Advisors' Opinion:- [By John Udovich]
Stem cells may not be in the news much�as the sector has moved beyond the use of embryotic�ones, but small cap stem cell stocks Cellular Dynamics International Inc (NASDAQ: ICEL), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been fairly active over the past several trading days as ICEL went public, ISCO raised additional funding and BRTX grabbed more attention:
5 Best Biotech Stocks To Buy For 2014: Quintiles Transnational Holdings Inc (Q)
Quintiles Transnational Holdings Inc. is a provider of biopharmaceutical development services and commercial outsourcing services. The Company operates in two segments: Product Development and Integrated Healthcare Services. The Company�� Product Development segment operates as a contract research organization (CRO) focused primarily on Phase II-IV clinical trials and associated laboratory and analytical activities. The Company�� Integrated Healthcare Services segment is a global commercial pharmaceutical sales and service organizations and Integrated Healthcare Services provides a range of services, including commercial services, such as providing contract pharmaceutical sales forces in geographic markets, as well as healthcare business services for the healthcare sector, such as outcome-based and payer and provider services. In August 2012, it acquired Expression Analysis, Inc.
Product Development
Product Development provides services and that allow biopharmaceutical companies to outsource the clinical development process from first in man trials to post-launch monitoring. The Company�� service offering provides the support and functional necessary at each stage of development, as well as the systems and analytical capabilities. Product Development consists of clinical solutions and services and consulting. Clinical solutions and services provides services necessary to develop biopharmaceutical products, including project management and clinical monitoring functions for conducting multi-site trials (generally Phase II-IV) (core clinical) and clinical trial support services that improve clinical trial decision making and include global laboratories, data management, biostatistical, safety and pharmacovigilance, and early clinical development trials, and strategic planning and design services that improve decisions and performance. Consulting provides strategy and management consulting services based on life science and advanced analytics, as well as regulatory and comp! liance consulting services.
The Company competes with Covance, Inc., Pharmaceutical Product Development, Inc., PAREXEL International Corporation, ICON plc, inVentiv Health, Inc. (inVentive), INC Research and PRA International.
Integrated Healthcare Services
Integrated Healthcare Services provides the healthcare industry with both geographic presence and commercial capabilities. The Company�� commercialization services are designed to accelerate the commercial of biopharmaceutical and other health-related products. Service offerings include commercial services (sales representatives, strategy, marketing communications and other areas related to commercialization), outcome research (drug therapy analysis, real-world research and evidence-based medicine, including research studies to prove a drug�� value) and payer and provider services comparative and cost-effectiveness research capabilities, clinical management analytics, decision support services, medication adherence and health outcome optimization services, and Web-based systems for measuring quality improvement.
The Company competes with inVentiv, PDI, Inc., Publicis Selling Solutions, United Drug plc, EPS Corporation and CMIC HOLDINGS Co., Ltd.
5 Best Biotech Stocks To Buy For 2014: 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 Caplinger]
But looming larger is the specter of increased competition in prostate cancer. Late last month, Medivation (NASDAQ: MDVN ) got a favorable opinion from an advisory panel for the European Medicine Agency for its Xtandi treatment, which will expand the drug's reach beyond the U.S., where the FDA approved Xtandi last August. Moreover, Johnson & Johnson's (NYSE: JNJ ) Zytiga saw sales grow 72% in the company's first-quarter report, with even faster growth internationally. Essentially, what the success of Dendreon's rivals shows is that the company is running out of time to carve out its niche in the industry.
- [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. - [By Lee Jackson]
Medivation Inc. (NASDAQ: MDVN) is a top stock to buy and makes the UBS Key Call list as well. The company expects to present top line phase 3 data from the crucial PREVAIL trial of Xtandi in castration-resistant metastatic prostate cancer. UBS is highly confident the trials will prove successful. Its price target for the stock is $74, and the consensus target is $69.50.
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