With healthcare costs rising, physicians and consumers are constantly looking for effective ways to manage medical cost inflation. Generic drugs may offer one piece of the puzzle to that solution.
Because of their attractive costs relative to branded drugs, and considering the world's population is increasing and living longer, we can probably expect an ever-increasing role for generic drugs in healthcare.
But investing in generic drug manufacturers is only prudent if you first understand the ins and outs of the industry -- so let's take a look at the main points.
What are generic drugs?
Perhaps the U.S. Food and Drug Administration says it best: "A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use."
New drugs are protected by patents for a set period of time. Once the patent expires, generic drugmakers are able to swoop in and offer a cheaper version of the drug as long as it meets the laundry list of critical FDA standards mentioned above.
Top Medical Stocks To Buy For 2015: Regulus Therapeutics Inc (RGLS)
Regulus Therapeutics Inc., incorporated on September 5, 2007, is a biopharmaceutical company focused on discovering and developing microRNAs to treat a range of diseases. microRNAs are naturally occurring ribonucleic acid (RNA), molecules that play a critical role in regulating key biological pathways. The Company uses its microRNA product platform to develop chemically modified, single-stranded oligonucleotides that the Company calls anti-miRs. As of December 31, 2012, the Company�� operations included acquiring and in-licensing intellectual property rights, developing its microRNA, undertaking basic research around microRNA targets and conducting preclinical studies for its initial programs.
The Company is developing RG-101 for the treatment of HCV and is advancing other microRNA therapeutics toward clinical development in several areas, including oncology, fibrosis and metabolic diseases. The Company intends to focus its resources on product opportunities in therapeutic areas where development and commercialization activities are appropriate for its size and financial resources, which the Company anticipates will include niche indications and orphan diseases.
The Company competes with Groove Biopharma, Inc., miRagen Therapeutics, Inc., Mirna Therapeutics, Inc., and Santaris Pharma A/S.
Advisors' Opinion:- [By Brian Orelli]
Partners like this investment idea
When Regulus Therapeutics (NASDAQ: RGLS ) went public last year, investors weren't the only ones buying the share offering; Regulus' partners and founders clearly thought it was a good investment idea, because they bought more shares. Lots of them. AstraZeneca, Biogen Idec, Sanofi, GlaxoSmithKline�and Isis combined to purchase more than 70% of the shares that raised nearly $81 million for the biotech. - [By Sean Williams]
A blast to the past
It's occasionally very difficult to value biotech stocks, because of the wide range of outcomes possible given their pipelines. Other times, as in the case with Regulus Pharmaceuticals (NASDAQ: RGLS ) , I bang my head against a table and wonder what the heck investors are thinking.
Top Medical Stocks To Buy For 2015: BioTime Inc (BTX)
BioTime, Inc., incorporated on November 30, 1990, is a biotechnology company focused on the emerging field of regenerative medicine. Its commercial strategy is focused on its line of research products, such as ACTCellerate cell lines and associated ESpan culture media, HyStem hydrogels, human embryonic stem (hES) cell lines, and royalties from Hextend. Its focus is to provide regenerative therapies for age-related degenerative diseases. In January 2011, the Company acquired the assets of Cell Targeting, Inc. (CTI), a biotechnology company focused on methods of painting molecules on the surface of cells, which in turn causes the cells to adhere to particular tissues, such as those afflicted with disease. On March 21, 2011, the Company acquired Glycosan BioSystems, Inc. (Glycosan) through a merger of Glycosan with OrthoCyte Corporation (OrthoCyte). Through the merger, OrthoCyte acquired all of Glycosan�� assets, including Glycosan�� Hystem hydrogel product line. In March 2011, the Company entered into an agreement with XenneX, Inc., pursuant to which it organized LifeMap Sciences, Inc. (LifeMap), a subsidiary formed to advance the development and commercialization of its human embryonic stem (hES) cell data base. In August 2011, four hES cell lines (ESI-035, ESI-049, ESI-051 and ESI-053) developed by its subsidiary ES Cell International (ESI) were approved by the National Institutes of Health (NIH) for inclusion in the NIH Human Embryonic Stem Cell Registry. In May 2012, the Company acquired XenneX, Inc., through a merger of XenneX into LifeMap Sciences. In September 2012, the Company formed a wholly owned subsidiary, BioTime Acquisition Corporation. In October 2013, Geron Corporation announced the closing of the transaction to divest the Company's stem cell assets to Asterias Biotherapeutics, Inc., a subsidiary of BioTime, Inc.
HyStem is a biomaterial, which mimics the human extracellular matrix, which is the network of molecules surrounding cells in organs and tissues which is essent! ial to cellular function. Its HyStem hydrogels may have other applications when combined with the diverse and scalable cell types its scientists have isolated from hES cells. HyStem-Rx is a clinical grade formulation of HyStem-C, a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. Its subsidiary, OncoCyte Corporation, is developing PanC-Dx, a non-invasive blood-based cancer screening test designed to detect the presence of various human cancers, including cancers of the breast, lung, bladder, uterus, stomach, and colon, during routine check -ups. BioTime Asia, Limited (BioTime Asia) sells products for research use and may develop therapies to treat cancer and neurological and orthopedic diseases in Asia. OrthoCyte Corporation (OrthoCyte) is developing therapies to treat orthopedic disorders, diseases and injuries. ReCyte Therapeutics, Inc. (ReCyte Therapeutics) is developing therapies for age-related cardiovascular and blood disorders. Cell Cure Neurosciences Ltd. (Cell Cure Neurosciences), is a biotechnology company focused on developing stem cell-based therapies for retinal and other neurological disorders, including the development of retinal pigment epithelial (RPE) cells for the treatment of age-related macular degeneration. LifeMap Sciences, Inc. (LifeMap) is advancing the development and commercialization of our embryonic stem cell database and plans to make the database available for the marketing of research products and for use by stem cell researchers at pharmaceutical and biotechnology companies and other institutions via paid subscriptions or on a fee per use basis.
The Company�� blood plasma expander product, Hextend, is a physiologically balanced intravenous solution used in the treatment of hypovolemia, a condition caused by low blood volume, often from blood loss during surgery or injury. Hextend maintains circulatory system fluid volume and blood pressure, and keeps vital organs perfused during surgery and t! rauma car! e. Hextend is manufactured and distributed in the United States by Hospira, Inc., and in South Korea by CJ CheilJedang (CJ), under license from it.
Human Embryonic Stem Cell Lines for Research Use
Combined with the Company�� ACTCellerate technology, it derives of a range of markets human embryonic progenitor cells (hEPCs). ESI�� six current good manufacturing practices (cGMP) hES cell lines have been approved by the NIH for inclusion in the Human Embryonic Stem Cell Registry, which renders those cell lines eligible for use in federally funded research. The ESI hES cell lines are available for purchase through www.biotimeinc.com. It also markets hEPCs developed using ACTCellerate technology. Its hEPCs are also available for sale through www.biotimeinc.com. It derived the complete genome sequence of five of the ESI hES cell lines to facilitate the development of products derived from these cell lines. It has made these GMP-grade cell lines, along with certain documentation and complete genomic deoxyribonucleic acid (DNA) sequence information, available for sale.
The Company offers human stem cell products and technology that can be used by researchers at universities and at companies in the bioscience and biopharmaceutical industries. It has developed research and clinical grade hES cell lines, which it markets for both basic research and therapeutic product development. It also markets human embryonic progenitor cell (hEPCs) developed using ACTCellerate technology. These hEPCs are purified lineages of cells, which are intermediate in the developmental process between embryonic stem cells and fully differentiated cells. The ACTCellerate cell lines are also available for purchase through http://www.biotimeinc.com.
Human Embryonic Progenitor Cells
Through the Company�� subsidiary ReCyte Therapeutics, it had a license from Advanced Cell Technology, Inc. (ACT) to use ACTCellerate technology, and the rights to market more than 200 human c! ell types! made using that process. ACTCellerate allows the rapid isolation of hEPCs, which are cells that are intermediate in the developmental process between embryonic stem cells and fully differentiated cells.
Through an agreement with ReCyte Therapeutics, Millipore Corporation became a global distributor of ACTCellerate hEPC lines. In addition to the products, which it is co-marketing with Millipore, it offers 92 other ACTCellerate hEPC lines for purchase at www.biotimeinc.com. Through its subsidiary LifeMap, it provides online biomedical database services to increase awareness of molecular markers and diverse cell types comprising its ACTCellerate hEPC lines. It also focuses to market additional cell types manufactured with its PureStem technology. PureStem cell lines are produced by the exogenous expression of specific transcription factors, which regulate the differentiation of cell types from hES or induced pluripotent stem (iPS) cells. BioTime Asia has an agreement with Shanghai Genext Medical Technology Co., Ltd. to sell ACTCellerate hEPC lines and related ESpan growth media to the medical and biological research communities in China, Taiwan, Hong Kong, and Macau on an exclusive basis. The marketing agreement includes provisions for an initial stocking inventory and annual milestones to maintain exclusivity. The Company�� California Institute of Regenerative Medicine (CIRM)-funded research addresses the need for industrial scale production of purified therapeutic cells.
hES Cells Carrying Genetic Diseases
The Company focuses to add to its product line muscle progenitor cells produced from five hES cell lines carrying genes for Duchenne muscular dystrophy, Emery-Dreifuss muscular dystrophy, spinal muscular atrophy Type I, facioscapulohumeral muscular dystrophy 1A, and Becker muscular dystrophy. It obtained the diseased hES cell lines from Reproductive Genetics Institute (RGI).
ESpan Cell Growth Media
The Company is marketing a range of! cell-gro! wth media products called ESpan. These growth media are optimized for the growth of hEPC types. Cells need to be propagated in liquid media, in both the laboratory setting, where basic research on stem cells is performed, and in the commercial sector. Its ESpan products are marketed through Millipore and Genext.
ESpy Cell Lines
The Company focuses for development of ESpy cell lines. The ability of the ESpy cells to emit light will allow researchers to track the location and distribution of the cells in both in vitro and in vivo studies.
HyStem Hydrogel for Research and HyStem-Rx for Cell Delivery Medical Devices
HyStem is a patented biomaterial that mimics the ECM, the network of molecules surrounding cells in organs and tissues that is essential to cellular function. Its HyStem technology forms the foundation for stem cell delivery products in both the adult and embryonic stem cell marketplace, including products manufactured using its ACTCellerate technology. As an injectable product, HyStem-Rx may address need in cosmetic and reconstructive surgeries and other procedures by transplanting adipose derived cells or other adult stem cells. The transfer of cells in HyStem-Rx localizes the transplanted cells at the intended site and by providing a three-dimensional scaffold upon which cells can rebuild normal tissue. HyStem-Rx may support other emerging cell and tissue transplant therapies, such as those derived from hES and iPS cells, in addition to its potential application in the treatment of a range of conditions such as osteoarthritis, brain tumors, stroke, bone fracture, and wounds.
Advisors' Opinion:- [By John Udovich]
Stem cell stocks have not exactly been the best performers lately in part because the controversy over their use has died down over the years while major breakthroughs have been few or far between, but the industry along with small cap stem cell stocks Pluristem Therapeutics Inc (NASDAQ: PSTI), BioTime, Inc (NYSEMKT: BTX) and BioRestorative Therapies (OTCBB: BRTX) are still quietly producing their share of news or minor breakthroughs worth taking note of. Just consider the following stem cell news or news from small cap players in the sector:
- [By Brian Pacampara]
Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool's free investing community, biotechnology company BioTime (NYSEMKT: BTX ) has received the dreaded one-star ranking.
5 Best Casino Stocks To Watch For 2015: DiaMedica Inc (DMA)
DiaMedica Inc. (DiaMedica) is a development-stage company. The Company is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of diabetes and related diseases. DiaMedica's compound, DM-199, is a recombinant human protein for the treatment of both Type I and Type II diabetes and their complications. DiaMedica is starting a Phase I/II clinical trial for DM-199. DM-199 is a recombinant human protein, which improves glucose control, protects beta cells through the expansion of a population of antigen-specific immunosuppressive cells (Tregs), and proliferates insulin producing beta cells through the activation of certain growth factors. The Company�� DM-204 is a G-protein-coupled receptor agonist (GPCR) monoclonal antibody to treat Type II diabetes and some of the associated complication's. activating a receptor resulted in insulin sensitivity, insulin secretion and vasodilation. Advisors' Opinion:- [By Richard Rhodes]
Given this economic backdrop, and developing pressure on corporate revenues, margins, and earnings, we feel that risk is being misplaced at current levels.
The 14-day and 40-day models are now overbought. Now, the 14-day and 40-day are peaking, which would certainly indicate a correction stands as the highest probability.
The % of stocks above their 10-day moving average (dma) is at the 70%-level; still a major divergence with prices.
The % of stocks above their 200-dma stands at 77%. The 87% level marked previous highs. The 50-dma/150-dma cross breakdown now confirms a larger correction. Bottoms form between 30%-40%.
Overall, the risk-reward remains skewed to the downside, regardless of whether prices remain above trendline resistance, as our model group suggests a correction to the 110-day moving average, currently at S&P 1711.
A clear breakdown at that level would accelerate the decline towards the wide 200-dma and 380-dma range, between 1657-1571.
Top Medical Stocks To Buy For 2015: Alcobra Ltd (ADHD)
Alcobra Ltd is an Israel-based Biopharmaceutical company. It focuses on the development and commercialization of a proprietary drug, MG01CI, to treat Attention Deficit Hyperactivity Disorder (ADHD), a common and morbid neuropsychiatric condition in children and adults. Adult ADHD is associated with increased health risks and healthcare costs, higher divorce rates, lower levels of socioeconomic attainment, lower academic achievement, unemployment and work place deficits, increased risks for motor vehicle accidents, greater likelihood of additional psychiatric disorders, increased criminal activity and incarceration, and higher rates of substance use and abuse. MG01CI product has completed phase two studies. Advisors' Opinion:- [By MONEYMORNING.COM]
For example, a phase 3 clinical trial on metadoxine extended release as a treatment for adult attention deficit hyperactivity disorder (ADHD) will be finishing up at the end of this year. Positive data could give the stock a huge boost.
Top Medical Stocks To Buy For 2015: Tonix Pharmaceuticals Holding Corp (TNXP)
Tonix Pharmaceuticals Holding Corp., incorporated on November 16, 2011, is a specialty pharmaceutical company focused on developing novel pharmaceutical products for disorders of the central nervous system (CNS). The Company develops TNX-102 sublingual tablet, or TNX-102 SL. TNX-102 SL is a novel dose and formulation of cyclobenzaprine (CBP), the active pharmaceutical ingredient of two prescribed muscle relaxant products, Flexeril and Amrix. TNX-102 SL is also intended for chronic use. It develops TNX-102 SL for the treatment of FM under a United States Investigational New Drug application (IND), and under three clinical trial applications (CTAs), filed in Canada. It also develops TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). As of January 25, 2013, the Company focuses on product development, and had not generated any revenues.
The Company searches for potential therapeutic solutions among known pharmaceutical agents that lack regulatory approval for the indications it seeks, but may be approved for use in other indications. It seeks to create new dose and formulation options that are tailored to the therapeutic uses to which it applies these agents. TNX-102 SL is a small, rapidly disintegrating tablet containing CBP for sublingual administration at bedtime. The Company designed TNX-102 SL for delivery of CBP to the systemic circulation through sublingual transmucosal absorption and to avoid first-pass liver metabolism.
CBP is the active pharmaceutical ingredient in its lead product candidate, TNX-102 SL. In addition to CBP, TNX-102 SL contains inactive ingredients, called excipients, which are approved for pharmaceutical use. In addition to TNX-102 SL, it develops other formulations of CBP, including TNX-102 promicellar gelatin capsule, or TNX-102 gelcap. It developed TNX-102 gelcap under an agreement with Lipocine, Inc. (Lipocine), a contract formulation developer and small-scale manufacturer. In addition it has other pipeline of other product cand! idates, including TNX-201 and TNX-301. TNX-201 is based on isometheptene mucate and is under development as a treatment for certain types of headaches.
Advisors' Opinion:- [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 Kell]
Tonix Pharmaceuticals Holding Corp.(TNXP) is planning to offer some shares to raise money to fund clinical trials and the continued development of the specialty pharmaceutical company’s treatments. Shares edged up 2.1% to $16.75 premarket.
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