Considering Eli Lilly & Co. (NYSE:LLY) as well as a co-development project between Johnson & Johnson (NYSE:JNJ) and Pfizer Inc. (NYSE:PFE) both failed in semi-recent effort to develop a similar-functioning Alzheimer's drug, it would be easy to assume that particular route towards an Alzheimer's might be the wrong path to take. Sometimes though, a small tweak or a seemingly-minor nuance with the underlying problem can make all the difference. Enter Prana Biotechnology Limited (NASDAQ:PRAN). Though the company acknowledges its focal point on the development of an Alzheimer's therapy is the same broad premise that ultimately led LLY, PFE, and JNJ to failure, PRAN may have found the proverbial missing link.
It's no real secret that a buildup of beta amyloid plaque in the brain has been named as the culprit for Alzheimer's. That's been a widely-held assumption for a couple of decades now. Though it's still not exactly clear how or why it forms and what the actual impact of this plaque is, it wasn't unreasonable to assume that preventing its formation or cleaning it out would be the first best approach to take en route to a designing a successful Alzheimer's treatment. That was the intent of bapineuzumab, from Pfizer and Johnson & Johnson, and it was the intent of solanezumab, from Eli Lilly. Both drugs were deemed failures before either company bothered to request the FDA's blessing, however, and though LLY is going to redefine the ideal AD sufferer for another trial of solanezumab, even the company doesn't appear to be hopeful.
Best Information Technology Stocks To Buy For 2015: Chromadex Corp (CDXC)
Chromadex Corporation, incorporated on June 19, 2008, is a provider of research and quality-control products and services to the natural products industry. The Company�� products are used by customers worldwide in the dietary supplement, food and beverage, cosmetic and pharmaceutical industries. The Company together with its subsidiaries supplies phytochemical reference standards, which are small quantities of plant-based compounds used to research an array of potential attributes, and reference materials, related contract services, technical consulting and ingredients. On December 3, 2012, ChromaDex Inc. acquired Spherix Consulting Inc. The Company�� principal subsidiaries include ChromaDex, Inc., Chromadex Analytics, Inc. and Spherix Consulting, Inc (Spherix).
The Company provides its clients in the food, supplement and pharmaceutical industries with solutions to manage potential health and regulatory risks. Its science-based solutions are for both new and existing products that may be subject to product liability and/or exposed to changing scientific standards or public perceptions; literature evaluations, and design and assessment of pre-clinical and clinical safety testing. It specializes in regulatory submissions for food and dietary supplement ingredients. For its clients involved in drug development within the pharmaceutical industry, the Company provides similar services, as well as risk-based strategies, including intellectual property data and compliance gap identification, due diligence assessments and investigational new drug writing.
Products and Services
The Company offers bulk raw materials for inclusion in dietary supplements, food, beverage and cosmetic products. Through its catalog, it supplies a range of products necessary to conduct quality control of raw materials and consumer products. The Company through Chromadex Analytics, provides a range of contract services ranging from routine contract analysis for the production of dietary sup! plements, cosmetics, foods and other natural products to elaborate contract research for clients in these industries. The Company provides a range of consulting services in the areas of regulatory support, new ingredient or product development, risk management and litigation support. With an addition of Spherix, it provides regulatory approval and scientific advisory services.
The Company competes with Sigma-Aldrich, Phytolab, US Pharmacopoeia, Extrasynthese, Covance, Eurofins, and Silliker Canada Co.
Advisors' Opinion:- [By Peter Graham]
Small cap stocks Chromadex Corp (OTCMKTS: CDXC) and 22nd Century Group Inc (OTCBB: XXII) are, one way or the other, focused on natural products and have been getting some extra attention lately. Moreover, one of these stocks have been the subject of a disclosed investor awareness campaign. Keeping that in mind, are these two small cap stocks natural winners for investors? Here is a quick look:
Top 10 Biotech Companies To Invest In 2014: Johnson & Johnson(JNJ)
Johnson & Johnson engages in the research and development, manufacture, and sale of various products in the health care field worldwide. The company operates in three segments: Consumer, Pharmaceutical, and Medical Devices and Diagnostics. The Consumer segment provides products used in baby care, skin care, oral care, wound care, and women?s health care fields, as well as nutritional, over-the-counter pharmaceutical products, and wellness and prevention platforms under the brands of JOHNSON?S, AVEENO, CLEAN & CLEAR, JOHNSON?S Adult, NEUTROGENA, RoC, LUBRIDERM, DABAO, LISTERINE, REACH, BAND-AID, CAREFREE, STAYFREE, SPLENDA, TYLENOL, SUDAFED, ZYRTEC, MOTRIN IB, and PEPCID AC. The Pharmaceutical segment offers products in various therapeutic areas, such as anti-infective, antipsychotic, contraceptive, dermatology, gastrointestinal, hematology, immunology, neurology, oncology, pain management, and virology. Its principal products include REMICADE for the treatment of immune me diated inflammatory diseases; STELARA for the treatment of moderate to severe plaque psoriasis; SIMPONI, a treatment for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis; VELCADE for the treatment of multiple myeloma; PREZISTA and INTELENCE for treating HIV/AIDS patients; NUCYNTA for moderate to severe acute pain; INVEGA SUSTENNAtm for the acute and maintenance treatment of schizophrenia in adults; RISPERDAL CONSTA for the management of bipolar I disorder and schizophrenia; and PROCRIT to stimulate red blood cell production. The Medical Devices and Diagnostics segment primarily offers circulatory disease management products; orthopaedic joint reconstruction, spinal care, and sports medicine products; surgical care, aesthetics, and women?s health products; blood glucose monitoring and insulin delivery products; professional diagnostic products; and disposable contact lenses. The company was founded in 1886 and is based in Ne w Brunswick, New Jersey.
Advisors' Opinion:- [By WALLSTCHEATSHEET]
Johnson & Johnson provides valuable and essential health care products and services to many consumers and companies operating worldwide. The company is working on a drug trial for people with�Castleman disease. The stock has been has been trending higher in the last several years, but is currently pulling back. Over the last four quarters, earnings have been mixed while revenues have been rising, which has led to positive feelings among investors about recent earnings announcements. Relative to its peers and sector, Johnson & Johnson has been a year-to-date performance leader. Look for Johnson & Johnson to OUTPERFORM.
Top 10 Biotech Companies To Invest In 2014: Inovio Pharmaceuticals Inc (INO)
Inovio Pharmaceuticals, Inc., incorporated on June 29, 1983, is engaged in the development of a new generation of vaccines, called synthetic vaccines, focused on cancers and infectious diseases. The Company's SynCon technology enables the design of universal vaccines capable of providing cross-protection against existing or changing strains of pathogens, such as influenza and human immunodeficiency virus (HIV). The Company's electroporation delivery technology uses brief, controlled electrical pulses to increase cellular uptake of the vaccine. Its clinical programs include cervical dysplasia (therapeutic), avian influenza (preventive), prostate cancer (therapeutic), leukemia (therapeutic), hepatitis C virus (HCV) and HIV vaccines. It is advancing preclinical research and clinical development for a universal seasonal/pandemic influenza vaccine, as well as preclinical work for other products, including malaria and prostate cancer vaccines. Its partners and collaborators include University of Pennsylvania, Drexel University, National Microbiology Laboratory of the Public Health Agency of Canada, Program for Appropriate Technology in Health/Malaria Vaccine Initiative (PATH/MVI), National Institute of Allergy and Infectious Diseases (NIAID), Merck, ChronTech, University of Southampton, United States Military HIV Research Program (USMHRP), the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and HIV Vaccines Trial Network (HVTN). As of December 31, 2011 it owned 16.1% interest in VGX Int��.
Inovio�� Solution
The Company�� synthetic vaccine platform consists of its SynCon vaccine design process and electroporation delivery technology. It has developed a preclinical and clinical stage pipeline of vaccines. The Company�� synthetic vaccines are designed to prevent a disease (prophylactic vaccines) or treat an existing disease (therapeutic vaccines). Its synthetic vaccine consists of a deoxyribonucleic acid (DNA) plasmid encoding a selected antigen! (s), which is introduced into cells of humans or animals with the purpose of evoking an immune response to the encoded antigen. The Company�� synthetic vaccines are designed to generate specific antibody and/or T-cell responses.
The Company�� SynCon technology provides processes that employ bioinformatics, which combine extensive genetic data and sophisticated algorithms. Its design process uses the genetic make-up of a common antigen(s) from multiple strains of a virus within a viral sub-type or taxonomic group (family) of pathogens, such as HIV, hepatitis C virus (HCV), human papillomavirus (HPV), influenza and other diseases to synthetically create a new antigen for the desired pathogen target that does not exist in nature. Its synthetic vaccine candidates are being delivered into cells of the body using its electroporation (EP) DNA delivery technology.
Cancer Synthetic Vaccines
The Company has two broad types of cancer vaccines: preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people, and treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body�� natural defenses against the cancer. Two types of cancer preventive vaccines are available in the United States. The United States Food and Drug Administration (the FDA) has approved two vaccines, Gardasil and Cervarix that protect against infection by the two types of HPV-types 16 and 18-that cause approximately 70% of all cases of cervical cancer worldwide. In addition, Gardasil protects against infection by two additional HPV types, 6 and 11, which are responsible for about 90% of all cases of genital warts in males and females but do not cause cervical cancer.
Cervarix manufactured by GlaxoSmithKline, is composed of virus-like particles (VLPs) made with proteins from HPV types 16 and 18. Cervarix is approved for use in females��ages 10 to 25 for the prevention of cervical cancer caused by! HPV type! s 16 and 18. Gardasil manufactured by Merck, is approved for use in females for the prevention of cervical cancer, and some vulvar and vaginal cancers, caused by HPV types 16 and 18 and for use in males and females for the prevention of genital warts caused by HPV types 6 and 11. The vaccine is approved for these uses in females and males ages 9 to 26. The FDA has also approved a cancer preventive vaccine that protects against hepatitis B virus (HBV) infection.
Inovio�� VGX-3100 is designed to raise immune responses against the E6 and E7 genes of HPV types 16 and 18 that are present in both pre-cancerous and cancerous cells transformed by these HPV types. E6 and E7 are oncogenes that play an integral role in transforming HPV-infected cells into cancerous cells. In March 2011, it initiated a randomized, double-blind Phase II study of VGX-3100 delivered using the CELLECTRA intramuscular electroporation device in women with HPV Type 16 or 18 and diagnosed with, but not yet treated for, cervical intraepithelial neoplasia (CIN) 2/3. The study is designed to enroll 148 subjects. In January 2011, it announced the publication of a scientific paper in the journal Human Vaccines detailing potent immune responses in a preclinical study of its SynCon vaccine for prostate cancer targeting two antigens, prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA).
In January 2011, the Company announced the regulatory approval of a Phase II clinical trial (WIN Trial) to treat leukemia utilizing its new ELGEN 1000 automated vaccine delivery device. The single dose level, Phase II study, called WT1 immunity via DNA fusion gene vaccination in haematological malignancies by intramuscular injection followed by intramuscular electroporation. Cancer Vaccines encodes for hTERT, an antigen related to non-small cell lung, breast and prostate cancers. The vaccine is delivered using its electroporation delivery technology.
Infectious Disease Synthetic Vaccines
In Marc! h 2011, the Company announced the initiation of a follow-on open label, single dose Phase II clinical study in collaboration with ChronTech of the ChronVac-C HCV DNA vaccine delivered using its electroporation technology in treatment naive HCV infected individuals. Its HIV vaccines consist of candidates for HIV prevention, as well as therapy or treatment. PENNVAX-B is designed to target HIV clade B (most commonly found in the United States, North America, Australia and the European Union (EU). PENNVAX-G is designed to target HIV clades A, C and D, which are more commonly found in Asia, Africa, Russia and South America. This Phase I clinical study of PENNVAX-B (HVTN-080) vaccinated 48 healthy, HIV-negative volunteers to assess safety and levels of immune responses generated by Inovio�� PENNVAX-B vaccine delivered with its CELLECTRA electroporation device. PENNVAX-B is a SynCon vaccine that targets HIV gag, pol, and env proteins.The Company�� VGX-3400X targets H5N1. The vaccine consists of three distinct DNA plasmids coded for a consensus hemagglutinin (HA) antigen derived from different H5N1 virus strains; a consensus neuraminidase (NA) antigen derived from different N1 sequences; and a consensus nucleoprotein (NP) fused to a small portion of the m2 protein (m2E) based on a broader cross-section of influenza viruses in addition to H5N1 and H1N1. Conventional vaccines are strain-specific and have limited ability to protect against genetic shifts in the influenza strains they target. They are therefore modified annually in anticipation of the next flu season�� new strain(s). It is focused on developing DNA-based influenza vaccines able to provide broad protection against known as well as newly emerging, unknown seasonal and pandemic influenza strains.
Animal Health/Veterinary
VGX Animal Health, Inc. (VGX AH), a majority-owned subsidiary, has licensed LifeTide, a plasmid-based growth hormone releasing hormone (GHRH) technology for swine. LifeTide is one of onl! y four DN! A-based treatments approved for use in animals and is the only DNA-based agent delivered using electroporation that has been granted marketing approval (Australia). VGX AH is also developing a GHRH-based treatment for cancer and anemia in dogs and cats. It is developing a synthetic vaccine for foot-and-mouth disease (FMD) administered by its vaccine delivery technology. The FMD virus is one of the most infectious diseases affecting farm animals, including cattle, swine, sheep and goats, and is a serious threat to global food safety.
The Company competes with Crucell N.V, Sanofi-Aventis, Novartis, Inc., GlaxoSmithKline plc, Merck, Pfizer, AstraZeneca, Inc., Novartis, Inc., MedImmune and CSL.
Advisors' Opinion:- [By George Budwell]
Inovio Pharmaceuticals (NYSEMKT: INO ) develops DNA-based vaccines and delivers them using a proprietary electroporation technique. Shares of Inovio have been a roller coaster all year long, and have certainly been the playground of day traders. Last week, Inovio shares lost more than 10% of their value on heavy volume, suggesting the stock may continue to experience downward pressure. This rapid move downward is surprising because the company recently signed a licensing deal with Roche (NASDAQOTH: RHHBY ) to commercialize Inovio's multi-antigen DNA immunotherapies for prostate cancer and hepatitis B. As part of the deal, Inovio received $10 million upfront, and milestone payments could go as high as $412 million.
- [By Jake L'Ecuyer]
Inovio Pharmaceuticals (NYSE: INO) was also up, gaining 10.53 percent to $3.57 after the company received the ��est Theraputic Vaccine��award at the World Vaccine Congress after the close Wednesday.
- [By Sean Williams]
On the clinical data front, Alnylam Pharmaceuticals (NASDAQ: ALNY ) and Inovio Pharmaceuticals (NYSEMKT: INO ) both put investors in their happy place.
Top 10 Biotech Companies To Invest In 2014: Cannabis Science Inc (CBIS)
Cannabis Science, Inc., incorporated on May 4, 2007, is a development-stage company. The Company is engaged in the creation of cannabis-based medicines, both with and without psychoactive properties, to treats disease and the symptoms of disease, as well as for general health maintenance. On February 9, 2012, the Company acquired GGECO University, Inc. (GGECO). On March 21, 2012, the Company acquired Cannabis Consulting Inc. (CCI Group).
The Company is engaged in medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products.
Advisors' Opinion:- [By Bryan Murphy]
Much like Nuvilex, Cannabis Science Inc. (OTCMKTS:CBIS) appears to simply be another conventional biotech outfit. And, truth be told, that's what CBIS is. It just happens to be developing two drugs based on cannabinoids... one to reat HIV/AIDS, and the other to treat cancer. Both drugs are in preclinical trials right now, so an actual marketable product is still years down the road for Cannabis Science Inc. But, as a legitimate biotechnology that isn't aiming to simply fuel tokers' needs, it's not going to hit any regulatory or law-enforcement roadblocks.
- [By James E. Brumley]
Wow. That didn't take long. It was only two days ago that marijuana stocks like Growlife Inc. (OTCBB:PHOT), Medical Marijuana Inc. (OTCMKTS:MJNA), Cannabis Science Inc. (OTCMKTS:CBIS), Medbox Inc. (OTCMKTS:MDBX), and Hemp, Inc. (OTCMKTS:HEMP) were all the rage, flying high on the heels of a new year... a new year in which marijuana was legalized (for one reason or another) in two more states. HEMP was up as much as 700% in less than three weeks at one point. MDBX gained 300% at the beginning of the year, when recreational marijuana began to be legally sold in Colorado. CBIS jumped 400% off of its December low. MJNA nearly doubled on the advent of new marijuana venues. PHOT soared more than 130% since the end of last year on the legalization of marijuana. It was, truthfully, some of the fastest big money that traders have ever made in the market.
- [By Bryan Murphy]
The last few days have been nothing less than incredible for stocks like Cannabis Science Inc. (OTCMKTS:CBIS), Medbox Inc. (OTCMKTS:MDBX), Growlife Inc. (OTCBB:PHOT), and Medical Marijuana Inc. (OTCMKTS:MJNA). MJNA shares have jumped 90% since last Friday. PHOT is up 51% for the same timeframe. CBIS has grown 150%, while MDBX is up 112%. The reason? It's largely the legalization of recreational marijuana in Colorado - a law that went into effect as of January 1st. The legalization of medical marijuana in Illinois on the same day didn't hurt either. And truth be told, the event-based rally from the likes of Medbox and Cannabis Science makes basic sense - it's a landmark shift in the way this country views and treats marijuana. On the flipside, before wading any deeper into stocks like Medical Marijuana or Growlife, current and would-be owners might want to take a step back and look at the bigger picture.
Top 10 Biotech Companies To Invest In 2014: ANI Pharmaceuticals Inc (ANIP)
ANI Pharmaceuticals, Inc., incorporated on April 11, 2001, is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. In two facilities with combined manufacturing, packaging and laboratory capacity totaling 173, 00 square feet, the Company manufactures oral solid dose products, as well as liquids and topicals, including narcotics. Its other products include The Food and Drug Administration (FDA) approved testosterone gel, which is licensed to Teva Pharmaceuticals USA. In December 2013, the Company acquired 31 generic drug products from Teva Pharmaceuticals, which includes 20 solid-oral immediate release products, four extended release products and seven liquid products.
The Company performs contract manufacturing for other pharmaceutical companies. It has launched three products and has 11 products in development. The Company�� targeted areas of product development include narcotics, anti-cancers and hormones (potent compounds), and extended release niche generic product opportunities.
Advisors' Opinion:- [By Ben Levisohn]
ANI Pharmaceuticals (ANIP) has climbed 8.9% to $18.80 after it said it would buy 31 generic drugs from Teva Pharmaceuticals (TEVA). Teva’s shares are little changed in pre-open trading.
Top 10 Biotech Companies To Invest In 2014: KYTHERA Biopharmaceuticals Inc (KYTH)
KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company�� initial focus is on the facial aesthetics market. The Company�� product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.
In Europe, Bayer, its collaborator outside the United States and Canada, recently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.
ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.
Advisors' Opinion:- [By John Udovich]
On Tuesday, small cap biotech stock Kythera Biopharmaceuticals Inc (NASDAQ: KYTH) surged around 25% after announcing that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints for the reduction of so-called double chins; but if investors missed out on that rally, small caps Zeltiq Aesthetics Inc (NASDAQ: ZLTQ), Solta Medical Inc (NASDAQ: SLTM) and Cynosure, Inc (NASDAQ: CYNO) each have a piece of the aesthetic market as well. In the case of Kythera Biopharmaceuticals, its ATX-101 can be injected to deal with double chins���meaning its less invasive than liposuction as the drug dissolves fat cells but leaves other tissue alone. JP Morgan has noted:
- [By Monica Gerson]
Kythera Biopharmaceuticals (NASDAQ: KYTH) shares jumped 28.69% to $43.15 in pre-market trading after the company reported positive ATX-101 top line phase III trial results for the reduction of submental fat.
Top 10 Biotech Companies To Invest In 2014: AMAG Pharmaceuticals Inc.(AMAG)
AMAG Pharmaceuticals, Inc., a biopharmaceutical company, engages in the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia (IDA). Its principal product includes Feraheme (ferumoxytol) injection for intravenous (IV) use, which was approved for marketing in the United States in June 2009 by the U.S. Food and Drug Administration, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease (CKD). The company is pursuing marketing applications in the European Union, Canada, and Switzerland for Feraheme for the treatment of IDA in CKD patients. AMAG Pharmaceuticals was founded in 1981 and is based in Lexington, Massachusetts.
Advisors' Opinion:- [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
- [By Monica Gerson]
AMAG Pharmaceuticals (NASDAQ: AMAG) shares fell 16% to $18.38 in the pre-market trading after the company received a CRL from the FDA for the supplemental NDA for Feraheme for broader IDA indication.
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