Sunday, January 5, 2014

Top Biotech Companies For 2014

With just a quick glance, Aastrom Biosciences Inc. (NASDAQ:ASTM) doesn't look like any less of a disaster today than it did a week ago, a month ago, or even a year ago. But, the longer you look at ASTM, the more it seems it may have already hit its ultimate bottom, and is now biding its time to start the rebound.

There's actually a lot of things going on with ASTM here, and all of them matter. But, first things first. Aastrom Biosciences is the biotechnology company developing a stem cell therapy specifically aimed at cardiovascular disease. The reason shares have tanked since early 2011 through last month - a selloff from a peak of more than $60 to a low of $3.16 - of course, is disappointing progress on the drug development front. And truth be told, the company probably deserved to see its stock sell off the way it did. The R&D effort could not only never live up to the hype surrounding the company's stem cell research from yesteryear, and once the results of its work failed to live up to lowered expectations, the market started to proverbially throw the whole thing in the trash pile.

Top Biotech Companies For 2014: InterMune Inc.(ITMN)

InterMune, Inc., a biopharmaceutical company, engages in the research, development, and commercialization of therapies in pulmonology and fibrotic diseases. In pulmonology, the company focuses on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. It markets pirfenidone, an orally active drug that inhibits the synthesis of TGF-beta under the Esbriet name in the European Union, as well as in a Phase III clinical trial in the United States. Pirfenidone is also approved for the treatment of IPF in Japan, where it is marketed by Shionogi & Co. Ltd. under the Pirespa trade name. The company?s research programs focus on the discovery of small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases. InterMune, Inc. was founded in 1998 and is headquartered in Brisbane, California.

Advisors' Opinion:
  • [By Brian Pacampara]

    What: Shares of biotechnology company Intermune (NASDAQ: ITMN  ) surged 13% today after its quarterly results and outlook topped Wall Street expectations.

  • [By Lee Jackson]

    InterMune Inc. (NASDAQ: ITMN) continues to soar on the strength of global sales of its top drug Esbriet. The company is still seeking FDA approval to sell Esbriet in the United States. Before approval can take place, the company is awaiting top-line results from the phase 3 ASCEND study. InterMune expects to release these results during the second quarter of 2014. This could be a huge catalyst. UBS has a $15 price target, which should rise soon, and the consensus is at $16.

Top Biotech Companies For 2014: EntreMed Inc (ENMD)

EntreMed, Inc. (EntreMed), incorporated in 1991, is a clinical-stage pharmaceutical company. EntreMed's drug candidate is ENMD-2076, an Aurora A and angiogenic kinase inhibitor for the treatment of cancer. ENMD-2076 has completed Phase I studies in patients with advanced solid tumors, multiple myeloma and leukemia and is completing data for a multi-center Phase II study in patients with platinum resistant ovarian cancer. The Company�� other product candidates have includes MKC-1, ENMD-1198 and 2-methoxyestrdiol (2ME2, Panzem) for treatment of rheumatoid arthritis.

ENMD-2076 is a novel orally-active, Aurora A/angiogenic kinase inhibitor with potent activity against Aurora A and multiple tyrosine kinases linked to cancer and inflammatory diseases. ENMD-2076 is relatively selective for the Aurora A isoform in comparison to Aurora B. Aurora kinases are key regulators of the process of mitosis, or cell division, and are often over-expressed in human cancers. ENMD-2076 exerts its effects through multiple mechanisms of action, including anti-proliferative activity and the inhibition of angiogenesis. ENMD-2076 has demonstrated significant, dose-dependent preclinical activity as a single agent, including tumor regression, in multiple xenograft models (such as breast, colon, leukemia), as well as activity towards ex vivo-treated human leukemia patient cells.

Best Medical Stocks To Watch For 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 Jake L'Ecuyer]

    Equities Trading DOWN
    Shares of Inovio Pharmaceuticals (NYSE: INO) were down on Friday's session, falling 13.28 percent to $2.488 despite seemingly little news on the company.

  • [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 Sean Williams]

    No fairytale ending
    Fairytale endings work great in the movies, but you rarely see them come to fruition in the real world. Small-cap biopharmaceutical Inovio Pharmaceuticals (NYSEMKT: INO  ) has seen shares nearly triple since April on the heels of multiple intriguing studies, but will the glass slipper fit over the long term?

Top Biotech Companies For 2014: Celsion Corporation(CLSN)

Celsion Corporation, an oncology drug development company, develops and commercializes targeted chemotherapeutic oncology drugs based on its proprietary heat-activated liposomal technology. The company is developing its lead product, ThermoDox that is in Phase III clinical trial for primary liver cancer; and in phase II clinical trial for treatment of recurrent chest wall breast cancer. It has a license agreement with Yakult Honsha to commercialize and market ThermoDox for the Japanese market. The company also has a license agreement with Duke University under which it received exclusive rights to commercialize and use Duke's thermo-liposome technology. In addition, Celsion Corporation has a joint research agreement with Royal Phillips Electronics to evaluate the combination of Phillips' high intensity focused ultrasound with its ThermoDox to determine the potential of this combination to treat a range of cancers. The company was founded in 1982 and is based in Columbia, M aryland.

Advisors' Opinion:
  • [By Paul Ausick]

    Stocks on the Move: NQ Mobile Inc. (NYSE: NQ) is up 26% at $11.09 as the company fights back against a short-seller report. Celsion Corp. (NASDAQ: CLSN) is up 339.3% at $5.14 following a reverse 1:4.5 stock split. Micron Technology Inc. (NASDAQ: MU) is up 4.7% at $17.50.

  • [By EquityOptionsGuru]

    The Prolieve Thermodilatation System was actually developed by the current management of Medifocus while employed at Celsion Corporation (NASDAQ:CLSN). The system was also jointly developed with Boston Scientific (NYSE:BSX) before being acquired by Medifocus in July 2012. Prolieve has already received FDA approval, is currently generating revenue, and is the only in office alternative to drug therapy. The system essentially uses microwave energy to treat Benign Prostatic Hyperplasia (BPH), which is a non-cancerous enlargement of the prostate gland that typically affects men over the age of 50. The Prolieve device works by compressing and heating prostatic tissue that may be blocking the flow of urine. This particular treatment option offers patients several benefits including the following:

Top Biotech Companies For 2014: Plandai Biotechnology Inc (PLPL)

Plandai Biotechnology, Inc., formerly Diamond Ranch Foods, Ltd., incorporated on February 24, 2004, through its subsidiaries focuses on the farming of whole fruits, vegetables and live plant material and the production of functional foods and botanical extracts for the health and wellness industry. Its principle holdings consist of land, farms and infrastructure in South Africa. On November 17, 2011, the Company sold its subsidiary, Diamond Ranch, Ltd., together with its wholly owned subsidiary, Executive Seafood, Inc.

The Company has a technology that extracts bio-available compounds from organic matter, including green tea leaves and most other organic materials. The Company intends to use its plantation leases to focuses on the farming of whole fruits, vegetables and live plant material and the production of functional foods and botanical extracts for the health and wellness industry using its extraction technology.

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