Monday, June 17, 2013

Top Medical Stocks To Watch For 2014

The Patient Protection and Affordable Care Act, perhaps better known as Obamacare, is certainly one of the most controversial pieces of legislation to come out of the Obama administration. Designed to reform our current health-care system by mandating individuals carry health insurance, and capping insurers medical loss ratios at 80% to ensure patients get the quality of care they expect when they need it, Obamacare's favorable ratings fell in a Kaiser Family Foundation poll last month to their second-lowest level since the bill passed in 2010.

The bill is polarizing, without question. But, with its implementation less than seven months away, Obamacare received a big boost earlier this week with the release of a study on hospital costs by the Centers for Medicare and Medicaid Services, or CMS. In this study, the CMS looked at more than 3,000 hospitals nationwide that accept government-sponsored Medicare and examined the cost for the 100 most frequently billed treatments and procedures. The results of the study were downright frightening and would definitely support the need for accountability, transparency, and some form of regulation with regard to hospital costs.

Top Medical Stocks To Watch For 2014: Curis Inc.(CRIS)

Curis, Inc., a drug discovery and development company, focuses on the research and development of cancer therapeutics. The company, under collaboration with Genentech, Inc., is conducting a pivotal Phase II clinical trial on its lead molecule, GDC-0449 in advanced basal cell carcinoma patients, as well as various Phase II clinical trials in first-line metastatic colorectal cancer and advanced ovarian cancer patients. It is also evaluating CUDC-101, a small molecule that is in a Phase I clinical testing and is designed to target histone deacetylase, epidermal growth factor receptor, and epidermal growth factor receptor 2. In addition, Curis has a development candidate, Debio 0932, which is a Heat Shock Protein 90 or Hsp90 inhibitor. The company holds a license agreement with Debiopharm related to its Hsp90 technologies. Further, it involves in preclinical testing for the development of candidates from its targeted cancer programs. The company was founded in 2000 and is base d in Lexington, Massachusetts.

Advisors' Opinion:
  • [By Michael Shulman]

    Curis (NASDAQ: CRIS) has developed a series of cancer treatments based on a technology that disrupts intercellular signaling in the Hedgehog pathway. Disrupting communication disrupts cell duplication, the foundation of tumor growth.

    Curis has more than 20 trials under way with Genentech/Roche and the National Cancer Institute. This year, Genentech will likely report results of a basal cell carcinoma trial for skin cancer, and it has said it will go from this mid-phase trial directly to an application for approval if the results are strong enough.

    One success means a volcanic eruption in the stock, as it will prove the core technology is a viable platform for cancer treatments. A failure could put the entire program — and the company — in jeopardy. I believe the technology will be a success, which means this $2 stock could be worth $40-plus. If I’m wrong, you will probably be looking at a 50-cent stock. I’d say it’s worth the risk.

Top Medical Stocks To Watch For 2014: Scancell Holdings PLC (SCLP)

Scancell Holdings PLC is a United Kingdom-based company. The Company�� principal activity of the consists of the discovery and development of monoclonal antibodies and vaccines for the treatment of cancer. In April 2012, the Company completed recruitment to the Phase 1 clinical trial of SCIBI. In May 2012, the Company commenced recruitment and treatment of the first patient in the second part of it Phase 1/2 clinical trial of SCIBI. The Phase 2 part of the trial is conducted in five United Kingdom centers in Nottingham, Manchester, Newcastle, Leeds, and Southampton. On August 15, 2012, the Company announced the development of a platform technology, Moditope.

Top 5 Biotech Stocks To Buy Right Now: Impax Laboratories Inc.(IPXL)

Impax Laboratories, Inc., a specialty pharmaceutical company, engages in the development, manufacture, and marketing of bioequivalent pharmaceutical products. The company operates in two divisions, Global Pharmaceuticals and Impax Pharmaceuticals. The Global Pharmaceuticals division develops, manufactures, sells, and distributes generic pharmaceutical products. It provides its generic pharmaceutical prescription products directly to wholesalers and retail drug chains; and generic pharmaceutical over-the-counter and prescription products through unrelated third-party pharmaceutical entities. The Impax Pharmaceutical division develops proprietary brand pharmaceutical products that address central nervous system disorders, including Alzheimer?s disease, attention deficit hyperactivity disorder, depression, epilepsy, migraines, multiple sclerosis, Parkinson?s disease, and schizophrenia, as well as promotes third-party branded pharmaceutical products. As of May 2, 2011, the com pany marketed 101 generic pharmaceuticals, which represent dosage variations of 29 different pharmaceutical compounds; and another 16 of its generic pharmaceuticals representing dosage variations of 4 different pharmaceutical compounds. It markets and sells its generic pharmaceutical prescription drug products in the continental United States and the Commonwealth of Puerto Rico. The company has a strategic alliance agreement with Teva Pharmaceuticals Curacao N.V. Impax Laboratories, Inc. was founded in 1993 and is headquartered in Hayward, California.

Advisors' Opinion:
  • [By Michael Shulman]

    The not-so-small generic drug maker Impax Laboratories (NASDAQ: IPXL) has arguably the best manufacturing technology for time-released drugs in the entire generic industry.

    Pfizer’s (NYSE: PFE) patent for its $11 billion cholesterol drug Lipitor expires this year, and we know IPXL believes it has the expertise to manufacture a sophisticated statin such as Lipitor given recent legal actions concerning Merck’s drug Vytorin, a combination of a competing statin and a blood pressure drug. In other words, IPXL has the technical expertise to enter this market should it choose to do so.

    Two other major product introductions are anticipated in 2011 — generic Concerta for ADHD and generic Solodyn for bacterial infections, currently with combined sales of $1.8 billion.

    My target for the stock is $35-$40 in one to two years. IPXL is also the possible target of an acquirer.

Top Medical Stocks To Watch For 2014: Galena Biopharma Inc (GALE.PH)

Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Preven tion of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).

The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovari an and endometrial adenocarcinomas. Folate binding protein! h! as very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.

In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.

The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that ! targ! ets! conne! ctive tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.

The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.

Top Medical Stocks To Watch For 2014: DENTSPLY International Inc.(XRAY)

DENTSPLY International Inc. designs, develops, manufactures, and markets dental consumable products, dental laboratory products, and dental specialty products worldwide. The company?s dental consumable products include dental sundries, such as dental anesthetics, prophylaxis pastes, dental sealants, impression materials, restorative materials, tooth whiteners, and topical fluoride; and small equipment, including high and low speed handpieces, intraoral curing light systems, dental diagnostic systems, and ultrasonic scalers and polishers used in dental offices for the treatment of patients. Its dental laboratory products comprise dental prosthetics, including artificial teeth, precious metal dental alloys, dental ceramics, and crown and bridge materials, as well as equipment, such as computer aided machining ceramic systems and porcelain furnaces used in the preparation of dental appliances by dental laboratories. The company?s dental specialty products consist of endodonti c instruments and materials, implants and related products, bone grafting materials, 3D digital implantology, and orthodontic appliances and accessories. Its customers include dentists, dental hygienists, dental assistants, dental laboratories, and dental schools. The company distributes its dental products directly to dental laboratories and dental professionals, as well as through distributors, dealers, and importers. DENTSPLY International Inc. was founded in 1983 and is headquartered in York, Pennsylvania.

Advisors' Opinion:
  • [By Newsy Stocks]

    DENTSPLY International Inc. (Nasdaq: XRAY) designs, develops, manufactures, and markets dental consumable products, dental laboratory products, and dental specialty products worldwide. The company has a total market capitalization of $4.8 billion and in the last 1-year the stock has given a return of 11.8 percent. The company has a dividend yield of 0.59 percent, and has a price of profit of 16. The stock is trading at a P/E of 17.46, higher than the industry’s average P/E of 15.81. The PEG ratio of the stock is 1.65 years, higher than industry’s PEG of 1.15 years. The average 5 years historical earnings growth is 7.50 percent and is expected to grow at 11.20 percent for the next 5 years. Its quarterly revenue growth is estimated at 6.83 percent. The stock has a P/B value of 2.30x percent. Analyst at Barrington Research has given it an outperform rating on $42.75 price target. Based on the price target the stock is trading at a dis count of 21.73 percent. XRAY was up 1.98 percent to $34.01 a share.

Top Medical Stocks To Watch For 2014: Telik Inc (TELK)

Telik, Inc. (Telik), incorporated in 1988, is a clinical-stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The Company discovers its product candidates using the Company�� drug discovery technology, Target-Related Affinity Profiling (TRAP). TELINTRA, its principal drug product candidate in clinical development, is a small molecule glutathione analog inhibitor of the enzyme glutathione S-transferase P1-1 (GST P1-1). TELCYTA, its other product candidate, is a small molecule cancer drug product candidate designed to be activated in cancer cells.

Clinical Product Development

TELINTRA is the Company�� lead small molecule product candidate in clinical development for the treatment of blood disorders, including cancer. It has a mechanism of action and acts by inhibiting GST P1-1, an enzyme that is involved in the control of cellular growth and differentiation. Inhibition of GST P1-1 results in the activation of the signaling molecule Jun kinase, a regulator of the function of blood precursor cells. Preclinical tests show that TELINTRA is capable of causing the death or apoptosis of leukemic or malignant blood cells, while stimulating the growth and development of normal blood precursor cells. TELINTRA has been studied in Myelodysplastic Syndrome (MDS) using two formulations. A liposomal formulation was developed for intravenous administration of TELINTRA and was used in Phase I and Phase II studies in MDS patients. The results from the Phase II intravenous liposomal TELINTRA clinical trials demonstrated that TELINTRA treatment was associated with improvement in all three types of blood cell levels in patients with all types of MDS, including those in intermediate and high-risk groups. An oral dosage formulation (tablet) was subsequently developed and results from a Phase I study with TELINTRA tablets showed clinical activity and the formulation to be well tolerated. In June 2011, the Company initiated a Phase II clinical ! trial to evaluate TELINTRA tablets. In October 2011, the Company initiated an additional Phase IIb clinical trial to evaluate TELINTRA tablets. '

The activity and safety profile of tablet formulation allowed the Company to complete a Phase II trial of TELINTRA tablets in MDS. The primary objective of the Phase II TELINTRA tablet study was to determine the efficacy of TELINTRA. A multivariate logistic regression analysis was conducted to identify MDS disease prognostic factors associated with erythroid improvement response rates, including prior MDS treatment, age, gender, the international prognostic scoring system (IPSS), risk, Eastern Cooperative Group performance status, years from MDS diagnosis, MDS World Health Organization subtypes, anemia only versus anemia plus other cytopenias, dose schedule and starting dose. Results from this study show that TELINTRA is the first GSTP1-1 enzyme inhibitor shown to cause clinically reductions in red blood cell transfusions, including transfusion independence in low to intermediate-1 risk MDS patients, as well as improvement in platelet count and white blood cell levels in certain patients. TELINTRA, administered orally twice daily, appeared to be convenient and flexible for chronic treatment administration.

TELCYTA is a small molecule drug product candidate that the Company is developed for the treatment of cancer. TELCYTA binds to GST. TELCYTA has been evaluated in multiple Phase II and Phase III clinical trials, including trials using TELCYTA as monotherapy and in combination regimens in ovarian, non-small cell lung, breast and colorectal cancer. Results from these clinical trials indicate that TELCYTA monotherapy was generally well-tolerated, with mostly mild to moderate side effects, particularly when compared to the side effects and toxicities of standard chemotherapeutic drugs. When TELCYTA was evaluated in combination with standard chemotherapeutic drugs, the tolerability of the combinations was similar to that expected of each! drug alo! ne.

Clinical activity including objective tumor responses and/or disease stabilization was reported in the TELCYTA Phase II trials; however, TELCYTA did not meet its primary endpoints in the Phase III studies. Positive results from a Phase I-IIa multicenter, dose-ranging study of TELCYTA in combination with carboplatin and paclitaxel as first-line therapy for patients with non-small cell lung cancer, or NSCLC, were published in a peer reviewed publication. Clinical data demonstrated positive results of TELCYTA in combination with carboplatin and paclitaxel in the treatment of first-line lung cancer followed by TELCYTA maintenance therapy. As of December 31, 2011, the Company had an on-going investigator-led study at a single site of TELCYTA in patients with refractory or relapsed mantle cell lymphoma, diffuse B cell lymphoma, and multiple myeloma.

Preclinical Drug Product Development

The Company has a small molecule compound, TLK60404, in preclinical development that inhibits both Aurora kinase and VEGFR kinase. Aurora kinase is a signaling enzyme whose function is required for cancer cell division, while VEGF plays a key role in tumor blood vessel formation, ensuring an adequate supply of nutrients to support tumor growth. These lead compounds prevented tumor growth in preclinical models of human colon cancer and human leukemia by inhibiting both Aurora kinase and VEGFR kinase. A development drug product candidate, TLK60404, has been selected.

The Company, using its TRAP technology has discovered TLK60357, a novel, potent small molecule inhibitor of cell division. TLK60357 inhibits the formation of microtubules that are necessary for cancer cell growth leading to persistent G2/M cancer cell cycle block and subsequent cell death. This compound demonstrates potent broad-spectrum anticancer activity against a number of human cancer cells. This compound also displays oral efficacy in multiple, standard preclinical models of cancer. TLK60596, a potent VG! FR kinase! inhibitor, blocks the formation of new blood vessels in tumors. Oral administration of TLK60596 to animal models of human colon cancer reduced tumor growth.

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