Top 10 Biotech Companies To Invest In 2014

Dialysis specialist DaVita HealthCare Partners (NYSE: DVA  ) has a new bean counter.

The Denver-based renal health care specialist announced today that Garry E. Menzel, Ph.D., will join the company in mid-Sptember�as senior VP of finance,�and will take on the role of chief financial officer�the day after the company files its third-quarter report with the SEC. The quarter ends Sept. 30. Jim Hilger, who has served as DaVita's interim CFO since 2012, will continue in his role as the company's chief accounting officer, a position he has held since 2010.

Menzel, 48, was most recently the COO and CFO at biopharmaceutical�Regulus Therapeutics, where he served since 2008. Before that, he had a 14-year career on Wall Street where he was a managing director and global head of life sciences for Credit Suisse and of biotechnology for Goldman Sachs. Menzel also spent several years as a strategy consultant for Bain & Company.

Belieiving they've found an executive with a versatile skill set,�DaVita HealthCare Partners Co-Chairman and CEO�Kent Thiry said, "Given the nimbleness that is required for all health care providers we are excited to have Garry join our leadership team."

Top 5 Recreation Companies To Invest In 2015: Elite Pharmaceuticals Inc (ELTP)

Elite Pharmaceuticals, Inc. (Elite), incorporated on October 1, 1997, is a specialty pharmaceutical company principally engaged in the development and manufactures of oral, controlled-release products, using technology and the development and manufacture of generic pharmaceuticals. Elite has four products: Phentermine 37.5 milligram tablets, Methadone 10 milligram tablets, Lodrane D Immediate Release capsules and Hydromorphone Hydrochloride 8 milligram tablets. During the fiscal years ended March 31, 2012 (Fiscal 2011), the Company manufactured and sold Lodrane 24 and Lodrane 24D (the Lodrane Extended Release Products).

The Company has a pipeline of additional generic drug candidates under active development, including, without limitation, ELI-154, a once-a-day oxycodone product and ELI-216, an abuse resistant oxycodone product which utilizes the Company�� propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite�� Abuse Resistant Technology). ECR Pharmaceuticals (ECR), a wholly owned subsidiary of Hi-Tech Pharmacal, Inc. and the owner and marketer of the Lodrane Extended Release Products. Elite also purchased from Mikah Pharma LLC, an approved Abbreviated New Drug Application (ANDA) for Naltrexone 50 milligram tablets.

For ELI-154, Elite has developed a once-daily oxycodone formulation using its technology. An investigational new drug application (IND) has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market, OxyContin marketed in the United States by Purdue Pharma LP. ELI-216 utilizes the Company's abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulat! ed to deter abuse of the drug. Products utilizing the pharmacological approach to deter abuse such as Suboxone, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda, a product marketed in the United States by Pfizer, have been approved by the United States Food & Drug Administration (FDA). ELI-216 demonstrates a euphoria-blocking effect when the product is crushed. Elite has developed ELI-154 and ELI-216 and retains the rights to these products.

The Company competes with Collegium Pharmaceuticals, Inc., Purdue Pharma LP, Acura Pharmaceuticals, Inc., Durect Corporation, Mylan Laboratories, Inc., Par Pharmaceuticals, Inc., Alkermes, Inc., Teva Pharmaceuticals Industries Ltd., Aptalis Pharma, Impax Laboratories, Inc., and Watson Pharmaceuticals.

Advisors' Opinion:

• [By CRWE]

  Today, ELTP has shed (-8.01%) down -0.009 at $.101 with 4,629,899 shares in play thus far (ref. google finance Delayed: 1:00PM EDT September 16, 2013).

  Elite Pharmaceuticals, Inc. previously reported the first quarter of fiscal year 2014 ended June 30, 2013. Manufacturing and profit split revenues comprised almost all of Elite’s quarterly revenues and totaled $717k for the quarter, an increase of 41% from the prior year. This growth is attributed to the launch of two new products during the quarter, Phentermine 15mg and 30mg capsules, combined with strong year-on-year growth of the Elite’s Hydromorphone 8mg tablets and contract manufactured Methadone 10mg product lines.

• [By James E. Brumley]

  Judging from the company it's keeping Green Automotive Co. (OTCMKTS:GACR) may have just made its way into the upper echelon of small cap stock opportunities. The electric car company joins Elite Pharmaceuticals Inc. (OTCBB:ELTP), Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS), and only three other companies as Wall-Street.com's "Best 6 Stocks" for January of 2014. As one of the top information resources for investors - particularly in terms of information regarding small and micro cap stocks - being named among the site's top pick is an accolade for AMBS, ELTP, and GACR. Even more impressive is that Green Automotive Co. was the only consumer-goods name among those six. Amarantus Bioscience Holdings and Elite Pharmaceuticals are biotechnology names... an industry that can and often does attract a lot of attention just by the nature of the business. The other three names making the "Best 6" list were an energy explorer, a power-management technology manufacturer, and prescription/medical food producer. For an electric car manufacturer to make the list speaks quite highly of GACR.

Top 10 Biotech Companies To Invest In 2014: Dendreon Corporation(DNDN)

Dendreon Corporation, a biotechnology company, engages in the discovery, development, and commercialization of therapeutics to enhance cancer treatment options for patients. The company offers active cellular immunotherapy and small molecule product candidates to treat various cancers. Its product candidates comprise Provenge (sipuleucel-T), an active cellular immunotherapy for the treatment of metastatic, castrate-resistant prostate cancer; DN24-02, an investigational active immunotherapy for the treatment of patients with bladder, breast, ovarian, and other solid tumors expressing HER2/neu; and TRPM8, a small molecule agonist to transient receptor potential ion channel, for multiple cancers. The company also has a range of products in preclinical studies, which include Carcinoembryonic antigen for the treatment of lung, colon, and breast cancer; and Carbonic AnhydraseIX for the treatment of kidney cancer. Dendreon Corporation was founded in 1992 and is headquartered in S eattle, Washington.

Advisors' Opinion:

• [By Dimitra DeFotis]

  There are two cancer vaccines on the market: Provenge, a prostate-cancer treatment from Seattle-based Dendreon�(DNDN), and Yervoy, a melanoma treatment from Bristol-Myers Squibb�(BMY), according to Dow Jones Newswires. In May, Roche�Holding (RHHBY) said its experimental cancer vaccine, called MPDL3280A, shrank tumors in 21% of 140 patients participating in a trial. It is now performing tests in lung cancer patients.

• [By Brian Orelli]

  "We believe that the fourth quarter may be our strongest quarter of the year," said John Johnson, Dendreon's (NASDAQ: DNDN  ) �chairman, CEO, and president.

• [By Debra Fiakas]

  Earlier this month biotech Dendreon (DNDN) announced the approval in the European Union of its only commercial product Provenge. Aimed at prostate cancer, Provenge is a novel therapeutic based on Dendreon's proprietary cellular immunotherapy technology. The good news could not have come at a better time. Dendreon has had Provenge on the market in the U.S. since spring 2010. While sales have ramped impressively to $304.3 million in the most recently reported twelve months, the top-line has failed to cover costs and expenses.

Top 10 Biotech Companies To Invest In 2014: Clovis Oncology Inc (CLVS)

Clovis Oncology, Inc. (Clovis) incorporated on April 20, 2009, is a Development-stage Company. The Company is a Biopharmaceutical Company. The Company focuses on acquiring, developing and commercializing anti-cancer agents in the United States, Europe and additional international markets. The Company also focuses on the treatment of specific subsets of cancer populations. During the year ended December 31, 2010, the Company was in the process of developing three product candidates for which it holds global marketing rights: CO-101, a lipid-conjugated form of the anti-cancer drug gemcitabine; CO-1686, an oral epidermal growth factor receptor (EGFR) mutant-selective inhibitor and CO-338, a poly ADP (Adenosine Diphosphate)-ribose polymerase (PARP) inhibitor. Effective November 19, 2013, Clovis Oncology Inc acquired the entire share capital of Ethical Oncology Science SpA.

CO-101 - a Lipid-Conjugated Form of the Anti-Cancer Drug Gemcitabine

CO-101 is designed to treat patients with pancreatic cancer whose tumors express low amounts of a membrane transporter protein on the surface of the cancer cell known as hENT1 and are thus expected to be resistant to standard gemcitabine-based therapy. Based on the published results of multiple studies assessing the correlation of hENT1 expression to survival outcomes in pancreatic cancer patients treated with gemcitabine, the Company estimates that approximately 40% to 50% of pancreatic patients express low levels of hENT1, and thus derive little or no benefit from gemcitabine therapy. CO-101 is in an international, randomized and controlled 360-patient study for the first-line treatment of metastatic pancreatic cancer. This open-label study compares CO-101 to gemcitabine as a first-line therapy in patients with metastatic pancreatic cancer. Clovis is partnered with Ventana Medical Systems for the development and commercialization of a companion diagnostic for the assessment of hENT1 levels.

CO-1686-an Oral EGFR Mutant-Selective ! Inhibitor

CO-1686 is an orally available, small molecule covalent inhibitor of the cancer-causing mutant forms of EGFR for the treatment of non-small cell lung cancer (NSCLC). CO-1686 targets both the initial activating EGFR mutations as well as the primary resistance mutation, T790M, it treats both first- and second-line NSCLC patients with EGFR mutations. Such initiating activating mutations occur in approximately 10% to 15% of NSCLC cases in Caucasian patients and approximately 30% to 35% of NSCLC cases in East Asian patients. Following treatment with approved NSCLC therapies, Tarceva (erlotinib) or Iressa (gefitinib), both known as tyrosine kinase inhibitors (TKIs), approximately half of these patients develop the T790M mutation.

The Company focuses on the development of CO-1686 as both a second-line therapy for EGFR-mutated NSCLC patients who become resistant to TKIs due to the emergence of the T790M secondary mutation and as a first-line treatment for EGFR-mutated NSCLC. Clovis is partnered with Roche Molecular Systems for the development and commercialization of a companion diagnostic for identification of EGFR mutations.

CO-338-a PARP Inhibitor

CO-338 is a small molecule PARP inhibitor that the Company focuses to develop as both monotherapy and in combination with chemotherapeutic agents for the treatment of selected cancer patients. CO-338 is in a Phase I clinical trial to determine the maximum tolerated dose of oral CO-338 that can be combined with intravenous, or IV, platinum chemotherapy in the treatment of solid tumors. This program is supplemented by two ongoing investigator-initiated trials, using the IV formulation of CO-338: a Phase I/II study in germ-line BRCA mutant breast and ovarian cancer and a Phase II study in the adjuvant treatment of germ-line BRCA mutant and triple-negative breast cancer. The Company also focuses on initiating a Phase I monotherapy study of the oral formulation, to determine an appropriate dose and schedule.!

The Company competes with Eli Lilly, Teva Pharmaceutical Industries, APP Pharmaceuticals, AB Science SA, Amgen Inc., Astellas Pharma, BioSante Pharmaceuticals, Inc., Celgene Corporation, Immunomedics, Inc., Lorus Therapeutics, Threshold Pharmaceuticals, Inc., Boehringer Ingelheim, Pfizer, Sanofi-Aventis, Astra Zeneca, Abbott, Merck, Eisai, Cephalon and Biomarin.

Advisors' Opinion:

• [By Lauren Pollock]

  Biotech company Clovis Oncology Inc.(CLVS), which was considering a sale, didn’t enter any deal talks and is no longer seeking bids, Bloomberg News reported, citing a person with knowledge of the matter. Shares dropped 14% to $63.51 premarket.

• [By Sean Williams]

  Clovis Oncology (NASDAQ: CLVS  ) certainly made a name for itself, more than doubling its share price, after reporting positive early stage data on CO-1686 for EGFR-mutant non-small cell lung cancer and rucaparib for solid tumors such as ovarian cancer. Rucaparib provided an 89% clinical benefit to patients with ovarian cancer while CO-1686 indicated a partial response in three out of four patients with the T790M resistance mutation. I would still urge caution among investors, though, as these are still early studies and Clovis lost its then lead drug, CO-101, to a failed mid-stage pancreatic cancer trial in November. �

Top 10 Biotech Companies To Invest In 2014: Navidea Biopharmaceuticals Inc (NAVB)

Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company�� radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson�� disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.

Lymphoseek

Navidea�� pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body�� immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea�� Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-center Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.

AZD4694

AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.

RadioImmunoGuided Surgery

As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.

The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.

Advisors' Opinion:

• [By Sean Williams]

  Diagnostics can also play an important role in early and late-stage breast cancer diagnoses. Navidea Biopharmaceuticals (NYSEMKT: NAVB  ) had Lymphoseek, its external lymph-node imaging and intra-operative lymphatic mapping diagnostic device, approved by the Food and Drug Administration earlier this year to help doctors stage cancer. Discovering whether breast cancer has invaded adjacent lymph nodes has never been easier or safer thanks to Lymphoseek, and it can dramatically aid physicians in determining the best course of action for breast cancer patients.

Top 10 Biotech Companies To Invest In 2014: Agios Pharmaceuticals Inc (AGIO)

Agios Pharmaceuticals, Inc., incorporated on August 7, 2007, is a biopharmaceutical company. The Company is intend to apply its deep understanding of metabolism, coupled with the Company�� ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and inborn errors of metabolism (IEMs) are treated. The Company has identified and validated novel and druggable targets in both cancer and IEMs. The Company�� two advanced cancer programs are targeting mutations in the enzymes isocitrate dehydrogenase 1 and 2, referred to as IDH1 and IDH2. The Company�� drug candidates are selective for the mutated forms of IDH1 and IDH2 found in cancer cells versus the normal forms of IDH1 and IDH2 found in all other cells.

The Company focused on developing medicines to address IEMs, with a novel approach to these orphan diseases for which no effective or disease-modifying therapy is available. The Company has also de-validated and terminated numerous programs, including many that have been reported in scientific journals. In the Company�� IEM portfolio, it uses an equally rigorous set of validation techniques.

Advisors' Opinion:

• [By Lisa Levin]

  Agios Pharmaceuticals (NASDAQ: AGIO) shares touched a new 52-week low of $18.83. Agios Pharmaceuticals' trailing-twelve-month profit margin is -102.87%.

Top 10 Biotech Companies To Invest In 2014: Gilead Sciences Inc.(GILD)

Gilead Sciences, Inc., a biopharmaceutical company, engages in the discovery, development, and commercialization of therapeutics for the treatment of life threatening diseases worldwide. Its products include Atripla, Truvada, Viread, Emtriva for the treatment of human immunodeficiency virus infection in adults; Hepsera, an oral formulation for the treatment of chronic hepatitis B; AmBisome, a amphotericin B liposome injection to treat invasive fungal infections; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa for the treatment of chronic angina; Vistide, an antiviral medication for the treatment of cytomegalovirus retinitis in patients with AIDS; and Cayston, an inhaled antibiotic used as a treatment to enhance respiratory systems. The company?s products also comprise Tamiflu, an oral antiviral for the treatment and prevention of influenza A and B; Macugen, an intravitreal injection for the treatment of neovascular a ge-related macular degeneration; and Lexiscan/Rapiscan, an injection used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. Its products under the Phase III clinical trials consist of Cobicistat, a pharmacoenhancer that is under evaluation as a boosting agent for HIV medicines; Elvitegravir, an oral integrase inhibitor being evaluated as part of combination therapy for HIV; Integrase Single-Tablet, a ?Quad? regimen of elvitegravir, cobicistat, tenofovir disoproxil fumarate, and emtricitabine for the treatment of HIV/AIDS in treatment-naive patients; and Aztreonam for inhalation solution for the treatment of cystic fibrosis patients with Pseudomonas aeruginosa. The company?s Phase II clinical trials products comprise Cicletanine, Ranolazine, and Aztreonam, as well as GS 9190, GS 9256, and GS 9451. Its Phase I clinical trial products include GS 7340, GS 5885, GS 6620, GS 9620, and GS 6624. The company was founded in 1987 and is headquartered in Fost er City, California.

Advisors' Opinion:

• [By Ben Levisohn]

  Shares of Gilead Sciences�(GILD) fell 3.6% today, and the experts I spoke with said that they didn’t see a catalyst for the drop, one that dragged the entire biotech sector down with it.

  Now there are two possibilities. StreetInsider.com and the Fly On the Wall both referred to a voluntary recall of Gilead’s HIV-drug Atripla, though both made referencer to a Deutsche Bank report that dismissed the recall as minor and unlikely to have a major impact.

  But there’s another possibility. Citigroup’s Yaron Weber explains:

  Today, at the CROI meeting, data from the NEAT 001/ANRS143 trial testing the combination of Isentress + Prezista/ritonavir (ie nuc sparing) in 805 new HIV patients showed non-inferiority to Prezista/ritonavir + Gilead’s Truvada.

  It looks to us that there is finally some legitimate competitor to Gilead�� HIV regimens that could be cheaper and viable for 85% of patients. However, the Isentress/Prezista regimen will require more pills/day and will have more side effects. At this point, a formal development plan will need to be undertaken by either Merck or JNJ or both to support registration of this regimen. As the standard of care is shifting, they might also need to test the regimen against Gilead�� Stribild. As such, we do not anticipate that this regimen will be licensed until at least another 2-3 years.�

  Whatever the reason, the day was clearly a painful one for biotech investors, who have already been facing charges of bubble-mania in the sector. The SPDR S&P Biotech ETF (XBI) fell 3.1%, the iShares Nasdaq Biotechnology Index ETF (IBB) dropped 2.7%, while Amgen (AMGN) fell 1.6% and Regeneron Pharmaceuticals (REGN) declined 2%.

• [By Cory Renauer]

  On May 21 the European Medicines Agency [EMA] delivered some very positive news for Gilead Sciences Inc. (GILD) and its oral hepatitis C drug sofosbuvir. The EMA will provide an accelerated review of Gilead's Marketing Authorization Application [MAA] the once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus [HCV] infection.

Top 10 Biotech Companies To Invest In 2014: Neurocrine Biosciences Inc.(NBIX)

Neurocrine Biosciences, Inc. engages in the discovery, development, and commercialization of drugs for the treatment of neurological and endocrine-related diseases and disorders in the United States. It develops drugs for endometriosis, stress-related disorders, pain, tardive dyskinesia, uterine fibroids, diabetes, insomnia, and other neurological and endocrine-related diseases and disorders. The company?s products in clinical development include Elagolix, a Phase II drug for endometriosis; Vesicular Monoamine Transporter 2 Inhibitor (VMAT2), a Phase II drug for movement disorders; CRF2 Peptide Agonist, a Phase II drug for cardiovascular diseases; CRF1 Antagonist, a Phase II drug for stress-related disorders; and Elagolix, a Phase II drug for uterine fibroids. Its research programs comprise G Protein-Coupled Receptor 119 (GPR119) for type II diabetes; VMAT2 for schizophrenia; GnRH Antagonists for men?s and women?s health, and oncology; Antiepileptic Drugs for epilepsy, essential tremor, and pain; and G Protein-Coupled Receptors for other conditions. The company has collaborations with GlaxoSmithKline to develop and commercialize CRF antagonists for psychiatric, neurological, and gastrointestinal diseases; Dainippon Sumitomo Pharma Co. Ltd. to develop and commercialize Indiplon in Japan; Abbott International Luxembourg S.�r.l. to develop and commercialize elagolix and GnRH antagonists for women?s and men?s health indications; and Boehringer Ingelheim International GmbH to research, develop, and commercialize small molecule GPR119 agonists for the treatment of type II diabetes and other indications. Neurocrine Biosciences, Inc. was founded in 1992 and is headquartered in San Diego, California.

Advisors' Opinion:

• [By Lisa Levin]

  Neurocrine Biosciences (NASDAQ: NBIX) shares moved up 76.95% to $17.27. The volume of Neurocrine Biosciences shares traded was 4406% higher than normal. Neurocrine Biosciences reported positive results of VMAT2 inhibitor NBI-98854 in Kinect 2 study.