Best Biotech Companies For 2015

Amgen Inc. (0.2%) (AMGN - $111.94 - NASDAQ)(AMGN) is one of the largest biotechnology companies in the world, with medicines for cancer, kidney dialysis, osteoporosis, and other conditions. Given its large size and mature product portfolio, revenue growth has slowed, but the company has been able to cut costs and repurchase shares to sustain double digit earnings per share growth. Earlier this year, Amgen offered to acquire Onyx Pharmaceuticals Inc. (less than 0.1%) to bolster its oncology portfolio, with Nexavar for liver cancer and Kyprolis for blood cancers. On Aug 25, after a brief auction, Amgen agreed to pay $125 per share, or $10.4 billion, for Onyx. While initially dilutive to earnings, this acquisition provides significant visibility into Amgen's future, with two blockbuster drugs that could eventually generate over $5 billion in annual sales.�

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From Mario Gabelli (Trades, Portfolio)'s�third quarter 2013 commentary.

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Best Biotech Companies For 2015: 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 John Kell and Lauren Pollock var popups = dojo.query(".socialByline .popC"); ]

  Clovis Oncology(CLVS) posted positive findings from a study of a lung-cancer treatment. The Phase 1 study of the oral treatment, called CO-1686, demonstrated “encouraging” results and progression-free survival in patients, Clovis said. Shares increased 4.2% to $80.75 in recent premarket trading.

• [By Brian Orelli]

  Plenty of data was presented at the American Society for Clinical Oncology meeting over the weekend, causing the first set of ASCO pops, but Clovis Oncology (NASDAQ: CLVS  ) looks like the clear winner, more than doubling today as the company presented data on its two cancer drugs rucaparib and CO-1686.

• [By Sean Williams]

  What: Shares of Clovis Oncology (NASDAQ: CLVS  ) , a biopharmaceutical company that's developing anti-cancer therapies, vaulted higher by as much as 136% (that's not a typo!) after reporting positive data on two early stage experimental treatments -- CO-1686 in EGFR-mutant non-small cell lung cancer (NSCLC) and Rucaparib in a monotherapy study of solid tumors -- at the American Society of Clinical Oncology's annual meeting.

Best Biotech Companies For 2015: Ophthotech Corp (OPHT)

Ophthotech Corporation, incorporated on January 05, 2007, is a biopharmaceutical company specializing in the development of therapeutics to treat diseases of the eye. The Company�� advanced product candidate is Fovista, which the Company is developing for use in combination with anti-VEGF drugs that represent the current standard of care for the treatment of wet age-related macular degeneration (wet AMD). Wet AMD is a serious disease of the central portion of the retina, known as the macula, which is responsible for detailed central vision and color perception. It is characterized by abnormal new blood vessel formation and growth, referred to as neovascularization, which results in blood vessel leakage, retinal distortion and scar formation. If untreated, the progressive retinal damage results in rapid, irreversible and severe vision loss. Wet AMD is the cause of blindness in patients over the age of 55 in the United States and the European Union.

The anti-VEGF market for the treatment of wet AMD consists predominantly of two drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD, Lucentis and Eylea, and off-label use of the cancer therapy Avastin. The use of anti-VEGF drugs has significantly improved visual outcomes for patients with wet AMD who have been treated with these drugs as compared to untreated patients.

Advisors' Opinion:

• [By Todd Campbell]

  That leads me to Medivation (NASDAQ: MDVN  ) , Ophthotech (NASDAQ: OPHT  ) , and Portola (NASDAQ: PTLA  ) , three companies with important therapies that may very well be destined to become top sellers.

Top 5 Financial Stocks To Buy Right Now: International Stem Cell Corp (ISCO)

International Stem Cell Corporation, incorporated on June 7, 2005 is a developmental-stage biotechnology company. The Company focused on therapeutic and biomedical product development. The Company�� wholly owned subsidiary Lifeline Cell Technology, LLC (LCT) develops, manufactures and commercializes over 130 human cell culture products, including frozen human primary cells and the reagents (media) needed to grow, maintain and differentiate the cells, in order to address this market opportunity. The Company�� scientists have used a technology called basal medium optimization to systematically produce optimized products designed to culture specific human cell types and to elicit specific cellular behaviors. The Company�� wholly owned subsidiary Lifeline Skin Care, Inc. (LSC) develops, manufactures and markets cosmetic skin care products using an extract derived from its pluripotent stem cells.

Therapeutic Product Candidates

Using the Company's technologies and know-how, the Company is exploring and creating a range of cell types that is useful in therapeutic treatments, which include Liver cells (hepatocytes) that may be used to treat a range of congenital and acquired liver diseases. Neuronal cells for potential treatment of Parkinson's disease and other central nervous system disorders, such as traumatic brain injury, stroke and Alzheimer�� disease. Three-dimensional eye structures to treat degenerative retinal diseases, corneal blindness, and to accelerate corneal healing.

Skin Care Products

The Company�� research scientists developed two skin care products, Defensive Day Serum and Recovery Night Serum, using an extract derived from human parthenogenic stem cells. Defensive Serum contains sunscreen, along with stem cell-derived ingredients. The day serum not only protects the skin from the aging effects of harsh light, but it continues to nurture the skin�� collagen and fibroblasts to give noticeably firmer, smoother, younger-looking ! skin. The Recovery Night Serum is a nighttime therapy that complements the Defensive Day Serum. The night serum nurtures the skin�� collagen and elastin and contains ingredients to defend against damaging free radicals, to help build firmer, smoother, younger and healthier-looking skin.

Research Products

The Company�� Lifeline subsidiary produces and sells over 250 human cell culture products. These products include frozen human cells and stem cells and the reagents needed to grow, maintain and differentiate the cells. These human cell-based products are used domestically and internationally by research scientists in pharmaceutical, academic and government research organizations to study human disease and basic cell biology.

The Company competes with Genzyme Corporation, StemCell, Advanced Cell Technology Inc., Aastrom Biosciences, ViaCyte, Obagi, SkinCeuticals, SkinMedica, Murad, Lonza, Chemicon, Life Technologies, StemCell Technologies, Merck, BioTime and Specialty Media.

Advisors' Opinion:

• [By John Udovich]

  From stem cell burgers to earnings reports, the stem cell industry and small cap players in it like NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX) have been producing some news lately that has probably been overlooked by investors and traders alike given its August. Nevertheless, you might want to pay attention to the following stem cell news:

Best Biotech Companies For 2015: 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 Johanna Bennett]

  The Dow Jones Industrial Average closed at�16,947.08, rising 25 points, or 0.15%, led by gains in shares of Caterpillar (CAT), Merck (MRK) and Johnson & Johnson (JNJ). The benchmark closed above its previous record of 16,945.92 hit on June 10.

• [By Brian Orelli]

  Axial spondyloarthritis is a precursor to ankylosing spondylitis, which all four TNF inhibitors --�Amgen (NASDAQ: AMGN  ) and Pfizer's (NYSE: PFE  ) Enbrel, Johnson & Johnson's (NYSE: JNJ  ) Remicade and Simponi, and AbbVie's Humira -- are all approved for. But none of them are approved for axial spondyloarthritis, and it doesn't look like Humira will get the nod on this go with the FDA.

• [By Nicole Seghetti]

  Patching up runners' annoying blisters, sore joints, and aching muscles will probably come from Johnson & Johnson (NYSE: JNJ  ) and Pfizer (NYSE: PFE  ) products. For more than 125 years, J&J has brought relief to millions of consumers with its Band-Aids, Tylenol, and Bengay. Pfizer's Advil is the No. 1-selling branded over-the-counter pain reliever, and its ThermaCare Heatwraps make heat therapy portable and long-lasting. And these two Dow Jones Industrial Average bellwether stocks both pay greater than a 3% dividend yield.

Best Biotech Companies For 2015: Prosensa Holding NV (RNA)

Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company�� primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington�� disease. The Company�� clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company�� platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.

DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five, when boys begin to show signs of impaired motor development. PRO044, the Company�� product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.

Advisors' Opinion:

• [By Garrett Cook]

  Prosensa Holding N.V. (NASDAQ: RNA) shares were also up, gaining 8.20 percent to $13.00 on the FDA requirement of additional data from Sarepta on Eteplirsen. Prosensa Holding is also looking to provide a drug to treat Duchenne muscular dystrophy.

Best Biotech Companies For 2015: Synergy Pharmaceuticals Inc (SGYP)

Synergy Pharmaceuticals, Inc., incorporated on February 11, 1992, is a biopharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (GI), disorders and diseases. The Company�� lead product candidate is plecanatide, a guanylyl cyclase C (GC-C), receptor agonist, to treat GI disorders, primarily chronic constipation (CC), and constipation-predominant-irritable bowel syndrome (IBS-C). It is also developing SP-333, the second generation GC-C receptor agonist for the treatment of gastrointestinal inflammatory diseases, such as ulcerative colitis (UC). The Company�� active pharmaceutical ingredients (APIs) and the final formulated drug products are manufactured for it by third party contractors.

As of December 31, 2011, the Company was developing plecanatide, a synthetic hexadecapeptide designed to mimic the actions of the GI hormone uroguanylin, for the treatment of CC and IBS-C. Plecanatide is an agonist of GC-C receptor. As of December 31, 2011, the Company was dosing patients in an 800-patient Phase II/III clinical trial of plecanatide to treat. It is also developing a second generation GC-C receptor analog, SP-333, which is in pre-clinical development for the treatment of gastrointestinal inflammatory diseases. SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone.

The Company competes with Ironwood Pharmaceuticals, Inc., Forest Laboratories, Inc., Takeda Pharmaceuticals America, Inc., Sucampo Pharmaceuticals, Inc., Salix Pharmaceuticals, Inc. and Shire Plc.

Advisors' Opinion:

• [By Sean Williams]

  Finally, Synergy Pharmaceuticals (NASDAQ: SGYP  ) may have had the wildest week of them all. Synergy's share price spiked 16% on Tuesday as an analyst at Cantor Fitzgerald raised her peak sales estimate for plecanatide, the company's midstage drug for chronic idiopathic constipation and irritable bowel syndrome with constipation, to $1.58 billion from $1.05 billion, as clinical data has been stronger than expected. However, the company didn't return the favor to shareholders by -- the very next day, mind you ��announcing a secondary offering of 16.375 million shares. The downside of clinical-stage companies is the always apparent risk of dilution. Shares have lost 25% since their Tuesday close.

• [By Monica Gerson]

  Breaking news

  Time Warner Cable (NYSE: TWC) reported a drop in its third-quarter profit. Time Warner Cable's quarterly profit fell to $532 million, or $1.84 per share, from $808 million, or $2.60 per share, in the year-ago period. To read the full news, click here. Synergy Pharmaceuticals (NASDAQ: SGYP) today announced the start of a phase 2 clinical trial to evaluate the safety and efficacy of SP-333, its second-generation GC-C agonist and once-daily oral treatment, in adult patients with opioid-induced constipation (OIC). To read the full news, click here. Cigna (NYSE: CI) reported a 19% rise in its third-quarter earnings and lifted its full-year earnings outlook. To read the full news, click here. Charm Communications (NASDAQ: CHRM) announced today that the special committee of the Company's board of directors, consisting of independent directors Mr. Zhan Wang, Mr. Andrew J. Rickards and Mr. Gang Chen, has retained China Renaissance Securities (Hong Kong) Limited as its financial advisor and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP as its legal advisor. To read the full news, click here.

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Best Biotech Companies For 2015: OncoSec Medical Inc (ONCS)

OncoSec Medical Incorporated, incorporated on February 8, 2008, is an emerging drug-medical device company. The Company focused on designing, developing and commercializing medical approaches for the treatment of solid cancers. In March 2011, the Company acquired from Inovio Pharmaceuticals, Inc. (Inovio) certain assets related to the use of drug-medical device combination products for the treatment of different cancers.

The Company�� acquired assets relate to certain non-deoxyribonucleic acid (DNA) vaccine technology and property relating to selective tumor ablation technologies, which it refers to as the OncoSec Medical System (OMS), a therapy which uses an electroporation device to facilitate delivery of chemotherapy agents, or nucleic acids encoding cytokines, into tumors and/or surrounding tissue for the treatment and diagnosis of various cancers. As of January 24, 2012, the Company had not generated any revenue from operations.

Advisors' Opinion:

• [By John Udovich]

  Small cap biotech stocks AVEO Pharmaceuticals, Inc (NASDAQ: AVEO), OncoSec Medical Inc (OTCMKTS: ONCS) and MetaStat Inc (OTCBB: MTST) are focused on or are developing treatments or diagnostic technologies for metastatic cancers. In case you aren�� familiar with the term metastasis or metastatic, it�� the�spread of cancer from its primary site to other places in the body as cancer cells break away from a primary tumor, penetrate into lymphatic and blood vessels, circulate through the bloodstream and then grow in a new focus (metastasize) in normal tissues elsewhere in the body. In other words, it�� a dangerous form of cancer, but there are some small cap biotech stocks targeting it for diagnostics or treatment:

• [By Bio-Wire]

  Another company that has benefitted from Inovio�� newfound attention is OncoSec Medical (OTC: ONCS) ��a newer ��ffshoot�� company that uses a similar but distinctly different electroporation device known as the OncoSec Medical System (OMS) that is based on Inovio�� technology. The specific amplitude and frequency of the OMS electroporation is calibrated such that plasmid delivery into solid tumor masses is fully optimized, while CELLECTRA electroporation is less specialized and focus more on the vaccination of skin cells. The cross-license agreement made between Inovio and Oncosec also covers the two devices for their distinctly different applications.

• [By James E. Brumley]

  If you're looking for the next big biotech breakout stock, then OncoSec Medical Inc. (OTCMKTS:ONCS) deserves a place on your watchlist. This volatile cancer play has been down more than up 2011, but if you look closely at a long-term chart of ONCS, you may find it's already wiggled its way into a new uptrend. And, it may be only a matter of time before the bullish fireworks start to go off.

• [By James E. Brumley]

  How does the old saying go? Beggars can't be choosers? Two weeks ago, yours truly penned some bullish comments regarding OncoSec Medical Inc. (OTCMKTS:ONCS). The long and short of it was, if ONCS could clear a technical ceiling around $0.36, then life would get much easier for the bulls.

Best Biotech Companies 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 Sean Williams]

  Regulus Therapeutics (NASDAQ: RGLS  )
  Since presenting at the Deutsche Bank Healthcare Conference two weeks ago, shares of Regulus Therapeutics have been absolutely on fire. A mixture of ASCO and IPO fever have revived the love for newer issues, and having big name pharmaceutical companies gobbling up a majority of its IPO'd shares certainly helps its cause.

• [By Sean Williams]

  What: Shares of Regulus Therapeutics (NASDAQ: RGLS  ) , a biopharmaceutical company focused on the development of therapies utilizing its proprietary microRNA product platform, saw its shares skyrocket as much as 127% at one point today after announcing the interim results for its human proof-of-concept trial for its early stage hepatitis C drug RG-101.