Leave it to a man with a big case of foot-in-mouth disease to reignite the heated conversation about whether women can handle money as well as men. At a recent forum at the University of Virginia, hedge fund manager Paul Tudor Jones remarked that women traders lose focus after becoming mothers and breastfeeding their babies. A predictable flap ensued, and Jones backpedaled and then apologized.
See Also: The Rules of Retirement for Women
Go ahead and roll your eyes, chuckle or stamp your foot, depending on your point of view. Arguing that there are differences in innate ability between the sexes always makes for trouble.
Certainly, when it comes to money management, women have plenty to crow about. Consider Sarah Ketterer, chief executive of Causeway Capital Management, who co-manages its International Value fund (CIVVX) and has helped guide it to the top 21% of its peer group for the ten-year period that ended June 30. In fact, the fund beat its competition in eight of the past ten calendar years.
Top 5 Biotech Companies To Buy For 2014: Enanta Pharmaceuticals Inc (ENTA)
Enanta Pharmaceuticals, Inc., incorporated on July 25, 1995, is a research and development-focused biotechnology company. The Company uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. The Company is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes-protease (partnered with AbbVie, the former research-based pharmaceutical business of Abbott Laboratories), NS5A (partnered with Novartis) and nucleotide polymerase, as well as a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. ABT-450, discovered through its collaboration with AbbVie, is a protease inhibitor that has demonstrated in vitro potency against known resistant HCV mutants.
In Phase I studies, ABT-450 co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors, was shown to be safe and well tolerated. Co-administration of ABT-450 with ritonavir, which it refers to together as ABT-450/r, has enabled once-daily dosing of ABT-450. Phase II studies have demonstrated the efficacy of ABT-450/r in patients with chronic HCV, and other interferon-free Phase II studies of ABT-450-containing regimens continue. AbbVie is developing a next-generation protease inhibitor discovered within the Enanta-AbbVie collaboration. EDP-239 is the NS5A inhibitor discovered by the Company. The Company also has a program to develop nucleotide inhibitors to HCV NS5B polymerase, which is another DAA mechanism considered to have a barrier to resistance. The Company’s Bicyclolide antibiotic product candidate is EDP-788, which it is developing for use as an intravenous drug in the hospital setting and for oral dosing in the home setting. EDP-788 is a prodrug, which means that it is inactive until it is converted in the body into an active compound. EDP-788 is! a water-soluble molecule which, when administered in preclinical models, is cleanly and rapidly converted into the active compound.
- [By Sean Williams]
The next big thing in treating hepatitis-C
The other currently experimental therapy very likely to make it onto the FDA’s desk before the midpoint of 2014 is AbbVie’s (NYSE: ABBV ) direct-acting antiviral combo drug. In similar fashion to Sovaldi, this DAA-combo therapy, which includes ABT-450 from Enanta Pharmaceuticals (NASDAQ: ENTA ) , is running six confirmatory late-stage trials on various genotypes. There are, however, two primary differences between AbbVie’s DAA-combo therapy and Sovaldi.
- [By James Fink]
And lastly I’ll go into healthcare, which is kind of a growth cyclical type name. It’s partially defensive, partially growth. I think the more growth-oriented section of healthcare would be biotech, and right now, a very promising biotech stock is Enanta Pharmaceuticals. That’s a NASDAQ stock; ticker symbol (ENTA).
Top 5 Biotech Companies To Buy For 2014: 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’s 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’s 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. A s 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.
- [By Monica Gerson]
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.
Posted-In: Bank of America US Stock FuturesNews Eurozone Futures Global Pre-Market Outlook Markets
- [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.
Top 5 Biotech Companies To Buy For 2014: Celgene Corp (CELG)
Celgene Corporation is a global biopharmaceutical company primarily engaged in the discovery, development and commercialization of therapies designed to treat cancer and immune-inflammatory related diseases. The Company is engaged in the research and development, which is designed to bring new therapies to market, and is engaged in research in several scientific areas that may deliver therapies, focusing areas, such as intracellular signaling pathways in cancer and immune cells, immunomodulation in cancer and autoimmune diseases, and therapeutic application of cell therapies. The Company’s primary commercial stage products include REVLIMID, VIDAZA, THALOMID, ABRAXANE and ISTODAX. Additional sources of revenue include a licensing agreement with Novartis, which entitles it to royalties on FOCALIN XR and the entire RITALIN family of drugs, the sale of services through its Cellular Therapeutics subsidiary and other miscellaneous licensing agreements. In March 2012, it acquir ed Avila Therapeutics.
The Company invests in research and development, and the drug candidates in its pipeline at various stages of preclinical and clinical development. These candidates include pomalidomide and apremilast, its oral anti-cancer and anti-inflammatory agents, PDA-001, its cellular therapy, oral azacitidine, CC-223 and CC-115 for hematological and solid tumor malignancies, CC-122, its anti-cancer pleiotropic pathway modifier, and ACE-011 and ACE-536 biological products for anemia in several clinical settings of unmet need. Celgene product candidates include Pomalidomide (CC-4047), Oral Anti-Inflammatory: Apremilast (CC-10004), CC-11050, Kinase Inhibitors:Tanzisertib (CC-930), Cellular Therapies: PDA-001, Activin Biology: Sotatercept (ACE-011) ACE-536, and Anti-tumor Agents: CC-22, CC-115, CC-122 and Oral Azacitidine. It owns and operates a manufacturing facility in Zofingen, Switzerland. The Company also owns and operates a drug product manufactur ing facility in Boudry, Switzerland.
Commercial! Stage Products
REVLIMID (lenalidomide) is an oral immunomodulatory drug marketed in the United States and many international markets, in combination with dexamethasone, for treatment of patients with multiple myeloma who have received at least one prior therapy. It is also marketed in the United States and certain international markets for the treatment of transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is distributed in the United States through contracted pharmacies under the RevAssist program, which is a risk-management distribution program. Internationally, REVLIMID is distributed under mandatory risk-management distribution programs.
REVLIMID continues to be evaluated in numerous clinical trials worldwide either alone or in combination with one or more other therapies in the treatm ent of a range of hematological malignancies, including multiple myeloma (MDS) various lymphomas, chronic lymphocytic leukemia (CLL) other cancers and other diseases. VIDAZA (azacitidine for injection) is a pyrimidine nucleoside. VIDAZA is a Category 1 recommended treatment for patients with intermediate-2 and high-risk MDS and is marketed in the United States for the treatment of all subtypes of MDS. In Europe, VIDAZA is marketed for the treatment of intermediate-2 and high-risk MDS, as well as acute myeloid leukemia (AML) with 30% blasts and has been granted orphan drug designation for the treatment of MDS and AML.
THALOMID (thalidomide) is marketed for patients with newly diagnosed multiple myeloma and for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) an inflammatory complication of leprosy and as maintenance therapy for prevention and suppression of the cutaneous manifestation of ENL recurrence. THA LOMID is distributed in the United States under its System f! or Thalid! omide Education and Prescribing Safety (S.T.E.P.S.) program. Internationally, THALOMID is also distributed under mandatory risk-management distribution programs. ABRAXANE (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free chemotherapy treatment option for metastatic breast cancer, which was developed using its nab technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin. As of December 31, 2011, ABRAXANE was in various stages of investigation for the treatment of expanded applications for metastatic breast; non-small cell lung; malignant melanoma; pancreatic; bladder and ovarian.
ISTODAX (romidepsin) has received orphan drug designation for the treatment of non-Hodgkin’s T-cell lymphomas, which includes CTCL and PTCL. The Company has licensed the worldwide rights (excluding Canada) regarding certain chirally pure forms of methylphenidate for FOCALIN and FOCALIN XR to Novartis. It also licensed to N ovartis the rights related to long-acting formulations of methylphenidate and dex-methylphenidate products which are used in FOCALIN XR and RITALIN LA.
Preclinical and Clinical-Stage Pipeline
The product candidates in the Company’s pipeline are at various stages of preclinical and clinical development. Pomalidomide is a small molecule that is orally available and modulates the immune system and other biologically important targets. Pomalidomide is being evaluated in a phase III clinical trial for the treatment of myelofibrosis and a phase III clinical trial evaluating pomalidomide as a treatment for patients with relapsed/refractory multiple myeloma is accruing patients.
The Company is developing a product, ORAL ANTI-INFLAMMATORY AGENTS, which is orally available small molecules that target PDE4, an intracellular enzyme that modulates the production of multiple pro-inflammatory and anti-inflammatory mediators, including interleukin-2 (IL-2), IL-10, IL-12, IL-23, INF-gamma, TNF-a, leukotrienes,! and nitr! ic oxide synthase. Its investigational drug, apremilast (CC-10004), is used for the treatment of moderate to severe psoriasis and active psoriatic arthritis and is being evaluated in a phase II trial for rheumatoid arthritis and six phase III multi-center international clinical trials. In addition, it is investigating its oral PDE4 inhibitor, CC-11050, which is an anti-inflammatory compound that treat a variety of chronic inflammatory conditions, such as Cutaneous Lupus Erythematosus (CLE).
The Company’s oral kinase inhibitor platform includes inhibitors of the c-Jun N-terminal kinase (JNK) mTOR kinase, spleen tyrosine kinase (Syk) c-fms tyrosine kinase (c-FMS) and DNA-dependent protein kinase (DNAPK). Its oral Syk, c-FMS and DNAPK kinase inhibitors are being investigated in pre-clinical studies. The Company’s new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis a nd a phase II trial for the treatment of discoid lupus is accruing patients. Amrubicin is a third-generation fully synthetic anthracycline molecule with potent topoisomerase II inhibition.
At Celgene Cellular Therapeutics (CCT), it is researching stem cells derived from the human placenta, as well as from the umbilical cord. CCT is the Company’s research and development division. Stem cell based therapies provide disease-modifying outcomes for serious diseases, which lack adequate therapy. It has developed technology for collecting, processing and storing placental stem cells with broad therapeutic applications in cancer, auto-immune diseases, including Crohn’s disease, multiple sclerosis, neurological disorders, including stroke and amyotrophic lateral sclerosis (ALS), graft-versus-host disease, and other immunological / anti-inflammatory, rheumatologic and bone disorders.
The Company has collaborated with Acceleron Pharma, Inc. (Acceleron) to de velop sotatercept. Two phase I clinical studies have been co! mpleted. ! An additional phase II clinical study has been initiated and is ongoing related to treatments for end-stage renal anemia and to evaluate effects on red blood cell mass and plasma volume.
The Company competes with Abbott Laboratories, Amgen Inc. (Amgen), AstraZeneca PLC., Biogen Idec Inc., Bristol-Myers Squibb Co., Eisai Co., Ltd., F. Hoffmann-LaRoche Ltd., Johnson and Johnson, Merck and Co., Inc., Novartis AG, Pfizer, Sanofi and Takeda Pharmaceutical Co. Ltd. (Takeda).
- [By DailyFinance Staff]
Stocks bounced in and out of the plus column before picking a direction on Friday. Unfortunately, the path chosen was down again, though not far. The Dow Jones industrial average (^DJI) extended its losing streak to five days, dropping another 43 points. The Standard & Poor’s 500 (^GSPC) fell 5 and the Nasdaq composite (^IXIC) lost 15 points. In all, each of the major averages lost in the neighborhood of a quarter of a percent Friday, and all lost ground for the week. Meanwhile, another once-popular teen retailer took a tumble. Shares of Aeropostale (ARO) tumbled 20 percent after the retailer posted a wider than expected quarterly loss. The stock is now down 60 percent over the past year. But investors were buying some other retailers. Zumiez (ZUMZ), also geared toward teens, rose 2½ percent despite forecasting a loss in the current quarter. A couple of chains geared toward women did well. Ulta Salon (ULTA) gained nearly 6½ percent as earnings topped expectations. Ann (ANN), best known for its Ann Taylor stores, rose 7½ percent. And Coach (COH) gained 2 percent. Other gainers today: Green Mountain (GMCR), maker of Keurig, was up 7 percent, after expanding its deal with Starbucks. Liberty Media (LSTZA) ended its deal to buy those shares of Sirius XM (SIRI) it doesn’t already own. Both stocks gained on the news; Liberty up 7 percent, Sirius up 2 percent. And Castlight Health (CSLT) soared nearly 150 percent above its $16 a share IPO price. The company, which helps workers choose healthcare benefits, stands to gain from Obamacare. On the downside: Tesla (TSLA) lost another 3 percent on reports that New York could become the fifth state to block the company from selling direct to consumers. Still, Tesla has a pretty good track record. It’s stock has soared more than 500 percent over the past year. Biotechs continued to lose ground. Celgene (CELG) fell 4 percent on a double dose of bad news. British regulators reportedly plan to rejec
- [By Ben Levisohn]
Shares of Gilead (GILD) and Celgene (CELG) have tumbled today after both companies revealed that they were facing patent pressures.
For Gilead, Idenix Pharmaceuticals (IDIX) filed a patent-infringement lawsuit that appears to target Gilead’s Sovaldi (someone please correct me if I’m wrong). For Celgene, it was the decision of a New Jersey court to schedule a hearing on a patent case for April 29, earlier than expected. It hasn’t helped that the UK’s National Institute for Health and Care Excellence also said that Celgene’s Revlimid doesn’t work well enough to be covered for “second line treatment of multiple myeloma.”
- [By Ben Levisohn]
Shares of Gilead Sciences has dropped 1.3% to $81.52 at 10:33 a.m., while Amgen (AMGN) has fallen 0.3% to $123.78, Biogen Idec (BIIB) has gained 0.8% to $331.07 and Celgene (CELG) has risen 1.1% to $166.59. The SPDR S&P Biotech ETF (XBI) has advanced 0.6% to $153.43.
Top 5 Biotech Companies To Buy For 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 trea tment 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.
- [By Jake L’Ecuyer]
Clovis Oncology (NASDAQ: CLVS) was also up, gaining 7.26 percent to $79.35 after the company announced 2014 objectives and financial outlook. The company projected to initiate three global registration studies for CO-1686.
- [By John Udovich]
On Wednesday, small cap cancer stock Clovis Oncology Inc (NASDAQ: CLVS) soared 16.68% after announcing a $200 million cancer deal plus the biotech has more than tripled since late 2011, meaning it might be time to take a closer look at what’s driving the stock higher as well as look at the performance of biotech ETF benchmarks like iShares NASDAQ Biotechnology Index ETF (NASDAQ: IBB) and SPDR S&P Biotech ETF (NYSEARCA: XBI).
- [By John Udovich]
Bubble talk, biotech IPO setbacks plus news about small cap biotechs like Intrexon Corp (NYSE: XON) and TNI BioTech (OTCMKTS: TNIB) have dominated biotech news this week or in recent weeks. Just consider the following news:
Why There is No Biotech Bubble & Where to Look for Value in Biotech. Marshall Gordon, the Director and senior health-care analyst of ClearBridge Investments, was recently interviewed by Barron’s where he stated his belief that there is no biotech bubble because biotech stocks have delivered new drugs and have shown an ability to innovate. With that said, he added that the sector got ahead of itself while some biotechs suffered setbacks plus hedge funds decided to trim risk from their portfolios. Nevertheless, Marshall likes or is watching mid cap biotechs BioMarin Pharmaceutical Inc (NASDAQ: BMRN) and Pharmacyclics, Inc (NASDAQ: PCYC) along with small cap biotechs Pacira Pharmaceuticals Inc (NASDAQ: PCRX) and Clovis Oncology Inc (NASDAQ: CLVS). He also added that recent biotech IPOs have been lesser quality names than earlier offerings. A Trio of Biotech IPO Setbacks. FierceBiotech has summarized how a trio of biotech IPO have suffered setbacks. Specifically, Relypsa (NASDAQ: RLYP), a late-stage biotech developing a treatment for hyperkalemia, slashed its asking price on 6.9 million shares to $12 a share to raise $82 million from a range of $16 to $19 a share while Xencor (NASDAQ: XNCR), a biotech developing antibodies for severe autoimmune/allergic diseases and cancer, has dropped its IPO price to $7 a share to raise $75 million from a range of $14 to $16. Meanwhile, Celladon, which is developing a first-in-class gene therapy for patients with systolic heart failure, has postponed its IPO citing poor market conditions. Coming Biotech IPOs. Nevertheless, FierceBiotech has noted that GeNO Healthcare (NASDAQ: GNO) is looking to raise $50 million for its new, patient-friendly approach for delivering inhaled nitric oxide on the
- [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.
Top 5 Biotech Companies To Buy For 2014: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company’s other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company’s distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursua nt to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA is a programmed release for mulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
- [By Jake L’Ecuyer]
Leading and Lagging Sectors
Wednesday morning, the healthcare sector proved to be a source of strength for the market. Leading the sector was strength from Horizon Pharma (NASDAQ: HZNP) and Pernix Therapeutics Holdings (NASDAQ: PTX). In trading on Wednesday, telecommunications services shares were relative laggards, down on the day by about 0.39 percent. Top decliners in the sector included Shenandoah Telecommunications Co (NASDAQ: SHEN), off 3.3 percent, and CalAmp (NASDAQ: CAMP), down around 2.4 percent.
- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares reached a new 52-week high of $17.12 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares gained 24.15% to $18.23 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Monica Gerson]
Horizon Pharma (NASDAQ: HZNP) shares dropped 5.29% to $12.90 in pre-market trading after the company reported Q4 results. Horizon Pharma posted a quarterly loss of $0.04 per share on revenue of $30.10 million. However, analysts were expecting a loss of $0.08 per share on revenue of $32.18 million.