The most important stake that you’ll drive into the ground in support of your company’s foundation should be comprised of your core values. But what exactly are these core values, and when it comes to developing them, who precisely should they be created for?
Rather than thinking of them as a client-facing marketing tool, your core values should be almost entirely “inward-focused,” meaning they should be designed to reinforce the internal principles that promote ethical business practices and consistent professionalism throughout your firm.
In this way, your core values are an aquifer through which each decision made by you or your associates can be vetted.
Top 5 Medical Companies To Invest In 2014: Inovio Pharmaceuticals Inc (INO)
Inovio Pharmaceuticals, Inc., incorporated on June 29, 1983, is engaged in the development of a new generation of vaccines, called synthetic vaccines, focused on cancers and infectious diseases. The Company’s SynCon technology enables the design of universal vaccines capable of providing cross-protection against existing or changing strains of pathogens, such as influenza and human immunodeficiency virus (HIV). The Company’s electroporation delivery technology uses brief, controlled electrical pulses to increase cellular uptake of the vaccine. Its clinical programs include cervical dysplasia (therapeutic), avian influenza (preventive), prostate cancer (therapeutic), leukemia (therapeutic), hepatitis C virus (HCV) and HIV vaccines. It is advancing preclinical research and clinical development for a universal seasonal/pandemic influenza vaccine, as well as preclinical work for other products, including malaria and prostate cancer vaccines. Its partners and collaborators incl ude University of Pennsylvania, Drexel University, National Microbiology Laboratory of the Public Health Agency of Canada, Program for Appropriate Technology in Health/Malaria Vaccine Initiative (PATH/MVI), National Institute of Allergy and Infectious Diseases (NIAID), Merck, ChronTech, University of Southampton, United States Military HIV Research Program (USMHRP), the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and HIV Vaccines Trial Network (HVTN). As of December 31, 2011 it owned 16.1% interest in VGX Int’l.
The Company’s synthetic vaccine platform consists of its SynCon vaccine design process and electroporation delivery technology. It has developed a preclinical and clinical stage pipeline of vaccines. The Company’s synthetic vaccines are designed to prevent a disease (prophylactic vaccines) or treat an existing disease (therapeutic vaccines). Its synthetic vaccine consists of a deo xyribonucleic acid (DNA) plasmid encoding a selected antigen! (s), which is introduced into cells of humans or animals with the purpose of evoking an immune response to the encoded antigen. The Company’s synthetic vaccines are designed to generate specific antibody and/or T-cell responses.
The Company’s SynCon technology provides processes that employ bioinformatics, which combine extensive genetic data and sophisticated algorithms. Its design process uses the genetic make-up of a common antigen(s) from multiple strains of a virus within a viral sub-type or taxonomic group (family) of pathogens, such as HIV, hepatitis C virus (HCV), human papillomavirus (HPV), influenza and other diseases to synthetically create a new antigen for the desired pathogen target that does not exist in nature. Its synthetic vaccine candidates are being delivered into cells of the body using its electroporation (EP) DNA delivery technology.
Cancer Synthetic Vaccines
The Company has two broad types of cancer vaccines : preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people, and treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body’s natural defenses against the cancer. Two types of cancer preventive vaccines are available in the United States. The United States Food and Drug Administration (the FDA) has approved two vaccines, Gardasil and Cervarix that protect against infection by the two types of HPV-types 16 and 18-that cause approximately 70% of all cases of cervical cancer worldwide. In addition, Gardasil protects against infection by two additional HPV types, 6 and 11, which are responsible for about 90% of all cases of genital warts in males and females but do not cause cervical cancer.
Cervarix manufactured by GlaxoSmithKline, is composed of virus-like particles (VLPs) made with proteins from HPV types 16 and 18. Cervarix is approved for use in females’ a ges 10 to 25 for the prevention of cervical cancer caused by! HPV type! s 16 and 18. Gardasil manufactured by Merck, is approved for use in females for the prevention of cervical cancer, and some vulvar and vaginal cancers, caused by HPV types 16 and 18 and for use in males and females for the prevention of genital warts caused by HPV types 6 and 11. The vaccine is approved for these uses in females and males ages 9 to 26. The FDA has also approved a cancer preventive vaccine that protects against hepatitis B virus (HBV) infection.
Inovio’s VGX-3100 is designed to raise immune responses against the E6 and E7 genes of HPV types 16 and 18 that are present in both pre-cancerous and cancerous cells transformed by these HPV types. E6 and E7 are oncogenes that play an integral role in transforming HPV-infected cells into cancerous cells. In March 2011, it initiated a randomized, double-blind Phase II study of VGX-3100 delivered using the CELLECTRA intramuscular electroporation device in women with HPV Type 16 or 18 and diagnosed with, but not yet treated for, cervical intraepithelial neoplasia (CIN) 2/3. The study is designed to enroll 148 subjects. In January 2011, it announced the publication of a scientific paper in the journal Human Vaccines detailing potent immune responses in a preclinical study of its SynCon vaccine for prostate cancer targeting two antigens, prostate specific antigen (PSA) and prostate specific membrane antigen (PSMA).
In January 2011, the Company announced the regulatory approval of a Phase II clinical trial (WIN Trial) to treat leukemia utilizing its new ELGEN 1000 automated vaccine delivery device. The single dose level, Phase II study, called WT1 immunity via DNA fusion gene vaccination in haematological malignancies by intramuscular injection followed by intramuscular electroporation. Cancer Vaccines encodes for hTERT, an antigen related to non-small cell lung, breast and prostate cancers. The vaccine is delivered using its electroporation delivery technology.
Infectious Disease Synthetic Vaccines
In Marc! h 2011, the Company announced the initiation of a follow-on open label, single dose Phase II clinical study in collaboration with ChronTech of the ChronVac-C HCV DNA vaccine delivered using its electroporation technology in treatment naive HCV infected individuals. Its HIV vaccines consist of candidates for HIV prevention, as well as therapy or treatment. PENNVAX-B is designed to target HIV clade B (most commonly found in the United States, North America, Australia and the European Union (EU). PENNVAX-G is designed to target HIV clades A, C and D, which are more commonly found in Asia, Africa, Russia and South America. This Phase I clinical study of PENNVAX-B (HVTN-080) vaccinated 48 healthy, HIV-negative volunteers to assess safety and levels of immune responses generated by Inovio’s PENNVAX-B vaccine delivered with its CELLECTRA electroporation device. PENNVAX-B is a SynCon vaccine that targets HIV gag, pol, and env proteins.
The Company’s VGX-3400X targe ts H5N1. The vaccine consists of three distinct DNA plasmids coded for a consensus hemagglutinin (HA) antigen derived from different H5N1 virus strains; a consensus neuraminidase (NA) antigen derived from different N1 sequences; and a consensus nucleoprotein (NP) fused to a small portion of the m2 protein (m2E) based on a broader cross-section of influenza viruses in addition to H5N1 and H1N1. Conventional vaccines are strain-specific and have limited ability to protect against genetic shifts in the influenza strains they target. They are therefore modified annually in anticipation of the next flu season’s new strain(s). It is focused on developing DNA-based influenza vaccines able to provide broad protection against known as well as newly emerging, unknown seasonal and pandemic influenza strains.
VGX Animal Health, Inc. (VGX AH), a majority-owned subsidiary, has licensed LifeTide, a plasmid-based growth hormone releasing hormone (GHRH) technology for swine. LifeTide is one of onl! y four DN! A-based treatments approved for use in animals and is the only DNA-based agent delivered using electroporation that has been granted marketing approval (Australia). VGX AH is also developing a GHRH-based treatment for cancer and anemia in dogs and cats. It is developing a synthetic vaccine for foot-and-mouth disease (FMD) administered by its vaccine delivery technology. The FMD virus is one of the most infectious diseases affecting farm animals, including cattle, swine, sheep and goats, and is a serious threat to global food safety.
The Company competes with Crucell N.V, Sanofi-Aventis, Novartis, Inc., GlaxoSmithKline plc, Merck, Pfizer, AstraZeneca, Inc., Novartis, Inc., MedImmune and CSL.
- [By MONEYMORNING]
Inovio Zooms: We recommended biotech Inovio Inc. (NYSE: INO) at 71 cents a share back on Feb. 1, 2013, and have re-recommended it a number of times since. With their 15.2% gain yesterday, the shares are now at $3.71, up 414% from where we first told you about them – and we believe there’s more to come. In fact, we’ll be bringing you an interesting update on this company very soon. Inovio is one of 24 recommendations that have doubled or better since we launched Private Briefing back in August 2011
- [By Jake L’Ecuyer]
Equities Trading DOWN
Shares of Inovio Pharmaceuticals (NYSE: INO) were down on Friday’s session, falling 13.28 percent to $2.488 despite seemingly little news on the company.
- [By George Budwell]
Inovio Pharmaceuticals (NYSEMKT: INO ) develops DNA-based vaccines and delivers them using a proprietary electroporation technique. Shares of Inovio have been a roller coaster all year long, and have certainly been the playground of day traders. Last week, Inovio shares lost more than 10% of their value on heavy volume, suggesting the stock may continue to experience downward pressure. This rapid move downward is surprising because the company recently signed a licensing deal with Roche (NASDAQOTH: RHHBY ) to commercialize Inovio’s multi-antigen DNA immunotherapies for prostate cancer and hepatitis B. As part of the deal, Inovio received $10 million upfront, and milestone payments could go as high as $412 million.
Top 5 Medical Companies To Invest In 2014: KYTHERA Biopharmaceuticals Inc (KYTH)
KYTHERA Biopharmaceuticals, Inc., incorporated in June 2004, is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of prescription products for the aesthetic medicine market. The Company’s initial focus is on the facial aesthetics market. The Company’s product candidate, ATX-101, is a injectable drug in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable double chin. Based on clinical trials conducted, ATX-101 has exhibited results in the reduction of submental fat. ATX-101 contains a synthetic form of sodium deoxycholate. In the United States and Canada, the Company is conducting two pivotal Phase III trials of ATX-101 for the reduction of submental fat. The Company initiated this pivotal Phase III clinical program, with planned enrollment of 1,000 patients, in March 2012.
In Europe, Bayer, its collaborator outside the United States and Canada, rec ently completed two pivotal Phase III trials of ATX-101 for the reduction of submental fat. In these multi-center, randomized, double-blind, placebo-controlled pivotal trials involving 723 patients, ATX-101 resulted in a reduction in submental fat, as assessed by a validated clinician scale and a patient satisfaction scale.
ATX-101 contains a synthetic form of sodium deoxycholate. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Upon subcutaneous injection under the skin, ATX-101 disrupts cell membranes in protein-poor tissues, such as fat, while being attenuated by interactions with protein-rich tissue, such as skin, muscle and blood vessels. This attenuation by protein-rich tissue results in the preferential destruction of adipocytes by ATX-101. The destruction of adipocytes, or adipocytolysis, elicits a natural response, in which macrophages are attracted to remove cellular debris and fat particles t! hrough the lymphatic system. The macrophages also emit low levels of chemical messengers, known as cytokines, which attract fibroblasts, another cell type, to the area. Fibroblasts produce collagen, and it is believed that new collagen production, or neocollagenesis, promotes retraction of the skin in the areas of fat reduction. The fat removal process with ATX-101 is incremental with each treatment, thereby allowing for control of the aesthetic outcome.
- [By Roberto Pedone]
One stock that’s quickly moving within range of triggering a major breakout trade is Kythera Biopharmaceuticals (KYTH), which is focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. This stock has been on a bullish run in 2013, with shares up by 48%.
If you take a look at the chart for Kythera Biopharmaceuticals, you’ll notice that this stock has been trending sideways and consolidating for the last month, with shares moving between $40.55 on the downside and $47.85 on the upside. Shares of KYTH are now starting to spike higher off some near-term support at $42.54 a share. That move is quickly pushing KYTH within range of triggering a major breakout trade above the upper-end of its recent range.
Traders should now look for long-biased trades in KYTH if it manages to break out above some near-term overhead resistance at $47.50 to its all-time high of $47.85 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 199,029 shares. If that breakout hits soon, then KYTH will set up to enter new all-time high territory, which is bullish technical price action. Some possible upside targets off that breakout are $55 to $57, or even $60 a share.
Traders can look to buy KYTH off any weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support at $42.54 a share, or at $40.55 a share. One can also buy KYTH off strength once it takes out those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By John Udovich]
On Tuesday, small cap biotech stock Kythera Biopharmaceuticals Inc (NASDAQ: KYTH) surged around 25% after announcing that its ATX-101 REFINE-1 and REFINE-2 Phase III trials met all primary and secondary endpoints for the reduction of so-called double chins; but if investors missed out on that rally, small caps Zeltiq Aesthetics Inc (NASDAQ: ZLTQ), Solta Medical Inc (NASDAQ: SLTM) and Cynosure, Inc (NASDAQ: CYNO) each have a piece of the aesthetic market as well. In the case of Kythera Biopharmaceuticals, its ATX-101 can be injected to deal with double chins – meaning its less invasive than liposuction as the drug dissolves fat cells but leaves other tissue alone. JP Morgan has noted:
Top 5 Medical Companies To Invest In 2014: Compugen Ltd.(CGEN)
Compugen Ltd. operates as a drug and diagnostic discovery company based on computer-based discovery capabilities to predict and select novel product candidates. Through in silico prediction and selection, the resulting novel molecules are synthesized and validated utilizing traditional in vitro and in vivo experimental procedures. The company provides these validated product candidates to pharmaceutical, biotech, and diagnostic companies under licensing and other commercialization arrangements. Its research and discovery efforts are focused primarily on therapeutic proteins and peptides, and monoclonal antibodies, and primarily in the fields of immunology and oncology. Its therapeutic peptide and protein related platforms include Protein Family Members Discovery Platform, Protein-Protein Interaction Blockers, GPCR Therapeutic Peptide Ligands, Disease-Associated Conformation Blockers, Intracellular Drug Delivery, Viral Peptides, and Splice Variant based Therapeutic Proteins . The company?s monoclonal antibody related platforms comprise Monoclonal Antibody Targets. Its other therapeutic and diagnostic platforms consist of Nucleic-Acid Disease Markers, Protein Disease Markers, Nucleic-Acid Preclinical Toxicity Markers, Non-SNP Drug Response Markers, and New Indications. Its therapeutic peptide and protein product candidates comprise CGEN-15001, a novel protein for the treatment of autoimmune disorders; CGEN-25017, a novel peptide antagonist of the Angiopoietin/Tie-2 pathway; CGEN-855, a peptide agonist of the FPRL1 GPCR receptor; CGEN-856 and CGEN-857, which are MAS GPCR peptide agonists; CGEN-25007, an antagonist of the gp96 protein; and CGEN-25009, a peptide of the LGR7 receptor. The company also offers monoclonal antibody target product candidates, including CGEN-671, a drug for multiple epithelial tumors; CGEN-928, a drug for multiple myeloma; and CGEN-15001T, a novel B7/CD28 family member. Compugen Ltd. was founded in 1993 and is based in T e l Aviv, Israel.
- [By Lisa Levin]
Compugen (NASDAQ: CGEN) climbed 3.54% to $11.86 after Jefferies initiated coverage on the stock with a Buy rating and a $17.00 price target.
Posted-In: market moversNews Intraday Update Markets Movers
- [By Sean Williams]
On Monday, small-cap biotechnology company Compugen (NASDAQ: CGEN ) gave investors something to cheer about when it announced a collaboration and licensing agreement with Bayer for two of its antibody-based immunotherapies. The deal could be worth as much as $540 million for Compugen and gives the company $10 million upfront, as well as the potential for $30 million more in milestone payments during preclinical trials. The two companies will co-develop these drugs, with Bayer getting worldwide rights upon commercialization (though Compugen would still receive a mid- to high-single-digit royalty). This is great news for Compugen, as it solves the problem of seeking out a partner later, helps reduce its clinical testing costs, and staves off the need to dilute shareholders with a secondary offering to raise cash. Shares added 44% this week.
Top 5 Medical Companies To Invest In 2014: Redhill Biopharma Ltd (RDHL)
Redhill Biopharma Ltd. is an Israel-based biopharmaceutical company. The Company is focused on the development and acquisition of therapeutic candidates. The Company’s pipeline consists of six late clinical development therapeutic candidates, two of which have completed bioequivalence clinical trials subject to review and approval by the United States Food and Drug Administration and, in some cases, regulatory authorities in other countries. The Company’s six clinical stage therapeutic candidates include RHB-101, RHB-102, RHB-103, RHB-104, RHB-105 and RHB-106.
RHB-101 is a treatment of hypertension, heart failure and left ventricular dysfunction (following myocardial infraction) by means of controlled release of an active ingredient known as carvedilol, which is designed to be administered to patients on a once-daily basis. RHB-101 is based on a patented technology for the controlled release of drugs administered orally.
RHB-102 is a once-daily controlled release oral formulation of ondansetron. RHB-102 utilizes a technology called CDT that uses salts to provide a controlled release of ondansetron.
RHB-103 is an oral thin film formulation of rizatriptan intended for the treatment of acute migraine headaches. Migraine is a neurovascular disorder (related to nerves and blood vessels) characterized by recurrent headaches in one side or both sides of the head.
The product is based on a technology called VersaFilm.
RHB-104 is an antibiotic combination therapy for the treatment of Crohn’s disease (with a PIII clinical study underway), as well as Multiple Sclerosis (with an ongoing PIIa clinical study) and Rheumatoid Arthritis. RHB-104 is a combination of clarithromycin, clofazimine and rifabutin, three generic antibiotic ingredients, in a single capsule.
RHB-105, an antibiotics and proton pump inhibitor drug targeting Helico! bacter Pylori infection. RHB-105 is a combination of three approved drug products omeprazole, which is a proton pump inhibitor (the natural body pump that produces the gastric acids used for digesting the food in the stomach), and amoxicillin and rifabutin which are antibiotics. Chronic infection with Helicobacter pylori irritates the mucosal lining of the stomach and small intestine.
RHB-106, is a tablet for the preparation and cleansing of the gastrointestinal tract prior to the performance of abdominal procedures. Its abdominal procedures include diagnostic tests, such as colonoscopy, barium enema or virtual colonoscopy, as well as surgical interventions, such as laparotomy.
The company competes with GlaxoSmithKline, Sanofi-Aventis Groupe, Hoffman-La Roche Ltd, Merck and Co., Inc, Ferring Pharmaceuticals and Salix Pharmaceuticals Inc.
- [By Monica Gerson]
Vitran Corporation (NASDAQ: VTNC) announced today that it has entered into a definitive arrangement agreement with TransForce pursuant to which TransForce has agreed to acquire all of the outstanding common shares of Vitran not already owned by TransForce for US$6.50 in cash per share, in accordance with TransForce’s prior proposal. To read the full news, click here. ReneSola (NYSE: SOL) today announced it signed a Memorandum of Intent (MOI) to sell three utility-scale projects in Western China, with a total capacity of 60MW, to Jiangsu Akcome Solar Science & Technology Co on December 30, 2013. To read the full news, click here. Cooper Tire & Rubber Company (NYSE: CTB) today announced it has terminated the merger agreement with Apollo Tyres (NSE:ApolloTYRE). To read the full news, click here. RedHill Biopharma (NASDAQ: RDHL) today announced that it has entered into a definitive agreement with leading healthcare investor OrbiMed Israel Partners Limited Partnership, an affiliate of OrbiMed Advisors LLC, for the sale of RedHill’s American Depository Shares and warrants in a private placement transactionor a total sum of $6.0 million. To read the full news, click here.
Posted-In: Guggenheim US Stock FuturesNews Eurozone Futures Global Pre-Market Outlook Markets
Top 5 Medical Companies To Invest In 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 Mani]
Shares of Celgene Corporation (NASDAQ:CELG) are down 13 percent year-to-date, and sentiment has been relatively weak ahead of the FDA’s action date for Celgene’s Otezla (apremilast).
- [By Susan J. Aluise]
IBB’s top five holdings — which currently comprise about 36% of its total assets — are Biogen (BIIB), Gilead Sciences (GILD), Amgen (AMGN), Regeneron Pharmaceuticals (REGN) and Celgene (CELG). It’s also a fairly cheap way to invest in biotech stocks, with expenses just running 0.48% for exposure to IBB has gained 65% over the past year and its expense ratio is on par with the rest of the sector at 0.48.
- [By Ben Levisohn]
Today’s selloff started when three Democratic Party congressmen challenged Gilead Sciences (GILD) pricing of its hepatitis C-drug Sovaldi. The indiscriminate selling of biotech stocks–Biogen Idec (BIIB), Celgene (CELG) and Regeneron (REGN) all dropped at least 3.7%–suggests that investors have itchy trigger fingers, says Bernstein’s Geoffrey Porges and team:
- [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