In the last reported quarter, the medical device major posted break-even earnings surprise. An improved operating margin on the back of the company�� restructuring efforts to streamline the underlying business helped offset declining organic revenue growth.
Factors to Consider This Quarter
We are primarily concerned about St. Jude�� declining top line. The core Cardiac Rhythm Management (CRM) division continues to face multiple headwinds. A still choppy U.S. defibrillator market remains an overhang on St. Jude, as reflected by sustained implant volume pressure. Additionally, we remain cautious about increased competition, pricing pressure, softness in cardiovascular sales along with currency fluctuations.
Meanwhile, we expect growth in international revenues to boost overall sales of the company. New growth drivers such as an innovative product line along with restructuring efforts to streamline the underlying business will likely be accretive for STJ in the long term. The company has received a number of regulatory approvals for its latest offerings as well as initiated a number of clinical trials in the second quarter, which is encouraging.
10 Best Medical Stocks To Own For 2014: Rexahn Pharmaceuticals Inc (RNN)
Rexahn Pharmaceuticals, Inc. (Rexahn) is a development-stage biopharmaceutical company. The Company focuses on the development of cures for cancer to patients worldwide. The Company�� pipeline features one drug candidate in Phase II clinical trials. The Company also has several other drug candidates in pre-clinical development. In addition, the Company has two renal cell carcinoma (CNS) candidates, Serdaxin, CNS Disorders drug for depression and neurodegenerative diseases and Zoraxel, which is a erectile dysfunction (ED) and sexual dysfunction drug that are in clinical stages and the Company is are exploring options for further development . The Company�� drug candidate, Archexin is an anticancer Akt inhibitor.
Archexin
Archexin is potent inhibitor of the Akt protein kinase (Akt) in cancer cells. Archexin has FDA orphan drug designations for five cancers (RCC, glioblastoma, and cancers of the ovary, stomach and pancreas). Multiple indications for other solid tumors can also be pursued. Archexin inhibit both activated and inactivated forms of Akt, and to reverse the drug resistance observed with the protein kinase inhibitors. Archexin is an antisense oligonucleotide (ASO) compound that is complementary to Akt mRNA, and selective for inhibiting mRNA expression and production of Akt protein. As of December 31, 2011, Archexin was in Phase II clinical trials for the treatment of pancreatic cancer with enrollment completed in September, 2011.
Serdaxin
Serdaxin is an extended release formulation of clavulanic acid, which is an ingredient present in antibiotics approved by the FDA. The Company had been developing Serdaxin for the treatment of depression and neurodegenerative disorders. From January to September, 2011, the Company conducted a randomized, double-blind, placebo-controlled study compared two doses of Serdaxin, 0.5 milligram and 5 milligram, to placebo over an eight-week treatment period for major depressive disorder (MDD) patients. As of Dec! ember 31, 2011, the Company had not made a determination of Serdaxin�� future paths or resource allocations to further develop Serdaxin to treat MDD.
Zoraxel
Zoraxel is an orally administered, on-demand tablet to treat sexual dysfunction. Zoraxel is a dual enhancer of neurotransmitters in the brain that play a key role in sexual activity phases of motivation and arousal, erection and release, and may be the ED drug to affect all three of these phases of sexual activity. As of December 31, 2011, the Company was evaluating how to proceed with the Phase IIb study of Zoraxel.
The Company�� Pre-clinical Pipeline Drug Candidates includes RX-1792, which is a small molecule anticancer EGFR inhibitor; RX-5902, which is a small molecule anticancer ribonucleic acid (RNA) helicase regulator; RX-3117, which is a Small molecule anticancer deoxyribonucleic acid (DNA) synthesis Inhibitor; RX-8243, which is a small molecule anticancer aurora kinase inhibitor; RX-0201-Nano, which is a nanoliposomal anticancer Akt inhibitor; RX-0047-Nano, which is an nanoliposomal anticancer HIF-1 alpha inhibitor and RX-21101, which is a nano-polymer Anticancer.
Advisors' Opinion:- [By Roberto Pedone]
One under-$10 biopharmaceutical player that's just starting to move into breakout territory is Rexahn Pharmaceuticals (RNN), which is engaged in the development of novel treatments for cancer to patients. This stock has been on fire so far in 2013, with shares up sharply by 62%.
If you take a look at the chart for Rexahn Pharmaceuticals, you'll notice that this stock has been uptrending strong for the last month, with shares moving higher from its low of 36 cents per share to its intraday high of 53 cents per share. During that uptrend, shares of RNN have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of RNN into breakout territory above some near-term overhead resistance levels at 49 cents to 50 cents per share. It's worth noting that volume today is tracking in extremely strong with over 3 million shares traded, versus its three-month average action of 1.22 million shares.
Traders should now look for long-biased trades in RNN if it manages to break out above Thursday's intraday high of 53 cents per share with high volume. Look for a sustained move or close above that level with volume that hits near or above its three-month average action of 1.22 million shares. If that breakout hits soon, then RNN will set up to re-test or possibly take out its next major overhead resistance levels at 64 cents to its 52-week high at 66 cents per share. Any high-volume move above 66 cents to 67 cents per share could then send RNN towards its next major overhead resistance levels at 81 cents per share.
Traders can look to buy RNN off any weakness to anticipate that breakout and simply use a stop that sits right below its 50-day moving average at 47 cents per share. One can also buy RNN off strength once it clears 53 cents per share with volume and then simply use a stop that sits a comfortable percentage from your entry point.
- [By James E. Brumley]
With just a quick glance at a chart of Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN), it would be easy to conclude it's nothing but a volatile mess. When you take a step back and look at a long-term weekly chart of RNN, however, it starts to become clear that this small cap biopharma name is on the verge of a monster-sized breakout. First things first, however.
10 Best Medical Stocks To Own For 2014: Scancell Holdings PLC (SCLP)
Scancell Holdings PLC is a United Kingdom-based company. The Company�� principal activity of the consists of the discovery and development of monoclonal antibodies and vaccines for the treatment of cancer. In April 2012, the Company completed recruitment to the Phase 1 clinical trial of SCIBI. In May 2012, the Company commenced recruitment and treatment of the first patient in the second part of it Phase 1/2 clinical trial of SCIBI. The Phase 2 part of the trial is conducted in five United Kingdom centers in Nottingham, Manchester, Newcastle, Leeds, and Southampton. On August 15, 2012, the Company announced the development of a platform technology, Moditope.Top Penny Companies To Watch For 2014: Elan Corporation PLC (ELN)
Elan Corporation, plc (Elan), incorporated in December 1969, is a neuroscience-based biotechnology company. The Company is focused on discovering and developing advanced therapies in neurodegenerative and autoimmune diseases. Elan�� business focuses on neurodegenerative diseases, such as Alzheimer�� disease and Parkinson�� disease; autoimmune diseases, including MS and Crohn�� disease and neo-epitope based targets for treatments across a range of therapeutic indications. Tysabri is a treatment for MS and Crohn�� disease that the Company markets and distributes with Biogen Idec. On September 16, 2011, Elan sold its EDT business to Alkermes, Inc. In November 2011, Elan launched a collaboration with the University of Cambridge, England, the Cambridge-Elan Centre for Research Innovation and Drug Discovery (Cambridge-Elan Centre). On December 21, 2012, the Company completed the demerger of Prothena Corporation plc. In April 2013, it closed the TYSABRI (natalizumab) Collaboration Transaction with Biogen Idec.
Tysabri
Tysabri, which is an alpha-4 integrin inhibitor, is a therapy for MS, a neurological disorder involving central nervous system dysfunction among adults. Tysabri is approved in more than 65 countries. Tysabri is approved in the United States as a monotherapy for relapsing forms of MS, for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS. As of December 31, 2011, there were approximately 64,400 patients on Tysabri therapy worldwide.
In June 2011, the European Commission (EC) approved the inclusion of the anti-JCV antibody status as an additional factor in stratifying patients at risk for developing PML in the Summary of Product Characteristics��(SmPC) for Tysabri in the European Union. The Company has developed a two-step ! enzyme-linked immunosorbent assay (ELISA), STRATIFY JCV, with Biogen Idec. The assay detects anti-JCV antibodies in the blood of patients, and is commercially available in Europe. In January 2012, the FDA cleared the assay for commercial use in the United States. As of December 31, 2011, over 80,000 tests had been administered using the assay. Tysabri is marketed and distributed by Elan and Biogen Idec. The Company�� research group, Neotope, is focused on creating monoclonal antibodies based on neo-epitope targets for the treatment of a range of therapeutic indications.
Beta Amyloid Immunotherapies (AIP)
Beta amyloid immunotherapy includes the treatment of Alzheimer�� disease by inducing or enhancing the body�� immune response in order to clear toxic species of beta amyloid from the brain. The AIP includes bapineuzumab (intravenous and subcutaneous delivery) and ACC-001, as well as other compounds. Bapineuzumab is an experimental humanized monoclonal antibody delivered intravenously that is being studied as a treatment for mild to moderate Alzheimer�� disease. It is designed to provide antibodies to beta amyloid directly to the patient (passive immunotherapy).
ELND005, an A� Aggregation Inhibitor
The small molecule ELND005 (Scyllo-inositol) is a beta amyloid anti-aggregation agent. Preclinical data suggest that ELND005 may act through the mechanism of preventing and reversing the fibrilisation of beta amyloid (the aggregation of beta amyloid into clumps of insoluble oligomers). ELND005 may have additional applications in psychiatric indications, such as bipolar disorder. In November 2011, the Company entered into a manufacturing agreement for the supply of the active pharmaceutical ingredient for ELND005 with Lonza Group AG.
Neotope Biosciences Limited
Neotope Biosciences Limited (Neotope) is the Company�� wholly owned subsidiary that focuses on the discovery and development of antibodies to neo-epitope related targ! ets for t! he treatment of a range of indications. It includes amyloidosis, diabetes, cancer and macular degeneration. Neotope�� portfolio of targets includes alpha-synuclein for the potential treatment of synucleinopathies, such as Lewy body dementia and Parkinson�� disease, tau for Alzheimer�� disease and other tauopathies. It also has a program for type 2-diabetes.
Onclave Therapeutics Limited
Elan�� wholly owned subsidiary Onclave Therapeutics Limited (Onclave) was formed to develop assets originating from Elan that have application in oncology related diseases. Onclave�� program, NEOD001, which originated from Neotope, is being investigated for the treatment of AL amyloidosis, which is a fatal disease involving abnormal accumulation of amyloid in organs and tissue. During the year ended December 31, 2011, Onclave filed for orphan drug designation of NEOD001. Onclave�� pipeline includes additional compounds with relevance in diverse cancer indications.
The Company competes with Biogen Idec, Bayer Schering Pharma AG, Bayer Schering Pharma, Merck Serono, Pfizer, Teva Neurosciences, Inc., Sanofi-Aventis and Novartis AG.
Advisors' Opinion:- [By Sarah Jones]
Elan Corp. (ELN) fell 3.4 percent to 9.80 euros. Shareholders risk losing $2 billion by listening to the company�� board and rejecting Royalty Pharma�� takeover bid at a ballot next week.
10 Best Medical Stocks To Own For 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 Te l Aviv, Israel.
Advisors' Opinion:- [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.
10 Best Medical Stocks To Own For 2014: Baxano Surgical Inc (BAXS)
Baxano Surgical Inc, formerly TranS1 Inc., incorporated in May 2000, is a medical device company focused on designing, developing and marketing products that implement its approach to treat degenerative conditions of the spine affecting the lower lumbar region. It develops its pre-sacral approach to allow spine surgeons to access and treat intervertebral spaces without compromising important surrounding soft tissue, nerves and bone structures. As of December 31, 2011, the Company was marketing the AxiaLIF family of products for single and multilevel lumbar fusion, the Vectre and Avatar lumbar posterior fixation systems and Bi-Ostetic bone void filler, a biologics product. All of the Company�� AxiaLIF products are delivered using its pre-sacral approach. It generates revenue from the sales of itsimplants and disposable surgical instruments. It has two distinct sales methods. The first method is when implants and/or disposable surgical instruments are sold directly to hospitals or surgical centers for the purpose of conducting a scheduled surgery. In November 2011, the Company launched its VEO Lateral Access and Interbody Fusion System.
The Company sells its products directly to hospitals and surgical centers in the United States and certain European countries, and to independent distributors elsewhere. The Company also markets its products at various industry conferences and through industry organized surgical training course. The Company has developed and markets two fusion products that are delivered using its pre-sacral approach include AxiaLIF 1L and AxiaLIF 2L+. Its products include surgical instruments for creating an access route to the L4/L5/S1 vertebral bodies, fusion implants, as well as supplemental stabilization products.
AxiaLIF Lumbar Fusion Implants
The Company markets AxiaLIF family of products for single and two level lumbar fusion, the VEO lateral access and interbody fusion system, the Vectre and Avatar posterior fixation systems and Bi-Ostet! ic bone void filler, a biologics product. The Company also market products that may be used with its AxiaLIF surgical approach, including bowel retractors, a bone graft harvesting system and additional discectomy tools. Its AxiaLIF implants and instruments, combined with facet screws or pedicle screws, provide surgeons with the tools necessary to perform a lumbar fusion.
The Company's AxiaLIF 1L and AxiaLIF 2L+ implants are threaded titanium rods, that come in varying lengths to enable one-level L5/S1 fusions and two-level L4/L5/S1 fusions. As they are implanted, its design allows for the separation of the vertebrae to restore disc height.
VEO Lateral Access and Interbody Fusion System
This system features a two-stage retraction method that focuses on nerve visualization followed by controlled retraction. The VEO Lateral System is designed for direct visualization of the psoas muscles and adjacent nerves prior to muscle dissection, and features a full range of PEEK lateral interbody implants and a variety of ergonomic instruments.
TranS1 Access and Disc Preparation Instruments
The Company�� pre-sacral approach requires the use of a sterile set of surgical instruments that are used to create a safe and reproducible working channel and to prepare the disc and vertebrae for its implant. The instrumentation contained in the set includes stainless steel navigation tools and tubular dissectors to create the working channel, as well as nitinol cutters and brushes to cut and remove the degenerated disc material and prepares the disc space for its implant and the bone graft material.
Vectre Facet Screw System
The Company's Vectre facet screw system offers a cannulated facet screw inserted over a guidewire to provide stability while reducing the muscle and tissue trauma associated with conventional pedicle screws. The Vectre system features offer a reproducible posterior fixation option in select patients.
A! VATAR Ped! icle Screw System
In January 2010, the Company entered into an agreement to distribute Avatar, a pedicle screw system. Avatar can be used with or without its implants to provide lumbar posterior fixation. The AVATAR MIS System offers cannulated pedicle screws inserted over a guidewire to reduce muscle and tissue trauma. Extended tabs integrated to the screws provide a pathway for implantation of the rod while minimizing tissue dissection.
Bi-Ostetic Bone Void Filler
In February 2010, TranS1 entered into an agreement to sell Bi-Ostetic, an osteoconductive bone substitute. Bi-Ostetic is an alternative to allografts or cadaver bone. The spongy granules are bioceramics with interconnected porosity that mimic the cancellous bone structure.
Iliac Crest Bone Graft Harvesting System
The Company�� Iliac Crest Bone Graft Harvesting System is developed to aid surgeons in harvesting iliac crest autograft via a minimally invasive approach. Use of autograft, which is osteogenic, osteoinductive and osteoconductive, further improves the chances of fusion success. It provides structural support as well as scaffolding for new bone growth.
The Company competes with Medtronic Sofamor Danek, Johnson & Johnson DePuy Spine, Stryker Spine, NuVasive, Zimmer Spine, Synthes, Orthofix International, Globus Medical and Alphatec Spine.
10 Best Medical Stocks To Own For 2014: Oxford BioMedica PLC (OXB)
Oxford BioMedica plc is a biopharmaceutical company developing gene-based medicines and therapeutic vaccines. The Company�� LentiVector platform products include ProSavin, RetinoStat, StarGen, UshStat, EncorStat, Glaucoma-GT and MoNuDin. Its 5T4 Tumour Antigen produces TroVax and Anti-5T4 antibody. The Prime Boost�� product includes Hi-8 Mel. Its GDEPT platform produces MetXia and Anti Angiogenesis platform produces EndoAngio-GT. The Company is developing four LentiVector platform product candidates for the treatment of ocular diseases: RetinoStat for wet age-related macular degeneration (AMD); StarGen for Stargardt disease; UshStat for Usher syndrome type 1B, and EncorStat for corneal graft rejection. TroVax is a therapeutic vaccine that stimulates the immune system to destroy cancerous cells expressing the 5T4 tumour antigen. On February 25, 2011, the Company purchased a freehold property, United Kingdom comprising a manufacturing facility.10 Best Medical Stocks To Own For 2014: Quintiles Transnational Holdings Inc (Q)
Quintiles Transnational Holdings Inc. is a provider of biopharmaceutical development services and commercial outsourcing services. The Company operates in two segments: Product Development and Integrated Healthcare Services. The Company�� Product Development segment operates as a contract research organization (CRO) focused primarily on Phase II-IV clinical trials and associated laboratory and analytical activities. The Company�� Integrated Healthcare Services segment is a global commercial pharmaceutical sales and service organizations and Integrated Healthcare Services provides a range of services, including commercial services, such as providing contract pharmaceutical sales forces in geographic markets, as well as healthcare business services for the healthcare sector, such as outcome-based and payer and provider services. In August 2012, it acquired Expression Analysis, Inc.
Product Development
Product Development provides services and that allow biopharmaceutical companies to outsource the clinical development process from first in man trials to post-launch monitoring. The Company�� service offering provides the support and functional necessary at each stage of development, as well as the systems and analytical capabilities. Product Development consists of clinical solutions and services and consulting. Clinical solutions and services provides services necessary to develop biopharmaceutical products, including project management and clinical monitoring functions for conducting multi-site trials (generally Phase II-IV) (core clinical) and clinical trial support services that improve clinical trial decision making and include global laboratories, data management, biostatistical, safety and pharmacovigilance, and early clinical development trials, and strategic planning and design services that improve decisions and performance. Consulting provides strategy and management consulting services based on life science and advanced analytics, as well as regulatory and comp! liance consulting services.
The Company competes with Covance, Inc., Pharmaceutical Product Development, Inc., PAREXEL International Corporation, ICON plc, inVentiv Health, Inc. (inVentive), INC Research and PRA International.
Integrated Healthcare Services
Integrated Healthcare Services provides the healthcare industry with both geographic presence and commercial capabilities. The Company�� commercialization services are designed to accelerate the commercial of biopharmaceutical and other health-related products. Service offerings include commercial services (sales representatives, strategy, marketing communications and other areas related to commercialization), outcome research (drug therapy analysis, real-world research and evidence-based medicine, including research studies to prove a drug�� value) and payer and provider services comparative and cost-effectiveness research capabilities, clinical management analytics, decision support services, medication adherence and health outcome optimization services, and Web-based systems for measuring quality improvement.
The Company competes with inVentiv, PDI, Inc., Publicis Selling Solutions, United Drug plc, EPS Corporation and CMIC HOLDINGS Co., Ltd.
10 Best Medical Stocks To Own 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�� 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 acquired 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 manufacturing 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 treatment 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. THALOMID 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 Novartis 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�� 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�� 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�� new second generation JNK inhibitor, tanzisertib (CC-930), is being evaluated in a phase II trial for the treatment of idiopathic pulmonary fibrosis and 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�� 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 develop 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).
Advisors' Opinion:- [By Maxx Chatsko]
Nonetheless, 12 of Amgen's 13 ongoing phase 3 trials involve biological compounds. That leads the industry and easily paces peers traditionally associated with biotechnology. Celgene (NASDAQ: CELG ) has seven biologics in phase 3 trials spread across three separate molecules, compared to 11 molecules for Amgen. Celgene is still my favorite biotech for 2013, but Amgen's flurry of activity is certainly worth a hard look. ��
- [By Ben Levisohn]
They did, however, show passion for Autonation (AN), which gained 3.1% to $46.76, benefiting, I suppose, from demand for Ford’s (F) Fusion. Biotech stocks continued their strong run today. Biogen (BIIB) gained 2.1% to $214.13, while Celgene (CELG) rose 2.5% to $142.58.
- [By Keith Speights and Max Macaluso, Ph.D.]
Which biotech stocks should investors take a hard look at buying now? Health care analyst Max Macaluso sat down with Fool.com contributor Keith Speights recently to find out which stocks he likes in the biotech sector. Two big biotechs that Keith recommends are�Biogen Idec (NASDAQ: BIIB ) and Celgene (NASDAQ: CELG ) .�
- [By Sean Williams]
Established pipeline suggestions
Celgene (NASDAQ: CELG ) : Celgene has been an absolute beast of a stock in 2013, and it could be just getting started if the company is able to meet on its guidance issued in January during the JPMorgan Healthcare Conference. At that annual meeting, Celgene noted its intentions to double its revenue, and triple EPS, by 2017 -- all through organic growth and drug approvals. Celgene has its blockbuster anemia drug Revlimid locked under patent protection for much of the remainder of this decade while its cancer drug Abraxane keeps racking up new indications. Already approved to treat metastatic breast cancer, and a first-line treatment for non-small cell lung cancer, Abraxane could also be well on its way to gaining approval in treating pancreatic cancer after improving PFS to 8.5 months from 6.7 months for the placebo in trials. Onyx Pharmaceuticals (NASDAQ: ONXX ) : Onyx shareholders also have plenty of reason to be dancing in the street over the past year, as its multiple myeloma cancer drug Kyprolis was approved in July, and its leading cancer treatment Nexavar, like Abraxane, continues to pile on the indications and positive data. Nexavar, which is co-developed with Bayer, is already approved by the FDA to treat renal cell carcinoma and unresectable hepatocellular carcinoma, but has shown promise in mid-stage trials in treating breast cancer, when combined with Roche's Xeloda and delivered promising results in a late-stage thyroid cancer trial. Roche: Finally, I'm not sure how any cancer discussion can be had where Roche isn't a possibility. I don't believe a single company appeared in more weekly Tackling Cancer
If taking big risks just isn't on your docket over the next couple of years, then the good news is that there are plenty of safer and/or less volatile selections to choose from that already have established pipelines. Here are three additional companies I would suggest you consider.
10 Best Medical Stocks To Own For 2014: Telik Inc (TELK.PH)
Telik, Inc. (Telik), incorporated in 1988, is a clinical-stage drug development company focused on discovering and developing small molecule drugs to treat cancer. The Company discovers its product candidates using the Company�� drug discovery technology, Target-Related Affinity Profiling (TRAP). TELINTRA, its principal drug product candidate in clinical development, is a small molecule glutathione analog inhibitor of the enzyme glutathione S-transferase P1-1 (GST P1-1). TELCYTA, its other product candidate, is a small molecule cancer drug product candidate designed to be activated in cancer cells.
Clinical Product Development
TELINTRA is the Company�� lead small molecule product candidate in clinical development for the treatment of blood disorders, including cancer. It has a mechanism of action and acts by inhibiting GST P1-1, an enzyme that is involved in the control of cellular growth and differentiation. Inhibition of GST P1-1 results in the activation of the signaling molecule Jun kinase, a regulator of the function of blood precursor cells. Preclinical tests show that TELINTRA is capable of causing the death or apoptosis of leukemic or malignant blood cells, while stimulating the growth and development of normal blood precursor cells. TELINTRA has been studied in Myelodysplastic Syndrome (MDS) using two formulations. A liposomal formulation was developed for intravenous administration of TELINTRA and was used in Phase I and Phase II studies in MDS patients. The results from the Phase II intravenous liposomal TELINTRA clinical trials demonstrated that TELINTRA treatment was associated with improvement in all three types of blood cell levels in patients with all types of MDS, including those in intermediate and high-risk groups. An oral dosage formulation (tablet) was subsequently developed and results from a Phase I study with TELINTRA tablets showed clinical activity and the formulation to be well tole rated. In June 2011, the Company initiated a Phase II clini! c! al trial to evaluate TELINTRA tablets. In October 2011, the Company initiated an additional Phase IIb clinical trial to evaluate TELINTRA tablets. '
The activity and safety profile of tablet formulation allowed the Company to complete a Phase II trial of TELINTRA tablets in MDS. The primary objective of the Phase II TELINTRA tablet study was to determine the efficacy of TELINTRA. A multivariate logistic regression analysis was conducted to identify MDS disease prognostic factors associated with erythroid improvement response rates, including prior MDS treatment, age, gender, the international prognostic scoring system (IPSS), risk, Eastern Cooperative Group performance status, years from MDS diagnosis, MDS World Health Organization subtypes, anemia only versus anemia plus other cytopenias, dose schedule and starting dose. Results from this study show that TELINTRA is the first GSTP1-1 enzyme inhibitor shown to cause clinically reductions in red blood cell transf usions, including transfusion independence in low to intermediate-1 risk MDS patients, as well as improvement in platelet count and white blood cell levels in certain patients. TELINTRA, administered orally twice daily, appeared to be convenient and flexible for chronic treatment administration.
TELCYTA is a small molecule drug product candidate that the Company is developed for the treatment of cancer. TELCYTA binds to GST. TELCYTA has been evaluated in multiple Phase II and Phase III clinical trials, including trials using TELCYTA as monotherapy and in combination regimens in ovarian, non-small cell lung, breast and colorectal cancer. Results from these clinical trials indicate that TELCYTA monotherapy was generally well-tolerated, with mostly mild to moderate side effects, particularly when compared to the side effects and toxicities of standard chemotherapeutic drugs. When TELCYTA was evaluated in combination with standard chemotherapeutic drugs, the tolera bility of the combinations was similar to that expected! of e! ac! h drug ! alone.
Clinical activity including objective tumor responses and/or disease stabilization was reported in the TELCYTA Phase II trials; however, TELCYTA did not meet its primary endpoints in the Phase III studies. Positive results from a Phase I-IIa multicenter, dose-ranging study of TELCYTA in combination with carboplatin and paclitaxel as first-line therapy for patients with non-small cell lung cancer, or NSCLC, were published in a peer reviewed publication. Clinical data demonstrated positive results of TELCYTA in combination with carboplatin and paclitaxel in the treatment of first-line lung cancer followed by TELCYTA maintenance therapy. As of December 31, 2011, the Company had an on-going investigator-led study at a single site of TELCYTA in patients with refractory or relapsed mantle cell lymphoma, diffuse B cell lymphoma, and multiple myeloma.
Preclinical Drug Product Development
The Company has a small molecule compound, TLK60 404, in preclinical development that inhibits both Aurora kinase and VEGFR kinase. Aurora kinase is a signaling enzyme whose function is required for cancer cell division, while VEGF plays a key role in tumor blood vessel formation, ensuring an adequate supply of nutrients to support tumor growth. These lead compounds prevented tumor growth in preclinical models of human colon cancer and human leukemia by inhibiting both Aurora kinase and VEGFR kinase. A development drug product candidate, TLK60404, has been selected.
The Company, using its TRAP technology has discovered TLK60357, a novel, potent small molecule inhibitor of cell division. TLK60357 inhibits the formation of microtubules that are necessary for cancer cell growth leading to persistent G2/M cancer cell cycle block and subsequent cell death. This compound demonstrates potent broad-spectrum anticancer activity against a number of human cancer cells. This compound also displays oral efficacy in multipl e, standard preclinical models of cancer. TLK6059! 6, a pote! nt! VGFR kin! ase inhibitor, blocks the formation of new blood vessels in tumors. Oral administration of TLK60596 to animal models of human colon cancer reduced tumor growth.
10 Best Medical Stocks To Own For 2014: Cerus Corporation(CERS)
Cerus Corporation, a biomedical products company, engages in the development and commercialization of the INTERCEPT Blood System. The company?s INTERCEPT system is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. It markets the INTERCEPT system for platelets and plasma primarily in Europe, the Russian Federation, and the Middle East. The company is also developing INTERCEPT Blood System for red blood cells or red blood cell system, which is designed to inactivate blood-borne pathogens in donated red blood cells for transfusion. Cerus Corporation has collaboration agreements with Baxter International, Inc.; and BioOne Corporation, as well as the United States Armed Forces. The company was founded in 1991 and is based in Concord, California.
Advisors' Opinion:- [By Seth Jayson]
Cerus (Nasdaq: CERS ) is expected to report Q1 earnings on April 30. Here's what Wall Street wants to see:
The 10-second takeaway
Comparing the upcoming quarter to the prior-year quarter, average analyst estimates predict Cerus's revenues will expand 15.0% and EPS will remain in the red.
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