One of our core biotech holdings surprised us by publishing positive results in the most recent online edition of The New England Journal of Medicine (NEJM), notes John McCamant, editor of The Medical Technology Stock Letter.
Novavax (NVAX) released its Phase I trial of 284 subjects injected with the H7N9 flu virus vaccine.
While the data was expected to be released before the end of the year, the fact that the NEJM published the Phase I study adds tremendous validation to the NVAX vaccine. We would note that the prestigious NEJM rarely publishes Phase I data.
The current Biomedical Advanced Research and Development Authority (BARDA) contract has directed the company to utilize the current portion of its pandemic flu contract on H7N9, underscoring the new virus' global pandemic potential.
NVAX cloned the genes and began human studies in a remarkable 91 days afterwards��esulting in a positive clinical outcome just 116 days after the announced lethal outbreak.
Top 5 Medical Stocks To Watch Right Now: Spectrum Pharmaceuticals Inc.(SPPI)
Spectrum Pharmaceuticals, Inc., a commercial-stage biotechnology company, primarily focuses on oncology and hematology. The company engages in acquiring, developing, and commercializing a broad and diverse pipeline of late-stage clinical and commercial products. It markets Zevalin, a prescribed form of cancer therapy, radioimmunotherapy; and Fusilev, a novel folate analog formulation and the pharmacologically active isomer of the racemic compound, calcium leucovorin. The company?s drugs in late stage development include Apaziquone, an anti-cancer agent; and Belinostat, a histone deacytelase inhibitor. Its drugs in development also include Ozarelix a luteinizing hormone releasing hormone antagonist, which is in Phase II clinical stage; SPI-1620, a peptide agonist of endothelin B receptors, which is in Phase I clinical stage; and RenaZorb, a lanthanum-based nanoparticle phosphate binding agent, which is in preclinical stage. The company was formerly known as NeoTherapeutics, Inc. and changed its name to Spectrum Pharmaceuticals, Inc. in December 2002. Spectrum Pharmaceuticals, Inc. was founded in 1987 and is based in Henderson, Nevada.
Advisors' Opinion:- [By Keith Speights]
Biotech stocks are highly volatile. A good example of this is Spectrum Pharmaceuticals (NASDAQ: SPPI ) . Spectrum rode a wave of generic leucovorin shortages in late 2010 and early 2011 to stock gains of more than 170%. Shares then plunged more than 30% from July through September 2011. But the ride wasn't over yet.
- [By James E. Brumley]
Eight months ago, Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) was a train wreck. Shares had plunged from $12.43 to $7.79 on the heels of bad news, and SPPI wouldn't stop bleeding until it hit a low of $6.92 a few days after the big selloff. That bad news? A warning that its full-year sales (and particularly sales of its cancer drug Fusilev) would be well short of expectations.
- [By Keith Speights]
Another prime case study for this comes from Spectrum Pharmaceuticals (NASDAQ: SPPI ) . Spectrum's stock more than doubled from October 2011 through July 2012. However, shares plunged 55% from those highs because business dynamics changed since then. A shortage of a generic rival to Spectrum's lead drug Fusilev was alleviated, resulting in sales slowing down considerably.�
Top 5 Medical Stocks To Watch Right Now: LeMaitre Vascular Inc (LMAT)
LeMaitre Vascular, Inc. (LeMaitre Vascular), incorporated on November 28, 1983, is a global provider of medical devices and implants for the treatment of peripheral vascular disease. The Company develops, manufacture, and market vascular devices to addresses the needs of vascular surgeons. The Company's diversified portfolio of peripheral vascular devices consists of brand name products that are used in arteries and veins outside of the heart and are well known to vascular surgeons, including the Expandable LeMaitre Valvulotome, the Pruitt F3 Carotid Shunt, and VascuTape Radiopaque Tape. The Company sells 12 product lines, most of which are used in open vascular surgery and some of which are used in endovascular procedures. The Company sells its products primarily through a direct sales force. The Company�� products are used by vascular surgeons who treat peripheral vascular disease through both open surgical methods and endovascular techniques. In July 2013, Lemaitre Vascular Inc acquired the assets of Clinical Instruments International, Inc. In August 2013, Lemaitre Vascular Inc acquired the assets of InaVein, LLC.
In June 2011, the Company divested its TAArget and UniFit stent grafts to Duke Vascular, Inc. In August 2011, the Company terminated its distribution of Endologix�� aortic stent graft products in Europe. In November 2011, it launched the second-generation of The UnBalloon Non-Occlusive Modeling Catheter. In December 2011, the Company launched the Over-The-Wire LeMaitre Valvulotome.
Open Vascular Products
The Company�� open vascular products are used primarily in conventional open vascular surgery for the treatment of peripheral vascular disease. LeMaitre line of embolectomy catheters are used to remove blood clots from arteries or veins. The Company manufactures single-lumen latex and latex-free embolectomy catheters, as well as dual-lumen latex embolectomy catheters. The dual-lumen embolectomy catheter allows clot removal and simultaneous irri! gation or guide-wire trackability. Its Pruitt line of occlusion and perfusion catheters reduces vessel trauma by using internal balloon fixation rather than traditional external clamp fixation.
Pruitt F3, Pruitt-Inahara, Inahara-Pruitt, and Flexcel Carotid Shunts are used to temporarily divert, or shunt, blood to the brain while the surgeon removes plaque from the carotid artery in a carotid endarterectomy surgery. Its Pruitt F3, Pruitt-Inahara, and Inahara-Pruitt shunts feature internal balloon fixation that eliminates the need for clamps, thereby reducing vessel trauma. Its Flexcel shunt is a non-balloon shunt offered for surgeons who prefer to secure their shunt using externally placed clamps.
EndoRE line of remote endarterectomy devices are used to remove severe atherosclerotic blockages from the major arteries of the leg in a minimally invasive procedure requiring a single incision in the groin. Its EndoRE devices are used to separate the sclerotic blockage from the vessel, cut the far end of the blockage to free it for removal, and then withdraw the blockage from the vessel.
Expandable LeMaitre Valvulotome and its Over-The-Wire LeMaitre Valvulotome cut valves in the saphenous vein, a vein that runs from the foot to the groin, so that the vein can function as a bypass vessel to carry blood past diseased arteries to the lower leg or the foot. The Expandable LeMaitre Valvulotome is the only self-sizing and self-centering valvulotome available, and the Over-The-Wire LeMaitre Valvulotome is the only over-the-wire self-sizing valvulotome available.
AlboGraft Woven and Knitted Vascular Grafts are collagen-impregnated polyester grafts used to bypass or replace diseased arteries. They are available in both straight tube and bifurcated versions. LifeSpan ePTFE Vascular Graft is an expanded polytetrafluoroethylene (ePTFE) graft used to bypass or replace diseased arteries, and to create dialysis access sites. They are available in both regular and thin wall ! options a! nd with an optional full or partial external spiral support to increase resistance to compression or kinking. Its LifeSpan models are designed to reduce the risk of steal syndrome and high cardiac output, which are complications that may arise in dialysis access grafts.
AlboSure Vascular Patch is a polyester patch used in conjunction with endarterectomy and vascular reconstructions. Vascular surgeons use patches in conjunction with carotid endarterectomy, remote endarterectomy, and other vascular reconstructions. The Company also distributes the XenoSure Biologic Vascular Patch, a patch made from bovine pericardium.
AnastoClip VCS and AnastoClip GC Vessel Closure Systems allow surgeons to attach vessels, native and prosthetic, to one another by deploying titanium clips in place of suturing. These vessel closure systems create an interrupted anastomosis, or a vessel attachment that expands and contracts as the vessel pulses.
Endovascular and Other Products
The Company�� endovascular products are used primarily by vascular surgeons in minimally invasive endovascular procedures, such as stent-grafting, angioplasty, stenting, and atherectomy, and it also sells non-vascular medical devices used in general surgery procedures, primarily laparoscopic cholecystectomy. UnBalloon Non-Occlusive Modeling Catheter is used to apply radial pressure to the inside of an aortic stent graft in order to seal the outer lining of the stent graft against either the aorta or an adjacent stent graft.
VascuTape Radiopaque Tape is a flexible, medical-grade tape with centimeter or millimeter markings printed with its radiopaque ink that is visible both to the eye and to an X-ray machine or fluoroscope. VascuTape Radiopaque Tape is applied to the skin and provides interventionalists with a simple way to cross-reference between the inside and the outside of a patient�� body, allowing them to locate tributaries or lesions beneath the skin.
In some hosp! itals, va! scular surgery procedures are performed by general surgeons. The Company sells on-vascular medical devices used in general surgery procedures, primarily laparoscopic cholecystectomy. The Company�� general surgery product, the Reddick Cholangiogram Catheter is used to inject dye into the cystic duct during laparoscopic cholecystectomy. The Company also offers two laparoscopic accessories used in laparoscopic gall bladder removal.
The Company competes with Applied Medical Resources Corporation, Cardiovascular Systems Inc., Cook Group Incorporated, C.R. Bard, Inc., Edwards Lifesciences Corporation, Getinge AB, Jotec GmbH, Medtronic, Inc., Terumo Medical Corporation, Uresil, LLC and W. L. Gore & Associates.
Top 5 Warren Buffett Companies To Invest In Right Now: Medtronic Inc (MDT)
Medtronic, Inc. (Medtronic), incorporated on April 23, 1957, is engaged in medical technology - alleviating pain, restoring health, and extending life for millions of people worldwide. As of April, 27, 2012, the Company functions in two operating segments that manufacture and sells device-based medical therapies. The Company's operating segments include Cardiac and Vascular Group, which consists of Cardiac Rhythm Disease Management (CRDM) and CardioVascular, and Restorative Therapies Group, which consists of Spinal, Neuromodulation, Diabetes and Surgical Technologies. Medtronic serves hospitals, physicians, clinicians, and patients in more than 120 countries worldwide. The Company's primary customers include hospitals, clinics, third-party health care providers, distributors, and other institutions, including governmental health care programs and group purchasing organizations. In August 2013, Medtronic, Inc. announced the closing of the acquisition of Cardiocom. Effective September 3, 2013, Medtronic Inc acquired a 30% stake in NGC Medical SpA.
Cardiac Rhythm Disease Management
CRDM develops, manufactures, and markets products for the diagnosis, treatment, and management of heart rhythm disorders and heart failure, including implantable devices, leads and delivery systems, products for the treatment of atrial fibrillation (AF), and information systems for the management of patients with CRDM devices. The Company's principal products offered by CRDM business include Implantable Cardiac Pacemakers (Pacemakers), Implantable Cardioverter Defibrillators (ICDs), Implantable Cardiac Resynchronization Therapy Devices (CRT-Ds and CRT-Ps), AF Products, Diagnostics and Monitoring Devices and Patient Management Tools. The Company's pacemaker systems are compatible with certain magnetic resonance imaging (MRI) machines. This includes the Revo MRI SureScan with United States Food and Drug Administration approval and the Advisa and Ensura MRI SureScan models with Conformite Europeene (CE)! Mark approval. Medtronic also continues to market the Adapta product family, which includes the Adapta, Versa, Sensia, and Relia models.
The Medtronic ICDs is the Protecta family with SmartShock technology, including the Lead Integrity Alert, a technology designed to improve the detection of lead fractures. Devices in the ICD family are the Protecta XT, Protecta, Cardia, and Egida models. Medtronic also continues to market the Secura and Maximo II devices. The Medtronic CRT-Ds is the Protecta family with SmartShock technology, including Protecta XT and Protecta, and the CRT-P devices are Consulta and Syncra. Medtronic also continues to market the Consulta, Cardia, Egida, and Maximo II CRT-D devices. In addition to these devices, Medtronic has an offering of left heart leads and delivery catheters with its Attain family of products. The Company's portfolio of AF products includes the Arctic Front Cardiac CryoAblation Catheter designed to treat paroxysmal AF by performing pulmonary vein isolation. The Company also offers the Reveal XT Insertable Cardiac Monitor, which is designed to identify and quantify episodes of AF. The Reveal DX and Reveal XT Insertable Cardiac Monitors devices are used to record the heart's electrical activity before, during, and after transient symptoms such as syncope and palpitations to help provide a diagnosis. It has a number of patient management tools, such as CareLink, Paceart, and CardioSight Service. CareLink enables patients to transmit data from their pacemaker, ICD, CRT-D, or Insertable Cardiac Monitors using a portable monitor that is connected to a standard telephone line or cellular network using the Medtronic M-Link accessory.
The Company competes with St. Jude Medical, Inc., Boston Scientific Corporation, Biotronik, Inc. and Sorin Group.
CardioVascular
CardioVascular is comprised of three businesses: Coronary, Endovascular and Peripheral, and Structural Heart. The Coronary business includes therapies to treat ! coronary ! artery disease (CAD) and hypertension. The products contained within this business include coronary stents and related delivery systems, along with a broad line of balloon angioplasty catheters, guide catheters, guidewires, diagnostic catheters, and accessories. The products offered by its Coronary business include Percutaneous Coronary Intervention (PCI) and Renal Denervation. The Endovascular and Peripheral business is comprised of a range of products and therapies to treat abdominal and thoracic aortic aneurysms and peripheral vascular disease (PVD). The Company's products include endovascular stent graft systems, embolic protection systems, and stent systems for the treatment of narrowed iliac arteries. The products offered by the Company's Endovascular and Peripheral business include Endovascular Stent Grafts and Peripheral Vascular Intervention (PVI). The Structural Heart business offers a range of products and therapies to treat a variety of heart valve disorders. The Company's products include products for the repair and replacement of heart valves, perfusion systems, positioning and stabilization systems for beating heart revascularization surgery, and surgical ablation products. The Company's principal products offered by its Structural Heart business include Heart Valves, Transcatheter Heart Valves, Arrested Heart Surgery, Beating Heart Surgery and Surgical Ablation.
The Company competes with Abbott Laboratories, Boston Scientific, and Johnson & Johnson, Cook, Inc., W. L. Gore & Associates, Inc., Endologix, Inc., C.R. Bard, Inc., Edwards LifeSciences Corporation, St. Jude, Terumo Medical Corporation and Sorin Group.
Spinal
The Company's Spinal business develops, manufactures, and markets a range of medical devices and implants used in the treatment of the spine and musculoskeletal system. The Company's products and therapies treat a range of conditions affecting the spine, including degenerative disc disease, spinal deformity, spinal tumours, fractures ! of the sp! ine, and stenosis. The Company's Spinal business also provides biologic solutions for the dental and orthopedic markets. The Company's Spinal products are used in spinal fusion of both the thoracolumbar region, referring to the mid to lower vertebrae, as well as of the cervical region, or upper spine and neck vertebrae. Products used to treat spinal conditions include rods, pedicle screws, hooks, plates, and interbody devices, as well as biologics products, primarily bone growth substitutes including bone graft extenders and structural allografts such as dowels and wedges. The products offered by the Company's Spinal business include Thoracolumbar Products, Cervical Products and Biologics Products.
The Company competes with DePuy Spine, Inc., Synthes, Inc., Stryker Corporation, NuVasive, Inc., Globus Medical, Inc., Zimmer, Inc., Alphatec Spine, Inc., Orthofix International N.V., Biomet, Inc. and Johnson & Johnson.
Neuromodulation
The Company's Neuromodulation business develops, manufactures, and markets medical devices for the treatment of chronic pain, movement disorders, psychological disorders, and urological, fecal, and gastroenterological disorders. The l products offered by the Company's Neuromodulation business includes Neurostimulators for Chronic Pain, Implantable Drug Delivery Systems, Deep Brain Stimulation (DBS) Systems and Urology, Fecal, & Gastroenterology Devices. The Company's portfolio of products includes the RestoreSensor (rechargeable), with the Company's AdaptiveStim technology, as well as the RestoreULTRA (rechargeable), RestoreADVANCED (rechargeable), and PrimeADVANCED (non-rechargeable) neurostimulation systems. The SynchroMed II Programmable Infusion System delivers small quantities of drug directly into the intrathecal space surrounding the spinal cord. These devices are used to treat chronic, intractable pain and severe spasticity associated with cerebral palsy, multiple sclerosis, spinal cord and traumatic brain injuries, and stroke.
DBS uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver carefully controlled electrical stimulation to precisely targeted areas in the brain. The Company's family of Activa Neurostimulators for DBS includes Activa SC (single-channel primary cell), Activa PC (dual channel primary cell), and Activa RC (dual channel rechargeable). The Company's therapeutic portfolio for urology and gastroenterology includes the InterStim Therapy System, which treats the symptoms of overactive bladder, urinary retention, and chronic fecal incontinence, and the Enterra Therapy System for the treatment of chronic nausea and vomiting caused by gastroparesis of diabetic or idiopathic origin for drug refractory patients.The Company's competes with Boston Scientific, St. Jude., Urologix, Inc. and Allergan.
Diabetes
The Company's Diabetes business develops, manufactures, and markets advanced, integrated diabetes management solutions that include insulin pump therapy, continuous glucose monitoring systems, and therapy management software. The products offered by the Company's Diabetes business includes Integrated Diabetes Management Solutions, Professional CGM and CareLink Therapy Management Software. Outside the United States, the Company offers its Paradigm Veo System, an integrated system that includes a Low Glucose Suspend feature that automatically suspends insulin delivery when glucose levels become too low. In the United States, the Company offers the Paradigm Revel System, which incorporates new CGM features, including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events. Medtronic offers physicians a Professional CGM product called the iPro CGM and iPro2 Professional CGM. The Company offers Web-based therapy management software solutions, including CareLink Personal software for patients and CareLink Pro software, to helps patients and their health care prov! iders con! trol their diabetes.
The Company competes with DexCom, Inc., Insulet Corporation, Johnson & Johnson and Roche Ltd.
Surgical Technologies
The Company's Surgical Technologies business develops, manufactures, and markets products and therapies to treat diseases and conditions of the ear, nose, and throat (ENT) and certain neurological disorders. In addition, the business develops, manufactures, and markets image-guided surgery and intra-operative imaging systems that facilitate surgical planning during precision cranial, spinal, sinus, and orthopedic surgeries. The products offered by the Company's Surgical Technologies business includes ENT, Neurological Technologies, Navigation and Advanced Energy. The ENT products treat diseases and conditions, such as NIM Nerve Monitoring Systems, Fusion ENT Navigation System, Hydrodebrider Endoscopic Sinus Irrigation System, Meniett Device for Meniere's Disease, Pillar Procedure for Snoring and Sleep Apnea, and Repose System for Obstructive Sleep Apnea. The Neurological Technologies products treat certain neurological disorders and conditions, such as Midas Rex Spine Shaver, the Midas Rex MR7 Pneumatic Platform, the Midas Rex Legend EHS High Speed Surgical Drill, the Strata Family of Adjustable Valves for the treatment of Hydrocephalus, Duet External Drainage & Monitoring System, the IPC System, and the Subdural Evacuating Port System.
The Navigation products are used in cranial, spinal, sinus, and orthopedic surgeries, such as the StealthStation S7 Navigation and i7 Integrated Navigation Systems, the O-Arm 2D/3D Surgical Imaging System, and the PoleStar Surgical MRI System. The products make up the Advanced Energy business: PEAK Surgery System, a tissue dissection system that consists of the PEAK PlasmaBlade and the PULSAR Generator and is cleared for use in a variety of settings, including ENT, plastic reconstructive and general surgery; and the Aquamantys System, which uses patented Transcollation technology to ! provide h! aemostatic sealing of soft tissue and bone and is cleared for use in a range of surgical procedures, including orthopedic surgery, spine, solid organ resection and thoracic procedures.
The Company competes with Gyrus ACMI, Stryker Corporation, Johnson & Johnson, Integra LifeSciences Holdings Corporation, BrainLAB, Inc., GE Healthcare, Siemens Medical Solutions USA, Inc., Philips Medical Systems, Covidien and ArthroCare Corporation.
Advisors' Opinion:- [By Dan Caplinger, Max Macaluso, and David Williamson]
In the following video, Fool health-care bureau chief Max Macaluso asks Dan for his pick on a stock that could benefit from Patient Protection and Affordable Care Act. Dan singles out Medtronic (NYSE: MDT ) as a potential winner, noting that with the current government shutdown impasse in Washington, lawmakers are looking to use Obamacare as leverage to make political gains. One possible issue that could come into play in the shutdown debate is the medical-device excise tax that Obamacare imposed on Medtronic and its peers, and opponents of the tax could seek to win its repeal in exchange for support of a spending measure and debt ceiling increase, potentially returning lost profits back to Medtronic. Moreover, the recent buyout offer that Stryker (NYSE: SYK ) made to acquire MAKO Surgical (NASDAQ: MAKO ) has turned attention to the medical-device sector once again. Dan and Max discuss the likelihood of a congressional deal to eliminate the tax, and Fool health-care analyst David Williamson also weighs in with his assessment of whether enough bipartisan support exists for the provision to get repealed.
- [By Chuck Carnevale]
Medtronic Inc. (MDT) My Due Diligence Example
Medtronic Inc. was a company that I had long admired based on the historical operating excellence that it achieved through good and bad times. However, Mr. Market was consistently pricing it too high for many years, perhaps because of its excellent operating record (consistent and above-average earnings growth). Therefore, I placed it on my dream list, periodically checking its valuation and patiently waiting for an opportunity to purchase it at a sensible valuation.
- [By Reuters]
David Mercer/APPatrick Lamanske of Champaign, Ill., works with Amanda Ziemnisky, right, of the Champaign Urbana Public Health District office in Champaign to try to sign his wife, Ping Lamanske, left, up for health care coverage through the Affordable Care Act. NEW YORK -- For Americans who are able to check out new insurance plans launched under President Barack Obama's health care reform, the price differences from state to state may be surprising. Residents of Minnesota, a Democratic-led state, are likely to pay the lowest monthly premiums in the country. Just two states away, some residents of Republican-dominated Wyoming might be surprised to find they will pay among the highest. But the ideological debate between Obamacare's supporters and opponents seems to have had little relevance when it comes to the affordability of care, the main goal of the Democratic president's signature program, health economists and actuaries say. Instead, they point to regional differences in medical costs, the relative health and age of local populations and competition among insurers as having greater influence over the monthly premiums. Those differences lead to a wide variance in prices between states, and even within states. Of the 24 states that fall below a national average of $328 in monthly premiums, laid out in a U.S. Department of Health and Human Services analysis last month, at least half are dominated by Republican state governments. The affordability of the plans will likely determine whether enough uninsured Americans, particularly young and healthy ones, sign up to make the program successful. The new insurance plans became available for enrollment nationwide on Oct. 1. But technical problems with the federal government's health care.gov website serving 36 states have blocked millions of people from accessing the information. In Wyoming, the cheapest mid-tier plan, or "silver" plan, costs $307 for a 27-year old in Laramie County, one of the state's only
Top 5 Medical Stocks To Watch Right Now: Hemispherx Biopharma Inc (HEB)
Hemispherx Biopharma, Inc. (Hemispherx) is a specialty pharmaceutical company engaged in the clinical development of new drugs therapies based on natural immune system enhancing technologies for the treatment of viral and immune based chronic disorders. Hemispherx focuses on two core pharmaceutical technology platforms Ampligen and Alferon N Injection.The commercial focus for Ampligen includes application as a treatment for Chronic Fatigue Syndrome (CFS) and as an influenza vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Alferon N Injection is a United States Food and Drug Administration (FDA) approved product with an indication for refractory or recurring genital warts. Alferon LDO (Low Dose Oral) is a formulation under development targeting influenza. It has three subsidiaries BioPro Corp., BioAegean Corp., and Core BioTech Corp. The Company's foreign subsidiary is Hemispherx Biopharma Europe N.V./S.A.
Ampligen
Ampligen is an experimental drug, which is undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Over 1,000 patients have participated in the Ampligen clinical trials representing the administration of more than 90,000 doses of this drug. The Company is also engaged in ongoing, experimental studies assessing the efficacy of Ampligen against influenza viruses.
Alferon N Injection
Alferon N Injection is the registered trademark for the Company's injectable formulation of natural alpha interferon. Interferons are a group of proteins produced and secreted by cells to combat diseases. The Company's natural alpha interferon is produced from human white blood cells. Alferon N Injection [Interferon alfa-n3 (human leukocyte derived)] is a highly purified, natural-source, glycosylated, multi-species alpha interferon product.
Alferon LDO (Low Dose Oral)
Alferon LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)]! is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic that works by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa.
The Company competes with Pfizer, GlaxoSmithKline, Merck, AstraZeneca, Baxter International, Fletcher/CSI, AVANT Immunotherapeutics, AVI BioPharma and Genta.
Top 5 Medical Stocks To Watch Right Now: Pharmacyclics Inc (PCYC)
Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company's clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton�� tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.
As of June 30, 2012, the Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.
Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).
PCI-27483 Factor VIIa Inhibitor
The Company�� Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.
Factor VIIa PCI-27483 Clinical Development Update
A multicenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.
A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.
Advisors' Opinion:- [By Dan Caplinger]
Yet J&J isn't satisfied with what it already has. Last week, the company joined with Pharmacyclics (NASDAQ: PCYC ) to seek approval for their lymphoma drug ibrutinib. J&J will get a 50% share of any profit from the venture, and J&J cited a Piper Jaffray estimate that just one of its indications could produce sales of more than $4 billion.
- [By Sean Williams]
We've witnessed first-hand what a crapshoot the space can be. Four years ago,�Pharmacyclics (NASDAQ: PCYC ) looked like just another biotechnology company that was going to waste away into nothing with its share price trading for less than $1. In the years since, it's forged nearly a $1 billion licensing partnership with Johnson & Johnson (NYSE: JNJ ) for its relapsed/refractory mantle cell lymphoma and chronic lymphocytic leukemia drug hopeful, Ibrutinib, and delivered some of the strongest overall response rates ever witnessed in trials for these two diseases. Shares of Pharmacyclics closed yesterday above $80 per share.
- [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�� 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
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