Normally when we think of investing in health care, medical device makers, pharmaceutical companies, and health insurers come to mind. However, buying Qualcomm (NASDAQ: QCOM ) stock could actually be a smart health care play as well. Here's why.
Mobile medical
What does a mobile communications giant have in common with health care? More than you might think -- especially in the growing area of telemedicine.
Telemedicine basically involves using medical information gathered at one location and sending this information electronically to another location to improve a patient's health. The opportunity for this technology to make a difference in improving health care is tremendous. Deloitte projects that $400 billion each year could be saved by using technology to address medical needs at home.
It's in the area of telemedicine that Qualcomm's technology shines. The company formed a business unit called Qualcomm Life in late 2011. Qualcomm Life focuses on remote health management using its 2net cloud platform. 2net enables integration of medical devices at a patient's home with a database hosted in the cloud. Other applications can access this data to provide a wide range of services to improve health care.
Top 10 Medical Companies To Watch For 2015: Cell Therapeutics Inc (CTIC)
Cell Therapeutics, Inc. (CTI), incorporated in 1991, develops, acquires and commercializes treatments for cancer. The Company�� research, development, acquisition and in-licensing activities concentrate on identifying and developing new ways to treat cancer. As of December 31, 2011, CTI focused its efforts on Pixuvri (pixantrone dimaleate) (Pixuvri), OPAXIO (paclitaxel poliglumex) (OPAXIO), tosedostat, brostallicin and bisplatinates. As of December 31, 2011, it developed Pixuvri, an anthracycline derivative for the treatment of hematologic malignancies and solid tumors. Another late-stage drug candidate of the Company, OPAXIO, is being studied as a potential maintenance therapy for women with advanced stage ovarian cancer, who achieve a complete remission following first-line therapy with paclitaxel and carboplatin. As of December 31, 2011, it also developed tosedostat in collaboration with Chroma Therapeutics, Ltd. (Chroma). On May 31, 2012, CTI completed its acquisition gaining worldwide rights to S*BIO Pte Ltd.'s (S*BIO) pacritinib.
Pixuvri
As of December 31, 2011, the Company developed Pixuvri, an aza-anthracenedione derivative, for the treatment of non-Hodgkin�� lymphoma (NHL), and various other hematologic malignancies, and solid tumors. Pixuvri was studied in the Company�� EXTEND, or PIX301, clinical trial, which was a phase III single-agent trial of Pixuvri for patients with relapsed, refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. On September 28, 2011, CTI announced that a second independent radiology assessment of response and progression endpoint data from its PIX301 clinical trial of Pixuvri was achieved with statistical significance. The results of the EXTEND trial met its primary endpoint and showed that patients randomized to treatment with Pixuvri achieved a significantly higher rate of confirmed and unconfirmed complete response compared to patients treated with standard chem! otherapy had a significantly increased overall response rate and experienced a statistically significant improvement in median progression free survival. Pixuvri had predictable and manageable toxicities when administered at the proposed dose and schedule in the EXTEND clinical trial in heavily pre-treated patients. In March 2011, the Company initiated the PIX-R trial to study Pixuvri in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Pixuvri has also been studied in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. In the second quarter of 2010, the NCCTG opened this phase II study for enrollment. The study is closed to accrual and results are expected to be reported by the NCCTG later in 2012.
OPAXIO
OPAXIO is the Company�� biologically-enhanced chemotherapeutic agent that links paclitaxel to a biodegradable polyglutamate polymer, resulting in a new chemical entity. As of December 31, 2011, the Company focused its development of OPAXIO on ovarian, brain, esophageal, head and neck cancer. OPAXIO was designed to improve the delivery of paclitaxel to tumor tissue while protecting normal tissue from toxic side effects. In November 2010, results were presented by the Brown University Oncology Group from a phase II trial of OPAXIO combined with temozolomide (TMZ), and radiotherapy in patients with newly-diagnosed, high-grade gliomas, a type of brain cancer. The trial demonstrated a high rate of complete and partial responses and a high rate of six month progression free survival (PFS). Based on these results, the Brown University Oncology Group has initiated a randomized, multicenter, phase II study of OPAXIO and standard radiotherapy versus TMZ and radiotherapy for newly diagnosed patients with glioblastoma with an active gene termed MGMT that reduces responsiveness to TMZ. A phase I/II study of OPAXIO combined with radi! otherapy ! and cisplatin was initiated by SUNY Upstate Medical University, in patients with locally advanced head and neck cancer.
Tosedostat
In March 2011, the Company entered into a co-development and license agreement with Chroma Therapeutics, Ltd. (Chroma), providing the Company with marketing and co-development rights to Chroma�� drug candidate, tosedostat, in North, Central and South America. Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood related cancers and solid tumors in phase I-II clinical trials. Interim results from the phase II OPAL study of tosedostat in elderly patients with relapsed or refractory acute myeloid leukemia (AML) showed that once-daily, oral doses of tosedostat had predictable and manageable toxicities and results demonstrated response rates, including a high-response rate among patients who received prior hypomethylating agents, which are used to treat myelodysplastic syndrome (MDS), a precursor of AML.
Brostallicin
As of December 31, 2011, the Company developed brostallicin through its wholly owned subsidiary, Systems Medicine LLC, which holds rights to use, develop, import and export brostallicin. Brostallicin is a synthetic deoxyribonucleic acid (DNA) minor groove binding agent that has demonstrated anti-tumor activity and a favorable safety profile in clinical trials, in which more than 230 patients have been treated as of December 31, 2011. The Company uses a genomic-based platform to guide the development of brostallicin. A phase II study of brostallicin in relapsed, refractory soft tissue sarcoma met its predefined activity and safety hurdles and resulted in a first-line phase II clinical trial study that was conducted by the European Organization for Research and Treatment of Cancer (EORTC).
The Company competes with Bristol-Myers Squibb Company, Sanofi-Aventis, Pfizer, Roche Group, Genentech, Inc., Astellas Pharma, Eli Lilly and Company, Celgene, Telik, I! nc., TEVA! Pharmaceuticals Industries Ltd. and PharmaMar.
Advisors' Opinion: - [By MONEYMORNING]
Cell Therapeutics Inc. (Nasdaq: CTIC), based in Seattle, Wash., acquires, develops, and commercializes treatments for cancers, including non-Hodgkin's leukemia and ovarian, neck, and brain cancers. The company just announced it has completed patient enrollment in clinical trials for an investigational agent to be used as a maintenance therapy in ovarian cancer patients. The trial is being conducted by the Gynecologic Oncology Group, one of the National Cancer Institute's funded research groups. Roth Capital recently reiterated a "Buy" rating on the stock and raised its price target from $6 to $7. Roth believes the company's treatment for leukemia, Pacritinib, is effectively evolving. Additionally, the investment firm sees potential in CTIC's Tosedostat, which deprives tumor cells of the amino acid building blocks needed to make proteins necessary for tumor cell survival. Shares rose 2% Tuesday to $3.52 on volume of 6 million shares.
Top 10 Medical Companies To Watch For 2015: Sonova Holding AG (SOON)
Sonova Holding AG is a Switzerland-based company operating in the healthcare sector. The Company, along with its subsidiaries, specializes in the design, development, manufacture, worldwide distribution and service of technologically advanced hearing systems for adults and children with hearing impairment. The Company is active in two operating segments: the Hearing instruments segment includes the companies that are active in the design, development, manufacture, distribution and service of hearing instruments and related products, and the Cochlear implants segment includes the companies that are active in the design, development, manufacture, distribution and service of hearing implants and related products. The Company operates worldwide and distributes its products in over 90 countries through its own distribution network and through independent distributors. Sonova Holding AG is the holding company of the Sonova Group.
Advisors' Opinion: - [By Sofia Horta e Costa]
ThyssenKrupp AG slid to a 10-week low after raising 882.3 million euros ($1.2 billion) through a share sale. Antofagasta Plc led a measure of mining companies to a seven-week low. Sonova Holding AG (SOON) declined 1.5 percent as Morgan Stanley cut its rating on the Swiss hearing-aid maker. Orange SA slipped 3.4 percent amid concern a price war in the French mobile market will extend to fourth-generation data services.
- [By Corinne Gretler]
Sonova (SOON) advanced 6.9 percent to 126.50 Swiss francs after predicting that annual earnings before interest, taxes and amortization would grow as much as 14 percent, compared with a previous forecast of 9 percent to 13 percent. Sales will increase 8 percent to 10 percent, up from an earlier projection of 6 percent to 8 percent.
Top 10 Life Sciences Stocks To Invest In 2015: 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 Jake L'Ecuyer]
Spectrum Pharmaceuticals (NASDAQ: SPPI) shares tumbled 9.77 percent to $8.18 after the company announced an offering of $100 million of convertible notes.
- [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.�
- [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.
Top 10 Medical Companies To Watch For 2015: Puma Biotechnology Inc (PBYI)
Puma Biotechnology, Inc., incorporated in April 2007, is a development-stage biopharmaceutical company that acquires and develops products for the treatment of various forms of cancer. The Company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. As of December 31, 2011, the Company licensed three drug candidates: PB272 (neratinib (oral)), which the Company is developing for the treatment of advanced breasts cancer patients and gastric cancer patients; PB272 (neratinib (intravenous)), which the Company is developing for the treatment of advanced cancer patients, and PB357.
PB272 (neratinib (oral))-Breast Cancer
Neratinib is a potent irreversible tyrosine kinase inhibitor, or TKI, that blocks signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4. The Company's initial focus is on the development of neratinib as an oral treatment of patients with HER2 positive metastatic breast cancer.
PB272 (neratinib (intravenous))
The Company develops neratinib as an intravenously administered agent. In pre-clinical studies the intravenous version of neratinib resulted in higher exposure levels of neratinib in pre-clinical models.
PB357
PB357 is an orally administered agent that is an irreversible TKI that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2, and HER4. PB357 is structurally similar to PB272. Pfizer completed single dose Phase I trials of PB357. The Company is evaluating PB357.
The Company competes with Genentech, GlaxoSmithKline, Roche, Boehringer Ingelheim, Takeda, Array Biopharma and Ambit Biosciences.
Advisors' Opinion: - [By John Udovich]
Recent news surrounding small cap biotech stocks like�Xencor Inc (NASDAQ: XNCR), Prosensa Holding NV (NASDAQ: RNA),�Puma Biotechnology Inc (NYSE: PBYI),�Geron Corporation (NASDAQ: GERN)
and TNI BioTech Inc (OTCQB: TNIB) show that while the sector and appetite for biotech�IPOs may have cooled, lottery tickets can still be found or occur in the sector. Just consider the following recent news or trends:
- [By Anna Prior]
Puma Biotechnology Inc.(PBYI) reported positive top-line data from the Phase II clinical trial of the biopharmaceutical company’s investigational drug PB272 for the neoadjuvant treatment of breast cancer.
Top 10 Medical Companies To Watch For 2015: Bacterin International Holdings Inc (BONE)
Bacterin International Holdings, Inc. (Bacterin), formerly K-Kitz, Inc., develops, manufactures and markets biologics products to domestic and international markets through Bacterin's biologics division. Its products are used in a variety of applications, including enhancing fusion in spine surgery, relief of back pain with a facet joint stabilization, promotion of bone growth in foot and ankle surgery, promotion of skull healing following neurosurgery and subcondral bone defect repair in knee and other joint surgeries. The Company has developed and manufacture and sell several human tissue-based products, primarily allografts, into the medical marketplace through its biologics division. In addition, it also manufactures and sells, directly under its own name and indirectly through distributors, various coating and surgical drain products through its medical devices division.
The Company�� medical devices division develops medical devices intended for use in several diverse clinical areas, including orthopedic, plastic, and cardiovascular surgery. The medical devices division also develops custom surgical instrument kits for use with allografts processed by its biologics division. The medical devices division actively develops intellectual property associated with its devices and coating platforms, for the purposes of protecting its Bacterin-branded devices and for use in alliance projects. The manufacturing and operations of the biologics and medical devices divisions are organized separately while products from both are marketed through several channels, including independent distributors, joint development projects and its direct sales network.
Biologics Division
The Company�� biologics products include OsteoSponge, OsteoSponge SC, OsteoWrap, OsteoLock and BacFast, as well as certain other allograft products, such as OsteoSponge, OsteoWrap, OsteoLock and BacFast and hMatrix. OsteoSponge is a form of demineralized bone matrix made from 100% human bone. Ost! eoSponge provides a natural scaffold for cellular in-growth and exposes bone-forming proteins to the healing environment. The malleable properties of OsteoSponge enable it to conform to, and fill, defects. Upon compressing the allograft, OsteoSponge springs back to completely fill the void. Its mechanical and biological properties make OsteoSponge an bone graft for use in various orthopedic practices, including spine, neurology, cranial/maxillofacial, trauma, plastic/reconstruction and general procedures where new bone growth is needed.
OsteoSponge SC is a form of OsteoSponge designed to be used in joint surgery. Bacterin has shown, in goat studies, the ability to re-generate cartilage in joint repair and believes that this product has the potential to significantly change the standard of care in human joint surgery. OsteoWrap is 100% human cortical bone demineralized through a process to make the graft flexible while maintaining allograft integrity. This product has various applications in orthopedic, neurological, trauma, oral/maxillofacial and reconstructive procedures. OsteoWrap can wrap around non-union fractures to assist with fusion, can act as a biologic plate or can be used in conjunction with a hardware plate system. Additionally, this product provides the surgeon with superior handling characteristics as the allograft can be easily sized using surgical scissors or a scalpel, and will withhold sutures or staples for fixation.
OsteoLock and BacFast are dowels made from human bone. BacFast HD, having the same design as OsteoLock, is optimized through its demineralization technology. OsteoLock and BacFast can be used to augment spinal procedures for mild spinal conditions. hMatrix dermal scaffold is an extension of Bacterin's core biologics technology and its third human acellular biological scaffold. hMatrix is an acellular matrix made from donated human dermal tissue that is used to replace a patient's damaged tissue. hMatrix provides a natural collagen tissue scaffold! that pro! motes cellular ingrowth, tissue vascularization and regeneration. The Company makes and sells sports allografts which are processed specifically for anterior and posterior cruciate ligament repairs, anterior cruciate ligament reconstruction and meniscal repair; milled allografts, which are consists of cortical bone milled to desired shapes and dimensions, also called milled spinal allografts, and traditional allografts for multi-disciplinary applications, including orthopedics, neurology, podiatry, oral/maxillofacial, genitourinary and plastic/reconstructive.
Medical Device Products
The Company�� medical devices division researches, tests and develops coatings for medical devices, particularly antimicrobial-based coatings. This division produces and distributes OsteoSelect DBM putty, an osteoinductive product used by surgeons as bone void filler in the extremities and pelvis. OsteoSelect DBM putty is engineered with the surgeon in mind. OsteoSelect can be molded into any shape and compressed into bony voids. Its medical devices division also develops custom surgical instrument kits for use with allografts processed by its biologics division. The Company sells a surgical drain series called ViaTM, which is used to drain exudate from a surgical site. Building upon the ViaTM platform, Bacterin plans on releasing a second generation product called the Elutia surgical drains, which will be performance enhanced through an antimicrobial coating to help reduce the incidence of surgical site infection.
The Company competes with Medtronic, DePuy, Synthes, Arthrex, Smith & Nephew, Nuvasive, OrthoFix, Biomet, Osteotech, Orthovita, MTF, Stryker, RTI, AlloSource, Lifenet Health, Integra, ConMed/Linvatec, Wright, Exactech, ArthroCare, Harvest and Arteriocyte.
Advisors' Opinion: - [By Bryan Murphy]
It may not be as big as NuVasive, Inc. (NASDAQ:NUVA), and it might not be as sexy as MiMedx Group Inc. (NASDAQ:MDXG). But, Bacterin International Holdings Inc. (NYSEMKT:BONE) offers something to investors that MDXG and NUVA don't - can't - right now... a distinct opportunity for a lot of upside in a short amount of time.
- [By James E. Brumley]
Traders may not want to get married for the long haul to any of them, but for speculators looking for a quick, profitable hit, Arca Biopharma Inc. (NASDAQ:ABIO), Pluristem Therapeutics Inc. (NASDAQ:PSTI), and Bacterin International Holdings Inc. (NYSEMKT:BONE) may be better-than-average bets. Here's why.
Top 10 Medical Companies To Watch For 2015: Mast Therapeutics Inc (MSTX)
Mast Therapeutics, Inc., formerly ADVENTRX Pharmaceuticals, Inc., incorporated in December 1995, is a development-stage company biopharmaceutical company focused on developing product candidates. The Company's product candidate is ANX-188, a rheologic, antithrombotic and cytoprotective agent that improves microvascular blood flow and has application in treating a range of diseases and conditions, such as complications arising from sickle cell disease. As of December 31, 2011, the Company also is developing ANX-514, a detergent-free formulation of the chemotherapy drug docetaxel. The Company offers ANX-188 (purified poloxamer 188), ANX-514 (docetaxel for injectable emulsion) and Exelbine (vinorelbine injectable emulsion). In April 2011, the Company acquired SynthRx, Inc. In February 2014, Mast Therapeutics Inc completed its acquisition of Aires Pharmaceuticals, Inc. Aires became a wholly-owned subsidiary of Mast Therapeutics.
ANX-188 (purified poloxamer 188)
ANX-188 is an aqueous solution of a purified form of poloxamer 188. Poloxamer 188 (P1880, is a nonionic, block copolymer that has been found to improve microvascular blood flow by reducing viscosity, particularly under low shear conditions, and by reducing adhesive frictional forces. The Company�� purified form of P188 (purified P188), which is the active ingredient in ANX-188, was designed to eliminate certain low molecular weight substances present in P188 (non-purified), which is primarily responsible for the moderate to moderately severe elevations in serum creatinine levels (acute renal dysfunction) observed in prior clinical studies of P188 (non-purified). Purified P188 has been evaluated in multiple clinical studies by a prior sponsor, including a 255-patient, phase III study.
ANX-514 (docetaxel for injectable emulsion)
ANX-514 is a detergent-free emulsion formulation of docetaxel, an intravenously-injected chemotherapy drug commonly used to treat solid tumors. Taxotere, a branded form! ulation of docetaxel, is approved to treat breast, non-small cell lung, prostate, gastric, and head and neck cancers. ANX-514 was designed to have clinically comparable release of docetaxel relative to Taxotere while eliminating the presence of polysorbate 80 and ethanol, both of which are used to solubilize docetaxel in the Taxotere formulation. The ANX-514 formulation solubilizes docetaxel using oil droplets consists of a combination of non-toxic excipients. Docetaxel is contained within these oil droplets and can be administered intravenously without using detergents as pharmaceutical vehicles. Once in central circulation, the emulsion is metabolized rapidly, leaving chemically-identical active ingredient to exert its cytotoxic effect. ANX-514 may reduce the incidence and severity of hypersensitivity reactions and delay the onset of fluid retention.
Exelbine (vinorelbine injectable emulsion)
Exelbine is an emulsion formulation of the chemotherapy drug vinorelbine. Navelbine, a branded formulation of vinorelbine, is approved in the United States to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer.
In August 2011, the Company received a complete response letter from the Food and Drug Administration (FDA) stating that it could not approve the Exelbine Non Disclosure Agreement (NDA) in its present form and that the bioequivalence study would need to be repeated because the authenticity of the drug products used in the bioequivalence trial could not be verified in accordance with FDA standards. However, the Company elected to discontinue independent development of Exelbine and as of December 31, 2011, the Company was seeking a partner or outside investor for the program to complete the necessary bioequivalence study.
The Company competes with GlaxoSmithKline, Provenge and Pfizer.
Advisors' Opinion: - [By John Udovich]
The start of 2014 shows that biotech is still a hot area with the sector along with small cap biotech stocks like AMAG Pharmaceuticals, Inc (NASDAQ: AMAG), Mast Therapeutics Inc (NYSEMKT: MSTX), Cell Therapeutics Inc (NASDAQ: CTIC), Imprimis Pharmaceuticals Inc (NASDAQ: IMMY) and TNI BioTech (OTCMKTS: TNIB) producing news or returns�plus Auspex Pharmaceuticals (NASDAQ: ASPX), Cara Therapeutics (NASDAQ: CARA), Egalet (NASDAQ: EGLT), Flexion Therapeutics (NASDAQ: FLXN) and Ultragenyx Pharmaceutical (NASDAQ: RARE) are among the (many�� planned biotech IPOs that have recently been announced publicly:
- [By Lauren Pollock]
Mast Therapeutics Inc.(MSTX) said the U.S. Food and Drug Administration gave orphan-drug designation to its MST-188 drug for the treatment of acute limb ischemia, providing a boost for the biopharmaceutical firm. Shares surged.
- [By James E. Brumley]
A little over a month ago, owning Mast Therapeutics, Inc. (NYSE: MSTX) was nothing but pure misery. Shares plunged from $0.63 to $0.43 in one day, when details of a dilutive public offering were unveiled. As is so often the case though, the market may have overshot with the selling effort that KO's MSTX. Though putting more shares 'out there' mathematically meant existing shareholders would have to share more of the company's upside with newcomers, what's slowly coming to light is that the inflow of new cash is still more advantageous to those prior shareholders; the company would progress little without it.
Top 10 Medical Companies To Watch For 2015: StemCells Inc (STEM)
StemCells, Inc. (StemCells), incorporated in August 1988, is engaged in the research, development, and commercialization of stem cell therapeutics and related tools and technologies for academia and industry. The Company is focused on developing and commercializing stem and progenitor cells as the basis for therapeutics and therapies, and cells and related tools and technologies to enable stem cell-based research and drug discovery and development. The Company�� primary research and development efforts are focused on identifying and developing stem and progenitor cells as potential therapeutic agents. The Company has two therapeutic product development programs, including its CNS Program, which is developing applications for HuCNS-SC cells, its human neural stem cell product candidate, and its Liver Program, which is characterizing the Company�� human liver cells as a therapeutic product.
CNS Program
The Company in its CNS Program, is in clinical development with its HuCNS-SC cells for a range of disorders of the central nervous system. The CNS includes the brain, spinal cord and eye. In February 2012, the Company had completed a Phase I clinical trial in Pelizeaus-Merzbacher Disease (PMD), a fatal myelination disorder in the brain.
The Company�� CNS Program is focused on developing clinical applications, in which transplanting HuCNS-SC cells protect or restore organ function of the patient before such function is irreversibly damaged or lost due to disease progression. The Company�� initial target indications are PMD, and more generally, diseases in which deficient myelination plays a central role, such as cerebral palsy or multiple sclerosis; spinal cord injury, disorders in which retinal degeneration plays a central role, such as age-related macular degeneration or retinitis pigmentosa. The Company�� product candidate, HuCNS-SC cells, is a purified and expanded composition of normal human neural stem cells. Its HuCNS-SC cells can be directly transp! lanted.
Liver Program
Liver stem or progenitor cells offer an alternative treatment for liver diseases. A liver cellular therapy or cell-based therapeutic provide or support liver function in patients with liver disease. The Company held a portfolio of issued and allowed patents in the liver field, which cover the isolation and use of both hLEC cells and the isolated subset, as well as the composition of the cells themselves.
The Company�� range of cell culture products, which are sold under the SC Proven brand, includes iSTEM, GS1-R, GS2-M, RHB-A, RHB-Basal, NDiff N2, and NDiff N2B27. Its iSTEM is a serum-free, feeder-free medium that maintains mouse embryonic stem cells in their pluripotent ground state by using selective small molecule inhibitors to block the pathways, which induce differentiation. RHB-A is a defined, serum-free culture medium for the selective culture of human and mouse neural stem cells and their maintenance and expansion as adherent cell populations. RHB-Basal is a defined, serum-free basal medium. When supplemented with specific growth factors, this media is formulated for the propagation and differentiation of adherent neural stem cells. RHB-Basal can also be tailored to specific-cell type requirements by the addition of customer preferred supplements.
The Company�� NDiff N2 is a defined serum-free scell culture supplement for the derivation, maintenance, expansion and/or differentiation of human and mouse embryonic stem (ES) cells and tissue-derived neural stem cells supplement. Its NDiff N2-AF is a serum-free and animal component-free version of NDiff N2. Its NDiff N2B27 is a defined, serum-free medium for the differentiation of mouse embryonic stem cells to neural cell types. NDiff N27-AF is a serum-free and animal component-free version of NDiff N27. Its GS1-R is a serum-free media formulation shown to enable the derivation and long-term maintenance of true, germline competent rat embryonic stem cells without the add! ition of ! cytokines or growth factors. Its GS2-M is a defined, serum- and feeder-free medium for the derivation and long-term maintenance of true, germline competent mouse iPS cells.
The Company also markets a number of antibody reagents for use in cell detection, isolation and characterization. These reagents are also under the SC Proven brand and it includes STEM24, STEM101, STEM121 and STEM123. Its STEM24 is a human antibody that recognizes human CD24, also known as heat stable antigen (HSA), a glycoprotein expressed on the surface of many human cell types, including immature human hematopoietic cells, peripheral blood lymphocytes, erythrocytes and many human carcinomas. Its CD24 is also a marker of human neural differentiation. Its STEM101 is a human-specific mouse antibody that recognizes the Ku80 protein found in human nuclei. Its STEM121 is a human-specific mouse antibody that recognizes a cytoplasmic protein of human cells. Its STEM123 is a human-specific mouse antibody that recognizes human glial fibrillary acidic protein (GFAP).
The Company�� Other products marketed under SC Proven include total cell genomic DNA (gDNA), RNA and protein lysate reagents purified from homogenous stem cell populations for intra-comparative studies, such as Epigenetic fingerprinting, Southern, Western and Northern blots, PCR, RT-PCR and microarrays. This range of purified stem cell line lysates includes mouse embryonic stem (ES) cells propagated in SC Proven 2i inhibitor-based GS2-M media and mouse ES cell-derived and fetal tissue-derived neural stem (NS) cells propagated in SC Proven RHB-A media.
Advisors' Opinion: - [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
- [By James E. Brumley]
When an investor thinks of spinal-related stem cell stocks, usually a name like Neuralstem, Inc (NYSEMKT: CUR) or StemCells Inc (NASDAQ: STEM) comes to mind. And well they should. STEM has logged some amazing breakthroughs in the field of spinal cord repair, while CUR has done the same. Not all back problems are spinal cord related though. In fact, most back problems - and therefore the most opportunity - are bone and disc related problems. That's where a young gun like BioRestorative Therapies (OTCBB: BRTX) can step in and make stem cell waves. BRTX has developed an approach to rejuvenate and revive failing spinal discs, potentially ending pain for millions of back-pain sufferers, and circumventing expensive spinal surgeries that are in increasing burden on insurance companies.
Top 10 Medical Companies To Watch For 2015: 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.
Advisors' Opinion: - [By MONEYMORNING]
Hemispherix Biopharma Inc. (NYSE: HEB) is a specialty pharmaceutical company. It engages in the clinical development of new drug therapies based on natural immune system enhancing technologies and targets the treatment of viral and immune-based clinical disorders. The Philadelphia, Pa.-headquartered company gained widespread attention over the last several months for its work on flu research. Its flagship products include Alferon N Injection, approved by the FDA for a category of sexually transmitted disease infection. Experimental treatments include Ampligen and Oragens, in development stages for the potential treatment of global viral diseases and disorders of the immune system including human papilloma virus, human immunodeficiency virus, chronic fatigue syndrome, hepatitis, and influenza. Shares have traded as low as $0.18 and as high as $0.55 over the last year. At last check, shares were changing hands around $0.50 on volume of 2 million shares.
Top 10 Medical Companies To Watch For 2015: 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�� 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�� six clinical stage therapeutic candidates include RHB-101, RHB-102, RHB-103, RHB-104, RHB-105 and RHB-106.
RHB-101
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
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
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
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
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
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.
Advisors' Opinion: Top 10 Medical Companies To Watch For 2015: Tonix Pharmaceuticals Holding Corp (TNXP)
Tonix Pharmaceuticals Holding Corp., incorporated on November 16, 2011, is a specialty pharmaceutical company focused on developing novel pharmaceutical products for disorders of the central nervous system (CNS). The Company develops TNX-102 sublingual tablet, or TNX-102 SL. TNX-102 SL is a novel dose and formulation of cyclobenzaprine (CBP), the active pharmaceutical ingredient of two prescribed muscle relaxant products, Flexeril and Amrix. TNX-102 SL is also intended for chronic use. It develops TNX-102 SL for the treatment of FM under a United States Investigational New Drug application (IND), and under three clinical trial applications (CTAs), filed in Canada. It also develops TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD). As of January 25, 2013, the Company focuses on product development, and had not generated any revenues.
The Company searches for potential therapeutic solutions among known pharmaceutical agents that lack regulatory approval for the indications it seeks, but may be approved for use in other indications. It seeks to create new dose and formulation options that are tailored to the therapeutic uses to which it applies these agents. TNX-102 SL is a small, rapidly disintegrating tablet containing CBP for sublingual administration at bedtime. The Company designed TNX-102 SL for delivery of CBP to the systemic circulation through sublingual transmucosal absorption and to avoid first-pass liver metabolism.
CBP is the active pharmaceutical ingredient in its lead product candidate, TNX-102 SL. In addition to CBP, TNX-102 SL contains inactive ingredients, called excipients, which are approved for pharmaceutical use. In addition to TNX-102 SL, it develops other formulations of CBP, including TNX-102 promicellar gelatin capsule, or TNX-102 gelcap. It developed TNX-102 gelcap under an agreement with Lipocine, Inc. (Lipocine), a contract formulation developer and small-scale manufacturer. In addition it has other pipeline of other product cand! idates, including TNX-201 and TNX-301. TNX-201 is based on isometheptene mucate and is under development as a treatment for certain types of headaches.
Advisors' Opinion: - [By John Udovich]
It�� a new year and the first one and a half trading weeks of 2014 has not disappointed biotech investors as the sector and mid cap or small cap biotech or�pharma stocks like Intercept Pharmaceuticals Inc (NASDAQ: ICPT), Epizyme Inc (NASDAQ: EPZM), Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP) and TNI BioTech Inc (OTCQB: TNIB) either surging or producing some news plus there have been IPO filings for future listings for�Flexion Therapeutics (NASDAQ: FLXN), Aldexa Therapeutics (NASDAQ: ALDX), Retrophin (NASDAQ:�RTRX) and Dicerna Pharmaceuticals (NASDAQ: DRNA). Consider the following news so far this year:
- [By John Kell]
Tonix Pharmaceuticals Holding Corp.(TNXP) is planning to offer some shares to raise money to fund clinical trials and the continued development of the specialty pharmaceutical company’s treatments. Shares edged up 2.1% to $16.75 premarket.
