The biotech sector has been hot this year with�small cap biotech stocks�Fate Therapeutics Inc (NASDAQ: FATE),�Omeros Corporation(NASDAQ: OMER) and TNI BioTech (OTCMKTS: TNIB) being among those biotech stocks in the news this week. However, there has also been talk�and perhaps�some signs of a bubble in biotech that investors and traders alike need to consider. With that in mind, here is a recap of the latest news for biotech or small cap biotech stocks:
Understanding What�� Driving the Performance of the Biotech Sector Right Now. JMP Securities' Mark Lehmann was recently on Bloomberg Television's "Street Smart��to�talk about�what is driving the biotech sector�� stellar performance. Mark noted the sector is being driven by optimism (as in when some things are working, more investors want to get in) and M&A activity because when a biotech gets taken over, investors (especially fund managers) need to find an alternative to invest in���such as small cap biotech stocks. Mark also pointed out that the JMP Securities' small cap biotech index is a good gauge for the sector because as soon as a small cap biotech goes over the $750 million mark, they yank it from the index. Finally, Mark noted that over the last 12 months, life sciences IPOs have averaged 50% to 60% gains and some are over 200%. Canadian Biotechs or Health Care Stocks Are Hard to Find. If you are an investor north of the border, the Globe and Mail has a lengthy article about how there are�only a few mid- to large-cap companies in the health sector in Canada and fewer still that pay dividends. The choices for investors is also set to get smaller as CML HealthCare Inc. is set to be taken over by its�private rival, LifeLabs Medical Laboratory Services. However, Alan Ridgeway, an analyst at Paradigm Capital Inc., was quoted as saying: ��here are lots of small caps, and there are some really interesting small caps, but it is such a different risk profile than CML.�� The Fate Therapeutics IPO Flops. FierceBiotech.com has noted how the IPO for Fate Therapeutics, a biopharmaceutical company focused on the discovery and development of adult stem cell modulators, was supposed to involve 4.6 million shares at $14 to $16 to raise up to $73.6 million. However, Fate Therapeutics went public earlier this week at only�only $6 a share to raise�$40 million on the sale of 6.7 million discounted shares. The Fate Therapeutics� is the 38th biotech to go public this year and some observers are expressing concern that the market�� appetite for new biotech IPOs may be waning. Omeros Corporation Surges on Good News. Small cap Omeros Corporation, a clinical-stage biopharmaceutical company�focused on�discovering, developing and commercializing small-molecule and protein therapeutics targeting inflammation, coagulopathies and disorders of the central nervous system,�has surged for two days in a row (its up over 35% since Tuesday) after announcing�that the New Drug Application (NDA) for its experimental eye-surgery drug, OMS302, has been confirmed for filing by US and European regulators. Wall Street expects the FDA to make an approval decision on OMS302 in the middle of next year. In addition, Omeros Corporation announced a�settlement agreement with its insurer, Carolina Casualty Insurance Company (CCIC), related to CCIC's defense of, and coverage of obligations owed to the company and its CEO and chairman, Gregory A. Demopulos, M.D., in previously settled litigation with�OMER�� former chief financial officer. What happened was the CFO had�claimed that he was wrongfully dismissed while Omeros Corporation settled the case in 2012 by�making a one-time payment of $3.94 million, which included legal costs, while the insurance company will pay�OMER $12.5 million to handle related costs. Omeros Corporation shares are now up 148.7% since the start of the year, up 40.7% over the past year and up 56.4% over the past five years. TNI BioTech Makes Important Announcements. TNI BioTech, which was formed in 2012 to�acquire patents, develop treatments, market and license immunotherapies for the treatment of cancer, HIV/AIDS and autoimmune diseases, has announced that its subsidiary,�TNI BioTech International, Ltd., has signed a distribution agreement with a Nigerian company called AHAR Pharma to market Lodonal��in Nigeria for the treatment of autoimmune diseases and cancer. TNI BioTech says that under the agreement, AHAR will generate just over $53,000,000 in gross revenue for�the company�in 2014 with approximate $21,000,000 in available cash flow to meet TNIB�� financial clinical trial commitments. AHAR has also�pre-paid for the API necessary for the soft launch and has committed to purchase a minimum of $1,000,000 of capsules between now and January 2014. Previously, TNI BioTech�had�announced a manufacturing and supply�agreement with Laboratorios Ramos for the production of Low Dose Naltrexone (��DN���and gave a�financing update which noted the company has�received $826,250 as consideration for the exercise of previously-issued warrants and $531,250 for the purchase of common stock under the Private Placement (for an aggregate sum of $1,357,500).
Top 10 Medical Companies To Own For 2014: Curis Inc.(CRIS)
Curis, Inc., a drug discovery and development company, focuses on the research and development of cancer therapeutics. The company, under collaboration with Genentech, Inc., is conducting a pivotal Phase II clinical trial on its lead molecule, GDC-0449 in advanced basal cell carcinoma patients, as well as various Phase II clinical trials in first-line metastatic colorectal cancer and advanced ovarian cancer patients. It is also evaluating CUDC-101, a small molecule that is in a Phase I clinical testing and is designed to target histone deacetylase, epidermal growth factor receptor, and epidermal growth factor receptor 2. In addition, Curis has a development candidate, Debio 0932, which is a Heat Shock Protein 90 or Hsp90 inhibitor. The company holds a license agreement with Debiopharm related to its Hsp90 technologies. Further, it involves in preclinical testing for the development of candidates from its targeted cancer programs. The company was founded in 2000 and is base d in Lexington, Massachusetts.
Top 10 Medical Companies To Own For 2014: Myriad Genetics Inc (MYGN)
Myriad Genetics, Inc. (Myriad) is a molecular diagnostic company. The Company is focused on developing and marketing predictive medicine, personalized medicine and prognostic medicine tests. It performs all of its molecular diagnostic testing and analysis in its own reference laboratories. These technologies include the cornerstone technologies of biomarker discovery, high-throughput deoxyribo nucleuc acid (DNA) sequencing, ribo nucleic acid (RNA) expression and multiplex protein analysis. The Company uses this information to guide the development of new molecular diagnostic tests that are designed to assess an individual's risk for developing disease later in life (predictive medicine), identify a patient's likelihood of responding to drug therapy and guide a patient's dosing to ensure optimal treatment (personalized medicine), or assess a patient's risk of disease progression and disease recurrence (prognostic medicine).
As of June 30, 2012, the Company had launched nine commercial molecular diagnostic tests. The Company markets these tests through its own approximate 385-person sales force in the United States. The Company also markets its BRACAnalysis, COLARIS, and COLARIS AP tests through its own European sales force and have entered into marketing collaborations with other organizations in selected Latin American, European and Asian countries. The Company also generates revenue by providing companion diagnostic services to the pharmaceutical, and biotechnology industries and medical research institutions utilizing its multiplexed immunoassay technology.
Molecular Diagnostic Tests
The Company's molecular diagnostic tests are designed to analyze genes, their mutations, expression levels and proteins to assess an individual's risk for developing disease later in life, determine a patient's likelihood of responding to a particular drug, assess a patient's risk of disease progression and disease recurrence and measure a patient's exposure to drug therapy to ensu! re optimal dosing and reduced drug toxicity. The Company's BRACAnalysis test is a analysis of the BRCA1 and BRCA2 genes for assessing a woman's risk of developing hereditary breast and ovarian cancer. BRACAnalysis accounted for 81.7% of the Company's total revenue during the fiscal year ended June 30, 2012. Its The Company's COLARIS test is an analysis of the MLH1, MSH2, MSH6 and PMS2 genes for assessing a person's risk of developing colorectal cancer or uterine cancer.
The Company's COLARIS AP test detects mutations in the APC and MYH genes, which cause a colon polyp-forming syndrome known as Familial Adenomatous Polyposis (FAP), a more common variation of the syndrome known as attenuated FAP, and the MYH-associated polyposis signature (MAP). The Company's MELARIS test analyzes mutations in the p16 gene to determine genetic susceptibility to malignant melanoma. The Company's OnDose test is a nanoparticle immunoassay that is designed to assist oncologists in optimizing 5-FU (fluorouracil) anti-cancer drug therapy in colon cancer patients on an individualized basis. The Company's PANEXIA test is a comprehensive analysis of the PALB2 and BRCA2 genes for assessing a person's risk of developing pancreatic cancer later in life. The Company's PREZEON test is an immunohistochemistry test that analyzes the PTEN gene and assesses loss of PTEN function in many cancer types.
The Company's Prolaris test is a 46-gene molecular diagnostic assay that assesses whether a patient is likely to have a slow growing, indolent form of prostate cancer that can be safely monitored through active surveillance, or a more aggressive form of the disease that would warrant aggressive intervention, such as a radical prostatectomy or radiation therapy. The Company's TheraGuide 5-FU test analyzes mutations in the DPYD gene and variations in the TYMS gene to assess patient risk of toxicity to 5-FU (fluorouracil) anti-cancer drug therapy.
Companion Diagnostic Services and Other Revenue
! Through M! yriad RBM Inc., the Company provides biomarker discovery and companion diagnostic services to the pharmaceutical, biotechnology, and medical researches industries utilizing its multiplexed immunoassay technology. The Company's technology enables the Company to screen large sets of clinical samples from both diseased and non-diseased populations against the Company's menu of biomarkers. The Company's companion diagnostic services consist of Multi-Analyte Profile (MAP), Multiplexed Immunoassay Kits and TruCulture.
The Company has compiled a library of over 550 individual human and rodent immunoassays for use in its multi-analyte profile (MAP) testing services. The Company has also developed RodentMAP, a panel for use in pre-clinical animal studies and OncologyMAP, which measures cancer-related proteins to assists researchers accelerate the pace of discovery, validation and translation of cancer biomarkers for early detection, patient stratification and therapeutic monitoring. The Company has developed multiplexed immunoassay kits that enable its customers to leverage its technology services with their in-house capabilities. The Company's internally developed multiplexed immunoassay kits include all of the components necessary for a customer to perform a test on their own Luminex instrument. TruCulture is a simple, self-contained whole blood culture that can be deployed to clinical sites around the world for acquiring cell culture data without specialized facilities or training.
Advisors' Opinion: - [By John Udovich]
On Monday, small cap molecular diagnostic stock Myriad Genetics, Inc (NASDAQ: MYGN) suddenly sank 9.34% to $23.50 just before the market closed���meaning its probably a good idea to take a closer look at what happened yesterday plus compare the stock�� performance verses small cap peer Sequenom, Inc (NASDAQ: SQNM) and mid cap peer Hologic, Inc (NASDAQ: HOLX).�
- [By Sean Williams]
Preventative treatments
In terms of preventative measures, genetic companies have made big strides over the past couple of decades with regard to disease detection. Myriad Genetics (NASDAQ: MYGN ) , for example, offers the BRACAnalysis genetic test to help determine if patients carry the BRCA1 or BRCA2 gene mutation that's responsible for a majority of hereditary breast and ovarian cancers. In addition to having a higher propensity to developing breast or ovarian cancer, BRCA1 or BRCA2 gene carriers are more susceptible to developing a second primary cancer. This test offered by Myriad gives patients a quick answer as to whether they're a carrier, helping them determine the next best course of action, which can include increased cancer screenings, hormone therapy, or, in Jolie's case, a preventative mastectomy.
- [By Dan Radovsky]
Myriad Genetics (NASDAQ: MYGN ) , almost one month after a landmark ruling in the U.S. Supreme Court both undermined and supported the company's claim of patents for the BRCA1 and BRCA2 genes, has filed suit against a company it says has infringed on those patents.
- [By Tim Brugger]
In a recent U.S. Supreme Court decision, a patent claim involving Myriad Genetics' (NASDAQ: MYGN ) complementary DNA, or cDNA, has been upheld, according to a company announcement. In addition to Myriad's patent victory, however, five of its isolated DNA-related claims were denied by the court.
Hanger Orthopedic Group, Inc. engages in the ownership and operation of orthotic and prosthetic (O&P) patient care centers in the United States. The company provides orthotic and prosthetic patient care services. Its orthotics business include the design, fabrication, fitting, and maintenance of a range of standard and custom-made braces and other devices that provide external support to patients suffering from musculoskeletal disorders, such as ailments of the back, extremities or joints, and injuries from sports or other activities. The company?s prosthetics business comprise designing, fabricating, fitting, and maintaining custom-made artificial limbs for patients, who are without limbs as a result of traumatic injuries, vascular diseases, diabetes, cancer, or congenital disorders. It also distributes branded and private label O&P devices, as well as develops programs to manage various aspects of O&P patient care for insurance companies. In addition, the company manufac tures and distributes therapeutic footwear for diabetic patients in the podiatric market, as well as develops and provides specialized rehabilitation technologies and integrated clinical programs to rehabilitation providers. As of June 30, 2011, it operated approximately 675 patient-care centers in 45 states and the District of Columbia. The company, formerly known as Sequel Corporation, was founded in 1861 and is headquartered in Austin, Texas.
Top 10 Medical Companies To Own For 2014: Galectin Therapeutics Inc (GALT)
Galectin Therapeutics Inc., formerly Pro-Pharmaceuticals, Inc., incorporated on January 26, 2001, is a development-stage company. The Company is engaged in drug development to create therapies for cancer and fibrotic disease. As of December 31, 2011, the Company has two compounds in development, one is to be used in cancer therapy and the other intended to be used in the treatment of liver fibrosis and fatty liver disease. These two compounds are produced from different natural starting materials, both possessing the property, which lends itself to binding to and inhibiting galectin proteins. GM-CT-01, the Company's product candidate for cancer therapy, is a linear polysaccharide polymer consisted of mannose and galactose that has a defined chemical structure and is derived from a plant source. GR-MD-02, the Company's product for treatment of liver fibrosis and fatty liver disease with inflammation and fibrosis, is a polysaccharide polymer possessing both linear and globular structures, which also is derived from a plant source.
GM-CT-01 has in development for the therapy of colorectal cancer and is in a Phase I/II clinical trial as a combination therapy with a tumor vaccine in patients with advanced melanoma. Based on the completed Phase I and partially completed Phase II clinical trials, the Company is exploring two additional potential indicia for the use of GM-CT-01 in combination with cancer chemotherapy. There are two additional pathways for the development of GM-CT-01 for use in treatment of cancer. GM-CT-01 was found to be generally safe when studied in a Phase I clinical trial in end-stage cancer patients with multiple tumor types alone and in combination with 5-Fluorouracil (5-FU), which is an Food and Drug Administration (FDA)-approved chemotherapy used for treatment of various types of cancer.
Advisors' Opinion: - [By Roberto Pedone]
Galectin Therapeutics (GALT) offers drug research and development to create new therapies for fibrotic disease and cancer. This stock closed up 9.6% to $12.06 in Monday's trading session.
Monday's Volume: 674,000
Three-Month Average Volume: 222,171
Volume % Change: 149%
Shares of GALT jumped higher on Monday after Ascendiant initiated coverage on the stock with a buy recommendation.
From a technical perspective, GALT spiked sharply higher here with strong upside volume. This stock has been uptrending for the last three months, with shares ripping higher from its low of $3.95 to its recent high of $13.21. During that move, shares of GALT have been making mostly higher lows and higher highs, which is bullish technical price action. That move has now pushed shares of GALT within range of triggering a near-term breakout trade. That trade will hit if GALT manages to take out Monday's high of $12.44 and then once it clears its 52-week high at $13.21 with high volume.
Traders should now look for long-biased trades in GALT as long as it's trending above some near-term support levels at $11 or at $10 and then once it sustains a move or close above those breakout levels with volume that hits near or above 222,171 shares. If that breakout hits soon, then GALT will set up to enter new 52-week-high territory above $13.21, which is bullish technical price action. Some possible upside targets off that breakout are $15 to $16.
Top 10 Medical Companies To Own For 2014: Cell Therapeutics Inc (CTIC.A)
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 acquisi tion 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 co mplete response compared to patients treated with standard! c! hemotherapy 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 pacli taxel 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 respons iveness to TMZ. A phase I/II study of OPAXIO combined ! with r! a! diothera! py 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 synd rome (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, Cel! gene, Tel! ik! , Inc., T! EVA Pharmaceuticals Industries Ltd. and PharmaMar.
Top 10 Medical Companies To Own For 2014: Organovo Holdings Inc (ONVO.PK)
Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.�� (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.
The C ompany has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.
The Company�� NovoGen MMX Bioprinter is an aut! om! ated device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.
The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.
Top 10 Medical Companies To Own For 2014: InspireMD Inc (NSPR.A)
InspireMD, Inc., incorporated on February 29, 2008, is a medical device company. The Company is focusing on the development and commercialization of its stent platform technology, MGuard. MGuard provides embolic protection in stenting procedures by placing a micron mesh sleeve over a stent. Its initial products are marketed for use mainly in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions (bypass surgery). The Company�� products include MGuard Coronary Plus Bio-Stable Mesh, MGuard Peripheral Plus Bio-Stable Mesh, MGuard Carotid Plus Bio-Stable Mesh and MGuard Coronary Plus Bio-Absorbable Drug-Eluting Mesh. Its initial MGuard Coronary products incorporated a stainless steel stent. The Company subsequently replaced this stainless steel platform with a more advanced cobalt-chromium based platform, which the Company refers to as the MGuard PrimeTM version of its MGuard Coronary. The Company operates in Germany through its wholly owned subsidiary InspireMD GmbH.
The Company focuses on applying its technology to develop additional products used for other vascular procedures, specifically carotid (the arteries that supply blood to the brain) and peripheral (other arteries) procedures. The MGuard stent is an embolic protection device based on a protective sleeve, which is constructed out of an ultra-thin polymer mesh and wrapped around the stent. The protective sleeve is comprised of a micron level fiber-knitted mesh, engineered in an optimal geometric configuration and designed for utmost flexibility while retaining strength characteristics of the fiber material.
MGuard - Coronary Applications
The Company�� MGuard Coronary with a bio-stable mesh and its MGuard Coronary with a drug-eluting mesh focuses on the treatment of coronary arterial disease. The Company�� first MGuard product, the MGuard Coronary with a bi o-stable mesh, is comprised of its mesh sleeve wrapped arou! n! d a bare-metal stent. The bio-absorbability of MGuard Coronary with a drug eluting bio-absorbable mesh is intended to improve upon the bio-absorbability of other drug-eluting stents, in light of the wide surface area of the mesh and the small diameter of the fiber.
MGuard - Carotid Applications
The Company focuses on marketing its mesh sleeve coupled with a self-expandable stent for use in carotid-applications. Expandable stent is a stent that expands without balloon dilation pressure or need of an inflation balloon. This product is under development, although the Company has temporarily delayed its development until additional funding is secured.
MGuard - Peripheral Applications
Peripheral Artery Disease, also known as peripheral vascular disease, is characterized by the accumulation of plaque in arteries in the legs, need for amputation of affected joints or even death, when untreated. Peripheral Artery Disease is treated either by trying to clear the artery of the blockage, or by implanting a stent in the affected area to push the blockage out of the way of normal blood flow.
The Company competes with Abbott Laboratories, Boston Scientific Corporation, Johnson & Johnson, Medtronic, Inc., The Sorin Group, Xtent, Inc., Cinvention AG, OrbusNeich, Biotronik SE & Co. KG, Svelte Medical Systems, Inc., Reva Inc. and Stentys SA.
Top 10 Medical Companies To Own For 2014: Galena Biopharma Inc (GALE)
Galena Biopharma, Inc. (Galena), formerly RXi Pharmaceuticals Corporation, incorporated on April 3, 2006, is a biotechnology company focused on discovering, developing and commercializing therapies addressing unmet medical needs using targeted biotherapeutics. The Company is pursuing the development of cancer therapeutics using peptide-based immunotherapy products, including its main product candidate, NeuVaxTM (E75), for the treatment of breast cancer and other tumors. NeuVax is a peptide-based immunotherapy intended to reduce the recurrence of breast cancer in low-to-intermediate HER2-positive breast cancer patients not eligible for trastuzumab (Herceptin; Genentech/Roche). On January 19, 2012, the Company initiated enrollment in its Phase 3 PRESENT clinical trial for NeuVax (E75 peptide plus GM-CSF) vaccine in low-to-intermediate HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence (Clinicaltrials.gov identifier NCT01479244). The Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment study is a randomized, multicenter, multinational clinical trial that will enroll approximately 700 breast cancer patients. The Company�� Phase 2 trial of NeuVax achieved its primary endpoint of disease-free survival (DFS). On April 13, 2011, the Company completed its acquisition of Apthera, Inc.,(Apthera).
The Company focuses to start a Phase 2 trial comparing NeuVax in combination with trastuzumab (Herceptin) versus trastuzumab, alone, in a 300-patient, randomized study in the adjuvant breast cancer setting. The Company's second product candidate, Folate Binding Protein-E39 (FBP), is a vaccine, consisting of the peptides E39 and J65, aimed at preventing the recurrence of ovarian, endometrial, and breast cancers. On February 14, 2012, the Company announced the initiation of a Phase 1/2 clinical trial in two gynecological cancers: ovarian and endometrial adenocarcinomas. Folate binding protein has ! very limited tissue distribution and expression in non-malignant tissue and is over-expressed in more than 90% of ovarian and endometrial cancers, as well as in 20% to 50% of breast, lung, colorectal and renal cell carcinomas.
In April 2011, the Company acquired Apthera Inc and its NeuVax product candidate. The Company focuses on developing a pipeline of immunotherapy product candidates for the treatment of various cancers based on the E75 peptide, the advanced of which is NeuVax, which is targeted at preventing the recurrence of breast cancer. NeuVax has had positive Phase 1/2 clinical trial results for the prevention of breast cancer recurrence in patients who have had breast cancer and received the standard of care treatment (surgery, chemotherapy, radiotherapy and hormonal therapy as indicated). The Company had also initiated its Phase 3 PRESENT clinical trial of NeuVax for the prevention of breast cancer recurrence in early-stage low-to-intermediate HER2 breast cancer patients. NeuVax directs killer T-cells to target and destroy cancer cells that express HER2/neu, a protein associated with epithelial tumors in breast, ovarian, pancreatic, colon, bladder and prostate cancers. NeuVax is comprised of a HER2/neu-derived peptide called E75. E75 is a nine-amino acid sequence that is immunogenic (produces an immune response) and GM-CSF is a commercially available protein that acts to stimulate and activate components of the immune system such as macrophages and dendritic cells.
The Company also develops novel applications for NeuVax based on preclinical studies and phases 2 clinical trials which suggest that combining NeuVax and trastuzumab (Herceptin; Genentech/Roche) can increase antigen presentation by tumor cells by promoting receptor internalization and subsequent proteosomal degradation of the HER2 protein. The Company also is pursuing additional therapeutic indications for NeuVax that are in Phase 1/2 clinical trials. RXI-109, is a dermal anti-scarring therapy that targets! connecti! ve tissue growth factor (CTGF) and that may inhibit connective tissue formation in human fibrotic disease.
The Company competes with Roche Laboratories, Inc., Pfizer Inc., Bayer HealthCare AG, Sanofi-Aventis, US, LLC, Amgen, Inc., GlaxoSmithKline plc, Renovo Group plc, CoDa Therapeutics, Inc., Sirnaomics, Inc., FirstString Research, Inc., Merz Pharmaceuticals, LLC, Capstone Therapeutics, Halscion, Inc., Garnet Bio Therapeutics, Inc., AkPharma Inc., Promedior, Inc., Kissei Pharmaceutical Co., Ltd., Eyegene, Derma Sciences, Inc., Healthpoint Biotherapeutics, Pharmaxon, Excaliard Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Marina Biotech, Inc., Tacere Therapeutics, Inc., Benitec Limited, OPKO Health, Inc., Silence Therapeutics plc, Quark Pharmaceuticals, Inc., Rosetta Genomics Ltd., Lorus Therapeutics, Inc., Tekmira Pharmaceuticals Corporation, Arrowhead Research Corporation, Regulus Therapeutics Inc. and Santaris.
Advisors' Opinion: - [By Sean Williams]
The waiting game
The tables are clearly stacked against small biotech companies developing cancer drugs. History has shown that few (if any) have successfully had the Food and Drug Administration approve a late-stage cancer drug. While mid-stage trials of Galena Biopharma's (NASDAQ: GALE ) HER2-targeting breast cancer vaccine have been promising thus far, the chances of an approval seem a long way off.
- [By Paul Ausick]
Stocks on the move: Galena Biopharma Inc. (NASDAQ: GALE) is down 15.4% at $1.93 after pricing a secondary offering of 17.5 million units at $2.00. Safeway Inc. (NYSE: SWY) is up 6.1% at $28.21, after an analyst�� upgrade which sent shares to a new 52-week high of $28.88 earlier. Avanir Pharmaceuticals Inc. (NASDAQ: AVNR) is down 18.2% at $4.08.
Top 10 Medical Companies 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 WALLSTCHEATSHEET.COM]
Celgene has new drugs that should boost revenue. The pipeline potential is strong, profits have been growing, and guidance is good. If the market takes a hit, then Celgene will take a hit with it, but it should hold up better than most stocks throughout the broader market. If the market holds up or continues its relentless ascent, then Celgene should see future gains.
- [By Keith Speights]
Celgene (NASDAQ: CELG ) did it again. Investors have grown accustomed to the company reporting solid numbers with its earnings announcements. Celgene's second quarter adds another log to the fire for this smoking hot biotech. Here are the three things you need to know from the latest results.
- [By Sean Williams]
Kyprolis won't have a completely clear path to success in spite of its rapid sales ascent due to the accelerated approval of Celgene's (NASDAQ: CELG ) Pomalyst in February. Kyprolis delivered a slightly better median duration of response at 7.8 months versus 7.4 months, yet Pomalyst combined with a low-dose dexamethasone produced a higher overall response rate of 29.2% as compared to 23% for Kyprolis. I feel that the multiple myeloma market is certainly big enough, and in need of any help it can get, that both drugs will be accommodated.
Top 10 Medical Companies To Own For 2014: RXi Pharmaceuticals Corp (RXII)
RXi Pharmaceuticals Corporation (RXi), incorporated on September 8, 2011, is a development-stage company. The Company is a biotechnology company focused on discovering, developing and commercializing therapies addressing medical needs using RNA interference (RNAi)-targeted technologies. As of July 12, 2012, RXi was focusing on its internal therapeutic development efforts in fibrosis. RXI-109 is its RNAi product candidate, which is a dermal anti-scarring therapy that targets connective tissue growth factor (CTGF). The Company�� therapeutic platform consists of two main components: RNAi Compounds (rxRNA) and Advanced Delivery Technologies. RNAi compounds include rxRNAori, rxRNAsolo and sd-rxRNA, or self-delivering RNA. On April 26, 2012, it completed the spin-off transaction from Galena Biopharma, Inc. (Galena).
In January 2011, the Company announced research results in collaboration with Generex Biotechnology Corporation, and RXi�� wholly owned subsidiary Antigen Express, Inc., in developing vaccine formulations for immunotherapy. In January 2011, it announced initial results as part of its collaboration with miRagen Therapeutics, Inc. in creating microRNA mimics, or artificial copies of microRNAs, using the Company�� sd-rxRNA technology. In February 2011, it announced the initiation of RXi�� development program for RXI-109.
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