Medical device maker Techne (NASDAQ: TECH ) announced today that it's taking a 100% ownership stake in�Bionostics Holdings for $104 million cash.
Headquartered in�Devens, Mass.,�Bionostics makes proprietary quality control devices for diagnostic testing equipment and has�strategic supply relationships with virtually all global in vitro diagnostic-device OEMs.�Controls for blood glucose and blood gas devices are the largest portion of Bionostics' business, which generated�approximately�$29.3 million in revenues�for fiscal year 2012 that ended last Aug. 31.
Techne President and CEO�Charles R. Kummeth said: "The addition of Bionostics adds capabilities in exciting new areas like coagulation and expands our controls portfolio, giving us the critical mass we need to remain competitive and offer our customers continued value and options to serve their needs."
The acquisition is expected to be slightly accretive to Techne's fiscal year 2014 net earnings, even though there will be acquisition accounting charges related to the step-up in basis for acquired inventories and the amortization of intangibles. Since there are possible adjustments to the final price paid based on working capital available at the closing of the transaction, Techne said it couldn't�assess the final impact the deal will have on its first-quarter earnings per share or those for the entire fiscal year.
Top 5 Integrated Utility Companies To Watch In Right Now: Navidea Biopharmaceuticals Inc (NAVB)
Navidea Biopharmaceuticals, Inc. (Navidea), formerly Neoprobe Corporation, incorporated in 1983, is a biopharmaceutical company focused on the development and commercialization of precision diagnostic agents. As of December 31, 2011, the Company�� radiopharmaceutical development programs included Lymphoseek (Lymphoseek, Kit for the Preparation of Technetium Tc99m for Injection), a radiopharmaceutical agent for lymph node mapping; AZD4694, an imaging agent, and RIGScan, a tumor antigen-specific targeting agent. In January 2012, the Company executed an option agreement with Alseres Pharmaceuticals, Inc. (Alseres) to license [123I]-E-IACFT Injection, also called Altropane, an Iodine-123 radiolabeled imaging agent, being developed as an aid in the diagnosis of Parkinson�� disease, movement disorders and dementia. In August 2011, the Company sold its gamma detection device line of business (the GDS Business) to Devicor Medical Products, Inc.
Lymphoseek
Navidea�� pipeline includes clinical-stage radiopharmaceutical agents used to identify the presence and status of disease. Lymphoseek (Kit for the Preparation of Technetium Tc99m for Injection) is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM) procedures and lymphoscintigraphy employed in the overall diagnostic assessment of certain solid tumor cancers. The lymph system is a component of the body�� immune system. The key components of the lymph system are lymph nodes-small anatomic structures that contain disease-fighting lymphocytes, filter lymph of bacteria and cancer cells, and signal infection in response to heightened levels of pathogens. In Navidea�� Phase III clinical studies of Lymphoseek, it detected over 99% of positive nodes identified by vital blue dye (VBD). As of December 31, 2011, Navidea, in co-operation with UC, San Diego affiliate (UCSD), completed or initiated five Phase I clinical trials, one multi-center Phase II trial and three multi-center Phase II trials inv! olving Lymphoseek. Two Phase III studies were completed in subjects with breast cancer and melanoma. During the year ended December 31, 2011, data from NEO3-09 were released, which indicated that all primary and secondary endpoints for the study were met. As of December 31, 2011, third Phase III clinical trial for Lymphoseek in subjects with head and neck squamous cell carcinoma (NEO3-06) was in progress.
AZD4694
AZD4694 is a Fluorine-18 labeled precision radiopharmaceutical candidate for use in the imaging and evaluation of patients with signs or symptoms of cognitive impairment such as Alzheimer's disease (AD). It binds to beta-amyloid deposits in the brain that can then be imaged in positron emission tomography (PET) scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. AZD4694 has been studied in several clinical trials. Clinical studies through Phase IIa have included more than 80 patients to date, both suspected AD patients and healthy volunteers. No significant adverse events have been observed. Results suggest that AZD4694 has the ability to image patients quickly and safely with high sensitivity.
RadioImmunoGuided Surgery
As of December 31, 2011, RIGScan had been studied in a number of clinical trials, including Phase III studies. Navidea has conducted two Phase III studies, NEO2-13 and NEO2-14, of RIGScan in patients with primary and metastatic colorectal cancer, respectively. Both studies were multi-institutional involving cancer treatment institutions in the United States, Israel, and the European Union.
The Company competes with Pharmalucence, Eli Lilly, Bayer Schering, General Electric and GE Healthcare.
Advisors' Opinion:- [By Lauren Pollock]
Navidea Biopharmaceuticals Inc.(NAVB) said the U.S. Food and Drug Administration has granted a priority review for an expanded use of its Lymphoseek drug for some patients with head and neck cancer. Shares dropped 5.4% to $1.97 premarket.
- [By Erin McCarthy]
Navidea Biopharmaceuticals Inc.(NAVB) said Chief Executive Mark Pykett would leave that post around the end of this month as the company restructures its biopharmaceutical product pipeline.
- [By Lauren Pollock]
Among the companies with shares expected to actively trade in Tuesday’s session are Toll Brothers Inc.(TOL) and Navidea Biopharmaceuticals Inc.(NAVB)
5 Best Medical Stocks 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 Monica Gerson]
Breaking news
Loews (NYSE: L) reported a 59% rise in its third-quarter earnings. Loews posted a quarterly profit of $282 million, or $0.73 per share, versus a year-ago profit of $177 million, or $0.45 per share. To read the full news, click here. BankUnited (NYSE: BKU) announced today the commencement of an underwritten offering of 9,000,000 shares of its common stock by certain of its existing stockholders, subject to market and other conditions. To read the full news, click here. Liberty Global (NASDAQ: LBTYA) announced today an agreement to sell substantially all of its international content division Chellomedia to AMC Networks (NASDAQ: AMCX).To read the full news, click here. Myriad Genetics (NASDAQ: MYGN) today announced that validation data for the Myriad myPlan Lung Cancer test showed that it significantly predicted patients' risk of death from early-stage lung adenocarcinoma within five years of being diagnosed. To read the full news, click here.Posted-In: Bank of America US Stock FuturesNews Eurozone Futures Global Pre-Market Outlook Markets
5 Best Medical Stocks For 2014: Intercept Pharmaceuticals Inc (ICPT)
Intercept Pharmaceuticals, Inc., incorporated on September 4, 2002, is a biopharmaceutical company focused on the development and commercialization of therapeutics to treat chronic liver diseases utilizing its bile acid chemistry.The Company�� product candidates treat orphan and more prevalent liver diseases for which there are limited therapeutic solutions. The Company�� product candidate, obeticholic acid, or OCA, is a bile acid analog, a chemical substance that has a structure based on a naturally occurring human bile acid. It is developing OCA initially for primary biliary cirrhosis, or PBC, as a second line treatment for patients who have an inadequate response to or who are unable to tolerate standard of care therapy and therefore need additional treatment. The Company is conducting a Phase 3 clinical trial of OCA in PBC, which it calls the POISE trial, that serves as the basis for seeking regulatory approval in the United States and Europe. As of December 19, 2012, the Company completed enrollment of the POISE trial with 217 patients.
The Company�� clinical focus is on the development of OCA, orally administered, first-in-class FXR agonist that has broad liver-protective properties and may a variety of chronic insults to the liver that cause fibrosis, which can eventually lead to cirrhosis, liver transplant and death. The Company owns worldwide rights to OCA outside of Japan and China, where it has licensed the compound to Dainippon Sumitomo Pharma, or DSP, and granted it an option to license OCA in certain other Asian countries.The Company is sponsoring an independent study involving more than ten leading PBC centers in North America and Europe, or collectively the Global PBC Study Group, that are pooling their long-term patient data to evaluate the relationship between biochemical and clinical endpoints.
The Company competes with Eli Lilly, Exelixis, Inc., Phenex Pharmaceuticals AG, , Johnson & Johnson, NovImmune SA, Dr. Falk Pharma GmbH, Galmed Medical Researc! h Ltd., Immuron Ltd., Mochida Pharmaceutical Co., Ltd., NasVax Ltd. , Raptor Pharmaceutical Corp. Astellas Pharma US, Inc., AstraZeneca, Salix Pharmaceuticals, Inc. and Tioga Pharmaceuticals, Inc.
Advisors' Opinion:- [By Sean Williams]
For this week's round of "Better Know a Stock," I'm going to take a closer look at Intercept Pharmaceuticals (NASDAQ: ICPT ) .
What Intercept Pharmaceuticals does
Intercept Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments aimed at chronic liver diseases. Specifically, Intercept differentiates itself through the utilization of its proprietary bile acid chemistry. The company's lead compound, known as obeticholic acid, or OCA, recently initiated phase 3 trials for primary biliary cirrhosis and has received orphan drug status from the Food and Drug Administration for this disease, which could ultimately expedite its review process and grant it seven years marketing exclusivity from the date of approval -- assuming it gets approved, of course! OCA is also being tested in a number of other indications. - [By Lisa Levin]
Intercept Pharmaceuticals (NASDAQ: ICPT) dropped 1.81% to $291.00 in pre-market trading after falling 3.66% on Thursday.
Posted-In: PreMarket LosersNews Movers & Shakers Pre-Market Outlook Markets
- [By Jake L'Ecuyer]
Equities Trading UP
Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) got a boost, shooting up 62.40 percent to $452.02. Citigroup lifted the price target on the stock from $60.00 to $400.00, while Bank of America raised the price target from $81.00 to $872.00. - [By Ben Levisohn]
Intercept Pharmaceuticals (ICPT) has�taken investors on a wild ride this year. After more than quintupling, it’s now up “only” 235% in 2014. And Deutsche Bank thinks it’s time to buy.
Special to The ChronicleDeutsche Bank analyst Alethia Young and team explain why they see “good risk/reward” in Intercept Pharmaceuticals:
Intercept’s lead asset is obeticholic acid (OCA) for treatment of liver diseases like PBC and NASH. Our conviction is based on 1) OCA will take meaningful stake in a large NASH market, 2) full results from the FLINT trial will be supportive of further development from a regulatory & commercial perspective, and 3) we think in the long-term that OCA will be a treatment for many other liver diseases beyond PBC and NASH…
On good data, we think Intercept trades to $336-$404/sh. On bad data, we think Intercept trades to $110-$146/sh. We think shares currently reflect ~35% chance of success for NASH. We see some downside protection in the fact that if NASH fails in Ph2b, the co will likely price PBC higher. We assume $65K, but every $5K in pricing is worth about $9/sh. At 100% success for PBC & NASH, our FV is $518/sh.
Our $395 TP is based on a probability adjusted DCF analysis (-100% terminal growth rate) and 11% discount rate which is in-line with biotech peers.
Shares of Intercept Pharmaceuticals have gained 2.9% to $229.03 at 11:44 a.m. today.
5 Best Medical Stocks For 2014: Sunshine Heart Inc (SSH)
Sunshine Heart, Inc., incorporated on August 22, 2002, is an early-stage medical device company focused on developing, manufacturing and commercializing its C-Pulse Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. The C-Pulse Heart Assist System utilizes the scientific principles of intra-aortic balloon counter-pulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. As of December 31, 2011, the Company was in the process of obtaining regulatory approvals necessary to sell its product.
The Company has developed tools to allow the C-Pulse to be implanted through a small pacemaker-like incision between the patient�� ribs and sternum rather than a sternotomy. Patients implanted through its minimally invasive procedure require a hospital stay of four to seven days in connection with implantation of the C-Pulse System, after which they return home. During the year ended December 31, 2011, the Company completed enrollment and implantation of 20 patients in the North American feasibility phase of its trial. In April 2011, the Food and Drug Administration (FDA) approved an expansion protocol to allow the Company to implant up to 20 additional patients and add two additional centers to its feasibility study.
The Company competes with Thoratec Corporation, HeartWare International Inc., CircuLite, Inc., CardioKinetix, Inc., AbioMed, Inc., Jarvik Heart, Inc., MicroMed Technology, Inc., SynCardia Systems, Inc., Terumo Heart, Inc., WorldHeart Corporation in the United States and Europe, and Berlin Heart GmbH in Europe.
Advisors' Opinion:- [By John Udovich]
Small cap heart stocks Sunshine Heart Inc (NASDAQ: SSH), Abiomed, Inc (NASDAQ: ABMD) and AtriCure Inc (NASDAQ: ATRC) each find different ways go to the heart of the problem for cardiac�patients and have all been good performers for investors this year. After all and according to statistics collected by the CDC, heart disease is the leading cause of death for both men and women as about 600,000 people die of heart disease in the United States every year���accounting�for 1 in every 4 deaths. Moreover, roughly 715,000 Americans have a heart attack every year and�ff these, 525,000 are a first heart attack and 190,000 happen to people who have already had one. In other words, there is a big market for the following small cap heart stocks to address:
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