Diversified medical firm Abbott Labs (NYSE: ABT ) has begun�a new clinical trial of its Absorb bioresorbable next-generation stent that will judge its safety and efficacy in patients with coronary artery disease, or CAD.
The randomized study will be used to support approval of the Absorb stent by Japanese regulators, according to Abbott. The ABSORB Japan trial will enroll approximately 400 patients.�The primary endpoint is "target lesion failure (TLF) at one year, a combined measure of safety and efficacy of the device." Absorb stents dissolves over time and that may allow the blood vessel to regain natural function, said the company.
According to Abbott, CAD is the leading cause of death in the world and the World Health Organization estimates that the disease causes one-third of all deaths in Japan. Abbott launched�a similar trial of the Absorb stent in the U.S. in January.
The company has plenty of prior experience with drug-eluting stents. Its Xience family of stents is a leader in the current market and sold nearly�$1.6 billion last year, a 3% year-over-year gain. The Absorb improves upon the Xience by offering a "scaffold" that dissolves completely in the blood stream over time.
Best Japanese Companies To Watch For 2015: Ophthotech Corp (OPHT)
Ophthotech Corporation, incorporated on January 05, 2007, is a biopharmaceutical company specializing in the development of therapeutics to treat diseases of the eye. The Company�� advanced product candidate is Fovista, which the Company is developing for use in combination with anti-VEGF drugs that represent the current standard of care for the treatment of wet age-related macular degeneration (wet AMD). Wet AMD is a serious disease of the central portion of the retina, known as the macula, which is responsible for detailed central vision and color perception. It is characterized by abnormal new blood vessel formation and growth, referred to as neovascularization, which results in blood vessel leakage, retinal distortion and scar formation. If untreated, the progressive retinal damage results in rapid, irreversible and severe vision loss. Wet AMD is the cause of blindness in patients over the age of 55 in the United States and the European Union.
The anti-VEGF market for the treatment of wet AMD consists predominantly of two drugs that are approved for marketing and primarily prescribed for the treatment of wet AMD, Lucentis and Eylea, and off-label use of the cancer therapy Avastin. The use of anti-VEGF drugs has significantly improved visual outcomes for patients with wet AMD who have been treated with these drugs as compared to untreated patients.
Advisors' Opinion:- [By John Udovich]
Yesterday, small cap biotech Acceleron Pharma Inc (NASDAQ: XLRN) rose 9.76%�plus shares are up 183.6% for retail investors since its September IPO, meaning its worth taking a closer look at the stock along with the performance of other biotech IPOs like BIND Therapeutics Inc (NASDAQ: BIND), Ophthotech Corp (NASDAQ: OPHT) and Foundation Medicine Inc (NASDAQ: FMI) which also debuted at the same time.
Top Medical Stocks To Buy For 2014: Foundation Medicine Inc (FMI)
Foundation Medicine, Inc., incorporated on November 12, 2009, is a commercial-stage company. The Company is focused on fundamentally changing the way patients with cancer are treated. The Company�� platform includes methods and algorithms for analyzing tumor tissue samples across all types of cancer, as well as information aggregation and concise reporting capabilities. Its products provide genomic information about each patient�� individual cancer, enabling physicians to optimize treatments in clinical practice and enabling biopharmaceutical companies to develop targeted oncology therapies more effectively.
FoundationOne, its first clinical product, is, to its knowledge, the only commercially available comprehensive molecular information product designed for use in the routine care of patients with cancer. In addition, the Company is considered a non-contracting provider by commercial third-party payors because it has not entered into specific contracts to provide FoundationOne to their covered patients, and as a result it takes on primary responsibility for obtaining reimbursement on behalf of patients.
Advisors' Opinion:- [By John Udovich]
If you have not been watching the biotech sector lately, you should start paying attention as the sector along with small cap biotech stocks like Cell Therapeutics Inc (NASDAQ: CTIC), BIND Therapeutics Inc (NASDAQ: BIND) and TNI BioTech (OTCMKTS: TNIB) continue to produce a steady stream of good news for investors thanks to positive industry trends. Moreover, Ophthotech Corp (NASDAQ: OPHT), Foundation Medicine Inc (NASDAQ: FMI), Evoke Pharma and Fate Therapeutics Inc (NASDAQ: FATE) are this week's biotech IPOs that will no doubt be watched closely by Wall Street and industry observers in general. With that in mind, consider the following biotech news or recent articles about the industry and the small cap players in it:
- [By RedChip]
According to Walter Isaacson�� biography, Steve Jobs paid a reported $100,000 to learn the DNA sequence of his cancer. This work, completed at MIT and Harvard, led to the launch of Foundation Medicine (NASDAQ: FMI). Foundation Medicine has grabbed headlines over the past couple of weeks as it entered the capital markets with a high-profile IPO led by Goldman Sachs.
- [By James E. Brumley]
It wouldn't be fair to say there's nothing like it "out there", because there is. A company called Foundation Medicine Inc. (NASDAQ:FMI) has developed a similar/comparable app. The CLRX version of the solution appears superior in most ways, however, if for no other reason than because of the projected revenue growth the company is apt to see.
Top Medical Stocks To Buy For 2014: Horizon Pharma Inc (HZNP)
Horizon Pharma, Inc. (Horizon), incorporated on March 23, 2010, is a biopharmaceutical company that develops and commercializes medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. On April 23, 2011, the United States Food and Drug Administration, approved DUEXIS (formerly HZT-501), a tablet formulation containing a fixed-dose combination of ibuprofen and famotidine in a single pill. The Company�� other product, LODOTRA (NP-01), is a programmed release formulation of low-dose prednisone that is marketed in Europe by the Company�� distribution partner, Mundipharma International Corporation Limited (Mundipharma). As of December 31, 2010, Horizon completed multiple Phase III clinical trials of LODOTRA. In addition to these product candidates, the Company has a pipeline of earlier-stage product candidates to treat pain-related diseases and chronic inflammation. On April 1, 2010, Horizon effected a recapitalization and acquisition pursuant to which Horizon Pharma, Inc. became a holding company, that operates through its wholly owned subsidiaries, Horizon Pharma USA, Inc. (formerly Horizon Therapeutics, Inc.) and Horizon Pharma AG (formerly Nitec Pharma AG (Nitec)).
DUEXIS
DUEXIS is a combination of 800 milligram ibuprofen and 26.6 milligram famotidine in a single pill and is indicated for the relief of signs and symptoms of rheumatoid arthritis (RA), and osteoarthritis (OA), and to decrease the risk of developing upper gastrointestinal (GI), ulcers in patients who are taking ibuprofen for those indications. The Company has completed two Phase III clinical trials in a total of over 1,500 patients with mild to moderate pain or arthritis that demonstrated a significant reduction in the incidence of non-steroidal anti-inflammatory drugs (NSAID)-induced upper GI ulcers when treated with DUEXIS versus ibuprofen alone.
LODOTRA
LODOTRA is a programmed release formulation of low-dose prednisone, a well-established drug use! d to inhibit the production of various pro-inflammatory cytokines, which are proteins associated with joint inflammation in RA. LODOTRA has received regulatory approval in Europe for the treatment of moderate to severe, active RA in adults when accompanied by morning stiffness. As of December 31, 2010, the Company had completed two pivotal Phase III clinical trials of LODOTRA in a total of over 600 patients with RA. The first pivotal Phase III trial supported the approval of LODOTRA in Europe in March 2009, where it is approved for marketing in 14 European countries. LODOTRA achieved significant results and met the primary endpoint in each of the two pivotal Phase III clinical trials. Its LODOTRA product was developed and is owned by Horizon Pharma AG. As of December 31, 2010, the Company markets LODOTRA in Europe through three separate agreements. Pursuant to two separate agreements, it granted Merck Serono GmbH and Merck GesmbH, an affiliate of Merck Serono, the rights to distribute and market LODOTRA in each of Germany and Austria, respectively, and pursuant to the third agreement, it granted Mundipharma rights to distribute and market LODOTRA in the rest of Europe. The Company also has a manufacturing and supply agreement with Jagotec AG under which Jagotec or its affiliates manufacture and supply LODOTRA to the Company as bulk tablets.
The Company competes with Pfizer Inc., Pozen Inc., Abbott Laboratories and Amgen Inc.
Advisors' Opinion:- [By Lisa Levin]
Horizon Pharma (NASDAQ: HZNP) shares reached a new 52-week high of $17.12 after the company announced its plans to acquire privately held Vidara Therapeutics International for around $660 million.
- [By Jake L'Ecuyer]
Top losers in the sector included Horizon Pharma (NASDAQ: HZNP), off 9.5 percent, and Anacor Pharmaceuticals (NASDAQ: ANAC), down 8.2 percent.
Top Headline
The Greenbrier Companies (NYSE: GBX) reported a 13% gain in its fiscal second-quarter earnings. Greenbrier's quarterly profit surged to $15.6 million, or $0.50 per share, versus a year-ago profit of $13.8 million, or $0.45 per share. Excluding one-time items, it earned $0.51 per share. Its revenue climbed 88% to $502.2 million. However, analysts were expecting earnings of $0.60 per share on revenue of $508.69 million. - [By Jake L'Ecuyer]
Top losers in the sector included Horizon Pharma (NASDAQ: HZNP), off 9.5 percent, and Anacor Pharmaceuticals (NASDAQ: ANAC), down 8.2 percent.
Top Headline
The Greenbrier Companies (NYSE: GBX) reported a 13% gain in its fiscal second-quarter earnings. Greenbrier's quarterly profit surged to $15.6 million, or $0.50 per share, versus a year-ago profit of $13.8 million, or $0.45 per share. Excluding one-time items, it earned $0.51 per share. Its revenue climbed 88% to $502.2 million. However, analysts were expecting earnings of $0.60 per share on revenue of $508.69 million.
Top Medical Stocks To Buy 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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