This sector has been one of the market's top performers for the last 18 months, and Nicholas Vardy talks about why he thinks there's more upside and how you can play it.
SPEAKER 1: Hi. I’m talking biotech with Nicholas Vardy. Hi, Nick, and thanks for coming by.
NICHOLAS: Thanks for having me.
SPEAKER 1: So you are recommending in your latest newsletter a Market Vectors Biotech ETF. Can you tell me a little bit about that?
NICHOLAS: Yes. The biotech industry has been one of the strongest performing sectors in the US market over the past 18 months and this is a way to play that. It has been really affected by a couple of fundamental factors. First, the rise of generic drugs or the expiration of patents or what they see of Glaxo is called the patent cliff, which is threatening the profits of the large pharmaceutical companies and also, the emergence of new drugs among the biotechnology companies. As a result, the biotechnology sector has really heated up because of potential takeovers, product pipelines, and really, an improving regulatory environment for biotech products in the sector.
5 Best Growth Stocks To Watch For 2015: Prosensa Holding NV (RNA)
Prosensa Holding N.V., formerly Prosensa Holding B.V., is a biotechnology company engaged in the discovery and development of ribonucleic acid-modulating (RNA)-modulating, therapeutics for the treatment of genetic disorders. The Company�� primary focus is on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including Duchenne muscular dystrophy, myotonic dystrophy and Huntington�� disease. The Company�� clinical portfolio of RNA-based product candidates is focused on the treatment of Duchenne muscular dystrophy (DMD). The Company�� platform technology allows the development of RNA-modulating therapeutics that either interferes with splicing (exon skipping, exon inclusion, or splice mutation correction), remove mutant RNA, or block RNA expression, for different indications.
DMD is a rare, severe muscle wasting disease that occurs in up to 1 in 3,500 male births. It is commonly diagnosed between the ages of three to five, when boys begin to show signs of impaired motor development. PRO044, the Company�� product candidate, addresses a separate sub-population of DMD patients. The Company developed PRO044 using its exon-skipping technology to generate a product candidate with the same mechanism of action that is used by drisapersen.
Advisors' Opinion:- [By Brian Orelli]
Ironically, phase 3 data from Sarepta's direct competitor -- GlaxoSmithKline (NYSE: GSK ) and Prosensa's (NASDAQ: RNA ) drisapersen -- that's due in the fourth quarter could help the FDA answer the question about whether dystrophin is an acceptable surrogate endpoint. If increases in dystrophin correlate with clinical outcomes, it would support approving eteplirsen with less data. It's not clear to me whether Glaxo and Prosensa would have to share that correlation with the FDA -- the clinical phase 3 data should be sufficient for approval -- and if it does make those calculations whether the FDA could legally use it to support the approval of another drug since NDA data is proprietary while under patent.
- [By Monica Gerson]
Prosensa Holding NV (NASDAQ: RNA) soared 25.89% to $8.51 in the pre-market trading after the company reported 48-week data from Phase 2 placebo-controlled study of drisapersen in 51 DMD boys.
- [By Keith Speights]
An "alley-oop" from the opponent
Prosensa (NASDAQ: RNA ) shares made something of a slam dunk this week, jumping more than 16%. That dunk was made with what amounts to an "alley-oop" from its primary rival, Sarepta Therapeutics (NASDAQ: SRPT ) . - [By John Udovich]
It should also be mentioned that earlier in the week, GlaxoSmithKline plc (NYSE: GSK) returned full rights of Duchenne muscular dystrophy drug drisapersen to their partner�Prosensa Holding NV (NASDAQ: RNA) and that news sent shares down 12.48% on�Monday. Moreover,�Prosensa Holding also sank some 70% last fall when Drisapersen failed a phase 3 trial by missing a primary endpoint measuring for how far patients could walk over the course of six minutes (the improvement�wasn't significantly better than the placebo).�However, Prosensa Holding also rose 24.37% yesterday after announcing�initial findings from further analyses from the aggregate data for drisapersen, with the CEO saying:
Best Biotech Companies To Buy For 2014: Savient Pharmaceuticals Inc(SVNT)
Savient Pharmaceuticals, Inc., a specialty biopharmaceutical company, focuses on developing KRYSTEXXA, a biologic PEGylated uricase in the United States. The KRYSTEXXA is being developed as a treatment for chronic gout in patients refractory to conventional therapy. The company also sells and distributes branded and generic versions of oxandrolone, a drug used to promote weight gain following involuntary weight loss. It sells its products directly to drug wholesalers. The company, formerly known as Bio-Technology General Corp. and changed its name to Savient Pharmaceuticals, Inc. in June 2003. Savient Pharmaceuticals, Inc. was founded in 1980 and is headquartered in East Brunswick, New Jersey.
Advisors' Opinion:- [By James E. Brumley]
It's still too soon to say Savient Pharmaceuticals Inc. (NASDAQ:SVNT) is off and running. In fact, the stock's decidedly NOT off and running yet. But, it's not too soon to put SVNT on your watchlist of potential breakout candidates, as it's much closer to a breakout than most anyone can see.
- [By James E. Brumley]
Since 2008's implosion from the stock, the interest in Savient Pharmaceuticals Inc. (NASDAQ:SVNT) has been waning. There was a brief burst of bullishness in September of last year, which stirred the bullish pot a little. But, when SVNT started to fade in October of that year - just as quickly as it had perked up - what lingering hopes there were for the stock finally started to melt away. By the middle of this year, pretty much everyone had written Savient Pharmaceuticals off as a lost cause. Big mistake. Over the last few days, SVNT has almost wiggled its way buck into a bullish zone.
Best Biotech Companies To Buy For 2014: Chromadex Corp (CDXC)
Chromadex Corporation, incorporated on June 19, 2008, is a provider of research and quality-control products and services to the natural products industry. The Company�� products are used by customers worldwide in the dietary supplement, food and beverage, cosmetic and pharmaceutical industries. The Company together with its subsidiaries supplies phytochemical reference standards, which are small quantities of plant-based compounds used to research an array of potential attributes, and reference materials, related contract services, technical consulting and ingredients. On December 3, 2012, ChromaDex Inc. acquired Spherix Consulting Inc. The Company�� principal subsidiaries include ChromaDex, Inc., Chromadex Analytics, Inc. and Spherix Consulting, Inc (Spherix).
The Company provides its clients in the food, supplement and pharmaceutical industries with solutions to manage potential health and regulatory risks. Its science-based solutions are for both new and existing products that may be subject to product liability and/or exposed to changing scientific standards or public perceptions; literature evaluations, and design and assessment of pre-clinical and clinical safety testing. It specializes in regulatory submissions for food and dietary supplement ingredients. For its clients involved in drug development within the pharmaceutical industry, the Company provides similar services, as well as risk-based strategies, including intellectual property data and compliance gap identification, due diligence assessments and investigational new drug writing.
Products and Services
The Company offers bulk raw materials for inclusion in dietary supplements, food, beverage and cosmetic products. Through its catalog, it supplies a range of products necessary to conduct quality control of raw materials and consumer products. The Company through Chromadex Analytics, provides a range of contract services ranging from routine contract analysis for the production of dietary sup! plements, cosmetics, foods and other natural products to elaborate contract research for clients in these industries. The Company provides a range of consulting services in the areas of regulatory support, new ingredient or product development, risk management and litigation support. With an addition of Spherix, it provides regulatory approval and scientific advisory services.
The Company competes with Sigma-Aldrich, Phytolab, US Pharmacopoeia, Extrasynthese, Covance, Eurofins, and Silliker Canada Co.
Advisors' Opinion:- [By Peter Graham]
Small cap stocks Chromadex Corp (OTCMKTS: CDXC) and 22nd Century Group Inc (OTCBB: XXII) are, one way or the other, focused on natural products and have been getting some extra attention lately. Moreover, one of these stocks have been the subject of a disclosed investor awareness campaign. Keeping that in mind, are these two small cap stocks natural winners for investors? Here is a quick look:
Best Biotech Companies To Buy For 2014: ViroPharma Incorporated(VPHM)
ViroPharma Incorporated, a biotechnology company, develops and commercializes therapeutic products that address serious diseases in the United States and internationally. It focuses on developing products used by physician specialists or in hospital settings. The company markets and sells Cinryze, a C1 esterase inhibitor therapy for the routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema, a life-threatening genetic disorder; and Vancocin HCl capsule, an oral capsule formulation for the treatment of C. difficile-associated diarrhea (CDAD) and to treat enterocolitis caused by staphylococcus aureus, including methicillin-resistant strains. It also offers Plenadren, an orphan drug for treatment of adrenal insufficiency in adults; Buccolam, a oromucosal solution for treatment of prolonged, acute, and convulsive seizures in infants, toddlers, children, and adolescents; and maribavir, an antiviral compound for the treatment o f CMV disease through a license agreement with GlaxoSmithKline. The company?s primary development programs include Cinryze, a C1 esterase inhibitor for management of hereditary angioedema; and VP 20621, a non-toxigenic strain of C. difficile. Its clinical stage drug candidate comprises VP-20629 for the treatment of Friedreich?s Ataxia. The company sells its products directly to wholesale drug distributors and specialty pharmacies/distributors. ViroPharma Incorporated was founded in 1994 and is headquartered in Exton, Pennsylvania.
Advisors' Opinion:- [By MONEYMORNING]
On Monday, Dublin-based pharmaceutical firm Shire (Nasdaq ADR: SHPG) announced that it will buy Pennsylvania-based ViroPharma (Nasdaq: VPHM) for $4.2 billion in cash. The $50 per share purchase price is a 27% premium to Viropharma's Friday close and a 64% premium to the price when sale rumors first emerged this summer.
- [By George Budwell]
Shire plc (NASDAQ: SHPG ) is in the process of buying orphan drug-specialist ViroPharma (NASDAQ: VPHM ) for $4.2 billion, strengthening Shire's already robust commercial drug portfolio for rare diseases. The deal is expected to be finalized no later than Jan. 9, after Shire extended its tender offer to acquire all outstanding ViroPharma shares last week.
Best Biotech Companies To Buy 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 Ben Levisohn]
I mean, just look at these returns: Gilead Sciences (GILD) has gained 41% so far this year as investors appear to have put their Sovaldi worries behind them; InterMune (ITMN) has quintupled in 2014 after Roche agreed to purchase it for $8.3 billion; and Intercept Pharmaceuticals (ICPT) has surged 350% as drug trials have been surprisingly good. All told, the iShares Nasdaq Biotechnology ETF (IBB) has risen 21%, more than double the S&P 500′s 8.3% rise.
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