VIVUS (NASDAQ: VVUS ) has found an Italian to help it out. The biotech announced Tuesday that Menarini�has agreed to market VIVUS' erectile dysfunction drug Spedra in more than 40 European countries plus Australia and New Zealand.
The Italian pharma is paying VIVUS about $21 million upfront and another $30 million -- at current exchange rates -- within the first year of the launch. VIVUS is also due undisclosed royalties and potentially another $102 million at current exchange rates in milestones and other payments over the life of the agreement.
Menarini�has more of the men's sexual health spectrum covered since it also sells Priligy, a treatment for premature ejaculation. The ability for the company to promote more than one drug to doctors shouldn't be underestimated. Having multiple drugs can help a sales rep get in the door and increases efficiency, which should result in higher profits.
Small key to unlocking value
No doubt, potential sales of Spedra outside the U.S. are important. First-quarter sales of Pfizer's (NYSE: PFE ) Viagra outside the U.S. were 47% of total Viagra sales. In the first quarter, Eli Lilly (NYSE: LLY ) actually sold more of its erectile dysfunction drug Cialis outside of the U.S. than inside it.
Top Gold Stocks To Own For 2015: NeoStem Inc (NBS)
NeoStem, Inc., incorporated on September 18, 1980, operates in cellular therapy industry. Cellular therapy addresses the process by which new cells are introduced into a tissue to prevent or treat disease, or regenerate damaged or aged tissue, and consists of a separate therapeutic technology platform in addition to pharmaceuticals, biologics and medical devices. The Company�� business model includes the development of novel cell therapy products, as well as operating a contract development and manufacturing organization (CDMO) providing services to others in the regenerative medicine industry. Progenitor Cell Therapy, LLC, the Company�� wholly owned subsidiary (PCT), is a CDMO in the cellular therapy industry. PCT has provided pre-clinical and clinical current Good Manufacturing Practice (cGMP) development and manufacturing services to over 100 clients advancing regenerative medicine product candidates through rigorous quality standards all the way through to human testing.
PCT has two cGMP, cell therapy research, development, and manufacturing facilities in New Jersey and California, serving the cell therapy community with integrated and regulatory compliant distribution capabilities. Its core competencies in the cellular therapy industry include manufacturing of cell therapy-based products, product and process development, cell and tissue processing, regulatory support, storage, distribution and delivery and consulting services. The Company�� wholly-owned subsidiary, Amorcyte, LLC (Amorcyte) is developing its own cell therapy, AMR-001, for the treatment of cardiovascular disease. AMR-001 represents its clinically advanced therapeutic product candidate and enrollment for its Phase II PreSERVE clinical trial to investigate AMR-001's safety and efficacy in preserving heart function after a heart attack in a particular type of post Acute Myocardial Infarction (AMI) patients.
Through the Company�� subsidiary, Athelos Corporation (Athelos), the Company is collaborating w! ith Becton-Dickinson in early stage clinical development of a therapy utilizing T-cells, collaborating for autoimmune and inflammatory conditions, including but not limited to, graft vs. host disease, type 1 diabetes, steroid resistant asthma, lupus, multiple sclerosis and solid organ transplant rejection. The Company�� pre-clinical assets include its Very Small Embryonic Like (VSEL) Technology platform. The Company has basic research and development capabilities, manufacturing facilities on both the east and west coast of the United States.
Advisors' Opinion:- [By John Udovich]
Summer and the slow news for the market that usually comes with it�is over with and both stem cell researchers or small� cap stem cell stocks like Advanced Cell Technology, Inc (OTCBB: ACTC), Neuralstem, Inc (NYSEMKT: CUR), NeoStem Inc (NASDAQ: NBS), International Stem Cell Corp (OTCMKTS: ISCO)�and BioRestorative Therapies (OTCBB: BRTX) having news for investors and traders alike. Consider the following:
- [By John Udovich]
The results of a recent Pew Center Poll regarding attitudes towards abortion and various forms of stem cell research could be a good sign for the stem cell industry along with small cap stem cell stocks like StemCells Inc (NASDAQ: STEM), NeoStem Inc (NASDAQ: NBS), Neuralstem, Inc (NYSEMKT: CUR),�International Stem Cell Corp (OTCMKTS: ISCO) and BioRestorative Therapies (OTCBB: BRTX). Basically, Americans think that having an abortion is a moral issue with 49% of American adults believing abortion is morally wrong, 23%�view it not as a moral issue and and 15% view it as morally acceptable. However and when Americans were asked about issues surrounding�human embryos, such as stem cell research or in vitro fertilization, as a matter of morality, their views were different.
- [By Stock Investor]
Back in April in my article titled, "Regenerative Medicine's Time Has Come", I covered two very interesting companies focused on this field: NeoStem Inc. (NBS) and Neuralstem Inc. (CUR).
- [By Monica Gerson]
NeoStem (NYSE: NBS) priced an underwritten public offering of 5,000,000 shares of common stock at an offering price of $7.00 per share. NeoStem shares dipped 9.44% to $7.10 in after-hours trading.
Top 10 Biotech Stocks To Buy For 2014: Kite Pharma Inc (KITE)
Kite Pharma, Inc., incorporated on June 1, 2009, is a clinical-stage biopharmaceutical company focused on the development and commercialization of cancer immunotherapy products designed to harness the power of a patient�� own immune system to eradicate cancer cells. The Company does this using its engineered autologous cell therapy (eACT). eACT involves the genetic engineering of T cells to express either chimeric antigen receptors (CARs, or T cell receptors, or TCRs). These modified T cells are designed to recognize and destroy cancer cells. The Company funds multiple Phase I-2a clinical trials with CAR- and TCR-based therapies that are being conducted by its collaborator, the Surgery Branch of the National Cancer Institute (NCI). The Company plans to conduct a Phase I-2 clinical trial for its lead product candidate KTE-C19, a CAR-based therapy, in patients with relapsed/refractory diffuse large B cell lymphoma (DLBCL).
eACT involves harvesting T cells from the patient�� blood; genetically engineering T cells to express cancer-specific receptors; increasing the number of engineered T cells and infusing the functional cancer-specific T cells back into the patient. Using eACT technology, T cells can be genetically modified to express one of two classes of cancer-specific receptors: CARs or TCRs. CARs can recognize native cancer antigens that are part of an intact protein presented on the cancer cell surface. TCRs broaden the therapeutic approach by recognizing fragments on the cancer cell surface derived from intracellular proteins. By combining both CAR and TCR approaches, it has the potential to generate a portfolio of products that can target both solid and hematological tumors. It has a Cooperative Research and Development Agreement (CRADA), through which it is funding the research and development of eACT-based product candidates utilizing CARs and TCRs for the treatment of advanced solid and hematological malignancies.
The Company�� lead product candidate, KTE-C19, ! is an anti-CD19 CAR T cell therapy. CD19 is a protein expressed on the cell surface of B cell lymphomas and leukemias. The Company is an ongoing NCI Phase I-2a clinical trial utilizing anti-CD19 CAR T cell therapy that is designed to establish a dose level and appropriate conditioning regimen, as well as to assess overall safety, in patients with B cell lymphomas and leukemias that had been heavily pretreated and were relapsed/refractory (unresponsive) to chemotherapy. KTE-C19 will use the identical anti-CD19 CAR construct and viral vector that is being used in the NCI trial. The Company a license with the NIH for intellectual property relating to a TCR-based T cell therapy targeting the antigen SSX2 for the treatment of head and neck cancer, hepatocellular carcinoma, melanoma, prostate cancer and sarcoma, and a co-exclusive license to this intellectual property for the treatment of certain additional cancer types.
Advisors' Opinion:- [By John Udovich]
Small cap cancer drug stock Kite Pharma Inc (NASDAQ: KITE) has surged after announcing a�strategic research collaboration and license agreement with Amgen, Inc (NASDAQ: AMGN)�involving Chimeric Antigen Receptors (CAR) ��meaning its worth taking a closer look at the stock, which had an IPO last June,�along with potential peers�Bellicum Pharmaceuticals Inc (NASDAQ: BLCM) and Juno Therapeutics (NASDAQ: JUNO) which are players in the CAR therapies space and had more recent IPOs.
- [By John Udovich]
Biotech news this week was dominated by a number of healthcare and biotech related IPOs, including Parnell Pharmaceuticals Holdings Ltd (NASDAQ: PARN), Signal Genetics Inc (NASDAQ: SGNL), ZS Pharma Inc (NASDAQ: ZSPH), Ardelyx Inc (NASDAQ: ARDX)�and Zafgen Inc (NASDAQ: ZFGN) with Kite Pharma Inc (NASDAQ: KITE), Microlin Bio Inc (NASDAQ: MCLB) and�Syndax Pharmaceuticals Inc (NASDAQ: SNDX) presumably set to debut today (Note:�See�This Week�� Biotech IPOs: Two Losers and One Winner So Far (PARN, SGNL & ZSPH)):
Top 10 Biotech Stocks To Buy For 2014: Amgen Inc.(AMGN)
Amgen Inc., a biotechnology medicines company, discovers, develops, manufactures, and markets human therapeutics based on advances in cellular and molecular biology for grievous illnesses primarily in the United States, Europe, and Canada. The company markets recombinant protein therapeutics in supportive cancer care, nephrology, and inflammation. Its principal products include Aranesp and EPOGEN erythropoietic-stimulating agents that stimulate the production of red blood cells; Neulasta and NEUPOGEN to stimulate the production of neutrophils, which is a type of white blood cell that helps the body to fight infections; and Enbrel, an inhibitor of tumor necrosis factor that plays a role in the body?s response to inflammatory diseases. The company also markets other products comprising Sensipar/Mimpara, a small molecule calcimimetic that lowers serum calcium levels; Vectibix, a monoclonal antibody that binds specifically to the epidermal growth factor receptor; and Nplate, a thrombopoietin (TPO) receptor agonist that mimics endogenous TPO, the primary driver of platelet production. In addition, it provides Denosumab, a human monoclonal antibody that targets RANKL, an essential regulator of osteoclasts. Further, the company offers product candidates in mid-to-late stage development in a variety of therapeutic areas, including oncology, hematology, inflammation, bone, nephrology, cardiovascular, and general medicine consisting of neurology. It markets its products to healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies; consumers; and wholesale distributors of pharmaceutical products. The company has various collaborative arrangements with Pfizer Inc.; GlaxoSmithKline plc; Takeda Pharmaceutical Company Limited; Daiichi Sankyo Company, Limited; Array BioPharma Inc.; Kyowa Hakko Kirin Co. Ltd.; and Cytokinetics, Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.
Advisors' Opinion:- [By Keith Speights]
I have jokingly referred to Amgen (NASDAQ: AMGN ) in the past as a "senior citizen" of biotech. The company was founded 33 years ago, making Amgen a virtual Methuselah when it comes to biotech companies. Regardless of age, every stock needs a checkup every now and then. Let's see how Amgen stock holds up in this month's checkup.
- [By Keith Speights]
1. Onyx Pharmaceuticals (NASDAQ: ONXX )
This one's virtually a no-brainer. A few weeks ago, Amgen (NASDAQ: AMGN ) made an unsolicited offer for Onyx. Although Onyx rejected Amgen's bid of $120 per share as being too low, that wasn't the end of the story. - [By Ben Levisohn]
After weeks of speculation, Amgen’s (AMGN) purchase of Onyx Pharmaceuticals (ONXX) looks like a done deal. The Wall Street Journal has the details:
Associated PressAmgen�Inc. reached a deal Sunday to buy fellow biotech�Onyx Pharmaceuticals�Inc. for roughly $10.4 billion, the latest proposed takeover aimed at tapping into growth expected from the cancer-drug industry.
The all-cash takeover values Onyx at $125 a share. The price Amgen is paying is below what investors expected in the days after the possible deal surfaced in late June. Amgen had approached Onyx with an offer of $120 a share for the company, whose primary attraction is a blood-cancer drug called Kyprolis…
The deal is expected to close at the beginning of the fourth quarter.
RBC’s Michael Yee and team list three reasons for Amgen stockholders to like the deal:
We reiterate our view AMGN will likely go higher after acquiring ONXX because: 1) adds growth ��changes the growth profile of AMGN and modestly accelerates top/bottom line (we see 5-15% accretion…), 2) diversification: it diversifies AMGN away from current portfolio of supportive care drugs where over 40% is exposed to biosimilars over next few years so it reduces biosimilar risk, 3) adds leverage through OUS infrastructure, reimbursement expertise, and existing cancer salesforce (tougher for small co’s).
Amgen has gained 8.5% to $114.54 and Onyx has risen 5.7% to $123.64.
Cantor Fitzgerald’s Mara Goldstein and Adeyemi Ogunkoya consider what the deal says about the current state of the biotech market–and the recent biotech rally (the SPDR S&P Biotech ETF (XBI) has gained 38% this year):
Because of the ebb and flow of pipelines in the drug development industry, valuations for biotech companies may also rise and fall depending on a given cycle. The last few years has been one of large cap industry pipeline ebb, and that suggests to us t
- [By RichardCox]
Another selection to consider is the Market Vectors Biotech ETF (BBH). The fund has seen returns of a massive 55% since its inception and has a net expense ratio of 0.35%. This fund is centered on fewer stock selections (in contrast to the SPDR S&P Biotech ETF), so there is an enhanced potential for price volatility. Fund holdings include Gilead (GILD), Celgene and Amgen (AMGN), which make up more than 2/3 of the fund. This essentially means investors will sacrifice some of the diversification that can be found in choices like the SPDR S&P Biotech ETF, but many of the individual selections are well-positioned for gains for the remainder of the year.
Top 10 Biotech Stocks To Buy For 2014: OncoSec Medical Inc (ONCS)
OncoSec Medical Incorporated, incorporated on February 8, 2008, is an emerging drug-medical device company. The Company focused on designing, developing and commercializing medical approaches for the treatment of solid cancers. In March 2011, the Company acquired from Inovio Pharmaceuticals, Inc. (Inovio) certain assets related to the use of drug-medical device combination products for the treatment of different cancers.
The Company�� acquired assets relate to certain non-deoxyribonucleic acid (DNA) vaccine technology and property relating to selective tumor ablation technologies, which it refers to as the OncoSec Medical System (OMS), a therapy which uses an electroporation device to facilitate delivery of chemotherapy agents, or nucleic acids encoding cytokines, into tumors and/or surrounding tissue for the treatment and diagnosis of various cancers. As of January 24, 2012, the Company had not generated any revenue from operations.
Advisors' Opinion:- [By James E. Brumley]
How does the old saying go? Beggars can't be choosers? Two weeks ago, yours truly penned some bullish comments regarding OncoSec Medical Inc. (OTCMKTS:ONCS). The long and short of it was, if ONCS could clear a technical ceiling around $0.36, then life would get much easier for the bulls.
- [By James E. Brumley]
If you're looking for the next big biotech breakout stock, then OncoSec Medical Inc. (OTCMKTS:ONCS) deserves a place on your watchlist. This volatile cancer play has been down more than up 2011, but if you look closely at a long-term chart of ONCS, you may find it's already wiggled its way into a new uptrend. And, it may be only a matter of time before the bullish fireworks start to go off.
- [By Bio-Wire]
Another company that has benefitted from Inovio�� newfound attention is OncoSec Medical (OTC: ONCS) ��a newer ��ffshoot�� company that uses a similar but distinctly different electroporation device known as the OncoSec Medical System (OMS) that is based on Inovio�� technology. The specific amplitude and frequency of the OMS electroporation is calibrated such that plasmid delivery into solid tumor masses is fully optimized, while CELLECTRA electroporation is less specialized and focus more on the vaccination of skin cells. The cross-license agreement made between Inovio and Oncosec also covers the two devices for their distinctly different applications.
Top 10 Biotech Stocks To Buy For 2014: Agios Pharmaceuticals Inc (AGIO)
Agios Pharmaceuticals, Inc., incorporated on August 7, 2007, is a biopharmaceutical company. The Company is intend to apply its deep understanding of metabolism, coupled with the Company�� ability to create medicines that can inhibit or activate metabolic enzymes, to fundamentally change the way cancer and inborn errors of metabolism (IEMs) are treated. The Company has identified and validated novel and druggable targets in both cancer and IEMs. The Company�� two advanced cancer programs are targeting mutations in the enzymes isocitrate dehydrogenase 1 and 2, referred to as IDH1 and IDH2. The Company�� drug candidates are selective for the mutated forms of IDH1 and IDH2 found in cancer cells versus the normal forms of IDH1 and IDH2 found in all other cells.
The Company focused on developing medicines to address IEMs, with a novel approach to these orphan diseases for which no effective or disease-modifying therapy is available. The Company has also de-validated and terminated numerous programs, including many that have been reported in scientific journals. In the Company�� IEM portfolio, it uses an equally rigorous set of validation techniques.
Advisors' Opinion:- [By Ben Levisohn]
3. We see 23+ partnered pipeline assets and are most positive on Phase I/II MOR202 anti-CD38 for myeloma with data in 2015, and others such as Acceleron Pharma (XLRN), Agios Pharmaceuticals (AGIO), Epizyme (EPZM), Concert Pharmaceuticals (CNCE) (just started Phase I for next-gen Revlimid).
- [By Jake L'Ecuyer]
Equities Trading UP
Sangamo Biosciences (NASDAQ: SGMO) shot up 16.32 percent to $22.81 announced the publication in the NEJM of the first-in-man study of genome editing using its ZFN technology. Shares of Agios Pharmaceuticals (NASDAQ: AGIO) got a boost, shooting up 27.72 percent to $40.41 after the company reported quarterly results. BJ's (NASDAQ: BJRI) was also up, gaining 21.04 percent to $33.48 after the company was upgraded toa Buy rating at Buckingham research.
Top 10 Biotech Stocks To Buy For 2014: Synergy Pharmaceuticals Inc (SGYP)
Synergy Pharmaceuticals, Inc., incorporated on February 11, 1992, is a biopharmaceutical company focused primarily on the development of drugs to treat gastrointestinal (GI), disorders and diseases. The Company�� lead product candidate is plecanatide, a guanylyl cyclase C (GC-C), receptor agonist, to treat GI disorders, primarily chronic constipation (CC), and constipation-predominant-irritable bowel syndrome (IBS-C). It is also developing SP-333, the second generation GC-C receptor agonist for the treatment of gastrointestinal inflammatory diseases, such as ulcerative colitis (UC). The Company�� active pharmaceutical ingredients (APIs) and the final formulated drug products are manufactured for it by third party contractors.
As of December 31, 2011, the Company was developing plecanatide, a synthetic hexadecapeptide designed to mimic the actions of the GI hormone uroguanylin, for the treatment of CC and IBS-C. Plecanatide is an agonist of GC-C receptor. As of December 31, 2011, the Company was dosing patients in an 800-patient Phase II/III clinical trial of plecanatide to treat. It is also developing a second generation GC-C receptor analog, SP-333, which is in pre-clinical development for the treatment of gastrointestinal inflammatory diseases. SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone.
The Company competes with Ironwood Pharmaceuticals, Inc., Forest Laboratories, Inc., Takeda Pharmaceuticals America, Inc., Sucampo Pharmaceuticals, Inc., Salix Pharmaceuticals, Inc. and Shire Plc.
Advisors' Opinion:- [By Sean Williams]
Finally, Synergy Pharmaceuticals (NASDAQ: SGYP ) may have had the wildest week of them all. Synergy's share price spiked 16% on Tuesday as an analyst at Cantor Fitzgerald raised her peak sales estimate for plecanatide, the company's midstage drug for chronic idiopathic constipation and irritable bowel syndrome with constipation, to $1.58 billion from $1.05 billion, as clinical data has been stronger than expected. However, the company didn't return the favor to shareholders by -- the very next day, mind you ��announcing a secondary offering of 16.375 million shares. The downside of clinical-stage companies is the always apparent risk of dilution. Shares have lost 25% since their Tuesday close.
Top 10 Biotech Stocks To Buy For 2014: PTC Therapeutics Inc (PTCT)
PTC Therapeutics, Inc., incorporated on March 31, 1998 , is a biopharmaceutical company focused on the discovery and development of orally administered, small-molecule drugs that target post-transcriptional control processes. The Company�� lead product candidate includes ataluren, which is used for the treatment of patients with genetic disorders that arise from a type of genetic mutation known as a nonsense mutation. Ataluren is in late stage clinical development for the treatment of Duchenne muscular dystrophy caused by nonsense mutations (nmDMD) and cystic fibrosis caused by nonsense mutations (nmCF).
Ataluren is orally administered small-molecule compound that targets nonsense mutations. The Company is engaged in the development of ataluren for the treatment of genetic disorders in, which a nonsense mutation is the cause of the disease. Genetic tests are available for many genetic disorders, including Duchenne muscular dystrophy and cystic fibrosis, to determine if the underlying cause is a nonsense mutation. The EMA has designated ataluren as an orphan medicinal product for the treatment of nmDMD and nmCF. During the year ended December 31, 2012, the Phase III clinical trial completed. The Company�� Ataluren clinical trials in patients with nonsense mutation genetic disorders include Ataluren for nmDMD: Phase 2b clinical trial complete; Confirmatory Phase III clinical trial initiated, and Ataluren for nmCF: Phase III trial completed.
Advisors' Opinion:- [By John Kell]
PTC Therapeutics Inc.(PTCT) said the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a negative opinion on the biopharmaceutical company’s marketing authorization application for its muscular dystrophy treatment. Shares slumped 21% to $20.60 in premarket trading.
- [By WWW.DAILYFINANCE.COM] Records fell on Wall Street Friday as another solid report on housing lifted the market for the second day in a row. There's a three-day weekend coming up -- something that often prompts investor caution -- but the gains were broad-based even though volume was fairly light. The VIX, which measures volatility, fell to its lowest level this year. The Dow Jones industrial average (^DJI) gained 63 points, the Nasdaq composite (^IXIC) rose 31, and the Standard & Poor's 500 index (^GPSC) added 8, topping the record high set last week. The Dow Transportation average also raced to an all-time high, lifted by airline stocks. United (UAL) soared more than 4 percent; Delta (DAL) gained more than 1 percent and Southwest (LUV) gained 2 percent. Southwest is at an all-time high, up 79 percent from a year ago. New home sales bounced back with a better than expected 6.4 percent increase last month. Lennar (LEN) and D.R. Horton (DHI) both rose 4 percent. Pulte (PHM), Beazer (BZH) and Hovnanian (HOV) also solid posted gains. Earnings continue to drive retail stocks. Gap (GPS) edged higher even though net fell. Foot Locker (FL) gained 1½ percent after topping expectations. GameStop (GME) rose 4 percent. Its net rose, helped by the rollout last year of new Xbox and PlayStation consoles. Zumiez (ZUMZ) rose 5½ percent on an earnings beat. But Aeropostale (ARO) tumbled 24 percent. Its loss widened and sales declined. The retailer continues to struggle with teen fashion trends. Also on the earnings front, TiVo (TIVO) rose 2 percent as it swung to a profit from a year ago loss. It also reported an increase in the number of subscribers. Hewlett-Packard (HPQ) rose 6 percent on news the company plans to eliminate up to 16,000 additional workers in an effort to cut costs. And several stocks extended big moves from yesterday. Best Buy (BBY) rose more than 3 percent for the second straight day after earnings beat expectations. Isis Pharmaceuticals (ISIS) jumped
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