This week, 11 biotechnology stocks are improving their overall ratings on Portfolio Grader. Each of these stocks is rated an “A” (“strong buy”) or “B” overall (“buy”).
Hot Defense Companies To Own In Right Now: Sucampo Pharmaceuticals Inc (SCMP)
Sucampo Pharmaceuticals, Inc., incorporated on December 9, 2008, is a global biopharmaceutical company focused on research, discovery, development and commercialization of drugs based on ion channel activators known as prostones. The Company�� prostone-based compounds target the ClC-2 and big potassium (BK), ion channels. It is focused on developing prostones to treat gastrointestinal, ophthalmic, neurologic, and oncology-based inflammatory disorders, and is also considering other therapeutic applications of its drug technology. The Company�� products include AMITIZA (lubiprostone) and RESCULA (unoprostone isopropyl).
AMITIZA
The Company�� AMITIZA is being marketed in the United States for three gastrointestinal indications under a license agreement, or the Takeda Agreement, with Takeda Pharmaceutical Company Limited, or Takeda. The three gastrointestinal indications include chronic idiopathic constipation (CIC), in adults, irritable bowel syndrome with constipation (IBS-C), in adult women, and opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. AMITIZA for OIC received approval from the United States Food and Drug Administration (FDA), in April 2013. In Japan, AMITIZA is marketed under a license, commercialization and supply agreement, or the Abbott Agreement, with Abbott Japan Co. Ltd. (Abbott), for the gastrointestinal indication of chronic constipation (CC), excluding constipation caused by organic diseases. In Switzerland, the Company is marketing AMITIZA.
RESCULA
The Company holds license agreements for RESCULA in the United States and Canada and the rest of the world, with the exception of Japan, Korea, Taiwan and the People�� Republic of China. The Company is commercializing RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% for the lowering of intraocular pressure (IOP), in patients with open-angle glaucoma or ocular hypertension in the United States. RESCULA may be used as an agent or concomit! antly with other topical ophthalmic drug products to lower intraocular pressure. RESCULA is a BK channel activator and has a different mechanism of action than other IOP lowering agents on the market.
Advisors' Opinion:- [By James Brumley]
Still, for the nimble who know when to get out, OREX is one of the few cheap stocks worth a closer look.
Sucampo Pharmaceuticals (SCMP)Finally, though the price of $7.60 clearly qualifies it as one pf the cheapest of the cheap stocks out there in the pharmaceutical world, that’s not the reason Sucampo Pharmaceuticals (SCMP) may be worth a look here. It’s the 30% slide we’ve seen SCMP stock suffer since peaking in mid-January. It’s not a pullback that’s bound to go unchallenged by the bulls.
- [By Roberto Pedone]
Another under-$10 stock that's starting to trend within range of triggering a major breakout trade is Sucampo Pharmaceuticals (SCMP), which is engaged in the discovery, development and commercialization of proprietary drugs based on prostones, and other novel drug technologies. This stock is off to a decent start in 2013, with shares up by 26%.
If you take a look at the chart for Sucampo Pharmaceuticals, you'll notice that this stock has been downtrending badly for the last four months, with shares dumping hard from its high of $10.48 to its recent low of $5.40 a share. During that downtrend, shares of SCMP have been consistently making lower highs and lower lows, which is bearish technical price action. That said, the downside volatility for SCMP looks to be over in the short-term since the stock has started to reverse its downtrend and enter an uptrend. That reverse is quickly pushing shares of SCMP within range of triggering a major breakout trade above a key downtrend line.
Traders should now look for long-biased trades in SCMP if it manages to break out above some near-term overhead resistance levels at $6.33 to $6.66 a share with high volume. Look for a sustained move or close above those levels with volume that hits near or above its three-month average action of 115,383 shares. If that breakout triggers soon, then SCMP will set up to re-test or possibly take out its next major overhead resistance levels at $7.09 to $7.67 a share. Any high-volume move above those levels will then give SCMP a chance to tag $8 to $9 a share.
Traders can look to buy SCMP off weakness to anticipate that breakout and simply use a stop that sits right below some key near-term support levels at $5.58 to $5.40 a share. One can also buy SCMP off strength once it clears those breakout levels with volume and then simply use a stop that sits a comfortable percentage from your entry point.
Top Biotech Stocks To Own For 2015: Bio-Path Holdings Inc (BPTH)
Bio-Path Holdings Inc is a development stage company. The Company, through its wholly owned subsidiary, Bio-Path, Inc. is engaged in the business of developing cancer therapeutics. As of December 31, 2011, the Company had licenses from The University of Texas M. D. Anderson Cancer Center (MD Anderson) for three lead products and nucleic acid delivery technology, including tumor targeting technology. The licenses provide drug delivery platform technology with composition of matter intellectual property for antisense that enables systemic delivery of antisense, formulation intellectual property for systemic delivery of small interfering Ribonucleic acid (RNA) (siRNA) and small molecules for treatment of cancer. The Company issued a press release announcing that the United States Food and Drug Administration (FDA) had allowed an IND (investigational new drug) for its lead cancer drug candidate liposomal BP-100-1.01 (or Liposomal Grb-2 or L-Grb-2) to proceed into clinical trials.
In February, 2012, the Company completed requirements for treating patients in the second cohort. The dose being used for treatment in the third cohort is double the dose that was used to treat patients in the second cohort. At the end of February, 2012, enrollment continued in the third cohort of the clinical trial and patients are being treated.
BP-100-1.01
BP-100-1.01 is the Company's lead lipid delivery antisense drug candidate, which is being clinically tested in patients having acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), myelodysplastic syndrome (MDS) and acute lymphoblastic leukemia (ALL). Receipt of an IND allowed the Company to commence its Phase I clinical trial to study L-Grb-2 in human patients. Phase I clinical trial is a dose-escalating study to determine the safety and tolerance of escalating doses of L-Grb-2. The clinical trial is being conducted at The University of Texas MD Anderson Cancer Center. As of December 31, 2011, the trial is in the middle of ! testing the third dose in patients.
BP-100-2.01
BP-100-1.02 is Liposomal Bcl-2 (also L-Bcl-2), another liposomal antisense drug candidate that was licensed from MD Anderson. This drug has pre-clinical testing data package. The target protein for this drug candidate, Bcl-2, is involved in regulating programmed cell death. In cancer, the Bcl-2 protein can over-express, which can lead to a situation, in which the Bcl-2 protein blocks the cell�� normal death signals, making the cancer cell resistant to chemotherapy. Types of cancer potentially treatable with L-Bcl-2 include lymphoma, prostate cancer, small cell lung cancer, breast cancer, melanoma, chronic lymphoid leukemia (CLL) and several others.
Advisors' Opinion:- [By Lisa Levin]
Bio-Path Holdings (NASDAQ: BPTH) shares declined 5.66% to touch a new 52-week low of $2.50. Bio-Path shares have jumped 349.15% over the past 52 weeks, while the S&P 500 index has gained 19.24% in the same period.
Top Biotech Stocks To Own For 2015: Juno Therapeutics Inc (JUNO)
Juno Therapeutics, Inc. (Juno) is a United States-based clinical-stage biopharmaceutical company. The Company is engaged in developing cell-based cancer immunotherapies based on its chimeric antigen receptor (CAR), and high-affinity T cell receptor (TCR), technologies to genetically engineer T cells to recognize and kill cancer cells. Through genetic engineering, the Company inserts a gene for a particular CAR or TCR construct into the T cell that enables it to better recognize cancer cells. Its CAR technology directs T cells to recognize cancer cells based on the expression of specific proteins located on the cell surface, whereas its TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell.
To provide treatment, the Company harvests blood cells from a cancer patient, separate the appropriate T cells, activate the cells, insert the gene sequence for the CAR or TCR construct into the cells��Deoxyribonucleic Acid (DNA), and grow these modified T cells to the desired dose level. The modified T cells can then be infused into the patient or frozen and stored for later infusion. Once infused, the T cells are designed to multiply, through a process known as cell expansion, when they encounter the targeted proteins and to kill the targeted cancer cells.
CD19-Directed Product Candidates
The Company�� product candidates, such as JCAR015, JCAR017, and JCAR014, which use CAR technology to target CD19, a protein expressed on the surface of almost all B cell leukemias and lymphomas. The Company has rights to commercialize each of these product candidates across the world. The Company�� JCAR015 is an advanced development product candidate, and it has demonstrated clinically meaningful complete remission rates in adult patients with r/r ALL. JCAR015 uses the CD28 costimulatory domain and CD3 enriched peripheral blood mononuclear cells (PBMC), which requires fewer process steps for! manufacture than its defined cell composition product candidates. JCAR015 is being tested in a Phase I open label clinical trial of patients with r/r ALL for the treatment of refractory chronic lymphocytic leukemia.
JCAR017 also targets CD19, but differs from JCAR015 in several important respects. JCAR017 uses the 4-1BB costimulatory domain and a defined cell composition of CD4+ T cells and CD8+ T cells. JCAR017 is in development for pediatric patients with r/r ALL. JCAR017 is being evaluated in a Phase I/II clinical trial in pediatric r/r ALL.
JCAR014 also targets CD19. JCAR014 uses the 4-1BB costimulatory domain and is composed of CD8+ central memory T cells and CD4+ T cells in a defined ratio. JCAR014 is being evaluated in a Phase I/II trial as a treatment for a number of B cell malignancies in patients relapsed or refractory to standard therapies.
Additional Product Candidates
The Company is exploring the potential of its CAR and TCR technologies against targets that have the potential to treat cancers not targeted by CD19-directed products, in particular, difficult-to-treat solid organ tumors, such as certain breast, lung, and pancreatic cancers, as well as B cell malignancies that do not express CD19. The Company�� CD22 is a cell surface protein widely expressed on B lymphocytes. It is expressed by B cell malignancies, including non-Hodgkin�� lymphoma (NHL), acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The Company�� L1CAM, also known as CD171, is a cell-surface adhesion molecule that plays an important role in the development of a normal nervous system. It is overexpressed in neuroblastoma, and there is increasing evidence of aberrant expression in a variety of solid organ tumors, including glioblastoma and lung, pancreatic, and ovarian cancers.
The Company�� MUC-16 is a protein overexpressed in the ovarian cancers, but not on the surface of normal ovary cells. CA-125 is a protein found in the ! blood of ! ovarian cancer patients that results from the cleavage of MUC-16. CA-125 levels in the blood are a common test for ovarian cancer progression because they correlate with cancer progression. Its MUC-16/IL-12 product candidate uses its armored CAR technology. IL-12 is a cytokine that can help overcome the inhibitory effects that the tumor micro-environment can have on T cell activity.
The Company�� ROR-1 is a protein expressed in the formation of embryos, but in normal adult cells its surface expression is predominantly found at low levels on adipocytes, or fat cells, and briefly on precursors to B cells, or pre-B cells, during normal B cell maturation. ROR-1 is overexpressed on a variety of cancers including a subset of non-small cell lung cancer, triple negative breast cancer, pancreatic cancer, and prostate cancer. It is expressed on B cell chronic lymphocytic leukemia and mantle cell lymphoma. The Company�� high-affinity TCR T cell product candidate targets WT-1, an intracellular protein that is overexpressed in a number of cancers, including adult myeloid leukemia, or AML, and non-small cell lung, breast, pancreatic, ovarian, and colorectal cancers.
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.
Top Biotech Stocks To Own For 2015: Enanta Pharmaceuticals Inc (ENTA)
Enanta Pharmaceuticals, Inc., incorporated on July 25, 1995, is a research and development-focused biotechnology company. The Company uses its chemistry-driven approach and drug discovery capabilities to create small molecule drugs in the infectious disease field. The Company is discovering and developing novel inhibitors designed for use against the hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes-protease (partnered with AbbVie, the former research-based pharmaceutical business of Abbott Laboratories), NS5A (partnered with Novartis) and nucleotide polymerase, as well as a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. ABT-450, discovered through its collaboration with AbbVie, is a protease inhibitor that has demonstrated in vitro potency against known resistant HCV mutants.
In Phase I studies, ABT-450 co-administered with ritonavir, a commonly used boosting agent to increase the blood concentrations of many protease inhibitors, was shown to be safe and well tolerated. Co-administration of ABT-450 with ritonavir, which it refers to together as ABT-450/r, has enabled once-daily dosing of ABT-450. Phase II studies have demonstrated the efficacy of ABT-450/r in patients with chronic HCV, and other interferon-free Phase II studies of ABT-450-containing regimens continue. AbbVie is developing a next-generation protease inhibitor discovered within the Enanta-AbbVie collaboration. EDP-239 is the NS5A inhibitor discovered by the Company. The Company also has a program to develop nucleotide inhibitors to HCV NS5B polymerase, which is another DAA mechanism considered to have a barrier to resistance. The Company�� Bicyclolide antibiotic product candidate is EDP-788, which it is developing for use as an intravenous drug in the hospital setting and for oral dosing in the home setting. EDP-788 is a prodrug, which means that it is inactive until it is converted in the body into an active compound. EDP-788 is! a water-soluble molecule which, when administered in preclinical models, is cleanly and rapidly converted into the active compound.
Advisors' Opinion:- [By Ben Levisohn]
The fundamentals of the biotech industry appear strong as measured by a robust list of ongoing and expected product launches. Large-cap biotech companies under our coverage (Alexion Pharmaceuticals, Amgen, Celgene, Gilead, Vertex Pharmaceuticals (VRTX)) all have ongoing or anticipated product launches in 2015. These launches…AbbVie (ABBV) /�Enanta Pharmaceuticals (ENTA) Viekirax + Exviera for hepatitis C…Other high-visibility launches include the expected launches of PCSK9 antibodies, evolocumab from�Amgen and alirocumab from Sanofi (SNY) / Regeneron (REGN) for high cholesterol, anticipated in 3Q:15. Although the expectation is for a slow ramp-up until cardiovascular outcome data (no later than 2017), the market is large enough to allow fast launches. For Celgene, Gilead, Medivation (MDVN) and Vertex, the launches are for their most important products; therefore the progress of the launches will be particularly important to watch.
- [By George Budwell]
Normally, such strong efficacy results would be hailed as a major achievement. However, these results are actually less impressive than those by competing drug's developed by AbbVie (NYSE: ABBV ) , Enanta Pharmaceuticals (NASDAQ: ENTA ) and Gilead. Bristol-Myers' therapy also has a treatment duration double that of Gilead's drug Sovaldi for genotype 1 patients. So, while these results are impressive in their own right, the therapy's commercial prospects may be limited due to the presence of superior competitors in the market.�
Top Biotech Stocks To Own For 2015: Sanofi(SNY)
sanofi-aventis engages in the discovery, development, and distribution of therapeutic solutions to improve the lives of everyone. The company offers a range of healthcare assets, including a broad-based product portfolio in prescription drugs, OTC/OTX, generics, vaccines, and animal health. It has a strategic alliance with Regulus Therapeutics Inc. to discover, develop, and commercialize micro-RNA therapeutics, initially in fibrosis. The company was founded in 1970 and is headquartered in Paris, France.
Advisors' Opinion:- [By Charles Rice, Associate Editor - November 6, 2013 Money Morning]
By acquiring Brazil's Medley Pharmaceuticals in 2009, Sanofi SA (NYSE ADR: SNY) became the largest generic pharmaceutical manufacturer in Latin America. The company holds a 12% market share in Brazil and reported annual revenue for its generics business of around $2.4 billion, a 5% increase over 2011 in constant exchange rates. Sanofi reported 2012 earnings of approximately $46 billion.
Top Biotech Stocks To Own For 2015: TESARO Inc (TSRO)
TESARO, Inc. (TESARO), incorporated in March 2010, is a development-stage, oncology-focused biopharmaceutical company for cancer patients. The Company focuses on rolapitant and TSR-011 product. The Company�� marketed products and product candidates in development treat cancer through non-specific damage to cellular components or alter cell metabolism or internal repair mechanisms to the demise of cancer cells.
Rolapitant
Rolapitant is a potent and long-acting neurokinin-1, or NK-1, receptor antagonist is in Phase III clinical trials for the prevention of chemotherapy induced nausea and vomiting (CINV). It is in Phase III clinical trials. CINV, if not prevented by prophylaxis, has the potential to afflict up to 90% or more of cancer patients undergoing chemotherapy, depending upon the type of chemotherapy administered the dosing schedule of the chemotherapy, and the patients' age and gender, among other predisposing factors. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization. The Company has in-licensed the rights to rolapitant from OPKO Health, Inc.
TSR-011
TSR-011 is an orally available ALK inhibitor in preclinical development. ALK is known to be involved in certain types of cancers, including subsets of NSCLC, neuroblastoma and lymphoma. For patients in these subsets, the ALK gene is fused to an activating partner or contains point mutations, resulting in constitutive activation of ALK and the growth of cancer cells and tumor development. Inhibition of ALK in these cancer cells results in cell death and tumor growth inhibition or regression. In August 2011, the United States Food and Drug Administration approved the first ALK inhibitor, developed by Pfizer Inc., Xalkori (crizotinib), which was approved for the treatment of patients with locally advanced or metastatic NSCLC that are ALK positive.
The Company competes with GlaxoSmithKline plc, Roche Holding Ltd! . and Sanofi S.A.
Advisors' Opinion:- [By Ben Levisohn]
Werber and Eckhard’s favorites include Gilead (GILD) and Celgene (CELG), and they find the “risk/reward…compelling” in Medivation (MDVN) and Tesaro (TSRO).
- [By Jake L'Ecuyer]
Equities Trading UP
Tesaro (NASDAQ: TSRO) shares shot up 20.78 percent to $29.00 after the company reported successful primary and secondary endpoints in final Phase 3 trial for rolapitant.
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