From the smallest biotech to the biggest pharmaceutical stock,�The Motley Fool's Market Check-Up�covers the health-care sector's biggest headlines, hottest market movers, and Obamacare's ongoing rollout.
In this segment, health-care analyst David Williamson looks at Arena Pharmaceuticals' (NASDAQ: ARNA ) deal with partner Eisai to market its obesity drug Belviq worldwide. Shares soared on the news, but could this really be as big of a blockbuster as it seems? David takes a look at the somewhat lackluster sales of both Arena's Belviq and competitor Vivus' (NASDAQ: VVUS ) Qsymia, and highlights some headwinds these companies face here, though he also notes several signs that show Eisai remains very optimistic.
Should investors be jumping in or holding off? David gives his thoughts.
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Hot Managed Healthcare Stocks To Watch For 2015: Elite Pharmaceuticals Inc (ELTP)
Elite Pharmaceuticals, Inc. (Elite), incorporated on October 1, 1997, is a specialty pharmaceutical company principally engaged in the development and manufactures of oral, controlled-release products, using technology and the development and manufacture of generic pharmaceuticals. Elite has four products: Phentermine 37.5 milligram tablets, Methadone 10 milligram tablets, Lodrane D Immediate Release capsules and Hydromorphone Hydrochloride 8 milligram tablets. During the fiscal years ended March 31, 2012 (Fiscal 2011), the Company manufactured and sold Lodrane 24 and Lodrane 24D (the Lodrane Extended Release Products).
The Company has a pipeline of additional generic drug candidates under active development, including, without limitation, ELI-154, a once-a-day oxycodone product and ELI-216, an abuse resistant oxycodone product which utilizes the Company�� propriety formulation for abuse resistant products utilizing the pharmacological approach (Elite�� Abuse Resistant Technology). ECR Pharmaceuticals (ECR), a wholly owned subsidiary of Hi-Tech Pharmacal, Inc. and the owner and marketer of the Lodrane Extended Release Products. Elite also purchased from Mikah Pharma LLC, an approved Abbreviated New Drug Application (ANDA) for Naltrexone 50 milligram tablets.
For ELI-154, Elite has developed a once-daily oxycodone formulation using its technology. An investigational new drug application (IND) has been filed and Elite has completed two pharmacokinetic studies in healthy subjects that compared blood levels of oxycodone from dosing ELI-154 and the twice-a-day product that is on the market, OxyContin marketed in the United States by Purdue Pharma LP. ELI-216 utilizes the Company's abuse-deterrent technology that is based on a pharmacological approach. ELI-216 is a combination of a narcotic agonist, oxycodone hydrochloride, in a sustained-release formulation intended for use in patients with moderate to severe chronic pain, and an antagonist, naltrexone hydrochloride, formulat! ed to deter abuse of the drug. Products utilizing the pharmacological approach to deter abuse such as Suboxone, a product marketed in the United States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda, a product marketed in the United States by Pfizer, have been approved by the United States Food & Drug Administration (FDA). ELI-216 demonstrates a euphoria-blocking effect when the product is crushed. Elite has developed ELI-154 and ELI-216 and retains the rights to these products.
The Company competes with Collegium Pharmaceuticals, Inc., Purdue Pharma LP, Acura Pharmaceuticals, Inc., Durect Corporation, Mylan Laboratories, Inc., Par Pharmaceuticals, Inc., Alkermes, Inc., Teva Pharmaceuticals Industries Ltd., Aptalis Pharma, Impax Laboratories, Inc., and Watson Pharmaceuticals.
Advisors' Opinion:- [By CRWE]
Today, ELTP has shed (-8.01%) down -0.009 at $.101 with 4,629,899 shares in play thus far (ref. google finance Delayed: 1:00PM EDT September 16, 2013).
Elite Pharmaceuticals, Inc. previously reported the first quarter of fiscal year 2014 ended June 30, 2013. Manufacturing and profit split revenues comprised almost all of Elite’s quarterly revenues and totaled $717k for the quarter, an increase of 41% from the prior year. This growth is attributed to the launch of two new products during the quarter, Phentermine 15mg and 30mg capsules, combined with strong year-on-year growth of the Elite’s Hydromorphone 8mg tablets and contract manufactured Methadone 10mg product lines.
- [By James E. Brumley]
Judging from the company it's keeping Green Automotive Co. (OTCMKTS:GACR) may have just made its way into the upper echelon of small cap stock opportunities. The electric car company joins Elite Pharmaceuticals Inc. (OTCBB:ELTP), Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS), and only three other companies as Wall-Street.com's "Best 6 Stocks" for January of 2014. As one of the top information resources for investors - particularly in terms of information regarding small and micro cap stocks - being named among the site's top pick is an accolade for AMBS, ELTP, and GACR. Even more impressive is that Green Automotive Co. was the only consumer-goods name among those six. Amarantus Bioscience Holdings and Elite Pharmaceuticals are biotechnology names... an industry that can and often does attract a lot of attention just by the nature of the business. The other three names making the "Best 6" list were an energy explorer, a power-management technology manufacturer, and prescription/medical food producer. For an electric car manufacturer to make the list speaks quite highly of GACR.
- [By James E. Brumley]
Exactly one month ago today I penned some bullish thoughts on Elite Pharmaceuticals Inc. (OTCBB:ELTP). If you're familiar with the company - or a regular reader of this site - then you may know why that sounds a little "off." See, at the time, ELTP shares were falling rather quickly, giving up all the gains they had made just a few days before. Almost needless to say, my premise was not a well received one. Let's just say I received some "colorful disagreements" by being optimistic about the biopharma company.
Top 5 Biotech Companies To Buy For 2014: 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 5 Biotech Companies To Buy For 2014: Nektar Therapeutics(NKTR)
Nektar Therapeutics, a clinical-stage biopharmaceutical company, engages in developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms. The company?s product pipeline consists of drug candidates across various therapeutic areas, including oncology, pain, anti-infectives, anti-viral, and immunology. Its research and development activities involve small molecule drugs, peptides, and other potential biologic drug candidates. The company?s proprietary drug candidates in clinical development comprise NKTR-118, a peripheral opioid antagonist, which has completed Phase II clinical trail for the treatment of opioid-induced constipation; BAY41-6551 that has completed Phase II clinical trail to treat gram-negative pneumonias; NKTR-102, a topoisomerase I inhibitor-polymer conjugate, which is in Phase II clinical trail for multiple cancer indications, including breast, ovarian, and colorectal; and NKTR-105 that is in Phase I clinica l trail to treat solid tumors. Its preclinical products consists of NKTR-119 (Opioid/NKTR-118 combinations) for the treatment of pain; NKTR-181 (abuse deterrent, tamper-resistant opioid) to treat pain; NKTR-194 (non-scheduled opioid) for the treatment of mild to moderate pain; NKTR-171 (tricyclic antidepressant) to treat neuropathic pain; and NKTR-140 (protease inhibitor candidate) to treat HIV. The company has collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061, Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside antibiotic; and a license agreement with AstraZeneca AB for the development and commercialization of Oral NKTR-118 and NKTR-119. In addition, Nektar Therapeutics has various license, manufacturing, and supply agreements for its technology with biotechnology and pharmaceutical companies, such as Affymax, Amgen, Baxter, Roche, Merck, Pfizer, and UCB Pharma. The company was founded in 1990 and is headquartered in San Franc isco, California.
Advisors' Opinion:- [By Rich Bieglmeier]
Wednesday, June 11, 2014 could be a happy or sad day for event traders who follow the Food and Drug Association's (FDA) calendar. Two biotechs with considerable potential are slated to hear from the regulatory body regarding their applications for approval.
Nektar Therapeutics (NASDAQ:NKTR) Orexigen Therapeutics, Inc. (NASDAQ:OREX)The duo hopes to see �thumbs up from the FDA in a little more than a week. If all things go well, it could be party time for shareholders too.
- [By Sean Williams]
This is particularly intriguing now both to Allergan, which purchased MAP Pharmaceuticals earlier this year for $958 million, and to�Nektar Therapeutics (NASDAQ: NKTR ) , which would gain royalties from the sale of Levadex due to its intellectual property contribution to the making of the drug.
Top 5 Biotech Companies To Buy For 2014: Provectus Pharmaceuticals Inc (PVCT)
Provectus Pharmaceuticals, Inc., incorporated on May 1, 1978, is a development-stage pharmaceutical company that is primarily engaged in developing ethical pharmaceuticals for oncology and dermatology indications. The Company develops and focuses to license or market and sells its two prescription drug candidates, PV-10 and PH-10. The Company has transferred all its intellectual property related to over the counter (OTC) products and non-core technologies to its subsidiaries and designated, such subsidiaries as non-core to its primary business of developing its oncology and dermatology prescription drug candidates. The Company focuses on developing its prescription drug candidates PV-10 and PH-10. The Company is developing PV-10 for treatment of several life threatening cancers, including metastatic melanoma, liver cancer, and breast cancer. The Company is developing PH-10 to provide minimally invasive treatment of chronic severe skin afflictions such as psoriasis and atopic dermatitis, a type of eczema. All of the Company's prescription drug candidates are in either the pre-clinical or clinical trial stage.
PV-10
As of December 31, 2011, the Company is developing PV-10, a sterile injectible form of rose bengal disodium (Rose Bengal), for direct injection into tumors. Its PV-10 is retained in diseased or damaged tissue but dissipates from healthy tissue. The Company had conducted Phase I and Phase IIstudies of PV-10 for the treatment of metastatic melanoma, and Phase I studies of PV-10 for the treatment of liver and breast cancers.
PH-10
The Company�� prescription drug candidate PH-10 is an aqueous hydrogel formulation of Rose Bengal for topical administration to the skin. The Company is developing PH-10 for the treatment of cutaneous skin disorders, specifically psoriasis and atopic dermatitis. In August 2011, the Company completed follow-up of all Phase IIc patients.
Over-the-Counter Pharmaceuticals
The Company had desi! gnated its subsidiary that holds its OTC products, GloveAid and Pure-ific, Pure-Stick, Pure N Clear as non-core. The Company�� GloveAid is a hand cream with both antiperspirant and antibacterial properties, for the comfort of users��hands during and after the wearing of disposable gloves. Its Pure-ific line of products includes two quick-drying sprays, Pure-ific and Pure-ific Kids, that immediately kill up to 99.9% of germs on skin and prevent regrowth for six hours. Pure-ific products prevent the spread of germs and thus complement its other OTC products designed to treat irritated skin or skin conditions, such as acne, eczema, dandruff and fungal infections. Its Pure-ific sprays have been designed with convenience in mind and are targeted towards mothers, travelers, and anyone concerned about the spread of sickness-causing germs.
The Company�� acne products Pure-Stick and Pure N Clear work by decreasing the production of fats, oils and sweat that create an environment conducive to unchecked growth of bacteria. Secondly, the products also act to reduce the number bacteria already present. The Pure-Stick and Pure N Clear are applied topically to affected areas there are no safety concerns with healthy skin.
Advisors' Opinion:- [By Luke Jacobi]
Provectus Biopharmaceuticals (NYSE: PVCT) was also down, falling 3.38 percent to $3.01, letting out some air after the company's opening on the NYSE Friday.
- [By Jake L'Ecuyer]
Provectus Biopharmaceuticals (NYSE: PVCT) was also down, falling 3.02 percent to $3.01, letting out some air after the company's opening on the NYSE Friday.
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