Best Medical Companies To Buy Right Now

Leslie Bocskor, one might say, is high on the legal cannabis industry.

Bocskor, who describes himself as an investment banker and entrepreneur, plans to roll out a hedge fund in the fourth quarter that will invest in legal cannabis-related businesses across the country.

The opportunity comes, he said in an interview with ThinkAdvisor, as a number of states decriminalize possession, others create medical marijuana programs and a few have full adult use regulatory frameworks and are currently selling cannabis and regulating it as they do alcohol.

“Gradually the misrepresentations regarding cannabis are starting to come to light as reasonable people have an honest conversation about cannabis’s benefits, issues surrounding it, about the reality of it,” he said.

The investment opportunity is huge. Bocskor, citing research by the ArcView Group of which he is a member, said the size of the legal cannabis industry this year would reach $2.8 billion, up from $1.5 billion at the end of 2013.

Best Biotech Stocks To Invest In Right Now: 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 Leo Sun]

  However, these three biotech stocks -- Amarin (NASDAQ: AMRN  ) , Dendreon (NASDAQ: DNDN  ) , Prosensa (NASDAQ: RNA  ) -- don't fit that category at all. Read on to understand why these dogs of the sector should never be mistaken as underdogs.

• [By Bryan Murphy]

  Anybody who knows at least something about Prosensa Holding NV (NASDAQ:RNA) will at least know the stock turned into a disaster a few weeks ago, plunging from a close of $24.00 on September 19th to a close of $7.14 on September 20th, thanks to the failure of its MS drug drisapersen, which was jointly developed with GlaxoSmithKline plc (NYSE:GSK). Such is the life of a company with only one drug anywhere close to being approved; drisapersen was in Phase 3 trials - RNA shares could have just as easily gained 70% rather than lost 70% had the drug worked.

• [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  ) .

Best Medical Companies To Buy Right Now: Redhill Biopharma Ltd (RDHL)

Redhill Biopharma Ltd. is an Israel-based biopharmaceutical company. The Company is focused on the development and acquisition of therapeutic candidates. The Company�� pipeline consists of six late clinical development therapeutic candidates, two of which have completed bioequivalence clinical trials subject to review and approval by the United States Food and Drug Administration and, in some cases, regulatory authorities in other countries. The Company�� six clinical stage therapeutic candidates include RHB-101, RHB-102, RHB-103, RHB-104, RHB-105 and RHB-106.

RHB-101

RHB-101 is a treatment of hypertension, heart failure and left ventricular dysfunction (following myocardial infraction) by means of controlled release of an active ingredient known as carvedilol, which is designed to be administered to patients on a once-daily basis. RHB-101 is based on a patented technology for the controlled release of drugs administered orally.

RHB-102

RHB-102 is a once-daily controlled release oral formulation of ondansetron. RHB-102 utilizes a technology called CDT that uses salts to provide a controlled release of ondansetron.

RHB-103

RHB-103 is an oral thin film formulation of rizatriptan intended for the treatment of acute migraine headaches. Migraine is a neurovascular disorder (related to nerves and blood vessels) characterized by recurrent headaches in one side or both sides of the head.

The product is based on a technology called VersaFilm.

RHB-104

RHB-104 is an antibiotic combination therapy for the treatment of Crohn's disease (with a PIII clinical study underway), as well as Multiple Sclerosis (with an ongoing PIIa clinical study) and Rheumatoid Arthritis. RHB-104 is a combination of clarithromycin, clofazimine and rifabutin, three generic antibiotic ingredients, in a single capsule.

RHB-105

RHB-105, an antibiotics and proton pump inhibitor drug targeting Helico! bacter Pylori infection. RHB-105 is a combination of three approved drug products omeprazole, which is a proton pump inhibitor (the natural body pump that produces the gastric acids used for digesting the food in the stomach), and amoxicillin and rifabutin which are antibiotics. Chronic infection with Helicobacter pylori irritates the mucosal lining of the stomach and small intestine.

RHB-106

RHB-106, is a tablet for the preparation and cleansing of the gastrointestinal tract prior to the performance of abdominal procedures. Its abdominal procedures include diagnostic tests, such as colonoscopy, barium enema or virtual colonoscopy, as well as surgical interventions, such as laparotomy.

The company competes with GlaxoSmithKline, Sanofi-Aventis Groupe, Hoffman-La Roche Ltd, Merck and Co., Inc, Ferring Pharmaceuticals and Salix Pharmaceuticals Inc.

Advisors' Opinion:

• [By Monica Gerson]

  Breaking news

  Vitran Corporation (NASDAQ: VTNC) announced today that it has entered into a definitive arrangement agreement with TransForce pursuant to which TransForce has agreed to acquire all of the outstanding common shares of Vitran not already owned by TransForce for US$6.50 in cash per share, in accordance with TransForce's prior proposal. To read the full news, click here. ReneSola (NYSE: SOL) today announced it signed a Memorandum of Intent (MOI) to sell three utility-scale projects in Western China, with a total capacity of 60MW, to Jiangsu Akcome Solar Science & Technology Co on December 30, 2013. To read the full news, click here. Cooper Tire & Rubber Company (NYSE: CTB) today announced it has terminated the merger agreement with Apollo Tyres (NSE:ApolloTYRE). To read the full news, click here. RedHill Biopharma (NASDAQ: RDHL) today announced that it has entered into a definitive agreement with leading healthcare investor OrbiMed Israel Partners Limited Partnership, an affiliate of OrbiMed Advisors LLC, for the sale of RedHill's American Depository Shares and warrants in a private placement transactionor a total sum of $6.0 million. To read the full news, click here.

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Best Medical Companies To Buy Right Now: Organovo Holdings Inc (ONVO)

Organovo Holdings, Inc. (Organovo), formerly Real Estate Restoration & Rental, Inc., incorporated in 2007, is a development-stage company. The Company has developed and is commercializing a platform technology for the generation of three-dimensional (3D) human tissues that can be employed in drug discovery and development, biological research, and as therapeutic implants for the treatment of damaged or degenerating tissues and organs. On December 28, 2011, Real Estate Restoration and Rental, Inc.�� (RERR) entered into an Agreement and Plan of Merger, pursuant to which RERR merged with its, wholly owned subsidiary, Organovo (Merger Sub). On February 8, 2012, the Company merged with and into Organovo Acquisition Corp. (Acquisition Corp.), a wholly owned subsidiary of Organovo, with the Company surviving the merger as a wholly owned subsidiary of Organovo Holdings (the Merger). As a result of the Merger, Organovo acquired the business of Organovo, Inc.

The Company has collaborative research agreements with Pfizer, Inc. (Pfizer) and United Therapeutic Corporation (Unither). As of March 31, 2012, it has five federal grants, including Small Business Innovation Research grants and developed the NovoGen MMX Bioprinter (its first-generation 3D bioprinter). The Company is engaged in the development of specific 3D human tissues to aid Pfizer in discovery of therapies in two areas of interest. In addition, in October 2011, it entered into a research agreement with Unither to establish and conduct a research program to discover treatments for pulmonary hypertension using its NovoGen MMX Bioprinter technology. Additionally, under the research agreement with Unither, the Company granted Unither an option to acquire from the Company a worldwide, royalty-bearing license in certain intellectual property created under the research agreement solely for use in the treatment or prevention of pulmonary hypertension and all other lung diseases.

The Company�� NovoGen MMX Bioprinter is an automate! d device that enables the fabrication of three-dimensional (3D) living tissues comprised of mammalian cells. A custom graphic user interface (GUI) facilitates the 3D design and execution of scripts that direct precision movement of the dispensing heads to deposit cellular building blocks (bio-ink) or supporting hydrogel. The Company is using a third party manufacturer, Invetech Pty., of Melbourne, Australia, to manufacture its NovoGen MMX Bioprinter. Its bioprinting technology and surrounding intellectual property and commercial rights serve as a platform for product generation across multiple markets that employ cell- and tissue-based products and services.

The Company competes with Organogenesis, Advanced BioHealing, Tengion, Genzyme, HumaCyte and Cytograft Tissue Engineering.

Advisors' Opinion:

• [By John Udovich]

  As the the year comes to end, there is still a steady flow of interesting news coming from small cap biotech stocks like Organovo Holdings Inc (NYSEMKT: ONVO), Advanced Cell Technology, Inc (OTCMKTS: ACTC) and TNI BioTech (OTCMKTS: TNIB)�plus still largely private biotech companies like Genocea Biosciences (NASDAQ: GNCA), Retrophin (OTCMKTS: RTRX), Auspex Pharmaceuticals (NASDAQ: ASPX) and GlycoMimetics (NASDAQ: GLYC) who have filed to become the next potentially hot biotech IPOs���presumably some time early�next year. Just consider the following biotech news:

• [By Paul Ausick]

  Stocks on the Move: Sprint Corp. (NYSE: S) is up 8.2% at $7.95 even though the firm�� service was ranked last in new Consumer Reports survey. Voxeljet AG (NYSE: VJET) is down 13.8% at $33.82, the third day in a row the stock has been hit with double-digit losses. Organovo Holdings In. (NASDAQ: ONVO) is up 11.5% at $8.86 after getting beaten up in the 3D printing debacle yesterday.

• [By James E. Brumley]

  I'll warn you now that if you a fan of or shareholder in Organovo Holdings Inc. (NYSEMKT:ONVO), you're not going to like what you're about to hear. Sorry, but I have to call 'em like I see 'em. And what I see with ONVO is an overbought stock ripe for a big tumble.

Best Medical Companies To Buy Right Now: Elan Corporation PLC (ELN)

Elan Corporation, plc (Elan), incorporated in December 1969, is a neuroscience-based biotechnology company. The Company is focused on discovering and developing advanced therapies in neurodegenerative and autoimmune diseases. Elan�� business focuses on neurodegenerative diseases, such as Alzheimer�� disease and Parkinson�� disease; autoimmune diseases, including MS and Crohn�� disease and neo-epitope based targets for treatments across a range of therapeutic indications. Tysabri is a treatment for MS and Crohn�� disease that the Company markets and distributes with Biogen Idec. On September 16, 2011, Elan sold its EDT business to Alkermes, Inc. In November 2011, Elan launched a collaboration with the University of Cambridge, England, the Cambridge-Elan Centre for Research Innovation and Drug Discovery (Cambridge-Elan Centre). On December 21, 2012, the Company completed the demerger of Prothena Corporation plc. In April 2013, it closed the TYSABRI (natalizumab) Collaboration Transaction with Biogen Idec.

Tysabri

Tysabri, which is an alpha-4 integrin inhibitor, is a therapy for MS, a neurological disorder involving central nervous system dysfunction among adults. Tysabri is approved in more than 65 countries. Tysabri is approved in the United States as a monotherapy for relapsing forms of MS, for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. In the European Union, it is approved for relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS. As of December 31, 2011, there were approximately 64,400 patients on Tysabri therapy worldwide.

In June 2011, the European Commission (EC) approved the inclusion of the anti-JCV antibody status as an additional factor in stratifying patients at risk for developing PML in the Summary of Product Characteristics��(SmPC) for Tysabri in the European Union. The Company has developed a two-step ! enzyme-linked immunosorbent assay (ELISA), STRATIFY JCV, with Biogen Idec. The assay detects anti-JCV antibodies in the blood of patients, and is commercially available in Europe. In January 2012, the FDA cleared the assay for commercial use in the United States. As of December 31, 2011, over 80,000 tests had been administered using the assay. Tysabri is marketed and distributed by Elan and Biogen Idec. The Company�� research group, Neotope, is focused on creating monoclonal antibodies based on neo-epitope targets for the treatment of a range of therapeutic indications.

Beta Amyloid Immunotherapies (AIP)

Beta amyloid immunotherapy includes the treatment of Alzheimer�� disease by inducing or enhancing the body�� immune response in order to clear toxic species of beta amyloid from the brain. The AIP includes bapineuzumab (intravenous and subcutaneous delivery) and ACC-001, as well as other compounds. Bapineuzumab is an experimental humanized monoclonal antibody delivered intravenously that is being studied as a treatment for mild to moderate Alzheimer�� disease. It is designed to provide antibodies to beta amyloid directly to the patient (passive immunotherapy).

ELND005, an A� Aggregation Inhibitor

The small molecule ELND005 (Scyllo-inositol) is a beta amyloid anti-aggregation agent. Preclinical data suggest that ELND005 may act through the mechanism of preventing and reversing the fibrilisation of beta amyloid (the aggregation of beta amyloid into clumps of insoluble oligomers). ELND005 may have additional applications in psychiatric indications, such as bipolar disorder. In November 2011, the Company entered into a manufacturing agreement for the supply of the active pharmaceutical ingredient for ELND005 with Lonza Group AG.

Neotope Biosciences Limited

Neotope Biosciences Limited (Neotope) is the Company�� wholly owned subsidiary that focuses on the discovery and development of antibodies to neo-epitope related targ! ets for t! he treatment of a range of indications. It includes amyloidosis, diabetes, cancer and macular degeneration. Neotope�� portfolio of targets includes alpha-synuclein for the potential treatment of synucleinopathies, such as Lewy body dementia and Parkinson�� disease, tau for Alzheimer�� disease and other tauopathies. It also has a program for type 2-diabetes.

Onclave Therapeutics Limited

Elan�� wholly owned subsidiary Onclave Therapeutics Limited (Onclave) was formed to develop assets originating from Elan that have application in oncology related diseases. Onclave�� program, NEOD001, which originated from Neotope, is being investigated for the treatment of AL amyloidosis, which is a fatal disease involving abnormal accumulation of amyloid in organs and tissue. During the year ended December 31, 2011, Onclave filed for orphan drug designation of NEOD001. Onclave�� pipeline includes additional compounds with relevance in diverse cancer indications.

The Company competes with Biogen Idec, Bayer Schering Pharma AG, Bayer Schering Pharma, Merck Serono, Pfizer, Teva Neurosciences, Inc., Sanofi-Aventis and Novartis AG.

Advisors' Opinion:

• [By Tim Brugger]

  Following the denial of an acquisition offer from Royalty Pharma on April 22 equal to $11.25 a share, or less, for all of Elan's (NYSE: ELN  ) outstanding shares, a revised offer from Royalty of $12.50 a share has also been rejected, Elan announced today.

• [By Brian Orelli]

  Royalty Pharma announced Monday that it's willing increase the $11-per-share offer it made for Elan (NYSE: ELN  ) back in February, depending on the result of Elan's buyback.

• [By Brian Orelli]

  Johnson & Johnson (NYSE: JNJ  ) is the leader for the long-acting antipsychotic, selling $1.4 billion worth of Risperdal Consta and $800 million worth of Invega Sustenna last year. Alkermes (NASDAQ: ALKS  ) also benefits from a royalty on both drugs. It developed the extended-release technology in Risperdal Consta, and Alkermes acquired the royalty rights to Invega Sustenna when it bought Elan's (NYSE: ELN  ) drug technology division.

Best Medical Companies To Buy Right Now: Cyberonics Inc (CYBX)

Cyberonics, Inc. (Cyberonics), incorporated in 1987, is a medical device company. The Company is engaged in the design, development, sales and marketing of implantable medical devices that provide a neuromodulation therapy, vagus nerve stimulation therapy (VNS Therapy), for the treatment of refractory epilepsy and treatment-resistant depression (TRD) and other device solutions for the management of epilepsy.VNS Therapy System includes an implantable pulse generator to provide stimulation to the vagus nerve; a lead that connects the generator to the vagus nerve; equipment to assist with implantation surgery; equipment to assist with setting the stimulation parameters for each patient; instruction manuals, and magnets to suspend or induce stimulation manually. The VNS Therapy pulse generator and lead are surgically implanted into patients generally during an outpatient procedure. The VNS Therapy System consists of a pulse generator, a bipolar lead, a programming wand and software and a tunneling tool.

The United States Food and Drug Administration (FDA) approved the Company's VNS Therapy System in July 1997 for use as an adjunctive therapy in epilepsy patients over 12 years of age for reducing the frequency of partial onset seizures that are refractory or resistant to antiepileptic drugs. Regulatory bodies in Canada, the European Economic Area, certain countries in Eastern Europe, Russia, South America, Africa, Australia and certain countries in Asia, including Japan, China and Taiwan, have approved the VNS Therapy System for the treatment of epilepsy, many without age restrictions or seizure-type limitations. In July 2005, the FDA approved the Company's VNS Therapy System for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a depressive episode and have not had an adequate response to four or more adequate anti-depressant treatments. Regulatory bodies in the European Economic Area, Canada and Israel have approv! ed the Company's VNS Therapy System for the treatment of chronic or recurrent depression in patients who are in a treatment-resistant or treatment-intolerant depressive episode without age restrictions.

In February 2011, the Company announced FDA approval of its fifth generation generator, the AspireHC generator. In August 2011, the Company announced that the Company discovered a hardware-related design issue with the AspireHC Model 105 and AspireSR (Seizure Response) Model 106 generators. In December 2011, the FDA approved the Company's re-designed AspireHC generator, and the Company resumed its limited commercial release of the generator in the United States.

Pulse Generator

The pulse generator is an implantable, programmable signal generator designed to be coupled with the bipolar lead to deliver mild electrical pulses to the vagus nerve. The pulse generator is a battery-powered device. Before or upon depletion of the battery, the pulse generator may be removed and a new generator implanted in a short, outpatient procedure. The Model 102 (Pulse), Model 102R (Pulse Duo ), Model 103 (Demipulse), Model 104 (Demipulse Duo) and Model 105 (AspireHC), are the VNS Therapy pulse generators the Company offers and are similar in design and manufactures to a cardiac pacemaker.

Bipolar Lead

The bipolar lead conducts the electrical signal from the pulse generator to the vagus nerve. The lead incorporates electrodes, which are self-sizing, minimizing mechanical trauma to the nerve. The lead's two electrodes and anchor tether wrap around the vagus nerve, and the connector end is tunneled subcutaneously to the upper chest area, where it attaches to the pulse generator. The Company offers three lead models in the United States. The leads are available in two inner spiral diameter sizes to ensure optimal electrode placement on different-sized nerves.

Programming Wand and Software

The Company's programming wand and software are us! ed to int! errogate the implanted pulse generator and to transmit programming information from a handheld computer to the pulse generator via an inductive coupling. Programming capabilities include modification of the pulse generator's programmable parameters (pulse width, amplitude and frequency and stimulation ON and OFF intervals) and storage and retrieval of telemetry data.

Tunneling Tool

The tunneling tool is a single use, sterile, disposable surgical tool designed to be used during surgical placement of the bipolar lead. The tool is used for subcutaneous tunneling of the lead between the nerve site in the neck and the pulse generator site in the upper chest area.

Accessory Pack

The accessory pack includes two resistor assemblies used to test the function of the device prior to implantation, the bipolar lead tie-downs and one hex screwdriver. The patient kit includes two magnets, one watch-style and one pager-style.

The Company competes with Medtronic, Inc., NeuroSigma Inc. and CerboMed GmbH.

Advisors' Opinion:

• [By Seth Jayson]

  Calling all cash flows
  When you are trying to buy the market's best stocks, it's worth checking up on your companies' free cash flow once a quarter or so, to see whether it bears any relationship to the net income in the headlines. That's what we do with this series. Today, we're checking in on Cyberonics (Nasdaq: CYBX  ) , whose recent revenue and earnings are plotted below.

Best Medical Companies To Buy Right Now: Pharmacyclics Inc (PCYC)

Pharmacyclics, Inc., incorporated on April 19, 1991, is a clinical-stage biopharmaceutical company focused on developing and commercializing small-molecule drugs for the treatment of cancer and immune mediated diseases. The Company's clinical development and product candidates are small-molecule enzyme inhibitors designed to target biochemical pathways involved in human diseases. As of June 30, 2011, it had three drug candidates under clinical development and a number of preclinical lead molecules. This includes an inhibitor of Bruton�� tyrosine kinase (Btk) (PCI-32765) in Phase II studies in hematologic malignancies; a Btk inhibitor lead optimization program targeting autoimmune indications, an inhibitor of Factor VIIa (PCI-27483) in a Phase II clinical trial in pancreatic cancer, and a histone deacetylase (HDAC) inhibitor (PCI-24781) in Phase I and II clinical trials in solid tumors and hematological malignancies as of June 30, 2012.

As of June 30, 2012, the Company developed ibrutinib, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a variety of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse B-cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its current or planned Phase Ib/II and Phase III development program. had development programs for B-cell malignancies and autoimmune diseases. For malignant indications it has developed PCI-32765, which has demonstrated clinical activity and tolerability in Phase I and Phase II clinical trials in a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL) and a number of non-Hodgkin�� lymphoma (NHL) subtypes. CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM) are specific indications of its Phase II development. It has developed an assay! to measure occupancy of Btk in PBMCs using a cell-permeable fluorescently-labeled derivative of PCI-32765.

Factor VII is an enzyme that becomes activated (FVIIa) by binding to the cell surface protein tissue factor (TF), a protein found in the body that helps to trigger the process of blood clotting in response to injury. TF is over expressed in many cancers including gastric, breast, colon, lung, prostate, ovarian and pancreatic cancers. In these tumors, the FVIIa/TF complex induces intracellular signaling pathways by activating protease activated receptor 2 (PAR-2), another cell-surface protein. This in turn increases the expression of interleukin-8 (IL-8), a protein produced by white blood cells and other immune cells in response to pathogenic stimulation, and vascular endothelial growth factor (VEGF), a signal protein produced by cells that stimulate the growth of blood vessels. Both proteins play an important role in tumor growth and metastases as well as angiogenesis (growth of new blood vessels). FVIIa/TF complex also initiates the coagulation (a process by which blood forms clots) processes implicated in the high incidence of thromboembolic (the process by which the blood clots within a blood vessel) complications seen in patients with TF-expressing cancers. Thromboembolic events are a cause of death in patients with cancer and anticoagulant treatment has been shown to improve survival in a variety of cancers (Klerk et al. JCO. 2005).

PCI-27483 Factor VIIa Inhibitor

The Company�� Factor VIIa inhibitor PCI-27483 is a first-in-human small molecule inhibitor that selectively targets FVIIa. As an inhibitor of FVIIa, PCI-27483 has two potential mechanisms of action: inhibition of intracellular signaling involved in tumor growth and metastases and inhibition of early coagulation processes associated with thromboembolism.

Factor VIIa PCI-27483 Clinical Development Update

A multicenter Phase I/II of PCI-27483 in patients with locally a! dvanced o! r metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). The objectives are to assess the safety of FVIIa Inhibitor PCI-27483 at pharmacologically active dose levels, to assess potential inhibition of tumor progression and to obtain initial information of the effects on the incidence of thromboembolic events. Due to a paradigm shift away from the use of gemcitabine alone for the treatment of pancreatic cancer, enrolling patients in this randomized study has been challenging. PCYC is evaluating other alternatives for development of this agent.

A multicenter Phase I/II of PCI-27483 in patients with locally advanced or metastatic pancreatic cancer that are either receiving or are planned to receive gemcitabine therapy has completed enrollment. The Phase II portion of the study randomized patients to receive either gemcitabine alone or gemcitabine plus PCI-27483 (1.2 mg/kg twice daily). PCI-27483 is covered by United States patents and patent applications and counterpart patents and patent applications in fourteen ex-United States territories, including Europe, Canada, Mexico, Japan, China, India, South Korea, Australia and Brazil.

Advisors' Opinion:

• [By Sean Williams]

  Very few breakthrough therapies have been approved up to this point -- then again, we're only working with about 100 days for the Food and Drug Administration to have assigned such a designation. Vertex Pharmaceuticals'�received the first two "breakthrough therapy" designations from the FDA for two cystic fibrosis treatments, of which both involve the use of the already FDA-approved Kalydeco. The more intriguing "breakthrough therapy" designation is Pharmacyclics' (NASDAQ: PCYC  ) Ibrutinib for the treatment of two rare blood cancers, which analysts feel could have a peak sales value of $5 billion if approved.

• [By Dan Caplinger]

  Yet J&J isn't satisfied with what it already has. Last week, the company joined with Pharmacyclics (NASDAQ: PCYC  ) to seek approval for their lymphoma drug ibrutinib. J&J will get a 50% share of any profit from the venture, and J&J cited a Piper Jaffray estimate that just one of its indications could produce sales of more than $4 billion.

• [By Keith Speights]

  Pharmacyclics (NASDAQ: PCYC  ) and development partner Janssen, a division of Johnson & Johnson (NYSE: JNJ  ) , announced on Wednesday that a New Drug Application, or NDA, has been submitted for ibrutinib. The NDA filed with the U.S. Food and Drug Administration requests marketing approval for the drug in the treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma and in the treatment of previously treated patients with mantle cell lymphoma.

• [By MONEYMORNING]

  We saw this last year with such Private Briefing recommendations as The Boeing Co. (NYSE: BA) and Pharmacyclics Inc. (Nasdaq: PCYC), which rose more than 100% and 400%, respectively, following our recommendation.