7/28/09

Hot Trades Cannabis Science and Acadia Pharmaceuticals




I see a huge market for Cannabis Science with their Swine Flu H1N1 treatment fast track status. I see this as a potentially nice trade right now trading around 1.14. Strong Buy Option for CBIS. The FDA rarely gives out fast track statuses for approval so this is another good trade right now and price right for those on a tight budget. This could be a huge payoff for a long trade option. We will have to see.

I have also included information about Acadia Pharmaaceuticals. They released Clinical Trial data last Friday for Acadia's pivotal Phase III trial of pimavanserin. There have been impressive gains in the past two days over the Parkinson's Disease Psychosis medication Pimavanserin. On a side note I love the wilderness and included some pictures of Maine's Acadia National Park and Lighthouse. Enjoy.




07/27/09 Cannabis Science to Apply to the FDA
Cannabis Science to Apply to the FDA to Utilize Their Fast Track Procedures to Help Speed the Approval of Its Cannabinoid Medicines in Treatment of H1N1 Swine Flu as AP Report Predicts Swine Flu Could Hit up to 40 Percent in the USA
SAN FRANCISCO, CA -- (MARKET WIRE) -- 07/27/09 -- Cannabis Science, Inc. (OTCBB: CBIS), an emerging pharmaceutical cannabis company, is pleased to report that it is moving as fast as possible to assist in the fight against the threat of a deadly influenza pandemic. In conjunction with its recent re-organization, the Company has begun discussions with the FDA as its program moves forward to provide FDA approved solutions for several critical illnesses.

H1N1 Swine Flu:
According to the CDC (http://www.cdc.gov/flu/avian/) the Avian flu (H5N1) has a 63% mortality rate. Unfortunately, the Swine flu, while causing death at a much lower rate than the Avian flu, appears to also result in death via a similar mechanism. The common cause of death with these strains is organ failure, especially as seen in the lungs with the development of Adult Respiratory Distress Syndrome (ARDS). ARDS is caused by an excess immune-generated inflammatory response that leads to apoptosis (cell death) and subsequently to organ failure. The Company's approach will mimic how the human body uses endocannabinoids (cannabinoids that occur naturally in the body) to regulate immune activity and cell survival, by regulating inflammatory biochemistry. Excessive inflammatory responses are associated with numerous disease states including autoimmune diseases, neurological imbalances, and cardiovascular disease. Phytocannabinoids provide a natural means to supplement illness-specific endocannabinoid deficiencies.

Cannabis Science H1N1 Swine Flu Formulation:
We now know that the endocannabinoid system plays a critical role in maintaining human health. The human body produces Endocannabinoids on demand when they are needed. They help restore homeostasis (biochemical balance). The Cannabis plant produces Phytocannabinoids. When the human body has endocannabinoid deficiencies, it cannot effectively restore the healthy biochemical state needed to counter a particular illness. Phytocannabinoids from the Cannabis plant can replace the deficient endocannabinoid activity in the human body to restore a health-promoting level of cannabinoid activity. Cannabis Science will test its cannabis extract lozenge with FDA guidance and oversight to determine if it will reduce ARDS-associated deaths from both the Avian and Swine influenza infections.

Dr. Robert Melamede, Ph.D., Cannabis Science, Inc., President and CEO, believes there is enormous potential value for cannabinoids to naturally reduce excessive inflammatory immune responses, and the Cannabis Science lozenge formulation could reduce the mortality rate and allow infected individuals to develop a strong natural immunity upon recovery. Dr. Melamede is the former Chairman (ret) of the Biology Department at the University of Colorado (Colorado Springs).

Dr. Melamede added, "Again, we recommend, based on sound scientific principles, that medical marijuana users should switch to edibles if they come down with an influenza infection. We believe that the irritation associated with the pulmonary route, when a person has an influenza infection, may lead to unnecessary deaths. In contrast, oral administration may prevent many deaths. We hope that due to the magnitude of this pandemic threat, that the FDA will fast track our proposal."

FDA's three rapid special drug release programs:
Fast Track, Accelerated Approval and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time. They do not compromise the standards for the safety and effectiveness of the drugs that become available through this process. These revitalized FDA drug review approaches have yielded tangible results in bringing safe and effective drugs to patients with serious diseases more quickly. For example, since 1996, 68 drugs for cancer therapies have received priority review and approval. The FDA reviewed Gleevec, a treatment for chronic myeloid leukemia, in four months. Shortened review times have also brought promising treatments to patients with HIV/AIDS more quickly. Kaletra for the treatment of HIV/AIDS was reviewed and approved in 3.5 months. Pegasys, a combination product for the treatment of Hepatitis C, was approved for marketing in 4 months.

Fast Track, Accelerated Approval, and Priority Review have evolved over time. The FDA has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious diseases. The median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.

About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. In sum, we are dedicated to the creation of cannabis-based medicines, both with and without psychoactive properties, to treat disease and the symptoms of disease, as well as for general health maintenance.

Here is another article from the Wall Street Journal on Cannabis Science

07/23/09 Today's Wall Street Journal Reports on Cannabis
Today's Wall Street Journal Reports on Cannabis Science Inc. in Article on Booming Medical Cannabis Industry; Indicates Great Demand for Products From a Patient Oriented Company
SAN FRANCISCO, CA -- (MARKET WIRE) -- 07/23/09 -- Cannabis Science Inc. (OTCBB: CBIS), an emerging pharmaceutical cannabis company, is pleased that today's Wall Street Journal article on the booming medical cannabis industry in California notes the role of Cannabis Science Inc.

Commenting on why Cannabis Science was mentioned in the article, Richard Cowan, chief financial officer of Cannabis Science Inc., said, "Although the company is beginning the FDA approval process for its products, we believe that the inclusion of Cannabis Science Inc. in an article about the struggle to get medical cannabis to patients is further evidence that we are a patient oriented company, whose business strategy does not depend on a continuation of marijuana prohibition."

Although the company is not involved in the state's gray market, the article notes, "A pot activist named Richard Cowan has opened what he envisions as an investment bank for pot-related businesses, called General Marijuana (General Marijuana.com). Mr. Cowan is also chief financial officer of Cannabis Science Inc., which is trying to market a pot lozenge for nonsmokers." Please click http://online.wsj.com/article/SB124829403893673335.html to read the article in full.

Cannabis Science CEO, Dr. Robert J. Melamede, observed, "This article is further demonstration of the huge need for FDA approved medical cannabis products."

Earlier this week, Cannabis Science reported that Dr. Melamede had spoken at a hearing in Denver in opposition to an attempt to undermine a voter-approved constitutional amendment that would have made it much more difficult for patients to get affordable medical marijuana.


Another strong trade right now is Acadia Pharmaceutical. Stock Ticker: ACAD.

This article can be found at BioMedReports at the following link:

http://biomedreports.com/articles/most-popular/2441-acadia-shares-soar-ahead-of-late-stage-trial-results.html

Acadia shares soar ahead of late-stage trial results
Written by Staff and Wire Reports
Saturday, 25 July 2009 08:37

(Reuters) - Acadia Pharmaceuticals Inc (NASDAQ:ACAD) shares rose as much as 44 percent to a year-high on Friday, amid speculation of an imminent release of data from a late-stage trial of its experimental drug for psychosis brought on by Parkinson's disease.

Shares of the company closed at $3.41 Friday on Nasdaq. They had earlier touched a high of $3.75.

"The speculation appears to be related to results that are due in this quarter for Acadia's pivotal Phase III trial of pimavanserin," Jon Najarian, a founder of Web information site optionMonster.com, said.

The company declined to comment on the stock movement and reiterated that it would release the late-stage data in the third quarter.

Acadia is co-developing pimavanserin, which is currently being studied in two late-stage trials, with a unit of Biovail Corp (NYSE:BVF) for the treatment of Parkinson's disease psychosis (PDP).

In the options market, Acadia attracted a flurry of trading in the stock's call options, which give the right to buy the underlying shares at a fixed price within a specified time period.

In all, about 15,000 calls and 1,635 puts traded, on combined daily volume 19 times the norm, according to option analytics firm Trade Alert.

(Reporting by Doris Frankel in Chicago and Anand Basu in Bangalore; Editing by Anthony Kurian)

This is a previous article discussing Acadia's partnership with Biovail on the Parkinson's Disease Psychosis medication. It can be found at the following link:

http://news.moneycentral.msn.com/ticker/article.aspx?Feed=BW&Date=20090506&ID=9873079&Symbol=US:ACAD

ACADIA Pharmaceuticals and Biovail Announce Completion of Enrollment in First Pivotal Phase III Trial with Pimavanserin in Patients with Parkinson’s Disease PsychosisMay 6, 2009 8:00 AM ET advertisement

Article tools E-mail this article Print-friendly version Discuss this articleStocks mentioned in this articleACADIA Pharmaceuticals Inc (ACAD) Stock Quote, Chart, News, Add to WatchlistBiovail Corp (BVF) Stock Quote, Chart, News, Add to WatchlistRecent investing newsBP Q2 profit up 71 pct from Q1, halved on the yearBP Q2 profit halved by oil fall, beats forecastCanon profits plunge 86 percent in 2QCall Buying Rises in Western DigitalFrank wants tougher rules for Wall Street pay
All Business Wire newsACADIA Pharmaceuticals Inc. ACAD and Biovail Corporation BVF (TSX:BVF), today announced the completion of enrollment in the first pivotal Phase III clinical trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP). Top-line results from this trial are expected to be announced by the end of the third quarter of 2009.

The Phase III trial is a multi-center, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of pimavanserin in patients with PDP. A total of 298 patients were enrolled in the trial and randomized to one of three study arms, including two different doses of pimavanserin (10 mg or 40 mg daily) and one placebo arm. Patients receive oral doses of either pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy.

Patient enrollment in the second pivotal Phase III clinical trial of pimavanserin in PDP is ongoing. The primary endpoint of each of the Phase III trials is antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Motoric tolerability is an important secondary endpoint in the Phase III trials and is measured using the Unified Parkinson’s Disease Rating Scale, or UPDRS (Parts II and III).

About Pimavanserin

Pimavanserin is a 5-HT2A receptor inverse agonist in Phase III development as a treatment for Parkinson’s disease psychosis. This new chemical entity, which was discovered by ACADIA, is a small molecule that can be taken orally as a tablet once-a-day. ACADIA and Biovail Laboratories International SRL, a subsidiary of Biovail, have formed a collaboration to co-develop and commercialize pimavanserin for neurological and psychiatric indications in the United States and Canada. ACADIA retains rights to pimavanserin in the rest of the world.

About Parkinson’s Disease Psychosis (PDP)

According to the National Parkinson Foundation, over 1.5 million people in the United States suffer from Parkinson’s disease. Up to 40 percent of patients with Parkinson’s disease may develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. Currently there is no therapy in the United States approved to treat PDP. The development of psychosis in patients with Parkinson’s disease is associated with increased caregiver burden, nursing home placement, and increased mortality.


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7/26/09

FDA calendar updates

Here's an updated calendar from Mike Havrilla. I truly value his work and hope to spread the word about Mike and his hard work to the industry. If you haven't heard of Mike, he's the featured editor of BioMedReports.com, an up to date newsource for FDA approvals and updates in Biophamra. Also, he's pretty popular on Seeking Alpha too. Here's his list. You can catch it at the following link:

http://biomedreports.com/articles/most-popular/2445-fda-calendar-2h09-binary-event-trades.html

Eli Lilly (NYSE:LLY) expects to report results from a third Phase 3 Clinical Trial are expected in late 2009 for arzoxifene to increase bone mineral density in post-menopausal women. Arzoxifene has been shown to reduce bone turnover/breakdown and is also being studied to reduce the risk of breast cancer. The drug significantly increased lumbar spine and total hip bone mineral density (BMD) in postmenopausal women with normal or low bone mass, versus placebo. The third Phase 3 trial, GENERATIONS, is a five-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density, with results expected in late 2009.

On 4/21/09, Alkermes (NASDAQ:ALKS) announced the completion of patient enrollment for the registration study of Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of opiate dependence. ALKS expects topline results for the study during 4Q09 and plans to file a sNDA with the FDA during 2010 to expand the label of Vivitrol from its current indication in the treatment of alcohol dependence.

On 4/29/09, Rockwell Medical (NASDAQ:RMTI) announced the completion of patient enrollment in the Phase 2b study of SFP, which is a six-month, dose-ranging study in about 130 hemodialysis patients to determine the safety parameters and optimal SFP concentration to maintain normal levels of iron and hemoglobin. The Phase 2b trial should be completed by the end of September and data should be released about 60 days later, which should occur in late November or early December. The Phase 3 clinical trial for SFP should begin sometime during 4Q09-1Q10 and RMTI has guided for adequate cash flow and liquidity to reach this point without the need for raising cash. Click here to view or download my PDF stock profile report for RMTI from late April 2009.

On 5/7/09, Avanir Pharma (NASDAQ:AVNR) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine) AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.

On 5/11/09, Acadia Pharma (NASDAQ:ACAD) provided the following update along with its quarterly financial results: Enrollment was completed in the Company's first pivotal Phase 3 trial of pimavanserin in patients with Parkinson's disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of the third quarter of 2009 (3Q09). ACAD is continuing to enroll patients in the second pivotal Phase 3 trial of pimavanserin in patients with PDP. ACADIA also is continuing to conduct an open-label safety extension study pursuant to which eligible patients who have completed either of the two pivotal Phase 3 trials have the opportunity to enroll if, in the opinion of the physician, a patient may benefit from continued treatment with pimavanserin.

On 5/11/09, GTx Inc. (NASDAQ:GTXI) reported quarterly results and stated that is conducting a pivotal Phase 3 clinical trial evaluating Acapodene (toremifene) 20 mg for the prevention of prostate cancer in men with high-grade pre-cancerous prostate lesions (high-grade PIN). The primary endpoint of the study is a reduction in the incidence of prostate cancer. GTXI anticipates reporting data for this Phase 3 study in late summer 2009 and will file a NDA with the FDA in late 2009 based upon a positive trial outcome. GTXI also has a pending NDA for toremifene 80 mg (standard 10-month review with FDA decision expected in late October) seeking approval for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy.

On 5/28/09, Poniard Pharma (NASDAQ:PARD) announced updated clinical data from its randomized, controlled Phase 2 trial of picoplatin in patients with metastatic colorectal cancer (CRC). The new data demonstrated that picoplatin, given once every four weeks in combination with 5-fluorouracil and leucovorin in the FOLPI regimen, and oxaliplatin, given in combination with 5-fluorouracil and leucovorin in the modified FOLFOX-6 regimen, have similar anti-tumor activity in the treatment of first-line metastatic CRC, as assessed by progression-free survival (PFS) and disease control measured by tumor response rate. New data derived by three independent assessments of neurotoxicity indicated a statistically significant reduction in neurotoxicities with the use of picoplatin. Overall survival data are expected 2H09 for this trial.

On 6/1/09, Raptor Pharma (RPTP.OB) announced that it has dosed the first patient in its Phase 2b clinical trial, conducted in collaboration with the University of California, San Diego ("UCSD"), to evaluate Raptor's proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") capsules in nephropathic cystinosis ("cystinosis"), a rare genetic lysosomal storage disease. Under Raptor's open Investigational New Drug application ("IND"), UCSD is performing the Raptor-sponsored trial at its General Clinical Research Center. The Phase 2b clinical trial will enroll up to six cystinosis patients with a history of good compliance using the currently available immediate-release form of cysteamine bitartrate, the only drug cleared for marketing by the FDA and European Medicines Agency ("EMEA") to treat cystinosis. The clinical trial will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of DR Cysteamine in patients. Data from the study are expected during 3Q09.

On 6/15/09, pSivida Corp. (NASDAQ:PSDV) announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company's lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010.

On 6/15/09, Aeterna Zentaris (NASDAQ:AEZS) reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of the week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033). Cetrorelix is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe. First efficacy results are expected during 3Q09 with a NDA filing targeted in 2010.

On 6/17/09, BioMimetic Therapeutics (NASDAQ:BMTI) announced that it has submitted both the pre-clinical pharmacology/toxicology and quality/manufacturing modules of its Premarket Approval (PMA) application for marketing of Augment Bone Graft in the U.S. These are two of the three parts, or modules, required for a complete PMA application to the FDA. The Company intends to file the third and final module, containing the clinical data during 4Q09. On 5/7/09, BMTI announced that the Company completed enrollment in its Augment Bone Graft 436-patient North American pivotal clinical trial in foot and ankle fusions in December 2008 and is on track with patient follow-up. The Company expects to release top line data from the trial during 2H09.

On 7/3/09, Novo Nordisk (NYSE:NVO) announced European Commission marketing authorization for Victoza (liraglutide) in the treatment of type 2 diabetes in adults. NVO will launch Victoza in Britain, Germany, and Denmark this summer and in other European markets during the remainder of 2009 and in 2010. Victoza is regarded as the most important compound in Novo's pipeline and a key FDA decision is still pending. The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending.

Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6 to 6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8 to 5 in favor of the drug's cardiovascular safety profile.

On 7/6/09, Protalix BioTherapeutics (AMEX:PLX) announced that it was approached by the FDA and asked to consider submitting a treatment protocol for the use of prGCD in patients with Gaucher disease in order to address an expected shortage of the drug Cerezyme, a mammalian cell expressed version of glucocerebrosidase (GCD) and the only enzyme replacement therapy currently approved for Gaucher disease. Gaucher disease is a rare and serious lysosomal storage disorder in humans with severe and debilitating symptoms. prGCD, the Company's lead product candidate, is a proprietary plant-cell expressed recombinant form of glucocerebrosidase and is currently the subject of a Phase 3 clinical trial for the treatment of Gaucher disease.

The FDA indicated to the Company that it believes the Company's development program for prGCD satisfies the regulatory criteria required to supply prGCD for expanded access to patients under a treatment protocol. PLX expects to submit a treatment protocol to the FDA for its review as a supplement to its current Investigational New Drug (IND) application for prGCD. PLX expects to report results of the Phase 3 trial during 2H09 and expects to submit a NDA for prGCD to the FDA and other global regulatory agencies during 4Q09.

On 7/7/09, Cell Therapeutics (NASDAQ:CTIC) announced that the EMEA has agreed to an oral explanation in support of the OPAXIO (paclitaxel poliglumex, CT-2103) Marketing Authorization Application (MAA) in September 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on European marketing approval until 4Q09. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile.

On 6/24/09, CTIC announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. The Company is now awaiting a likely mid to late August response from the FDA to accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for pixantrone.

On 7/22/09, Hemispherx Biopharma (AMEX:HEB) provided guidance that it does not expect a FDA decision on its Ampligen New Drug Application (NDA) until fall 2009. President/CEO Dr. William Carter said staffing problems at the FDA this year have resulted in the agency missing deadlines for final decisions on nearly two-thirds of NDAs under review. During a 7/22 conference call, Dr. Carter said HEB has been in contact with the FDA since May, has been regularly providing reports to different reviewers, and does not believe any additional documentation will be required by the Agency. Ampligen (Poly I: Poly C12U) is an experimental treatment for chronic fatigue syndrome (which has no FDA-approved treatments) with Orphan Drug Status.

Bristol-Myers (NYSE:BMY) and AstraZeneca (NYSE:AZN) have a pending NDA for Onglyza (saxagliptin oral tablets), which is a dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes. On 4/1/09, the FDA panel voted 10 to 2 that the clinical data for the drug rule out the risk that the drug hastens heart attack, stroke and other problems. On 4/23/09, the FDA extended the PDUFA decision date by three months to 7/30/09.

United Therapeutics (NASDAQ:UTHR) announced on 4/28/09 that the FDA has extended the PDUFA action date for the Company's pending Tyvaso (inhaled treprostinil) NDA. The new PDUFA date is 7/30/09 and UTHR expected the delay (which was announced in a PR in mid-March) due to the submission of additional clinical trial data to the FDA, which was considered a major amendment by the agency. The additional data was related to human factors testing to validate the instructions for using the Optineb nebulizer device which delivers the medication.

On 6/16/09, a FDA Advisory Panel ruled that Savient Pharma's (NASDAQ:SVNT) experimental gout drug is safe and effective for certain patients with the disorder. SVNT is seeking FDA approval for the infused drug (Krystexxa) for those who have the painful type of arthritis, but fail to improve with first-line treatments or cannot tolerate other treatments. The FDA's panel of outside experts (in a 14-1 vote) ruled that the dramatic results in nearly half of the patients studied were encouraging, despite risks that could include serious heart problems and allergic reactions. In December, the FDA accepted the Company's BLA and granted priority review status, but SVNT submitted several key amendments for the BLA earlier this year in January. The FDA accepted the amendments and determined that the additional information constituted a major amendment and extended the original PDUFA decision date by three months to 8/1/09.

On 3/12/09, Endo Pharma's (NASDAQ:ENDP) majority-owned subsidiary Indevus Pharma announced that the FDA accepted for review the complete response submission to the NDA for Nebido (testosterone undecanoate) intramuscular injection, an investigational testosterone preparation for the treatment of male hypogonadism. The FDA is targeting 9/2/09 as the PDUFA action date for a possible decision on the NDA. Nebido is a long-lasting injection designed to treat hypogonadism, a hormonal condition that interferes with the functioning of the testes. The drug is already approved in Europe, where it is marketed by BayerSchering.

On 7/8/09, Spectrum Pharma (NASDAQ:SPPI) submitted a formal response to the Complete Response Letter (CRL) it received from the FDA 7/2/09 regarding its supplemental Biologics License Application (sBLA) for Zevalin (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin's Lymphoma (NHL) patients. Zevalin is currently FDA approved and marketed by SPPI for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL. The FDA requested the Company to submit data files from the FIT study to support and verify a subset of the data that are currently under review to support the proposed labeling. On 7/20/09, SPPI announced that the FDA accepted the Company's CRL resubmission for filing as a Class 1 (60-day) review with a new PDUFA action date of 9/7/09 (which falls on Labor Day, so a decision is more likely to be announced on Tuesday 9/8).

The FDA accepted Spectrum Pharma's supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for Injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8, 2009. The FDA approved FUSILEV on March 7, 2008 for rescue after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

On 4/24/09, the FDA accepted as complete for review Theravance's (NASDAQ:THRX) response to the Agency's February 2009 Complete Response Letter (CRL), which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI). Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia (HAP) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). The FDA assigned a PDUFA action date of 9/16/09 for approval of telavancin in the treatment of cSSSI.

On 4/6/09, the FDA Accepted Theravance's NDA for Telavancin as a once-daily injectable antibiotic for the treatment of hospital-acquired pneumonia (HAP), including MRSA strains of antibiotic-resistant and other Gram-positive bacteria. The FDA has established a goal of a standard 10-month review of the telavancin NDA, resulting in PDUFA decision date deadline of 11/26/09 and triggering a milestone payment of $10M from THRX partner, Astellas Pharma (ALPMF.PK).

Allos Therapeutics (NASDAQ:ALTH) filed a NDA on 3/25/09 with the FDA for pralatrexate in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH received a priority (six-month) review designation on 5/26/09 with a PDUFA decision date of 9/24/09. PTCL comprises a biologically diverse group of hematologic malignancies that typically has a worse prognosis than other types of lymphoma and is less responsive to traditional chemotherapy regimens. There are currently no agents approved by the FDA for the treatment of patients with PTCL.

Amgen (NASDAQ:AMGN) has a pending BLA for denosumab with a PDUFA action date of 10/19/09 for a possible FDA decision. On 6/22/09, the FDA announced that Amgen's experimental osteoporosis drug denosumab (proposed brand name Prolia) will be revied by an Advisory Panel at a meeting on 8/13/09. The FDA Advisory Panel will discuss the Company's proposed uses of (1) treating and preventing osteoporosis in post-menopausal women and (2) treating and preventing bone loss in patients undergoing hormone ablation therapy for prostate and breast cancer.

On 7/7/09, AMGN announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa (zoledronic acid) in the treatment of bone metastases in 2,049 patients with advanced breast cancer met its primary and secondary endpoints and demonstrated superior efficacy compared to Zometa. Superiority was demonstrated for both delaying the time to the first on-study Skeletal Related Events, and delaying the time to the first-and-subsequent SREs. Both results were statistically significant.

On 7/15/09, Cadence Pharma (NASDAQ:CADX) announced that its New Drug Application (NDA) for Acetavance (intravenous acetaminophen), its investigational product candidate for the treatment of acute pain and fever in adults and children, has been accepted for filing by the FDA and designated for a priority (six-month) review. The FDA has issued a PDUFA action date for the NDA of 11/13/09 for a possible decision by the Agency.

GlaxoSmithKline (NYSE:GSK) and XenoPort (NASDAQ:XNPT) have a pending NDA for Solzira (gabapentin enacarbil) seeking approval for the treatment of moderate to severe restless leg syndrome with an early November PDUFA action date for a possible FDA decision.

On 6/8/09, Dyax Corp. (NASDAQ:DYAX) announced that the FDA accepted the Company's submission in response to the FDA's March 2009 Complete Response Letter (CRL), which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new PDUFA action date of 12/1/09, which represents a six-month, Class 2 Review. In the CRL received 3/25/09, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, which was submitted 6/1/09.

On 6/19/09, BioElectronics (BIEL.PK) announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II.

The Company will conduct a conference call on 7/28/09 to discuss the results of a recently completed clinical study and to discuss the status of current FDA filings and additional FDA filings expected to occur over the coming weeks, including one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.


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Congressional Hearing on Generics



This article was in NYT Sunday. Biologics Copyright Law coming under fire with Obama's administration. So whats the take???

Personally, I do enjoy having a job in the Biotech industry and would like to keep one in the future. With that being said, I do wish we had some type of healthcare coverage out there for people without jobs, those who can't afford it, and the elderly. But at what costs???

Already pharmaceutical companies are contemplating moving our jobs overseas and the fallout of the NC textile industry shows how quickly jobs that were once thriving in North Carolina and other parts of the country have gone elsewhere. If Obama's plan is inacted is there any assurance that our jobs won't go overseas. I see little congressional interest for this. I am worried with the State already in a deficit and close to bankrupcy how many more industry fallouts can we have in NC, tobacco, textiles, and future Biopharma industry. Or is Biopharma here to stay? We will have to see.

But how long should these companies retain copyright protection? 7-14 years is the current standard but with billions of dollars set in Research and Development of these medications is it fair to those researchers to shorten that.

Im torn because we have to fix the healthcare industry but at what price. I wish people who were sick had better options but at the same time we need jobs. This is a tough dilemna that ultimately congress will pass some law that absolutely does nothing to help the situation. It still comes down to lobbyist in Washington and those paying for the votes in Congress and the Senate. We all know that and the pharmaceutical industry is no different when it comes to special interest groups with the power and those who needs the medicine pretty much helpless in the cause.

Already the elderly are going to Canada and outside the US to get there drugs. But are generics really as safe as the real thing. I don't know but I have a feeling that there are some side effects and potency issues that are taking place that we don't know about. Lets face it people make mistakes. Biopharma is no different. But you really do see a difference in price of the generics. Why are the medicines people need so expensive and why can't the govenrnment do something that isn't going to cost us jobs that we ultimately lose someday.

So thats my take. Here's a great article on the whole news.

Also check out this good blog on generics at:
http://genericdrugs.blogs.ie/

Setting a price on life
Biotech drugs facing pressure from generics. Costly Drugs Known as Biologics Prompt Exclusivity Debate


A bitter congressional fight over the cost of super-expensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition?

But what few people in Washington seem to recognize — or publicly acknowledge, anyway — is this magic number may ultimately not matter as much as the most vitriolic debaters insist.

At issue are such drugs as Cambridge-based Biogen Idec’s Avonex, for multiple sclerosis, which costs more than $20,000 a year; Genentech’s Avastin for cancer, which costs more than $50,000; and several Genzyme drugs for rare diseases that can cost $200,000 a year or more. Typically, such drugs are given by injection or intravenous infusions.

These drugs, known as biologics, are complex proteins made in vats of living cells. Because they are hard to copy exactly, they have not been subject to the generic competition that eventually knocks down the price of drugs such as Lipitor and Prozac. Pills such as Lipitor, known in the industry as small-molecule drugs, are made from simple chemicals whose recipes are easy to reproduce.

But now Congress, as a cost-cutting piece of the overall health care effort, is preparing legislation to enable the Food and Drug Administration to approve copycat versions of biologic drugs. That could save consumers, insurers and the government billions of dollars in the coming years.

The trick is to allow competition without undermining the financial incentives the pharmaceutical industry needs to undertake the risky job of developing the next drugs for cancer and other diseases. That is where the magic year number comes in. Trade groups for the big pharmaceutical and biotechnology companies say that to recoup their investments, they need an exclusivity period free of generic competition that would last 12 to 14 years from the time the FDA approves a drug for sale.

But consumer groups, insurers, employers and generic drug companies say anything more than five years — the exclusivity period now given to small-molecule drugs such as Lipitor — would eviscerate any potential savings from the new competition.

So far, the biotechnology industry appears to be winning. The Senate’s health committee, for example, has agreed to 12 years of exclusivity. In the House, a bill that provides at least 12 years of exclusivity has many more co-sponsors than one that would provide five years. The Obama administration has said seven years would be a “generous compromise.”

But in reality, neither the threat to innovation nor the potential savings from generic competition are as great as claimed.

For starters, whatever the exclusivity period, biologic drugs would also continue to be protected from copycats by patents. And in many cases, the patent protection would last longer than the exclusivity period, making the congressionally mandated exclusivity a moot point.

San Francisco-based Genentech’s Avastin, for instance, has patent protection until 2019 — 15 years after the drug’s 2004 approval by the FDA. The company’s breast cancer drug, Herceptin, has patents that extend 21 years from its 1998 approval.

Where the exclusivity period might matter most would be in the cases of drugs whose patents were nearing expiration by the time the developer succeeded in winning FDA approval. But that seldom happens.

“I can’t think of a biotech drug that’s been on the market that doesn’t have more than 7 to 14 years of patent protection,” said Eric Schmidt, biotechnology analyst at Cowen and Co.

Still, it is probably not true, as the other side claims, that the legislation would be virtually worthless if it granted a long exclusivity period. There are plenty of blockbuster biologics, like Amgen’s Epogen and Neupogen, that have been on the market more than 12 or 14 years and thus would get no extra protection from even an exclusivity period in the longer of the ranges now being discussed.

As for cost savings, the Congressional Budget Office has estimated that generic biologics might save the government only about $10 billion in the next 10 years. That is a relative drop in the bucket when it comes to paying for health care reform, which is expected to cost about $1 trillion over 10 years.

One reason for limited savings in the first decade is that it would probably take a few years for copycat biologics to reach the market after the law was enacted. Another factor is that biologics accounted for only 16 percent — about $46 billion — of total prescription drug spending last year, according to the market researchers IMS Health. And pharmaceuticals represent only about 10 percent of the nation’s overall health care spending.

The real savings might come more than 10 years out, as new biologic drugs appear and as biologics represent an increasingly greater part of overall spending on drugs. That ramp-up is already evident: Express Scripts, a pharmacy benefits manager, says its spending on biologics grew 10 percent last year, compared with 2.5 percent for other drugs.

But anyone expecting the price wars that ensue when generic pills come on the market — when prices often drop by more than 60 percent — might be disappointed by the way competition plays out.

Because it is harder and costlier to make biologic drugs than it is to copy pills, fewer generic competitors are likely to enter the fray. Many experts, including the Federal Trade Commission, expect price declines of more like 10 percent to 40 percent in biologics.

Even that would be a savings for the overall health care system. But for many individuals, a $35,000 copycat version of a $50,000 cancer drug would still be unaffordable.

Another factor is that generic biologics are likely to undergo greater regulatory scrutiny than generic pills require.

It is difficult or impossible to verify that a copy of a biologic is exactly the same as the original — which is why the drugs are often called “biosimilars” rather than generic biologics. Because even small changes might affect the drug’s safety or activity, it is likely that makers of biosimilars will have to conduct at least some clinical trials to win FDA approval of their drugs, which makers of generica small-molecule pills are not required to do. Such trials can cost a lot of money.

And because biosimilars will not be exact replicas of the drugs they mimic, the generic makers will probably need sales forces to persuade doctors to prescribe their drugs and pharmacists to dispense them. All of that costs money, too.

In Europe, which has already approved biosimilar versions of three biologic drugs, the market impact has been relatively small so far. In Germany, where biosimilars have made the biggest advances, the products have captured about 30 percent of the market for anemia drugs and prices have dropped only about 20 percent to 30 percent.

The likelihood that biosimilar competition might be somewhat muted means that sales and profits of the originals not necessarily dry up.

Kevin W. Sharer, Amgen’s chief executive, told investors in May that he hoped biotechnology companies would retain 30 percent to 50 percent of the cash flow from their drugs even after biosimilars reached the market. That, he said, “is a dramatically different outcome than we see in the small-molecule companies.” That is also one reason the Federal Trade Commission, in a report last month, said that no exclusivity period at all was needed. At the very least, because biologic drugs do not require appreciably more time or money to bring to market than small-molecule drugs, it is reasonable to ask why they should deserve longer protection from competition than the five years that small-molecule drugs now receive.

The reason, biotechnology executives say, has to do with patents, which may offer less protection for biologics than for small-molecule drugs. Because a biosimilar is not an exact knock-off of the original, a competitor might persuasively claim that it is not infringing the patents on the original drug.

So far biologic patents have held up well in court cases. Amgen, for example, has won legal victories preventing two separate competitors from introducing anemia drugs that were slightly different from its own Epogen.








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7/23/09

Bristol Myers Squibb Purchases Medarex




This was shockingly huge news yesterday as Medarex went from 8 to 16 points in a matter of an instant. Do regular people say points or dollars. Nonetheless. This was front page of CBS MarketWatch last night.

July 22, 2009, 7:54 p.m. EST
Bristol-Myers to buy Medarex for $16 a share cash
Deal values Medarex at almost double its Wednesday close

This happened last night during aftermarket hours but it happened so fast I don't know how anyone who hadn't purchased it that afternoon could have gotten in on that one. It is exciting to see these kinds of things and you wish you could have some forewarning and there probably was but I just hadn't heard about it. Anyways, MED fizzled out at 15.87 and well they're getting bought for 16 so unless you are buying Bristol Stock, or you wish to, good luck with that one. Anyways, they do have a few good things in the pipeline and that is good for Bristol. There have been so many mergers that I guess I need to get more research on the merger deals. Unfortunately most of that info comes real close to insider trading and you know how Wall St frowns on all of that. Thanks Martha Stewart!!!

So Lets Talk Mergers Why Don't We.

Oh there's the whole Merck-Schering deal. Roche-Genentech, oh that one was bruttle wasn't it. Wyeth and Pfizer Ahhh wasn't that so nice and sweet, for Pfizer maybe but I think it was dumb. Most of these are. Just the big fish feeding on down the food chain and getting rid of hardworking people in the Biopharma industry. All in the name of a buck. Hey I need money too but it gets a little old after working in the industry for awhile, constantly getting bought out and name changes and new corporate bull.

That brings me to my little company's ordeal that I used to work for. Covance to Akzo Nobel to Organon Biosciences to umm what the hell, to Schering Plough To Merck. I mean how many times does one place have to change the sign out front. Seriously can't be a good environment when all that is happening. But many stay with mergers, many leave, many quit, and many are fired or laid off or whatever to generate more profits for the big fish. I also went through this when Bayer sold their plant to some Venture capitalist firm and called it Talecris. But just recently Talecris was getting bought by an Australian firm and that deal was blocked by the SEC earlier this year. So who knows anymore. There is little stability in the biotech industry when it comes to small companies. Eventually no matter how promising they all sell out and spend the rest of their days on the coast of France while the rest of the workers are generally screwed.

Aghhhh, biotech and its turnover can get rough when companies are constantly buying and selling each other out. Its bruttle out there sometimes and you have to decide what you really want out of life and how much do you like the flourescent lighting in the labs. Anyways, got a little off topic here.

Point was, I will work on more merger deals here as they can make or break your portolio sometimes.

This was from BioHealth Investor. Maybe my future rival but I hope maybe we could team up someday as I own invest-biohealth.com. I am still working on that website along with biopharmainvestor.com too.

Bristol picks up multiple potential gems with a Medarex deal (BMY, MEDX, ABT, JNJ, AMGN, WYE)
July 23, 2009

Bristol Myers Inc. (NYSE: BMY) plans to spend $2.4 billion to buy partner Medarex Inc. (Nasdaq: MEDX), and it’s getting more than just the cancer monoclonal antibody that developed together.

There are other potential gems in the Medarex pipeline.

The monoclonal antibody ipilimumab is by far the main reason that Bristol pulled the trigger. It is currently in Phase III trials for both metastatic melanoma and hormone-refractory prostate cancer.

Last month, the U.K.’s Independent reported that patients that took a single does of ipilimumab in a trial obliterated the prostate cancer. The paper called the research a “shock breakthrough”. Researchers took the unusual step of releasing case details ahead of the drug trial in which the patients took part, mostly because the recovery of those patients was so surprising. One metastatic patient apparently had a tumor the size of a golf ball. It shrank enough to be surgically removed and the patient made a full recovery.

There could be no bigger potential cancer market for a monoclonal antibody than prostate cancer. It is the largest potential cancer market with 192,280 cases diagnosed each year, according to the National Cancer Institute — more new cases than even breast cancer.

With ipilimumab, Bristol has picked up a candidate that has the potential to become a drug in not only advanced prostate cancer, but also non small-cell lung cancer and melanoma.

The other potential products in the Medarex pipeline that show promise include MDX-1106, a fully human IgG4 antibody in patients with refractory solid tumors including non-small cell lung cancer, colon cancer, melanoma, or prostate cancer. It’s in early stage trials, but so far has shown anti-tumor activity. In the future, it may be something that Bristol tests as a combination therapy along with ipilimumab.

One additional big candidate that Bristol would own if the deal gets shareholder approval would be MDX-1100, which recently went through a Phase II study in rheumatoid arthritis. The drug met its primary endpoint; full data is expected later this year.

While rheumatoid arthritis is a crowded market with market leader Humira from Abbott Laboratories Inc. (NYSE: ABT) Johnson & Johnson’s (NYSE: JNJ) Remicade and Amgen Inc. (NYSE: AMGN) and Wyeth’s (NYSE: WYE) Enbrel, there is promise with any new arthritis drug that shows safety and efficacy. The CDC projects that the number of people age 65 or older who have arthritis or chronic joint symptoms will nearly double from 21.4 million in 2001 to 41.4 million in 2030, as more people are living longer.

Shareholders may balk at the high price Bristol plans to pay for Medarex. But there are likely to be few questions about the strength of the Medarex pipeline, or that Bristol Myers is the natural acquirer given the strength of their partnership. — Mike Tarsala

If you're out there Biohealth investor, I like your site and would like to introduce myself as biopharma investor. Anyways.



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7/22/09

HEB down after Heavy Trading and July 22 Call

TheStreet posted today the following article concerning Hemispherx Biopharma. Still I think this is a good trade but with news about Human Genome the Biotech Industry is under huge pressure to reach expectations and everyone's looking for a quick buck. Hold onto those investments people. The market fluctuates, you just have to ride it out sometimes. But many buy and sell on the Clinical Trial news and I can't blame them. However, I still say Long on HEB. I like companies that have more than one option in their pipeline. Anyways, shares plunged today and I say its still a good buy. Invest with caution as anything can happen. Diversify and spread your stocks out so you don't loose everything is things go sour. Here's the news on HEB today.




Updates on Hemispherx Conference Call Fail to Sooth Investors (HEB)

Selling in shares of Hemispherx BioPharma (AMEX: HEB) has intensified since 10am ET, when the company began a teleconference to provide updates on its recent Influenza research initiatives. After opening today's trading session down about 5%, the stock has now fallen more than 27%, most recently trading at $2.43. Notably, Hemispherx shares are seeing extremely heavy volume today, already trading nearly 26 million times, which compares to the stock's average daily volume of just 7 million shares.

Before this morning's decline, shares of Hemispherx jumped more than 55% since the beginning of this week, when the company first announced that it would be holding today's call.

On the call, Hemispherx said it is target 25-50 million doses of Ampligen per year, as well as at least 100 million doses of Alferon LDO at capacity, two initiatives which are expected to cost the company about $10 million. The company said that a continually mutating flu virus is the main reason for concern related to this pandemic. Hemispherx also noted that is expects to see several more complete Ampligen trials during the month of August.






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7/21/09

Human Genome Sciences Lupus News and Stock Future.



With the news of Human Genome Science's Lupus drug, HGSI stock soared to about 275% the previous value. This is reminiscent of Dendreon's huge gain with their Prostate Cancer drug. With this said I am sceptical of the overall longevity of this trade and with so many cashing out I see a huge fallout, as this is simply a Phase III clinical trial and another phase must be acheived before FDA approval. I see this stock dropping like a rock and many late investors will lose a lot of money tomorrow. Usually after a huge spike the stock has to come down. It's a simple supply and demand chart when it comes to stocks and this one is not any different than the price of gas, or the value of the dollar. I wasn't the best at Econ101 in college as I'm more of a finance person but this stock is going down.

Although I feel the drug will eventually be approved, this could be years down the road. With Human Genome's shaky past I see this as a longshot for longevity. So buyer beware. I too have taken the plunge and followed eagerly on Clinical Trial news like this only to see the stock dropping heavily in the days to weeks to come. Still this is great news for the biotech community and we should be focused on the treatment of Lupus but if you are in it for a quick buck, you've missed out. I still like the long option of HGSI but for day trading its too late and you need to be careful on following the hype and look for the next Human Genome Science or Dendreon out there. Check the FDA calendars and follow closely with the news and PR newswires and another will come along. With that said, it can take years to manufacture a drug for a biotech and many problems can arise even after the drug's approval.

I've seen it all when it comes to biotech manufacturing. The molecule can drop out of solution producing low yeilds. The manufacturing facility can have sterility issues. This is very common although we won't admit it. Sure the final product is sterile, but what did they have to do to acheive this? So many things can go wrong. I'm not saying they will, I'm just saying they can. It takes a considerable amount of time before the molecule hits the market and the company makes a profit. HGSI is not out of the woods just yet. Wait for it to drop and buy it up for the next round.

Here is a nice article on Human Genome Sciences found on Barron's website.

http://online.barrons.com/article/SB124809851547865115.html?ru=yahoo

MONDAY, JULY 20, 2009
BARRON'S TAKE

What's Next for High-Flying Human Genome Sciences? By TERESA RIVAS | MORE ARTICLES BY AUTHOR

Positive results for the company's experimental lupus drug sent shares skyrocketing on Monday.
HUMAN GENOME SCIENCES (ticker: HGSI) investors don't have a case of the Monday blahs. With a 231% gain in mere hours, how could they?

Before the bell Monday, Human Genome and GlaxoSmithKline (GSK) announced that the experimental lupus drug Benlysta showed promise in treating the stubborn autoimmune disease in its first Phase III trials.

The results were huge news -- the FDA has not granted approval for a new lupus treatment in half a century -- and investors' reactions were even bigger. Human Genome shares more than tripled in early afternoon trading, up $7.68, or 231%, to $11.

There's no doubt that Benlysta could be enormously important for Human Genome and lupus sufferers worldwide, but given past volatility and uncertainty, investors might want to take profits in light of today's phenomenal pop and look to pick up shares later, and ostensibly at a lower price, before Benlysta makes it to market.

Benlysta, although promising, still has to pass the second Phase III trial in November to assess its long-term effectiveness. Given the nature of the disease, many lupus sufferers will likely relapse over time, meaning that the November trial may not be as resounding a success as the first, according to Thomas Weisel analyst Ian Somaiya.

Somaiya thinks that the strength of the first Phase III trial alone, combined with the current antiquated lupus treatment, should be enough for approval. However, one might expect that with a stock that has risen so dramatically, investors may not read into the nuances of a less than stellar November trial.

Even taking Benlysta's approval for granted, the drug will likely not make it to market until 2011. That leaves Human Genome the rest of 2009 and all of 2010 without the benefit of its sales. Analysts do not expect the company to turn a profit either year, with losses projected to jump from 13 cents this year to well over $1 in 2010. And before today's pop, Human Genome's more than $580 million in debt well outstripped its market cap.

Additionally, Human Genome has a history of hype without results. In 2004, the company was touted as the one of the main beneficiaries of Project Bioshield, a government program aimed at developing and stockpiling vaccines and antidotes to bioweapons, but enthusiasm quickly faded.

Likewise, in March shares lost more than half their value in one day, when Albuferon, Human Genome's Hepatitis C drug, was trumped by Roche's (RHHBY) competing treatment in a late-stage trial, despite meeting other trial goals.

Not to mention that it is difficult to justify chasing a stock that has risen from 45 cents in March to a high of just over $11 in midday trading today (a 2,349% rise in four months), especially months before an FDA decision and more than a year before any sales start rolling in.

That said, Lazard Capital Markets analyst Terence Flynn pegs the global lupus market as a $2.9 billion opportunity, given the paucity of treatments. Flynn notes that when Benlysta finally hits the market in 2011, it will likely see sales of $207 million, eventually hitting the $1 billion mark in 2014. Still, he doesn't see the stock running much further than today's price, putting its fair value at $10.

Therefore, Benlysta is undoubtedly a boon for the five million lupus sufferers worldwide, and may eventually reward investor as well. But given the stock's furious run-up, history of volatility, interim earnings losses, and the time lapse before the drug's first sales, it seems wise to take profits. Investors should have plenty of time to pick up the shares cheaper and still benefit from Benlysta's promise.


Another good article is on Bloomberg at the following link.

http://www.bloomberg.com/apps/news?pid=20601085&sid=am8d7NnxYQ9Y

Human Genome Science Triples on Success of Lupus Drug (Update3)

By David Olmos and Lisa Rapaport

July 20 (Bloomberg) -- Human Genome Sciences Inc. more than tripled in New York trading after the company and GlaxoSmithKline Plc said their experimental lupus drug reduced patients’ symptoms in a yearlong study.

Human Genome Sciences leaped $9.19 to $12.51 at 4 p.m. in Nasdaq Stock Market composite trading, its greatest single-day rise since shares began trading in December 1993. London-based Glaxo’s American depositary receipts rose 4 percent, or $1.45, to $37.81 in New York Stock Exchange trading, after the study raised hopes of the first new therapy in more than 50 years for the autoimmune disease.

The positive results for Benlysta were unexpected by analysts who cited disappointing data in earlier clinical trials and a history of failures for treatments of lupus, which triggers the immune system to attack healthy cells. Ten of 12 analysts rated Human Genome a “hold” or “sell” as of July 17, according to Bloomberg data. No cure exists for the disease, which affects about 5 million people worldwide.

“The lupus community has really been on tenterhooks waiting for a positive announcement,” Sandra Raymond, chief executive of the Lupus Foundation of America, a Washington, D.C.-based patient advocacy group, said in a July 17 telephone interview, before the results were announced. “Since lupus was first discovered over a century ago, there has never been a drug specifically developed for lupus.”










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7/20/09

Human Genome Sciences Up over 200 percent Monday July 20, 2009




This has been one of my favorites for awhile after learning about Craig Venter and Sequencing the Human Genome. Craig partnered with Human Genome Sciences but you can learn more by reading Craig Venters A Life Decoded Biography which shows the ups and downs a scientist can have especially when dealing with the Government and the Human Genome Project.

Wikipedia on Human Genome Sciences.
The company was founded by William A. Haseltine, a noted Harvard professor and AIDS researcher. HGS had a partnership for several years after its founding with Craig Venter and his non-profit TIGR to begin sequencing and submitting patents on hundreds of thousands of protein-encoding DNA fragments. In 2000, Haseltine said that his work "speeds up biological discovery a hundredfold, easily." He talked of finding in genes "the fountain of youth" in the form of "cellular replacement" therapies. More than $2 billion in investments was raised by the company by 1999-2000. Two initial drugs failed in clinical trials, and the stock share price declined from its highs. For example, in September 2000, the company reported that it had found a way to treat large, painful sores that often plague elderly patients, using a protein spray called repifermin, made by a human gene called keratinocyte growth factor-2. In February 2004, the company said that it was ending the development of repifermin because it showed no more benefit than a placebo in clinical trials.


On 7/20/09, Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline (NYSE:GSK) announced that Benlysta (belimumab, formerly LymphoStat-B) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo groups. Assuming positive results in November 2009 from a second Phase 3 trial of Benlysta, the companies plan to submit marketing applications in the United States, Europe, and other regions during 1H10.




Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. "The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010."
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

"Lupus is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide and can have a devastating effect on both patients living with the disease and their families," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE."

Key Findings from BLISS-52

"The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We are delighted to report that the efficacy of treatment with BENLYSTA plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI and Physician's Global Assessment. Of note, a greater percentage of patients receiving BENLYSTA achieved a clinically meaningful reduction in steroid dose. We hope to have a full presentation of BLISS-52 results at an appropriate scientific meeting later in 2009."

About the BENLYSTA (belimumab) Phase 3 Development Program

The Phase 3 development program for belimumab includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in serologically active (i.e., autoantibody-positive) patients with SLE. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials is similar, but the duration of therapy in the two studies is different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. The data from BLISS-76 will be analyzed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorization Application in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.

The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate at Week 52, as defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); and (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat (ITT) and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race.

In each of the two Phase 3 trials, patients were randomized to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290), 1 mg/kg belimumab (BLISS-52, n=288), or placebo (BLISS-52, n=287). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies.

About BENLYSTA (belimumab)

Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. BLISS 52 results suggest that belimumab can reduce SLE disease activity, and a second Phase 3 trial, BLISS-76, is underway to confirm these results.

About the Collaboration with GSK

In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.


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7/15/09

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Teva and Boston Scientific Thursday July 15 2009



BOSTON SCIENTIFIC CP(NYSE: BSX)
After Hours: 10.18 0.00 (0.00%) 4:39PM
Last Trade: 10.18
Trade Time: 4:01pm ET
Change: 0.05 (0.49%)
Prev Close: 10.13
Open: 10.32
1y Target Est: 11.65
Day's Range: 10.01 - 10.32
52wk Range: 5.41 - 14.20
Volume: 15,123,145
Avg Vol (3m): 14,615,000
Market Cap: 15.34B
P/E (ttm): N/A
EPS (ttm): -1.58
Div & Yield: N/A

Boston Scientific Corp. said it received European approval to introduce its Latitude remote-monitoring program for heart-failure devices and defibrillators across the continent in a move that could boost the adoption of its products there.

The remote-monitoring system is already approved for use in the U.S.

Analysts say that no single U.S. player in cardiac rhythm management has advanced far beyond the others in device function, so service aspects such as remote monitoring, sometimes called telemedicine, have the potential to help differentiate the companies.

The big U.S. players in cardiac rhythm management have been expanding, even touting, their possibly cost-saving telemedicine systems, as the federal government initiates widespread health-care changes. Boston Scientific, Medtronic Inc. and St. Jude Medical Inc. offer these programs in the U.S., although Medtronic has the lion's share of the market and offers its service for pacemakers, unlike the other two.

"This is where therapy is going," said Fred Colen, president of cardiac rhythm management for Boston Scientific. "Remote monitoring for patients, for any condition, is on the rise."

Boston Scientfic said it earned CE-mark approval, which certifies that the product meets consumer-safety and health standards in Europe, where the market for heart-failure devices and defibrillators is estimated to be around $1.5 billion.

So far, the Latitude program has been used for patients in the Netherlands and Denmark, and the company hopes to expand to 14 European Union countries in a phased approach.

Keay Nakae, an analyst with Collins Stewart LLC, said the company's recent U.S. growth hasn't been mirrored in Europe. Among the reasons is the lack of a monitoring system. The system "isn't a primary reason you'd use one device," he said. "But having it as a function and a capability is certainly a positive."

Telemedicine allows doctors to monitor their patients without in-office appointments and to intervene early if they see problems. This has the potential to reduce hospital visits and length of stays, though no company has completed clinical studies on the effect. Analyst Jan David Wald of Noble Financial said it will be helpful as the government begins to focus on medical cost efficiency.

"I think remote monitoring helps," he said. "On net, you're going to decrease the cost of health care."

The yearly cost of patient rehospitalization for congestive heart failure in the U.S. is estimated to be close to $10 billion, according to the West Wireless Health Institute, a research organization for wireless health technology.

The companies' services are included with the charge for the heart devices, and there is no monthly charge for patients. Doctors are reimbursed by insurance or Medicare for remote monitoring checkups as well.

Each company offers different amenities with its devices. For example, Medtronic's system monitors fluid levels automatically. Boston Scientific's system can monitor patients' weight and blood pressure. St. Jude plans to use its system for its pacemakers, pending Food and Drug Administration approval for the devices, and Boston Scientific plans to use it in its next generation of pacemakers, company representatives said.

Collins Stewart's Mr. Nakae thinks that telemedicine is more of a necessity than a bonus for the companies.

"I think it's something that everybody wants to have, and if you don't have it in the bigger picture, you could be at a disadvantage," he said.



Teva Pharma Plan B Approved by the FDA

Teva Pharmaceutical Industries (NasdaqGS: TEVA)
After Hours: 49.61 0.18 (0.36%) 4:24PM EThelp
Last Trade: 49.79
Trade Time: 4:00pm ET
Change: 0.29 (0.59%)
Prev Close: 49.50
Open: 49.71
Bid: 46.70 x 200
Ask: N/A
1y Target Est: 55.13
Day's Range: 49.51 - 49.99
52wk Range: 35.89 - 50.35
Volume: 4,219,948
Avg Vol (3m): 5,294,170
Market Cap: 42.47B
P/E (ttm): 43.91
EPS (ttm): 1.13
Div & Yield: 0.58 (1.20%)

WASHINGTON -- The Food and Drug Administration approved labeling
that will allow 17-year-olds access to the Plan B emergency-contraceptive pill
without a prescription.The agency also approved a one-dose version of the product called Plan B One-Step that will also be available over-the-counter to women age 17 and older. Both products are sold by Duramed Pharmaceuticals, a unit of Teva
Pharmaceuticals Industries Ltd.

Duramed loses market exclusivity on the traditional Plan B pill -- which is
taken in two steps -- next month, allowing generic versions to be made available.
Teva said the Plan B One-Step would be available in pharmacies next month. In March a federal court ordered the FDA to lower the age requirement set by the Bush administration for Plan B to be sold over-the-counter from 18 to 17.

In 2006, the FDA agreed to make Plan B available without a prescription to
women over 18 and required the product to be placed behind the pharmacy counter. In 2004, the FDA rejected an application to make Plan B available without a prescription even though an advisory panel of outside medical experts voted to support the switch from prescription to non-prescription status.

Plan B was approved as a prescription "emergency" contraceptive in 1999. It is
made of the hormone progestin, and is designed to prevent pregnancy if taken
within 72 hours of unprotected sexual intercourse. The original Plan B pill is designed to be taken in two doses 12 hours apart.

The pills are similar to birth-control pills but contain higher doses of
progestin to block a potentially fertilized egg from becoming implanted in a
woman's uterus.The court ruling came in response to a lawsuit filed in 2005 by the Center for Reproductive Rights, a women's health advocacy group.




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