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Dimebon isn't dead, the drug can be saved
do a phase 3 trial in Russia
I hope it is good news but I do not think the company would have the data on tuesday night and try to keep it quiet until friday evening.
OT not biotech.
a company called Virnetx symbol vhc is suing Microsoft for a few billion dollars. the trial starts on monday. If it was a small company with that created the patents I probably wouldn't have gotten involved, but the patents were created by SAIC, which did most of the internet security work for the CIA.
If I am right this stock can go to 100.
TIME: MINUTES:
9:00 am Case called. Mr. Cawley announced ready for Plaintiff. Mr. Powers announced ready for
Defendant VirnetX.
Court addressed the parties on timing. Mr. Powers responded. Court will allow 14 hours for
both sides.
Court addressed the parties on VirnetX’s Motions in Limine and Microsoft will present on the
papers. Mr. Cawley presented Plaintiff’s Motions in Limine. Mr. Bobrow responded. Mr.
Cawley replied. Court will grant for now, but asked if needed for voir dire. Mr. Powers
responded. Court will grant for now and Court will look at prior to opening, and asked parties
to bring up again and Court will take a look at it.
Court moved on to Item #16 and asked to hear from Microsoft. Ms. Weiswasser responded. Mr. Cawley responded
Court and parties discussed mentioning Weil.
Court addressed the parties on the voir dire timing.
9:20 am Court in recess.
9:40 am Jury panel seated in the courtroom.
Case called. Court welcomed the jury panel to the Eastern District for jury service.
Case called. Mr. Cawley announced ready for Plaintiff, VirnetX. (Also for Plaintiff, Mr. Parker,
Mr. Caldwell, Mr. McLeroy, Mr. Cassady, and Edmund “Gif” Munger, Client Representative).
Mr. Powers announced ready for Microsoft. (Also present for Defendant, Richard Sayles, Mr.
Bobrow, Ms. Weiswasser, and Robert Lytle and Gurdeep Pall, Client Representatives)
Court addressed the jury panel and outlined the procedures of voir dire.
Court asked the parties to introduce self, co-counsel and list witnesses for the jury.
Mr. Cawley introduced self, co-counsel, and Mr. Munger, client representative. Mr. Cawley
also listed witnesses for VirnetX.
Mr. Powers introduced self, co-counsel, and Mr. Pall and Mr. Lytle, Client Representatives. Mr.
Powers also listed witnesses for Microsoft.
Court asked panel if they knew any of the parties, representatives or witnesses. No one
answered.
Mr. Cawley conducted voir dire of the panel on behalf of the Plaintiff, VirnetX.
Mr. Sayles conducted voir dire of the panel on behalf of the Defendant, Microsoft.
Court addressed the jury panel and asked some further questions.
Court asked Juror #4, 5, 8, 9, 13, 17,32, 34, 35, 36, to remain in the courtroom. Court excused
the rest of the panel until
Court questioned Juror #36. Court questioned Juror #32. Court questioned Juror #34 (MB).
Court addressed Juror #35. Court questioned Juror #17. Court questioned Juror #13 (KC).
Court addressed Juror #9. Court questioned Juror #8. Court questioned Juror #5. Court
questioned Juror #4.
Court excused the rest of the panel for their break. Jurors left the courtroom.
Court addressed the parties and will excuse for cause Juror #4, #5, #8, #9, #17, #28, #32, #34,
#35, #36. No objections to excuse those. Court will give each side 11 strikes and gave them 20
minutes to get their strike lists to the Clerk.
11:50 am Court asked the Clerk to read the names of the jurors selected. Clerk read the names of the 8
persons selected. Jury Seated in the jury box.
Court asked clerk to administer the oath. Oath administered.
Court addressed the remaining panel, thanked them for their service, and excused them.
PAGE 3 - Proceedings Continued
TIME: MINUTES:
Court addressed the panel and gave them instructions. Court excused the panel and asked them
to call the 1-800 number for any changes. Court will reconvene at 9:00 am on March 8, 2010.
Court addressed the parties. The parties have nothing further to take up at this time.
Court addressed the parties and encouraged them to continue in settlement discussions.
12:10 pm There being nothing further, Court adjourned.
na, nana na na
I hope it works for patients,
If the results are positive why wouldn't they release it at night.
does the stock trade in Europe?
Medivation to Host Conference Call at 8:30 a.m. Eastern Time Tomorrow to Discuss Phase 3 Trial Results for Dimebon in Alzheimer's Disease
stock was up at the end of the day
Companies:Medivation, Inc.
Press Release Source: Medivation, Inc. On Tuesday March 2, 2010, 8:25 pm
SAN FRANCISCO, March 2 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq:MDVN - News) today announced that it will hold a teleconference and webcast at 8:30 a.m. Eastern Time tomorrow, Wednesday, March 3, to discuss Phase 3 trial results for dimebon (latrepirdine) in patients with mild-to-moderate Alzheimer's Disease. A press release will be issued at 7:30 a.m. Eastern Time tomorrow prior to this call.
Teleconference/Webcast Details
To participate in the live call on Wednesday, March 3, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time), please dial 877-303-2523 for domestic callers and 1-253-237-1755 for international callers. In addition, the live conference call is being webcast and can be accessed on the "Events and Presentations" page of the "Investor Relations" section of the Company's website at www.medivation.com. A replay also will be available for 30 days following the live call.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer's and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer's medications in patients with mild, moderate and severe Alzheimer's disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for both early- and late-stage prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. For more information, please visit us at www.medivation.com.
iBio, Inc. Announces Agreement in Principle for Licensing Large-Scale Vaccine Production Facility Using Green Plant Technology
Companies:iBio, Inc.
Press Release Source: iBio, Inc. On Friday February 26, 2010, 8:30 am
NEWARK, Del.--(BUSINESS WIRE)--iBio, Inc. (OTCBB:IBPM - News) announced today that it has agreed in principle to license its technology, the iBioLaunch™ platform, and provide technology transfer services to G-Con, LLC, a private Texas company, and its affiliates, for the development and manufacture of plant-expressed influenza vaccines at a new facility being constructed in Bryan, Texas. The “GreenVax Project” will show proof of concept for a large-scale vaccine production facility using Nicotiana plants grown hydroponically in a contained environment. In contrast to current methods of production, the iBio green plant technology platform holds the promise of shortening vaccine production from months to weeks and allowing rapid response to newly emerging viruses not possible with conventional vaccine technology. Although the Project’s initial goal is to produce candidate H1N1 vaccines, iBio’s technology is highly adaptable to other influenza strains, other infectious diseases, as well as cancer.
The iBioLaunch platform, the enabling technology for the GreenVax Project, was developed by the Fraunhofer USA Center for Molecular Biotechnology. The technology has been successfully applied to a wide range of vaccine and therapeutic targets, and in addition to the investments made by iBio, has attracted funding from the U.S. government and the Bill & Melinda Gates Foundation.
“The iBioLaunch technology with its rapid response capability provides a valuable alternative to traditional vaccine production systems,” said Dr. Vidadi Yusibov, Executive Director of the Fraunhofer USA Center for Molecular Biotechnology. “The GreenVax Project is a significant step towards practical implementation of the iBioLaunch technology.”
“This is a landmark new technology that could dramatically increase the nation’s capability to produce vaccines for infectious diseases, including influenza,” said Dr. Brett Giroir, vice chancellor for research of the Texas A&M University System. Texas A&M is a member of the GreenVax consortium.
“The flexibility of the plant-based system, combined with its low cost and ability to massively scale, may provide vaccine protection not only to citizens of the United States, but also to many parts of the world that cannot currently afford vaccines,” said Dr. Barry Holtz, President of G-Con.
“We expect vaccines against influenza, including seasonal influenza, to be among the earliest applications of the iBioLaunch technology,” said Robert Kay, Chairman and Chief Executive Officer of iBio. “In the new GreenVax facility, G-Con’s modular production technology should significantly enhance the economy, speed and flexibility advantages of our system for application to a broad range of biologic products.”
Research and development for the GreenVax Project will occur on a secure, 21-acre site on the campus of the Texas A&M Health Science Center in Bryan, Texas. There will be a custom-designed, 145,000-square-foot bio-production facility that is being constructed by G-Con. The facility has been optimized to achieve the goals of this project, yet remains expandable as required without interruption of core operations. The projected final scale capacity of the facility is 100 million doses per month. Although there are currently no approved plant-based flu vaccines, a clinical development program for influenza vaccines produced with the iBioLaunch platform is underway.
About iBio, Inc.
iBio, Inc. is a biopharmaceutical company commercializing its proprietary technology, the iBioLaunch™ platform, for the production of biologics including vaccines and therapeutic proteins. The iBioLaunch platform uses transient gene expression in green plants for superior efficiency in protein production. Advantages include significantly lower capital and process costs, and the technology is ideally suited to infectious disease applications where speed, scalability and surge capacity are important. iBio’s strategy is to utilize its technology for development and manufacture of its own product candidates and work with both corporate and government clients to reduce their costs during product development and meet their needs for low cost, high quality biologics manufacturing systems. iBio owns technology developed at the Fraunhofer USA Center for Molecular Biotechnology, and continues to sponsor development and refinement of the technology for broad applications in human healthcare. Further information is available at www.ibioinc.com. An iBio corporate video is available at www.client.dssimon.com/fe/ibio_webisode.wmv
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
Statements included in this release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's Reports filed with the Securities and Exchange Commission.
Contact:
iBio, Inc.Robert Erwin, 302-355-2335Presidentrerwin@ibioinc.comorMediaRx Communications, Inc.Eric Goldman, 917-322-2563Vice Presidentegoldman@rxir.com
Teasing Vaccines From Tobacco
Swine Flu Epidemic Spurs Military to Join the Hunt for Plant-Based Alternatives
By GAUTAM NAIK
The U.S. Department of Defense, caught off guard by the swift spread of the H1N1 flu virus last year and delays in producing a vaccine, is backing an unusual plan to use tobacco plants to make the vaccine.
Flu vaccines are typically grown in chicken eggs. Although the technique is slow and expensive, vaccine makers have done little to improve on this reliable method for more than 60 years. The urgent need for a better way became apparent last year.
"The response to H1N1 was a disaster," said Brett Giroir, vice chancellor for research at Texas A&M University System, part of a consortium testing plant-based vaccines for H1N1, or swine flu.
The Defense Advanced Research Projects Agency—which conducts research to protect soldiers from infectious diseases, and also is concerned about the U.S. capability to react swiftly to a bioterrorist attack, among other things—has awarded the consortium $40 million to make an initial 10 million doses of H1N1 vaccine.
Texas A&M and closely held firm G-Con will together invest a further $21 million. Details of the project, known as GreenVax, will be announced Wednesday.
For several years, vaccine companies have worked on harvesting vaccines in everything from caterpillar cells to cocker-spaniel kidney cells. Plants have certain advantages over animal parts, which may contain pathogens harmful to humans. The tobacco plant is particularly promising: It has been extensively researched, is cheap to grow and can yield large amounts of vaccine quickly—potentially reducing production time to weeks instead of several months.
Earlier this month, Arizona State University researchers showed a plant-based drug could prevent and treat West Nile virus infection in mice. In January, Germany's Bayer AG said it was testing a plant-based vaccine for non-Hodgkins lymphoma.
In December, Medicago Inc. of Quebec City reported positive results for a tobacco-based vaccine for avian flu, or H5N1, which has killed more than 250 people world-wide. Biotechnology firm VAXX Inc. of Tucson, Ariz., says it soon plans to start a human trial of a tobacco-based vaccine for Norwalk norovirus—or "cruise ship virus"—which causes gastroenteritis in as many as 74 million Americans annually.
GreenVax is one of the more ambitious of the plant-based vaccine projects. It is partly based on research done at Fraunhofer USA Center for Molecular Biotechnology, in a partnership with the biotech firm iBio Inc., both based in Newark, Del.
As a first step, researchers at Fraunhofer isolated a protein from the H1N1 virus known to trigger a protective immune response in a patient without causing an infection. A gene for this protein was then introduced into a bacterium. Tobacco plants were placed in a special chamber and dipped into a soup of the bacteria, which caused the plants to get infected with the gene-carrying bacteria.
The infected plants then began to produce the protein from H1N1 in large quantities. The plants grew for about a week. Their leaves were then chopped up and crushed, and the protein from H1N1—the essence of the vaccine—was extracted from the slurry and purified.
Initial tests on ferrets, which can catch human flu, showed the vaccine was safe and effective. "The good news is that this vast amount of human protein isn't toxic to the plant," so it can keep producing large amounts of the vaccine's raw material, said Barry Holtz, president of G-Con. And the plants don't become "transgenic"—their seeds, for example, aren't changed, so they can't spread genetic alterations to normal plants.
The GreenVax project still has a long way to go. It needs to show that it can produce sufficient quantities of purified vaccine-ready protein quickly and safely. And such a vaccine would have to be tested in humans and get the approval of the Food and Drug Administration before it can be provided more widely.
The consortium plans to build a 145,000-square-foot vaccine production facility in Bryan, Texas, managed by G-Con. One innovation being developed: Mobile manufacturing "pods" that can be deployed swiftly in areas where the vaccine is urgently needed.
GreenVax hopes to produce the initial 10 million doses of H1N1 vaccine within 12 months. Large-scale human clinical trials are expected to begin in 2011, and could take up to 18 months to complete. The setup could be used to produce other vaccines as well.
"The science hasn't yet been unleashed to get past chicken eggs for making vaccines," says Dr. Giroir. "But now that the system is stressed, there's a reason to get past it."
Write to Gautam Naik at gautam.naik@wsj.com
xnpt from Rodman and Renshaw
Xenoport
XNPT: Price: $9.05; Market Cap (MM): $274.6
Market Perform;
Boris Peaker, Ph.D. - Senior Associate Analyst (212-430-1778)
Elemer Piros, Ph.D. - Senior Biotechnology Analyst (212-430-1754)
XenoPort Reports 2009 Financial Results
Click for Full PDF
Key Points
XenoPort believes the current cash balance is adequate through 2H11
The company did not disclose additional details from the complete response letter beyond those announced on February 17th, 2010, but did provide additional data on rat studies
The rat carcinogenecity data shows a dose-dependent increase in adenomas and carcinomas, but does not appear to be any worse than prior results with gabapentin
We estimate that the FDA was not aware of the rat carcinogenicity data at the time of the end-of-Phase 2 meeting
We maintain our Market Perform rating without a price target on XenoPort shares
Rat Data Shows A Dose-Dependent Increase In Carcinomas and Adenomas
Following the Complete Response letter to its NDA for Horizant in RLS, which sited concerns about pancreatic carcinogenicity observed in rats, XenoPort presented additional details on its preclinical findings. The company conducted a two year carcinogenicity study in rats, which included four arms (control, 500mg/kg/day, 1000mg/kg/day, and 2000mg/kg/day). Horizant or control were administered via gavage, which is a feeding tube directly to the stomach. Each arm of the trial included 60 males and 60 female rats. Adenomas were observed in 2/120 (1.7%) of rats in the placebo arm (both males), 4/120 (3.3%) in the 500mg/kg/day arm (all males), 4/120 (3.3%) in the 2000mg/kg/day arm (all males), and 13/120 (11%) in the 5000mg/kg/day arm (8 males, 3 females). Carcinomas were less frequent, with only 1 case (0.8%) in a male rat at the 2000mg/kg/day arm, and two cases (1.6%, one male and a female) in the 5000mg/kg/day arm. One rat died prematurely (male, carcinoma in the 2000mg/kg/day arm), and no alternative cause of death was identified.
For comparison, Sigler et. al. (Toxicology 98(1995); 73-82) conducted a two year carcinogenicity study of orally-administered gabapentin in rats. The results showed a carcinogenicity rate of 4/50 (8%) at the 250mg/kg dose, 3/50 (6%) at the 1000mg/kg dose, and 8/50 (16%) at the 2000mg/kg dose. While comparing results across trials may introduce errors resulting from difference in protocols, Siglers data appears to show a higher carcinoma frequency than what was observed by XenoPort. One notable distinction is that XenoPort observed carcinomas and adenomas in male and female rats, while only male rats developed carcinomas in Sigler's experiment.
Timeline Suggests Rat Data Came After End-Of-Phase 2 Meeting
The general drug development process includes a meeting with the FDA following the completion of the Phase 2 studies to discuss available human and pre-clinical data, Phase 3 trial design, data and safety analysis, and many other topics related to the individual drug in development. In March 2006 XenoPort announced the commencement of its first Phase 3 study. While the press release does not specify the timing of the Phase 2 meeting, we suspect the meeting occurred in early 2006 or late 2005. However, management noted the completion of the rat carcinogenicity study May 2007. Therefore, while we do not know the exact timing of the end-of-phase 2 meeting and the time of submission of the rat carcinogenicity data, we believe that the agency was not in possession of this data during the negotiations of Phase 3 program design.
Maintain Our Market Perform Rating Pending Update From The FDA
While we are unaware of data suggesting that the observed pancreatic carcinogenicity signal in rats translate to human carcinogenicity risk, it is not clear if and how this finding may be viewed by the FDA. Additionally, even if the agency agrees to a plan towards approval, we remain concerned about GSKs commitment to the program and the investment required to launch a new product for the treatment of Restless Legs Syndrome. We believe that a restrictive label (black box warning and/or patient registry) may substantially limit the commercial potential of Horizant given the availability of approved agents in RLS, generic gabapentin, lyrica, and lack of head-to-head studies of Horizant vs. other agents.
HeartWare International Reports Fourth Quarter Revenues of $12.2 Million; Full Year 2009 Revenues of $24.2 Million
This appears a bit overpriced
Companies:Heartware International Inc.
Press Release Source: HeartWare International, Inc. On Monday February 22, 2010, 6:14 pm
FRAMINGHAM, Mass. and SYDNEY, Feb. 22 /PRNewswire-FirstCall/ -- HeartWare International, Inc. (Nasdaq: HTWR; ASX: HIN), a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced revenues of $12.2 million for the fourth quarter ended December 31, 2009. This compares to $7.5 million in revenues for the third quarter ended September 30, 2009. For the 2009 fiscal year, the Company reported $24.2 million in revenues, compared with $332,000 in 2008.
"Since our first international commercial sale in March 2009, we have continued to receive positive physician feedback -- both in approved international markets, where physician acceptance continues to build, and also in the U.S., where the pace of enrollment in our clinical study accelerated toward year end," explained HeartWare President and Chief Executive Officer Doug Godshall. "Today we have 20 sites implanting the HeartWare HVAD pumps internationally and, importantly, our U.S. bridge-to-transplant trial recently completed enrollment, paving the way for a submission to the FDA for pre-market approval in the second half of this year."
Total operating expenses for the fourth quarter of 2009 were $9.8 million, as compared to $6.8 million in the prior year period. For the 2009 year, total operating expenses were $31.5 million compared to $29.6 million in 2008. The increases reflect expansion of commercialization activities in Europe following the receipt of CE Marking in January 2009, non-recurring costs associated with the terminated Thoratec merger, additional expenditure on the Company's technology pipeline and the expansion of the Company's U.S. clinical trial.
Net loss for the fourth quarter of 2009 was $1.9 million, or a $0.17 loss per basic and diluted share, compared to a $3.9 million net loss, or a loss of $0.44 per basic and diluted share, in the fourth quarter of 2008. For the 2009 year, net loss was $20.9 million, or a loss of $2.15 per basic and diluted share, compared to a $23.8 million net loss, or a loss of $3.00 per basic and diluted share, in 2008.
"To capitalize on strong growth prospects for the HVAD pump, we are investing in additional marketing and customer support infrastructure in international markets and domestically, as well as other key areas such as reimbursement and patient outcome management," added Mr. Godshall. "Importantly, we are also now in a position to strongly advance the development of a broad array of technologies in our pipeline portfolio given the completion of a $62 million public offering earlier this month."
At December 31, 2009, the Company's balance sheet reflected $50.8 million in cash and cash equivalents, which does not include the proceeds from the February 2010 public offering. This compares to approximately $20.8 million in cash and cash equivalents at December 31, 2008.
The Company will host a conference call on Tuesday, February 23, 2010 at 8:00 a.m. U.S. Eastern time (being 12:00 a.m. Australian Eastern Daylight Time between February 23 and 24, 2010) to discuss its fourth quarter and full year 2009 results. The call may be accessed by dialing 1-877-407-9039 five minutes prior to the scheduled start time and referencing "HeartWare." For callers outside the United States, dial +1-201-689-8470. Doug Godshall, Chief Executive Officer, President and Executive Director, and David McIntyre, Chief Financial Officer and Chief Operating Officer, will host the conference call.
A live web cast of the call will also be available at the Company's website (www.heartware.com) by selecting "Q4 2009 HeartWare International Earnings Conference Call" under the section titled "Corporate Presentations" on the HOME page. A replay of the conference call will be available through the above weblink immediately following completion of the call.
About HeartWare International
HeartWare International develops and manufactures miniaturized implantable heart pumps, or ventricular assist devices, to treat Class IIIb and Class IV patients suffering from advanced heart failure. The HeartWare® Ventricular Assist System features the HVAD™ pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices. HeartWare has received CE Marking for the HeartWare System in the European Union. The device is currently the subject of a United States clinical trial for a bridge-to-transplant indication. For additional information, please visit the company's website at www.heartware.com.
HeartWare International, Inc. is a member of the Russell 2000(R) and its securities are publicly traded on The NASDAQ Stock Market and the Australian Securities Exchange.
For further information:
Christopher Taylor
HeartWare International, Inc.
Email: ctaylor@heartwareinc.com
Phone: +1 508 739 0864
Forward-Looking Statements
This announcement contains forward-looking statements that are based on management's beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to the progress of clinical trials. Management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on forward-looking statements because they speak only as of the date when made. HeartWare does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. HeartWare may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including without limitation those described in "Item 1A. Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission. We may update our risk factors from time to time in "Part II, Item 1A. Risk Factors" in our Quarterly Reports on Form 10-Q, or other current reports, as filed with the Securities and Exchange Commission.
- Tables to Follow-
HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except share and per share data)
(unaudited)
Three Months Ended
December 31, Year Ended December 31,
------------ ----------------------
2009 2008 2009 2008
---- ---- ---- ----
Revenues, net $12,219 $244 $24,172 $332
Cost of revenues 6,809 78 13,211 78
----- --- ------ ---
Gross profit 5,410 166 10,961 254
Operating expenses:
Selling, general and
administrative expenses 4,723 2,988 16,444 10,981
Research and
development expenses 5,073 3,842 15,067 18,644
----- ----- ------ ------
Total operating
expenses 9,796 6,830 31,511 29,625
Loss from operations (4,386) (6,664) (20,550) (29,371)
Other income (expense) 2,475 2,738 (359) 5,607
----- ----- ---- -----
Net loss $(1,911) $(3,926) $(20,909) $(23,764)
======= ======= ======== ========
Net loss per common
share - basic and
diluted $(0.17) $(0.44) $(2.15) $(3.00)
====== ====== ====== ======
Weighted average
shares outstanding -
basic and diluted 11,369,289 8,866,702 9,713,925 7,929,054
========== ========= ========= =========
HEARTWARE INTERNATIONAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
December 31, December 31,
2009 2008
--------- ---------
ASSETS
Current assets:
Cash and cash equivalents $50,835 $20,804
Accounts receivable 11,385 244
Inventories, net 8,871 3,508
Prepaid expenses and other current assets 1,663 1,062
----- -----
Total current assets 72,754 25,618
Property, plant and equipment, net 3,719 3,609
Other intangible assets, net 1,192 823
Restricted cash 288 288
--- ---
Total assets $77,953 $30,338
======= =======
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $3,122 $699
Accrued expenses and other current liabilities 3,848 2,883
----- -----
Total current liabilities 6,970 3,582
Commitments and contingencies
Stockholders' equity 70,983 26,756
------ ------
Total liabilities and stockholders' equity $77,953 $30,338
======= =======
DARPA and Accelerating Critical Therapeutics
http://www.darpa.mil/news/2009/AMPFactSheet17Feb.pdf
DARPA has a long-standing research program to protect warfighters from infectious diseases
encountered during deployments. Current research activities include development of new, rapid
mechanisms to discover, test and manufacture large quantities of critical therapeutics.
In response to emerging and novel biologic threats, DARPA’s Accelerated Manufacture of
Pharmaceuticals (AMP) program started in 2005. AMP focuses on identifying, developing and
demonstrating new ways to produce large amounts of pharmaceuticals, such as high-quality
vaccine-grade protein within three months of sequencing the pathogen DNA. Inspiration for this
scalable approach is a preparedness strategy that provides capability to respond quickly to
emerging biothreats.
In response to the 2009 H1N1 swine flu pandemic, AMP's plant-based platform redirected its
rapid scale-up processes that were initially developed for avian influenza. After receiving the
H1N1 DNA sequence April 29, a candidate recombinant H1 protein, an essential component of a
vaccine, was produced within four weeks.
AMP’s plant-based system combines three major components to rapidly express vaccine
candidate proteins: non-genetically modified plant seedlings, viral-based protein expression
vectors and vacuum infiltration/viral infection methodologies. Upon receipt of the gene
sequence for a target protein, that sequence is cloned into a viral-based protein expression vector.
This virus vector provides the mechanism for transferring millions of copies of the target gene
Fact Sheet
Defense Advanced Research Projects Agency
3701 North Fairfax Drive
Arlington, VA 22203-1714
sequence into the plant cells. Upon transfer to the plant, the virus replicates the target gene and
stimulates protein expression in those plants.
Essentially, this platform uses the plant's protein synthesis capabilities to produce the specific
recombinant protein material that will be the active component of a vaccine. Scale-up could be
as simple as infiltrating additional non-genetically modified seedlings. Compared to other
vaccine technologies, this platform's production time allows for protein expression, the first step
in vaccine production, in less than five weeks.
DARPA is pursuing this technology development along two, parallel paths:
1) A pilot facility to produce a vaccine-grade recombinant protein under current good
manufacturing practices (cGMP) for formulation, immunogenicity and toxicology
studies. Data along with results from those studies will lead to filing of an
investigational new drug package with the FDA allowing the start of a phase 1
clinical trial. The data generated would be needed to approve this approach for rapid,
flexible vaccine manufacturing under an emergency use authorization scenario.
2) Demonstrate a proof-of-concept capability for cGMP scale up of the plant-based
platform to 10 million doses per month.
Because of the time required to address key FDA regulatory requirements, this program is not
anticipated to deliver H1N1 vaccine for widespread human use during the 2010 flu season.
Protein produced in a facility that meets FDA requirements, is formulated into a vaccine and has
completed phase 1 clinical studies has a higher chance of being authorized by the FDA for use in
a public health emergency under an emergency use authorization.
I was at a cancer presentation and a doctor from Sloan-Kettering mentioned this as a very promising drug, I think he was referring to prostate cancer so it has more indications.
This shows you that if Roche wasn't involved and a smaller company was in control of the drug, they would have gone into phase 2 with the wrong dose and it would have been a failed drug.
Biotech Stock Mailbag: Health Discovery
By Adam Feuerstein 02/19/10 - 07:00 AM EST
BOSTON (TheStreet) -- This week's Biotech Stock Mailbag opens with an email from Edward M. with a question about Health Discovery Corp(HDVY.OB Quote).
"Health Discovery Corp. recently received a bullish write-up by Biomedreports that said certain undisclosed actions would be taken very soon to implement the company's urine-based test for prostate cancer. Did you see this report and if so, what is your position? If Health Discovery Corp.'s urine-based test works it could become the gold standard for prostate cancer and replace PSA tests because those don't work at all and doctors want something else."
Health Discovery (HDC) is working on a urine-based genetic test for prostate cancer, along with partners that include Quest Diagnostics(DGX Quote), Clarient(CLRT Quote) and Abbott Labs(ABT Quote). That much from Biomedreports' recent coverage of the company is true.
Unfortunately, more of what was reported by Biomedreports about HDC contained factual omissions and exaggerations that distort both the timeliness of the company's prostate cancer test as well its near-term commercial potential.
HDC's urine-based test doesn't appear to be close to clinical validation or commercialization, according to checks I made with HDC's partners. And even if a convenient and accurate urine-based gene test for prostate cancer was launched soon, it would not replace the widely used, if flawed, PSA blood test -- certainly not right away, according to cancer experts.
Trading in Health Discovery (HDC) surged on Jan. 29, triggered by a Biomedreports alert to its paying subscribers that morning:
"... speculation centers on news surrounding the company's new gene-based molecular diagnostic test for prostate cancer -- which has successfully completed its phase III double-blind clinical trial and is now ready for commercialization. The new prostate cancer test will be performed at Clarient's clinical laboratory in Aliso Viejo, Calif. HDC will receive 30% royalty on each test performed," the Biomedreports alert stated.
By the close of trading on Jan. 29, HDC's stock price rose 6 cents, or 27%, to 28 cents a share. The intraday high reached 31 cents. More than 12 million shares traded hands, 12 times the average daily trading volume in the stock.
This "news" was more than a year old! HDC announced a tissue-based genetic test for prostate cancer ready for commercialization in the fall of 2008 after the completion of a phase III study earlier that year. This test requires a piece of a patient's prostate obtained through a biopsy, and looks for the presence of four genes that HDC claims signals the presence of aggressive prostate cancer cells.
More on HDVY.OB
Market Activity
Clarient Incorporated| CLRT
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Abbott Laboratories| ABT
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ADVENTRX Pharmaceuticals Inc.| ANX
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Clarient, one of HDC's partners, launched this tissue-based prostate cancer test in January 2009 as a so-called "homebrew" or in-house laboratory test, which doesn't require approval from the U.S. Food and Drug Administration.
A year later, however, sales of the HDC-Clarient prostate cancer test are "immaterial," according to Clarient spokesman Matt Clawson.
The HDC prostate cancer test is a "very small part of our business and we don't spend a lot of time talking about it," added Clawson.
On Feb. 1, Biomedreports published a more detailed, follow-up report on HDC available for free on its web site. This story suggested that HDC was about to announce a major development with a urine-based prostate cancer test and quoted an unnamed HDC executive who said the company wouldn't be able to say very much for "at least a few days" because of some "very sensitive non-disclosure agreements that are in place with both existing and potential partners."
"Speculators appear to be betting that HDC's new prostate cancer test is not only about to be commercialized, but that it has a very good chance of replacing the current PSA test for multiple reasons, including the fact that HDC's urine-based prostate cancer test is non invasive (only requiring a urine sample) while the PSA test requires an invasive blood collection procedure," according to Biomedreports.
That report helped push shares of HDC to an intraday high of 38 cents on Feb. 5, again, on larger-than-average volume.
More on HDVY.OB
Market Activity
Clarient Incorporated| CLRT
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Abbott Laboratories| ABT
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ADVENTRX Pharmaceuticals Inc.| ANX
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Quest Diagnostics, one of the country's largest laboratory testing companies, confirmed for me that it did license from HDC last year the rights to develop a urine-based aimed at detecting aggressive or clinically significant prostate cancer. Quest is also working with technology from other companies to accomplish the same thing.
Quest spokeswoman Wendy Bost declined to say how close such a test is to reaching the market but she did say that any urine-based test for prostate cancer from Quest would not replace the PSA test.
"Our research and development activities center on developing new techniques, employing urine and tissue specimens, that can complement, not replace, PSA testing. PSA testing plays an important role in the detection of this cancer. This role could be more powerful if the results of other validated biomarkers are available to physicians for assessing, in concert with a PSA result, a patient's likelihood for malignancy prior to biopsy or surgery," said Bost, in an email.
Abbott Labs spokeswoman Adelle Infante, likewise, confirms the company is working with HDC's urine-based prostate cancer screening technology, but "we are still early in the development process," with initial studies only underway, she said. Any test coming out of Abbott's labs will have to first be approved by the FDA before it reaches the market, she added.
Clarient also has rights to develop a urine-based prostate cancer test based on HDC technology, but any such test is "not ready for commercialization," said spokesman Clawson.
HDC won't say much about the timelines for a urine-based prostate cancer-screening test, nor does the company have any clinical data to share on such a test. HDC spokesman Tom Gallagher said the company is restricted by confidentiality agreements with its partners.
More on HDVY.OB
Market Activity
Abbott Laboratories| ABT
DOWN
ADVENTRX Pharmaceuticals Inc.| ANX
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Amgen Incorporated| AMGN
UP
Gallagher declined to provide details about any clinical trials specifically investigating the accuracy of a urine-based prostate cancer test that relies on the HDC-discovered genes that allegedly signal aggressive tumors. On several occasions, Gallagher promised to connect me with HDC CEO Stephen Barnhill, but he never followed through.
Researchers working on behalf of HDC did publish a paper in the journal UroToday International last year on the company's tissue-based test, but no details about extending the technology to urine-based screen were included, nor has the FDA reviewed the data.
Other companies and research groups are busy working on developing urine-based tests for prostate cancer. The diagnostics firm Gen-Probe(GPRO Quote) already sells a urine test for prostate cancer in Europe. The company is now running clinical trials in the U.S. with plans to get the test approved here.
A need does exist for a better way to screen patients for prostate cancer because the current PSA test is not specific enough, which means it doesn't do a good job of distinguishing between non-cancerous conditions like an enlarged prostate and serious, aggressive cancers, says Dr. Otis Brawley, medical director of the American Cancer Society.
But any new prostate cancer test that is developed will need to be reviewed and approved by the FDA. Then, it will take years of follow-up data before doctors are comfortable replacing the PSA test completely, Brawley says.
"This is not something that is going to happen overnight," he added.
Meantime, HDC issued Tuesday what has to be the most far-fetched and ridiculous press release I've seen in a long time. The company announced it was completing a mobile phone application that will allow anyone to take a picture of a suspicious mole on their bodies, email the photo to HDC, then immediately receive back a report outlining a risk assessment for melanoma.
Any company that claims to be able to diagnose skin cancer based on an emailed cell phone snapshot is acting completely irresponsibly, even recklessly, because it puts peoples' lives at risk. Hopefully, the FDA learns about this nonsense and orders HDC to cease and desist before someone gets hurt.
By the way, Biomedreports described the mobile phone app for skin cancer as "impressive" and "good news." I'm gobsmacked. Is there anything Biomedreports won't do or say to promote penny biotech stocks?
Department of Pathology and Experimental Toxicology, Parke-Davis Pharmaceutical Research Division, Warner-Lambert Company, 2800 Plymouth Road, Ann Arbor, MI 48105, USA
I guess gsk and xnpt didn't bring a paper bag to the fda. Who were those Vanda consultants? Look like xnpt need to make a visit to the person at the fda that can help them
Received 19 May 1994; accepted 25 September 1994. ; Available online 21 April 2000.
Abstract
Gabapentin, an anticonvulsant agent designated chemically as 1-(aminomethyl)-cyclohexaneacetic acid, was evaluated in a 2-year tumor bioassay in male Wistar rats. Three groups of 50 rats were fed gabapentin at 250, 1000 and 2000 mg/kg in the diet for 104 weeks. A fourth group was fed diet without drug. All rats were subjected to full histopathological evaluation. Body weight gain suppression occurred at 1000 and 2000 mg/kg. Survival was comparable across all groups. There was a treatment-related increase in the number of pancreatic acinar cell carcinomas; 0, 4, 3 and 8 of these carcinomas were observed in the control, 250, 1000 and 2000 mg/kg groups, respectively. There were no other increases in other tumor types, and there were no tumor increases in female rats. The frequency of pancreatic acinar cell hyperplasia was similar in treated and control groups. Biologically, the pancreatic carcinomas were not invasive, did not metastasize, were of late onset and did not compromise survival. Thus, gabapentin was a carcinogen in male Wistar rats. However, the tumorigenic response was of low-grade because it constituted a late tumor response which required very high doses. We reported recently that mice treated with gabapentin had no increase in pancreatic tumors. Therefore, neoplastic development was confined to the pancreas in a single sex and species of rodent. Consequently, gabapentin at therapeutic doses poses a low carcinogenic risk to humans.
verizon.
about 3 years ago, I saw three verizon trucks parked across the street from my house.
I saw all three drivers were on walkie talkies speaking to each other like they were on a job looking for broken wires.
In reality they were just booking their overtime and doing no work.
I had somewhere to go. when I came back three hours later the three trucks were leaving the neigborhood while I was retuning.
four hours of overtime each for sitting on their asses in a truck.
I guess they had to speak on the walkie talkie in case their supervisor wanted to know what they were doing.
otherwise they probably would have found another job to work at and get two checks
Ancient Man in Greenland Has Genome Decoded By NICHOLAS WADE
http://www.nytimes.com/2010/02/11/science/11genome.html?ref=todayspaper&pagewanted=print
The genome of a man who lived on the western coast of Greenland some 4,000 years ago has been decoded, thanks to the surprisingly good preservation of DNA in a swatch of his hair so thick it was originally thought to be from a bear.
This is the first time the whole genome of an ancient human has been analyzed, and it joins the list of just eight whole genomes of living people that have been decoded so far. It also sheds new light on the settlement of North America by showing there was a hitherto unsuspected migration of people across the continent, from Siberia to Greenland, some 5,500 years ago.
The Greenlander belonged to a Paleo-Eskimo culture called the Saqqaq by archaeologists. Using his genome as a basis, a team of researchers from the University of Copenhagen determined that the Saqqaq man’s closest living relatives were the Chukchis, people who live at the easternmost tip of Siberia. His ancestors split apart from Chukchis some 5,500 years ago, according to genetic calculations, implying that the Saqqaq people’s ancestors must have traveled across the northern edges of North America until they reached Greenland.
The team, led by Morten Rasmussen and Eske Willerslev of the University of Copenhagen, decoded the genome from four tufts of hair dug out of the permafrost at Qeqertasussuk, on the west coast of Greenland. The hair was excavated in 1986 and kept in a plastic bag in the National Museum of Denmark. It was found with other waste, and the scientists speculate that it was the result of a haircut.
There it moldered, unfrozen, until discovered by Dr. Willerslev, an expert on ancient DNA. Having spent two months digging for ancient human DNA in Greenland without finding any human remains, he concluded that ancient Greenlanders must have disposed of their dead by laying them on the sea ice. Only on complaining of his bad luck to a friend did he learn that the friend’s father had found the hair sample 20 years earlier.
No traces of the Saqqaq people have been found in North America, said Michael H. Crawford, an expert on circumpolar populations at the University of Kansas and a co-author of the report. Because the land bridge that once connected Siberia and Alaska had long since foundered, the Saqqaq people might have crossed to Alaska on the winter ice or could have used the boats on which they hunted fish and seals. They evidently kept to Arctic latitudes, perhaps because more southerly regions were already occupied by the Inuit, or because they were better adapted to life in the Arctic, Dr. Rasmussen said.
The Saqqaq man’s genome is so complete that the Danish researchers have been able to reconstruct his probable appearance and susceptibility to disease from the genetic information in his genome. They conclude that he would have had brown eyes because of variations, at four positions along his DNA, that are associated with brown eye color in East Asians.
He has the East Asian version of a gene known as EDAR, which endows people with hair that is thicker than that of most Europeans and Africans. Another gene suggests that he would have had dry earwax, as do Asians and Native Americans, not the wet earwax of other ethnic groups.
Perhaps reflecting the so far somewhat limited reach of personal genomics, the researchers note that the ancient Greenlander was at risk for baldness, a surprising assessment given that all that remains of him is his hair. Dr. Rasmussen said he assumed the man died young.
Biologists used to think that DNA would be found only in the cells at the roots of the hair, not in the keratin of which the hair shaft is made. But it now seems that the cells become incorporated into the growing shaft and their DNA is sealed in by the keratin, protecting it from attack by bacteria and fungi.
The Danish researchers, using an advanced DNA sequencing technology developed by Illumina of San Diego, reported that they were able to decode 80 percent of the ancient Greenlander’s genome to a high degree of accuracy. Their findings appear in the journal Nature.
An ever present danger in analyzing ancient human DNA is contamination, particularly from modern human DNA from all the archeologists and curators who have touched the samples. The Danish researchers said they took precautions to exclude this and other contaminants, and they seem to have succeeded.
maybe that means take it from whom it comes
maybe of a reputable outfit like Biomed reports (ME Garza)put it out the stock would have reacted
Onyx brings in former Nuvelo boss to lead growing R&D unitSan Francisco Business Times - by Ron Leuty
Someone at ONYX must love Love
Former Nuvelo Inc. CEO Dr. Ted Love will head Onyx Pharmaceuticals’ growing research and development unit.
Love will oversee a growing cache of preclinical and clinical programs as well as regulatory affairs, safety, and quality assurance and control at Emeryville-based Onyx. That includes Onyx’s cancer-fighting proteasome inhibitors, which it picked up in the November acquisition of Proteolix Inc.
Proteolix’s proteasome inhibitor, named carfilzomib, is in a Phase IIb trial for relapsed, refractory multiple myeloma.
Dr. Michael Kauffman, who came to Onyx as part of the Proteolix deal, was named chief medical officer, reporting to Love. Kauffman had been interim chief medical officer and was chief medical officer at Proteolix and from 2002 to 2008 was president and CEO of Predix Pharmaceuticals Inc., now EPIX Pharmaceuticals Inc.
Love is Onyx’s first head of R&D since a restructuring about seven years ago. The company has focused on development and marketing of its cancer drug Nexavar with pharmaceutical giant Bayer but under CEO Dr. N. Anthony Coles it has gone the route of licensing and acquisition to deepen its portfolio of cancer drugs.
Onyx spent $92 million on R&D in the first nine months of last year, including half of the development costs for Nexavar, and $123.7 million for full-year 2008.
Coles called Love a “strategic thinker” with a track record of developing successful cancer therapies. “We were looking for someone with extraordinary leadership and deep R&D experience,” Coles said.
At Genentech Inc., for example, Love was vice president of product development and regulatory affairs, overseeing development of Herceptin and Rituxan, now two of Genentech’s top-selling drugs.
Love was CEO of San Carlos-based Nuvelo when its blood-thinning drug alfimeprase, a stroke treatment also aimed at improving catheter function, in December 2007 failed a mid-stage trial. Nuvelo also was developing cancer drugs.
Nuvelo in January 2009 completed a reverse merger with ARCA Biopharma Inc. of Broomfield, Colo., that took ARCA public and gave it access to abot $60 million in Nuvelo cash and securities.
rleuty@bizjournals.com / (415) 288-4939
From Alex To -- AMGN: Could There Be a D-mab Commercial Strategy Centered on Cancer SRE?
maybe amgen stays out of osteoporosis market to increase pricing in the cancer market
• Amgen announced yesterday after the market close the top-line results of the third
and last of the 3 pivotal Phase 3 trials of D-mab in the cancer skeletal-related event
(SRE) trial. The study investigated the drug's ability to minimize fractures in cancer
patients with bone metastases. Like the two successful Phase 3 trials presented before,
this trial (in prostate cancer patients) demonstrated that D-mab is efficacious in this
setting. The drug demonstrated statistically superior results in lowering the number of
SREs as compared to Zometa, the most commonly used the drug in this setting. The
superiority is consistent when measured in the time to first event while on drug or in
the number of multiple fractures.
• One adverse event that is numerically more prevalent in this trial, as was the case
in the 2 previous pivotal trials, is osteonecrosis of the jaw (ONJ). While the higher
incidence of ONJ, no doubt, will be exploited by Novartis in defense of Zometa, we don't
think ONJ alone will be a killer of the drug in the regulatory sense. The devil will be
in the details. The most likely hold-up in the regulatory process, if there is one, will
still be any red flag relative to the incidence or progression of existing cancer. The
red flags could be from the pooled analysis of all of the D-mab trials to date. So, we
may not ascertain if there is any issue until we see the briefing documents for the
advisory panel meeting. Assuming Amgen files in 2H10, we will not get clarity until 2H11.
The cancer red flag which haunted D-mab in its osteoporosis panel can also be raised
again when a regulatory decision is due for the SRE indication.
• However, based on what we have seen so far, D-mab is clearly the best in the cancer
SRE market segment in terms of efficacy. Assuming the company successfully navigates
through the regulatory process and gets a clean label for the SRE indication, wouldn't it
be possible to construct a commercial strategy centered on cancer SRE, with peripheral
considerations for the osteoporosis market? In other words, if Amgen maximizes the
pricing of D-mab in cancer SRE, even to the point that the price is too high and not
competitive in osteoporosis market, Amgen may still maximize the overall commercial
potential for D-mab. With the difficulties Amgen encountered in the osteoporosis label in
front of both the FDA and EMEA, it is not certain how big the drug would be as a
treatment for osteoporosis even if Amgen prices competitively for that market and is
consequently price constrained in the cancer SRE market.
Alex To, MD
Managing Member
Cross Current Research, LLC
2 Research Way, 2nd Floor
Princeton, NJ 08540
609-243-0082 (office)
917-584-6903 (cell)
alex.to@crosscurrentllc.com
https://www.crosscurrentllc.com
thank you rkrw
I sold almost all of my chemgenx stock at about the time they announce their partnership. I would have kept a lot more had it not been for the warnings from you.
We are in an economy that was growing at the rate of almost 6 percent of GDP in the fourth quarter of last year
Except for Volker and Gates, all of Obama's braintrust is made of of people that are even further left than he is. Is it any wonder that he is doing things the way he is. You can't get impartial advice when everyone around you is drinking the same spiked Kool Aid that you are.
The female condom Making the world a better place
New female condom raises sexual libido
Thursday, 17th December, 2009 E-mail article Print article
The new female condom
http://www.newvision.co.ug/D/8/13/704629
By Charles Ariko
A NEW brand of female condoms that was introduced in the country for a pilot study, has been found to increase sexual libido among its users.
The condom that was introduced in 2007 to replace the one that was introduced in 2000, has been reported to be more user-friendly and increase sex libido.
Unlike the older condom that was made of latex, the new one is made of artificial rubber and does not make noise during sexual intercourse.
Vasta Kibirige, the condom focal person in the Ministry of Health, yesterday said the new condom was introduced with improved features following complaints that the first type was noisy, smelly and irritable.
Presenting a paper on female condom experiences by Most At Risk Populations Initiative (MARPI), Janeva Busingye, the project coordinator at Mulago Hospital, said the feedback by some users was that the new condom was better than the first.
She told stakeholders attending a meeting on the re-introduction of the female condom at Imperial Royale Hotel in Kampala, that the users reported difficulties in inserting the condoms for the first time.
“The feedback we got was that the new condom is well lubricated and can be used even when a partner is drunk since the woman is in control,” Busigye said.
She said most of the clients who were sampled were commercial sex workers from Kisenyi, Bwaise and Mbuya.
Programme for Accessible Health Communication and the United Nations Population Fund are spearheading the re-introduction of the female condom in the country.
They are currently carrying out a study for the re-introduction of the condom in Kampala, Pader and Kitgum districts.
from Wells Fargo **Today, Protalix, and partner Pfizer, announced that the FDA has requested additional data regarding the Chemistry, Manufacturing and Controls (CMC) section of the New Drug Application (NDA) for Uplyso (taliglucerase alfa) for the treatment of Gaucher disease prior to accepting the filing and establishing a PDUFA date. The request centered predominately on validation of the manufacturing process in the company's scaled-up manufacturing facility a process which has been established and reviewed by the FDA. Protalix completed its rolling NDA filing for Uplyso (taliglucerase alfa) on December 9, 2009, suggesting an early June 2009 PDUFA and approval. This delay will likely push approval back until Q4 2010 as Protalix will submit the requested data to the FDA in Q2 2010. This is an incremental positive for Genzyme.
**Protalix's taliglucerase lacked the initial penetration/ capacity (~100 patients) of Shire's velaglucerase. Recall Shire has capacity to treat and 300-600 Gaucher patients in 2009 and up to around a total of 900 in 2010. However, according to a U.S. clinical investigator who treats a wide spectrum of rare genetic disorders and involved in the velaglucerase and GENZ-112638 Ph. III programs; due to the lengthy IRB process, Gaucher patients were not able to access velaglucerase until December thus most waited for Cerezyme. Of 45 Gaucher patients treated at the center, only 3 opted to participate in the Shire program and likley not to return to Cerezyme. The center opted not to participate in the Protalix program (Uplyso). Through conversations with other U.S. colleagues the clinician felt their Gaucher experience was at worse similar to other clinics (i.e., a only few patients switching off Cerezyme for good and some not accessing velaglucerase at all).
***Recall on Monday November 23 Genzyme began shipping Cerezyme. Genzyme released the guidance for the Gaucher community on restarting Cerezyme to treating clinicians on November 24, 2009 outlining basic details on the release of Cerezyme and Genzyme made patients aware of the new product shipments on November 25. Initially, Cerezyme was available for the most vulnerable patients. On December 28, 2009 Genzyme began making Cerezyme available for all patients. This reintroduction enabled Cerezyme to be available for two months prior to the approval of Shire's velaglucerase alfa NDA which has been given a PDUFA of February 28, 2010 and is manufactured using a mammalian vector.
If I was in xoma I would be real upset. the stock was trading at 65 cents and the price a deal at 50cents with warrant
Link to your statement
The company also announced that it has agreed to amend the terms of its outstanding warrants to purchase a total of 11,099,744 common shares, issued in May and June 2009, to eliminate the provisions that would have required reduction of the warrant exercise price and an increase in the number of shares issuable on exercise of the warrants each time the company sold common shares at a price less than the exercise price of such warrants. The exercise price of the May 2009 warrants has also been reduced to $0.001 per share from $1.02. The exercise price of the June 2009 warrants remains unchanged at $1.30 per share.
Ms. Sullivan is Goldenberg's wife
has biomed reports issued something on this?
me garza could account for the volume getting in before his pump.
Under the plan, Dr. Barnhill has elected to sell up to 975,000 shares per quarter of the Company's common stock through December 31, 2010, which is substantially less than the approximately 1,922,000 shares per quarter he would be permitted to sell in compliance with Rule 144, based on the Company's 192,212,845 common shares outstanding as of December 30, 2009. The number of shares included in the 10b5-1 plan represents a fraction of the total shares and options beneficially owned and/or controlled by Dr. Barnhill.
I think there are more warrants out there at about 11 cents as there are shares outstanding
Here is a company that would have gone bankrupt without this NIH grant
this should make people sick. since they are already in the MRI business it would be part of their life cycle management to improve their products. why should a behemoth like GE get a grant like this. They probably filed for the grant to keep it away from a small company that actually could have used the money.
GE gets NIH grant to build a better MRI magnet
Wed, Jan 27 2010
* Plan is to make smaller, easier-to-maintain machines
* Team plans to use newly discovered superconducting wire
By Julie Steenhuysen
CHICAGO, Jan 27 (Reuters) - Researchers at General Electric Co <GE.N> won a $3.27 million grant from the National Institutes of Health to develop a better magnet for MRI machines that will make them cheaper and easier to use in underdeveloped nations, the company said on Wednesday.
The aim is to make an electromagnetic coil that will deliver the same quality of images produced on current magnetic resonance imaging or MRI machines without the need to be kept at ultra-cool temperatures.
The need for a large vessel of liquid helium inside the machines for cooling is one reason MRI machines are so big and costly.
Kathleen Amm, lab manager at GE Global Research in Niskayuna, New York, said her team aims to eliminate the need for liquid helium. To do that, they plan to replace the coils of niobium-titanium superconducting wire used in its current magnets with magnesium diboride, a new superconductor discovered in 2001.
Amm would not say exactly what the company will use to keep the system cool, but she said, "It's a lot easier to deal with."
The company's GE Healthcare unit is a key player in the estimated $5.5 billion MRI equipment market, along with Siemens Medical Solutions <SIEGn.DE> and Philips <PHG.AS>.
Amm said GE is working on the project now in anticipation of future shortages of liquid helium, a limited resource that comes from natural gas wells.
Getting rid of the liquid helium will allow the group to build smaller MRI machines, and allow the company to place the machine in underdeveloped countries that have limited access to liquid helium. All that will be needed is electricity.
Minfeng Xu, a researcher in Amm's lab who is heading up the project, said the new niobium-titanium superconductor will likely be cheaper because the raw materials cost will be less.
The group is starting on a four-year research project that will culminate in a prototype magnet.
(Editing by Cynthia Osterman)
© Thomson Reuters 2010. All rights reserved. Users may download and print extracts of content from this website for their own personal and non-commercial use only. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters. Thomson Reuters and its logo are registered trademarks or trademarks of the Thomson Reuters group of companies around the world.
Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
This stock is set to explode on Bioterror threat/hype. It's been irrationally oversold.
how about explode and bioterror for a combo
Gene discovery may help guide breast cancer care
1:00pm EST
* Abnormality in 2 genes makes chemotherapy less effective
http://www.reuters.com/article/idCNN2417447620100124?rpc=44
* Findings could be used to tailor treatment
By Julie Steenhuysen
This is one of the most important articles I have seen in a long time
CHICAGO, Jan 24 (Reuters) - An abnormality in two genes can make a common class of chemotherapy drugs used to fight breast cancer less effective, U.S. researchers said on Sunday in a finding that could help doctors better tailor treatments.
They said changes in two genes on a small region of chromosome 8q made tumors resist the effects of drugs called anthracyclines, but not other types of chemotherapy drugs.
"This is useful because it helps select who might be resistant to anthracyclines," said Dr. Andrea Richardson of the Dana-Farber Cancer Institute in Boston, whose study appears in the journal Nature Medicine.
"This can potentially be used to help guide therapy on a more personalized way based on a patient's own tumor. That's why it's exciting," Richardson said in a telephone interview.
She said it may be possible to develop a genetic test to better tailor treatments to a patient's individual tumor.
Doctors already can test for certain genes to tell whether a woman's breast cancer is sensitive to estrogen, making her a candidate for hormone-blocking drugs such as tamoxifen.
Breast cancer patients whose tumors generate a protein called HER-2, which can fuel cancer growth, are often treated with Herceptin, or trastuzumab, a drug developed by Genentech, now a unit of Roche Holding AG <ROG.VX>.
Last month, a study presented at the American Association for Cancer Research San Antonio Breast Cancer Symposium found that a gene-based test called Oncotype DX made by Genomic Health Inc <GHDX.O> helped identify women who are not likely to benefit at all from chemotherapy.
WHICH DRUG WORKS BEST
But Richardson said there were no tests to help doctors sort out which chemotherapy drug is best to use after surgery.
"In breast cancer, most patients get two or three types of chemotherapy and every patient gets basically the same thing. Those drugs have their own toxicities. It would be great if we could not give something that is going to be toxic and not effective," she said.
For the study, Richardson, colleague Zhigang Charles Wang and others studied the DNA of breast tumor samples taken from 85 patients before they had any chemotherapy.
In tumors that turned out to be drug-resistant, the team found a region on chromosome 8 that had many extra or amplified copies of DNA stretches.
When two genes in this region called LAPTM4B and YWHAZ were overexpressed -- working too hard -- the tumors were resistant to anthracycline drugs.
Tests on cells in the lab confirmed that.
Using data from a Belgian study in which breast cancer patients were first treated with chemotherapy drugs including anthracyclines before their tumors were removed, the team accurately predicted that patients who had the abnormal gene signature would fare poorly with anthracycline drugs.
"We were able to test in a blinded way. The expression level of those genes predicted who would be resistant to the anthracycline. That validated the finding in a very direct way," Richardson said.
Richardson said the team was now testing three different approaches to developing a genetic test for this problem.
"Hopefully, we'll be able to develop an assay within the next year or so. We'd need to test it in a larger number of patients to confirm that our findings hold up," she said. (Editing by Vicki Allen)
© Thomson Reuters 2009. All rights reserved. Users may download and print extracts of content from this website for their own personal and non-commercial use only. Republication or redistribution of Thomson Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters. Thomson Reuters and its logo are registered trademarks or trademarks of the Thomson Reuters group of companies around the world.
Thomson Reuters journalists are subject to an Editorial Handbook which requires fair presentation and disclosure of relevant interests.
Further, some patients (I think about 20%) that were initially classified non-responders in the phase III trial, later met responders criteria at one year in the extension study.
as a general rule, I think you would agree that in an extension study everyone knows they are getting the drug so there is a placebo effect and the results are a lot better than the trial. That is why the extension study is used to get additional safety data
Radiation Offers Cures—And Ways to Harm
This is an important article for people to read. I do not know how it can be prevented but people should know that exposure to radiation should never be considered riskless
Poniard needed the small cell lung cancer trial to work.
If that would have worked the sales in that market would have paid for the trials in other indications, so the company or partner would have had much less risk in advancing into other indications because they would have been internally funded
Poniard picked up this drug from big pharma, I believe GSK. The data in colon cancer wasn't as good as I thought it would be in fact the pfs in the soc arm outperformed their drug. The side effects are less. It will cost a lot of money to run a survival trial in the indication and if the survival is equal but they show lower neuro side effects but higher blood based side effects how is a decision made to approve the drug.
I wrote the above and below info before seeing the Overall survival was lower on the Pico arm. The purpose of running this trial was supposed to support the notion that since there were fewer neurological side effects the patients could stay on the active arm longer and the survival would improve. That obviously didn't happen.
I think there prostate cancer data is a lot better than the colon cancer data but by then Cougar's drug, now J and J or Medivation's drug will probably be approved so they would have to have data against those two drugs or after patients have relapsed those drugs before it could be approved.
I am surprised that the stock isn't trading at 10 cents. If the trial had failed in 2008 instead of 2009, that is where it would have been trading.
Some of you may be saying, how can I make these statements? My wife is on compounded 4AP. I have observed my wife benefiting within hours of the first dose across a wide range of deficits.
then I would say she is a responder. You can't escalate that to the claims that it will help everyone
my last post on this. as my responses serve no purpose in this thread
you take too much tylenol - so give me a break. also your assumption on responders is way off for real world scenarios (as evidenced by the retention rates for all comers in the extension trials - which include even "non-responders" from the trials
can you explain to me why a non responder from the trial would take the drug. It does nothing to delay the progression of the disease or reduce pain. Please tell me why in the world they are on it.
ACOR - There is a lot of doubts surrounding Fampridine which is surprising to me. The clinical studies clearly show that the drug works in 30 - 40% of MS patients.
it doesn't work in 30 to 40 percent, maybe 20percent
Other drugs slow the disease progression, but this one actually improves their functional abilities.
this doesn't even slow the disease progression, it only helps them walk faster. Is that a good reason to take bird poison that can cause seizures.
The only way to determine whether the drug works is to try it & once their on it I doubt they will be taken off no matter if no improvement is actually shown.
if they don't improve why would they stay on, unless they are Acorda shareholders? It doesn't even make them feel better
The label does not require that an improvement be shown or limit the duration on drug.
I believe the 7% royalty to ELAN you referred to in a previous message is for manufacturing the drug. ELAN supplies the drug for US and ex. Total milestones to ELAN are $15 million.
70 percent of patients with gait problems
I believe the study has shown that the drug only has an effect in 25 percent of the patients that were in the trial, so the 70 percent should get multiplied by 25 percent, and then figure out the percent of that market that they will be able to get, to use the bird poison.
achn
you actually worry too much about dilution.
If they raise a lot of money the stock will be able to go up because they will have enough money to progress the drugs further. If the drugs show good results the Hep C market is big enough to maintain a high market cap.
The writing was on the wall that this financing was going to get done. I do mot know why the didn't do a quick deal when the stock was in the three's
Dew, I see that you are saying that they attempted to get the deal done in the three's. I am not so sure about that
isph
I guess they only hold conference calls when the drug works.
INSPIRE ANNOUNCES RESULTS OF PHASE 3 PROLACRIA(TM) TRIAL FOR DRY EYE
- Primary and Secondary Endpoints Not Met -
DURHAM, NC - January 21, 2010 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH)
announced today that its Phase 3 clinical trial (Trial 03-113) of
PROLACRIA(TM) (diquafosol tetrasodium ophthalmic solution) 2% for the
treatment of dry eye disease did not meet its primary endpoint (p = 0.526)
or its secondary endpoint (p = 0.368).
"We have provided the top-line results from this trial to our partner
Allergan and we will be conducting a thorough review of the program before
determining next steps, if any," stated Christy L. Shaffer, Ph.D., President
and CEO of Inspire.
Trial 03-113 was a six-week, randomized, placebo-controlled trial in 490
patients who had a fluorescein staining score of three in the central region
of the cornea at baseline, using the National Eye Institute scale of zero to
three. The primary endpoint was the proportion of subjects receiving
PROLACRIA, administered four times daily as eye drops, that achieved
clearing, or a staining score of zero, in the central region of the cornea
in the study eye at the six-week trial endpoint, compared to those receiving
placebo. The secondary endpoint was the proportion of patients receiving
PROLACRIA that achieved greater than or equal to a two-unit reduction in
staining scores at the six-week trial endpoint, compared to those receiving
placebo.
About Inspire
Inspire is a biopharmaceutical company focused on researching, developing
and commercializing prescription pharmaceutical products for ophthalmic and
pulmonary diseases. Inspire's goal is to build and commercialize a
sustainable portfolio of innovative new products based on its technical and
scientific expertise. The most advanced compounds in Inspire's clinical
pipeline are PROLACRIA(TM) (diquafosol tetrasodium ophthalmic solution) 2%
for dry eye and denufosol tetrasodium for cystic fibrosis, which are both in
Phase 3 development, and AZASITE(R) (azithromycin ophthalmic solution) 1%
for blepharitis, which is in Phase 2 development. Inspire receives revenues
related to the promotion of AZASITE for bacterial conjunctivitis, the co-
promotion of ELESTAT(R) (epinastine HCl ophthalmic solution) 0.05% for
allergic conjunctivitis and royalties based on net sales of RESTASIS(R)
(cyclosporine ophthalmic emulsion) 0.05% for dry eye. For more information,
visit www.inspirepharm.com.
Forward-Looking Statements
The forward-looking statements in this news release relating to management's
expectations and beliefs are based on preliminary information and management
assumptions. Specifically, no assurances can be made with respect to: the
timing or outcome of the review of our PROLACRIA program, including the
determination of next steps, if any. Such forward-looking statements are
subject to a wide range of risks and uncertainties that could cause results
to differ in material respects, including those relating to product
development, revenue, expense and earnings expectations, the seasonality of
ELESTAT, intellectual property rights, competitive products, results and
timing of clinical trials, success of marketing efforts, the need for
additional research and testing, delays in manufacturing, funding, and the
timing and content of decisions made by regulatory authorities, including
the U.S. Food and Drug Administration. Further information regarding factors
that could affect Inspire's results is included in Inspire's filings with
the SEC. Inspire undertakes no obligation to publicly release the results of
any revisions to these forward-looking statements that may be made to
reflect events or circumstances after the date hereof.
###
Investor Contact:
Inspire Pharmaceuticals, Inc.
Thomas R. Staab, II
Chief Financial Officer and Treasurer
(919) 941-9777, Extension 267
Media Contact:
Inspire Pharmaceuticals, Inc.
Cara Amoroso
Manager, Corporate Communications
(919) 941-9777, Extension 266
Inspire Pharmaceuticals, Inc.
4222 Emperor Blvd., Suite 200
Durham, N.C. 27703
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Osteologix Inc. Announces Plans to File for European Marketing Authorization for Proprietary Osteoporosis Drug
this drug could be approved in 2012 in Europe. That is pretty unbelievable. It has better biovailability than the drug that is selling over 300 million dollars a year. And this is a once a day pill as opposed to a sachet. that is a big deal
Companies:Osteologix, Inc.
Press Release Source: Osteologix Inc. On Wednesday December 9, 2009, 8:15 am EST
GLEN ALLEN, Va.--(BUSINESS WIRE)--Osteologix Inc. (OLGX.OB) announced today that the company anticipates that it will be prepared to file a marketing application in 2011 in the European Union for its proprietary second-generation strontium therapy, NB S101 (strontium malonate). If successful, this will be Osteologix' first marketing approval of NB S101 for the treatment of postmenopausal osteoporosis.
Following the successful completion of the company's initial Phase 2 study comparing NB S101 (strontium malonate) to Protelos® (strontium ranelate), which is marketed by Les Laboratoires Servier (Servier), Osteologix sought feedback on its development program from various regulatory authorities. As a result of these discussions, Osteologix has determined that the company will be positioned to pursue a European Marketing Application for NB S101 as a treatment for post-menopausal osteoporosis. The company expects that it can complete the additional development work in 2010 and will be prepared to file a marketing application during the first half of 2011. This pathway is in keeping with the Company's overall strategy of developing its once-daily strontium tablet for the osteoporosis market. Osteologix has initiated discussion with potential regional and global partners and believes that the selected partner(s) will be able to begin marketing the novel product by 2012, providing them with at least 12 years of patent protection in the European Union.
"Following the regulatory meetings, we now believe we are well positioned to leverage our existing data package combined with new clinical data that we expect to generate in the next year to obtain European approval for our lead product. Our strategy to obtain approval for NB S101 is in keeping with current regulatory directives," said Philip J. Young, President and CEO of Osteologix. Young continued: "We are well on our way to achieving a significant milestone for Osteologix and our stakeholders. We believe that our product will be a significant addition to the osteoporosis market, and we anticipate that our product will benefit the millions of women with osteoporosis who are in search of a safe and tolerable therapy.”
As previously reported during the 35th European Symposium on Calcified Tissue, the Phase 2 study comparing NB S101 to Protelos demonstrated that NB S101 was safe and well tolerated in the target patient population with the frequency and types of adverse events comparable to those with the active comparator, Protelos (strontium ranelate). NB S101 induced a significant dose-dependent reduction in bone resorption relative to placebo. In addition, all three doses of NB S101 significantly increased bone mineral density (BMD) as measured at the total hip and lumbar spine.
Strontium ranelate, marketed in Europe since 2004 by Servier as Protelos or Osseor®, is the only prescription strontium-based therapy for the treatment of osteoporosis. This year the product is projected to reach sales of more than $300 million, with approximately 80% of this revenue being generated in Europe. Unlike Protelos (strontium ranelate), which is formulated as a powder and packaged in a sachet, NB S101 (strontium malonate) is manufactured as a tablet. Young further states, "We believe our tablet will be preferred over a powder formulation, and should rapidly garner significant market share. We expect the overall strontium market to grow as NB S101 establishes itself as a viable alternative for the treatment of osteoporosis.”
About Osteologix
Osteologix develops proprietary therapeutics for the treatment of unmet medical needs in bone disease and women's health. The Company's lead product, NB S101, is being evaluated in a phase II clinical trial for the treatment of osteoporosis. Based on the Company's own data as well as data from phase III clinical trials conducted on a similar drug that is approved for sale in Europe, Osteologix believes that NB S101 increases formation of new bone and decreases loss of existing bone. Osteologix further believes that NB S101 will provide patients with greater convenience and fewer side effects than drugs currently approved for osteoporosis in the United States, Europe and elsewhere. For more information please visit, www.osteologix.com.
Forward Looking Statements
Certain of the statements set forth in this press release constitute "Forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may" "project," "plan," "will," "should," "could," "would," or words or expressions of similar meaning, including without limitations statements about Osteologix’ plans for regulatory approval of NB S101, clinical trial plans, uses and benefits of NB S101 and plans to enter into an agreement with a global or regional partner for the development and commercialization of NB S101. All such forward looking statements involve risks and uncertainties, including, but not limited to Osteologix’s ability to: enroll and conduct required clinical trials to support regulatory approval of NB S101, obtain regulatory approval for NB S101, raise additional capital necessary to fund its clinical trials and operations; maintain, protect and enforce its intellectual property rights; identify and negotiate agreements with third parties for the continued development and commercialization of NB S101 and retain and hire key personnel. Additional risk and uncertainties include the identification of potential adverse side-effects or toxicities involving NB S101, the effect of competition and proprietary rights of third parties and other factors affecting the health care industry in general, including pricing pressure and regulatory and reimbursement changes. There can be no assurance that such forward-looking statements will prove to be accurate and Osteologix undertakes no obligation to update any forward-looking statements.
Contact:
Osteologix Inc.Investor and Media Contact:Baxter Phillips, IIISr. Director, Corporate Development804.747.6026