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GORX.....The plot thickens. I hope nobody bet the farm.
http://www.thestreet.com/_yahoo/comment/adamfeuerstein/10196897.html?cm_ven=YAHOO&cm_cat=FREE&am...
Dew,
What do you think of the following idea... Levitt and GENR are positioning Squalamine to be a monthly or bi-monthly nasal spray/pill that would be taken by all people starting at some age (say 30 and over) that will prevent future Wet AMD. If the 10mg has no long-term side effects, all people could take this monthly dosage and thus approx. no one would ever have to face Wet AMD. This market would seem to be massive relative to the current AMD market.
Also, based on all of your concerns why would institutional investors be willing to invest $13 million in GENR?
Let me know what you think.
Thanks,
10nis
DEW - Why don't you call Dr. Levitt personally or Investor Relations and talk to them about your concerns below. I see no reason why they/he wouldn't talk to you about this. Also, do you think GENR's top management/investor relations reads this board? Thanks to everyone for all of their posts about the R&R presentation....10nis
>> we are toying around with ruminating (about dosing frequencies) before we indeed know the scientific proof of Squalamine’s probable efficacy. <<
We are discussing the dosing frequency and possible subcutaneous administration because Dr. Levitt mentioned these matters in his talk. Our job is to figure out why he did, and I don’t think we have a convincing answer yet.
Dew,
When I was talking about the Homeland Investment Act (HIA), which is current in the ETI replacement legislation and I believe Barron's has an article on the act in its latest edition (10.18.2004), I was referring to the legislation that would allow U.S. companies to repatriate foreign earnings back into the U.S. at a reduce rate of 5%. The significance of the legislation is it allows companies to repatriate up to $500 million at the reduce rate of 5% (compared to the typical 35% corporate rate), however, the repatriated funds must be reinvested within the next taxable year (essentially reinvested sometime in 2005). JPM came out with a research report estimating the potential repatriation of the S&P 500 companies at nearly $400 billion. They believe the act could boost GDP by one-half percent and lead to a 2-3% increase in the national level of capital spending.
The strongest supporters have been large-cap manufacturing and the following pharmaceutical companies: BOL, LLY, GDT, JNJ, MRK, SGP, WYE.
Both the House and Senate have approved the act so its currently waiting approval by the President. Experts predict no matter who's President (Bush or Kerry) they will approve the act. Hopefully the passing of this act will encourage big pharma to open up their wallets and strike some lucrative partnership deals with the GENR's of the world.
Dew, what's your take on ACL? Do you think they have GENR on speed dial?
10nis
Dew,
Have you thought about what kind of impact the Homeland Investment Act (HIA) could have on small biotech companies like GENR (if the passed it into law.) Large-cap Pharma (BOL, MRK, SGP, JNJ, LLY) have been the biggest supporters of the Act and should be some of the largest beneficiaries of the Act. IMO, the passing of the Act will increase the number of lucrative big-pharma partnership deals in the upcoming tax year.
10nis
ADSX LOOKS INTERESTING........
Press Release Source: Applied Digital
CORRECTING and REPLACING FDA Clears VeriChip for Medical Applications in the United States
Wednesday October 13, 10:33 am ET
DELRAY BEACH, Fla. & SOUTH ST. PAUL, Minn.--(BUSINESS WIRE)--Oct. 13, 2004--In BW5418 issued Oct. 13, 2004: (Second graph, domestic conference call number should read (800) 472-8309, sted (800) 472 9309
ADVERTISEMENT
The corrected release reads:
FDA CLEARS VERICHIP FOR MEDICAL APPLICATIONS IN THE UNITED STATES
Applied Digital (NASDAQ: ADSX - News), a provider of Security Through Innovation(TM) and Digital Angel Corporation (AMEX:DOC - News) announced today that VeriChip(TM), the world's first implantable radio frequency identification (RFID) microchip for human use, has been cleared by the U.S. Food and Drug Administration (FDA) for medical uses in the United States. The FDA clearance follows the completion of a de novo application review.
The Company will hold a conference call today at 10:30 am eastern time in order to discuss the FDA's decision, Company's marketing strategy and medical applications for VeriChip. Interested participants should dial (800) 472-8309. The conference ID is 1531948. International callers should dial (706) 643-9561 and use the same conference ID. The call will also be webcast and will be available on the Home Page of Applied Digital's web site at www.adsx.com.
As previously disclosed, the FDA response is the result of the Company's 510(k) application and subsequent de novo application for the medical and healthcare uses of VeriChip, originally submitted in October 2003. Digital Angel Corporation is the manufacturer of VeriChip and has licensed the technology to VeriChip Corporation, a wholly owned subsidiary of Applied Digital, for human applications.
The VeriChip Health Information Microtransponder System consists of an implantable RFID microtransponder, an inserter, a proprietary hand-held scanner, and secure database containing the patient approved healthcare information. About the size of a grain of rice, VeriChip is a subdermal radio frequency microchip. Once inserted under the skin in a brief outpatient procedure, the VeriChip cannot be seen by the human eye. Each VeriChip contains a unique 16-digit verification number that is captured by briefly passing a proprietary scanner over the insertion site. The captured 16 digit number links to the database via encrypted Internet access. The previously stored information is then conveyed via the internet to the registered requesting healthcare provider.
About VeriChip(TM)
VeriChip is a subdermal RFID device that can be used in a variety of security, financial, emergency identification and other applications. About the size of a grain of rice, each VeriChip product contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. The recommended location of the microchip is in the triceps area between the elbow and the shoulder of the right arm. The brief outpatient "chipping" procedure lasts just a few minutes and involves only local anesthetic followed by quick, painless insertion of the VeriChip. Once inserted just under the skin, the VeriChip is inconspicuous to the naked eye. A small amount of radio frequency energy passes from the scanner energizing the dormant VeriChip, which then emits a radio frequency signal transmitting the verification number. In October 2004, the U.S. Food and Drug Administration (FDA) cleared VeriChip for medical applications in the United States. VeriChip is not an FDA-regulated device with regard to its security, financial, personal identification/safety applications. VeriChip Corporation is a wholly owned subsidiary of Applied Digital.
About Applied Digital
Applied Digital develops innovative security products for consumer, commercial, and government sectors worldwide. Our unique and often proprietary products provide security for people, animals, the food supply, government/military arena, and commercial assets. Included in this diversified product line are RFID applications, end-to-end food safety systems, GPS/Satellite communications, and telecomm and security infrastructure, positioning Applied Digital as the leader of Security Through Innovation(TM). Applied Digital is the owner of a majority position in Digital Angel Corporation (AMEX: DOC - News). For more information, visit the company's website at http://www.adsx.com.
About Digital Angel Corporation
Digital Angel Corporation develops and deploys sensor and communications technologies that enable rapid and accurate identification, location tracking, and condition monitoring of high-value assets. Applications for the Company's products include identification and monitoring of pets, fish, livestock, and humans through its patented implantable microchips; location tracking and message monitoring of vehicles and aircraft in remote locations through systems that integrate GPS and geosynchronous satellite communications; and monitoring of asset conditions such as temperature and movement, through advanced miniature sensors.
For more information about Digital Angel, visit the company's website at www.DigitalAngelCorp.com.
Statements about the Company's future expectations, including future revenues and earnings, and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and the Company's actual results could differ materially from expected results. The Company undertakes no obligation to update forward-looking statements to reflect subsequently occurring events or circumstances.
--------------------------------------------------------------------------------
Contact:
CEOcast, Inc. for Applied Digital
Ken Sgro, 212-732-4300
ksgro@ceocast.com
or
Allen & Caron Inc. for Digital Angel Corporation
Investors:
Mike Lucarelli, 212-691-8087
m.lucarelli@allencaron.com,
Media:
Len Hall, 949-474-4300
len@allencaron.com
Dew,
When you say your officially concerned, what does that mean? Concerned enough to sell some shares? Are you concerned about all the Phase II trials or just about the combo-trial?
TIA,
10nis
Dew,
I'm glad you think so highly of the University of Wisconsin. I'm a UW alumni w/an undergraduate and graduate degree (both in Accounting.) I'll definitely ask around and see if I know anybody participating in the study as I know a few people in the Madison area that have some form of AMD. I'll let you know if I hear of anyone participating in the study.
Take Care,
10nis
(OT) Article from the latest ONline Wisconsin - September Issue.
Discovery may halt progression of Alzheimer's
(Posted: 9/2/2004)
Aaron Conklin
In a finding that may cause a dramatic shift in the way scientists and researchers search for a therapy for Alzheimer's disease, a team of researchers led by Jeff Johnson, an associate professor at the School of Pharmacy, has discovered that increased expression of a protein called transthyretin in the brain appears to halt the progression of the disease. The findings appear in the current issue of The Journal of Neuroscience.
"This work shows convincingly that if we can intervene in Alzheimer's pathology by introducing molecules and drugs into the brain and increase transthyretin levels, we could slow the progression of the pathology," says Johnson, who co-authored the report with Thor Stein, a former graduate student in UW's M.D./Ph.D. program who performed most of the experiments. "Even if patients have plaque formation in the brain, they still could have normal function."
For years, researchers have focused on creating an animal model that mimics the pathology of Alzheimer's disease to test potential therapies. By genetically engineering mice to express mutated genes from the families of patients with early-onset Alzheimer's disease, researchers produced several mouse lines that over-express the human amyloid precursor protein (APP), a protein involved in the disease development. While the mice developed plaque formation in their brains, they didn't develop the other hallmark of Alzheimer's disease -- neurofibrillary tangles, a leading indication that neural cells are dead or dying.
Most researchers noticed this and continued to search for a way to create the perfect mouse model. Johnson had a different thought.
"I said to myself, everybody is trying to kill neurons in mice to create the Alzheimer's pathology," he explains. "And here we have a mouse that has amyloid deposition and plaques yet no neurons are dying. Let's try to figure out why these mice aren't getting the disease."
The answer was surprising, and could completely alter the way researchers think about treating Alzheimer's disease.
Johnson's research is based on the widely held amyloid hypothesis: When amyloid precursor protein (APP) is cut into pieces in the human brain, there are "good" cuts - proteins that help to protect neurons - and "bad" cuts, toxic beta-amyloid protein that, when present in large amounts, causes massive neural cell death, leading to cognitive function loss. In Alzheimer's patients, "bad-cut" proteins significantly outnumber "good cut" proteins.
Stein, under Johnson's supervision, analyzed the brains of the mice with plaque formation, and noticed something interesting: The levels of a pair of specific proteins, transthyretin and IGF-2, increased dramatically. Since transthyretin had been shown in test tubes to bind to the toxic beta-amyloid protein, Johnson and Stein hypothesized that in the mice, the transthyretin was preventing the "bad cut" toxic beta-amlyoid protein from interacting with the neuronal cells, thereby preventing tangle formation and subsequent neuronal cell death.
"Somehow, the adapted mechanism in the mice was due to the balance between the good cut and the bad cut," says Johnson. "The good cut product was causing the increase in transthyretin, which was balancing the toxicity of the beta-amyloid, or bad-cut protein."
Further experimentation bore out their theory. When Stein introduced an antibody into the mouse brain that prevented transthyretin from binding with beta-amyloid protein, the mice developed early signs of neurofibrillary tangles and increased neuronal cell death. Johnson and Stein verified that this "good" cut product has similar protective effects in human brain tissue in vitro. The latter finding is particularly significant.
"If we couldn't show that, we wouldn't have known if this protective mechanism is as relevant to humans as it was to mice," Johnson explains.
The next question - and it's a big one - involves developing a reliable method to deliver transthyretin into the brain, or developing drugs that increase transthyretin expression in the brain to combat the neurotoxicity of beta-amyloid.
"This gives us a great opportunity to identify a new concept in the field that other people and drug companies will pick up on," says Johnson. "Hopefully this will spur a new approach to Alzheimer's disease. Instead of treating the cognitive symptoms, we can actually prevent the loss of the neurons that result in the cognitive symptoms."
Johnson foresees a time when family members with a genetic predisposition to Alzheimer's disease could take a yet-undeveloped drug or molecule to increase transthyretin protein and prevent the disease from developing. It could also theoretically halt the progression of the disease in patients in the early stages of the pathology, preserving a higher level of cognitive function.
The Wisconsin Alumni Research Foundation (WARF) has filed a U.S. patent application on behalf of the chool of Pharmacy on specific protein sequences that confer this protective effect. In the coming months, WARF hopes to begin licensing this technology to drug companies that can begin researching an effective delivery method.
Johnson and Stein believe that these new discoveries may eventually be combined with other therapies to help prevent the progression of Alzheimer's disease.
"What makes this interesting and novel is that nobody has really identified this mechanism for potential therapeutics," Johnson says. "I believe there will be drugs that cross the blood-brain barrier that can be used for Alzheimer's therapy. We'll find those molecules. They may already be out there, but nobody has looked at them in this context."
Johnson and Stein's research was and continues to be funded by the National Institute of Environmental Health Sciences. To view the report in full, visit www.jneurosci.org
Dew - Is there any truth to the recent Yahoo posts regarding the CF Foundation starting a larger Phase II trial for Lomuncin? Here's the link that was posted on the Yahoo message board...
http://www.cff.org/UploadedFiles/Home/HomePageBottomSection/SpecialAnnouncements/CFFTPipeline8-26-04...
Thanks in advance, 10nis
Dew that link does not work as well.
Do you know the time and day of the Hambrecht CC on Phase II?
TIA,
10nis
How about this one...........
Driver: 'Arrest me, I'm drunk'
Wednesday, August 11, 2004 Posted: 8:49 PM EDT (0049 GMT)
This guy was hilarious. And he was very cooperative and polite, unlike your average drunk driver.
-- Ian McCollin, chief of police
BOSTON, Massachusetts (Reuters) -- In this story, it was the drunk driver who pulled over the police officer.
"He pulled up behind me, rolled down the passenger side window and said he was looking for a police officer to arrest him," Ian McCollin, chief of police in Vernon, Vermont, said in an interview on Wednesday. "When I asked him why, he replied 'I'm drunk."'
To make matters worse, the drunk driver was operating on a suspended license, which was taken away after a previous drunk driving charge, McCollin said.
Bryan Condo, 28, was driving on a quiet Vermont road at night when he asked McCollin to take him in. Since drivers rarely pull over police cruisers, a cautious McCollin called a colleague for backup with an amused "You won't believe this one."
"I was a little concerned but I also wanted him to hear the story too," he said. "I was afraid they'd think I was senile or losing my mind."
Police discovered Condo, a resident of North Pownal in Western Vermont, was four times over the legal limit and charged him with driving under the influence as well as driving without a license.
Condo was released hours after his arrest and will be arraigned on August 17. He could not be reached for comment.
"This guy was hilarious," McCollin said. "And he was very cooperative and polite, unlike your average drunk driver."
Thanks Dew for your help w/the messages boards. Definitely send an E-mail to Arlene regarding the GENR omission. Personally, I think Squalamine/GENR deserves to be mentioned. Maybe you can convince her to write up another AMD article including GENR once they start Phase III trials.
I have to admit I love seeing the buying by Osagie and the other directors. Maybe I'm just hopeful however, I get the feeling Osagie has the utmost confidence that GENR will strike a very lucrative partnership deal (partly because he knows how to strike a deal?)
Dew - Any revisions to your prediction on who GENR could/will partner up with? As mentioned earlier, MRK is most likely off the table.
Thanks for everyone's great responses...
Anyone else having trouble retrieving messages from the Yahoo GENR message board? I keep getting the following error:
Sorry!
We can't find the message you've requested. This message may have been deleted or may have expired. You may also want to check the URL and try again.
Merck makes yet another deal....
DOV Pharmaceutical and Merck Announce Agreement to Develop and Commercialize Novel Depression Compounds
Thursday August 5, 4:15 pm ET
WHITEHOUSE STATION, N.J., and HACKENSACK, N.J., Aug. 5 /PRNewswire- FirstCall/ -- Merck & Co., Inc. (NYSE: MRK - News) and DOV Pharmaceutical, Inc. (Nasdaq: DOVP - News) today announced an agreement for the development and commercialization of DOV's novel triple uptake inhibitors being developed for depression and related psychiatric disorders.
Merck has licensed exclusive worldwide rights to DOV 21,947, which is in Phase I, for all therapeutic indications. Merck has also licensed exclusive worldwide rights to DOV 216,303 for the treatment of depression, anxiety and addiction. DOV retains rights to DOV 216,303 for other indications.
Subject to approval under the Hart-Scott-Rodino Act, DOV will receive a $35 million up-front licensing payment. In addition, DOV could receive as much as $300 million for achieving certain clinical development and regulatory milestones for multiple territories and approval of two indications, and up to $120 million upon achievement of certain sales thresholds. Merck will assume responsibility for the full development, manufacturing and commercialization of DOV 21,947 and pay DOV royalties which increase based upon certain sales thresholds. DOV has an option to co-promote in the U.S. to psychiatrists and other specialists who treat depression.
"Merck's premier research and development capabilities, coupled with its extensive sales and marketing resources, make it the ideal partner for our novel depression program," said Dr. Arnold Lippa, President and CEO of DOV. "Our co-promotion right provides DOV with the enhanced ability to build a first-rate, central nervous system-focused sales force in the United States. In addition, the $35 million initial payment and reduced clinical development expenditures will enable us to aggressively pursue our other clinical development programs."
"Merck is pleased to enter this agreement with DOV," said Dr. Peter S. Kim, President of Merck Research Laboratories. "We believe that a triple uptake inhibitor that affects the neurotransmitters norepinephrine, serotonin and dopamine has the potential to offer physicians a real advance in the treatment of depression and related conditions."
Clinical depression is one of the most common mental illnesses, affecting more than 50 million people worldwide each year. Depression is associated with significant loss of functioning and high morbidity. Despite the availability of medicines to treat depression, there is significant unmet medical need because of variable response to therapy or negative drug side effects, causing many patients to report inadequate response or incomplete remission. As a result, novel medicines are needed to provide new options to treat depression.
Serotonin, norepinephrine and dopamine are neurotransmitters often linked to depression and other psychiatric disorders. In preclinical studies to date, DOV's compounds have shown to be potent and highly efficacious compared to commonly used antidepressants and have been generally safe and well-tolerated in early-stage clinical studies.
About DOV
DOV is a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular that involve alterations in neuronal processing. We have six product candidates undergoing clinical development that address therapeutic indications with significant unmet needs.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human health, directly and through its joint ventures.
DOV Cautionary Note
Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act, each as amended, including statements regarding our expectations with respect to the progress of our clinical trial programs and our regulatory efforts. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or perhaps even relatively confident. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop, test and commercialize our drugs. Further development and commercialization of any of our product candidates are subject to numerous factors outside our control including our ability to:
* demonstrate the safety and efficacy of product candidates at each stage
of development;
* meet our development schedule for our product candidates;
* meet applicable regulatory standards and receive required regulatory
approvals on our anticipated time schedule or at all;
* meet obligations and achieve milestones under our license and other
agreements;
* obtain collaborations as required with pharmaceutical partners;
* obtain substantial additional funds;
* obtain and maintain all necessary patents or licenses; and
* produce product candidates in commercial quantities at reasonable costs
and compete successfully against other products and companies.
Other factors that may cause our actual results to differ materially from our forward-looking statements include the fact that we or the FDA may suspend one or more of our clinical trials, patient recruitment may be slower than expected or patients may drop out of our clinical trials and our success depends on the performance of our licensees and collaborative partners who among other things may not fulfill their obligations to us. You should also refer to the risks discussed in our other filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K filed on March 15, 2004. We qualify all our forward-looking statements by these cautionary statements. There may be other factors that may materially affect our forward-looking statements and our future results. Readers should not, therefore, place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.
Anyone,
Any thought on buying some AXYX at current levels? I don't hold any shares, however, I may buy some if it falls to the lower 3's. Strong balance sheet and if Phenserine (sp) trials are solid it should result in some nice gains.
Thanks,
10nis
Masterlongevity,
I totally agree with you regarding OVTI. I have and will continue to accumulate shares at these levels.
10nis
Modest Milestone.... (IMO) Probably $1.5 - 3.0 million.
DEW - What's your estimate?
Dew,
What's your estimate of an equity valuation for NTMD if BiDil is FDA approved? Any help would be greatly appreciated.
Thanks as always,
10nis
Dew,
Any word on how enrollment is progressing regarding the Phase II trials?? Or any word on when the last Phase II trial will begin enrolling patients??
Thank you for all your great posts,
10nis
OT....
http://www.cnn.com/2004/HEALTH/06/24/muscle.gene.ap/index.html
Gene mutation makes tot super strong
Thursday, June 24, 2004 Posted: 11:01 AM EDT (1501 GMT)
A seven-month old baby with a genetic mutation that boosts muscle growth is seen in an undated image.
(AP) -- Somewhere in Germany is a baby Superman, born in Berlin with bulging arm and leg muscles. Not yet 5, he can hold seven-pound weights with arms extended, something many adults cannot do. He has muscles twice the size of other kids his age and half their body fat.
DNA testing showed why: The boy has a genetic mutation that boosts muscle growth.
The discovery, reported in Thursday's New England Journal of Medicine, represents the first documented human case of such a mutation.
Many scientists believe the find could eventually lead to drugs for treating people with muscular dystrophy and other muscle-destroying conditions. And athletes would almost surely want to get their hands on such a drug and use it like steroids to bulk up.
The boy's mutant DNA segment was found to block production of a protein called myostatin that limits muscle growth. The news comes seven years after researchers at Johns Hopkins University in Baltimore created buff "mighty mice" by "turning off" the gene that directs cells to produce myostatin.
"Now we can say that myostatin acts the same way in humans as in animals," said the boy's physician, Dr. Markus Schuelke, a professor in the child neurology department at Charite/University Medical Center Berlin. "We can apply that knowledge to humans, including trial therapies for muscular dystrophy."
Disease relief
Given the huge potential market for such drugs, researchers at universities and pharmaceutical companies already are trying to find a way to limit the amount and activity of myostatin in the body. Wyeth has just begun human tests of a genetically engineered antibody designed to neutralize myostatin.
Dr. Lou Kunkel, director of the genomics program at Boston Children's Hospital and professor of pediatrics and genetics at Harvard Medical School, said success is possible within several years.
"Just decreasing this protein by 20, 30, 50 percent can have a profound effect on muscle bulk," said Kunkel, who is among the doctors participating in the Wyeth research.
Muscular dystrophy is the world's most common genetic disease. There is no cure and the most common form, Duchenne's, usually kills before adulthood. The few treatments being tried to slow its progression have serious side effects.
Muscle wasting also is common in the elderly and patients with diseases such as cancer and AIDS.
"If you could find a way to block myostatin activity, you might slow the wasting process," said Dr. Se-Jin Lee, the Johns Hopkins professor whose team created the "mighty mice."
Lee said he believes a myostatin blocker also could suppress fat accumulation and thus thwart the development of diabetes. Lee and Johns Hopkins would receive royalties for any myostatin-blocking drug made by Wyeth.
Boy's background, future
Dr. Eric Hoffman, director of Children's National Medical Center's Research Center for Genetic Medicine, said he believes a muscular dystrophy cure will be found, but he is unsure whether it will be a myostatin-blocking drug, another treatment or a combination, because about a dozen genes have some effect on muscles.
He said a mystotatin-blocking drug could help other groups of people, including astronauts and others who lose muscle mass during long stints in zero gravity or when immobilized by illness or a broken limb.
Researchers would not disclose the German boy's identity but said he was born to a somewhat muscular mother, a 24-year-old former professional sprinter. Her brother and three other close male relatives all were unusually strong, with one of them a construction worker able to unload heavy curbstones by hand.
In the mother, one copy of the gene is mutated and the other is normal; the boy has two mutated copies. One almost definitely came from his father, but no information about him has been disclosed. The mutation is very rare in people.
The boy is healthy now, but doctors worry he could eventually suffer heart or other health problems.
In the past few years, scientists have seen great potential in myostatin-blocking strategies.
Internet marketers have been hawking "myostatin-blocking" supplements to bodybuilders, though doctors say the products are useless and perhaps dangerous.
Some researchers are trying to turn off the myostatin gene in chickens to produce more meat per bird. And several breeds of cattle have natural variations in the gene that, aided by selective breeding, give them far more muscle and less fat than other steer.
Dew - Regarding number #5 (6-month FDA review). When would you expect the FDA to actually give GENR Fast-Track status for Squalamine? Is there a typical timeline the FDA likes to grant Fast-Track status or is it totally random in general.
TIA.
Dew,
How much would an intravenous injection/dosing cost? One would have to think that MediCare/Insurance companies would pull more weight than the doctors, if the cost of deliverying a similar effective drug (i.e., Squalamine) was a lot cheaper.
I guess the doctors wouldn't have to use Squalamine, however, why wouldn't Medicare/Insurance lower its coverage rates thus forcing doctors to use Squalamine or a cheaper yet as effective drug.
Do you think patients would have anything to say in the matter?
Thanks. 10nis.
Phase II trials are beginning, although no PR from GENR......
May 04, 2004 08:05:00 (ET)
PLYMOUTH MEETING, Pa., May 4, 2004 /PRNewswire-FirstCall via COMTEX/ -- Genaera Corporation (GENR, Trade) today announced the opening of enrollment for the first U.S. Phase II clinical trial of its systemically administered anti-angiogenic drug, squalamine, for the treatment of the "wet" age-related macular degeneration (AMD).
This pharmacokinetic and safety trial is designed to evaluate 18 patients with "wet" AMD at three different doses of squalamine. In this open-label, parallel group study; squalamine will be administered intravenously at three doses, once a week for four weeks and all patients will be followed for up to four months. The study will be performed at leading ophthalmic centers in the United States.
"As we recently announced, Genaera intends to conduct three Phase II clinical trials for squalamine in AMD and begin Phase III trials in early 2005," commented Roy C. Levitt, MD, President and Chief Executive Officer. "This study marks the first step in our expedited development plan for squalamine in ophthalmic indications."
http://biz.yahoo.com/prnews/040427/nytu052_1.html
Inspire Pharmaceuticals Announces Positive Results in Cystic Fibrosis Study
Tuesday April 27, 7:35 am ET
Study Drug Was Well-Tolerated and Demonstrated Statistically Significant Benefit in Lung Function Compared to Placebo
DURHAM, N.C., April 27 /PRNewswire-FirstCall/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH - News) today announced top-line results in a Phase II study of INS37217 Respiratory in patients with mild cystic fibrosis (CF) lung disease. Inspire plans to present additional data from the study at the 18th Annual North American Cystic Fibrosis Conference, which will be held in St. Louis in October.
ADVERTISEMENT
The study was a double-blind, randomized comparison of three doses of INS37217 Respiratory to placebo in 90 patients with CF at 14 clinical centers in the United States. INS37217 Respiratory or placebo was administered three times daily for 28 days by standard jet nebulizer.
The trial was designed to determine the tolerability of three times daily administration of INS37217 Respiratory in doses up to 60mg. All three doses of INS37217 Respiratory were well-tolerated and 93% of enrolled patients completed the study. The most common adverse event was cough, which occurred in 46% of subjects overall and was comparable across all groups, including placebo.
The study was not powered to demonstrate statistically significant differences between INS37217 Respiratory and placebo with respect to efficacy. However, at the end of four weeks of treatment, subjects receiving INS37217 Respiratory had significantly better lung function compared to patients receiving placebo for FEV(1) (p = 0.006), FEF(25-75%)(p = 0.007) and FVC (p = 0.022). The demonstrated benefit in FEF(25-75%) is particularly notable given that decline in small airway function, as assessed by FEF(25-75%), is the earliest manifestation of CF lung disease. Importantly, Inspire plans to develop INS37217 Respiratory as an early intervention therapy. Inspire has received Orphan Drug Status and Fast Track designations from the Food and Drug Administration (FDA) for INS37217 Respiratory for the CF indication.
Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation, funded the majority of the external costs for the Phase II study. Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation and CFFT, commented, "We are delighted with these results, which far surpassed the success criteria that were set forth as part of the agreement between Inspire and CFFT. We are very pleased that Inspire will be moving forward with this exciting potential product, which addresses the basic CF defect."
The study was conducted in collaboration with the CF Therapeutics Development Network (TDN). Bonnie Ramsey, M.D., Director, TDN Coordinating Center, stated, "This is a big win for the CF community and we look forward to working with Inspire on future trials to expedite the development of this early intervention approach for CF patients."
Christy L. Shaffer, Ph.D., Inspire CEO, stated, "The results of this study exceeded our expectations and have provided important scientific support for the concept of INS37217 Respiratory as early intervention therapy. We have the resources needed to advance this program in 2004 and we look forward to continuing to work with the Cystic Fibrosis Foundation and to discussing the program with the FDA in the coming months to gain input on the overall development plan and the design of the next clinical trial."
Inspire will host a conference call and live webcast to discuss these results on Tuesday, April 27th at 9:30 am EDT. Participants in the U.S. may call (877) 780-2276 to access the call. Participants outside of the U.S. may call (973) 582-2757. The conference call will be webcast live on Inspire's website at www.inspirepharm.com. Replays of the conference call and webcast will be available for a limited time following the call. Replay numbers are available on Inspire's website.
About Cystic Fibrosis
Cystic fibrosis is a fatal disease involving a genetic mutation that disrupts the cystic fibrosis transmembrane regulator (CFTR) protein. This protein acts as an ion-specific channel that moves salt and water to the surface of the airways. The defect in this ion channel in CF patients leads to poorly hydrated, thick, mucous secretions in the airways and severely impaired mucociliary clearance. INS37217 Respiratory is believed to enhance the lung's mucosal hydration and mucociliary clearance mechanisms by activating an alternative ion channel that acts in the same way as the defective ion channel in moving salt and water to the surface of the airways. It is well established that mucociliary clearance is impaired early in life in CF patients, and average life expectancy for these patients is early thirties. This unique, early intervention approach is different from the approach of other approved CF products and may be important in intervening in the early clinical course of CF lung disease.
About Inspire
Inspire Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to discovering, developing and commercializing novel prescription products in disease areas with significant commercial markets and unmet medical needs. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology and respiratory and is a leader in the field of P2 receptor technology with a current focus on P2Y2 and P2Y12 receptors that show therapeutic promise. Inspire's specialty sales force promotes Elestat(TM) and Restasis®, ophthalmology products developed by Inspire's partner, Allergan, Inc. In addition to its partnership with Allergan, Inspire has development and commercialization alliances with Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd., and has a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc.
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. 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 and earnings expectations, intellectual property rights and litigation, competitive products, results of clinical trials, the need for additional research and testing, delays in manufacturing, funding and the timing and content of decisions made by regulatory authorities, including the United States Food and Drug Administration. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the Securities and Exchange Commission. 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.
Contacts:
Inspire Pharmaceuticals, Inc.
Mary Bennett
Senior Vice President, Operations and Communications
(919) 941-9777, Extension 245
EURO RSCG Life NRP
Emily Poe (212) 845-4266
More News.......
http://biz.yahoo.com/prnews/040423/nyf008_1.html
Press Release Source: Genaera Corporation
Genaera Announces Appointments to Ophthalmic Advisory Board
Friday April 23, 8:30 am ET
PLYMOUTH MEETING, Pa., April 23 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) today announced the recent appointment of ten world-renowned ophthalmic and retinal specialists to its Ophthalmic Advisory Board:
-- Susan B. Bressler, MD, Professor of Ophthalmology, Director, Wilmer
Photograph Reading Center, Johns Hopkins University School of
Medicine, Baltimore, Maryland*;
-- Charles A. Garcia, MD, Bernice Weingarten Distinguished Professor of
Ophthalmology and Visual Science, University of Texas Health Science
Center, Houston, Texas;
-- Glenn J. Jaffe, BA, MD, Professor of Ophthalmology, Duke University
Eye Center and Director of the Uveitis Service Duke Optical Coherence
Tomography Reading Center, Durham, North Carolina;
-- Michael L. Klein, MD, Professor, Casey Eye Institute-Oregon
Health & Science University, Portland, Oregon;
-- Hugo Quiroz-Mercado, MD, Chief of the Retina Service, Chief of
Experimental Surgery Laboratory and the Coordinator of the Research
Committee at the Asociacion Para Evitar la Ceguera en Mexico;
-- Gholam A. Peyman, MD, Professor of Ophthalmology, Co-Director of
Vitreo-Retinal Service, Tulane University School of Medicine, New
Orleans, Louisiana;
-- Lawrence I. Rand, MD, Retinal Specialist, Private Practice, Waban,
Massachusetts;
-- Carl D. Regillo, MD, FACS, Professor of Ophthalmology, Thomas
Jefferson University, School of Medicine and Wills Eye Hospital,
Philadelphia, Pennsylvania;
-- Jack Owens Sipperley, MD, Senior Partner, Retinal Consultants of
Arizona, Ltd., Phoenix, Arizona; and
-- Edgar L. Thomas, MD, Retina-Vitreous Associates, Beverly Hills,
California.
"I believe squalamine has demonstrated the potential for systemic anti-angiogenesis therapy to be used safely to preserve or improve vision in patients with AMD, and to treat a broader range of ophthalmic indications characterized by neovascularization," noted Dr. Edgar Thomas.
"The current safety profile for squalamine as a systemic anti-angiogenic is excellent and certainly supports its use in Genaera's upcoming AMD studies," said Dr. Carl Regillo. "I look forward to participating in the development of squalamine for AMD with such an outstanding team of investigators and advisors."
"Squalamine provides a number of important advantages as a systemic anti-angiogenic therapy for AMD including treating both eyes, which is often necessary, with no additional risk. It also avoids the complications associated with intraocular and periocular injections, such as infection, needle associated injuries, and not to be overlooked, poor patient acceptance," commented Dr. Charles Garcia. "AMD is a chronic disease and systemic therapy such as squalamine also has the potential to allow a safer long-term maintenance or retreatment regimen, compared to ocular injection treatments."
"We are delighted and honored to have these experts in the field of ophthalmology and eye disease join our Ophthalmic Advisory Board," commented Roy C. Levitt, MD, President and Chief Executive Officer. "Each member brings extraordinary scientific knowledge and a reputation as a thought leader in their field. Their involvement with Genaera will enable us to fulfill the goal of developing squalamine for the large, underserved age-related macular degeneration population."
Genaera Corporation is a biopharmaceutical company committed to developing medicines for serious diseases from genomics and natural products. Research and development efforts are focused on anti-angiogenesis and respiratory diseases. Genaera has three products in development addressing substantial unmet medical needs in major pharmaceutical markets. These include squalamine, an anti-angiogenesis treatment for cancer and eye disease; interleukin-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease. For more information on Genaera, visit the company's website at www.genaera.com.
* Participation by Dr. Susan B. Bressler as a member of the Scientific
Advisory Board does not constitute or imply endorsement by the Johns
Hopkins University, the Johns Hopkins Hospital, or the Johns Hopkins
Health System. Dr. Bressler's has been an advisor to Genaera since
July of 2003 under a one year consulting agreement that comes up for
renewal in July 2004.
Thanks for the great posts. Dew, do you think GENR could be selling off due to another financing/PIPE? It would seem like GENR has enough cash at least for now, however, I don't understand the recent weakness in the share price. TIA..
Thanks for your posts Dew!! I'm buying more...
GENR at $3.85?? Its crazy... Dew/Others, could the PPS be a result of IND problems? Has anyone spoken w/Jennifer (IR) regarding how the process of the IND is going? (Not that she or they can really say anything).
TIA..
OT: Anyone own any (Axonyx) AXYX? Dew any thoughts on AXYX. TIA.
PRAN was up huge today....
Press Release Source: Prana Biotechnology Ltd.
Journal of Neuroscience Paper Further Validates Prana Science
Wednesday April 7, 10:04 am ET
MELBOURNE, Australia, April 7 /PRNewswire-FirstCall/ -- Prana Biotechnology Ltd. (Nasdaq: PRAN - News; ASX: PBT - News), today announced the publication of a new paper in the current edition of Journal of Neuroscience. The results further support Prana's theory that metals in the brain, rather than proteins on their own, are responsible for the pathology of Alzheimer's Disease and that attenuating the action of these metals may hold the key to effective therapeutic intervention.
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It is known that zinc reacts with amyloid beta to cause the amyloid plaques around nerve endings in Alzheimer's disease. The role of zinc in the formation of damaging amyloid plaques in blood vessels supplying the brain has, up to now, not been clear.
Amyloid deposits in arteries cause damage to the blood vessel wall resulting in impaired blood flow. If these deposits occur in arteries that supply blood to the brain then this may starve the brain tissue of oxygen compounding the dementia associated with Alzheimer's Disease.
This Journal of Neuroscience article demonstrates that zinc plays a central role in the formation of amyloid plaques not only at the nerves but also in the blood vessels of the brains of people with Alzheimer's Disease.
Prana's scientific consultants produced a mouse model which lacked a protein from nerve endings that transports and mediates the levels of zinc in the nerves and surrounding tissue. They observed that not only did the blood vessel walls in the brains of these mice have lower levels of zinc, but with less zinc there is also significantly fewer amyloid deposits. These new results show that the same zinc responsible for toxic amyloid deposits around nerves is also responsible for causing amyloid deposits in blood vessels.
Dr. Ashley Bush, chief scientific consultant to Prana, and senior author on the publication explained; "These findings strongly support the suitability of Prana's MPAC* class of drugs for targeting amyloid deposits in Alzheimer's disease, both in the blood vessels in the brain and in the brain tissue around the nerve endings.
"It is yet another piece of evidence that attenuating the interaction of metals and amyloid protein could be beneficial in treating Alzheimer's Disease," said Dr Bush.
Prana's MPAC technology is designed to attenuate the interaction of zinc and amyloid protein in the brain of patients with Alzheimer's Disease.
To view the abstract on the Journal of Neuroscience website please visit: http://www.jneurosci.org/cgi/content/abstract/24/13/3453
Background: Amyloid beta and amyloid plaques
Prana's MPACs (metal protein attenuating compounds) are chemicals that bind zinc and copper, and have been shown by Prana to lower the levels of amyloid beta and the associated toxicity in the brains of transgenic mice used as a model of Alzheimer's Disease. Prana's scientists first described the metal-based structure of the beta amyloid
The brains of patients with Alzheimer's Disease are affected by the chemical changes associated with the formation of 'clumps' of amyloid beta (plaques) near and around nerve endings and in blood vessels, particularly in the areas used for memory and other cognitive functions. The normal form of amyloid beta is soluble, but in Alzheimer's Disease, the protein comes out of solution to become a major component of insoluble amyloid plaques. Inappropriate accumulation of amyloid beta in the brain is intimately associated with the loss of neuronal function causing the dementia.
Metals, also a component of the brain, have chemical roles in the development and progression of plaque formation. Abnormal binding of zinc to amyloid beta leads to protein clumping. Abnormal binding of copper to amyloid beta can lead to the formation of hydrogen peroxide through oxidative reactions. Hydrogen peroxide is toxic to brain cells.
Experimentally, the amyloid can be dissolved by the use of metal-binding chemicals such as clioquinol that specifically reverse the copper and zinc interaction with amyloid beta.
About Prana:
Prana is a Melbourne-based biotechnology established in 1997 to commercialize research into Alzheimer's disease and other major age-related degenerative disorders (Nasdaq: PRAN - News; ASX: PBT - News). Prana's technology was discovered by the company's researchers at prominent international institutions including Massachusetts General Hospital at Harvard Medical School, the University of Melbourne and the Mental Health Research Institute in Melbourne.
--------------------------------------------------------------------------------
UPDATE - SEC suspends trading in Vaso Active stock
Thursday April 1, 10:54 am ET
(Adds details, stock price)
WASHINGTON, April 1 (Reuters) - U.S. securities regulators on Thursday halted trading of Vaso Active Pharmaceuticals Inc. (NasdaqSC:VAPH - News), a marketer of over-the-counter pharmaceuticals, through April 15.
The Securities and Exchange Commission questioned assertions made by the Danvers, Massachusetts-based company of an FDA approval of certain key products and regulatory consequences of the future application of their primary product, among others.
Vaso Active was not immediately available for comment.
The SEC said it questioned the accuracy of assertions made in the company's press releases, annual report, registration statement and public statements to investors.
Vaso shares closed at $7.59 Wednesday on Nasdaq.
Eyetech Pharmaceuticals' Officers and Directors Adopt 10b5-1 Securities Trading Plans
Wednesday March 31, 7:20 pm ET
NEW YORK, March 31 /PRNewswire-FirstCall/ -- Eyetech Pharmaceuticals, Inc. (Nasdaq: EYET - News), today announced that, as described in its prospectus relating to its initial public offering, its chief executive officer and a director adopted pre-arranged stock trading plans in accordance with Rule 10b5-1 of the U.S. Securities Act of 1933. The Eyetech officers and directors who have adopted plans are David R. Guyer, Anthony P. Adamis and Samir Patel, who are also co-founders of the company. As also described in our prospectus, certain other officers and directors have or may adopt 10b5-1 plans in which they will contract with a broker to exercise and sell options or sell shares on a periodic basis. Sales of any shares under such plans are currently subject to the 180-day lock-up agreement that our officers and directors have entered into with the underwriters of our initial public offering.
Rule 10b5-1 allows persons who may be considered insiders to establish written pre-arranged stock trading plans when they do not have material, non-public information. The plans establish predetermined trading parameters that do not permit the person adopting the plan to exercise any subsequent influence over how, when or whether to effect trades. Implementation of these plans seeks to avoid concerns about executing stock transactions while in possession of material, non-public information and also permits corporate officers and directors to gradually diversify their investment portfolios and may minimize the market impact of stock trades by spreading them over an extended period of time.
The types of transactions contemplated by these plans may include direct sales and collar transactions, as well as the sale of shares received through option exercises. The transactions under these plans will be disclosed publicly through Form 4 filings by each of the executive officers and directors who have adopted a plan. In addition, these transactions will be subject to the restrictions and filing requirements mandated by Rule 144 of the U.S. Securities Act of 1933.
ABOUT EYETECH
Eyetech Pharmaceuticals, Inc. is a biopharmaceutical company that specializes in the development and commercialization of novel therapeutics to treat diseases of the eye. Eyetech's initial focus is on diseases affecting the back of the eye. The company's most advanced product candidate is Macugen(TM) (pegaptanib sodium), which Eyetech is developing with Pfizer Inc. for the prevention and treatment of diseases of the eye and related conditions. Eyetech's lead clinical trials include two Phase 2/3 pivotal clinical trials for the use of Macugen(TM) in the treatment of the wet form of age-related macular degeneration and a Phase 2 clinical trial for the use of Macugen(TM) for the treatment of diabetic macular edema.
SAFE HARBOR STATEMENT
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our plans and objectives of management are forward-looking statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including risks related to: our heavy dependence on the success of Macugen(TM), which is still under development; our dependence on our strategic collaboration with Pfizer; obtaining regulatory approval to market Macugen(TM) and any other products that we may develop in the future; our dependence on third parties to manufacture Macugen(TM); obtaining, maintaining and protecting the intellectual property incorporated into our product candidates; and our ability to obtain additional funding to support our business activities. These and other risks are described in greater detail in the "Risk Factors that May Affect Results" section of our Annual Report on Form 10-K, filed with the SEC. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. We do not assume any obligation to update any forward-looking statements.
Company Contact:
Glenn Sblendorio
Chief Financial Officer
(212) 997-9241
glenn.sblendorio@eyetk.com
Deals, Deals, and more Deals... Is GENR next??
Press Release Source: QLT Inc.
QLT to acquire Kinetek Pharmaceuticals Inc.
Monday March 29, 7:56 pm ET
VANCOUVER, March 29 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI - News; TSX: QLT - News) QLT Inc. announced today that it will be acquiring Kinetek Pharmaceuticals, Inc., a Vancouver-based privately-held biopharmaceutical company. The acquisition required the approval by special resolution of Kinetek shareholders, as well as that of the B.C. Supreme Court, both of which were obtained today.
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"As a result of our previous involvement with Kinetek, we are well acquainted with Kinetek's scientific programs," said Paul Hastings, QLT's President and Chief Executive Officer. "Given QLT's research and development capabilities and resources, we feel the Kinetek science has strong potential in our hands, particularly in the area of oncology, an area of research that we did not have rights to in our collaboration."
Since June of 2001, QLT and Kinetek have collaborated on a research and early development program to develop signal transduction inhibitors for the treatment of eye, immune system and kidney diseases. Kinetek has a unique proprietary position on Integrin-linked kinase or ILK. Inhibition of the kinase activity of ILK has the potential of a broad range of clinical applications including cancer, inflammation, kidney, and eye diseases. In cancer, peer-reviewed published studies of small molecule ILK inhibitors discovered by Kinetek have recently shown that they block tumor angiogenesis and cause tumor shrinkage in animal models.
"We are pleased to be able to gain access not only to the target, but the proprietary ILK inhibitor small molecules in development," said Dr. Mohammad Azab, QLT's Chief Medical Officer and Executive Vice-President of Research and Development. "Inhibition of angiogenesis by targeting ILK through a small molecule may represent a potential advantage over current anti-angiogenic drugs in development."
The acquisition transaction is expected to close on Wednesday, March 31, 2004. Under the terms of the acquisition, QLT will make an aggregate cash payment to Kinetek shareholders of approximately $2.7 million. The net result of the acquisition transactions, which will include the recognition of a tax asset, will be favorable to EPS by between 14 and 16 cents. Further, QLT expects that the ongoing investments in developing the acquired targets could cost up to 5 cents per share in 2004. As a result, the effect of this transaction is an increase of 10 cents on the EPS guidance range of $0.74 to $0.86, provided in QLT's earnings press release on February 11, 2004, bringing the EPS range to $0.84 to $0.96.
Background on QLT/Kinetek Collaboration
In June of 2001, QLT acquired just over 3 million shares of Kinetek and rights and options to receive compounds to be developed in the area of ocular and renal disease. Kinetek retained the rights to develop ILK for oncology. The shares acquired were valued based on a concurrent private placement transaction and from 2001 until the end of 2002 the investment was held at cost. However, due to the general decline in equity markets, the lack of Kinetek resources applied to our collaboration, the decline in biotech industry valuations, and the reduced level of working capital available to Kinetek, QLT contracted an impairment assessment by an independent firm of chartered accountants. Based on this assessment, QLT wrote off its investment in Kinetek shares and consequently recorded a charge against earnings of $6.2 million in the fourth quarter of 2002. QLT's primary interest in this asset today is to gain the rights to develop ILK and ILK targeted molecules in the area of oncology.
In recommending that Kinetek shareholders approve the acquisition agreement, the current board of directors of Kinetek advised shareholders that the company did not have sufficient resources to otherwise continue its operations.
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies to treat eye diseases, cancer and dermatology-related conditions. Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialized two products to date, including Visudyne® therapy which is one of the most successfully launched ophthalmology products. For more information, visit our web site at www.qltinc.com.
Visudyne(R) is a registered trademark of Novartis AG
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol "QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT." Certain statements in this press release constitute "forward looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward looking statements include, but are not limited to, the statements with respect to: the potential of Kinetek's scientific programs, including without limitation ILK, the potential advantage of inhibition of angiogenesis by targeting ILK through a small molecule, the Company's expectations as to the impact of the transaction on EPS, the Company's expectations as to the cost of ongoing investment in developing the acquired targets, as well as all statements which use the words: "will", "may", is expected to", QLT
"expects" or we "feel". Such statements are only predictions and actual events or results may differ materially. There are a number of factors that could cause such actual events or results expressed or implied by such forward looking statements to differ materially from any future results expressed or implied by such statements include, which factors
include but are not limited to those factors described in detail in QLT's Annual Information Form on Form 10 K, quarterly reports on Form 10 Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward looking statements are based on our current expectations and QLT assumes no obligation to update such information to reflect later events or developments except as required by law.
QLT Inc.:
Therese Hayes
Telephone: (604) 707-7000 or 1-800-663-5486
Fax: (604) 707-7001
Dew - Thanks for your comments regarding the latest management change. Do you think it increases the chance of a MRK and GENR partnership? TIA..
7:49AM EYET started with an Overweight at Morgan Stanley 35.05: Morgan Stanley initiates coverage of Eyetech Pharma with an Overweight rating and a $42 target; with Macugen, firm believes that the co possesses an exciting late-stage commercial opportunity with $1 bln plus peak sales potential; with solid Phase III data in hand, a strong commercial partner (Pfizer) targeting a large potential mkt, and retention of a large share of future potential profits from sales of Macugen (50% in the U.S.), firm believes that the stock represents a compelling investment opportunity.
Dew - Could you call Investors Relations and find out more about what's going on with the IL-9 collaboration with MEDI. Specifically, what impact does the latest Ludwig PR have on the MEDI partnership.
I would call myself however, I don't think I'd get the same kind of response as you would......TIA.
Dew what do you think of the news? TIA.
Press Release Source: Genaera Corporation
Genaera and Ludwig Institute Extends Alliance on Discovery and Development of Novel Pharmaceutical Targets and Therapeutics
Monday March 8, 8:02 am ET
PLYMOUTH MEETING, Pa., March 8 /PRNewswire-FirstCall/ -- Genaera Corporation (Nasdaq: GENR - News) and the Ludwig Institute for Cancer Research (LICR) today announced a two-year extension of a collaborative agreement on the joint discovery and development of novel genes and proteins as pharmaceutical targets and therapeutics, including further research related to interleukin-9 (IL-9).
"The goal of this collaboration is to provide new therapeutic products for asthma, cancer, and other diseases, based on our combined efforts in genomics and biological research," said Roy C. Levitt, MD, Genaera's President and Chief Executive Officer. "We are extremely pleased to further our alliance with the world class investigators at the Ludwig Institute who originally identified IL-9 and its receptor. Their expertise in the area of biological discovery and developing new therapeutics such as monoclonal antibodies, adds further depth to our product development programs."
Genaera has developed IL-9 and IL-9 receptor intellectual property and exclusively in-licensed certain other related intellectual property from LICR including the original patents to IL-9 and its receptor. Studies by Genaera scientists identified a role for IL-9 and its receptor in the pathogenesis of asthma and potentially other respiratory disorders including chronic obstructive pulmonary disease (COPD) and cystic fibrosis. Biopsies from asthmatic patients have shown an increase in expression of IL-9 as compared to healthy individuals. Published findings, highlighting the central role of IL-9 in asthma, demonstrate its contribution to certain clinical features including bronchial hyperresponsiveness, IgE, mucus overproduction and eosinophil up-regulation in animal models and in patients. Genaera believes that a neutralizing antibody to IL-9 provides a novel approach to prophylaxis or treatment for asthma, and provides an important alternative to the non-specific therapies currently in use.
In April 2001, Genaera entered into a Collaboration and License agreement with MedImmune, Inc. to co-develop an IL-9 related product for asthma. This alliance provided Genaera with a significant upfront payment, guaranteed research and development support through April 2003, future royalties, and up to $55 million in milestone payments. MedImmune will conduct all development, manufacturing, marketing and sales for any product.
According to the National Institute of Allergy and Infectious Diseases and the American Lung Association, there are over 65 million patients suffering from diseases that may be IL-9 mediated, including 17 million asthmatics, 35 million respiratory allergy sufferers, 13 million sufferers of chronic bronchitis, and 2.4 million patients afflicted with COPD, a disease which claims the lives of over 107,000 Americans annually. Currently, there is a significant unmet medical need for safe and effective therapies for the respiratory distress caused by many chronic respiratory disorders, including moderate to severe asthma. Many of these disorders currently are treated symptomatically with non-specific anti-inflammatory drugs, antibiotics, or bronchodilators for prophylaxis or rescue use.
The Ludwig Institute for Cancer Research is the largest international academic institute dedicated to understanding and controlling cancer. With ten Branches in seven countries, and numerous Affiliates and Clinical Trial Centers in many others, the scientific network that is LICR quite literally covers the globe. The uniqueness of LICR lies not only in its size and scale, but also in its philosophy and ability to drive its results from the laboratory into the clinic. LICR has developed an impressive portfolio of reagents, knowledge, expertise, and intellectual property, and has also assembled the personnel, facilities, and practices necessary to patent, clinically evaluate, license, and thus translate, the most promising aspects of its own laboratory research into cancer therapies. The Cytokine Group of the LICR, led by Jean-Christophe Renauld and Jacques van Snick, studies the biology of IL-9, which was discovered by the group in 1989.
Genaera Corporation is a biopharmaceutical company committed to developing medicines for serious diseases from genomics and natural products. Research and development efforts are focused on anti-angiogenesis and respiratory diseases. Genaera has three products in development addressing substantial unmet medical needs in major pharmaceutical markets. These include squalamine, an anti-angiogenesis treatment for cancer and eye disease; IL-9 antibody, a respiratory treatment based on the discovery of a genetic cause of asthma; and LOMUCIN(TM), a mucoregulator to treat the overproduction of mucus and secretions involved in many forms of chronic respiratory disease.
This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. Such statements include, among others, statements regarding the IL-9 antibody program. You may identify some of these forward looking-statements by the use of words in the statements such as "anticipate," "develop," "continuing," and "progress," or other words of similar meaning. Genaera's actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to, Genaera's history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera's product candidates may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; Genaera's reliance on its collaborators, including MedImmune, in connection with the development and commercialization of Genaera's product candidates; market acceptance of Genaera's products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology industry; and the other risks and uncertainties discussed in this announcement and in Genaera's filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting pharmaceutical companies in the development stage, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.
Dew, would do you think of this?
From the Yahoo Message Board:
2:02PM Regeneron Pharma: Novartis ends participation in IL-1 Trap development program for rheumatoid arthritis (REGN) 16.15 +0.99: Co announces that it plans to initiate a Phase IIb study of the Company's Interleukin-1 (IL-1) Trap for the treatment of rheumatoid arthritis in the 2nd-half of 2004 and that Novartis Pharma AG notified the Company today that it has decided to forgo its rights under the parties' collaboration agreement to jointly develop and commercialize the IL-1 Trap. After evaluating the results of the Phase II study, Novartis informed Regeneron that as a condition for participating in the continued clinical development of the IL-1 Trap, it would require revisions to the terms of the original agreement applicable to the IL-1 Trap. Regeneron declined to accept revisions to the collaboration agreement on the terms proposed by Novartis, and Novartis has elected not to proceed with the joint development of the IL-1 Trap. Under the terms of the collaboration agreement, which began in March 2003, Novartis has to date paid $102 mln to Regeneron in up-front payments, equity investments, and development expenses.
From Briefing.com:
2:52PM EYET also finding bid following Avastin approval news 35.00 +2.63...
EYET's Macugen is a Anti-VEGF like Avastin. I hope EYET goes to $50/sh (non-shareholder of EYET)as one would think GENR's PPS would be bid up as well.
Got to like this!!!
GENR initiated at WR Hambrecht with Buy and $9 target 4.30: WR Hambrecht initiates coverage of Genaera with a Buy and 12-mo price target of $9. The firm says Genaera possesses a diverse and still undervalued pipeline of proprietary drug candidates. Most important for value creation is its Phase I/II drug, Squalamine, for the treatment of age-related macular degeneration (AMD) and, potentially, cancer. This anti-angiogenic drug has demonstrated safety and efficacy in treating wet AMD, and is likely to attract a lucrative pharmaceutical partnership in the near term. Squalamine is one of the only drugs for AMD that can be administered systemically rather than by injection in the eye. This competitive feature makes this product attractive despite its forecast late entrance to the market. The firm expects its IL-9 antibody for asthma to gain greater visibility as its partner, MedImmune, advances it in early stage clinical studies in 2004.