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No I didn't ask him about financing, but he did say it may take a few more months to get all the patients enrolled into their trials. -- not sure which ones.
I am also suspicious about the price run up as an opportunity to raise funds too. Some fund (one of the institutions?) started to dump yesterday, and continued throughout today. Maybe they sensed that a financing could happen.
I may cut my losses if this keeps up tomorrow.
fwiw, I just spoke to Joe, ZONA CEO, and he said there was no material news to report other than what came out yesterday. If there was ZONA would have reported it. He had checked in with some institutions and they don't have any clues either.
One could speculate that hedge funds ran the price up (on thinly traded stock) and then shorted it yesterday at the new highs.
ZONA continues it move back up to new 52-wk highs today now on heavier volume. Under strong accumulation, with block buys up to 50k in size yesterday.
http://finance.yahoo.com/q/bc?s=ZONA&t=5d
Thanks io_io and D Miller for pointing this one out.
io io,
Yes, very convincing and detailed presentation, and I really like the depth and relavance of their BOD and Science Advisory Board. Looks like a very streamlined and cost effect approach for getting Proellex and Androxal a high probability for approval by FDA.
I still think the pricing between 11-12 is very attractive for a position. Sure beats DNDN at the moment, and the technicals are also attractive too!
Sorry, io io, did you mean their Dec. webcast? I went to the Feb 2006 which was just slides.
http://www.zonagen.com/html/presentations.htm
I looked at their Feb powerpoint. Do you have a link to their conf call or is there a number? I didn't see one immediately available at web site.
thank you
Red Cross
David, any updates on ZONA's fundamentals?
Last weeks move appears to have been driven by some institutions getting word from the company on confidence about their current drug trials per this Punk Ziegel upgrade of their target (below).
Do you have a target price on ZONA over the next year?
Thanks!
09:01 ZONA Zonagen tgt raised to $25 from $14 at Punk Ziegel (12.42 )
Punk Ziegel raises their tgt to $25 from $14 saying several recent developments diminish risks inherent to Zonagen's clinical programs that they had incorporated into their valuation of Zonagen and increase their confidence in the safety and efficacy of Proellex and Androxal as well as their respective market sizes. The firm says most importantly, following recent discussions with thought-leaders, their concerns about the potential for "endometrial hyperplasia" to be observed in patients receiving selective progesterone receptor modulators like Asoprisnil or Proellex and the associated risk of uterine cancer have largely been mitigated.
Thanks Dew. Looks like it makes sense to some insulin-dependent diabetics that don't like to take shots. I give myself lunchtime "Humalog" shots right through my shirt or pants after getting a pinch of my skin. Occassionally you get the small internal bleeding/bruise from the shots that slice small capillaries. In general, it hasn't been a barrier for me, but I'm probably an atypical diabetic with my more aggressive approach to management and exercise.
I don't think I would use the inhalent product as I don't want to lose my lung capacity. I'm going to try to qualify for another Boston Marathon this fall.
I am interested in this upcoming realtime blood sugar monitoring system that may come out this summer. I don't mind the test kits and strips, but this new system would simplify monitoring for me during the day and while exercising.
From Sundays Washington Post: 4/23/06
New Devices May Free Diabetics From Constant Monitoring
By Justin Gillis
Washington Post Staff Writer
Sunday, April 23, 2006; Page A01
When Casey Burkhalter, 12, was diagnosed with diabetes 2 1/2 years ago, her parents started waking up repeatedly at night to test her blood sugar, typical of the exhausting tasks many of the nation's 21 million diabetics go through to extend their lives.
But no more. For four months the Jacksonville, Fla., girl has been wearing an experimental gadget that provides a continuous reading of her blood sugar and wakes the family if it falls dangerously low. The Burkhalters can sleep now, confident that their youngest child will be alive when the sun comes up. "My parents -- it's just been a cinderblock off their backs, not having to get up at night," Casey said.
A new Medtronic device can pump insulin into the body as well as monitor glucose levels. In this rendering, the light beam represents transmitted data. (Medtronic Diabetes)
Device Offers Relief to Diabetics
Casey Burkhalter, 12, is participating in a research study that is testing a continuous glucose monitoring device for diabetics. Although the device is not perfect yet, it promises diabetics a new measure of freedom and is expected to be widely available in the United States by late this summer.
The technique she's helping test is called continuous glucose monitoring, and it's a goal researchers have chased for nearly 50 years. Now, they say, they can finally see the finish line. Sophisticated monitoring devices that promise diabetics a new measure of freedom are just coming to market and are expected to be widely available in the United States by late this summer.
The monitors aren't perfect yet -- they're not as accurate as blood tests, and they're slow to discern the rapid changes in blood sugar that can accompany activities such as exercise. At least for now, patients who wear them are urged to draw blood periodically for comparison. But researchers hope that within a year or two, the devices will allow diabetics to go for long stretches, possibly days, without using the hated finger lances that are the bane of their existence.
People who have used the monitors say that, despite the limitations, they work without much discomfort. More importantly, initial research suggests the devices could improve the control of blood sugar, a task at which diabetics do poorly on average. That would offer a new way to cut the nation's $100-billion-a-year bill from diabetes complications and reduce the suffering -- heart disease, stroke, amputations, blindness, impotence, kidney failure -- associated with the disease.
"I want to tell the world about this," said Leslie Burkhalter, Casey's mother and a jewelry saleswoman in Jacksonville. "It's going to add years to people's lives. All these things going on right now -- amputations, heart disease -- it's all going to be stopped."
Few doctors are ready to go that far yet, but they are paying attention. "The idea that there are devices that are marketable is a big breakthrough," said William V. Tamborlane, a diabetes researcher at Yale University.
The devices from different manufacturers resemble one another. A patch worn on the abdomen carries a tiny wire that pokes through the skin to measure glucose in cellular fluid. The patch hurts a bit going on but is comfortable afterward, patients say. The patch is worn for several days, wirelessly transmitting information to a receiver the size of a mobile phone, before it is replaced with a new one.
The Juvenile Diabetes Research Foundation, a principal advocacy group for people with the most serious form of diabetes, has gone into overdrive in recent months as its officers concluded that the new devices could represent a big improvement in care.
"I think this signals a new era where we can take diabetes by the horns and really start to control it aggressively," said Aaron J. Kowalski, the group's director of strategic research. "Diabetics have been waiting a long, long time for this."
With money raised from bake sales and diabetes marches across the country, the foundation is launching a series of independent studies designed to test manufacturer claims about the new devices and provide information on their worth. Among the big questions are how much they can cut rates of hospitalization, car accidents caused by drivers with low blood sugar and the many other problems attributable to diabetes.
The group is also pushing to mate the glucose sensors with insulin pumps, which have been on the market for years, to create automated systems that might be able to control diabetes for days with minimal intervention. That technique has been tested on a small scale recently at Yale University, and the creation of a commercial system was recently designated a priority by the Food and Drug Administration.
Page 2 of 2 < Back
New Devices May Free Diabetics From Constant Monitoring
In fact, one manufacturer has already combined a glucose monitor and a pump into a single product that won approval from the FDA on April 13 and is going on sale now. Patients won't be able to activate the monitor portion until this summer, and the device isn't fully automatic yet -- it will require a patient to consult a glucose readout and make decisions about insulin use.
But the manufacturer, Medtronic Inc., is working on software to automate much of the decision-making. The resulting device could amount to an external, artificial pancreas that basically controls blood sugar on its own for days, with the exception that a patient would have to inform it of upcoming meals and exercise. "We're fairly close," said Alan O. Marcus, director of medical affairs for Medtronic's diabetes unit.
A new Medtronic device can pump insulin into the body as well as monitor glucose levels. In this rendering, the light beam represents transmitted data. (Medtronic Diabetes)
Photos
Device Offers Relief to Diabetics
Casey Burkhalter, 12, is participating in a research study that is testing a continuous glucose monitoring device for diabetics. Although the device is not perfect yet, it promises diabetics a new measure of freedom and is expected to be widely available in the United States by late this summer.
The body burns glucose, a simple sugar, the way a car burns gasoline. But the level in the blood must be tightly controlled to prevent short-term coma or long-term health damage. In a healthy body, the pancreas releases a hormone, insulin, to instruct tissues to absorb sugar from the blood. But this fundamental life process is broken in diabetics: Their bodies either don't make insulin or resist its effects.
Diabetes is one of the nation's most pervasive ailments, afflicting 7 percent of the population and fully 10 percent of adults. One form of the disease is linked to weight, and the problem is growing as Americans get fatter.
Pills help some people, but many need injected insulin. Until now, the state of the art in controlling diabetes has been to prick the fingers repeatedly throughout the day, drawing blood into a test strip and placing it in a glucose sensor to calculate insulin doses and guide eating.
Researchers have been trying to develop continuous glucose monitors since the early 1960s, and the field is littered with false starts and over-hyped gadgets that failed, most recently a watchlike device that caused burns and rashes. But now, doctors say, companies are finally making monitors that work.
The first of the new devices, from Medtronic, won FDA approval last year, but the company has rolled it out slowly, selling it in only seven cities to date. Medtronic is working out kinks and, like other manufacturers, studying how to educate patients in complex new procedures.
A device from DexCom Inc. of San Diego won FDA approval late last month, and one from Abbott Laboratories of North Chicago, Ill., is on the FDA's desk for approval. Overall, three or four continuous monitors are expected to be available nationwide by late this summer.
The new monitors don't entirely eliminate the need for finger-sticks, at least not yet.
Each time the sensor patch is changed, every three to five days, the glucose monitor must be calibrated using blood tests. And for the moment, the FDA and manufacturers are urging patients to draw blood to confirm a gadget reading before adjusting their blood sugar. If people follow that advice, the main advantage of the gadgets will be to alert them when to test.
But already, it's clear patients are becoming more dependent on the devices than the official instructions recommend. After finding it accurate most of the time and figuring out when it's likely to be less accurate -- during hard exercise, for example -- they start relying on the gadget with few finger-sticks.
"I trust it almost completely," Casey Burkhalter said.
The manufacturers are conducting studies to show their products can replace finger-sticks most of the time, a set of claims the diabetes foundation plans to check with its own studies.
A looming question is whether insurance companies will pay for the gadgets, expected to run from $500 to $2,000, and for the $35-and-up sensor patches that must be changed every few days. Historically, insurers have resisted new diabetes technology until studies prove it can cut costs or reduce medical complications, and those aren't finished.
Matt Vogel, a San Francisco diabetic and triathlete, ordered a DexCom monitor two days after the FDA approved the device. He has been comparing it to blood tests and keeping an Internet journal. The biggest problem so far is a time lag in detecting low sugar after exercise. But the device has awakened him at night when his sugar fell dangerously low, and overall, he rates it highly -- "about 90 percent."
A big issue for diabetics, he said, will be adjusting overnight from too little glucose information to a surfeit of it.
"This isn't going to be like a cure or any sort of silver-bullet solution," he said. "It's going to take quite a bit more thinking and quite a bit more problem-solving in order to really take advantage of it."
http://www.washingtonpost.com/wp-dyn/content/article/2006/04/22/AR2006042201354.html?sub=AR
Io_io, what price did you get in at on ZONA? I noticed that the float is very thin, and probably why the institutions buying it the past week took it from 9 to 13 bucks.
They only have $16 mil cash on had. Do you know what their burn rate is and if they have any partnerships to help pay for their trials.
Looks interesting as a speculative play, but I sure wish I reacted faster when you mentioned it near $10.
Thanks
Thanks Dew. I see that NVS has been an ADR on the NYSE for around 9 years, and has moved up more modestly over that period of time. Was it listed elsewhere on the US exchanges before NYSE? In other words, what kind of multiple were you able to get on NVS from the early stages? Thanks and good luck.
http://finance.yahoo.com/q/bc?s=NVS&t=my
Pharmaceuticals--Profitless prosperity
Apr 20th 2006 | CHICAGO
From The Economist print edition
The biotechnology industry needs to grow up
EVERY industry has its big conferences, but biotechnology must host one of the largest. Some 18,000 scientists, businessmen, financiers and hangers-on descended upon Chicago recently for the annual Bio conference. The gathering boasted plenty of posh parties, high-flying political visitors and boozy nights out at blues bars. To judge by this expense-account fiesta, biotech certainly seems to enjoy a lot of easy money just now.
By some measures the industry is indeed booming. Its American stockmarket value is up tenfold over the past decade, to about $500 billion. Burrill and Company, an industry investment bank, estimates that $350 billion has been invested in biotech, nearly half of that in the past five years. Global revenues have risen from $23 billion in 2000 to more than $50 billion last year.
And what of profits? Best not to mention those. Thirty years after the biotechnology revolution began, the industry has yet to turn an aggregate profit (see chart). Take away the huge profits of a few success stories such as Genentech and Amgen (two Californian firms which together make up a third of the American industry's stockmarket value) and the picture darkens further. David Beier of Amgen estimates that the industry as a whole has lost $100 billion since its creation in the 1970s.
Gary Pisano, a professor at Harvard Business School, argues that biotech needs a radically different business model. He thinks its problems arise because “this is the first time that science is the actual business.” Traditional industries, such as aeronautics or pharmaceuticals, are in business to make products and science merely serves that end. By contrast, most biotech firms are start-ups that have no products and little clue about how to convert their wizardry into things they can sell.
Few would deny that biotechnology has the potential to produce plenty of breakthroughs. Decoding the human genome has helped unlock some of the mysteries of the human body that biotechnologists are striving to turn into products. Optimists speak of drugs targeted to genetic subpopulations, and perhaps even personalised medicine. Firms such as Monsanto, Dow and DuPont are looking to biotech for better catalysts and enzymes, and working with food companies to produce healthier oils and tastier foods.
The trouble is that, after the bursting of a “biotech bubble” on the stockmarket a few years ago, investors are now understandably more discerning. Today's way of financing biotechnology, chiefly through the venture financing of start-up firms, looks unsustainable. On one plausible estimate, such early-stage investors are “holding the bag on 500 to 600 biotech firms they can't unload via public offering” on the stockmarkets. Frederick Frank, a vice-chairman of Lehman Brothers is convinced that there will be a slow but sure shakeout in the industry in the coming years. Up to half of today's 1,500 or so biotech firms (fewer than 400 of which are public) will disappear, aided by mergers.
But if biotech companies are so far from breakthrough products, why will anybody buy them? The answer is that there is an industry in bigger trouble than biotechnology: conventional pharmaceuticals. Big drugs firms are hugely profitable today, but they fear for the future. Their product pipelines are often weak, tens of billions of dollars' worth of drugs will lose patent protection in the next few years, and generics are already eating away at margins.
So the big drugs firms are looking for the next big blockbuster drug under every possible rock—and the most promising rock is biotech. A new report by Ernst & Young, a consultancy, says that 2005 saw a big upsurge in mergers involving biotech firms, with Europe alone seeing 66 deals. Just this week, Novartis won final approval for its $5.4 billion takeover of Chiron, a biotech firm known for its cancer drugs and its blood-testing expertise. Novartis also runs its own start-up fund that invests in biotech firms. Daniel Vasella, the drug giant's chief executive officer, wants to keep his “hand on the technology edge” by keeping a close eye on, and acquiring, biotech companies. He reckons only a portfolio approach makes sense, since “there are 10,000 failures for each success—but when you win, you win big.”
Biotech firms sometimes sneer at big pharma as slow, bureaucratic and even stupid: “They're just barely smart enough to recognise genius,” sniffs one biotech man. But such posturing looks self-indulgent. The future may lie in a convergence of these industries with famously clashing cultures. John LaMattina, head of research and development for Pfizer, the world's largest drugs firm, insists that there is no big difference between biotech and pharma: “Molecules are molecules—I just don't buy this cultural argument.”
The convergence of big pharma and biotech also makes sense to Harvard's Mr Pisano, who sees a fundamental problem with the old financing model for biotech. Venture funds like to see quick returns, usually within five years, but the science involved often takes 15 to 20 years to come to fruition—if at all. He argues that biotech firms, which often pride themselves on their small size and freewheeling culture, need to grow up: “Size is key to integration of science, to learning and to manage risk.”
In the end, despite its paucity of profits, the biotechnology industry offers too much promise to be starved of funding. Burrill, the investment bank, estimates that it will attract some $35 billion in fresh investment in 2006. About $10 billion will come from joining up with big drugs firms and other integrated firms in alliances. The rest, reckons the bank, will come from the public equity markets.
Big Pharma plainly needs biotechnology, so those alliances make sense. But why would biotech be able to earn so much money on the stockmarket given its pitiful returns? Shreefal Mehta of Rensselaer Polytechnic Institute, an American engineering school, observes that there are always punters willing to gamble on very risky stocks in the hope of hitting the jackpot. The secret to biotech's future finances, he sums up, lies in “need and greed”. And perhaps, one distant day, in profits too.
http://www.economist.com/business/displaystory.cfm?story_id=6838715
Dew, is IDIX a 12 month or longer "hold" for you? What is your target price?
I picked up some shares below $11 yesterday based on your alert and the beaten down price (value) of the shares.
Thanks.
PS: Running the Boston Marathon last Monday was a thrill. The people along the course were the greatest.
So he's already lost out on his home state of Texas, eh?
Ooops.
"Quiz answer: Bill Gates is a funny guess, but the answer is…"
Actually Bill Gates doesn't sound as funny of a guess to me. He is the world's premier developer of operating system software (which now needs many firewalls to protect) and is also a large donor to health organization dealing with issues related to HIV and other diseases.
<I'm guessing this puts another question mark on the "Pfizer will buy YMI" theory.>
So DNDN may still be in the running as a possibility for a Pfizer partnership or acquisition this year? Seems like a reasonable hypothesis from David M's earlier article.
<Plus that DSCO seems to have the absolute very worst management in all of biotech - their drug can perform, but they can not.>
We'll see, DNDN also appears to be in the running for that award. :(
Discovery Labs Receives Second Approvable Letter From FDA for Surfaxin for RDS
Wednesday April 5, 7:00 am ET
WARRINGTON, Pa., April 5, 2006 (PRIMEZONE) -- Discovery Laboratories, Inc. (NasdaqNM:DSCO - News) today announced that it has received a second Approvable Letter from the U.S. Food and Drug Administration (FDA) for Discovery's lead product candidate, Surfaxin(r) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative to animal-derived surfactants. Discovery will hold a conference call today at 8:45 AM EDT. The call in number is 866-332-5218.
ADVERTISEMENT
The Approvable Letter is an official notification from the FDA and contains conditions that must be satisfied by Discovery prior to obtaining final U.S. marketing approval. Specifically, the FDA is requesting certain information primarily focused on the Chemistry, Manufacturing and Controls (CMC) section of the NDA. The information predominately involves the further tightening of active ingredient and drug product specifications and related controls. Consistent with previous review, the FDA does not have any clinical or statistical comments. Discovery is in the process of arranging a meeting with the FDA regarding conditions for final approval. The Company anticipates that this meeting will clarify timelines with respect to its response to the FDA.
This is the second Approvable Letter received by the Company from the FDA since the Company's NDA for Surfaxin was filed in April 2004. Our previously submitted responses to the first Approvable Letter were accepted by the FDA as a complete response in October 2005.
Robert J. Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented, ``Our top priority is to satisfy the FDA's requests as soon as possible, so that we can obtain final approval for this important life-saving therapy and make it available to the neonatal community. In light of today's news, we are analyzing all aspects of our business with an intention to conserve cash while remaining focused on developing our NICU franchise of Surfaxin and Aerosurf(tm).''
RDS is a life-threatening and costly breathing disorder that strikes tens of thousands of premature infants in the United States each year, with a global at-risk population in excess of 500,000 infants. Approximately 75,000 infants are treated with surfactants in the United States annually. Current surfactant treatment options are limited to animal-derived surfactants harvested from bovine (cow) and porcine (pig) sources.
Data from Discovery's pivotal, multinational SELECT study demonstrates that Surfaxin was significantly more effective in the prevention of RDS and improved survival and other outcomes versus comparator surfactants. The SELECT and STAR (a supportive Phase 3 study) trials, as well as a pooled Phase 3 analysis, have been presented at several international medical meetings and the results from the two studies were published in Pediatrics.
Discovery will hold a conference call today at 8:45 AM EDT to further discuss in greater detail the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. This audio webcast will be available to shareholders and interested parties through a live broadcast on the Internet at http://audioevent.mshow.com/295458/ and http://www.discoverylabs.com. It is recommended that participants log onto one of these sites at least 15 minutes prior to the call. The Internet broadcast will be available for up to 30 days after the call at both website addresses. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 7560777.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing its proprietary surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery's technology produces a precision-engineered surfactant that is designed to closely mimic the essential properties of natural human lung surfactant. Discovery believes that through its technology, pulmonary surfactants have the potential, for the first time, to address respiratory diseases where there are few or no approved therapies available.
Discovery's SRT pipeline is initially focused on the most significant respiratory conditions prevalent in the neonatal intensive care unit. Discovery's lead product, Surfaxin(r), for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, has received an Approvable Letter from the FDA and is under review for approval in Europe by the EMEA. Surfaxin is also being developed for the prevention and treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung Disease) in premature infants. Discovery is preparing to conduct multiple Phase 2 pilot studies with Aerosurf, aerosolized SRT administered through nasal continuous positive airway pressure (nCPAP), for the treatment of neonatal respiratory failure.
To address the various respiratory conditions affecting pediatric, young adult and adult patients in the critical care and other hospital settings, Discovery has completed a Phase 2 clinical trial to address Acute Respiratory Distress Syndrome (ARDS) in adults, and is developing aerosol formulations of SRT to address Acute Lung Injury (ALI), asthma, COPD, and other respiratory conditions.
For more information, please visit our corporate website at http://www.Discoverylabs.com.
To the extent that statements in this press release are not strictly historical, including statements as to business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of Discovery's product development, events conditioned on stockholder or other approval, or otherwise as to future events, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Among the factors which could affect Discovery's actual results and could cause results to differ from those contained in these forward-looking statements are the risk that financial conditions may change, risks relating to the progress of Discovery's research and development, the risk that Discovery will not be able to raise additional capital or enter into additional collaboration agreements (including strategic alliances for aerosol and Surfactant Replacement Therapies), risk that Discovery will not be able to develop a successful sales and marketing organization in a timely manner, if at all, risk that Discovery's internal sales and marketing organization will not succeed in developing market awareness of Discovery's products, risk that Discovery's internal sales and marketing organization will not be able to attract or maintain qualified personnel, risk that approval by the FDA or other health regulatory authorities of any applications filed by Discovery may be withheld, delayed and/or limited by indications or other label limitations, risks that any such regulatory authority will not approve the marketing and sale of a drug product even after acceptance of an application filed by Discovery for any such drug product, risks that Discovery's CMC will not satisfy the FDA, risk in the FDA review process generally, risks relating to the ability of Discovery's third party contract manufacturers and development partners to provide Discovery with adequate supplies of drug substance, drug products and expertise for completion of any of Discovery's clinical studies, risks relating to drug manufacturing by Discovery, risks relating to the integration of manufacturing operations into Discovery's existing operations, other risks relating to the lack of adequate supplies of drug substance and drug product for completion of any of Discovery's clinical studies, risks relating to the ability of the Company and its collaborators to develop and successfully commercialize products that will combine our drug products with innovative aerosolization technologies, risks relating to the significant, time-consuming and costly research, development, pre-clinical studies, clinical testing and regulatory approval for any products that we may develop independently or in connection with our collaboration arrangements, and risks relating to the development of competing therapies and/or technologies by other companies. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced clinical trials, even after obtaining promising earlier trial results. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Those associated risks and others are further described in Discovery's filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
Contact:
Discovery Laboratories, Inc.
Lisa Caperelli, Manager, Investor Relations
(215) 488-9413
--------------------------------------------------------------------------------
Source: Discovery Laboratories
http://biz.yahoo.com/pz/060405/96849.html
Dew, I believe Caris and Company agrees with your views on RHEO. They just initiated coverage today as a "SELL"
I'm still puzzled how the company's value is 3.5 times their cash holding.
http://finance.yahoo.com/q/ud?s=RHEO
My apologes for posting what was apparently a two year old article on Mitch Gold, CEO of Dendreon. I saw the date of the Seattle paper at the top and swore it was the a March date. I got spoofed from the yahoo message board.
Won't happen again Dew!
<DNDN hit a new 52 week low today. Currently trading at 4.27>
$4.22 may have been the low for this year??
DNDN now trading at $4.73, up $0.25, on vol of 600k+ shares.
Well, indeed, and it wasn't good news for AGEN either. Sort of reminds me recently of a fashion magazine which profiled (interviewed) Sheryl Crow about her engagement last fall to Lance Armstrong, only to find out upon the release of that publication that the latest news was they had now broken up!
Oooops!
I believe CEGE's CEO Shervin put out a realistic forecast. My question is who will be the first "success"? DNDN? I believe this field is very exciting/revolutionary from a scientific point of view, as an innovative way to treat cancer, as well as financial investment. The growing pains may soon (12-18 months) result in investment gains.
For cancer vaccines, the cycle of hyperbole, disappointment, and success now appears closer to the end than to the beginning. Okarma believes his stem cell plan could be less than three years away, and several other vaccines are poised to test the waters before then. "There will be more failure, but I am absolutely confident there will be success," Sherwin says. "It only takes one success to wipe away years of skepticism."
http://www.usnews.com/usnews/health/articles/060403/3vaccine.htm
http://pubs.acs.org/cen/business/84/8413bus1.html
DNDN mentioned in both of these cancer articles.
Dew, sure longs are nervous as the stock is at a
52-week low.
btw, did you look at the link on Nicole Provost's presentation and CBER panel questions? Curious what
you think about this and Nicole's slide presentation.
Regards
Nicole Provost's presentation and panel questions start on page 135 in the link below.
http://www.fda.gov/ohrms/dockets/ac/06/transcripts/2006-4205T1.pdf
FDA Advisory Panel, Au naturel
Doing What Comes Natural. I read with interest the transcript and viewed the slides from the FDA CBER advisory panel to which dwmcdonald2003 and jersey posted links.
The purpose of convening this panel was to discuss what measures can be used to determine if biologic therapies are working. In other words, is there a measurable data that correlates with effectiveness? Why is the FDA doing this? The new leaders at the FDA have started a push to get effective drugs/therapies through the regulatory process. The push is for drugs that have a measurable value that correlate with clinical effectiveness. An example would be the drug Herceptin. Patients’ breast cancers are tested for Her-2/neu status. If the tumors are found to be Her-2/neu positive, the patients respond better to the drug, herceptin. Patients that are Her-2/neu negative usually don’t respond and therefore do not receive the drug saving the expense and side-effects from the drugs. Drugs that have a clear, measurable value that help predict which patients will respond to the treatment will have an easier time during the regulatory process.
DNDN is too late in the game to totally gain from the paradigm shift at the FDA since DNDN has a late stage product but the FDA wanted their expertise concerning measurable values. DNDN’s Nicole Provost was testifying. She presented data for DNDN’s lead product, Provenge (sipuleucel-T). She was discussing CD54 and CD54 upregulation as a measure of potency for Provenge. She showed slides that clearly showed that CD54 upregulation correlated with survival.
After seeing the data, the members of the panel did what would come natural to any in the medical field. They started asking about the trials. At times they seem to lose focus on what they were there for, a discussion of how to obtain measurable data to determine a biological’s effective, and discussed the striking results of the Provenge trial. For example: Dr. Harlan: The Kaplan-Meier curves are compelling. I just wonder if the studies are large enough for those curves to be statistically significantly different… and Dr. Tomford: What is the time line on the survial curves, and have you looked at something beyond the time - -you know, long time. What happens over a long period of time?
This prompted the moderator, Dr. Mule, to have to make the following statement: Dr. Mule: I think these questions are important but, again, our mission here is to really work with the speakers and others as far as the potency release criteria of the product.
You can see why if a group from CBER gets to be on Provenge’s advisory panel, Provenge’s chances for approval greatly increase. These people seem to recognize a good thing when they see it.
Read it for yourself. Look at the slides with data for CD54 upregulation and compare the p-11 and D9902b results with the D9901 and D9902a results. The p-11 CD54 upregulation data is as good as or better than D9901. The D9902a CD54 upregulation data was slightly lower. We all know that the D9902a survival data was slightly lower than D9901. Is this a coincidence?
http://www.fda.gov/ohrms/dockets/ac/cber06.html#CellularTissueGeneTherapies
Go to: Transcript for Feb. 9, 2006
Potency Testing for Autologus Cellular Therapy
Nicole Provost PhD.
P. 131
Go to: Slides February 9,2006
From DNDN yahoo MB posted by zurdoc1
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600905258&tid=dndn&sid=...
DNDN hit a new 52 week low today. Currently trading at 4.27
Anyone buying here in this range?
Thanks
Thanks Dew. Any idea on how long it would take to fold P-11 into an approvable treatment? 2 years?
Thanks for our thoughts
Dew, any thoughts on what DNDN is doing as a strategy with their P-11 trial as it relates to FDA BLA filing and review for approval?
See this post by eagleeye (yahoo dndn MB); some interesting thoughts on what could possibly play out.
Thanks, Spartex
<<They're not submitting p-11 efficacy data unless the BLA is still in process while that data happens to mature.>>
It was curious to listen to yesterday's call. Gold said he expected a panel in early 2007 and approval in mid 2007. Why? DNDN knew its trial results in August 2005 or earlier. August 2005 until June/July 2007 makes no sense. DNDN is not taking 2 years from the date it has data to get Provenge approved. IMO, DNDN is purposefully waiting so that it can go for the whole enchilada early next year. And, DNDN will wait on p-11 efficacy before it goes to a panel -- guaranteed. Yesterday proved it. I never thought that until yesterday, but now I fully believe that. That is also why DNDN will not have any partner until after approval.
I think many wonder why PFE (or whoever) would wait to partner. They say why not do it now. Well yesterday gave us all the answer. The partner delay is not because of the partner, it is because of DNDN and the time value of money. If Provenge gets approved with a larger label (p-11), any partnership is instantly worth multiples more than on 9901 alone.
Another thought is that if DNDN includes p-11 efficacy data and that data is good, then IMPACT becomes utterly meaningless. I think the FDA could tell DNDN to scrap IMPACT if p-11 is good. That could be another reason why DNDN is submitting p-11 efficacy. Scrapping IMPACT would save DNDN a lot of money for sure.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600905258&tid=dndn&sid=...
OT: Atrial Fibrillation and Kaiser
Beachgal,
First off, I am a type I diabetic (the past 19 years) and have been very aggressive in management of my blood sugars, along with strict attention to exercise and diet. Around 10 or so years ago I had been under Kaiser's plan (as of 1996 w/ BlueCross BlueShield) and found, as you said, they were very good about being preventive-care, but not good at being proactive with illnesses and treatment. I test my blood sugar 8+ times a day, and had to almost go to battle with them to write my prescriptions for blood test strips for that amount (they were going to give me 6/day to control their cost...though they wouldn't say that directly). Funny thing is my aggressive monitoring and routine is what may be keeping me free from any diabetic-related affects. I'm still "clean" of any kidney, eye, or nerve damage. Bottom line message here is that you HAVE to be an advocate for yourself or your loved ones with Kaiser. Otherwise, you may not get the needed treatment available and which I feel you deserve.
Now, more recently (last 1.5 years) I had been diagnoised with AF (atrial fibrillation). While I'm in excellent health (run marathons, heart stress/echo tests show I'm fine) it turns out my AF was possibly due to either a low resting heartrate at night (mid-40's) or possibly due to low blood sugar events which also occur in the early morning period while I'm sleeping.
So, what my cardiologist ended up giving me (as pointed out by someone else; medication) was a prescription for 240 mg/day of Cardizem (see link below), which is a calcium channel blocker for the heart and which is supposed to lower blood pressure a bit, while also keeping the left atrial chamber of heart from triggering a AF event. So far, to my knowledge, I have not yet re-experienced an AF event, so am pleased with the way in which the medication is working. Granted, I hate to be on a medication (other than my insulin, which I won't argue for good reasons) that I may not need, but in this case it appears to take care of my possible AF events.
I'd be curious if the Kaiser doctors would recommend something like this for your father. Granted, they may not do the blood thinners (warfarin, aka Coumadin) due to your fathers age.
http://www.cardiologychannel.com/afib/treatment.shtml
Good luck! From what I've heard from you and Dew, your fathers are the type of people that inspire me to live life to its fullest by staying active.
Regards,
Spartex (quadkk on DNDN yahoo message board; long DNDN)
Ouch, bummer. Glad I sold half of my position in the 2.2's yesterday (5000 shares). The other 1/2 was bought at 1.16. So I may hold onto it for a little while.
Good luck to others on weathering the GTCB storm.
Pick up 10k shares of GTCB at 1.16
Already up a dime +. Better put in my stops just in case! :)
Hopefully he uses stop orders. That is a lesson I've learned when I can't monitor action hour to hour.
ImClone: Hammered on the Block?
was yesterday morning the time to "sell on the news"?
The maker of cancer drug Erbitux appears to be sparking little interest with potential buyers. This outfit could be a tough sell
It's been a long, strange trip for ImClone Systems (IMCL), and it may finally be drawing to a close. Twenty years after its founding, and two years after its first and only product won Food & Drug Administration approval, the controversial New York-based biotech company announced on Jan. 24 that it has hired investment bank Lazard to explore a possible sale, merger, or strategic alliance. Advertisement
But industry analysts are skeptical that the company will succeed in its quest for a mate. "When you are serious about selling a company you approach likely buyers in a non-public manner," says S.G. Cowen analyst Eric Schmidt. "The history of these kinds of announcements is that they rarely lead to a definite transaction."
Just ask Serono. The Swiss biotech, which specializes in multiple sclerosis and infertility drugs, has been trying to sell itself since November, with no luck. On the same day that ImClone announced its own availability, Serono reported that it was continuing to examine strategic options, a sign that the Jan. 20 deadline it set for bidders came and went without anyone coming forward.
SLOWING SALES. ImClone and Serono have the same liabilities: a limited number of drugs on the market and thin pipelines of hopefuls. ImClone has the added disadvantage of imminent competition. Sales of Erbitux, ImClone's first-in-class drug for colon cancer, have been steadily increasing since it hit the market in 2004.
Bristol-Myers Squibb (BMY) markets the drug in the U.S., and in the fourth quarter of 2005 royalty payments for Erbitux rose to $52.6 million from $36.5 million a year earlier. But biotech giant Amgen (AMGN) has a rival drug, Panitumumab, that is widely expected to win FDA approval in 2006. If and when it does, Erbitux sales are likely to slow.
It appears that ImClone's existing partner isn't keen on any closer ties. After ImClone announced that it was on the block, Bristol-Myers issued a statement saying that it recently learned of ImClone's decision "and we understand that as the process moves forward they will continue to consult with their partners, including BMS." Hardly an expression of overwhelming interest.
REVOLVING DOOR. Bristol may still have a bitter taste in its mouth from paying an eye-popping $2 billion for a 20% stake in ImClone and marketing rights to Erbitux back in September, 2001. Three months later, the FDA refused to accept ImClone's application for the drug, because it didn't like the design of the clinical trials used to prove Erbitux's efficacy. The stock price plummeted and the ensuing insider-trading scandal landed ImClone founder Samuel Waksal in jail, along with his close friend Martha Stewart (see BW Online, 7/16/04, "A Split Sentence for Martha").
ImClone's stock has been on a roller coaster ever since, dropping as low as $5.24 in mid-2002 , when Waksal went to jail, and soaring to more than $80 in mid-2004, shortly after Erbitux reached the market. On the day ImClone announced that it had hired Lazard, the stock rose almost 4% to close at $35.36.
ImClone also announced a new acting CEO, the fourth chief executive in its history. The first was Sam Waksal
http://yahoo.businessweek.com/technology/content/jan2006/tc20060125_754504.htm
Simonetti news (ex-DNDN CFO)
Friday, January 6, 2006
Ex-Dendreon exec joins VLST Corp.
Biotech picks Simonetti as new CEO, president
By BRAD WONG
SEATTLE POST-INTELLIGENCER REPORTER
When Martin Simonetti left Seattle's Dendreon Corp. in July, the biotech was focusing on bringing its lead product, a widely watched prostate cancer treatment, to market. It still is.
But instead of continuing there, as its chief financial officer, Simonetti has opted to work for a smaller Seattle biotech, a company years away from introducing any product to market.
VLST Corp. is announcing today that the 48-year-old has joined the biotech as its president and chief executive. It is developing therapeutics for autoimmune and inflammatory disorders.
In addition to hiring Simonetti, VLST is announcing that biotech pioneer Steven Gillis is joining its board as executive chairman. Gillis, co-founder of Immunex and Corixa, is a partner in the Seattle office of ARCH Venture Partners.
Simonetti's hiring comes as VLST is close to securing a second round of financing, said co-founder Craig Smith. Its first round brought in about $4 million.
Once the second round closes, the nine-person company will move into its own office and research space. That move would make VLST the first biotech to leave -- or "graduate" from -- the Accelerator Corp., the Seattle incubator that backs promising companies.
For Simonetti, working for a smaller company suits him fine. "I like to build things. This is an opportunity to be creative."
Launched in May 2004 by Smith and Steve Wiley, VLST studies how viruses survive in order to eventually identify targets to treat various diseases.
Simonetti said an autoimmune disorder could be something such as lupus. An inflammatory disorder, he added, could be something such as bowel disease.
So far, VLST has identified more than 70 targets. Eight of those are "novel," meaning that no other company has identified them, Simonetti said.
Smith and Wiley said Simonetti's business and research background impressed them. Simonetti has served in various scientific, research, operations and financial positions at Dendreon, Amgen Inc. and Genentech Inc.
"He knows the biotech world very well," Smith said. "We need someone like that at this stage."
Simonetti earned an MBA degree from the University of Santa Clara in California and a master's degree in nutritional sciences from the University of California-Davis.
One reason he wanted to lead a biotechnology company is personal, he said. In late 2004, his father and brother-in-law died, prompting him to examine his life and career. "I did some thinking about what I wanted to do," he said.
With 25 years of biotech experience, he also knows there is work to be done in his new positions.
"The challenge is to simultaneously build a business and march research forward," he said. "It's not simple. You need to keep focused."
And in his six years at Dendreon, Simonetti often worked up to 70 hours a week. Those long hours are likely to return for him at VLST.
But as many entrepreneurs, doctors and scientists in the region's biotech field know, the rewards -- whether medical, personal or financial -- can be huge.
More headlines and info from Eastlake.
P-I reporter Brad Wong can be reached at 206-448-8137 or bradwong@seattlepi.com.
http://seattlepi.nwsource.com/business/254691_vlst06.html
<I assume you know that the defunct biocrio account on iHub belonged to the poster who goes by thedoubledipper and various other aliases on Yahoo.>
Dew, no I did not know that, as I haven't been following this MB as long or religiously as some. But thanks for the background!
Looks like DNA beat the pants off GENR in 2005.
http://finance.yahoo.com/q/bc?t=1y&s=GENR&l=on&z=m&q=l&c=dna
biocrio was a good contrarian indicator.
New Products and Line Extensions are the Contributing Factors to Growth in the Four Major Cancer Markets
Tuesday December 20, 12:00 pm ET
DUBLIN, Ireland--(BUSINESS WIRE)--Dec. 20, 2005--Research and Markets (http://www.researchandmarkets.com/reports/c29800) has announced the addition of Cancer Therapeutics 2006: to their offering.
Together, the four major cancer markets, which include colorectal, prostate, lung and breast cancer were valued at well over $16 billion in 2005, which was an increase of 14 percent in value since 2004. Driving this growth are innovative new products, line extensions for existing products, and the coming of age of the biotech industry.
Our new report entitled Cancer Therapeutics 2006: Market Dynamics and R&D Trends examines these four major cancer markets in light of newly emerging therapeutics, shifting market shares and line extensions for major products on the market.
Features of this Report
market analysis by class, cancer type, product, company, and geographic region sales data from 2000 through Sept 2005 as well as full-year 2005 estimates profiles of leading products in the four major cancer markets and analysis of their market impact presentation and analysis of clinical data underscoring success of key therapies market share data for leading companies and products in the field SWOT analysis for key products in each market profiles of key emerging therapies and clinical data supporting development financial forecasts for the four major cancer markets 133 tables/graphs/diagrams illustrating historical sales data, growth rates and market share by product, class, therapeutic category, and company, company portfolios, pipelines, clinical efficacy data, as well as epidemiologic
data
Additionally, Cancer Therapeutics 2006 offers readers a critical examination of emerging and pipeline products in colorectal, prostate, lung, and breast cancer. Pipeline products with the greatest potential are assessed for their clinical efficacy and possible market impact. Briefs are provided for companies that are either firmly entrenched in one of these four cancer markets or are developing groundbreaking new drugs that are being designed to treat not only one of the leading four cancers, but other cancers as well.
Key Findings
The market for colorectal cancer therapies has increased by over seven-fold since 2000. The increase in the value of this market can be explained by new and improved chemotherapeutic agents now on the market, the introduction of key biologic therapies, and improved chemotherapeutic regimens which take into account various new options.
The value of the prostate cancer therapy market is over $2.6 billion in 2005. Hormone therapies continue to dominate the market, as they have proven to be the most effective at treating later-stage prostate cancer and are usually second in line to radiation therapy for patients with locally-advanced disease. However, with the looming approval of vaccines, angiogenesis inhibitors, and increased use of chemotherapy in metastatic disease, future treatment will take into account the benefits and disadvantages associated with ALL of these therapies.
The market for the pharmaceutical treatment of lung cancer is still largely dominated by cytotoxics in 2005-2006, although targeted therapies are beginning to make an impact. Continued uptake of Tarceva and potential approvals for Avastin, Zactima, Erbitux and other new therapies will offset the decline in value that has come as a result of patent expirations in this market.
The breast cancer market is the most vibrant and dynamic of the four major cancer markets. Currently, the market is divided between chemotherapeutic agents, anti-hormonals, and Herceptin. The strongest growth in recent years has been in the anti-hormonal sector. The overall value of branded products should increase significantly during the next five years. Uptake of aromatase inhibitors, targeted therapies, and new cytotoxic combinations should increase patient options and result in increased competition and better clinical outcomes in this dynamic market.
Topics Covered
1 Methodology and Executive Summary
2 The Global Impact of Cancer
3 Product, Company and Geographic Market Analysis
4 The Colorectal Cancer Therapy Market
5 The Prostate Cancer Therapy Market
6 The Lung Cancer Therapy Market
7 The Breast Cancer Therapy Market
8 Company Briefs
Appendices
Tables
Graphs
Diagrams
Companies Mentioned
Abgenix, Aeterna Zentaris, Amgen, Antigenics, Antisoma, Aphton Corp., AstraZeneca, AVI Biopharma, Biogen Idec, Biomira, Bristol-Myers Squibb, Celgene, Cell Genesys, Chiron, Dendreon, Eli Lilly, Genentech, Genitope, Genmab, Genta, Genzyme (Oncology), GlaxoSmithKline, Hybridon, Igeneon, ImClone Systems, Intracel Holdings Corp, Lorus Therapeutics, Medarex, MedImmune, Novartis, Pfizer, Roche, Sanofi Aventis, Schering, Schering-Plough, Seattle Genetics, Therion Biologics
For more information visit http://www.researchandmarkets.com/reports/c29800
Contact:
Research and Markets
Laura Wood
Fax: +353 1 4100 980
press@researchandmarkets.com
http://biz.yahoo.com/bw/051220/20051220005040.html?.v=1
DNDN post by saft_stock_trader on yahoo.
Mentioned on CNBC. Up 6.5% on 300k vol the first 1/2 hour fwiw.
http://finance.messages.yahoo.com/bbs?.mm=FN&action=m&board=1600905258&tid=dndn&sid=...
Guy named Michael Shulman, analyst with some firm which I did not catch, named DNDN as one of his biotech picks due for a 'breakout' (his words) in 2006.
Also said it is currently out of favor, but the fda seems to support them.
Also said the results of their trials were very positive (can't remember the precise words he used).
That was it. It was short and sweet.
Great article Dew, especially to support what I've been doing for the past 19 years as a Type 1 diabetic (trying to eat right, daily exercise, close monitoring of blood sugars, and good management of insulin shots).
I've been keeping my A1c in a range of 5.7-6.4, and have NO measurable adverse affects to my eyes, kidneys or feet.
It requires one to work diligently, and of course have a higher chance of hypoglycemia, but if you also test your blood sugar often enough (I do 8-10 x day) you can catch lows before they get too low.
Unfortunately, I believe even if doctor's were more aggressive in their push to have patients improve their control, the results come down to the patient's willingness to change their behavior. That is the single most important barrier.
Have a great holiday!