Investors of Antigenics Inc. (
AGEN) expecting big news from Wednesday's shareholder meeting were mostly disappointed with the fact that the conference call was just a rehash of recent events and was not the stage for a significant announcement. However, those who were disappointed by the lack of significant news were most likely just day and swing traders potentially looking to make a quick buck. For the long term shareholder, CEO Garo Armen provided some encouraging updates.
The regulatory process for Oncophage in Europe is moving along smoothly. Mr. Armen stated that, although the EMEA has come back to the company with various questions, nothing up to this point has indicated that Oncophage would be denied approval. Antigenics, as well as shareholders, will be anxiously awaiting news of an EMEA decision.
The launch of Oncophage in Russia is close, with only some administrative matters needing to be resolved before sales commence. Mr. Garo expects to see a revenue stream from those sales in short time. Additionally, Oncophage will participate in a named patient program that will reach various countries around the world, adding to the possibility of an additional imminent revenue stream.
Garo also noted that QS-21 is "very profitable" for Antigenics because, due to its licensing agreement with GlaxoSmithKline (
GSK), it costs the company "very little" to progress through the pipeline. Garo was also quick to note that GlaxoSmithKline is the world leader regarding vaccines. His statement was in the context of QS-21, but it immediately sparked my curiousity and re-ignited my own speculation that GSK and Antigenics, with an already existing partnership, would make for a perfect marriage right now. If GSK is king of the vaccine world now, imagine if they added the world's first approved cancer vaccine, Oncohphage, to their repertoire.
Antigenics has given no indications that they are looking for a buyer or that they are in advanced negotiations with a prospective partner for Oncohophage, but one could only assume that, behind the scenes, things are happening.
Especially when the company has been able to reduce its debt load from $50 million down to about $12 million, as Garo noted, by issuing shares for nearly a buck higher than the price for which they were trading on the open market. There's no way that those debtors take that deal unless they have extreme confidence that will be able to make some serious money in return.
In my opinion, the speed and precision with which Antigenics has wiped out most of its debt means that the company is looking at a buyout. That's purely speculation on my part, but there is something in the works that has debtors taking on shares for over $3.00 when they could have bought them for just over $2. It could be that a prospective buyer / partner is waiting on an EMEA decision before jumping in, but that's a risky proposition because an approval in Europe will significantly boost the value of Oncophage and adding tens of millions dollars, if not more, to any potential deal.
Thursday's trading could be choppy as the short term speculator had nothing to gain by Wednesday's conference call and will exit their positions in AGEN and look for the next swing move, but the long term investor should feel as confident as ever about this company and should take advantage of any dip in stock price, especially if it drops below two again.
If you bought in under a buck, HOLD longer, and add on dips if you're not satisfied with your position. If you bought in after the news presented at ASCO, BUY all you can for around $2.
When / if AGEN blows, it'll be quick (see: Dendreon (
DNDN)) and you might not get another chance.
LEXINGTON, Mass., Jun 17, 2009 (BUSINESS WIRE) -- Antigenics Inc. /quotes/comstock/15*!agen/quotes/nls/agen (AGEN 2.20, +0.26, +13.40%) today announced that GlaxoSmithKline (GSK) has launched a Phase 3 study with the world's most clinically-advanced malaria vaccine, RTS,S, which contains Antigenics' QS-21 Stimulon(R) adjuvant.
About QS-21 Stimulon Adjuvant
Antigenics' QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants under development. QS-21 has not only become a critical component in the development of preventative vaccine formulations across a wide variety of infectious diseases, but may also be essential in enabling a new generation of therapeutic vaccines to treat cancer, infectious diseases and degenerative disorders. QS-21 is currently being evaluated in approximately 20 vaccine indications, of which several are in late-stage clinical trials by Antigenics' licensees, including GlaxoSmithKline and Elan.
UPDATE 2-Merck to test stimuvax cancer drug in Phase III
Mon Jun 22, 2009 2:12pm EDT
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* Merck says will test drug against advanced breast cancer
* Company in race to bring cancer vaccine to market
* Oncothyreon shares jump 18 percent (Adds Oncothyreon stock movement)
FRANKFURT, June 22 (Reuters) - Merck KGaA (MRCG.DE) moved its experimental cancer vaccine Stimuvax into the third and last phase of testing required for regulatory approval to investigate its use against breast cancer.
Germany's Merck, which co-develops Stimuvax with U.S. biotech firm Oncothyreon (ONTY.O) (ONY.TO), said on Monday the trial, dubbed STRIDE(a), will involve patients with advanced, inoperable breast cancer.
The news sent the shares of Oncothyreon up 17.8 percent to C$3.04 on the Toronto Stock Exchange on Monday afternoon after touching a high of C$3.20 earlier in the day. On Nasdaq, the shares were up 16.7 percent at $2.66.
The small biotechnology company changed its name from Biomira and moved to the United States from Canada late last year.
Breast cancer is the second most common form of cancer after lung cancer and is the leading cause of cancer deaths in women.
The drug, which is also being tested against lung cancer in Phase III, has been shown to prime the body's immune system to detect and attack cancer cells.
Germany's Merck is racing with biotech firms including Transgene (TRNG.PA), Dendreon Corp (DNDN.O) and Antigenics (AGEN.O) to bring cancer vaccines to market.
While Transgene's TG4010 compound also targets lung tumors, the most common form of cancer, the Dendreon and Antigenics drug candidates are aimed at prostate cancer and brain cancer, respectively. (Reporting by Ludwig Burger and Scott Anderson in Toronto; editing by Peter Galloway)
Antigenics boosted by Glaxo malaria trials
Boston Business Journal - by Julie M. Donnelly
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GlaxoSmithKline has launched a Phase 3 study for a potential malaria vaccine, which contains a component developed by Antigenics Inc.
Lexington, Mass.-based Antigenics said that there are now four Phase 3 clinical studies for vaccines that include its QS-21 Stimulon component, which is designed to increase vaccine efficacy.
Under the terms of the license and supply agreements announced in July 2006, GSK (NYSE: GSK) will make payments contingent upon successful milestone achievements and will pay royalties to Antigenics on net sales for a period of at least 10 years after the vaccine’s first commercial sale.
Antigenics said recent Phase 2 malaria studies showed that, over an eight-month follow-up period, its so-called RTS,S component reduced clinical episodes of malaria by 53 percent and had a promising safety and tolerability profile when used alongside standard infant vaccines.
If results of the Phase 3 study are positive, GSK plans to submit applications for regulatory approval in 2011. If successful, RTS,S could be introduced in 2012 for babies aged 5 months to 17 months. GSK officials said if the drug is approved for use in infants and recommended by international and African health organizations, the company could make the vaccine more widely available by 2014.
Investors responded positively to the news, buoying Antigenic’s (NASDAQ: AGEN) stock over 8 percent in morning trading Wednesday to $2.10 a share, up from $1.94 at the previous day’s close
Investors Surging into Defensive Healthcare Stocks
President Obama's plans to cut healthcare costs have made some investors in the sector nervous, but across the board on Wednesday healthcare stocks were showing relative strength as investors sought out defensive names amid broader market weakness.
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{"s" : "abt,agen,bmy,dva,genz,gsk,jnj","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Stocks in the Big Pharmaceutical Stocks Index were putting up consistent gains. The Index is ahead by 1.6%. It is now ahead of the S&P 500 by 1% over the last month.
Blue chips like Johnson & Johnson (NYSE: JNJ - News), Pfizer (NYSE: PFE - News), Merck (NYSE: MRK - News), Bristol Myers Squibb (NYSE: BMY - News), and Abbott Laboratories (NYSE: ABT - News) were all up by 1% or more in early trading.
Stocks in the Biotechnology Stocks Index are also seeing action to the upside. The Index is ahead by 0.4%. It is now ahead of the S&P 500 by 9.2% over the last month.
Share of Molecular Insight Pharmaceuticals (NASDAQ: MIPI - News) are up more than 35% after the company presented positive data on a prostate cancer drug. Savient Pharmaceuticals (NASDAQ: SVNT - News) is up more than 30% after the company received a positive recommendation for its gout drug from the FDA.
Elsewhere in biotechs, Antigenics (NASDAQ: AGEN - News) is up more than 7% on news that GlaxoSmithKline (NYSE: GSK - News) has proceeded with late-stage clinical trials of a malaria vaccine that uses an ingredient developed by Antigenics. Genzyme (NASDAQ: GENZ - News), meanwhile, is rebounding after analysts at Oppenheimer and Jefferies maintained their outlook on the stock, despite news that the company will have to halt production on of its plants due to a virus.
Elsewhere in the sector, the Specialized Healthcare and Outpatient Services Stocks Index is up today by 1.9%. It is ahead of the S&P 500 by 4.6% over the last month.
Analysts at Bank of America relaunched coverage of several names in the sector. Dialysis services DaVita (NYSE: DVA - News) was initiated with a "buy" rating and a price target of $57. Inpatient behavioral healthcare services provider Psychiatric Solutions (NASDAQ: PSYS - News) also garnered a "buy" rating and a price target of $25. The stocks are up 3% and 1% respectively on the day. Leading the Index higher is U.S. Physical Therapy (NASDAQ: USPH - News) with a 5% gain.
As of this writing, though the market is showing broad weakness, 20 of 32 healthcare Indexes are trading in positive territory.
Investors can follow Indexes and view related performance charts and metrics at tickerspy.com.
Fun and informative, tickerspy.com is a free investing website where you can track multiple stock portfolios and compare against 250 proprietary Indexes tracking themes from nanotech to agriculture to precious metals. Best of all, tickerspy.com lets you spy on the portfolios of nearly 3,000 Wall Street institutions and hedge funds and see graphs of their performance. Try tickerspy.com today and find out how you stack up against investing legends like Warren Buffett!
Biodelivery Sciences, Antigenics: Biotech Stocks That Require Patience
by: VFC's Stock House July 12, 2009 | about: AGEN / BDSI
Another week has passed and there has still been no news released regarding the FDA approval of Onsolis, BioDelivery Sciences' lead drug candidate to treat pain in cancer patients.
While the FDA did not meet their timeline of June 15th for a decision, they indicated at that point that a decision was imminent and that there was no need to issue an extension letter. It's been nearly a month now since that announcement and, in VFC's opinion, a month is too long a time to not have issued an extension letter.
The fact that the silence following the FDA delay has been accompanied by a large amount of insider selling has investors understandably worried. The stock price has dropped from nearly eight dollars to under six in just a couple of weeks.
I still like the chances of an Onsolis approval, but I have to admit I've become a little more skeptical with each passing day without news. The insider sells don't worry me as much, as I've described here, as the time it is taking the FDA to release their decision.
It seems a bit irresponsible on the part of the FDA to leave such a gap between their self-imposed deadline and an actual decision without covering that gap with an official announcement as to why they are taking so long. I'm no employee of the FDA, but I do know that government agencies need to have proper paper trails to cover such eventualities (of course in many cases, as we all know, those paper trails lead to the shredder if the heat comes calling). That is, only if the government adheres to the same accountabilities that they impose on everyone else, which is also debatable.
Of note, the price decline of BDSI has offered an interesting entry point for those building a position in anticipation of Onsolis approval. That being said, I would not be a buyer at this point. Sometimes it is better to say "Too bad I missed out on that run" than to take a chance on a stock after it has already had a significant run and is looking more risky every day.
I like lower priced speculative plays like Antigenics (AGEN) or Cel-Sci (CVM) more than BDSI because both are filled with potential, but you're only risking two bucks and forty cents a share (respectively) than the six bucks that BDSI is currently trading for.
If Onsolis is approved, there's nothing wrong with missing the boat. If Onsolis is not approved, however, you'll be glad that you didn't buy in at six because the price will drop to under three again. At that point I'd address possibly buying again based on the BioDelivery pipeline which, as a speculative play, I like better at $3 than $6.
Again, do your own DD. I like the chances of an Onsolis approval, but I'm not too keen on the predictability of the FDA right now and would pass on BDSI if I was just looking to get in. But that's just me and I am holding long because I bought my shares on the cheap.
Antigenics
Shares of Antigenics (AGEN) have traded down the mid-$1 level this week on no news and fairly light volume. Some investors who purchased shares during the spike to $3 have grown worried as the priced has slowly declined.
I remind investors that, unless you are a swing / momentum / day trader, the day-to-day price swings of a mid to long term investment should not concern you. I purchased the majority of my shares in this company for sub $1, but I also bought at $2 and will undoubtedly purchase more, especially when I see where this current drop in price settles.
QS-21 and Oncophage offer a lot of potential for Antigenics and its stock, especially while GlaxoSmithKline (GSK) is working so closely with the company through an existing partnership.
In the near-term, news of Russian reimbursement for Oncophage should hit the wires soon followed by a commercial launch of the product in that country shortly thereafter. Then, later this year the EMEA should issue their decision on European approval.
Let's identify the risk:
* Oncophage does not gain traction in Russia and does not garner European approval.
* News on the progress of QS-21 is not encouraging.
If those two things happen, then the stock drops to sub $.50 before possibly recovering longer term.
The rewards, however, could be plentiful:
* Russian reimbursment and launch go according to plan.
* The EMEA approves the marketing, distribution and sale of Oncophage.
* QS-21 progresses.
If any of those three events take place, AGEN will prove to be a solid investment. If two of the three take place then we're looking at a $5 stock for the short term, in my opinion.
As time progresses, the effectiveness of cancer vaccines is looking better and better, as the last ASCO conference showed us, especially when used in patients who have less-progressed cancer. The biggest benefit of that success goes to the patients, but be assured, it will also be good to be an investor if the approval rumors start rolling in (see: Provenge, Dendreon (DNDN)).
If you bought AGEN for prices above the current trading levels, average down as the stock drops if, through your DD, you still consider the stock a worthwhile investment.
As for VFC, I'm averaging up right now- not something I like doing, but AGEN is on my list of a few 'cancer vaccine' companies that could become the next Dendreon.
Disclosure: VFC is long BDSI, AGEN.
Antigenics Inc. (NASDAQ: AGEN), a biotechnology company, engages in developing and commercializing technologies to treat cancers and infectious diseases, primarily based on immunological approaches. Its products include Oncophage (vitespen), a patient-specific therapeutic cancer vaccine registered for use in the Russia Federation, as well as under review by the European Medicines Agency for the treatment of kidney cancer patients with earlier-stage disease. The company tested Oncophage in phase 3 clinical trials for the treatment of renal cell carcinoma and metastatic melanoma; and phase 1 and phase 2 clinical trials for various indications, as well as in phase 2 clinical trial for the treatment of recurrent glioma, a type of brain cancer. Its product candidate portfolio also includes QS-21 Stimulon adjuvant, which is used in various vaccines under development in trials for diseases, such as hepatitis, human immunodeficiency virus, influenza, cancer, Alzheimeras disease, malaria, and tuberculosis; AG-707, a therapeutic vaccine program for the treatment of genital herpes; and Aroplatin, a liposomal chemotherapeutic for the treatment of solid malignancies and B-cell lymphomas. The company was formerly known as Antigenics L.L.C. and changed its name to Antigenics, Inc. in February 2000. Antigenics was founded in 1994 and is headquartered in Lexington, Massachusett
Antigenics
Shares of Antigenics (
AGEN) soared over thirty percent on Tuesday before retreating to close the day at $2.99. Volume was over three times the daily average and no significant news was released. Since there has not been a news release during the run up period, we can only speculate as to what is going on.
In my opinion, one of the following scenarios is taking place:
- The launch of Oncophage in Russia is imminent and the commercial launch will be accompanied by news of Russian government reimbursement,
- Rumors of a buyout or another significant partnership are circulating
- Significant news regarding QS-21 is to be released.
- Something big is brewing in the 'cancer vaccine' market that will positively effect associated companies. Shares of Dendreon (DNDN) and Oncothyreon (ONTY) have also traded with increased volatility lately.
I do not believe that an update on an EMEA approval decision for Oncophage is the reason for the spike; it's still a little bit too early for that.
Whatever the reason for the spike, this run looks like it's for real.
I'm a holder at this point, having accumulated while the stock traded for under a buck and then adding to my position while it traded for around two, but any investor that is still waiting on the sideline should be quick to grab a position. I wouldn't go all-in at this point, but I'd go in half of what you expect to put in AGEN and then wait to see if there is any sort of a pullback.
If a pullback takes place then average down; if the stock continues to rise, add at your own discretion depending on what, if any, news is released that would warrant a continued rise in price.
I've long considered AGEN to be a possible candidate to become the next DNDN and Tuesday's rise in price could just be a taste of things to come.
BioDelivery Sciences
On Monday I called it awfully suspicious that Adam Feuerstein decided to weigh in on BioDelivery Sciences (
BDSI) and Tuesday's trading action, after the Feuerstein piece, raises my eyebrows even more.
Somehow, in my opinion, and based on Adam's previous just as shady antics, he is involved with the mess that Elliot Associates is making of the post-Onsolis-approval BDSI stock.
For investors that are quickly losing patience, I maintain my position that BDSI is a solid Hold, if not buy, at these levels and I will certainly buy if it drops below five dollars.
With the unpredictability of the stock of late, I will not venture to say when I think the stock will bounce back but I will say that it's only a matter of time before it does.
For new investors looking to get in, buy now while the stock is dropping. As the time approaches for an Onsolis launch later this year, the stock price should recover.
For long time holders of BDSI, have patience.
Disclosure: VFC is long AGEN, BDSI.
FDA experts back Cervarix, new Gardasil use
By John Carroll Comment | Forward
In twin votes likely to add considerable force to U.S. marketing efforts for HPV vaccines, an FDA expert panel has voted to back GlaxoSmithKline's long delayed application to market its HPV vaccine Cervarix to women and soon after supported Merck's application to extend the use of Gardasil to males.
Glaxo had originally tried and failed to gain FDA approval for Cervarix back in 2007 but was thwarted by the agency's desire to see more information on potential side effects, particularly a heightened risk of miscarriage. Since that time the pharma giant has gained approvals in more than 100 countries, while biding its time with the FDA. And while the panel concluded that the link between Cervarix and miscarriages is tenuous, the experts suggested a warning to prevent pregnant women from getting the vaccine. The panel vote makes it all but certain that Glaxo will gain final marketing approval from the FDA, opening the door to the world's biggest drug market and finally offering Merck some competition for Gardasil. Glaxo's shares were buoyed by the news.
Merck, meanwhile, is seeking an FDA approval to use its HPV vaccine to guard against genital warts in boys and men. The panel gave Merck its support, but there was widespread agreement that the use of an HPV vaccine for males 9 to 26 offered little protection against cancer, as HPV-related penile and anal cancer cases are extremely rare. The FDA has indicated that any final approval on Gardasil's use in males will require post-marketing safety studies.
EXINGTON, Mass. (
TheStreet) -- I spent a very long day at the Rodman & Renshaw investor conference Wednesday (Amtrak's Acela between Boston and New York City is a nice way to travel, but roundtrip in a single day? Arduous).
I'll have updates and news from my Rodman conference trip over the next several days, but let's get started with
Antigenics(
AGEN). The company's royalty rate for its experimental vaccine adjuvant QS21 ranges from 1.5% to 6% depending on the vaccine, but is generally in the low single digits, said CFO Shalini Sharp in a response to my question after her presentation.
I'm glad she answered the question because the company hasn't been willing in the past to shed much light on the QS21 royalty rate agreements it has with various partners who are developing vaccines containing the Antigenics' adjuvant as a booster.
The not-so-good news for Antigenics is that a low single-digit royalty rate doesn't bring in that much money, especially compared to the company's current valuation.
For example, let's assume that
GlaxoSmithKline's(
GSK) malaria vaccine (which contains QS21) is launched in 2011 and peaks at $1 billion in sales by the end of 2014. I'm going to also assume Antigenics' royalty rate at 1.5% (likely since a malaria vaccine is a low-margin product sold primarily in the undeveloped world.)
That works out to $15 million in royalty revenue for Antigenics. But of course, that's five years in the future, so the net present value of that revenue today is just over $7 million. At a multiple of six times, that's worth just under $43 million in current enterprise value, or 48 cents a share, for Antigenics.
Antigenics Vaccine Booster Baked Into Valuation: BioBuzz
09/10/09 - 11:35 AM EDT Leave a Comment
I'll have updates and news from my Rodman conference trip over the next several days, but let's get started with Antigenics(AGEN Quote). The company's royalty rate for its experimental vaccine adjuvant QS21 ranges from 1.5% to 6% depending on the vaccine, but is generally in the low single digits, said CFO Shalini Sharp in a response to my question after her presentation.
I'm glad she answered the question because the company hasn't been willing in the past to shed much light on the QS21 royalty rate agreements it has with various partners who are developing vaccines containing the Antigenics' adjuvant as a booster.
The not-so-good news for Antigenics is that a low single-digit royalty rate doesn't bring in that much money, especially compared to the company's current valuation.
For example, let's assume that GlaxoSmithKline's(GSK Quote) malaria vaccine (which contains QS21) is launched in 2011 and peaks at $1 billion in sales by the end of 2014. I'm going to also assume Antigenics' royalty rate at 1.5% (likely since a malaria vaccine is a low-margin product sold primarily in the undeveloped world.)
That works out to $15 million in royalty revenue for Antigenics. But of course, that's five years in the future, so the net present value of that revenue today is just over $7 million. At a multiple of six times, that's worth just under $43 million in current enterprise value, or 48 cents a share, for Antigenics.
I'm not probability adjusting for the malaria vaccine's success (I'm assuming 100% that it works and reaches $1 billion in sales) so even these calculations are a bit on the high side.
If I add two more vaccines to this valuation exercise, one generating $1 billion in sales and another $500 million in sales, both by 2015, and give Antigenics a higher, 3.5% royalty, the total enterprise value today for Antigenics is $173 million,
or $1.90 a share.
Throw in the company's cash and you're basically at par with Antigenics' current valuation.
Would you give 100% odds to three QS21-containing vaccines reaching the market and generating $2.5 billion in sales within the next five years? I wouldn't, which is why Antigenics is actually over-valued today.
And no, I don't give any valuation credit to Oncophage, the company's kidney cancer vaccine for reasons I've made abundantly clear previously. It doesn't work.
In her comments Wednesday, Antigenics' CFO Sharp didn't sound very confident on Oncophage either. The company is offering no timeline for the launch of the vaccine in Russia, the only country where it's approved.
"The timeline is uncertain at this point," said Sharp, when asked about reimbursement negotiations between Antigenics and the Russian government.
Whatever timelines Antigenics has offered for Russian sales of Oncophage are clearly slipping away fast.
TOKYO (Reuters) – Japan's health ministry is set to buy enough H1N1 flu vaccine for nearly 50 million people from British drug maker GlaxoSmithKline and Switzerland's Novartis, a Japanese newspaper reported on Friday.
The country can produce enough vaccine for about 18 million people but the government hopes to push that figure close to 70 million with the added imports, the Asahi newspaper said.
The government will spend about 100 billion yen ($1.1 billion) to buy enough vaccine for 35 million people from GlaxoSmithKline and for another 12 million from Novartis, the paper said.
Talks on the purchases were supposed to have ended in July but liability concerns delayed the process, the Asahi added. The government hopes to begin administering the vaccines by late December.
A spokeswoman for Glaxo in London said the British drugmaker was currently in discussions with the Ministry of Health, but the talks had not yet reached a conclusion. Novartis had no immediate comment.
The World Health Organization said in late August that the new H1N1 swine flu had reached epidemic levels in Japan, signaling the early start to what may be a long influenza season this year.
Japan's Chugai Pharmaceutical Co Ltd, a subsidiary of Swiss drugmaker Roche, said on Monday that in addition to its current stocks of the influenza drug Tamiflu, it would obtain supplies for 12 million people in Japan until March 2010.
like Antigenics(AGEN Quote). Thanks a lot for providing a professional viewpoint. I wanted you to know that there are a lot of real investors out here who really appreciate it."
Speaking of Antigenics, Stan M. takes issue with my valuation metrics for the company's vaccine adjuvant candidate Q21.
"Your low-ball estimates for Antigenics royalty income from QS21 are ridiculous, especially when the company has already told us that it expects $500 million in peak royalty revenue," writes Stan, adding. "Get a life!"
Sorry, that's wrong. What Antigenics' CFO Shalini Sharp said Wednesday was that $500 million in royalty revenue represented the total market potential if all QS21-containing vaccines garnered 100% market share in malaria, flu, cancer etc.
She did not say that Antigenics expects to receive $500 million in royalty revenue from QS21.
Think about it this way: If Antigenics received a 3.5% royalty (low-single digits) on sales of all QS21-containing vaccines, it would take more than $14 billion in vaccine sales to kick back $500 million in royalty revenue.
You believe Antigenics' partners are working on $14 billion worth of peak vaccine sales? Really?
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DNDN: Shares of Dendreon (Stock Quote, News and Research" target="_blank" href="/symbol/DNDN">DNDN) traded higher by nearly eight percent during early trading on Monday after it became apparent that the company had recently appointed two new members to its Board of Directors, one being the Chief Executive of Genentech, Ian Clark and the other being Pedro Granadillo, a one time executive for Eli Lilly & Co.
The appointment of Clark has fueled speculation that a partnership deal (with Roche) is imminent since Genentech is wholly-owned by Roche after a recent merger between the two companies. The DNDN stock price has now approached the thirty dollar level, most likely the result of speculation after the board appointments - in my opinion.
Dendreon, for those not familiar with the situation, is looking to have the company's prostate cancer immunotherapy treatment (Provenge) approved by the US FDA sometime in 2010. Barring any unforeseen delays, the FDA decision should come at sometime in the first half of next year since Dendreon intends to file for Provenge approval in November of this year, according to previously released reports. In a recent Phase III trial, Provenge proved to extend the survivability of patients who received the treatment.
While a US partner is a possibility, Dendreon has previously indicated that they would rather 'go it alone' in marketing Provenge in the United States, but would be open to a 'Rest of World' partner - that's where Roche would come into play.
If Provenge is approved by the FDA next year, then I would expect a pretty significant run in the 'cancer immunotherapy' sector. Stocks such as AGEN and ONTY, both also working on their own immunotherapy treatments, would be sure to benefit from such a run - among many others.
Provenge, if approved, would also become the first approved cancer vaccine in the United States. Antigenics' Oncophage claims the title as the the world's first approved cancer vaccine after the Russian medical authorities approved the vaccine for the treatment of kidney cancer in April of last year.
The Provenge story has been long and marred with protest, controversy and conflicts of interests - namely by two Doctors who served on the FDA's advisory committee for Provenge in 2007 - but it looks like Dendreon and and the thousands of prostate cancer patients who have lobbied for the vaccine's approval will finally have their day in the sun.
As always, it's important to keep in mind that the FDA is a fickle and unpredictable bunch, so only time will tell what the final outcome for Provenge will be.
That being said, things have never looked brighter for the company after bringing two big time heavyweights on board to help bring Provenge to market.
Disclosure: No position in DNDN, long AGEN and ONTY.
The Big Money
Can Innovation Save the Economy?
Sunday, October 18, 2009
For all the discussions of "green shoots" in housing or consumer spending over the past few months, too little attention has been paid to a classic American economic advantage: innovation. If cash flow is the blood of the global economy and spending and investment are its main arteries, then innovation is the heart that does the pumping.
Over the long term, innovation is what drives cost reduction, higher employment, spending, health care, investment and ultimately, better living standards. Many business owners see it as their No. 1 priority. When consulting group McKinsey asked executives in February where the government should direct the majority of its stimulus spending, 59 percent of respondents said on "fostering innovation and potential new industries," putting it in the top spot, even before potential solutions such as "helping workers who have been laid off" or "helping existing companies."
So here's some good news: Right now, the economy is abundant with innovation -- so much so that it might end up saving the day or, at least, making the way for future prosperity. In some sectors, there are signs that it is already. After years of intensive research and development, a band of small biotechnology companies is teaming up with larger drug producers to rush out what many scientists consider to be an effective replacement for chemotherapy, a painful and traumatizing stopgap to cancer. Immunotherapy drugs aim to stimulate the body's natural immune system so that it can attack or destroy tumors on its own, without the need for invasive radioactive treatments.
So far, the drugs, many of which are undergoing Phase 3 trials by the Food and Drug Administration, seem to be working pretty well. Dendreon, which manufactures Provenge, a prostate-cancer drug, said in April that its drug had proven to be safe in the Phase 3 stages of its FDA trial and had extended the life span of patients by an average of four months, compared with 2 1/2 months from Sanofi-Aventis' conventional Taxotere vaccine. As a result, the share price of the $2.6 billion biotech has risen about 800 percent this year.
Antigenics, a drug developer for small-cell cancer, has also entered its flagship product, Oncophage, into Phase 3 trials. In June, GlaxoSmithKline launched a Phase 3 study for a new malaria vaccine, which includes an adjuvant provided by Antigenics. Shares in Antigenics have soared more than 300 percent this year.
All the excitement over revolutionary cancer medicine has led to the creation of an index designed just to track the leading developers' shares. Mentor Capital's Cancer Immunotherapy Index, which tracks 10 cancer immunotherapy drugmakers, has risen nearly 30 percent since it was created July 10.
There are signs of innovation in other corners of the economy, too. The urgency for the development of cleaner and cheaper fuels has notched up a gear as oil prices have been on the rebound this year. In August, Rentech, a synthetic fuel maker, signed a contract with eight airlines, including Delta, United and Continental, to provide fuel for their ground service operations at Los Angeles International Airport. That led to an upgrade of its shares by Raymond James & Associates analyst Pavel Molchanov to "Market Perform," and a subsequent doubling of the firm's stock price. Other fuel producers, such as Synthesis Energy Systems and Syntroleum, have fared similarly.
For these small companies, excitement generated by exterior circumstances over their products is not just a short-term trading advantage: It represents an opportunity to raise much-needed capital to keep surviving, growing and, ultimately, innovating. "Quite simply, higher oil prices draw more investors to Rentech's stock," Molchanov said in an interview. "Higher oil prices also support the company's underlying business model."
This year's concentrated rally in the share prices of the small biotechs and synthetic fuel producers has made for exactly that. It could possibly end up reducing costs and creating jobs in the near future, too. For example, Rentech raised $15 million from investors at the end of August and a further $20 million at the end of last month.
Others are aiming to combine industries to propel growth in different ways. Philadelphia-based e3Bank is what founding Chairman Sandy Wiggins describes as "a green triple-bottom line financial institution." The bank seeks to be just like any other commercial bank that makes loans and receives deposits guaranteed by the Federal Deposit Insurance Corp., except that it will give incentives in the form of reduced interest rates to corporate and retail customers who build more environmentally-friendly buildings and act in a greener way.
Such innovative-industry hybrids now dominate the IPO market. In the past two months, 20 hybrid companies have filed for a public listing out of a total of 31 this year. Of the companies that are looking to raise money, the majority are health-care and education providers that use technology to differentiate their products or services and real estate investment trusts, which are taking advantage of the recent downturn in house prices, according to Bill Buhr, an IPO strategist at Morningstar. "There is a lot coming out of these industries, and we will continue to see a lot coming out of these industries," Buhr said in an interview. "What you're seeing now is a lot of high-quality companies coming to market, whereas four or five years ago everyone and their brother came to market."
LONDON--(BUSINESS WIRE)-- Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), of the
European Medicines Agency (EMEA), has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) in early-stage, localized renal cell carcinoma (kidney cancer).
Antigenics will evaluate its options, including an appeal of this decision, after the CHMP has formally adopted an opinion at the November 2009 plenary meeting. The patient population for which approval is being sought represents a major unmet medical need. There are no approved drugs in Europe or the United States for the post-surgical treatment of adjuvant kidney cancer, a disease characterized by a high risk of recurrence. Antigenics believes clinically relevant benefits were demonstrated with Oncophage in both recurrence-free survival and overall survival endpoints and that this benefit has persisted for nearly five years.
"With the considerable support of the urology and oncology communities, we will continue to evaluate our options for making Oncophage available to kidney cancer patients in the EU," said Garo Armen, Chairman and CEO of Antigenics.
About Oncophage
Antigenics has treated nearly 800 patients in clinical trials throughout North America and Europe with Oncophage produced in their commercial facility located in Lexington, Massachusetts. Studies with Oncophage have demonstrated efficacy signals in multiple cancers, including melanoma, glioma, colorectal, pancreatic, renal cell carcinoma, gastric cancer and non-hodgkins lymphoma.
In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Pre-commercial launch activities are ongoing.
Derived from each individual's tumor, Oncophage contains the 'antigenic fingerprint' of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in Phase 2 trials in recurrent and newly diagnosed glioma.
Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.
In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer, accounting for almost 90 percent of all kidney tumors. According to a report in the Annals of Oncology, there were more than 63,000 new cases of RCC diagnosed in 2006 along with 26,000 deaths related to the disease.1 Despite earlier detection, patients with locally advanced disease face a poor prognosis, with a 5-year survival rate of approximately 50 percent due to recurrence of disease. Currently, no approved therapies exist in the EU for use in localized disease.
Antigenics (
AGEN): The recent news regarding Oncophage in Europe hit the stock pretty hard, but the long term potential of Antigenics is still alive, in my opinion.
The glioma trials look promising enough to date. I don't believe that Oncophage for the treatment of kidney cancer is DOA just yet and QS-21 is alive and well.
While I do believe that any positive news from Russia regarding the Oncophage launch in that country (combined with news of Russian government reimbursement) would be good for both the company and the stock, I consider AGEN more in the 'Phase II' portion of my portfolio - alongside Pharmacyclics (PCYC), Peregrine (PPHM) and Keryx Biopharmaceuticals (KERX).
I'll wait and see how low this one goes before adding more shares, but I consider Russia news a possible short term mover, QS-21 updates a mid term mover and Oncophage a long term mover.
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dice che AGEN è + avanti nel senso che è il primo ad aver ottenuto un approvazione per un vaccino contro il cancro (per la Russia).
Peccato che AGEN abbia finora fallito in tutti gli altri paesi in cui ha provato ad ottenere l'approvazione, mentre dndn non ha ancora il responso, chi vivrà vedrà.
Certo che dndn quota talmente tanto che un suo fallimento gli farebbe fare un -95%, e non si esclude che un approvazione eventuale sia venduta.
Agen quota veramente poco per tutti i progetti che ha in moto, però ha fallito molte volte in passato
Antigenics Oncophage Well Ahead of Dendreon (NASDAQ:AGEN)
6658
(29 votes, average 3.90 out of 5)
Written by Joseph Krueger
Monday, 12 April 2010 19:42
1diggdigg
Antigenics, Inc. (Nasdaq:AGEN) Oncophage, not Denderon’s Provenge, is the First Cancer Vaccine to Gain Approval
Active cancer immunotherapy treatment of cancer (“cancer vaccines”) refers to agents which rely on the body’s immune system to ward off cancer. Immunity against one’s own cancer can be induced (theoretically) by either applying an external stimulus to the immune system to “activate” it against the cancer or by provoking the immune system to attack a tumor specific protein by immunizing patients with man-made copies of that protein. The basic premise of immunotherapy is to directly treat cancer, but after repeated failures as a single agent, it is more often used in combination with traditional treatments like radiation, chemotherapy, and surgery in order to enhance their effects. Immunotherapy does not result in the toxicity seen in these approaches and can be easily combined, allowing for a different angle of attack on cancer.
Currently no cancer vaccines are approved in the US. However, all eyes are currently on Dendreon Corporation’s (Nasdaq:
DNDN) Provenge (sipuleucel-T) for the treatment of castration-resistant metastatic prostate cancer. The Prescription Drug User Fee Act (PDUFA) date for Provenge is assigned for May 1, 2010. This near event has excited investors: Shares of Dendreon went from about $5 in March 2009, to about $40 recently ($5 billion market cap). Beyond Provenge, investors are becoming excited by a resurgence of enticing progress utilizing cancer immunotherapies: Cell-Sci (
CVM) is gearing up to manufacture sufficient Multikine to run their pivotal phase III trial in head and neck cancer. Bristol-Myers Squibb Company (BMY) announced that they will present the data from their phase III trial at the American Society for Clinical Oncology (ASCO) in June 2010. In addition, GlaxoSmithKline may present mid term data on their immunotherapy phase III clinical trial in lung cancer at ASCO. In addition to these much anticipated results, there are nearly a dozen other companies who are running phase III trials utilizing active immunotherapy, and the “fever” (no pun intended) is starting to spread.
One currently overlooked company who is in fact much farther along than all the above mentioned companies is Antigenics (Nasdaq:
AGEN). Since its inception in March 1994, Antigenics has been developing Oncophage (vitespen). Oncophage is a therapeutic cancer vaccine that is patient-specific, meaning it is derived from the patient's own tumor. In contrast, Provenge is a vaccine derived from an external immunogen specific to prostate cancer. Although Dendreon’s Provenge is being touted as the first to potentially gain approval, Antigenics already gained approval for Oncophage from the Russian Ministry of Public Health for the treatment of kidney cancer patients in April 2008. The Russian registration was Antigenic’s first product approval from a regulatory authority, and the first approval of a patient-specific therapeutic cancer vaccine in a major market. So even though Provenge looks to be the closest to gain approval in the US, they really cannot boast of being the first biotech company with an approved cancer vaccine.
Source:
http://www.antigenics.com/news/2008/0408.phtml
Like the dozens of companies who have come and gone trying to develop cancer vaccines to treat various forms of cancer, Antigenics has had its past failures (even Provenge failed its first trials). In 2006, Antigenics announced top-line results from the first part of the phase III study of Oncophage in renal cell carcinoma. The trial did not meet its primary endpoint, and they subsequently announced the termination of part II of the trial. Based on the Russian approval of Oncophage, Antigenics had submitted a marketing authorization application to the European Medicines Agency ("EMEA") requesting conditional authorization of Oncophage in earlier-stage, localized kidney cancer. Unfortunately, the Committee for Medicinal Products for Human Use ("CHMP") of the EMEA revealed a negative opinion for this approval in October 2009 and subsequently Antigenics withdrew the MAA. This decision was based on strategy and deficiencies in the trial design, not necessarily efficacy.
Clinical Studies:
Like Dendreon and Provenge, Antigenics is learning from their mistakes with Oncophage and are proceeding with the trials to gain FDA approval for Oncophage for renal cell carcinoma. The Eastern Cooperative Oncology Group (ECOG) is currently sponsoring a large adjuvant renal cell carcinoma trial that stratifies patients by certain prognostic risk factors for recurrence, and puts patients into intermediate risk, high risk, and very high risk categories. They are applying these definitions utilizing the data generated from the failed phase 3 trial of Oncophage in renal cell carcinoma. In the ECOG study, Antigenics found that in the intermediate risk group, significant improvement in favor of the Oncophage arm was demonstrated. At the 2009 ASCO annual meeting, they announced results of an interim analysis from the ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46 percent lower risk of death when treated with Oncophage cancer vaccine after surgery compared with no treatment (n = 362; P < 0.05; hazard ratio = 0.54).
This study is following patients until March 2010, an additional three years from closure of the initial trial, providing more than five years of data collection following the enrollment of the last patient in the trial. Perhaps more importantly to investors, the trial follow-up was scheduled to be completed just last week. Antigenics has not yet announced that they will release the concluding data from March at ASCO in June, but in the tradition of “late-breaking-abstracts”, which makes ASCO a much watched event, I expect to hear about this data soon.
But this is not all investors may hear about soon: Oncophage is currently in Phase 2 clinical trials in glioma, a type of brain cancer. This study is being lead by the Brain Tumor Research Center at the University of California, San Francisco ("UCSF"), with grants from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence. Phase 1 results presented at the Society for Neuro-Oncology Annual Meeting Conference in November 2008 showed that Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months, with four patients surviving beyond 12 months and one patient surviving almost 2.5 years. The study also showed that all 12 treated patients demonstrated a significant immune response after vaccination with Oncophage (P < 0.001) and that patients with minimal residual disease at time of first vaccination (n = 7) were more likely to survive beyond nine months compared with patients with significant residual disease.
Interim data from the Phase 2 portion was presented at the Society for Neuro-Oncology meeting in October 2009. This data showed a median survival of 10.1 months in the first 20 patients treated with Oncophage, and that to date six patients (30 percent) had survived at or beyond 12 months. This early data shows an improvement in overall survival over the previous long-established historical median survival of 6.5 months, and is also slightly favorable to the recently reported median survival of 9.2 months with Avastin(bevacizumab) in patients with recurrent high-grade glioma. UCSF also recently initiated an additional Phase 2 clinical trial in newly diagnosed glioma testing Oncophage in combination with Temodar (temozolomide). Antigenics has stated that they anticipate updating on this trial in mid 2010. Given the timing, I would also expect to hear a significant update on this trial around ASCO time.
In addition to its testing in phase III clinical trials for the treatment of renal cell carcinoma, Oncophage has been tested in a phase I trial for the treatment of metastatic melanoma, and in Phase 1 and Phase 2 clinical trials in a range of indications. Antigenics is exploring the steps necessary to seek approval of Oncophage in other markets directly through one or more partnering arrangements. They have stated that they have had formal and informal discussions with international regulatory authorities, key opinion leaders, and consultants with country-specific regulatory experience regarding potential applications for full or conditional marketing approval, and/or named patient programs. Antigenics have stated that they will seek a meeting with the FDA to discuss the results of the updated analyses from their Phase 3 renal cell carcinoma to determine whether there is an opportunity to file a BLA on the basis of these results.
Financial Condition:
Antigenics has about $20 million in cash, which the company states should fund them into mid 2011 at their current burn rate. Antigenics does have incoming cash flow, and were even cash flow positive last quarter due to milestone payments and licensing fees from their QS-21 investigational vaccine adjuvant. Over a dozen experimental vaccines containing QS-21 are in clinical-stage development; some by giant partners such as GlaxoSmithKline (GSK). Antigenics is entitled to receive milestone payments as these vaccine programs advance in development as well as royalties for at least 10 years after commercial launch.
With a market cap of about $80 million, a vaccine that is the truly first-in-class, partnerships, and far-along trials, AGEN seems undervalued. Compared to the massive market cap of Dendreon, it seems a steal. I expect that investors will take notice of AGEN now, given all the recent excitement DNDN is spreading. The near catalysts mentioned could have a dramatic effect on the company’s share price and future potential, and between now and ASCO(June 2010) should be an exciting time for AGEN investors. I look forward to seeing where AGEN goes in the next couple of months.
Updates on AEZS, AGEN, CXM
Posted by Patrick On Tuesday, May 11, 2010 1 comments
These two have caught the majority of my attention the last week or so and they will for the next few weeks. The other has been a long term interest of mine.
They have both had solid trading volume and I hope those who did their follow-up research on AGEN got in today. It even opened up a nice entry point if you missed it in the morning. It hit closed at $1.29 but did not stop there. The volume continued into the AH trading session with 583,646 traded; hit $1.51 and settled at $1.49 (although my Zecco is showing $1.50). They traded about 15 times the daily average. I have emailed Investor Relations about the possibility for a forthcoming PR to confirm the results presented in the program for the 18th International Conference on Brain Research and Therapy. I will update you when I hear back. This after-hours volume is a very bullish signal in my opinion.
(SOURCE - NASDAQ)
More on the glioma trial we will hear more about from AGEN soon. The glioma study is lead by the Brain Tumor Research Center at the University of California, San Francisco ("UCSF"), with grants from the American Brain Tumor Association and the National Cancer Institute Special Programs of Research Excellence. Phase 1 results were presented at the Society for Neuro-Oncology Annual Meeting Conference in November 2008, they showed that the Oncophage vaccination following brain cancer surgery increased overall median survival to approximately 10.5 months. This includes 4 patients surviving beyond 12 months and 1 patient surviving almost 2.5 years. They also showed that all 12 treated patients demonstrated a significant immune response after vaccination with Oncophage (P < 0.001) and that patients with minimal residual disease at time of first vaccination (n = 7) were more likely to survive beyond nine months compared with patients with significant residual disease.
Antigenics has about $20 million in cash, which the company states should fund it into middle of 2011.
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AEZS had a healthy pullback today and those who are still intrigued by them should have another chance to get in. They have many future catalysts that I will lay out there.
1. Juergen Engel, Ph.D., President and CEO of AEterna Zentaris stated, "We intend to file, as quickly as possible, the NDA for the use of macimorelin (AEZS-130) as a diagnostic test for GHD in adults, the timing of which will depend on the outcome of the Company's discussions with the FDA and the completion of the clinical program ultimately agreed upon. We believe an approval for this indication can be achieved in 2011."(SOURCE- PR following complete Phase 3 trial)
2. In multiple myeloma, the SPA-agreed upon Phase 3 study is a double-blind, placebo-controlled study of perifosine combined with bortezomib (Velcade(R)) in bortezomib pretreated patients. Progression-free survival will be the primary efficacy endpoint in this trial, which will include follow-up for overall survival. The advice from the EMA indicates that, in principle, the proposed study is considered sufficient to provide all data necessary to support a marketing authorization of perifosine in combination with bortezomib (Velcade(R)).
3.Æterna Zentaris has also requested Scientific Advice for the development of perifosine in refractory advanced colorectal cancer, where the SPA-agreed upon Phase 3 study is a double-blind placebo-controlled study comparing the combination of perifosine and capecitabine (Xeloda(R)) with single-agent capecitabine (Xeloda(R)).
...
Dr. Juergen Engel, President and CEO of Æterna Zentaris stated, "We are very pleased with the outcome of our discussions with the European Medicines Agency so far. For the development of perifosine in multiple myeloma, we believe that the planned North American clinical program, which is sponsored by our partner Keryx, is sufficient to support an application for marketing authorization in Europe and the rest of the world. We are looking forward to the outcome of our discussions with the EMA which is expected during the third quarter of this year, regarding our development program in colorectal cancer." ( Source - EMEA advice )
4- Juergen Engel, Ph.D., President and Chief Executive Officer of Æterna Zentaris, commented, "We now look forward to the initiation and sponsorship by our partner, Keryx, of this key registration Phase 3 trial in refractory metastatic colorectal cancer in North America which they expect to complete in 2011, with product launch, in the USA, in 2012.
These data will be very supportive of our efforts to register perifosine in the rest of the world, and in some countries, we expect they will be sufficient to do so without any additional studies."
In addition to colorectal cancer, perifosine is currently in a Phase 3 trial, under a SPA, for the treatment of relapsed/refractory multiple myeloma, with Orphan Drug Status and Fast Track Designation granted. This trial is also sponsored by our partner, Keryx.( SOURCE - Fast Track approval)
5- TWST: What are major milestones for you next year?
Dr. Engel: For perifosine, potentially with our help, our partner Keryx will pursue enrollment for the ongoing Phase III study in multiple myeloma. Still, with perifosine a Phase III study in metastatic colon cancer is expected to be initiated by Keryx. We will also disclose additional clinical data on running Phase II and Phase I studies. One of the Phase I studies is being conducted in pediatric brain cancer at the Sloan Kettering Memorial Institute in New York. This could be very interesting because again, there is nothing currently available for these children. We will also continue to discuss with European regulatory agencies so that they will allow us to use the data from studies in the United States for approval in Europe. For AEZS-108, as I mentioned earlier, we expect to disclose final results for the Phase II study in endometrial and ovarian cancer by the end of the year, where we will be mainly looking at progression-free survival and overall survival. (SOURCE - Interview with CEO Engel)
As you can see, they have a lot going for them this year and we have only scratched the surface. Be a smart investor on this one or you may regret it.
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Lastly, I am going to talk about CXM. They seem to have come back to life ever since their quarterly report came back out. It confirmed that their 510(k) has yet to have a decision made on it. This is great news, since some investors have really been hurt by the lack of transparency in the 510(k) process. Obviously, there is the hope that we will hear something in the next month. I think volume will be a very good indicator of when we get close to decision time. I actually just got my shareholder packet from CXM today. It's a good read.
Good luck to all.
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I am still working on making some major changes to the site. Some of which I have not decided whether or not they will be free or very cheap($1-2/month or $12-24 a year). The reason being is that I want to continue to do this, but I also feel like I should be rewarded a bit more than my current AdSense revenue. Anyways, nothing has been decided yet and I will be sure to send out invites to a beta version. More on this at a future data
I prodotti principali comprendono Oncophage che è un vaccino cancro ed è usato per il trattamento del carcinoma renale e glioma, QS-21 Stimulon adiuvante utilizzata nel trattamento dell'epatite, influenza e cancro, un vaccino terapeutico utilizzato per il trattamento di herpes genitale e Aroplatin utilizzati nel trattamento dei linfomi AG-707.
Antigenics Inc è andato in partnership con GlaxoSmithKline per lo sviluppo clinico di 15 vaccini che contiene Antigenics prodotto QS-21 adiuvante fase di sperimentazione. Questi vaccini verranno utilizzati per la malaria, melanoma e cancro al polmone non piccola cella. Antigenics possederà i diritti e i canoni per almeno 10 anni dopo il lancio commerciali i vaccini. Si prevede che saranno lanciati il primi vaccini entro l'anno 2012-2013 e tutti lo sviluppo e le spese di marketing sono a carico licenziatari dell'azienda.
riassumendo direi che nel breve (al di là dei 15 vaccini 2012-13) questi sono gli eventi che possono lanciare il titolo
I rumors su possibile take over.
Il 20 maggio la presentazione dei dati su Onco (anche se già in qualche modo conosciuti-incremento del survival).
Il prossimo annuncio di partner per lo sviluppo e commercializzazione dei prodotti (soprattutto in russia dove sono in fase avanzata colloqui con 3 partner).
questo è un riassunto fatto
GA - 707 trial to be presented shortly by investigator, very excited because of some important neurological signals.
Switching gears to QS21 - Talking about partners and programs, nothing we don't know already. 15 products in development, 3 in stage 3 development and 5 soon in stage 3.
Very diversified interest being pursued with their own money saving us cash and giving great ROI.
In a position to collect significant royalties soon into 100's of millions with very little cost.
We have regained compliance with Nasdaq, so no problem with that.
Conclusion, it is our goal as management to maximize product line and with a strong conviction, privledge that we have resources to keep pressing forwards.
Hopeful that that technology will prevail and deliver shareholder value.
