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Preview of a Coming Attraction: Michael Milken, 60,000 Deaths, and The Story of Dendreon
http://www.deepcapture.com/preview-of-a-coming-attraction-michael-milken-60000-deaths-and-the-story-of-dendreon/
Deutsche Bank - Equity Research
Dedreon Corporation {Ticker: DNDN, Closing Price: USD 25.46, Target Price: USD 36, Recommendation: BUY}.
** Top 7 questions & controversies
(1) Is the pivotal data sound? (2) Is there risk to manufacturing?
(3) Can management deliver? (4) Will there ever be a generic
Provenge? (5) How big is the Provenge market? (6) What will the
sales ramp look like? (7) What is the stock worth? We rate the
stock Buy, based on our assumptions that Provenge will be approved
by 1H10 and that it will be a blockbuster therapy for prostate
cancer.
** Initiating at Buy - we assume Provenge will be approved in early
2010
Provenge is a personalized immunotherapy for metastatic prostate
cancer. Recently phase 3 data from IMPACT was released, confirming
two previous trials showing Provenge increases survival by ~4
months. The trial was conducted under a special protocol agreement
with the FDA. Dendreon expects to file in 4Q09, with approval early
2010.
** We believe the FDA is unlikely to find fault with the IMPACT study
Provenge was rejected in 2007 by the FDA following a positive Adcom panel on the basis that the two trials submitted did not define survival as a primary endpoint and statistical analyses were not predefined. We believe the data is strong enough for approval, given the survival benefit was significant across multiple subpopulations, even when adjusting for later lines of therapy. The fact that the data are consistent with previous trials and our view that the FDA will likely face public scrutiny, as it did following its last decision, support our thesis.
**We did a manufacturing deep-dive & believe CMC issues have beenresolved
The primary issues raised by the FDA in its 2007 inspection were bar
coding and lack of data supporting handling multiple samples at a
time. We believe DNDN has resolved all issues. The real risk in our
view is that scale up will not be fast enough to meet demand. We
address key manufacturing hurdles for DNDN in our report.
**We see at least 35% upside upon approval
We believe Provenge has the ability at peak to be a ~$1.8B+ product
in the US alone, with limited generic risk following patent
expiration in 2020. Our NPV analysis suggests 35%+ upside upon
approval in 1H10. Nevertheless, a lack of apparent near-term
catalysts could keep the stock range-bound near term.
**Valuation/Risks
Our one-year $36 target priced is based on a discounted cash flow analysis. Downside risks include FDA rejection of Provenge, delay of
approval, poorer-than-expected sales, and a lower price point.
(Please see pages 5, 9, and 34 for details)
> For those paying attention, the RPRX bashing may be a positive.
How so?
And what about Dew's frequent assertions that RPRX is a scam set up to dupe investors? Where was your criticism?
Given: 1) recent revelations about how (at least some) IHUB boards have allegedly operated as part of illegal stock manipulation schemes; 2) your penchant for pumping crappy little biotechs that decline in value; I'd say it is reasonable to think that something suspect may be going on here. I also find it humorous to see how one of the biggest spewers of venom in the biotech space reacts when a bit of criticism comes his way.
Is this another IHUB pump-and-dump board? If not, why is so much attention given to crappy little losers like IDIX and MNTA? And 10 baggers like DNDN are mercilessly bashed? Something doesn't smell right here.
I wasn't aware that manipulation only occurred in one direction. IHUB (Matt) and his buddies are currently being investigated for upside manipulation, but that does not mean downside manipulation has also been going on. I'd say this board seems to fit the bill - the owner of an RPRX competitor is allowed to bash the stock at will and everybody else's posts are deleted. That's why this board is the disgrace that it is. Shut down IHUB!
An excerpt from a transcript of Quidel's (QDEL) conference call earlier this week:
And finally, as you are aware of the CDC published in MMWR regarding the first two cases of a Flu A H1N1 virus that occurred in period on San Diego, counties here in California, we have gotten some questions on the CDC's report so I will give you a brief update on what we know. First, let me quote from MMWR, "The viruses from the two cases that are closely related genetically resistant to amantadine and rimantadine and contain a unique combination of gene segments that previously has not been reported amongst swine or human influenza viruses in the United States or elsewhere. In addition, the MMWR report states although this is not a subtype of influenza A in humans, concern exist that this new strain of swine influenza A H1N1 is substantially different from human influenza A H1N1 viruses that a large proportion of the population might be susceptible to infection and that the seasonal influenza vaccine H1N1 strain might not provide protection. The lack of non-exposure to pigs in the two cases increases the possibility that human-to-human transmission of this new influenza virus has occurred."
Based upon that, let me tell you what Quidel is doing. We have contacted the San Diego County health department as well as the Texas State health department because one of the children traveled to Texas in early April and the CDC and we let each of them know that Quidel has product inventory that we can make available for immediate delivery should they request it. It is important to remember that while our test is appropriate for human, H1N1, its applicability in this case has not been determined and at this point, that is really all we can say about this issue.
http://seekingalpha.com/article/132451-quidel-corporation-f1q09-earnings-call-transcript?page=1
http://investorvillage.com/smbd.asp?mb=971&mn=261276&pt=msg&mid=7068826
A classy mea culpa Dew. Somewhere down the line you'll be doing the same for RPRX. You're probably safe bashing PP, AEN, or whatever the hell they are calling themselves these days ...
Profit taking. I sold a few thousand shares of DNDN this morning and put the money into other stocks - mostly biotechs.
Congrats to all DNDN longs! Finally prostate cancer patients will have a non toxic treatment option.
Short interest down over 30%!
Repros Therapeutics Inc. - Common Stock
Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
02/27/2009 294,976 (30.30) 79,770 3.70
02/13/2009 423,180 (6.76) 57,892 7.31
01/30/2009 453,870 (14.58) 82,617 5.49
01/15/2009 531,368 12.73 106,227 5.00
12/31/2008 471,365 (28.95) 39,804 11.84
12/15/2008 663,464 (28.90) 80,408 8.25
11/28/2008 933,184 (10.19) 82,251 11.35
11/14/2008 1,039,066 (1.55) 37,148 27.97
10/31/2008 1,055,407 (2.38) 35,544 29.69
http://www.nasdaqtrader.com/trader.aspx?id=ShortInterest
RPRX, well I suppose its a rocketship from here, broke thru all
resistance imho, probably back close to $14/share....imo
Borg
.....$$$$$
Shorts continue running for the hills while hptaxis, idzi and DD provide covering fire:
Repros Therapeutics Inc. - Common Stock
Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
01/30/2009 453,870 (14.58) 82,617 5.49
01/15/2009 531,368 12.73 106,227 5.00
12/31/2008 471,365 (28.95) 39,804 11.84
12/15/2008 663,464 (28.90) 80,408 8.25
11/28/2008 933,184 (10.19) 82,251 11.35
11/14/2008 1,039,066 (1.55) 37,148 27.97
10/31/2008 1,055,407 (2.38) 35,544 29.69
10/15/2008 1,081,177 (10.86) 48,327 22.37
09/30/2008 1,212,861 (4.52) 98,358 12.33
http://www.nasdaqtrader.com/trader.aspx?id=ShortInterest
A 200k share dump. Looks like the shareprice is recovering. Doc - any idea what that was?
Agreed - I wonder about about Dew's motivation here. He even put that cocktail party post as a sticky note at the top of the page. Dew doesn't pass the smell test.
Biotech Roundup: Judgment Day for Dendreon; Just Say No to Pfizer-Wyeth Combo
http://www.minyanville.com/articles/PFE-BMY-NBIX-WYE-ZGEN-rprx/index/a/20780/from/yahoo
Repros Therapeutics
At the end of September, I wrote about Repros Therapeutics (RPRX) and a recent financing deal. I was hopeful the deal would start a new trend in financing in the space. In the deal, the current investors decided to make a meaningful additional financing commitment to the company at a price that did not represent a significant discount to the stock price. This is unusual in the biotech space, where even current shareholders often like to extract a pound of flesh from companies they already own.
My hope that this might start a trend in the sector has not yet been borne out – though I’ve heard the performance of the stock since the deal was done (up over 58% from the deal to today) has turned some heads in the investment space. I’ve even read at least one fund manager suggesting this financing might be a model going forward. Let’s hope so.
Repros itself is doing well. It released updated data on a successful Phase II trial in endometriosis, and is demonstrating good progress on enrollment for pivotal trials for their lead drug Proellex. Some folks who have fallen in love with a competitive drug from Neurocrine Biosciences (NBIX) called Elagolix are sniping about the Proellex data, but that’s OK. That’s what makes a market. Elagolix, essentially a reformulation of Lupron, is an improvement over current therapy in this disease. It will sell, but more like an improved buggy whip sold in the age of the automobile.
About the same number of people that think the Royal Bank of Canada is owned by the Canadian gov't or the American Nut Company is a branch of the US federal gov't. Let's just dumb everything down so misunderstandings don't occur.
Implications of DNDN hitting event threshold in December (at least 6 months ahead of anticipated date)? What can be read into that?
From the RPRX board. I would still like to know where Dew got these numbers from. Were they made up? Some using the moniker DewDiligence surely recognizes the need for such information.
Posted by: docbanker Date: Thursday, January 15, 2009 12:35:42 AM
In reply to: corpstrat who wrote msg# 6222 Post # of 6227 [Send a link via email]
thanks- there is also an article on endometriosis in the 9/11/08 NEJM.
The outlook is solid. The people at the JPM HC conference who noticed the endo data all thought it was solid. No one questioned the datas quality. Our friend who cited the dropout rate of 40% is not correct- he hasnt stated how he got to that number and upon calling the company- it was confirmed that number was NOT correct- its far lower. Its also a positive that the rate in the placebo group was 2x the treat group. good luck to those still long.
Grandpa - the short numbers you posted were old. Here's the most recent (end of year) numbers:
Repros Therapeutics Inc. - Common Stock
Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
12/31/2008 471,365 (28.95) 39,804 11.84
12/15/2008 663,464 (28.90) 80,408 8.25
11/28/2008 933,184 (10.19) 82,251 11.35
11/14/2008 1,039,066 (1.55) 37,148 27.97
10/31/2008 1,055,407 (2.38) 35,544 29.69
10/15/2008 1,081,177 (10.86) 48,327 22.37
09/30/2008 1,212,861 (4.52) 98,358 12.33
09/15/2008 1,270,224 46.99 121,621 10.44
http://www.nasdaqtrader.com/Trader.aspx?id=ShortInterest
I'm one of those "gaga over RPRX". And I don't recall seeing anybody ever post about Coprexa or Pipex on the RPRX board. Dew has it in for RPRX and mindlessly bashes the stock. Apparently now making up data to support his nonexistent case ... sad really.
--ZymoGenetics Due Off After-Hours Halt at 4:35 p.m. ET
Should be interesting to see where it trades. At $3/ share the market cap is about $200 million. This deal gives ZGEN over $100 million in 2009.
Bristol-Myers, ZymoGenetics in $1B hepatitis deal
Monday January 12, 4:03 pm ET
By Linda A. Johnson, AP Business Writer
Bristol-Myers, ZymoGenetics sign hepatitis C drug development deal worth up to $1.1B for Zymo
TRENTON, N.J. (AP) -- Drugmaker Bristol-Myers Squibb Co. and biotech company ZymoGenetics Inc. have signed a deal worth up to $1.12 billion to develop a hepatitis C drug based on a new type of the immune-system stimulant interferon.
New York-based Bristol-Myers will pay ZymoGenetics, of Seattle, Wash., $85 million in cash up front for the rights to develop its PEG-Interferon lambda, which already is in early testing in people. Bristol-Myers also will pay its new partner a license fee of $20 million this year, followed by additional payments that could total just over $1 billion if a series of milestones are reached.
The two companies will test the drug jointly in the United States and Europe and share those costs. The companies said they expect ZymoGenetics will conduct much of the ongoing early human studies, plus some of the midstage testing in people. ZymoGenetics will have an option to jointly sell and share in product profits from U.S. sales, and will receive roylaties from Bristol-Myers on foreign sales.
Interferon is a substance that stimulates the immune system to fight invaders. It has been used to treat hepatitis C, a viral infection of the liver, as well as some forms of cancer.
The two partners will do research on a new, type-3 interferon with a technology, called pegylation, designed to keep the drug active in the body as long as possible, something now standard for advanced hepatitis C treatments. The companies said their compound affects a different cell receptor then existing interferon treatments, and that that could result in more targeted therapy and more effectiveness.
Bristol-Myers Squibb, the world's No. 14 drugmaker by revenue, currently has no hepatitis C drugs on the market. However, it has three other compounds in development, according to a company spokeswoman. Bristol-Myers co-markets blood thinner Plavix, the world's second-best-selling drug.
About 170 million people worldwide are infected with hepatitis C, a virus transmitted by blood that damages the liver and is difficult to treat. Among people with chronic hepatitis C infection, 1 percent to 5 percent develop liver cancer, and others may need a liver transplant.
ZymoGenetics would get up to $430 million if it reaches set milestones for development and approval of PEG-Interferon lambda for treating hepatitis C, up to $287 million for development and regulatory approvals of drugs to treat other conditions, and up to $285 million for meeting certain sales goals.
ZymoGenetics develops drugs based on proteins and currently sells Recothrom, a genetically engineered treatment to stop bleeding.
FDA Advisory Committee Recommends GTC Biotherapeutics' ATryn* (antithrombin [Recombinant])
Friday January 9, 6:30 pm ET
If approved, ATryn will be first recombinant human antithrombin available in the U.S.
ROCKVILLE, Md.--(BUSINESS WIRE)--GTC Biotherapeutics ("GTC", NASDAQ: GTCB) and OVATION Pharmaceuticals, Inc. announced today that the Blood Products Advisory Committee of the U.S. Food and Drug Administration (FDA) voted that ATryn is safe and efficacious for the prevention and treatment of venous thromboembolism in hereditary antithrombin deficient patients undergoing surgery or childbirth procedures. The FDA considers the recommendations of its Advisory Committees when making its determinations. If approved, ATryn will be the first recombinant human antithrombin available in the U.S.
ADVERTISEMENT
“We are very pleased with the Advisory Committee’s recommendation in support of the safety and efficacy of ATryn,” said Geoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “ATryn is the first transgenically produced therapeutic to achieve approval in Europe and undergo review by the FDA. ATryn is also a testament to our established strength in recombinant technology, and has the potential to provide an important new treatment option for patients with hereditary antithrombin deficiency.”
In September 2008, the FDA assigned Priority Review to GTC’s Biologic License Application, or BLA, for ATryn. Priority Review is granted to applications for products that, if approved, would provide significant advances in treatment or provide a treatment where no sufficient one already exists. Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009. GTC has licensed ATryn to OVATION to develop and market it in the U.S.
"The committee’s recommendation takes us a step closer to making ATryn available to people in the U.S. with hereditary antithrombin deficiency, a rare clotting disorder associated with severe complications for which there are few treatment options," said Jeffrey S. Aronin, OVATION President and Chief Executive Officer. “Consistent with our overall focus on addressing unmet medical needs of small patient populations, bringing ATryn to market would give us the opportunity to make a meaningful difference in the lives of people suffering from this rare disorder.”
Antithrombin works as a natural anticoagulant in the human body by regulating thrombin, which plays an important role in controlling the formation of blood clots. ATryn was developed with the key objective to provide the purity, safety and consistency of an unlimited supply of recombinant antithrombin. Purified recombinant antithrombin has the same amino acid sequence as antithrombin derived from human plasma.
People with hereditary antithrombin deficiency are at increased risk for venous blood clots, including pulmonary embolism and deep vein thrombosis. The prevalence of hereditary antithrombin deficiency in the general population is approximately one in 2,000 to one in 3,000. Half these patients may experience a thrombosis before 25 years of age and based on one study, up to 85 percent may suffer a thromboembolic event by age 50.
> doesnt it cost like $400 mil to get a drug thru th FDA??
The trials are in phase 3 and the first NDA should be submitted this year. $400 mil for what? Fees? I don't get your thesis here.
Didn't see you complaining this much when it was being taken down from the mid-teens to the $5s. This thread needs to be dropped.
I was talking to a fellow investor today about recent pps movements by RPRX. I initially attributed it as being a short squeeze, but then thought a bit more about it. The short position here is not particularly large for a biotech, and the only upcoming event in the near term is the endo data. It could be a delayed reaction to last years financing and improving markets. Any other ideas? I prematurely sold IDEV last year at $2 - I'm not going to make the same mistake here.
Short Interest Report: Is Repros Therapeutics Inc. Immune to Broad-Market Woes?
http://www.schaeffersresearch.com/commentary/content/short+interest+report+is+repros+therapeutics+inc+immune+to+broad-market+woes/observations.aspx?click=home&ID=90126#
New 52-week high. Having to cover at these levels must be a bitch. Hopefully the endo data will be released this week.
SmallCapInvestor.com
Citizens Holdings, China Sky One Medical and Repros Therapeutics among 52-week highs
Monday January 5, 4:02 pm ET
Claire Caldwell
Citizens Holdings Co.(NasdaqGM:CIZN - News), China Sky One Medical Inc. (NasdaqGM:CSKI - News) and Repros Therapeutics Inc. (NasdaqGM:RPRX - News) are among the new 52-week highs in Monday's trading among companies with market capitalizations under $1 billion.
Here are the new 52-week highs among small caps:
Price at 4:08 ET Change % Change Volume Year High Year Low
CIZN CITIZENS HLDG CO MISS 22.99 +1.99 +9.5% 4.9k 22.00 15.88
CSKI CHINA SKY ONE MED INC 17.45 +1.55 +9.7% 297.1k 17.10 6.29
RPRX REPROS THERAPEUTICS INC 11.46 +0.56 +5.1% 47.1k 11.25 5.31
AVAV AEROVIRONMENT INC 39.35 +1.09 +2.8% 695.4k 38.74 18.44
EMS EMERGENCY MEDICAL SVCS CORP 3
Repros Therapeutics Inc. Board of Directors Elects Mark Lappe of Efficacy Capital as Its Chairman of the Board
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) announced today that it has, by unanimous agreement by its Board of Directors, elected Mark Lappe of Efficacy Capital as its Chairman. Efficacy Capital is the Company’s largest shareholder with a position approximating 28% of the Company’s outstanding stock. The composition of the rest of the Repros Board remains intact. The Company currently has nine directors.
In other news Dr. John Reed, President of the Burnham Institute, has been named to the Compensation Committee. Dr. Reed became a Board member of Repros in September 2008 in conjunction with the completion of the last round of financing, which was led by Efficacy Capital. In addition, both Mark Lappe and Dr. Reed have been appointed to the Nominating and Corporate Governance Committee.
Joseph Podolski, President and CEO of Repros commented, “I applaud the actions of our Board. I have worked closely with Mark Lappe since his firm, Efficacy Capital led the last round of financing and I appreciate not only what he brings to the Board by the way of his financing acumen but also his integrity. Mark’s vision and actions have convinced me he is the best man for the job of Chairman going forward. I look forward to working with Mark to build both near- and long-term shareholder value.”
As Chairman, Mark Lappe has declined any additional compensation from the Company relating to holding that position.
About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Our lead drug, Proellex®, is a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. We are also developing Proellex as a short course pre-surgical treatment for anemia associated with excessive menstrual bleeding related to uterine fibroids. There is no currently approved effective long-term orally administered drug treatment for uterine fibroids or endometriosis. In the United States alone, 300,000 women per year undergo a hysterectomy as a result of severe uterine fibroids.
Our second product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing Androxal for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone. In November 2008, we received guidance from the FDA suggesting submission of a new IND to the Division of Metabolic and Endocrine Products, or DMEP, for the investigation of Androxal as a potential treatment for type 2 diabetes. We plan to submit a new IND for this indication to the DMEP as soon as practicable.
For more information, please visit the Company's website at http://www.reprosrx.com.
http://www.nasdaqtrader.com/Trader.aspx?id=ShortIntPubSch
12/10 numbers will be published at 4pm on Xmas Eve.
Repros Therapeutics Inc. - Common Stock
Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
11/28/2008 933,184 (10.19) 82,251 11.35
11/14/2008 1,039,066 (1.55) 37,148 27.97
10/31/2008 1,055,407 (2.38) 35,544 29.69
10/15/2008 1,081,177 (10.86) 48,327 22.37
http://www.nasdaqtrader.com/trader.aspx?id=ShortInterest
http://img503.imageshack.us/my.php?image=rprxso2.jpg
Short interest down 10% (data out two days ago).
I plotted short interest vs shareprice and have posted the graph here:
http://img503.imageshack.us/my.php?image=rprxso2.jpg
The conclusion is shorts have been controlling the shareprice since late last summer.
Some recent additions to the resident jokers website:
http://www.hptaxis.com/2008/11/
Short interest flat:
Repros Therapeutics Inc. - Common Stock
Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
11/14/2008 1,039,066 (1.55) 37,148 27.97
10/31/2008 1,055,407 (2.38) 35,544 29.69
10/15/2008 1,081,177 (10.86) 48,327 22.37
09/30/2008 1,212,861 (4.52) 98,358 12.33
09/15/2008 1,270,224 46.99 121,621 10.44
08/29/2008 864,144 61.84 70,305 12.29
08/15/2008 533,942 18.72 56,575 9.44
07/31/2008 449,758 35.49 73,583 6.11
07/15/2008 331,957 (0.23) 70,781 4.69
06/30/2008 332,729 (47.94) 50,158 6.63
06/13/2008 639,126 (24.99) 137,404 4.65
05/30/2008 852,103 (10.73) 62,820 13.56
05/15/2008 954,511 (6.56) 42,288 22.57
04/30/2008 1,021,502 3.04 54,807 18.64
04/15/2008 991,404 1.25 71,296 13.91
03/31/2008 979,155 (22.12) 113,826 8.60
03/14/2008 1,257,186 8.24 115,126 10.92
02/29/2008 1,161,472 0.86 59,932 19.38
02/15/2008 1,151,580 (9.95) 55,279 20.83
01/31/2008 1,278,783 (7.91) 77,639 16.47
01/15/2008 1,388,551 17.07 61,643 22.53
12/31/2007 1,186,120 35.63 128,710 9.22
12/14/2007 874,526 57.68 273,273 3.20
11/30/2007 554,631 39.90 111,740 4.96
http://www.nasdaqtrader.com/trader.aspx?id=ShortInterest
RPRX
Sorry, I didn't see that he had written "reasonable".
market cap = 6-7x peak revenues
5 billion x 6.5 = 32.5 billion/ 12.77 million shares outstanding = $2545/share
ZymoGenetics Presents Positive Interim Phase 1b Results in Hepatitis C
11/3/2008
- Significant Viral Load Reduction and Encouraging Tolerability
With PEG-Interferon lambda -
SEATTLE--(BUSINESS WIRE)--Nov. 3, 2008--ZymoGenetics, Inc. (NASDAQ:ZGEN) today reported that PEG-Interferon lambda showed a meaningful reduction in the amount of Hepatitis C Virus (HCV) and was well tolerated in patients with relapsed HCV in an ongoing Phase 1b clinical trial. Anti-viral activity was observed at all dose levels tested. The six patients treated once a week with 1.5 mcg/kg of PEG-Interferon lambda had a mean maximum decrease of 3.6 logs in viral load at Day 29. Treatment had minimal side effects and no hematologic toxicity. Results from 18 patients, or 3 cohorts with 6 patients each, were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting.
"PEG-Interferon lambda has become one of our company's key assets," said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "Based on these early results, we're encouraged by the potential for PEG-Interferon lambda to become an effective treatment with improved tolerability for treating patients with Hepatitis C. We've accelerated the timeline for the second part of the study, where the combination of PEG-Interferon lambda and ribavirin will be investigated."
The Phase 1b clinical trial is evaluating the safety and anti-viral activity of PEG-Interferon lambda in genotype 1 HCV patients with relapsed disease. To date, in the single agent part of the study, PEG-Interferon lambda has been administered subcutaneously either with a weekly or biweekly schedule at doses of 1.5 mcg/kg or 3.0 mcg/kg for four weeks.
Anti-viral activity was seen in all cohorts, with the best anti-viral effect documented at 1.5 mcg/kg given weekly. All 6 patients treated in this cohort showed a 2 log or greater decrease in viral load at Day 29, with 4 of these patients having less than 1,000 HCV RNA copies at the end of treatment.
PEG-Interferon lambda was well tolerated at all dose levels, with no discontinuations due to toxicity, no treatment-related fever, no signs of hematological toxicity and no meaningful changes in hematological parameters. Adverse events were all Grade 1 or 2. Most common adverse events were fatigue and myalgia, which were observed in only 3 patients. Primary safety findings consist of asymptomatic, reversible and mild increases in liver enzymes in some patients.
Presentation
The AASLD presentation is available on the ZymoGenetics website at: www.zymogenetics.com.
PEG-Interferon lambda
The native human protein Interferon lambda is generated by the immune system in response to viral infection. Interferon lambda mediates anti-viral activity through a receptor that is distinct from that used by Interferon alpha and is present on fewer cell types within the tissues of the body. Receptors for Interferon lambda are present on several important sites of viral infection, most notably cells of the lung and liver. Recombinant PEG-Interferon lambda, a novel, pegylated Type III interferon, has shown in vitro anti-viral activity against several viruses, including HCV. A Phase 1a healthy volunteer, single dose study showed dose-dependent pharmacokinetics, evidence of biological activity (starting at 1.5 mcg/kg) and that PEG-Interferon lambda was well tolerated at pharmacologically active doses with no fever, flu-like symptoms or hematological effects. ZymoGenetics holds worldwide rights to PEG-Interferon lambda.
Hepatitis C
Chronic infection with HCV is a leading cause of cirrhosis, liver failure and hepatocellular carcinoma worldwide. The current standard of care for chronic HCV infection involves treatment with PEG-Interferon alpha and ribavirin. This form of HCV therapy has been associated with a number of significant side effects including flu-like symptoms, anorexia, depression, hemolytic anemia and myelosuppression. This side-effect profile often necessitates additional medications to manage the side effects and can lead to early discontinuation of treatment and poor adherence to prescribed therapy, leading to poor treatment outcomes. Currently, the response rates for the most common form of HCV in the United States to standard treatment are only 50%. Therefore, there remains a need for better tolerated and more effective therapy for HCV. The development of PEG-Interferon lambda is intended to provide an alternative to PEG-Interferon alpha.
About ZymoGenetics
ZymoGenetics discovers and develops novel protein therapeutics that are based on the company's research and biological insights into key disease pathways. The Company developed and markets RECOTHROM(R) Thrombin, topical (Recombinant). Other product candidates span a wide array of clinical opportunities that include cancer, autoimmune and viral diseases. ZymoGenetics intends to commercialize product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics' actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven product sales and marketing abilities, discovery strategy, preclinical and clinical development, strategic partnering, regulatory oversight, intellectual property claims and litigation and other risks detailed in the company's public filings with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31, 2007. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.
CONTACT: ZymoGenetics, Inc.
Susan W. Specht, 206-442-6592
Director, Corporate Communications
or
Michael Fitzpatrick, 206-442-6702
Associate Director, Corporate Communications
SOURCE: ZymoGenetics, Inc.