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6:05AM ZymoGenetics secures $100 mln funding commitment (ZGEN) 8.49 : Co announces that it has received a $100 mln funding commitment from Deerfield Management, a healthcare investment organization and ZymoGenetics' shareholder.
ZymoGenetics Announces FDA Approval of RECOTHROM(TM) 20,000-IU Vial Size and Co-Packaging with Spray Kit
Tuesday May 27, 6:00 am ET
Surgeons to Be Offered Broader Line of Product Presentations
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) announced today that the United States Food and Drug Administration (FDA) has approved a Prior Approval Supplement application for a 20,000 international unit (IU) vial of RECOTHROMTM Thrombin, topical (Recombinant) and also approved co-packaging of the 20,000-IU vial with the ZymoGenetics Spray Applicator Kit.
“RECOTHROM, the first and only recombinant thrombin, is now available in both 5,000 and 20,000-IU vial sizes,” said Bruce L.A. Carter, Chief Executive Officer of ZymoGenetics. “Within two weeks, we’ll be ready to ship the 20,000-IU vials, as well as spray kits co-packaged with the larger vial. This product introduction will provide our customers with flexibility to meet their needs while enhancing our ability to convert hospital thrombin usage to RECOTHROM. Additionally, we believe that our spray kit has design and convenience advantages, based on market research conducted with surgeons.”
About RECOTHROM™ Thrombin, topical (Recombinant)
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled up to meet market demand.
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
IMPORTANT SAFETY INFORMATION
RECOTHROM is for topical use only and should not be injected directly into the circulatory system. There is a potential risk of thrombosis if the product is absorbed systemically. RECOTHROM should not be used for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
No specific adverse events have been established as adverse reactions causally related to RECOTHROM administration. In a clinical study comparing RECOTHROM to bovine thrombin, adverse events were reported with similar frequency in both treatment groups. The most common event was incision site complication. Limited data (n = 6) are available on repeat exposure to RECOTHROM.
Please see full prescribing information at: http://www.zymogenetics.com/products/recothrom.html.
For additional information, please visit: http://www.recothrom.com.
RECOTHROM is being commercialized in a global collaboration between ZymoGenetics and Bayer HealthCare which began in June 2007. ZymoGenetics retains US market rights and Bayer provides its trained surgical sales force to support the first three years of the US market launch. Bayer HealthCare acquired the rights to RECOTHROM in all markets outside the US. Bayer will be responsible for conducting any required clinical trials, securing regulatory approvals and commercializing the product in all countries outside the US.
ZymoGenetics Inc. Q1 2008 Earnings Call Transcript:
http://seekingalpha.com/article/77107-zymogenetics-inc-q1-2008-earnings-call-transcript?source=yahoo
Buy ZymoGenetics Up to $16
Thursday May 8, 8:55 am ET
By Grant Zeng, CFA
ZymoGenetics, Inc. (NasdaqGM: ZGEN - News) is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic proteins for the prevention or treatment of human diseases. Recent approval of rhThrombin by the FDA and the clinical progress made by the company will drive the value for the company.
We believe rhThrombin will provide significant boost to the company's top-line growth in the coming quarters. Other candidates should provide long-term growth for the company.
We are optimistic about the prospect of rhThrombin and believe it will capture a fair market share in the thrombin market due to its advantages over existing plasma derived thrombin products. ZymoGenetics reported its financial results for the first quarter ended March 31, 2008. The company reported a net loss of $40.9 million, or $0.60 per share, compared to a net loss of $33.3 million, or $0.49 per share, for the first quarter of 2007.
The 2008 net loss increased according to the company's plan, reflecting initial sales and marketing efforts associated with the U.S. launch of RECOTHROM (TM) Thrombin, topical (Recombinant), the company's first commercial product, which was approved by the FDA in January 2008. We are also impressed by the company's strong pipeline which we believe will provide long-term growth for ZymoGenetics in the years to come.
Therefore, we maintain our Buy rating for the company with a price target of $16. We arrive at our price target of $16 by applying biotech industry average P/S ratio of 8x, multiplied by our estimated sales of $235.5 million in 2010, discounted at 30% for one and half years assuming outstanding shares of 80 million.
UPDATE 1-ZymoGenetics clot drug promotion misleading-US FDA
Wed May 7, 2008 12:36pm EDT
WASHINGTON, May 7 (Reuters) - The U.S. Food and Drug Administration told ZymoGenetics Inc (ZGEN.O: Quote, Profile, Research) that promotional material for its Recothrom product, used to help control bleeding, was false or misleading, according to a letter released on Wednesday.
The FDA, in the April 25 letter, said a review of the company's website found that ZymoGenetics, in a press release, had omitted "material facts" about Recothrom, a topical coagulation protein.
ZymoGenetics spokeswoman Susan Specht said the company had received the FDA's letter and made necessary changes to the press release, which is online ">here
"Now all of our materials are consistent," she told Reuters.
The Jan. 17 press release about the product's approval suggested that Recothrom is safer that another similar product, the FDA said.
"This statement excludes important contextual information necessary to understand the limitation of this finding," the FDA told ZymoGenetics in its letter, posted on the FDA's own website here
Shares of Seattle-based ZymoGenetics fell 1 percent after news of the FDA letter but then recovered to $8.68, up 8 cents, in early-afternoon trade on the Nasdaq. (Reporting by Susan Heavey; Editing by Tim Dobbyn and John Wallace)
http://www.reuters.com/article/marketsNews/idINN0720764520080507?rpc=44
ZymoGenetics Reports First Quarter 2008 Financial Results
Tuesday May 6, 4:00 pm ET
January FDA Approval of RECOTHROM(TM) and Launch Highlights
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News), today reported its financial results for the first quarter ended March 31, 2008. The company reported a net loss of $40.9 million, or $0.60 per share, compared to a net loss of $33.3 million, or $0.49 per share, for the first quarter of 2007. The 2008 net loss increased according to the company’s plan, reflecting initial sales and increased sales and marketing efforts associated with the U.S. launch of RECOTHROM™ Thrombin, topical (Recombinant), the company’s first commercial product, which was approved by the FDA in January 2008.
“The approval of RECOTHROM was a major accomplishment. We’re now a commercial company focused on sales growth as well as on driving development of our novel protein therapeutics,” stated Bruce L.A. Carter, Ph.D., chief executive officer of ZymoGenetics. “We believe the launch is going well, and we’re seeing strong interest in the marketplace, reflecting an appreciation for the advantages of a recombinant topical hemostat.”
ZymoGenetics reported significantly higher revenues in the first quarter of 2008. Revenues for the quarter were $13.5 million, compared to $5.2 million for the first quarter of 2007. The increase resulted from revenues related to the RECOTHROM collaboration with Bayer Healthcare, milestone payments related to IL-20 and rFactor XIII, and initial RECOTHROM sales of $1.0 million.
Costs of product sales were approximately 11 percent of product sales and include only the costs of manufacturing and distributing RECOTHROM that were incurred subsequent to FDA approval. All manufacturing related costs for RECOTHROM prior to FDA approval were expensed to research and development as incurred.
Research and development expenses were $39.2 million in the first quarter of 2008, compared to $29.8 million in the first quarter of 2007. The primary increases were due to expansion of the atacicept clinical program to include multiple disease indications and registrational studies in lupus, and $2.0 million of severance costs related to the company’s February 2008 restructuring.
Selling, general and administrative expenses were $14.6 million in the first quarter of 2008, a $4.9 million increase from the first quarter of 2007. The increase was primarily due to the deployment of the RECOTHROM sales force and marketing costs associated with the first quarter 2008 U.S. launch of RECOTHROM.
Net other expense in the first quarter of 2008 was $0.4 million, compared to $1.0 million net other income for the first quarter of 2007. The decrease reflects lower investment income, which was driven by lower cash balances to invest and decreased interest rates.
Business Highlights:
http://biz.yahoo.com/bw/080506/20080506006663.html?.v=1
ZymoGenetics Presents Positive Results from RECOTHROM(TM) Thrombin, topical (Recombinant) Spray Study in Burn Patients
Safety and Low Immunogenicity Observed in Patients Undergoing Skin Grafting for Burns
ZymoGenetics, Inc. (NASDAQ:ZGEN), today presented results at the American Burn Association annual meeting from a clinical trial with RECOTHROM™ Thrombin, topical (Recombinant) administered by spray device to burn wound excision sites. The study evaluated the safety and immunogenicity of RECOTHROM for patients undergoing skin grafting for burns. Topical application of RECOTHROM using a pump spray device was well tolerated and demonstrated a similar safety profile and rate of antibody formation to that observed in the rThrombin Phase 3 clinical trial.
“Burn wound excision poses unique challenges to hemostasis,” said David G. Greenhalgh, MD, FACS, University of California, Davis Medical Center, and primary study investigator. “The results of this study suggest that rThrombin may be a viable hemostatic alternative in burn patients.”
“Results from the trial show that RECOTHROM was well-tolerated when sprayed onto excised burn wounds prior to skin graft placement, with a very low rate of antibody development consistent with data generated in our earlier clinical trials,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics.
The multiple site, single-arm, open-label clinical trial treated 72 subjects receiving partial- or full-thickness autologous sheet or mesh graft following burn injury. RECOTHROM was applied to newly excised wounds (graft recipient sites) using a ZymoGenetics-developed pump spray device. Adverse events, skin graft survival and formation of anti-RECOTHROM antibodies were measured at baseline and Day 29 after application of RECOTHROM.
There were no deaths or study drug discontinuations. Adverse events occurred in 63 (88%) of patients and were typical of adverse events seen following acute burn wound treatment. The most common adverse events were procedural pain (25 patients, 35%) and pruritis (itching) (18 patients, 25%). Most adverse events were minor in severity and judged to be unrelated to the study drug. Skin graft survival was consistent with the rate commonly observed in such procedures.1
One patient had antibodies to RECOTHROM product at baseline (1.4%); another patient developed specific antibodies to RECOTHROM at Day 29 resulting in a low rate of antibody formation (1.6%). The antibodies detected did not neutralize human thrombin. These rates are similar to the low immunogenicity findings of the rThrombin Phase 3 pivotal clinical trial. RECOTHROM was well tolerated when administered with a pump spray device.
About RECOTHROM™ Thrombin, topical (Recombinant)
RECOTHROM is a recombinant form of human thrombin that is structurally and functionally similar to human thrombin. It is not derived from animal or human blood. With thrombin being used in more than 1 million surgeries each year in the United States, RECOTHROM gives surgeons the opportunity to provide their patients with a plasma-free thrombin alternative for surgical hemostasis. The production of recombinant proteins is not dependent on the availability of blood from animals or human donors and can be scaled-up to meet market demand.
RECOTHROM is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP.
IMPORTANT SAFETY INFORMATION
RECOTHROM is for topical use only and should not be injected directly into the circulatory system. There is a potential risk of thrombosis if the product is absorbed systemically. RECOTHROM should not be used for the treatment of massive or brisk arterial bleeding or in patients with known hypersensitivity to RECOTHROM, any components of RECOTHROM or hamster proteins.
No specific adverse events have been established as adverse reactions causally related to RECOTHROM administration. In a clinical study comparing RECOTHROM to bovine thrombin, adverse events were reported with similar frequency in both treatment groups. The most common event was incision site complication. Limited data (n = 6) are available on repeat exposure to RECOTHROM.
Please see full prescribing information at: http://www.zymogenetics.com/products/recothrom.html.
For additional information, please visit: http://www.recothrom.com.
RECOTHROM is being commercialized in a global collaboration between ZymoGenetics and Bayer HealthCare which began in June 2007. ZymoGenetics retains US market rights and Bayer provides its trained surgical sales force to support the first three years of the US market launch. Bayer HealthCare acquired the rights to RECOTHROM in all markets outside the US. Bayer will be responsible for conducting any required clinical trials, securing regulatory approvals and commercializing the product in all countries outside the US.
Merck Serono and ZymoGenetics Initiate Atacicept Phase 2 Clinical Trial in Relapsing Multiple Sclerosis
ZymoGenetics, Inc. (NASDAQ:ZGEN), today announced that its development partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has initiated a Phase 2 clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).
“Patients with multiple sclerosis need more treatment options,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our preclinical models have shown biological activity of atacicept in multiple sclerosis and, because of the growing body of supporting data in the literature indicating the importance of B cells and antibodies in the pathology of multiple sclerosis, we believe there is strong rationale for the clinical testing of atacicept in patients with RMS.”
The four-arm randomized, double blind, placebo controlled, multicenter study will evaluate the safety and efficacy of atacicept in patients with RMS over 36 weeks of treatment. The primary objective of the study is to evaluate the efficacy of atacicept in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures.
Approximately 300 RMS patients meeting the eligibility criteria will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks. Patients will have follow-up visits at 48 weeks.
About Relapsing Multiple Sclerosis (RMS)
Multiple sclerosis (MS) is a disease of the central nervous system that can lead to permanent damage of the nerves in the brain and spinal cord. Patients with RMS may experience an attack or series of attacks followed by a complete or partial remission. Permanent disability may be accrued by incomplete recovery from relapses and by neurodegenerative processes, which are more prominent in the later stages of the disease. RMS is the most common form of MS. According to the National MS Society, approximately 400,000 people in the U.S. have MS, and every week about 200 people are diagnosed; worldwide, 2.5 million individuals may have MS.
About Atacicept
Merck Serono and ZymoGenetics are developing atacicept (formerly referred to as TACI-Ig) as a potential treatment of autoimmune diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), rheumatoid arthritis and multiple sclerosis, as well as B-cell malignancies.
Atacicept contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as systemic lupus erythematosus. Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, lupus erythematosus, B-cell malignancies and multiple sclerosis. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies.
Five Biotech Stocks to Weather a Down Market
http://seekingalpha.com/article/73289-five-biotech-stocks-to-weather-a-down-market?source=yahoo
Whither Thrombin?
Tuesday, April 01, 2008
On seeing today’s New York Times article “Seeking Alternative to Animal-Derived Drugs,” my first thought was that it could’a/should’a mentioned the January 2008 approval of the first recombinant human thrombin, which has the potential to replace bovine- and plasma-derived equivalents now on the market. But as noted in stories in IN VIVO and The RPM Report this month, ZymoGenetics, the developer of recombinant thrombin, can’t seem to catch a break these days, especially from Wall Street analysts.
ZymoGenetics saw its recombinant thrombin, Recothrom, the first product it decided to commercialize on its own, as a way to balance the risk in its portfolio. Management has noted that all previous recombinant clotting factors -- along with insulin, hGH and a host of women's health hormones -- had succeeded in clinical trials and in the market. When it initiated the program, “we thought the major risk wouldn’t be clinical trials or commercial, but whether we could manufacture with an appropriate cost of goods,” says CEO Bruce Carter. Bovine thrombin, sold by King Pharmaceuticals, carries a Black Box warning about the severe bleeding risks associated with potential antibody formation. It’s also blocked from the market in Europe because of fears around potential transmission of Mad Cow disease.
But despite the implicit logic that a recombinant product is safer, for various reasons, it’s near impossible to directly correlate bleeding and bovine thrombin, and therefore there's no baseline with which to measure improvement in patient outcome, which poses a problem for reimbursement. As a surgical adjunct, recombinant thrombin also has to make its way through hospitals’ Pharmacy & Therapeutics Committees before it’s stocked, which takes time.
Plus, because Recothrom is a biotech product (and as a biotech company, ZymoGenetics is covered by biotech analysts with little experience following the launch of such a device-like medical product), there appears to be even more uncertainty over how to gauge the product’s trajectory in the market.
It’ll take time to prove the value proposition. Oppenheimer’s Kevin DeGeeter, for example, in a March 31 note, perhaps unfairly used Recothrom’s modest February sales ($26,164) to say that while it’s still very early in the product launch, there are concerns that conversion from bovine-derived thrombin “will take much longer than the Street expects.”
In any event, it is true that ZymoGenetics is in a tough position in a tough biotech stock environment, as it starts to be judged less on the value of its pipeline than on its commercial performance. It'll also be facing a cash crunch later this year and, with hindsight, probably should have financed in 2007 instead of waiting for a potential bump in stock price on the Recothrom approval.
The company likely could have done a better job of prepping analysts for a slow conversion process and launch, instead of believing validation would have come more easily after it found a partner (Bayer) to help with the US launch and open up the European market, and got the drug through FDA with a broad label despite analysts' worries over that.
That said, a tipping point favoring a safer if somewhat more expensive thrombin could come anytime, especially in this politically charged, safety-first health care environment.
http://invivoblog.blogspot.com/2008/04/whither-thrombin.html
Warburg Pincus Owns ZymoGenetics Stake
Wednesday March 12, 10:09 am ET
Warburg Pincus Reports Owning 13.7 Percent Stake in ZymoGenetics
NEW YORK (AP) -- Warburg Pincus on Wednesday reported a 13.7 percent stake in biotechnology company ZymoGenetics Inc. in a filing with the Securities and Exchange Commission.
The investment firm beneficially owns about 9.4 million shares in the Seattle company, which had 68.6 million shares outstanding as of Feb. 22.
Warburg Pincus said it may seek to engage in future discussions with management regarding the company's strategy or the possibility of additional representation on the board. Two of the nine members currently serving on the company's board were designated by the shareholder.
According to the filing, Warburg Pincus acquired shares of the company's series B convertible preferred stock in 2000, prior to ZymoGenetics' initial public offering. These shares automatically converted into roughly 7.2 million shares of common stock following the IPO and a subsequent stock split. The investor has since purchased an additional 2.2 million shares.
I agree with all your conclusions Corpstrat, I was just surprised that they made any sales at all. And since it is priced higher than Recothrom, I don't expect things to pick up. OMRI down 17% right now - things are not looking good for Aschoff's clients.
The increase in biosurgery sales was $2.2 million Q4 to Q4 and they attribute this to both "an increase in unit sales of fibrin sealant, [and] the introduction of Evithrom."
Ergo, we know they sold less than 2.2mm of Evithrom and probably less than 1.1 mm, or they would not have put Evithrom second to sealant in the list of explanations of the 2.2 mm.
Further, if they'd sold a respectable amount, presumably they would have broken out the product sales and made Evithrom a line item. And of course they would have trumpeted the number if it had been a positive.
I stand corrected:
http://biz.yahoo.com/bw/080306/20080306005304.html?.v=1
It looks like they did have some sales - not clear how much. I suppose I'll have to listen to the CC.
http://seattlepi.nwsource.com/business/353717_zymogenetics5.html
Talking about negative press take a look at this one. Shorts are doing all they can to get out without a huge loss all thanks to WP'insider buying.
Yup. But street.com wouldn't miss an opportunity to act as amplifier for a short shill like Oppenheimer. The headline led me to expect data on good King sales and weak Recothrom sales. Nothing of the kind.
ZymoGenetics' Stock Falters as King Guards Thrombin Throne
Excerpt: "Omrix's earnings, slated for Thursday, will provide the first clue to how the competition is shaping up."
Should be interesting. Prediction: no sales.
http://www.thestreet.com/_yahoo/newsanalysis/biotech/10406293.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
Someone just sold 325,100 shares at $9.19 right at 4PM... This is getting really strange...
Recent insider buying in ZGEN:
http://www.form4oracle.com/company?cik=0001129425&ticker=ZGEN
Zymogenetics cutting 80 jobs, announces '07 loss of $148M
Wednesday February 13, 4:41 pm ET
Zymogenetics Inc. said it's cutting 80 positions, mainly in its research department, and also announced it lost $148 million in fiscal 2007.
The Seattle biotech reported a fourth-quarter loss of $38.6 million, or a loss of 56 cents per share, which compares with a loss of $37.1 million, or a loss of 55 cents per share, a year earlier. For fiscal 2007, the company reported a loss of $148.1 million, or a loss of $2.17 per share, which compares with a loss of $130 million, or a loss of $1.94 per share, in 2006.
Analysts polled by Thomson Financial Network expected a fourth-quarter loss of 70 cents per share and a fiscal 2007 loss of $2.33.
Zymogenetics (NASDAQ: ZGEN) said the job cuts "reflect the evolving focus of its business." Jobs are being cut through attrition, elimination of unfilled positions, and layoffs. The cuts are expected to save the company $14 million per year.
"We have made some difficult choices to reposition our workforce after extensive review of our business plan for the next five years. Reducing our overall spend and focusing on a smaller number of proprietary programs fits with our desire to create greater value for shareholders while maintaining capacity to fill our pipeline," said Dr. Bruce Carter, CEO, in a statement
I must say i have to agree with you on this one.Pipeline has big time potential and revenue will start coming in the first quarter.In 2 years they dominate thrombin market.however one or more of their current pipeline drugs could be worth 5x the current market cap.
I bought some more today...
I am not sure why ZGEN is not trading north of $15 yet but I have to assume we are heading there soon. Perhaps the wall-street mafia had to keep this one suppressed through the end of the month for one reason or another but I doubt this charade can continue much longer...
Breathe again pastemp and congrats!
ZymoGenetics Down on 'Sell' Initiation
Wednesday January 16, 1:39 pm ET
ZymoGenetics Falls As Analyst Starts Coverage at 'Sell' on Possible Product Delays
NEW YORK (AP) -- Shares of biotechnology company ZymoGenetics Inc. fell Wednesday after a Brean Murray, Carret & Co. analyst started coverage with a "Sell" rating, saying the company's lead experimental product could face further approval delays.
http://biz.yahoo.com/ap/080116/zymogenetics_mover.html?.v=1
ZymoGenetics Announces Special Protocol Assessment for Atacicept in General SLE
Tuesday January 15, 6:00 am ET
Second Clinical Study Will Complement Lupus Nephritis Clinical Trial
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News), today announced that its partner Merck Serono has received agreement from the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for a Phase 2/3 trial with atacicept in patients with general systemic lupus erythematosus (SLE). Together with a previously announced agreement from the FDA for a Phase 2/3 study in lupus nephritis, which was initiated in December 2007, these studies are intended to support an application for marketing authorization in the U.S. for the treatment of patients with SLE.
http://biz.yahoo.com/bw/080115/20080115005084.html?.v=1
Can't answer your post because i am currently holding my breath waiting for FDA response this week.
Interesting Atacicept exchange on Values board
http://investorshub.advfn.com/boards/read_msg.asp?message_id=25941200
He was talking about the rest of the pipeline.
Added to my position today as well and lowered my cost basis to boot.
Approval could come any day now. It's hard to believe it's down so much on a downgrade based on delays that are almost over. I'm adding here.
Looks like a chance to buy some more cheap before the market notices the rhthrombin approval in a few weeks.
Bank of America downgrades from buy to neutral and reduces price to $12/share.Give me a break!I listened to the investor presentation 2x last week and they have 3 drugs they are testing that could each be blockbusters.Granted that the results are early,but this is a proven team that can bring drugs to market.
In addition for the first time the CEO stated that their rThrombin drug will eventually take the company to profitability.
IL 21 also being tested in Melanoma and Renal cell carcinoma(RCC).I doubt they can afford to take all 3 into phase 2 at same time with everything else that is going on.
ZymoGenetics Presents Positive Interim Phase 1 Results for IL-21 in Combination with Rituxan(R) in B Cell Lymphoma
Monday December 10, 6:00 am ET
Good Safety Profile and Anti-Lymphoma Activity Observed
SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News) today presented interim results from a Phase 1 clinical trial of Interleukin 21 (IL-21) in combination with Rituxan® (rituximab) in patients with relapsed low-grade B Cell lymphoma at the American Society of Hematology (ASH) 2007 Annual Meeting. The Phase 1 study is part of a larger clinical program examining the use of IL-21 both as a single agent and in combination with approved cancer therapeutics.
“The Phase 1 data show that the combination of IL-21 with rituximab was well tolerated and resulted in anti-lymphoma activity,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “IL-21 may increase the ability of approved therapies like rituximab to target and kill cancer cells.”
The ASH poster presentation, “Recombinant Interleukin-21 Plus Rituximab: Clinical Activity in a Phase 1, Dose-Finding Trial in Relapsed Low-Grade B Cell Lymphoma,” reviewed results from 15 subjects from the two-part open label multi-center study. Part 1 of the study included 9 patients and consisted of dose-escalation portion to identify a dose of IL-21 that can be safely combined with rituximab. Part 2 of the study is evaluating the safety and anti-tumor effects of the combination in an expanded cohort of 12 additional patients to be treated at the dose identified in Part 1. Results from 6 subjects in Part 2 were reported at ASH.
The study evaluated three dose levels of IL-21 (30, 100 and 150 mcg/kg), given intravenously once per week in combination with a standard dose of rituximab (375 mg/m2) for four weeks. While no dose limiting toxicities were seen at any dose level, a dose of 100 mcg/kg of IL-21 in combination with rituximab was selected for cohort expansion as re-treatment at 150 mcg/kg was associated with increased toxicity. The majority of adverse events and lab abnormalities at all dose levels were Grade 1 or 2 and included flu-like symptoms, headache, fatigue and nausea. One subject with a prior history of cardiac disease who experienced chest pain during the study died of complications after a stenting procedure and was not evaluable for response. Evidence of anti-tumor activity was seen in this heavily pretreated group of patients, most of whom had previously received rituximab. Best response during the study, per investigator assessment, included 2 complete responses, 4 partial responses, 7 stable disease and 1 progressive disease. Final data from the study will provide more information about the overall safety and anti-tumor effects of this combination therapy.
http://biz.yahoo.com/bw/071210/20071210005261.html?.v=1
The Piper presentation showed how much upside there is to this company.
1)rThrombin-Zgen believes the market potential for this drug in the US is $500+ million and a similar amount in ROW.ZGEN US sales force is in place totaling 64 reps and support staff,In addition Bayer has 95 people in place.Upon approval we will gain share quickly.Results for phase 2 "spray" trial will be mid year--expand the label.
2)Williams stated that each of the other 3 drugs has blockbuster potential in the US.
3)IL 21-RCC-In the US it is being tested with Nexavar.Europe with its ROW partner Novo Nordisk it is being tested with sutent.Also being tested for melanoma,NHL,and metastatic RCC.
4)Atacicept-being tested for 5 different diseases both in US and with ROW partner Serono.Most important trial is RA but no data until 2009.
5)PEG-Will initiate phase 1 study for HCV now and if proof of concept will look to partner asap.
I could go on and on with the pipeline.However,after listening 2x to presentation i have the feeling that Williams is very confident that more then one of these drugs will be a home run.I know Williams from his days at Immunex(Enbrel) and he is not the type of guy to pump up the pipeline.
INVESTMENT CONSIDERATION- we have a pipeline with multiple blockbuster potetial.However it will be sometime in 2009 before we will be able to start putting our arms around this potential.The driver of the stock for the next 18 months will be rThrombin and how quickly we can build revenue.REMEMBER ZGEN has structured their deal with Bayer to get cashflow to fund those potential blockbusters.
Therefore we can get a bump on approval but remember what happened after the Bayer partnership--run up--run down--same can easily happen here given the overall market.
I have been surprised by the recent strength.Long term this company as all kinds of potential.I am worried that the hedges might sell off after approval and wait for actual sales results.
Late 2008 will bring critical data on other drug candidates--in between stock will move with the results oh sales.
Pastemp, looking forward to reading your summary. Working today and could not listen to presentation. Today's price action was predictable selling into a conference after a run-up. Did you notice 50,000 share block near close and immediate price improvement after? Tomorrow's action should be interesting. Regards.
Listened to the Piper Jaffary presentation today.This will be a very exciting investment.Will post a summary on Wednesday.
ZymoGenetics(or Ziggy) has been acting like the Everyready Bunny lately. Nice to see fundamentals and technicals in synch. Looks like S/T trend has passed into intermediate uptrend. Price action is indicative of accumulation.
It does appear that way.With my other bio's tanking it helps.
Improving Chaikin Money Flow (ZGEN)
Currently one of the few biotech stocks with positive money flow into the stock.
Recombinant products always end up with the majority of the revenue in every product category.This should be no exception.I am suprised that the analysts are so bullish on Omrix human version.Maybe it is the marketing muscle of J&J.
In the end ZGEN will dominate.However i believe that the stock price will only move when the actual sales results are in.
I think worldwide sales for ZGEN will eventually exceed $500 million with line extentions.
I shorted KG with its bovine version 9 months ago-good trade.
Pastemp, very positive price action today on 2 1/2 times normal volume. Stock appears to be ready for a major breakout. What are your expectations on the marketing potential of rhThrombin vs bovine thrombin?
Market tried to move stock toward the $15 strike price over the last 3 weeks but never got close.Stock will drift lower for a while as we await approval date.Near term catalysts are:
1)Analyst day in NYC i believe on December 13
2)Release of phase 1A data re. healthy volunteers at a December hepatitis meeting for IL29.
Major data release points will start with 2008 ASCO meeting and continue big time for next 18 months thru 2009.
My sense is that approval will move the stock to the $15-$16 range(sustainable price) until we get a feel for actual product sale.
Point of information-own 24000 shares at a price of around $13.Could be a $40-$50 stock in 2 years.
I second your nomination and would appreciate your efforts.
i currently own 20444(lucky#444) of ZGEN.I will gladly be asst moderator.
I sold my final shares a couple of weeks ago because of the overall market conditions. ZGEN has held up compared to the 80% of biotech that has dropped, but currently I plan on funding other more beaten down biotech stocks and will revisit ZGEN in Jan. If you want to be an assistant mod I will add you to the iBOX, just let me know(you can help provide a pulse to the iBOX)
surf
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http://www.zymogenetics.com/
http://finance.yahoo.com/q/ks?s=ZGEN
http://finance.google.com/finance?client=ob&q=ZGEN
http://www.form4oracle.com/company?cik=0001129425&ticker=ZGEN
ZymoGenetics, Inc. engages in the discovery, development, manufacture, and commercialization of therapeutic proteins for the treatment of human diseases in the areas of hemostasis, inflammatory and autoimmune diseases, cancer, and viral infections. Its preclinical stage internal products include IL-31, for the treatment of atopic dermatitis and inflammatory diseases. The company's phase II internal candidates comprise atacicept for the treatment of systemic lupus erythematosus, rheumatoid arthritis, and multiple sclerosis; and IL-21 for the treatment of metastatic melanoma/metastatic renal cell carcinoma. Its phase I out-licensed candidates consist of rFactor XIII for congenital factor XIII deficiency and cardiac surgery. ZymoGenetics also develops rhThrombin, a phase III product, for the treatment of general surgical hemostat and line extensions; and PEG-Interferon lambda, which is in phase I clinical trial for the treatment of hepatitis C virus infection. In addition, it provides six out-licensed products, which include Novolin and NovoRapid, which are used in the treatment of diabetes; NovoSeven for use in the treatment of hemophilia; Regranex for wound healing; GEM 21S for the treatment of periodontal defects; GlucaGen for hypoglycemia and gastrointestinal motility inhibition; and Cleactor, which is used for the treatment of myocardial infarction. ZymoGenetics has a strategic alliance with Merck Serono S.A for the research, development, and commercialization of novel protein and antibody therapeutics derived from the company's proprietary portfolio of genes and proteins; and a collaboration with Bayer HealthCare for the development and commercialization of recombinant human thrombin. The company was founded in 1981 and is headquartered in Seattle, Washington.
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