Nektar Therapeutics (NKTR)

[Ratan09]

PDUFA for MOVANTIK on Sept 16th

[Ratan09]

Picked some up here @13.96

[maytepper]

Roth Capital Reiterates Buy On Nektar Therapeutics; Sees 46% Potential Upside http://www.smarteranalyst.com/2014/08/25/william-blair-maintains-outperform-on-el-pollo-loco-following-20-new-franchise-agreements/

[RealGenius]

600K shares in AH

[blackcat]

Sweet. I'm awfk but looking forward to the next several days as we see how she trades going forward.

[mathew633]

NKTR...trading halt lifted and trading at 13.90 with high of 15.00

[blackcat]

Thanks! I looked through the materials, but missed the meeting URL. I do like to follow along when I can. (Although I sometimes get totally lost)

[ghmm]

Its a two day panel so I imagine the vote is just tomorrow. You can watch (free) here if your interested:

https://collaboration.fda.gov/aadpac614/
(use Guest login)

other info available here:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ucm390304.htm

[mathew633]

No I don't

[blackcat]

Does anyone have a link so we can follow the voting when it happens?

[mathew633]

Trading halted this morning

[mathew633]

Good to see us making a nice move today into the 6/11 AdCom

[mathew633]

NKTR...news this evening, positive data release

http://ih.advfn.com/p.php?pid=nmona&article=62403071&symbol=NKTR

[mathew633]

NKTR...AdCom set for 6/11-12

http://www.biopharmcatalyst.com/2014/03/nktr-adcom-date-set-icpt-meets-phase-3-poise-endpoint-gwph-ino-updates/

[TheFinalCD]

NKTR 8-K http://archive.fast-edgar.com//20140121/AE2BGQ2CZC2ROZZK222C2ZXQSBRNZZ22Z262/

[surf1944]

8:15AM Nektar Therapeutics: Etirinotecan Pegol (NKTR-102) passes interim efficacy analysis for BEACON pivotal Phase 3 clinical study in patients with metastatic breast cancer (NKTR) 12.38 : Co announces that the Independent Data Monitoring Committee created to provide safety oversight for the Company's pivotal clinical study for etirinotecan pegol (NKTR-102) has recommended continuation of the BEACON phase 3 trial, based upon the completion of a planned interim efficacy analysis in accordance with the DMC charter. The BEACON trial is evaluating NKTR-102 versus an agent of physician's choice for the treatment of locally recurrent or metastatic breast cancer, with a primary efficacy endpoint of overall survival. NKTR-102 is the first long-acting topoisomerase I-inhibitor designed to concentrate in tumor tissue, provide sustained tumor suppression throughout the entire chemotherapy cycle, and to reduce the peak exposures that are associated with toxicities of other cytotoxics.

The independent DMC performed the pre-defined interim efficacy analysis, which consisted of a review of ongoing efficacy and safety data, including 50% of patient events necessary to evaluate the primary endpoint of overall survival. In August 2013, the BEACON study completed enrollment of 852 patients with advanced breast cancer whose disease has progressed following treatment with anthracycline, taxane and capecitabine therapies.

[surf1944]

6:52AM Nektar Therapeutics reported that partner AstraZeneca (AZN) announced European Medicines Agency acceptance of Marketing Authorisation Application for Naloxegol (NKTR) 10.54 : Co reported that AstraZeneca (AZN) announced that the European Medicines Agency has accepted the Marketing Authorisation Application for Naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, which has been specifically designed for the treatment of opioid-induced constipation for adult patients 18 years and older, including patients with inadequate response to laxatives. The MAA filing was based on comprehensive data from the core Phase III KODIAC programme, comprised of four clinical trials designed to investigate the safety and efficacy of naloxegol for the treatment of OIC.

Naloxegol is part of the exclusive worldwide license agreement announced on 21 Sep 2009, between AstraZeneca and Nektar Therapeutics. Under the terms of the recently amended License Agreement, AstraZeneca will pay Nektar a $25 mln milestone within five business days of acceptance of the MAA by the EMA.

[surf1944]

1:38AM Nektar Therapeutics presents target-specific biomarkers being assessed in ongoing Phase 3 BEACON study of etirinotecan pegol for the treatment of metastatic breast cancer (NKTR) 9.47 : Co announces a series of target-specific biomarkers that are being evaluated in the development of etirinotecan pegol for the treatment of breast cancer. A series of assays for target-specific pharmacodynamic biomarkers for etirinotecan pegol, including the molecular target topoisomerase I, have been established and are being measured in the Phase 3 BEACON study. The biomarkers were identified from Circulating Tumor Cell samples which were collected prior to patient treatment. Additional CTC patient samples are being collected at regular intervals during treatment and at the end of treatment.

Preliminary results from the initial pre-dose samples found CTCs in over 90% of patient samples, with a median of 200 CTCs per 7.5 mL blood draw. Patient participation in the CTC sub-set of the BEACON study is projected to be over 75%. Measurements of each biomarker expression over time will be analyzed in order to identify potential predictive biomarkers for clinical response to etirinotecan pegol.

[pammy]

does nektar manufacture medical marijuana?

[surf1944]

1:38AM Nektar Therapeutics reports positive preclinical data for NKTR-214, an investigational cancer immunotherapy targeting the il-2 receptor complex (NKTR) 10.50 : Co presents positive preclinical data for NKTR-214, a novel cancer immunotherapy which targets the IL-2 receptor complex. NKTR-214 is a new immunocytokine that is being developed as a potential treatment for multiple cancers. NKTR-214 targets the IL-2 receptor complex through selective receptor binding to the IL2Rb subtype. Activation of the IL2Rb subtype promotes tumor killing by the body's own immune system.

In the preclinical data presented at AACR, NKTR-214 exhibits differentiated IL-2 receptor binding which results in significantly altered immune cell populations in the tumor microenvironment compared to the clinically validated IL-2 protein therapy, aldesleukin. Specifically, NKTR-214 maintains high affinity for the IL-2 receptor subunit beta, which activates tumor-killing T cells within the tumor microenvironment. At the same time, NKTR-214 exhibits up to 100-fold reduced affinity to the IL-2 receptor subunit alpha-beta, which activates immuno-suppressive regulatory T-cells. In a well-validated animal model of melanoma, NKTR-214 demonstrated significantly improved dosing, at once every 9 days as compared to twice a day dosing with aldesleukin.

[surf1944]

8:33AM Nektar Therapeutics intiates investigator-initiated trial evaluating Etirinotecan Pegol as a third-line treatment in patients with metastatic and recurrent non-small cell lung cancer (NKTR) 8.88 : Co announces the start of a Phase 2 investigator-initiated study of etirinotecan pegol in patients with metastatic and recurrent NSCLC. The primary endpoint of the Phase 2 study is overall response rate. Secondary endpoints include progression free survival, overall survival, median duration of response and the safety profile of etirinotecan pegol in patients with NSCLC after failure of second-line therapy. The open label, single-arm trial is expected to enroll ~37 patients who will receive etirinotecan pegol once every 3 weeks as monotherapy.

[surf1944]

Bull keeps faith even as Nektar slips
By Mike Yamamoto ([e-mail]) | optionMONSTER – Fri, Jan 25, 2013 5:47 AM EST

Nektar Therapeutics has cooled after rebounding sharply this year, but one trader apparently believes that the stock will resume its run in coming months.

optionMONSTER's Heat Seeker system shows that a trader sold 3,000 May 8 calls for $1.55 and
bought the same number of August 10 calls for $1.10. The May options were below previous open interest while the August contracts were above it.

This indicates that the investor is closing the May 8 calls, which are now in the money , and is rolling the position to the higher strike in August. The trader probably made a profit on the initial calls and is using those gains to buy another three months of upside exposure.

The new long calls , which lock in the price where the stock can be bought, are now looking for NKTR to trade above $10 by mid-August but will expire worthless if the stock is below that strike price. The move follows another roll from the May 8 calls on Jan. 16 . (See our Education section)

NKTR slipped 1.72 percent to $8.57 yesterday, continuing to drift lower since hitting resistance around the $9.50 level last week. The clinical-stage biopharmaceutical company plunged from above $10 in mid-October to below $6 less than a month later but then bounced sharply.

Yesterday's call roll made up almost all of the option volume in the name, which was about 6 times its daily average in the last month. Only 26 puts changed hands in the entire session, a further reflection of the day's bullish sentiment.

[Odeen Odessit]

Breakout!

Loaded 6.50sss. Looking for 200 dma

[pj McMulligan]

Nice pincher breaking outtie! :)

[surf1944]

6:31AM Nektar Therapeutics announces top-line Phase III results from naloxegol pivotal trials in patients with opioid-induced constipation (NKTR) 8.15 : Co announced positive top-line results from two Phase III trials and one safety extension trial in patients with non-cancer related pain and opioid-induced constipation (OIC). These Phase III KODIAC trials evaluated the safety and efficacy of naloxegol, an oral peripherally-acting, mu-opioid receptor antagonist for the treatment of OIC, a common side effect of prescription opioids. Under the design of both trials, statistical significance for the primary endpoint would be achieved if at least one of the two naloxegol doses had a p-value <0.025 compared with placebo. Analysis of the data indicates that in KODIAC-04 both naloxegol doses (12.5 mg and 25 mg) demonstrated statistically significant results for the primary endpoint. P-values were 0.015 and 0.001 respectively. In KODIAC-05, the 25 mg dose demonstrated a statistically significant result for the primary endpoint but the 12.5 mg dose did not. P-values were 0.202 for 12.5 mg and 0.021 for 25 mg. The analyses also showed no clinically relevant imbalances in serious adverse events (SAEs), including externally adjudicated major cardiovascular events, across the three treatment arms in KODIAC-04, -05 and -07. The most common adverse events (AEs) in the naloxegol treatment arms in both trials were abdominal pain, diarrhea and nausea.

[surf1944]

8:07AM Nektar Therapeutics announces that FDA grants fast track designation to Etirinotecan Pegol (NKTR-102) for the treatment of metastatic breast cancer (NKTR) 8.85 : Co announced that the U.S. Food and Drug Administration has designated etirinotecan pegol (NKTR-102) as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC). Etirinotecan pegol is a unique, targeted topoisomerase I inhibitor designed using Nektar's proprietary polymer conjugate technology. The drug candidate is currently being evaluated in a Phase 3 study in women with metastatic breast cancer.

[surf1944]

Nektar Therapeutics' CEO Presents at UBS Global Life Sciences Conference - Transcript

http://seekingalpha.com/article/876911-nektar-therapeutics-ceo-presents-at-ubs-global-life-sciences-conference-transcript?source=yahoo

[surf1944]

8:01AM Nektar Therapeutics announces private placement of $125 mln of senior secured notes due in 2017 (NKTR) 8.34 : Co announced the private placement of $125 million of 12.0% Senior Secured Notes Due in 2017 in an offering exempt from the registration requirements of the Securities Act of 1933. Nektar intends to use the net proceeds from the offering of the Senior Secured Notes towards the repayment of its Convertible Subordinated Notes due September 28, 2012. The sale of the Senior Secured Notes is expected to close on July 11, 2012, subject to customary closing conditions.

[surf1944]

8:03AM Nektar Therapeutics announces that FDA grants Fast Track designation to NKTR-181 for the treatment of moderate to severe chronic pain (NKTR) 6.82 : Co announced that the FDA as designated NKTR-181 as a Fast Track development program for the treatment of moderate to severe chronic pain. NKTR-181 is a novel mu-opioid agonist molecule, which is designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse and to reduce its CNS-mediated side effects. Nektar requested Fast Track designation from the FDA for NKTR-181 based upon what is known about its safety and efficacy profile to-date from both preclinical and Phase 1 clinical studies, as well as NKTR-181's potential to treat chronic pain conditions with an improved safety profile over existing therapies. Given the properties and potential of NKTR-181 in the treatment of chronic pain, Nektar believes that this promising therapy could provide a unique solution to pain management with its intrinsic abuse deterrent design.

[dangerx]

Good stock to watch for the time being. I currently have 3 pharmaceutical stocks on my radar and the stocks for all 3 seem to have a similar niche within the industry. I see the downside potential of Nektar being similar to Anthera Pharmaceuticals (AN*TH) which dropped from ~$7 to $2 after missing on a late stage clinical trial. The upside potential looks similar to Vivus pharmaceuticals (VV*US), which jumped from ~$8 to ~$26 after approval on two drug candidates. Pharmaceutical R&D is almost always a gamble, but by the time investors know whether a drug candidate is going to make it to the market, it will be too late to get in a position to maximize profit (or minimize loss) GLTA!

[dangerx]

Great DD here, Surf! The two drug candidates currently in clinical trials and the 124 million dollar deal for the royalties on Cimzia and Mircera have made this long term biotech gamble a lot more appealing. Corporate updates for the BEACON phase III trial for NKTR-102 can be found on the company's website: http://www.nektar.com/product_pipeline/oncology_nktr-102.html and the NIH information on the status of the clinical trial can be found here: http://clinicaltrial.gov/ct2/show/NCT01492101?term=BEACON&rank=2

It may be a little early to buy and hold, though... the primary outcome for the BEACON trial is overall survival after 36 months, and the trial is still recruiting new patients, but from what I can tell, the current financials look good for a biotech company (increased rev on sales and licensing of their technology platform, increased assets from the sale of royalties). If any seasoned trader has an eye on this company, could you please share what you're seeing from a technical analysis view point? My background is in pharmacy, not business, but if near-dollar swings are gonna be the norm with this stock, it could be fun to play with until the results from the clinical trials are announced.

[ghmm]

I wouldn't put too high of expectations. I was very bullish on 102 in Ovarian cancer but the company talking less about it and the enrollment being stopped early (perhaps due to shortages of doxil?) make odds on an accelerated filing very, very unlikely.

On the 118 front AZ has two more studies look like drug-drug interaction studies. For whatever people may say about competition in the space by the number of trials and AZ continuing to feature it I think we stand a good chance to perhaps get a broader label and certainly have a strong marketing effort (presuming the data look good and we get approved of course).
http://www.clinicaltrials.gov/ct2/show/NCT01533870
http://www.clinicaltrials.gov/ct2/show/NCT01533155

[easymoney123]

I'm interested in NKTR-102 Phase 2 expansion study in ovarian cancer at Nektar's R&D Day on April 16, hope to hear positive news.

[surf1944]

8:55AM On The Wires (WIRES) :Nektar Therapeutics (NKTR) announced that the first subjects were dosed last week in a Phase 1 clinical study to evaluate the pharmacokinetics and safety of NKTR-192, the co's short-acting mu-opioid analgesic candidate.

[easymoney123]

Upcoming catalysts:

http://views.thomsononeim.com/gateway/PORTALSxDOCUMENTVIEWER.aspx?DocId=59155412&mode=plain&relateditems=false

[easymoney123]

Surf, are you still holding NKTR?

[surf1944]

8:04AM Nektar Therapeutics confirmed that partner Affymax (AFFY) has announced FDA approval of OMONTYS (NKTR) 8.21 : Co reported that its partner Affymax announced that the FDA has approved OMONTYS Injection for the treatment of anemia due to chronic kidney disease in adult patients on dialysis. Nektar and Affymax have an exclusive agreement under which Nektar provides Affymax with its proprietary PEGylation technology for use in OMONTYS. Under the terms of the agreement, Nektar is entitled to milestones, manufacturing revenues, and royalties on the global sales of OMONTYS.

[easymoney123]

NKTR, its time to make money. GO AFFY.

[mlkrborn]

"Nektar Therapeutics announces agreement to sell Cimzia and Mircera royalties to Royalty Pharma for $124 mln (NKTR) 6.75 : Co announced that it agreed to sell to Royalty Pharma its royalties on future sales of CIMZIA, under Nektar's agreement with UCB Pharma, and MIRCERA, under Nektar's agreement with Roche (RHHBY). In consideration for the sale, Royalty Pharma will pay Nektar an aggregate cash payment of $124.0 million. Nektar intends to use the net proceeds of the transaction towards the repayment of its $215.0 mln of convertible debt. For the twelve month period ended December 31, 2011, Nektar recognized $8.3 mln in aggregate royalties from net sales of CIMZIA and MIRCERA."

[kzivann]

http://finance.yahoo.com/news/nektar-therapeutics-announces-agreement-sell-133000525.html

[surf1944]

8:39AM Nektar Therapeutics presents 'positive' proof-of-concept clinical data for its new opioid molecule, NKTR-181 (NKTR) 6.98 : Co announced a presentation of positive clinical data for NKTR-181, its new oral opioid analgesic molecule, at the 2012 American Academy of Pain Medicine's 28th Annual Meeting. NKTR-181 is a novel mu-opioid agonist molecule, which was designed to have a slow rate of entry into the brain to reduce the attractiveness of the molecule as a target of abuse and to reduce its CNS-mediated side effects. Using pupil constriction as a measure of the onset of central opioid effect, the study showed that NKTR-181 enters the brain slowly and produces centrally-mediated opioid effects that are dose-dependent and statistically meaningful (P<0.001) following twice daily oral doses of 200-400 mg. Further, NKTR-181 enters the CNS from the plasma at a rate approximately ten-times slower than historical published rates for oxycodone. NKTR-181's slow rate of entry into the CNS may reduce the euphoria and other CNS side effects that are associated with rapid CNS uptake of current standard opioid therapies. In a separate presentation of preclinical data at the AAPM Meeting, NKTR-181 resulted in less sedation and abuse liability as compared to oxycodone in multiple animal models across a wide range of doses. As predicted from its molecular design, NKTR-181 has a reduced rate of entry into the brain in rodents. This feature contributed to a 30-fold shift in the dose-response for abuse liability and a 10-fold shift in the dose response for sedation relative to oxycodone.

[Penny Roger$]

~ Monday! $NKTR ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $NKTR ~ Earnings expected on Monday *
Want more like this? Search Keyword: MACMONEY >>> http://tinyurl.com/MACMONEY <<<
One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








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*If the earnings date is in error please ignore error. I do my best.

[surf1944]

Nektar Therapeutics: Often Forgotten, But Worth A Look

A few weeks into 2012, it looks like investors are much more eager to take on some risk in their portfolios and biotechs are coming back into favor. With that in mind, it makes sense to check out some of the promising biotechs that languished a bit in 2011. Although Nektar Therapeutics (NASDAQ: NKTR) hasn't had much bad news in a while, in the world of biotech "no news" can be almost just as bad and it seems that the market has perhaps forgotten this name a bit.

Changing Course

Nektar has long been in the business of partnering with larger pharmaceutical companies and licensing its proprietary PEGylation technology. PEGylation basically introduces polyethylene glycol into a compound and alters its performance in the body - most notably by slowing the process of clearing in from the body. Companies including Amgen (NASDAQ: AMGN), Pfizer (NYSE: PFE), and Merck (NYSE: MRK) have licensed this technology for major drugs like Neulasta and PEG-INTRON, but Nektar gets only relatively small royalties for this technology.

Realizing the limits of how far technology licenses can take the company, management has been working on a pipeline for proprietary products for several years now and two of them - NKTR-102 and NKTR-181 are particularly worth noticing.

Two Interesting Proprietary (For Now) Programs

NKTR-102 is a modified version of irinotecan - a cancer drug that Pfizer marketed as Camptosar (in the unmodified form). A toposomerase 1 inhibitor-polymer conjugate, NKTR-102 has shown encouraging signs of efficacy in ovarian, breast, and colorectal cancer. A phase 3 study in breast cancer (BEACON) is already underway and a phase 3 study in ovarian cancer could begin in 2012 as well. If BEACON can reach its goal of 30% (or better) improvement in overall survival, NKTR-102 could definitely be a $1 billion/year drug.

So far, NKTR-102 seems notably efficacious in hard-to-treat breast cancers that have not sufficiently responded to prior treatments. That said, its efficacy in colorectal cancer is less certain. Management had hoped to partner this drug back in 2010, but has not yet found a deal to its liking. With Phase 2 data coming from an ovarian cancer trial (presumably Q1 of 2012), this data will likely go a long way toward determining whether Nektar can get a good partnership for this drug, or whether the company will have to contemplate dilutive financing.

Further behind is NKTR-181 - a long-acting drug for pain. Early studies have been encouraging, suggesting a half-life of about 12 hours. That's well ahead of the typical 3-4 hour half-life of oxycodone and the 8-hour half-life of long-acting formulations. Not only might NKTR-181 provide a longer-acting solution for pain, but the design of the drug is such that it should be difficult to abuse (a major concern with the FDA).

Nektar should begin phase 2 studies this year and good results could very well lead to partnership discussions. Pfizer has been very active over the years in partnering on pain drugs, and others like Johnson & Johnson (NYSE: JNJ) and Teva (NASDAQ: TEVA) could be logical partners as well.

More Doubt With Two Partnered Programs

The outlook for Nektar's two most advanced partnered programs is not quite as appealing. AstraZeneca (NYSE: AZN) is developing NKTR-118 (PEG-naloxol) for opioid-induced constipation and has the drug in a Phase 3 study called KODIAC. Unfortunately, this has become very crowded real estate, with other companies like Salix (NASDAQ: SLXP), Theravance (NASDAQ: THRX), Cubist (NASDAQ: CBST), and Alkermes (NASDAQ: ALKS) all developing drugs with this targeted indication. Unless the data from KODIAC is incredible (and early trial results don't suggest that), it may well be the case that competition limits the sales potential of this drug.

Bayer (BAYRY.PK) is Nektar's partner on NKTR-061, inhaled amikacin for gram-negative pneumonia. Early results have been favorable and Bayer is expected to start a Phase 3 study in 2012, but this is a drug with relatively limited end-market potential.

A Pipeline Targeted At Bringing The Pain Relief

Beyond these high-profile programs, Nektar has several additional drugs in early clinical or preclinical studies. Three of these are for pain, with the the fourth targeted at solid tumors. While pain is very much a worthwhile clinical target, it will be a while before these drugs really factor into the valuation of the company.

Data And A Good Partner Could Lift The Stock

Right now, I see fair value on Nektar shares of around $8 a share - undervalued, but not dramatically so and arguably not undervalued enough to meet a margin of safety requirement. Investors should also note that the company has a convertible bond due in 2012 that is equal to about half of its cash resources. That obligation squeezes the company's liquidity today, and it is likely that management is weighing multiple options like a basic refinancing or monetizing other assets for repayment.

That said, that valuation could rise on some 2012 developments. Solid data on NKTR-102 in ovarian cancer would certainly boost the end-market sales estimate and increase the chance of a favorable partnership. It may be ambitious to hope that partnering NKTR-181 (pain) would be a 2012 event, but doing so will improve the company's liquidity projection and add some external validation to the nascent pain franchise.

All in all, Nektar shares are well worth a look. With some good news in 2012, fair value on Nektar shares could easily move into the low teens and offer a pretty decent return from today's prices.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

http://seekingalpha.com/article/321201-nektar-therapeutics-often-forgotten-but-worth-a-look?source=yahoo

[ghmm]

Here is the clinical trials entry for the BEACON study
http://www.clinicaltrials.gov/ct2/show/NCT01492101

[mlkrborn]

Nektar Therapeutics announces positive clinical data from second Phase 1 clinical study of NKTR-181; exhibits sustained and dose-dependent analgesic effect, reduced rate of entry into the CNS and wide therapeutic window (NKTR) 5.35 : Co announced positive data from a Phase 1 clinical study of NKTR-181 evaluating multiple ascending oral doses of NKTR-181 over an 8-day treatment period in healthy subjects. NKTR-181 is Nektar's new oral opioid analgesic candidate designed to address the abuse liability and serious central nervous system side effects associated with current opioid therapies. In this multiple dose Phase 1 study, NKTR-181 exhibited a sustained analgesic response, supporting its development as a twice-daily oral tablet for the treatment of chronic pain conditions. Pupillometry data from the study demonstrated that NKTR-181's centrally-mediated opioid effects are dose-dependent and that the molecule enters the brain slowly, which could reduce the euphoria and other CNS side effects that are associated with current opioids. NKTR-181 was also well-tolerated over the entire 8-day dosing period in the study at all doses evaluated.

[surf1944]

NKTR-102 Demonstrates Synergistic Anti-Tumor Activity in Combination with Pegylated Liposomal Doxorubicin in Platinum-Resistant Ovarian Cancer
New Preclinical Studies for NKTR-102 Presented at 2011 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
PR NewswirePress Release: Nektar Therapeutics – Tue, Nov 15, 2011 6:00 PM EST

SAN FRANCISCO , Nov. 15, 2011 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR - News) today presented positive preclinical data for NKTR-102, a next-generation topoisomerase I inhibitor, at the 2011 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer being held in San Francisco, California . The preclinical data demonstrates that NKTR-102 administered in combination with pegylated liposomal doxorubicin (PLD) in vivo has strong synergistic anti-cancer properties exhibiting a 100% complete response rate with no tumor re-growth in over 90% of animals. In addition, the study showed that there was no additive toxicity when combining NKTR-102 with PLD in a preclinical model of ovarian cancer.

"Results from these nonclinical studies of NKTR-102 combined with PLD and as a single agent are highly compelling," said Robert Medve , M.D., Chief Medical Officer of Nektar Therapeutics. "In the models of platinum-resistant ovarian cancer, NKTR-102 showed synergistic anti-tumor activity with PLD. These preclinical data support the future exploration of NKTR-102 in combination with PLD in platinum-resistant ovarian cancer."

The data presented at the 2011 AACR-NCI-EORTC meeting show that in an in vivo model of platinum-resistant human ovarian cancer, a single-dose of single-agent NKTR-102 resulted in a 100 percent complete response rate and a delay in tumor growth of up to 38 days at the highest dose. In the same model, multiple doses of single-agent PLD achieved only one partial response and a delay in tumor growth of up to only 24 days at its highest dose. NKTR-102 administered in combination with PLD showed synergistic anti-tumor activity with a 100 percent complete response rate and no tumor re-growth for 93% of the animals within a 69-day observation period.

NKTR-102 and PLD Nonclinical Data

These data were presented today at the 2011 AACR-NCI-EORTC meeting during the Topoisomerase Inhibitors session (Abstract C209) entitled "Strong synergistic activity of NKTR-102 - Pegylated Liposomal Doxorubicin (PLD) Combination Therapy in a Nonclinical Model of Platinum-Resistant A2780 Human Ovarian Cancer." The poster presentation is also available at http://www.nektar.com/product_pipeline/oncology_nktr-102.html .

About NKTR-102

Nektar is developing NKTR-102, a next-generation topoisomerase I inhibitor with reduced peak concentrations and a continuous concentration profile. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform, and is the first oncology product candidate to leverage Nektar's releasable polymer technology platform.

NKTR-102 is being evaluated in multiple clinical studies. In ovarian cancer, a 71-patient Phase 2 clinical trial of NKTR-102 has been completed in patients with platinum-refractory/resistant ovarian cancer. In June 2010 , the ovarian cancer Phase 2 study was expanded to evaluate single-agent NKTR-102 in women who progressed while on Doxil therapy, and this study is ongoing. In metastatic breast cancer, a 70-patient study of NKTR-102 in second- and third-line metastatic breast cancer is completed. A Phase 3 clinical trial of NKTR-102 in patients with metastatic breast cancer, the BEACON study (BrEAst Cancer Outcomes with NKTR-102) study, is planned to start in December 2011 . NKTR-102 is also being tested in second-line colorectal cancer as both a single-agent and in combination with 5-fluoracil/leukovorin.

[mlkrborn]

NKTR $5.00 Nektar Therapeutics beats by $0.16, beats on revs (NKTR) 4.96 -0.34 : Reports Q3 (Sep) loss of $0.21 per share, $0.16 better than the Capital IQ Consensus Estimate of ($0.37); revenues fell 28.5% year/year to $27.1 mln vs the $15.83 mln consensus. The sales increase was primarily the result of the completion as of December 31, 2010 of the amortization of the $125.0 million upfront payment received in 2009 from AstraZeneca for the NKTR-118 and NKTR-119 license agreement. "AstraZeneca's Phase 3 KODIAC program for NKTR-118 for opioid-induced constipation is continuing on-track with AZ targeting regulatory filing in 2013. We are targeting the start of the Phase 3 BEACON study for NKTR-102 in metastatic breast cancer before year-end. NKTR-181, our novel opioid candidate to treat chronic pain, is moving rapidly through Phase 1 clinical development and we plan to announce topline data before year-end. Finally, we plan to file an IND for NKTR-192, our new clinical candidate to treat acute pain, in the first quarter of 2012."

[surf1944]

1:08AM Nektar Therapeutics reports positive results from Phase 2 clinical study of NKTR-102 in metastatic breast cancer (NKTR) 5.06 : Co announces positive results from the co's Phase 2 clinical study of NKTR-102 in patients with metastatic breast cancer. NKTR-102 achieved a confirmed objective response rate by RECIST of 29 percent. In addition, 71 percent of patients in the study had no tumor progression, defined as complete response, partial response and stable disease, as measured by RECIST criteria. NKTR-102 also demonstrated a high clinical benefit rate of 46% (30 of 66). Six patients experienced 100% resolution of all target lesions, with two complete RECIST responses and four near-complete responses. Objective tumor responses were maintained in heavily pretreated and poor prognosis subsets, including patients previously treated with anthracycline/taxane/capecitabine, patients with metastatic triple-negative breast cancer and patients with visceral disease. Eighty-nine percent (62/70) of patients in the study received a prior anthracycline/taxane with or without capecitabine. A total of 66 of the 70 patients treated with single-agent NKTR-102 in the Phase 2 clinical study were assessable for the primary endpoint of objective tumor response rate.

[surf1944]

Nektar shares at a signficant discount, says Morgan Joseph
theflyonthewall

On Wednesday August 24, 2011, 9:24 am EDT

Morgan Joseph recommends buying Nektar aggressively given its strong pipeline, leadership in PEGylation technology, and sound business strategy, among other reasons. Shares are Buy rated with a $16 price target

[mlkrborn]

NKTR $7.39 on positive news: