Nektar Therapeutics (NKTR)

[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 *
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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:

[surf1944]

NKTR-102 Receives Positive Opinion From EMA COMP for Orphan Medicinal Product Designation in Ovarian Cancer

Press Release Source: Nektar Therapeutics On Monday July 18, 2011, 8:00 am

SAN FRANCISCO, July 18, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq:NKTR - News) today announced that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on its application for orphan medicinal product status for the company's lead oncology candidate, NKTR-102, for the treatment of women with ovarian cancer.

"There is a significant unmet need for additional treatments to address ovarian cancer," said Carlo DiFonzo, PhD, Vice President of Drug Development and Regulatory Affairs for Nektar. "We are pleased to have received a positive opinion from COMP for orphan medicinal product status in Europe to augment the U.S. Orphan Drug Designation recently received in April, as we continue the treatment of patients in our Phase 2 study of NKTR-102 in women with platinum-resistant ovarian cancer."

Nektar has a multi-national Phase 2 study ongoing for NKTR-102 that is enrolling approximately 125 patients with platinum-resistant ovarian cancer whose disease has progressed following treatment with pegylated liposomal doxorubicin (PLD) therapy. In addition, Phase 3 planning is also underway for NKTR-102 in ovarian cancer. For more information about clinical trials for NKTR-102, please visit the Nektar Therapeutics website at www.nektar.com or www.clinicaltrials.gov.

NKTR-102 is an investigational agent and is not yet approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities. Following the issuance of a positive opinion from the EMA COMP, the opinion is forwarded to the European Commission for adoption of the decision and subsequent listing in the Community Register of Orphan Medicinal Products.

About Orphan Medicinal Product Designation in Europe

In the European Union, orphan medicinal product designation is designed to encourage the development of medicinal products for the diagnosis, treatment or prevention of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the European Union (EU). The designation provides incentives for sponsors to develop orphan medicinal products, including market exclusivity to a drug for a particular indication for a ten-year period after the drug is granted marketing approval. Additional incentives for the sponsor may include protocol assistance, filing fee reductions, and research grants.

About European Medicines Agency (EMA):

The EMA is a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. Further information about EMA may be found at http://www.ema.europa.eu.

About Ovarian Cancer

Ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.(1) In the European Union, there are approximately 44,000 newly diagnosed cases of ovarian cancer each year and approximately 29,000 deaths result from ovarian cancer each year. (2) In the U.S., approximately 22,000 new cases of ovarian cancer will be diagnosed and 14,000 deaths are expected to be caused by ovarian cancer this year.(1) Treatment options following relapse are limited and overall long-term survival among ovarian cancer patients has not changed significantly in nearly 40 years.(3)

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 has been evaluated in two separate Phase 2 studies for the treatment of platinum-refractory/resistant ovarian cancer and for the treatment of second- and third-line metastatic breast cancer patients. In addition, NKTR-102 is also being tested as a single agent in a Phase 2 clinical trial in patients with second-line colorectal cancer and a Phase 1 clinical trial evaluating NKTR-102 in combination with 5-FU therapy.

[surf1944]

2. Nektar Therapeutics (NKTR): Biotechnology Industry. Market cap of $857.88M. Net institutional purchases over the current quarter at 15.6M shares, representing 15.01% of the company's 103.90M share float. RSI(14) at 35.89. The stock is trading 4.52% above its 52-week low. The stock is a short squeeze candidate, with a short float at 10.29% (equivalent to 11.52 days of average volume). The stock has lost 41.93% over the last year.

http://seekingalpha.com/article/278987-14-oversold-stocks-trading-near-lows-but-being-bought-up-by-the-smart-money?source=yahoo

[oldberkeley]

Yesterday showed how the the market generally reacts to data coming out of ASCO.

Hoping for a steady recovery from here, best of luck to all.

[surf1944]

NKTR-102 Demonstrates Sustained Clinical Benefit in 46% of Patients with Metastatic Breast Cancer in Data Presented at 2011 American Society of Clinical Oncology Annual Meeting
High rate of confirmed response maintained in poor prognosis and heavily pre-treated patients including those with visceral disease

Press Release Source: Nektar Therapeutics On Saturday June 4, 2011, 3:00 pm EDT

CHICAGO and SAN FRANCISCO, June 4, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq:NKTR - News) today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 as a second- and third-line treatment in patients with metastatic breast cancer during the 2011 American Society of Clinical Oncology Meeting (ASCO). NKTR-102, a next-generation topoisomerase I inhibitor, is Nektar's lead oncology drug candidate and is being evaluated in multiple cancer indications. The randomized Simon two-stage study presented at ASCO evaluated two 145 mg/m2 dose schedules of single-agent NKTR-102, every two weeks (q14d) and every three weeks (q21d), in 70 metastatic breast cancer patients who failed a prior taxane therapy. Eighty-nine percent (62/70) of patients in the study received a prior anthracycline/taxane with or without capecitabine.

More than one million women worldwide are diagnosed with breast cancer every year and the disease is the leading cause of cancer-related death among women.(1)

A total of 66 of the 70 patients treated with single-agent NKTR-102 in the Phase 2 study were assessable for the primary endpoint of objective tumor response rate (ORR), including confirmed complete responses (CRs) and partial responses (PRs) per RECIST 1.0. As of May 9, 2011, for the q14d day schedule, the confirmed and unconfirmed ORR was 35 percent (11/31) and the confirmed ORR was 32 percent (10/31), including two confirmed CRs. Clinical benefit rate for the 31 evaluable patients in the q14d schedule was 42% (13/31) (defined as confirmed CR+ PR+ Stable Disease (SD) >6 mos). For the q21d schedule, the confirmed and unconfirmed ORR was 31 percent (11/35) and the confirmed ORR was 26 percent (9/35). Clinical benefit rate for the 35 evaluable patients in the q21d schedule was 49% (17/35). Clinical benefit rate for the overall study population was 46%. An additional four patients in the study had near CRs, with 100% disappearance of all target lesions.

"NKTR-102 is emerging as a promising anti-cancer investigational treatment with the potential to become the first topoisomerase I-inhibitor to be used in the fight against breast cancer," said Prof. Ahmad Awada, Head of the Medical Oncology Clinic at the Institut Jules Bordet in Brussels, Belgium. "The drug's high confirmed objective response rate and clinical benefit is very interesting, particularly when one observes that this response rate was maintained in patients pre-treated with anthracyclines, taxanes with or without capecitabine, and also maintained in poor prognosis subsets within the study, such as triple-negative breast cancer and patients with visceral disease."

The confirmed ORR in patients previously treated with anthracycline/taxane/capecitabine was 31% (5/16); confirmed ORR in patients with metastatic triple-negative breast cancer was 39% (7/18); and confirmed ORR in patients with visceral disease was 30% (17/57).

"The every three week dose schedule appears well-tolerated overall and demonstrates encouraging PFS and OS of 5.3 months and 13.1 months, respectively," continued Dr. Awada. "We are in need of effective new therapeutic options whose mechanism of action is different from those already available for women with metastatic breast cancer and we look forward to NKTR-102 entering Phase 3 development."

Patients treated in the single-agent NKTR-102 study had a median of two lines of prior cytotoxic treatments for metastatic disease. Seventy-four percent (52/70) of the patients received neoadjuvant and/or adjuvant therapy and 86% (60/70) had visceral disease.

"The clinical benefit we've observed in multiple tumor settings with NKTR-102, where a highly active topoisomerase 1 inhibitor could be extremely useful, makes us very excited about the future of this new anticancer drug candidate," said Lorianne Masuoka, M.D., Senior Vice President and Chief Medical Officer.

Side effects were generally manageable with dose-limiting toxicity consisting primarily of Grade 3 diarrhea (20-23%) typically occurring after three months of therapy for both schedules. Neuropathy and alopecia were minimal with only one patient experiencing G2 alopecia in the study. Both neuropathy and alopecia are significant adverse events commonly associated with standard breast cancer therapies [Safety Tables, Figures D and E].

NKTR-102 Phase 2 Data Presentation in Metastatic Breast Cancer



Awada et. al., Antitumor activity in a randomized phase II study comparing two schedules of NKTR-102 in patients (Pts) with pretreated metastatic breast cancer (MBC).




Abstract #1034, Poster Board #24




Poster Discussion Session: Breast Cancer - Triple-negative/Cytotoxics/Local Therapy




Session Date and Time: Saturday, June 4, 2011, 2:00 PM – 6:00 PM, Central Time




Location: E450b




Figure A: Efficacy Table: Objective Tumor Response Rate by RECIST (Investigator Assessment)




Response by RECIST v 1.0


NKTR-102

145 mg/m2

q14d


NKTR-102

145 mg/m2

q21d


TOTAL


N


31*


35


66


ORR (confirmed + unconfirmed)


11 (35%)


11 (31%)


22 (33%)


ORR (confirmed)


10 (32%)


9 (26%)


19 (29%)







CR (confirmed)


2 (7%)


0


2 (3%)


PR (confirmed)


8 (26%)


9 (26%)


17 (26%)


SD


12 (39%)


16 (46%)


28 (42%)


PD


9 (29%)


10 (29%)


19 (29%)


Median duration of response


8.3 months


4.4 months


5.8 months


Clinical benefit

(CR+PR+SD>6 months)


13 (42%)


17 (49%)


30 (46%)


Median progression-free survival**


3.5 months


5.3 months


4.6 months


Median overall survival**


8.8 months


13.1 months


10.3 months






*4 patients in the Q14 day arm with no post-baseline scans, but no evidence of progression were excluded from analysis in the evaluable population.

**based on a Kaplan-Meier analysis for the intent-to-treat population.

Figure B: Efficacy Table: Response rate by prior therapy




Prior Therapy Subgroup


Response by RECIST v 1.0

Evaluable Patients




NKTR-102

145 mg/m2

q14d

N=31


NKTR-102

145 mg/m2

q21d

N=35


TOTAL

N=66


Prior A/T only

ORR (confirmed)


7/22 (32%)



5/21 (24%)



12/43 (28%)



Prior A/T in MBC

ORR (confirmed)


3/7 (43%)



2/9 (22%)



5/16 (31%)



Prior A/T/C

ORR (confirmed)


2/6 (33%)



3/10 (30%)



5/16 (31%)







Figure C: Efficacy Table: Response rate by tumor characteristics




Disease Subgroup


Response by RECIST v 1.0

Evaluable Patients




NKTR-102

145 mg/m2

q14d

N=31


NKTR-102

145 mg/m2

q21d

N=35


TOTAL

N=66


ER+ and/or PR+

ORR (confirmed)


8/21 (38%)



4/21 (19%)



12/42 (29%)



Triple-negative breast cancer

ORR (confirmed)


2/8 (25%)



5/10 (50%)



7/18 (39%)



Visceral Disease

ORR (confirmed)


8/25 (32%)



9/32 (28%)



17/57 (30%)







Figure D: Safety Table: Safety-Summary of Drug Related AEs




Most Common Drug-related Grade 3 and 4 Adverse Events > 5% or event of interest

N (%)



NKTR-102

145 mg/m2

q14d

N=35


NKTR-102

145 mg/m2

q21d

N=35


Grade 3


Grade 4


Grade 3


Grade 4


Diarrhea


6 (17%)


1 (3%)


8 (23%)


0


Neutropenia


2 (6%)


2 (6%)


3 (9%)


1 (3%)


Dehydration


3 (9%)


0


4 (11%)


0


Fatigue


4 (11%)


0


3 (9%)


0


Vomiting


3 (9%)


0


0


0


Anaemia


1 (3%)


0


0


1 (3%)


Asthenia


2 (6%)


0


0


0


Lethargy


2 (6%)


0


0


0


Lymphopenia


1 (3%)


1 (3%)


0


0


Neutropenic sepsis


0


0


1 (3%)


0


Febrile neutropenia


0


0


1 (3%)


0






Note: There were two possible treatment-related deaths: sepsis (q21d) and acute renal failure following diarrhea (q14d).

Figure E: Safety Table: Other Safety-Neuropathy and Alopecia

No grade 3 or 4 neuropathy was reported.






NKTR-102

145 mg/m2

q14d

N=35


NKTR-102

145 mg/m2

q21d

N=35


Grade 1


Grade 2


Grade 1


Grade 2


Alopecia


6 (20%)


0


3 (9%)


1 (3%)






About Metastatic Breast Cancer

More than one million women worldwide are diagnosed with breast cancer globally every year(1). The chance of developing invasive breast cancer at some time in a woman's life is a little less than one in eight (12%). There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year.(2) Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body.

Anthracyclines and taxanes (AT) are the most active and widely used chemotherapeutic agents for breast cancer, but the increased use of these agents at an early stage of disease often renders tumors resistant to these drugs by the time the disease recurs, thereby reducing the number of treatment options for metastatic disease. Drugs used to treat patients who progress following AT treatment can have response rates as high as 20-30%; however, resistance develops rapidly and new agents with different mechanisms of action, such as topoisomerase I inhibitors, are needed to allow novel ways to overcome the problem of drug resistance. (3) There are currently no FDA-approved topoisomerase I inhibitors to treat breast cancer.

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.

In addition to the fully-enrolled Phase 2 studies in platinum-refractory/resistant ovarian cancer and metastatic breast cancer, NKTR-102 is also being tested in a separate Phase 2 clinical trial in patients with second-line colorectal cancer and a Phase 1 clinical trial evaluating NKTR-102 in combination with 5-FU therapy. An expansion arm of the Phase 2 study of single-agent NKTR-102 in platinum-refractory/resistant ovarian cancer in women who failed prior Doxil therapy is also currently enrolling. A Phase 3 study of single-agent NKTR-102 is planned in metastatic breast cancer.

[surf1944]

Data from Phase 1 Study of NKTR-181 Demonstrate Proof-of-Concept for Nektar's Novel Opioid Analgesic Candidate
Interim data analysis shows NKTR-181 achieved long-acting PK profile with analgesic response and excellent safety profile

Press Release Source: Nektar Therapeutics On Tuesday June 7, 2011, 9:00 am

SAN FRANCISCO, June 7, 2011 /PRNewswire/ -- Nektar Therapeutics (NASDAQ:NKTR - News) announced today positive interim data from an ongoing single-dose Phase 1 clinical trial evaluating NKTR-181, the company's novel mu-opioid analgesic candidate. Interim study results show that the molecule achieved its study objectives with an extended PK profile, slow entry into the CNS, and analgesic response. This interim data also show that the drug candidate exhibits an excellent safety and tolerability profile with no dose-limiting tolerability issues observed in the study to-date.

NKTR-181, a novel mu-opioid analgesic investigational drug candidate, was created using Nektar's small molecule polymer conjugate technology. With slower entry into the CNS when compared to historical oxycodone data, NKTR-181 has the potential to greatly reduce the euphoria that underlies opioid abuse liability and dependence, as well as the serious CNS-related side-effects of respiratory depression and sedation. The unique molecular design of the polymer drug conjugate also prevents conversion of NKTR-181 into a rapidly-acting, more abusable opioid.

"NKTR-181 is an exciting development in pain management research," said Lynn R. Webster, MD, Medical Director of Lifetree Clinical Research. "New therapeutics to manage chronic pain without the serious risks associated with existing opioids are desperately needed. A novel opioid therapy, such as NKTR-181, with lower potential for abuse liability and fewer CNS-related side effects than existing opioids provides great promise for pain practitioners looking for safer, more effective pain management. The profile and properties observed with NKTR-181 in the clinic are highly interesting because these properties are inherent to the molecule's novel structure, which represents a significant potential advance over existing long-acting opioid drugs, which are typically simply re-formulations of many traditional opioids."

Interim pharmacokinetic (PK) data from the Phase 1 study show that single doses of NKTR-181 achieved a dose-linear PK profile and the plasma half-life is greater than 10 hours across all five dose cohorts tested to-date, which includes 75 healthy subjects. NKTR-181 also displayed good oral bioavailability with rapid absorption, and its plasma half-life supports its potential to be dosed on a once-daily (QD) or twice-daily (BID) schedule. Short-acting opioid therapies, such as oxycodone, exhibit half-lives of approximately 3.5 hours, and extended release formulations, such as Oxycontin®, exhibit plasma half-lives of approximately 8 hours.(1)

Additional interim data from the study show that NKTR-181 exhibits pharmacological activity in humans. The study found that NKTR-181 elicited an analgesic response in a cold pressor test, an experimental model of pain used to measure CNS analgesic response in healthy subjects. Preliminary pupillometry data demonstrate that although NKTR-181 is rapidly absorbed and is detected in plasma within 15 minutes, its centrally-mediated opioid effects appear slowly, consistent with slowed entry of the molecule into the CNS.

"NKTR-181 shows linear kinetics, dose proportionality and a half-life following oral administration that should allow once or twice daily dosing," said Robert Medve, MD, Vice President of Development and Clinical Head of the NKTR-181 Program at Nektar Therapeutics. "The results we've seen to date with NKTR-181 in the clinic add to our excitement over the potential of this novel analgesic candidate and the role it could play in treating chronic pain while addressing the risks associated with existing opioids. The data from this first Phase 1 study to-date support continued rapid development of NKTR-181. We look forward to initiating the multi-dose Phase 1 study in the second half of 2011."

About the Single-Dose Phase 1 Study

The Phase 1 study is assessing the pharmacokinetics, pharmacology, safety and efficacy of single doses of NKTR-181 in approximately 125 healthy subjects. The primary objective of the Phase 1 trial is to establish the effective analgesic dose range of NKTR-181 associated with minimal CNS side effects. The study is being conducted in the U.S. and is currently ongoing. Final data from the NKTR-181 single-dose Phase 1 study are planned to be presented at an upcoming medical meeting.

[surf1944]

Sweet on Nektar Therapeutics
The biopharmaceutical firm is seeing much activity for its NKTR-102 drug.

Nektar Therapeutics (NKTR: Nasdaq) By Boenning & Scattergood ($9.95, May 16, 2011)

We are initiating coverage of Nektar Therapeutics with an Outperform rating and a target price of $15.

Based on the remarkable activity of Nektar's (ticker: NKTR) drug called NKTR-102 (made of polymer conjugated irinotecan) in advanced ovarian (platinum resistant and refractory) and breast cancers (taxane and anthracycline failures), we are not surprised that management has retained control of ...

http://online.barrons.com/article/SB50001424052970204038504576329714169261514.html?ru=yahoo&mod=yahoobarrons

[surf1944]

Nektar Therapeutics NKTR Boenning & Scattergood Outperform $15

Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1McJXmGKL

[ghmm]

[ghmm]

Thanks for posting. I figured that was the reason we are up.

I am mixed on a (possible) takeover. I've only been a shareholder a short time so can't complain about a quick profit but I like several of their compounds and the not-so-distant royalty revenue could be fairly significant.

If they were to be taken over my guess would be some company looking to acquire them for their oncology program/potential or perhaps AstraZeneca is so high on 118 that they don't want to pay the royalty .

[MrBruce]

Biotechnology Stocks Advancing On Cephalon Takeover Offer

3/30/2011 11:24 AM ET

(RTTNews) - Biotechnology stocks have shown a strong upward move on Wednesday, with Cephalon (CEPH) leading the way higher after receiving a hostile takeover offer from Valeant Pharmaceuticals (VRX).

The strength among biotech stocks is reflected by the 2.8 percent gain currently being shown by the NYSE Arca Biotechnology Index, which has risen to a record intraday high.

Shares of Cephalon have shown a substantial upward move on the day, advancing by 28 percent. With the gain, the stock has risen to its best intraday level in over two years.

The gain by Cephalon comes after Valeant offered to acquire the company for $73 per share in cash, representing a total value of approximately $5.7 billion. The offer represents a 24 percent premium to Cephalon's closing price on Tuesday and a 29 percent premium over its 30-day trading average.

Amylin Pharmaceuticals (AMLN) is also turning in a strong performance, with the biopharmaceutical company currently up by 4.2 percent. Shares of Amylin are climbing further off a two-year closing low set last Wednesday.

Nektar Therapeutics (NKTR), Qiagen (QGEN) and Alexion Pharmaceuticals (ALXN) are also posting notable gains, contributing to the strength in the sector.

by RTT Staff Writer

For comments and feedback: [e-mail]

[surf1944]

http://finance.yahoo.com/q/is?s=nktr

[surf1944]

NKTR-102 Demonstrates Superior Activity to Irinotecan in Nonclinical Studies Presented at ESMO 12th World Congress on Gastrointestinal Cancer

http://finance.yahoo.com/news/NKTR102-Demonstrates-Superior-prnews-4066739061.html?x=0&.v=1

[surf1944]

Nektar Announces Dosing of First Patients in Phase 1 Clinical Study of NKTR-102 in Combination With 5-Fluorouracil/Leucovorin

http://finance.yahoo.com/news/Nektar-Announces-Dosing-of-prnews-3232603478.html?x=0&.v=1

[surf1944]

NKTR-102 Has High Response Rate and Sustained Clinical Benefit in 48 Percent of Women with Platinum-Resistant/Refractory Ovarian Cancer

http://finance.yahoo.com/news/NKTR102-Has-High-Response-prnews-391539708.html?x=0&.v=1

[surf1944]

NKTR-102 Phase 2 Clinical Data Accepted for Oral Presentation at 2010 ASCO Annual Meeting

http://finance.yahoo.com/news/NKTR102-Phase-2-Clinical-Data-prnews-1430001494.html?x=0&.v=1

[surf1944]

Nektar Therapeutics Reports First Quarter 2010 Financial Results

Press Release Source: Nektar Therapeutics On Wednesday May 5, 2010, 4:15 pm
SAN CARLOS, Calif., May 5 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq:NKTR - News) today reported its financial results for the first quarter ended March 31, 2010.

Cash, cash equivalents, and short-term investments at March 31, 2010 were $362.0 million as compared to $396.2 million at December 31, 2009.

Revenue for the first quarter of 2010 increased to $33.2 million as compared to $9.7 million in the first quarter of 2009. The increase in revenue year over year is largely the result of the amortization of the $125.0 million milestone payment received from AstraZeneca in September 2009 under the new partnership agreement for NKTR-118.

Total operating costs and expenses in the first quarter of 2010 declined by 9% to $36.6 million, compared to $40.0 million in the first quarter 2009.

Research and development expense was $23.3 million in the first quarter 2010 as compared to $23.4 million for the same quarter in 2009. General and administrative expense declined to $9.0 million in the first quarter 2010 from $11.0 million in the first quarter of 2009.

“We are excited about our product opportunities in pain and oncology generated by Nektar’s advanced polymer conjugate technology platform,” said Howard W. Robin, President and Chief Executive Officer of Nektar. “In particular, we are pleased with the recent recognition that NKTR-102 has received from the oncology community with the acceptance of our NKTR-102 Phase 2 ovarian data for oral presentation at the 2010 American Society of Clinical Oncology meeting in June.”

Net loss for the first quarter ended March 31, 2010 was $6.1 million or $0.07 loss per share as compared to a net loss of $31.8 million or $0.34 loss per share in the first quarter of 2009.

Conference Call to Discuss First Quarter 2010 Financial Results

A conference call to review results will be held today, Wednesday, May 5, 2010 at 2 PM Pacific Time.

Details are below:

Howard Robin, president and chief executive officer, and John Nicholson, chief financial officer, will host a conference call beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT) on Wednesday, May 5, 2010.



To access the conference call, follow these instructions:

Dial: [phone] (U.S.); [phone] (international)


Passcode: 61205652 (Nektar is the host)

An audio replay will also be available shortly following the call through Thursday, May 20, 2010 and can be accessed by dialing [phone] (U.S.); or [phone] (international) with a passcode of 12368379.

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.

[surf1944]

Nektar (NKTR) A Dream Stock For Senior Biotech Analyst; Solid Phase I Data For NKTR-105 Predicted

On Monday April 26, 2010, 10:26 am
67 WALL STREET, New York - April 26, 2010 - The Wall Street Transcript has recently published its Biotechnology & Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This Special feature contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling [phone] or via The Wall Street Transcript Online.

In the following brief excerpt from the Biotech And Pharmaceuticals Report, expert analysts discuss the outlook for the sector and for investors.

Dr. Jonathan Aschoff, Ph.D., is a Senior Equity Analyst at Brean Murray, Carret & Co., LLC. Prior to joining the firm in 2003, he held positions as a Senior Biotechnology Analyst at Friedman, Billings, Ramsey & Co., Inc., and at what is now RBC. He also served as an Analyst at Sturza Institutional Research. Prior to Wall Street, Dr. Aschoff was a Research Technician at New England Medical Center. He earned a Ph.D. in molecular biology and microbiology, as well as a B.S. in biology from Tufts University.

TWST: What about Dendreon? You had a "sell" rating for five years and now you have a "buy" rating. What happened?

Dr. Aschoff: They put up solid data early in 2009. I think the thing to learn from Dendreon (DNDN) is when a stock is essentially at an all-time low going into a pivotal event, you might want to back off from being so aggressive with a "sell" rating. You might have wanted to consider that hardly anyone favored it then, so how much lower could it go? I was able to see the data presented in Chicago last year, and then my last concern of stroke imbalance, which was an imbalance in the first two Phase III trials, was assuaged when there was no imbalance in the IMPACT trial.

The trial arms were perfectly balanced, 6-3 for a 2-1 randomized trial. So I had no safety concerns, and that's when I went from the "hold" rating that I went to about a week before to a "buy" rating at about $20 per share, and it has been almost a double from there. I don't see anything getting in the way of FDA approval for Provenge. Approval would be a material risk reduction that would justify the stock to be well into the $40s because now you have removed FDA risk and Dendreon now just has to commercialize it, which they have enough money to do smoothly, and to train the employees properly.

TWST: Why do you like Ardea?

Dr. Aschoff: Because by the time this interview is published, I think you are going to get a very positive Phase IIb monotherapy result. The bears think Ardea's drug is unsafe; they think it works, but that it's unsafe. I think it works, I agree with them on that, and I think it's safe. I don't think you are going to have kidney complications - that's the whole argument. I cover a lot of battle ground stocks and RDEA is one of them. Their monotherapy Phase IIb data should look good and so should their combination therapy data in April. And so we have imminent catalysts, which is why I launched coverage in December. I expect positive Phase IIb data to beget acquisition of the company.

TWST: What about Nektar?

Dr. Aschoff: Nektar (NKTR) is one of my favorite companies. I had an excellent experience with the CEO and the Chief Operating Officer when they ran Sirna, my best-performing stock. Now Howard Robin is the CEO of the company. He came in, completely altered the company, just like he did at Sirna, and he's taking it in a different direction successfully and getting deals that are far more lucrative than Nektar ever got prior to Howard joining the company in January 2007, which was a month after Merck (MRK) bought Sirna. To come into a platform technology and completely revamp that platform technology to something much more appealing to partners and investors - and he clearly did that - I'm looking for him to sell this company just like he sold Sirna. It's ready to be sold for a specific reason, and that is that this is the only company I know that can reproducibly pegylate or add polymers to small-molecule drugs.

This is common with protein drugs, but this company is the only one that can reproducibly do this to small-molecule drugs. And that gives you 20 more years of patent life because you've changed a generic drug, meaning that you've actually covalently bound something to it. You are not putting it in some control-release pill or something like that. When you change the chemistry of it, now it is a new chemical entity and you get a full 20-year patent on it. And they've already done this; they had some great Phase II data. I assume they are going to get some very solid Phase I data from the next cancer drug they'd modified, NKTR-105.

And you can take less of those drugs, NKTR-102 and NKTR-105, because you increase the half-life through modifying them. The drugs last almost 50 times, 40 times, 20 times as long as the original versions. So the drug stays in your body for a lot longer than the original drug. I don't know of too many other instances where you get a safety benefit and an efficacy benefit. They are generally at odds with one another - improve one, lose the other. Nektar's pipeline is something that would keep a pharma company busy, altering small-molecule drugs that they know work, but just making them materially better.

The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This Special issue is available by calling [phone] or via The Wall Street Transcript Online .

The Wall Street Transcript does not endorse the views of any interviewees nor does it make stock recommendations.

For Information on subscribing to The Wall Street Transcript, please call 800/246-7673

[surf1944]

Nektar Therapeutics NKTR Brean Murray Buy $15 to $20

[surf1944]

9:01AM Nektar Therapeutics announces positive Phase 2 clinical data from first stage of NKTR-102 study in women with platinum-resistant ovarian cancer (NKTR) 14.94 : The co announces preliminary progression-free survival data from the first stage of a two-stage Phase 2 clinical study evaluating single-agent treatment with NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients were enrolled with platinum-resistant disease and were evaluable for the secondary endpoint of progression-free survival (PFS). The study showed that women who received NKTR-102 once every 21 days (q21 day) had a median PFS of 21.0 weeks. In the second arm of the study, women who received NKTR-102 once every 14 days (q14 day) had a median PFS of 12.2 weeks. Progression-free survival is a measure of how long patients live without their disease advancing. Current agents approved by the FDA to treat women with platinum-resistant ovarian cancer have median PFS of between 9.1 and 13.6 weeks. "NKTR-102 has demonstrated a progression-free survival time of nearly five months, which is remarkable for a largely refractory population that is expected to have a PFS of less than three months," said Lorianne Masuoka, M.D., Senior Vice President and Chief Medical Officer.

[surf1944]

Nektar Therapeutics NKTR Morgan Joseph Buy $12 to $15

[surf1944]

4:27PM Nektar Therapeutics misses by $0.13 (NKTR) 12.53 -0.24 : Reports Q4 (Dec) ($0.08), $0.13 worse than the First Call consensus of $0.05; revenues rose 37.3% year/year to $39.0 mln vs the $51.4 mln consensus. Co said, "The decrease in revenue year over year is largely the result of lower contract research and manufacturing revenues primarily resulting from the sale of certain of the co's pulmonary assets to Novartis which occurred on December 31, 2008."

[surf1944]

Nektar Therapeutics NKTR Wedbush Morgan Outperform $12 to $14

[surf1944]

Nektar Therapeutics Announces Positive Topline Results for NKTR-102 From First Stage of Phase 2 Study in Platinum-Resistant Ovarian Cancer

Press Release Source: Nektar Therapeutics On Tuesday January 12, 2010, 9:00 am
SAN CARLOS, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced preliminary results from the first stage of a two-stage Phase 2 clinical study evaluating NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients enrolled with platinum-resistant disease were evaluable for the primary endpoint of overall response rate using Gynecologic Cancer InterGroup (GCIG) criteria, i.e., a combination of response by tumor imaging (RECIST) and/or ovarian cancer biomarker (CA-125) criteria(1). The first stage of the NKTR-102 Phase 2 study showed an overall GCIG response rate of 32% (6/19) in the once every 14 days (q14 day) dose schedule and 35% (7/20) for the once every 21 days (q21 day) dose schedule. Confirmed objective response rates using RECIST were 21% (4/19) and 22% (4/18) for the q14 day and q21 day dose schedules, respectively. CA-125 response rates were 31% (5/16) and 38% (6/16), for each dose schedule, respectively. The Phase 2 study has now completed enrollment with a total of 71 patients. Approximately one-third of the patients in the study remain on NKTR-102 treatment, including a number of patients in the first stage of the study.

"The early and dramatic reductions in CA-125 in many of the patients with platinum-resistant and refractory ovarian cancer indicate that NKTR-102 has great therapeutic potential," said Prof. Dr. Ignace Vergote, Head of the Department of Obstetrics and Gynaecology and Gynaecologic Oncology at the Catholic University of Leuven, European Union and Lead Investigator of the NKTR-102 study. "NKTR-102 is one of the most promising agents for platinum-resistant ovarian cancer I have seen in 25 years, as evidenced by the number of women in the study with tumor response and rapid biochemical response. This drug warrants further definitive Phase 3 testing as quickly as possible. The investigators look forward to presenting the final data at an upcoming scientific meeting."

The most commonly observed grade 3 or grade 4 side effects in the study to date (every 14 day/every 21 day dose schedule) were diarrhea (29%/10%) and neutropenia (14%/10%).

"This population of heavily pre-treated patients, which includes a high proportion of women with platinum-refractory disease, is among the most challenging to treat in oncology," said Lorianne Masuoka, M.D., Senior Vice President and Chief Medical Officer. "Almost half of the patients in the first stage of our study had platinum-refractory disease, having progressed within three weeks of their last platinum regimen. We are highly encouraged by the compelling efficacy seen to-date in the patients from the first stage of our study. This efficacy is accompanied by a favorable safety profile with regard to both GI side effects and neutropenia."

About the Study

The Phase 2 study is evaluating two dose regimens (q14 day and q21 day) of single-agent NKTR-102 in women with platinum-resistant ovarian cancer. The study employs a two-stage design, with 41 patients in the first stage and 30 patients in the second stage. Two patients in the q14 day dose regimen in the first stage had platinum-sensitive disease and were not evaluable for the primary outcome measure. 44% of the patients in the first stage were platinum-refractory, having progressed within three weeks of their last platinum therapy. 77% of the patients in the first stage had a platinum-free interval of less than three months (progression within three months of last platinum therapy). Secondary endpoints of the Phase 2 study include progression-free survival and safety.

CA-125 is a biochemical marker that is found in the blood of ovarian cancer patients and is measured to assess disease progression and recurrence. RECIST classifies response based upon tumor reduction measured by imaging methods.

Ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system(2). Agents currently approved by the U.S. Food & Drug Administration to treat women with platinum-resistant ovarian cancer have modest overall response rates of between 6.5 to 13.8%(3,4).

About NKTR-102

Nektar is developing NKTR-102, a topoisomerase I inhibitor-polymer conjugate 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.

In addition to the fully-enrolled Phase 2 study currently underway in platinum-resistant ovarian cancer, NKTR-102 is also being tested in two separate Phase 2 clinical trials in patients with metastatic breast cancer and second-line colorectal cancer.

The company also announced today that it has opened the second stage of its Phase 2 study of NKTR-102 in women with metastatic breast cancer evaluating two dose regimens (q14 and q21 day dose schedules). Enrollment of the first stage of this two-stage study is complete for both regimens (20 patients per regimen).

[surf1944]

4:28PM Nektar Therapeutics beats by $0.05 (NKTR) 8.20 -0.25 : Reports Q3 (Sept) ($0.33), $0.05 better than the First Call consensus of ($0.38); revenues fell 52.3% year/year to $10.2 mln vs the $10.95 mln consensus.

[surf1944]

Nektar could get up to $1.12B from AstraZeneca
AstraZeneca gets rights to 2 Nektar pain drug candidates in deal valued at about $1.12B
On Monday September 21, 2009, 7:57 am EDT

Companies:AstraZeneca PlcNektar Therapeutics
NEW YORK (AP) -- Nektar Therapeutics said Monday it licensed a pair of experimental pain treatments to AstraZeneca PLC in a deal valued at about $$1.12 billion.

AstraZeneca will pay Nektar $125 million upfront for the rights to two drugs: NKTR-118, an oral product intended to treat constipation caused by opioid pain drugs, and NKTR-119, which is intended to combine NKTR-118 with opioid pain drugs to create a painkiller that doesn't cause constipation.

AstraZeneca, which is based in London, will handle further development of the drugs, including the start of late-stage clinical trials for NKTR-118, as well as manufacturing and marketing. It expects to file for regulatory approval in 2013. NKTR-119 is in early-stage development.

Nektar, of San Carlos, Calif., could get as much as $235 million in payments if the constipation drug advances through regulatory review, and another $375 million if it reaches sales goals. Nektar could also receive $75 million in development payments for NKTR-119, and $310 million in sales milestone payments, according to a filing with the Securities and Exchange Commission.

If the drugs are approved, it will receive royalty payments of at least 10 percent on each.

About 230 million prescriptions for opioid drugs were written in 2007 in the U.S., according to IMS Health. It is estimated that between 40 and 90 percent of the patients who take opioid drugs develop constipation.

Shares of Nektar closed at $8.46 on Friday.

[surf1944]

AstraZeneca and Nektar Sign Worldwide Agreement for Nektar Drug Development Programmes -- NKTR-118 and NKTR-119 -- to Address Opioid-Induced Constipation
Press Release
Source: Nektar Therapeutics
On Monday September 21, 2009, 6:00 am EDT

Companies:Nektar Therapeutics
LONDON and SAN CARLOS, Calif., Sept. 21 /PRNewswire-FirstCall/ -- AstraZeneca and Nektar Therapeutics announced today that they have entered into an exclusive worldwide license agreement for two drug development programmes: NKTR-118, a late stage investigational product being evaluated for the treatment of opioid-induced constipation, and the NKTR-119 programme, an early stage programme that is intended to deliver products for the treatment of pain without constipation side effects. Both programmes were developed by Nektar, utilizing their proprietary small molecule advanced polymer conjugate technology platform.

Under the terms of the agreement, AstraZeneca will assume the responsibility for the continued development of both the NKTR-118 and NKTR-119 programmes, including the initiation of late-stage clinical studies for NKTR-118. AstraZeneca expects completion of the design of the phase III programme in the near term, and anticipates filing the drug with regulators in 2013. AstraZeneca will also be responsible for global manufacturing and marketing for both programmes. Under the agreement, Nektar will receive an upfront payment of $125 million for both NKTR-118 and NKTR-119.

NKTR-118 has completed a Phase 2 clinical trial and is being developed to treat constipation caused by the use of opioid pain products. Under the agreement, for NKTR-118, Nektar is eligible to receive up to $235 million in aggregate payments upon the achievement of certain regulatory milestones, as well as additional tiered sales milestone payments of up to $375 million if the product achieves considerable levels of commercial success. Nektar will also be eligible to receive significant double-digit royalty payments on net sales of NKTR-118 worldwide.

NKTR-119 is an early stage drug development programme that is intended to combine oral NKTR-118 with selected opioids, with the goal of treating pain without the side effect of constipation traditionally associated with opioid therapy. AstraZeneca will continue the development of this programme, including determining the appropriate opioid combinations with NKTR-118. For NKTR-119, Nektar would receive development milestone payments as well as tiered sales milestone payments. Nektar will also receive significant double-digit royalty payments on NKTR-119 net sales worldwide.

"NKTR-118 is an important late stage programme that has the potential to address a real need for patients," said David Brennan, Chief Executive Officer of AstraZeneca. "We are excited about this agreement with Nektar, as it provides us the opportunity to apply our deep knowledge and expertise in neuroscience, oncology and gastrointestinal areas of medicine to create real value for patients. This is a good example of using externalisation to enrich the company's late-stage pipeline."

"We are extremely pleased to enter into this exclusive global license agreement with AstraZeneca," said Howard W. Robin, President and Chief Executive Officer of Nektar Therapeutics. "AstraZeneca has a strong history of creating and establishing market-leading brands, which makes them the ideal development and commercial partner for our NKTR-118 and NKTR-119 programmes. In addition to the promise that these potential products provide to patients, this partnership validates Nektar's successful strategy to create novel oral small molecule drug candidates with our advanced polymer conjugate technology platform."

NKTR-118 is an investigational drug candidate that combines Nektar's advanced small molecule polymer conjugate technology platform with naloxol, a derivative of the opioid-antagonist drug, naloxone. Results from NKTR-118's Phase 2 clinical trial will be presented at an oral plenary session of the American College of Gastroenterology 2009 Annual Scientific Meeting in October.

The agreement is subject to review by the United States Government under the Hart-Scott Rodino Act and becomes effective after the expiration or earlier termination of the waiting period (or any extension thereof).

[surf1944]

Nektar Therapeutics Reports Second Quarter 2009 Financial Results
Press Release
Source: Nektar Therapeutics
On Tuesday August 4, 2009, 4:15 pm EDT

Companies:Nektar Therapeutics
SAN CARLOS, Calif., Aug. 4 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) today reported its financial results for the second quarter ended June 30, 2009.

Net loss for the quarter ended June 30, 2009 was $32.1 million or $0.35 per share, compared to net loss of $33.4 million or $0.36 per share in the second quarter of 2008.

Nektar made improvements to its operating efficiencies as compared to a year ago. Total operating costs and expenses were down 19% to $43.5 million in the second quarter of 2009 as compared to $53.8 million in the second quarter of 2008. For the first half of 2009, total operating costs and expenses were down 28% to $83.5 million as compared to $115.6 million in the first half of 2008.

"In the first half of 2009, we made a strong commitment to advancing our clinical pipeline," stated Howard W. Robin, President and Chief Executive Officer of Nektar. "We completed our Phase 2 clinical program for NKTR-118, and we are poised to report Phase 2 data for NKTR-102 and Phase 1 data for NKTR-105 by year-end. These achievements underscore the strength of Nektar's drug development organization and our successful strategy to focus on developing proprietary drugs with our advanced polymer conjugate technology."

Research and development expense was $24.2 million in the second quarter of 2009 as compared to $33.5 million for the same quarter in 2008. For the first half of 2009, research and development expense was $48.0 million as compared to $70.9 million for the first half of 2008. Included in the $48.0 million of overall research and development expense in the first half of 2009 is approximately $27.4 million of investment in Nektar preclinical and clinical development programs.

Revenue for the three month period ended June 30, 2009 was $13.0 million compared to revenue of $20.4 million in the second quarter of 2008. Revenue for the first half of 2009 was $22.7 million as compared to revenue of $40.4 million in the first half of 2008. This decrease in revenue is primarily the result of lower contract research and manufacturing revenues resulting from the sale of certain of the company's pulmonary assets to Novartis which occurred on December 31, 2008.

Cash, cash equivalents, and short-term investments at June 30, 2009 were $294.3 million.

Conference Call to Discuss Second Quarter 2009 Financial Results

A conference call to review results will be held on August 4, 2009 at 2 PM Pacific Time.

Details are below:

Howard Robin, president and chief executive officer, and John Nicholson, chief financial officer, will host a conference call beginning at 5:00 p.m. Eastern Time (ET)/2:00 p.m. Pacific Time (PT) on Tuesday, August 4, 2009.


To access the conference call, follow these instructions:

Dial: [phone] (U.S.); [phone] (international)
Passcode: 25099763 (Howard Robin is the host)

An audio replay will also be available shortly following the call through Wednesday, August 19, 2009 and can be accessed by dialing [phone] (U.S.); or [phone] (international) with a passcode of 26851386.

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Nektar Therapeutics Announces Second Quarter 2008 Results
Wednesday August 6, 4:39 pm ET

SAN CARLOS, Calif., Aug. 6 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) today announced the company's financial results for the second quarter and six-months ended June 30, 2008.

Cash, cash equivalents, and short-term investments were $373.9 million at June 30, 2008 compared to $412.6 million at March 31, 2008.

Revenue for the three month period ended June 30, 2008 was $20.4 million compared to revenue of $65.9 million in the second quarter of 2007. For the first half of 2008, revenue was $40.4 million as compared to $150.9 million in the same period of 2007. This decrease in revenue is the result of lower product manufacturing revenues due to the termination of the Exubera collaboration by Pfizer in late 2007.

Nektar has made significant improvements to our operating efficiencies as compared to a year ago. For the first half of 2008, the company's general and administrative expense was $24.8 million as compared to $29.9 million for the same period a year ago. Research and development expense was $70.9 million in the first half of 2008 as compared to $78.5 million for the same six month period in 2007. Included in the $70.9 million of overall research and development spending is approximately $32 million of new investments in Nektar's preclinical and clinical development programs.

Nektar reported a net loss for the quarter ended June 30, 2008 of $33.4 million or $0.36 per share, compared to a net loss of $27.5 million or $0.30 per share in the second quarter of 2007. For the first half of 2008, the company reported a net loss of $74.1 million or $0.80 per share, compared to a net loss of $53.2 million or $0.58 per share for the same period in 2007.

The increase in net loss for the second quarter and first half of 2008 compared to a year ago is primarily the result of a loss of gross margin associated with Pfizer's termination of the Exubera collaboration and maintenance of Exubera manufacturing capacity through April 2008. The final spending and charges associated with the termination of the Exubera inhaled insulin program were paid and recorded in the second quarter of 2008.

"Over the past year, Nektar has made excellent progress in expanding and advancing our pipeline while at the same time maintaining financial discipline," said Nektar President and CEO Howard W. Robin. "In 2008, we will have seven proprietary programs in clinical development and an impressive preclinical pipeline of important, high-value therapeutics. We have executed on our strategy of building valuable proprietary programs without pursuing any dilutive financings."

Nektar will host a conference call today for analysts and investors at 2:00 p.m. Pacific time to discuss the company's second quarter performance. This conference call will be available via webcast and can be accessed through a link that is posted on the Investor Relations section of the Nektar website, www.nektar.com. The web broadcast of the conference call will be available for replay through August 20, 2008.


To access the conference call, follow these instructions:
Dial: [phone] (U.S.); [phone] (international)
Passcode: 33430853 (Howard Robin is the host)

Audio replay dial-in and passcode:
Dial: [phone] (U.S.); [phone] (international)
Passcode: 67859021

http://biz.yahoo.com/prnews/080806/aqw082.html?.v=56



surf's up......crikey

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Nektar Announces Expanded Phase 2 Clinical Development Plan For NKTR-102 (PEG-irinotecan)
Monday June 2, 8:31 am ET
Phase 2 Study for NKTR-102 Will Target Newly-Identified K-Ras Mutated Oncogene Population in Patients with Advanced Colorectal Cancer
New Phase 2 Clinical Trials Will Evaluate NKTR-102 in Advanced Breast and Ovarian Cancers

SAN CARLOS, Calif., June 2 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) today announced an expanded Phase 2 development plan for NKTR-102 (PEG-irinotecan). The company will target newly-characterized colorectal cancer patients with K-Ras mutated gene status in its Phase 2 study in advanced colorectal cancer. In addition, NKTR-102 will be evaluated in Phase 2 trials in two new indications: platinum-refractory ovarian cancer and advanced breast cancer that is refractory to anthracycline and/or taxane-based therapies. These studies are expected to commence in the second half of 2008.

Recent data(2) presented at the 2008 American Society of Clinical Oncologists (ASCO) Annual Meeting shows colorectal cancer (CRC) patients with tumors that have K-Ras oncogene mutations (K-Ras mutant types) do not respond to EGFR-inhibitors, such as cetuximab. It is estimated that up to 45% of colorectal cancer cases have this mutated K-Ras gene. To target this newly- characterized K-Ras mutant patient population, Nektar will initiate a prospective study to evaluate the efficacy of NKTR-102 monotherapy in these patients. The primary endpoint of this randomized trial will be a clinically meaningful improvement in progression-free survival as compared to standard irinotecan monotherapy.

"With these recent clinical studies on K-Ras, there is no longer a clear standard of care for the second-line treatment of advanced colorectal cancer in patients with the K-Ras gene mutation," said Daniel Haller, M.D., Professor of Medicine at the Abramson Cancer Center at the University of Pennsylvania. "This novel oncolytic, NKTR-102, could offer an alternative and promising approach for tumors in this patient population."

The company also announced new trials for NKTR-102 in breast and ovarian cancer. These studies will be open-label, single-arm studies to evaluate the overall response rate (ORR) of NKTR-102 monotherapy in each tumor setting. The studies will implement a minimax design, known as the Simon design, which was first proposed by Dr. Richard Simon of the National Cancer Institute in 1989. The two-stage design is routinely used in the evaluation of oncolytics.(1)

"The promise of NKTR-102 and our small molecule PEGylation platform is capturing a great deal of attention among oncologists and clinical investigators," said Howard W. Robin, Nektar President and CEO. "We've seen significant and repeat anti-tumor activity in our Phase 1 study with NKTR-102. Our expanded Phase 2 clinical development plan will potentially accelerate our understanding and development of this novel therapy in multiple cancer types."

Details on the NKTR-102 Phase 2 clinical development plan will be discussed at an event on June 2, 2008 at 6:30 PM Central time. The event will be Webcast and can be accessed from the company's website at the following url: http://www.nektar.com/wt/page/asco.

About NKTR-102 (PEG-irinotecan)

Nektar is developing NKTR-102, a PEGylated form of irinotecan, which was invented by Nektar using its world-leading small molecule PEGylation technology platform. The product is currently in a Phase 2a study to evaluate NKTR-102 in combination with cetuximab.

Irinotecan is an important chemotherapeutic agent used for the treatment of solid tumors, including colorectal and lung cancers. By applying Nektar's small molecule PEGylation technology to irinotecan, NKTR-102 may prove to be a more powerful and tolerable anti-tumor agent. Preclinical studies show that treatment with NKTR-102 results in significant suppression of tumor growth in an irinotecan-resistant mouse colorectal tumor model and in similar models of breast and lung cancer. Administration of NKTR-102 in an animal model also results in a markedly improved time-concentration profile for SN38, the active metabolite of irinotecan, as compared to treatment with irinotecan.

Nektar PEGylation technology can enhance the properties of therapeutic agents by increasing drug circulation time in the bloodstream, decreasing immunogenicity and dosing frequency, increasing bioavailability and improving drug solubility and stability. It can also be used to modify pharmaceutical agents to preferentially target certain systems within the body. It is a technique in which non-toxic polyethylene glycol (PEG) polymers are attached to therapeutic agents, and it is applicable to most major drug classes, including proteins, peptides, antibody fragments, small molecules, and other drugs. Nektar PEGylation technology is also used in eight additional approved partnered products in the U.S. or Europe today, including UCB's Cimzia® for Crohn's Disease, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.

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Amikacin Inhale Shows Promising Results in Phase II Study
Monday May 19, 1:30 pm ET
- Bayer together with Nektar Therapeutics present preliminary Phase II data for the adjunctive treatment of pneumonia in intubated and mechanically-ventilated patients

TORONTO and BERLIN, May 19 /PRNewswire-FirstCall/ -- Bayer HealthCare together with Nektar Therapeutics (Nasdaq: NKTR - News), today presented positive preliminary Phase II data on their unique drug-device combination Amikacin Inhale at the American Thoracic Society (ATS) annual meeting. Amikacin Inhale, currently being studied for the adjunctive treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients, achieved over 1000 times greater lung exposure to the antibiotic amikacin as compared to intravenous route of administration. This shows that targeting antibiotic therapy to the site of infection might offer superior bacterial eradication and increased efficacy, which may result in a higher likelihood of the patient's survival. Currently, Gram-negative pneumonia carries a mortality risk as high as 50 percent in mechanically-ventilated patients(1).

"Mechanically-ventilated patients in critical care units are at particularly high risk of developing pneumonia. Most of them are already seriously ill because of severe underlying diseases," said Professor Michael Niederman, Chairman, Department of Medicine, Winthrop University Hospital, New York, and one of the lead investigators of the study. "Because of the high morbidity and mortality of Gram-negative pneumonia, fast and efficient treatment is essential. Intravenous therapies cannot always reach effective concentrations in infected lungs at tolerable doses. The new study data shows that the device successfully delivers the antibiotic directly to the site of infection, without reaching high systemic concentrations."

Amikacin Inhale is a unique drug-device combination, being developed by Bayer HealthCare in cooperation with Nektar Therapeutics, combining a special liquid formulation of the aminoglycoside antibiotic amikacin with Nektar Therapeutics' proprietary Liquid Pulmonary Technology (LPT(TM)), designed to deliver amikacin deep into the infected lungs.

The device can be integrated into mechanical ventilation systems and can also be used as a handheld 'off-vent' device for patients no longer requiring breathing assistance. This allows for a unique full course of drug therapy in critically ill patients with Gram-negative pneumonia. 'Gram-negative pneumonia' refers to pneumonia caused by a laboratory-defined group of pathogens, the Gram-negative bacteria. These account for a substantial proportion, if not the majority of pneumonias in intensive care units (ICUs).

"A challenge in treating Gram-negative pneumonia in ICUs is that they have grown increasingly resistant to currently available antibiotics," said Professor Donald Low, Head of the Department of Microbiology at the Toronto Medical Laboratories and Mount Sinai Hospital, Toronto, Canada. "A new treatment option such as Amikacin Inhale, which fights pneumonia directly at the site of infection, may be able to help decrease resistance -- especially if concomitant intravenous antibiotic therapy can also be reduced."

Amikacin Inhale will enter Phase III trials later this year to further assess its efficacy and safety in mechanically ventilated patients with Gram-negative pneumonia. The enrolment for two pivotal Phase III studies will start in the fourth quarter of 2008.

About Phase II Studies

High Amikacin Lung Deposition in MVP(2)

In the multi-center, randomized, double-blind, placebo-controlled Phase II study mechanically ventilated patients (MVP) received 400 mg doses of amikacin with Amikacin Inhale every 24 hours (n=24) or every 12 hours (n=21) for 7-14 days.

Serial serum, tracheal aspirate and urine samples were collected on Day 3. Clinical parameters, such as Clinical Pulmonary Infection Score (CPIS), days on ventilator and intravenous antibiotic use were monitored. In another study healthy volunteers (n=14) inhaled a single dose of 400 mg of amikacin via the proprietary delivery system using the hand held adaptor. This was done to compare the lung doses between on-vent and hand-held adaptors using the same proprietary nebulizer.

Mean peak tracheal aspirate of amikacin after Amikacin Inhale use every 12 hours was 16,212 +/- 3,675 mcg/mL as compared to 14 +/- 4.2 mcg/mL after intravenous administration (15mg/kg per day)(3). After Amikacin Inhale use, peak serum levels of amikacin were 3.2 +/- 0.5 mcg/mL versus 47 +/- 4.2 mcg/mL after intravenous administration. On average, 43 percent of the dose was delivered to the lungs using the hand-held system with a comparable low systemic exposure. The dose delivered to the lungs with the proprietary nebulizer is comparable between the on-vent and hand-held adaptors.

Penetration of Amikacin Inhale in Lower Respiratory Tract(4)

This study evaluated Amikacin Inhale penetration into the fluid lining of the epithelial surface (ELF) of the lower respiratory tract of the pneumonia-infected lung. Treatment was adjunctive to IV treatment. Mechanically ventilated patients (n=28) with Gram-negative pneumonia received 400 mg doses of aerosolized amikacin every 12 hours for 7-14 days. The delivery of aerosolized Amikacin Inhale achieved high aminoglycoside amikacin concentrations in the ELF of the lower respiratory tract, including in the pneumonic area of the lung while maintaining safe serum concentrations. Median ELF levels were 976.1 mcg/mL [135.7-16,127.6], always exceeding the amikacin MIC (minimum inhibitory concentration) for microorganisms usually responsible for Gram-negative pneumonia.

High in vivo Amikacin Lung Deposition Correlates with in vitro Findings(5)

This study describes the in-vitro and in-vivo characterization of a handheld version of Amikacin Inhale, intended for use in extubated patients. In-vitro, amikacin 400 mg was aerosolized continuously, and emitted mass captured on absolute filters distal to the mouthpiece during simulated adult tidal breathing. Emitted mass was 87 percent of the 400 mg amikacin nominal dose, with a predicted lung dose of 45-50 percent. In-vivo, Amikacin Inhale (400 mg amikacin) labeled with 99mTc was administered to healthy subjects using the hand-held version. In these, mean amikacin lung dose determined via scintigraphy was 172.2 mg, 43 percent of the nominal dose. These results show that the hand-held drug-device combination delivered a large fraction of the starting dose, confirming the high delivery efficiency predicted by in-vitro aerosol characterization. The study also confirmed that the in-vitro model is predictive of the in-vivo experience. Lung doses in the range of those observed are expected to achieve bacteriological eradiation.

Copies of abstracts are available and can be viewed online at the ATS website: http://www.abstracts2view.com/ats08/

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Significant Anti-Tumor Activity of NKTR-102 in Patients With Refractory Solid Tumors; Interim Data Published in ASCO 2008 Proceedings
Friday May 16, 8:30 am ET
Nektar's Technology Enables First-Ever PEGylation of a Small Molecule with Demonstrated Therapeutic Activity

SAN CARLOS, Calif., May 16 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) announced initial results today from a Phase 1 study of NKTR- 102, PEGylated irinotecan. The data shows significant anti-tumor activity in patients with refractory solid tumors. The study also demonstrates that Nektar's small molecule PEGylation technology produced an increase in SN38 exposure that was up to six-fold higher than the exposure previously reported with irinotecan at equivalent doses. SN38, a topoisomerase I inhibitor, is the active metabolite of irinotecan.

The ASCO abstract reports interim data on 27 of 32 patients in the first of three dose schedules from the Phase 1 trial.(1) Results for the first schedule (weekly x3 q4 weeks) found anti-tumor activity in 7 out of the total 32 patients evaluable for efficacy. Partial responses were confirmed in three patients, or 10% (greater than 30% tumor regression per RECIST), and other evidence of anti-tumor activity was confirmed in four patients, or 12% (tumor regression by more than 15% but less than 30% per RECIST, or significant biomarker evidence).

"This significant anti-tumor activity in a number of patients whose tumors have progressed on prior therapies makes NKTR-102 one of the most promising cancer drugs I have ever studied," said Daniel D. Von Hoff, M.D., lead Phase 1 investigator for NKTR-102, Physician-in-Chief at the Translational Genomics Research Institute and Chief Medical Officer for the Scottsdale Clinical Research Institute at Scottsdale Healthcare.

Nektar's proprietary PEGylation technology can enhance the properties of therapeutic agents by increasing drug circulation time, improving pharmacokinetics, decreasing immunogenicity and dosing frequency, increasing bioavailability and improving drug solubility and stability.

"The impressive Phase 1 results with NKTR-102 represent a major advancement for our small molecule PEGylation platform," said Howard W. Robin, President and CEO of Nektar. "Using our proprietary technology, Nektar is the first company to create a PEGylated small molecule with a unique pharmacokinetic profile that has demonstrated therapeutic activity in patients. This pioneering success with NKTR-102 validates our platform and opens the door to a wide range of potential small molecule opportunities. "

Clinical Trial Summary

In the Phase 1 dose-escalation trial, the safety, pharmacokinetics and anti-tumor activity of NKTR-102 monotherapy was evaluated in patients with refractory solid tumors. Patients received 90-minute infusions of NKTR-102 (PEGylated irinotecan) repeated as follows: weekly for three weeks with the fourth week off; every two weeks; or every three weeks. Tumor responses are being evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.

In the first dose schedule (weekly x3 q4 weeks), NKTR-102 was administered to a total of 32 patients with advanced solid tumors who had failed prior treatments or had no standard treatment available to them. Doses ranged from 58 mg/m2 to 230 mg/m2. Tumor regression, anti-tumor activity or prolonged disease stabilization was observed in a number of cancer types, including non- small cell lung cancer, ovarian, small cell lung cancer, cervical, adrenocortical, esophageal, and Hodgkin's lymphoma.

Results from the second and third dose schedules of this Phase 1 trial will be presented by featured speaker, Dr. Daniel D. Von Hoff, at an investor event on June 2, 2008. The Webcast event will begin at 6 pm Central time and will occur during the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting in Chicago, Illinois. Nektar will also present its Phase 2 clinical development plan for NKTR-102.

Side effects in the first dose schedule were diarrhea and neutropenia and were identified as manageable toxicities, with diarrhea being the dose- limiting toxicity associated with administration of NKTR-102. The recommended Phase 2 dose (RP2D) was 115 mg/m2. No Grade 4 or Grade 5 toxicities were observed with administration of NKTR-102.

The Phase 1 trial, sponsored by Nektar Therapeutics, includes clinical sites at Translational Generational Clinical Research Services at Scottsdale Healthcare and the Louisville Oncology Clinical Research Program. The company also expects to present results from this trial at additional scientific forums later this year.

The NKTR-102 abstract entitled "Phase 1 dose finding and pharmacokinetic study of NKTR-102 (PEGylated irinotecan): early evidence of anti-tumor activity" (Abstract No. 13518, published in the ASCO proceedings) can also be found on Nektar's website at http://www.nektar.com/wt/page/nktr102media.

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Nektar Therapeutics shares fall on wider-than-expected loss
Thursday May 8, 12:34 pm ET
Nektar Therapeutics shares drop on 1st-quarter loss following loss of Exubera revenue

NEW YORK (AP) -- Shares of Nektar Therapeutics Inc. fell Thursday after the biotechnology company reported a wider-than-expected first-quarter loss, primarily because of the loss of revenue from the inhaled insulin Exubera.

The company also said it would end all negotiations to find a development and distribution partner for the drug, which was discontinued by Pfizer Inc. in October because of lackluster sales.

Shares fell 41 cents, or 8 percent, to $4.80 in afternoon trading. The stock has traded between $4.43 and $12.45 over the past 52 weeks.

Late Wednesday, the San Carlos, Calif.-based company said it lost $40.7 million, or 44 cents per share, compared with a loss of $25.7 million, or 28 cents per share, during the same period a year prior. Revenue plunged to $20 million from $85 million because of the loss of Exubera sales.

Analysts polled by Thomson Financial expected profit of 33 cents per share on revenue of $29 million.

Nektar had partnered with Pfizer to develop and sell Exubera, but Pfizer discontinued the product in October because of disappointing sales. Marketing rights were given back to Nektar.

The company also pegged the wider loss to a $4.1 million expense for maintaining Exubera manufacturing capacity and $5.3 million for job cuts. In February, it cut about 150 employees, or about 20 percent of its work force.

"Today we have moved past inhaled insulin, and our proprietary small molecule PEGylation drug development platform is generating a great deal of industry and scientific interest," President and Chief Executive Howard W. Robin said in a statement. "We intend to build and advance our impressive pipeline while continuing to exercise financial responsibility."

Analysts expect the impact of the Exubera loss to linger on the company's profit report throughout the year.

Friedman, Billings, Ramsey analyst Jim Reddoch reaffirmed a "Market Perform" rating, but lowered his price target to $6 from $7. He also changed his forecast for the year and expects a loss of $1.22 in 2008, wider than his prior outlook for a loss of 54 cents per share. He doesn't expect the company to be profitable until 2011.

Soleil Securities Group Inc. analyst Noelle Tune reaffirmed a "Hold" rating on the stock and said the company's development programs remain on track and a handful could advance by the end of the year.

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NKTR-118 Shows Substantial Oral Bioavailability and Extended Half-Life in Phase 1 Clinical Data Presented at American Pain Society Meeting
Wednesday May 7, 9:00 am ET

SAN CARLOS, Calif., May 7 /PRNewswire-FirstCall/ -- New Phase 1 clinical trial results for NKTR-118 (oral PEG-naloxol) were presented by Nektar Therapeutics (Nasdaq: NKTR - News) this week at the Annual Meeting of the American Pain Society (APS) in Tampa, Florida. In this multiple-dose Phase 1 study, oral NKTR-118 was shown to have substantial oral bioavailability with rapid absorption and an extended half-life that is up to ten times the known half-life of unPEGylated naloxone.

NKTR-118 is Nektar's proprietary peripheral opioid antagonist candidate currently in a Phase 2 trial in patients with opioid-induced bowel dysfunction (OBD), including opioid-induced constipation. Nektar's advanced small molecule PEGylation technology has been shown to reduce NKTR-118's penetration across the blood-brain barrier, an important potential advance for this and many other potential therapies.

"For the first time, it has now been shown that Nektar's proprietary PEGylation technology can be used to enhance oral bioavailability for a small molecule drug," said Timothy A. Riley, Ph.D., Vice President of PEGylation Research at Nektar. "In addition, this PEGylated drug exhibited an exceptionally long half-life of eleven hours, enabling a once-daily dosing regimen for NKTR-118 as an oral therapy."

NKTR-118 was also shown to be safe and generally well-tolerated at doses up to 250 mg twice daily, with no serious or severe adverse events. The pharmacokinetics of NKTR-118 were dose-proportional and the observed terminal half-life of the drug was approximately eleven hours, independent of dose. This compares to a known half-life of between 45 and 100 minutes for naloxone.(1) At all dose levels, NKTR-118 was rapidly absorbed after oral administration, as evidenced by a steep increase of plasma NKTR-118 concentration. Plasma concentrations of NKTR-118-glucuronide were approximately 100-fold less than plasma NKTR-118 concentrations. Studies have shown that the bioavailability of oral naloxone is limited by first-pass metabolism of naloxone.(1)

"The prevalence and impact of opioid-bowel dysfunction among chronic pain patients are underestimated today," said Sunil J. Panchal, M.D., President of the National Institute of Pain and the Coalition for Pain Education (COPE) Foundation. "The condition can have a serious deleterious impact on a patient's quality of life and can also limit chronic pain management treatments. There is a clear need for an oral therapy that targets the underlying cause of OBD while preserving the desired analgesic effects of opioid treatment."

About the Phase 1 Clinical Trial

The primary objective of this Phase 1 multi-dose, double-blind, randomized, placebo-controlled study was to evaluate the safety and tolerability of multiple doses of oral NKTR-118 in healthy human subjects not receiving opioid therapy. A total of 32 subjects enrolled in the trial. The secondary objective of the trial was to evaluate the pharmacokinetics of oral NKTR-118 and its metabolite (NKTR-118 glucuronide) following twice-daily oral administration for seven days. Escalating doses up to 250 mg twice daily were studied. Subjects were randomized 3:1 to NKTR-118 or placebo twice daily (every 12 hours) for seven days, with a single dose on the eighth day.

Prior Clinical Study Results for NKTR-118

Nektar previously presented results from a proof-of-principle, single-dose Phase 1 study at the American College of Clinical Pharmacology Meeting (ACCP) conference in September of 2007. In this proof-of-principle study, single oral doses of NKTR-118 antagonized morphine-induced delay in gastrointestinal transit time demonstrating the potential of the drug to relieve constipation. Further, no diminution of morphine-induced miosis, a CNS effect, was observed at single oral doses of NKTR-118 of 125 mg or less. In addition, NKTR-118 at single doses up to 1,000 mg was well-tolerated. The drug was rapidly absorbed with dose-proportional pharmacokinetics over the 8-1,000 mg dose range.

Data Presentations for NKTR-118

The poster presentation made this week at the APS Meeting, as well previous data presentations for NKTR-118, can be found on Nektar's website at http://www.nektar.com/wt/page/nktr118_media

APS Poster #210: "Results from a Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study Evaluating the Safety, Tolerability and Pharmacokinetics of Oral Doses of NKTR-118 (PEG-Naloxol)"
http://biz.yahoo.com/prnews/080507/aqw097.html?.v=46