Nektar Therapeutics (NKTR)

[surf1944]

FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform
Wednesday April 23, 8:00 am ET
Cimzia(R) marks the first FDA approval of a PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody

SAN FRANCISCO, April 23 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) approved UCB's Cimzia® (certolizumab pegol) for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.

Cimzia® is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody approved by the FDA. Cimzia® is the ninth marketed product enabled by Nektar's (Nasdaq: NKTR - News) industry leading PEGylation technology platform. Every PEGylated product approved over the last decade was enabled using Nektar's PEGylation and polymer chemistry.

"The FDA approval of Cimzia® is great news for both UCB and patients suffering from the debilitating effects of Crohn's disease," said Howard W. Robin, President and CEO of Nektar. "Cimzia represents another example of the value of Nektar's PEGylation technology and its potential to create important new therapeutics."

Under the terms of the agreement between Nektar and UCB, Nektar will receive manufacturing revenues and royalties on global sales of Cimzia® for all indications.

Nektar PEGylation Platform

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 used in nine approved partnered products in the U.S. or Europe today, including UCB's Cimzia®, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.

About Cimzia® (certolizumab pegol)

Cimzia® is the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF- alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. UCB is developing Cimzia® in Crohn's Disease, RA and other autoimmune disease indications. For additional information, including safety information, please refer to the Cimzia® factsheet in the "News" section of UCB's website (http://www.ucb-group.com). Cimzia® is a registered trademark of UCB.

About Crohn's Disease

Crohn's disease is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). If not effectively treated, it results in the need for surgery. Crohn's disease has been estimated to affect as many as half a million Americans. People with Crohn's can experience an ongoing cycle of flare-up and remission throughout their lives. Together with ulcerative colitis, Crohn's disease is an inflammatory bowel disease (IBD).

[surf1944]

Additive Anti-Tumor Activity of NKTR-102 in Combination With Bevacizumab Highlighted in Positive Preclinical Data Presented at AACR Meeting
Monday April 14, 8:00 am ET

SAN FRANCISCO, April 14 /PRNewswire-FirstCall/ -- Positive preclinical data was presented by Nektar Therapeutics (Nasdaq: NKTR - News) this week for its lead oncolytic candidate, NKTR-102 (PEG-irinotecan), which demonstrated enhanced anti-tumor activity in a mouse xenograft model of colorectal cancer when co-administered with bevacizumab. Presented at the American Association for Cancer Research (AACR) Annual Meeting 2008 in San Diego, California, the data also featured the enhanced pharmacokinetic profile and tolerability of NKTR-102, as compared to irinotecan in animal models.

NKTR-102 is a PEGylated form of irinotecan developed using Nektar's innovative small molecule PEGylation technology platform. NKTR-102 is currently in a Phase 2 development program to evaluate its safety and efficacy as a second-line colorectal cancer therapy in combination with cetuximab. Nektar had previously announced its intention to expand the NKTR-102 Phase 2 clinical development program later this year with additional indications.

"NKTR-102 is demonstrating important promise as a solid tumor treatment that could be used in a number of critical cancer care regimens," said Tim Riley, Ph.D., Vice President of PEGylation Research at Nektar. "These data reinforce our confidence in the potential of our small molecule PEGylation technology platform to improve the therapeutic potential of oncolytics that are widely used to treat cancer. We look forward to presenting new data from our clinical trials at additional major oncology conferences this year."

In the preclinical studies presented at AACR, NKTR-102 was co-administered with bevacizumab to evaluate the effects of combination therapy. The combination therapy had an additive effect, inhibiting tumor growth by up to 97% in an irinotecan-resistant mouse xenograft model of colorectal cancer (HT29), which was greater than monotherapy with either NKTR-102 or bevacizumab. NKTR-102 at 46 mg/kg, co-administered with bevacizumab, also resulted in eight partial tumor regressions and one complete tumor regression. This compares to no tumor regressions observed with bevacizumab monotherapy, and two partial regressions and one complete regression with NKTR-102 monotherapy. NKTR-102 alone, and in combination with bevacizumab, was well-tolerated, with minimal weight loss.

NKTR-102 also exhibited superior pharmacokinetics in a repeated dose study in dogs, with a 6-fold increase in exposure (AUC) and a 4-fold lower peak plasma concentration (Cmax) of SN38, the active metabolite of irinotecan, as compared to the equivalent dosing of irinotecan. The lower peak plasma concentration of NKTR-102 was associated with a superior tolerability profile, with less gastrointestinal and hematopoietic toxicity than comparable doses of irinotecan.

In animal models, NKTR-102 had a markedly improved safety and tolerability profile when compared to irinotecan in animal models. Both the incidence and severity of diarrhea and neutropenia were lower in dogs treated with NKTR-102 as compared to irinotecan. Diarrhea and neutropenia are the most common side effects associated with irinotecan treatment, and can limit treatment with the therapy.

Data Presentations

The three poster presentations made this week at the AACR Annual Meeting can be found on Nektar's website at http://www.nektar.com/wt/page/nktr102media

#766: "Enhanced anti-tumor activity of NKTR-102, a novel
PEGylated-irinotecan, when administered in combination with bevacizumab
in a mouse model of human colorectal tumors"

#5741: "NKTR-102, a novel PEGylated-irinotecan, has an enhanced
pharmacokinetic profile with reduced gastrointestinal and hematopoietic
toxicity compared to irinotecan with repeat dosing in dogs"

#5742: "NKTR-102, a novel PEGylated-irinotecan, has a superior acute
safety, tolerability, and pharmacokinetic profile compared to irinotecan
in rats and dogs"


Prior data presentations on the anti-tumor activity and pharmacokinetics of NKTR-102 in mouse xenograft models of colorectal, breast and lung cancer can be found at http://www.nektar.com/wt/page/nktr102media.

[surf1944]

Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical Studies of Inhaled Insulin Patients
Wednesday April 9, 8:30 am ET

SAN CARLOS, Calif., April 9, 2008 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) announced today that it has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. All new incidences of lung cancer were in patients that are former smokers.


"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said Howard W. Robin, President and CEO of Nektar. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin. We have made great progress expanding our research efforts and have built a deep pipeline of novel partnered and proprietary drugs in various stages of development."

Nektar will cease all spending associated with its inhaled insulin programs and will not incur any additional charges related to this event.

The Exubera label was updated by Pfizer to contain the following safety information warning:

"In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking."

[surf1944]

Stay away from NKTR for now, heading to its cash levels!

[surf1944]

Bayer HealthCare and Nektar Therapeutics Launch Global Development and Commercialization Agreement to Fight Gram-Negative Pneumonias
NKTR-061 (Inhaled Amikacin) Would Combine a Powerful Antibiotic With Innovative Pulmonary Drug Delivery System

TARRYTOWN, N.Y. and SAN CARLOS, Calif., Aug. 6 /PRNewswire-FirstCall/ -- Bayer HealthCare and Nektar Therapeutics (Nasdaq: NKTR) announced today that the two companies have agreed to develop and commercialize NKTR-061 (inhaled amikacin). This potentially innovative therapy would utilize Nektar's proprietary pulmonary technology to deliver a specially-formulated amikacin, an aminoglycoside antibiotic, for inhalation deep into the lung. NKTR-061 is under development for adjunctive treatment of Gram-negative pneumonias that often lead to significant morbidity and mortality.

'This new development agreement reinforces our commitment to fight infectious and respiratory diseases and is a natural fit with Bayer HealthCare's strategy of developing and marketing specialty pharmaceutical products,' said Dr. Ulrich Kostlin, Member of the Executive Committee of Bayer HealthCare. There is a large, unmet medical need for a new approach to fight Gram-negative pneumonias, particularly in ventilated patients infected with difficult to treat, resistant organisms. Nektar's pulmonary drug delivery technology offers a very promising approach to address this unmet medical need.

As part of this agreement, Nektar will receive milestone payments of up to $175 million associated with the successful development and commercialization of NKTR-061. This includes an upfront payment of $50 million. Subsequent to the successful clinical and regulatory development of the product, Bayer HealthCare and Nektar have agreed to a co-promotion of the product in the United States and to share profits. For sales outside the United States, Nektar will receive tiered performance royalties up to a maximum of 30%.

Under the terms of the agreement, Bayer HealthCare is responsible for the global clinical development, regulatory strategy, manufacturing and marketing of the product, with Nektar participating in all aspects of decision-making and governance.

'We're very pleased to be collaborating with Bayer HealthCare, a world leader in anti-infective therapies,' said Howard W. Robin, President and Chief Executive Officer of Nektar Therapeutics. 'Utilizing Nektar's proprietary pulmonary technology to address life-threatening infections, Bayer HealthCare and Nektar are building on the important work we're doing in the area of pulmonary therapeutics.'

Currently, NKTR-061 is being studied in Phase 2 trials for the adjunctive therapy of ventilated patients with hospital-acquired, Gram-negative pneumonias. These pneumonias are a serious problem afflicting patients even in the world's most advanced clinical settings and are responsible for a significant number of deaths. Increasingly, multi-drug resistant, Gram-negative bacteria have magnified the problem of hospital-acquired infection. Gram-negative pneumonias are commonly seen in patients receiving immunosuppressive therapy, the elderly, and patients undergoing major surgical procedures, aspiration, long hospital stays and prolonged mechanical ventilation. Current treatment involves the administration of systemic antibiotics, which produces significant toxicities and results in marginal benefit to the patient. Some 20-50 percent of patients intubated and on ventilators who acquire Gram-negative pneumonia will die. NKTR-061 (inhaled amikacin), if approved, would be administered while the patient is on the ventilator and also would allow for ongoing dosing (transition therapy) after the patient no longer requires ventilatory support.

This collaboration is Bayer HealthCare's second with Nektar. In 2005, Bayer and Nektar agreed to collaborate on the joint development of inhaled ciprofloxacin as a potential dry powder therapy for treating pseudomonal infections in patients suffering from cystic fibrosis.

A

[toomanycrybabies]

THIS IS A DEAD BOARD

[surf1944]

Cowen Sees Nektar Outperforming Market By 30%+
Wednesday June 27, 8:27 am ET

Notable Calls submits: Cowen is yet again out positive on Nektar Therapeutics (NasdaqGS: NKTR - News) noting that at the American Diabetes Association meetings (June 22-26), Pfizer reps demonstrated Exubera to all who would listen, rolled out the print advertising campaign, and revealed that the long-awaited DTC television ads would hit the U.S. market next month.

Yet NKTR shares sunk to a three-year-low on concerns that Pfizer may pull the plug on its Exubera support. Firm's checks at the meetings indicate those concerns are misplaced. They believe Pfizer will run the DTC program for at least 9-12 months to drive patient demand, and all of clinical consultants (whether bullish or bearish on Exubera) believe that DTC advertising will have a significant positive impact on Exubera use. With Exubera expectations virtually eliminated from the share valuation in firm's view, clinician sentiment beginning to turn, the DTC advertising catalyst coming in Q3, and visibility on Nektar's internal pipeline rising in Q4, they believe NKTR shares can outperform the market by 30%+ over the next 6-12 months.

Early prescription trends for Exubera have been disappointing, due to a deliberate launch by Pfizer and low patient awareness. However, the firm believes that patient dissatisfaction with current diabetes therapies has created pent-up demand for Exubera, and will drive accelerating use as Pfizer's primary care launch gains traction in H2:07 and direct-to-consumer advertising begins this summer. Recent clinical checks indicate high patient satisfaction with Exubera and, in many cases, an improvement in glucose control over injections.

Notablecalls: Last time I was positive on NKTR, the stock took out my stops in a heartbeat. Not only that, it took another 15% dive over the following weeks. The shorts sure like to chop this one down.

Yet Cowen's comments make too much sense not to be highlighted. Not calling it actionable here, though.

[alt=]

[stockguard]

www.horizonstudy.com

you have type 2 diabetes – and are currently using Lantus® – you are invited to see if you may qualify to participate in a new medical research study called the Exubera® Horizon Study. The purpose of the study is to determine if Exubera®, an approved inhaled insulin, works in controlling blood glucose levels when used with Lantus. Half of the study participants will receive Exubera, and the other half will receive an approved injectable form of mealtime insulin. Physicians right in your area are conducting the Exubera® Horizon Study.

Each individual will be evaluated to determine his or her eligibility. If you qualify, you’ll receive study medication– including Lantus and mealtime insulin – study-related medical exams, lab tests, and blood glucose testing supplies at no charge. Financial compensation for time and travel may also be available.

[stockguard]

UPGRADES & DOWNGRADES HISTORY
Date Research Firm Action From To
28-Sep-06 Miller Johnson Upgrade Market Perform to Outperform
18-Aug-06 Morgan Stanley Upgrade Underweight to Equal weight
10/14/05 WR Hambrecht + Co Nektar "buy"
10/05/05 Pac. Growth Equities Nektar Therapeutics upgraded to"buy"

Watch when the shorts start to cover.......

[SeriousMoney]

So does ChangeWave Biotech Investor - 7/13/06

NEKTAR (NKTR): Exubera, its inhaled insulin product marketed by Pfizer, should be available in the U.S. within days and the debate has begun with the naysayers winning the battle in the press.

Ignore them!

Very recent ChangeWave Alliance survey results show Exubera is going to do very, very well, especially with new insulin-using patients. I will share final data with you next week. The stock is holding up very well at around $17 and is at an excellent entry point. You can expect the positive stories will start hitting the press sometime in the next few weeks.

[serfdom]

InfinitiStocks.com likes NKTR

NKTR Nektar Therapeutics
June 11: Nektar, the maker of the delivery device for Pfizer's Exubera, said the drug will be launched in the United States in mid-July. Exubera is the first non-invasive inhaled insulin treatment. InfinitiStocks also notes that as of May 10, approximately 20% of the NKTR float is sold short (17 million shares). Price at the time of this alert was $19.71.

http://www.infinitistocks.com

Story:
http://www.alphatradefn.com/story/2006-06-10/BIZ/200606101230BIZWIRE_USPR_____BW5004.html

[SeriousMoney]

Nektar Gets Fast-Track for Lung Drug
The Associated Press
May 22, 2006, 9:38AM

SAN CARLOS, Calif. — Biotech drug maker Nektar Therapeutics said Monday that Food and Drug Administration has given a fast-track designation to its lung infection prevention drug.

A fast-track designation allow a company to submit clinical trial data to the FDA as it becomes available, and get feedback, rather than having to wait and file it all at once.

The designation covers Nektar's Amphotericin B Inhalation Powder to help prevent fungal infections in the lungs in patients who are taking medications that suppress the immune system following organ or stem cell transplants to reduce the chances of rejection.

In February, Nektar received orphan drug status for the treatment. The status is given to drugs that treat diseases affecting less than 200,000 people in the United States. It allows seven years of market exclusivity if the drug is approved along with tax credits and help in designing a clinical trial for approval.

Nektar shares fell 2 cents to $19.68 in morning trading on the Nasdaq.

http://www.chron.com/disp/story.mpl/ap/fn/3879543.html

[SeriousMoney]

Nektar Therapeutics "buy"
Wednesday, May 17, 2006 4:56:33 AM ET
WR Hambrecht & Co

NEW YORK, May 17 (newratings.com) - Analysts at WR Hambrecht maintain their "buy" rating on Nektar Therapeutics (NKTR.NAS). The target price is set to $30.

In a research note published yesterday, the analysts mention that the company's Exubera product has been approved and is to be launched soon. Nektar Therapeutics has implemented cost cutting measures on everything except Exubera, which is expected to boost the company's earnings over the next several years, the analysts say. The recent decline in the company's share price offers an attractive investment opportunity, WR Hambrecht adds.

http://www.newratings.com/analyst_news/article_1277370.html

[SeriousMoney]

Great assessment, B. I think we've got a real winner here, thanks to the baby boomers who are rapidly blooming into diabetic candidates. Hey, I resemble that remark! :)

[bernoulli]

Bottom line, if insurance companies decide to pay part of the cost, seems most likely, users would have a higher co-pay, then instead of 60% audience one might look at an 80% figure. I consider the convience part,

xubera's clinical advantages over injected insulin do not appear to extend beyond patient convenience - a feature not traditionally highly valued by third-party payors.,

to be what it is all about anyway. That is what will drive sales. The American Diabetes Assoc. stated they were behind Exubera because, many more diabetics will use insulin than currently do. They said this because it removes the fear of needles, inconvience of refrigeration etc. Meaning, there is a much much larger potential user base than is currently indicated. If the audience were to double, type 2 diabetes is growing expotentially, then even using the crappy numbers below, 60%, one would still have 120% of the existing user base. It amazes me how jounalist, ????, use only the data they choose, to justify their article. Sorry, but I am not impressed with the poor reasoning abilities of this mental midget. I am not discounting the below article because I am closed minded. I am because, they left out most of the facts.

[SeriousMoney]

Pfizer/Nektar: Exubera to enjoy strong mid-term growth
Pharmaceutical Business Review
By Staff Writer, 18th April 2006

Pfizer's Exubera is expected to experience strong sales growth from 2007 to 2009.

Pfizer and Nektar Therapeutics' Exubera looks set to experience strong mid-term growth in type 1 and type 2 diabetes, driven by patient interest and physician acceptance of efficacy and safety data. By 2010, global sales of the drug are expected to reach $2 billion. However, Wall Street expectations of strong first year sales may be disappointed due to pricing and reimbursement difficulties.

Pfizer and Nektar's Exubera garnered US and EU approvals in January and is expected to launch in both markets by mid-2006. It appears that patient demand for Exubera in both type 1 and type 2 diabetes is high, and physicians are willing and ready to prescribe the product promptly following its launch.

Use of Exubera is, therefore, likely to grow steadily. However, premium pricing and poor reimbursement could well dampen the drug's potential, especially in the initial years post-launch.

Exubera's clinical advantages over injected insulin do not appear to extend beyond patient convenience - a feature not traditionally highly valued by third-party payors. This means that, with a cost expected to be three or four times higher than injected insulin, Exubera's reimbursement is likely to be poor or non-existent among managed care plans. Consequently, Datamonitor estimates that only 60% of Exubera candidates are likely to have adequate financial coverage for the product in 2006.

With this in mind, while Exubera is forecast to generate global sales of $1.7 billion in 2008 and $2 billion in 2010, H2 2006 sales are only estimated to reach around $186 million. Wall Street consensus puts the H2 2006 figure at $257 million; this seems overly aggressive considering the likelihood of strong pushback from third-party payers following the product's launch.

In addition, Exubera looks set to face stiff additional competition from 2009 onwards. Three late-stage inhaled insulin products are currently in development - Eli Lilly/Alkermes' AIR insulin, Mannkind's Technosphere Insulin (TI) and Novo Nordisk's AERx. Approvals for AIR and TI are anticipated in mid-2009, while AERx is expected to gain approval mid-2010.

Interviewed opinion leaders believe the efficacy of all products is comparable. However, due to their smaller, more convenient devices, AIR Insulin and TI are expected to rapidly inherit Exubera's share, with sales for each new product likely to reach over $1.5 billion in 2010. Conversely, AERx is expected to lag behind due to a late launch, bulkier device and the need for refrigeration, generating peak sales of $1.3 billion in 2012.

http://www.pharmaceutical-business-review.com/article_feature.asp?guid=C1ADE381-E877-472E-9F82-37A63...

[SeriousMoney]

Bad link... try this one for AMLN [#msg-10433899]

[SeriousMoney]

NEKTAR (NKTR): An interesting note about short positions from WR Hambrecht's research team that believes up to 17 million shares of Nektar held short may have to be covered (i.e., bought) before too long. Why? At the end of June the Russell 2000 index of small- and mid-cap stocks gets re-balanced. Hambrecht believes that at that time the four largest biotech firms will be removed from the index because they have grown too large, including Buy List companies Alkermes and Amylin.

The overall weighting for biotechs within the index needs to remain close to the same level and NKTR would be the only remaining biotech stock in the Russell 2000. Many, many hedge funds and mutual funds buy the stocks in the Russell 2000 as a basket, so if the weighting of Nektar goes up, the number of shares of Nektar that need to be bought to mirror the Russell 2000, goes up. If the weighting of NKTR goes up to equal Amylin's current weighting, Hambrecht believes the stock could hit $50. The "shorts" know this, so a short squeeze may start sooner rather than later.

BIOTECH ChangeWave 3/30/06
http://ww2.changewave.com/bt_login.html?dest=/biotech/

[SeriousMoney]

We're on the same page on NKTR.

AMLN, another diabetes play, appears to be showing the way. [#msg-0181512]

[bernoulli]

NKTR painted a pretty bleak picture for this year, however, I think they were projecting income based on Pfizers figures. I might be wrong but I think once this product hits the market we will have another Lipitor. I know all the hype about transdermal insulin, my thoughts are, if skin could absorb insulin in a manner necessary to affect blood sugar, someone would of discoverd that a long time ago.

I think NKTR was simply oversold and the market is bringing it back to its potential around $22.00.

[SeriousMoney]

Where's the news?

[SeriousMoney]

Advisory: Bear Biotech West Coast Confab to Webcast Nektar Corporate Presentation
3/20/2006 5:48:00 PM EST

Nektar Therapeutics (Nasdaq:NKTR) announced today that its corporate presentation will be webcast live from the Bear Biotech West Coast Confab, Thursday, March 23 beginning at 1:30 p.m. Pacific Standard Time. The audio-only presentation may be accessed on Nektar's Investor Relations' page at http://www.nektar.com/wt/page/Press_Releases and will be available within 24 hours following the live presentation until April 6, 2006.

Nektar Therapeutics develops and enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.

http://www.nektar.com/wt/page/Press_Releases

[SeriousMoney]

Loss Widens for Nektar
By Robert Steyer
TheStreet.com Staff Reporter
2/28/2006 6:27 PM EST

Nektar Therapeutics (NKTR:Nasdaq) said Tuesday it will lose more money this year than Wall Street is estimating, as it works on new products now that the inhaled insulin Exubera is ready for the market.

The revenue prediction of $160 million to $190 million is within the consensus range and includes $60 million to $80 million in royalties from Pfizer (PFE:NYSE) for developing Exubera. Nektar contributed the inhaler that dispenses the dry-powder form of insulin.

The Food and Drug Administration approved Exubera on Jan. 27, one day after the European Union endorsed the drug. Pfizer has said Exubera will be available by midyear. In the meantime, Pfizer is conducting an education campaign for doctors and patients.

Nektar predicts 2006's loss will be in the range of $115 million to $130 million, including $15 million in stock-based compensation charges. Analysts polled by Thomson First Call predicted a loss of $80.7 million, excluding one-time items. The consensus revenue forecast was $171 million.

For the fourth quarter of 2005, Nektar lost $35 million, or 40 cents a share, excluding items. Revenue totaled $32.9 million. Analysts were expecting a loss of 38 cents a share on revenue of $31.1 million.

On a GAAP basis, Nektar reported a fourth-quarter loss of $108.2 million, or $1.23 a share, compared with a loss of $19.3 million, or 23 cents a share, for the same period in 2004.

Looking ahead, Nektar said its expenses will include preparing clinical trials for an inhalable powder that treats fungal infections in the lungs of patients taking immunosuppressive drugs. Nektar also is testing an inhalable antibiotic to treat pneumonia among intensive-care patients who require ventilators.

Robert Chess, the company's chairman, said it would take five to nine months to conduct a search for a new chief executive to replace Ajit S. Gill, 56, who recently announced his retirement. Gill, who joined the company in 1992, has been CEO since April 2000 and a director since 1998. Chess will become interim CEO starting in mid-March.

The new CEO will join a host of other new executives. In recent months, Nektar has hired a new chief financial officer, controller and head of cost accounting.

Nektar issued its financial results after the markets had closed. In regular trading, the stock fell 74 cents, or 3.4%, to $20.91. After hours, the stock lost 2 cents.

http://www.thestreet.com/_googlen/stocks/biotech/10270947.html?cm_ven=GOOGLEN&cm_cat=FREE&cm...

[SeriousMoney]

Inhaling medicine removes the sting
AFTER 20 YEARS, IDEA COMES TO FRUITION
By Steve Johnson, Mercury News
Posted on Sun, Feb. 19, 2006

John Patton has been trying for 20 years to get others to believe in his idea that people with various ailments could inhale medicine into their lungs instead of having to endure painful injections.

And for years critics called his concept unworkable or unsafe.

But last month, the 59-year-old Patton finally won vindication. The U.S. Food and Drug Administration and European authorities both gave their approval to begin selling the inhalable form of insulin he helped invent, called Exubera.

Analysts have predicted sales of the product -- co-developed by Nektar Therapeutics of San Carlos, the company he founded, and drug giant Pfizer -- eventually could hit $3 billion a year. That would be a major plus for Patton, who co-founded the company in 1990, when it was called Inhale Therapeutic Systems. He went through much of his savings trying to get the business off the ground, and it hasn't been profitable since it went public in 1994.

Patton spoke with the Mercury News about some of the hurdles he overcame in getting Exubera approved. Here are edited excerpts from his remarks.

Q Why did Genentech hire you in 1985?

A They made these proteins that had to be injected and they said, ``Can you help us get around the needle?' My background was in gastrointestinal absorption and digestion. My Ph.D thesis was fat digestion in fish, which I don't even think my committee members read, it was so obscure.

Q But Genentech wasn't interested in pursing your research?

A In fairness to Genentech, they let me work on it for four years. And I think, all totaled, I probably spent about $4 million on it. There were a lot of people there at Genentech who were very enthusiastic about the program, and there were a lot who weren't, and mostly it was fear of long-term safety. I just, like, threw up my hands.

Q After Genentech turned you down, you and Robert Platz at SRI International in Menlo Park decided to form your own company to pursue the research. Was that a difficult time financially?

A I sold all my Genentech stock. It was worth about $200,000, and after taxes it was $120,000. I then used that money to live on -- and to start the company -- for the next 13 months and wound up using it all up.

Q You tried to get financing from various venture capital firms and finally got it from Onset Ventures of Menlo Park. What was that process like?

A You know, Bob and I were not well known. We were kind of damned by faint praise. We had no business experience. They kept telling us our business plan was not a business plan. And it was like, you know, speaking a foreign language to those guys. But we shopped the plan very frugally. We'd give it to one, take their input and try to change it and we'd give it to another. We were really getting jerked around, because each one wanted us to be a different kind of company.

Q Was that a pretty scary time for you?

A I'm very frightened of certain things. I'm terribly frightened of getting cancer. I'm afraid of people who want to kill me and stuff like that. But I've never been afraid of not having money. I did not go into this business for money. As a matter of fact, I've kind of avoided it. I wanted to do something for people. And I've never been motivated by money. For some people, some things are really scary and for other people they're very exhilarating. Toward the end, when nobody was funding us, I was looking at a job as director of this marine biotechnology center back in the harbor in Baltimore. There were some other contingencies.

Q What was the biggest hurdle you had to overcome in convincing people that inhaled insulin could be a viable product?

A Safety. The knee-jerk reaction from the lay scientists or the lay smart person was, ``You can't do that. You'll get asthma. It won't be safe. The lungs are supposed to breathe fresh air, you shouldn't put anything in there.' Actually, the lungs take in literally billions of particles everyday. There's all these processing mechanisms and self-cleansing mechanisms. And we're talking about putting something in there that's very bio-compatible.

Q You're already working on an updated version of Exubera. What do you envision for Nektar in coming years?

A We've never, ever sought or wanted to be taken over by anybody. That has never been our goal. We want to be a very, very innovative drug delivery company, and we want to bring the latest technology. I'd like to see us, through innovative biology, become a dominant player as our own pharmaceutical company.

Q Can you describe the work atmosphere at Nektar?

A We don't tend to single out employees and hold them up above the other ones. We just haven't had that culture. Whether we keep it or not, I don't know. But it's always so subtle, who invented this and what role did so-and-so play in that. So we don't celebrate inventors or anything like that. Sure, they can be compensated in a very quiet way. But we don't tend to call out individuals. It's a little controversial. Some people think we should.

Q You work in a cubicle and have been described by some co-workers as a humble person. How did you get that way?

A Well, I'm a total believer in your DNA. Your behavior is so fixed. I love it. We get into these reviews of the employees and people always say this person needs to be more aggressive or this person needs to take a stand or be more outgoing or not leave so many dead bodies around. And I'm, like, you know what, that's the way Joe is. We've been telling him that for 15 years.

http://www.mercurynews.com/mld/mercurynews/13911329.htm

[SeriousMoney]

Local ties assist new Pfizer drug
By John George
Philadelphia Business Journal
Updated: 7:00 p.m. ET Feb. 19, 2006

Pfizer Inc. is getting ready to launch what it hopes will be its next blockbuster: a new insulin product for diabetics that can be inhaled rather than injected.

Behind the scenes, two local companies played key roles in the development of Exubera, which just secured Food and Drug Administration approval.

Plexus Ventures in Maple Glen brokered the partnership of Nektar Therapeutics, which initially developed the drug, and Pfizer, which had the deep pockets needed to get the product through the regulatory approval process.

Meanwhile, a subsidiary of West Pharmaceutical Services in Lionville helped create, and will continue to make, the delivery system that will be used by patients taking the drug.

Exubera is a rapid-acting, dry-powder insulin designed to be inhaled into the lungs prior to each meal.

With more than 18 million people suffering from diabetes in the United States alone, many of whom have difficulty adhering to insulin shot regimens, industry analysts believe Exubera could quickly become a multibillion-dollar product for Pfizer.

In 1993, Plexus Ventures was retained by Nektar, then known as Inhale Therapeutic Systems, to assist the San Carlos, Calif., company's efforts to find a development and commercialization partner for its experimental inhaled insulin.

Plexus, founded in 1990 by a former SmithKline Beecham executive, is a life sciences consulting firm that specializes in helping pharmaceutical and biotechnology companies license drug candidates. Plexus was acquired by two other former SmithKline Beecham (now GlaxoSmithKline) executives, Robert P. Moran and Michael O'Sullivan, in 1993.

"It took a long time to get Exubera to market," said Moran, the firm's president. "Where the company had difficulty is its management, and I don't blame them for thinking this way, assumed the insulin companies would flock to the idea of an inhaled insulin product."

As it turned out, the three companies -- Eli Lilly, Novo Nordisk and Hoechst -- with the top selling insulin drugs in the market were all skeptical of an insulin formulation that required inhaling a powder into the lungs.

"We came up with the strategy of going after a respiratory treatment company since they already had knowledge about inhalation through their asthma medicines," Moran said.

Plexus also targeted pharmaceutical companies marketing orally administered anti-diabetic drugs other than insulin.

About 20 companies were identified as potential partners including Pfizer, which markets the oral anti-diabetic drug, Glucotrol, and was interested in extending its diabetes franchise into insulin.

After conducting thorough due diligence of Inhale's technologies, Pfizer -- best known for Lipitor and Viagra -- emerged as the top contender to license Nektar's insulin technologies. New York-based Pfizer signed a deal securing development and commercialization rights to the product in 1996.

Moran declined to disclose specific financial components of the deal, but he did say Pfizer has spent "hundreds of millions of dollars" getting the drug tested and approved.

"I give Pfizer a lot of credit," Moran said. "They were committed to this product and they stuck with it. Both companies showed a lot of commitment to each other. I think this is going to be an important product for Pfizer, whose pipeline is not as robust as it was a few years ago."

West Pharmaceutical also stands to benefit financially from Exubera through its subsidiary, The Tech Group, which it acquired last year for $140 million.

The Tech Group and West's device group merged into a single entity. It operates out of engineering and manufacturing facilities in Pennsylvania, Arizona, Indiana, Michigan, Puerto Rico, Ireland and Mexico.

The subsidiary specializes in injection molding components and devices.

Mike Treadaway, general manager of drug-delivery devices at Tech Group, said the company has been working with Nektar on an Exubera delivery device for seven years.

Treadaway said the device they created is about the size of a sunglasses case, weighs 4 ounces and is made primarily of plastic injection molding components.

Exubera will be sold in a blister pack. After a dose is loaded into the device the medicine is released. It appears as a cloud of insulin powder, resembling smoke, Treadaway explained, that is suspended in a chamber until inhaled by the patient.

"There is an enormous benefit to this delivery technique over the injection of insulin, which can be cumbersome," he said. "A lot of diabetic patients don't adhere to their treatment regimen. We are really hopeful the market will embrace this and it will revolutionize how people take insulin."

As one of two contract manufacturers of the delivery device, along with Bespak in England, West stands to benefit financially as well.

Treadaway said it's too early to estimate the potential revenue from the product for West, which last year generated sales of about $700 million. Last month the company said it expects revenue to grow by about 17.5 percent to between $810 million and $839 million.

"This [Exubera contract] does have an enormous potential for us," he said.

http://msnbc.msn.com/id/11454518/

[SeriousMoney]

MICHAEL SHULMAN: Editor ChangeWave Biotech Investor

http://www.leadingauthorities.com/Talent/S/Shulman_Michael/Shulman_Michael.doc



Michael Shulman is currently the Managing Director of Research for ChangeWave Investment Research. Michael joined ChangeWave after spending twenty years in various high tech industries. Prior to joining ChangeWave Michael was the CEO of AtYourBusiness.com, now Primewire, a benefits administration Application Service Provider he founded in 1998.

Michael began his career doing in-depth company and market analysis for a variety of companies, building databases and simulation models to estimate the success of various technologies across a wide range of market segments. He moved "inside" the high tech community as a manager at high-tech companies including AT&T. Michael was an early private investor in several Internet start-ups, notably XOOM.com (went public in 1998 and was bought by NBC in 1999) and brings a unique perspective to the ChangeWave research effort, as a combination of technologist, investor and financial analyst.

Michael currently sits on the Executive Board of NextGen Capital, a venture fund based in Fairfax, Virginia, Chairman and Board member of Primewire, and sits on the Advisory Boards of Sandbox.com and Brainbench.

He has published in a variety of trade and general business publications, including CD-ROM Today, Worth Online, The Motley Fool, Bonjour Paris and The Los Angeles Times.

Michael began work for Phillips Investment Resources by performing independent research and financial analysis for several of its publications. Prior to taking on his current role as Editor of the ChangeWave Biotech Investor he was Editor of ChangeWave Hedge Fund Investing.

[SeriousMoney]

thx, B! Toby Smith's ChangeWave Biotech reco'd this to subscribers back in March/April 2005 along with ALKS & AMLN & others (see below).

And now that NKTR is getting their management right, perhaps Cramer with come aboard!

ChangeWave Biotech
Date and Time: 2005-03-31 17:00:00
Speculative Company - - Nektar Therapeutics (NKTR)- DIABETES

Nektar (NKTR), formerly Inhale Therapeutics, is a speculative play on inhalable insulin. The company has other agreements for cystic fibrosis and for osteoporosis – but forget about them for now.

I have watched the stock and the company for three years. In March 2002, the ChangeWave Insight service for institutional investors recommended shorting the stock due to improper trial design, predicting it would fail to get FDA approval. A good call – Nektar withdrew its application and the stock blew up.

Subsequent to this fiasco, the company renamed itself and turned over much of the trial design and implementation to marketing partner Pfizer (PFE). Pfizer and NKTR released preliminary data this summer, have submitted a drug application to European regulatory authorities, and prompted some analysts to speculate if it would get limited regulatory approval in 2005. Late last year Pfizer announced it was planning to submit an application to the FDA for Exubera sometime in 2005. The stock popped but now the pessimists are coming back into the debate.

Why I See Approval

Within a few years more than 50 million people worldwide will have diabetes – there are already 17 million-19 million people in the U.S. with some form of the disease. Many know what they are supposed to eat but do not. Many know they are supposed to monitor their glucose levels but they do not. Many know when they are supposed to take medications and inject themselves with insulin but they do not. The cost to society of diabetes and related maladies, many due to under-treatment? More than $125BN per annum (according to the American Diabetes Association) and climbing by double digits every year.

Public health authorities are desperate to contain health costs and this $125BN is a big target. Some analysts estimate 80% of diabetics under medicate themselves, leading to many costly maladies. Inhalable insulin would solve a good part of this problem.

What if There Is Limited Approval?

Many analysts lined up against inhalable insulin are betting it will get only limited regulatory approval in Europe, with a requirement for follow-up lung testing and perhaps a shot a day of insulin. I asked ChangeWave’s survey group to ask doctors about these potential limitations – and they said it would be a hit even if lung function tests and some injections of insulin are still required.

Why is this so? Simply put, many people hate needles and a large number of diabetics under-medicate themselves because of their unwillingness or inability to inject themselves.

Risks?

The risk? There is still a reasonable probability of regulatory rejection –maybe 25%-35% -- and that would cut the stock in half. If approved, it is a rocketship, even with requirements for follow-up testing and/or injected insulin to supplement Exubera.

Why Now?

European regulators are going to start talking soon and approval will occur in 2005
Pfizer is preparing its drug application and more data on the trials will be made public.
The stock has been in a holding pattern for a while.

Conclusions: High risk – a 1-in-3 chance that Pfizer and Nektar will be asked for more data or more trials, although there is little chance the drug will be killed outright. High reward – a ten bagger over the next three to four years with an approved version of Exubera – unless Pfizer takes them out.

[bernoulli]

Over the years one gets a sense of those companies who have discovered a gold mine and in this case it has been Nektar Therapeutics, not Pfizer, without the atomizer developed by Nektar, Pfizers insulin tablet would be of little use, now with this new Orphan Drug status obtained by Nektar we are begining to see their atomizer is capable of a lot more than delivering insulin. According to what I have been reading, Nektar's new insulin delivery system is already being asked for by every diabetic in the country. Almost every physician out there has been innundated with request for it. Talk about your blockbusters, this is it, and the market hasn't woken up to it, " YET. " I realize that Merck, Johnson and Johnson and others have recently announced they are working on new drugs for diabetics, however, that will take years to get to FDA approval stage, by then, every diabetic in the county will have an atomizer in their glove box, by the bed, in their travel bag, purse, or inside their jacket pocket. I can hardly wait for the release of this system in June or July of this year.

I have SeriousMoney to thank for this information, without his informing me of it I probably would never of seen it, Thanks !!

[SeriousMoney]

Nektar Announces That U.S. FDA Has Granted Orphan Drug Designation to the First Amphotericin B Inhalation Powder to Prevent Pulmonary Fungal Infections in Immunosuppressed Patients
Genetic Engineering News, 2/14/2006 8:30:00 AM EST

Nektar Therapeutics (Nasdaq:NKTR) announced today the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the first amphotericin B inhalation powder for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy. Using a small proprietary pocket size inhaler, the company has conducted two Phase I trials and has long-term toxicity studies underway to support the planned pivotal trials early next year.

Immunosuppressed patients -- i.e., those receiving organ or stem cell transplants, or chemotherapy or radiation therapy for hematologic malignancies -- commonly develop fungal infections in their lungs which spread throughout the body (aspergillosis). Inhaling amphotericin B inhalation powder into the lungs prior to developing an aspergillosis infection may potentially reduce the incidence of these infections as well as the subsequent high morbidity and mortality and significant treatment costs associated with them. Nektar developed the amphotericin B inhalation powder to target the lungs directly with this potent, broad spectrum, fungicidal "gold-standard" antifungal drug, while potentially eliminating systemic toxicities associated with current formulations of amphotericin B which must be delivered intravenously.

Orphan products are developed to treat diseases or conditions that affect fewer than 200,000 people in the U.S. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first sponsor who obtains marketing approval for a designated orphan drug.

"Given the high incidence of invasive aspergillosis in immunocompromised patients, and high mortality rates despite available therapies, this potential new therapy could represent a significant breakthrough in antifungal medicine," said Kieren Marr, M.D., Assistant Professor Medicine, Allergy and Infectious Diseases, Fred Hutchinson Cancer Research Center, Seattle, Washington.

"In the U.S., more than 75,000 immunocompromised patients annually are at risk of developing often fatal and costly fungal infections in the lungs. There are no approved pharmaceutical therapies to prevent fungal infections like aspergillosis, caused when Aspergillus, a widely prevalent genus of molds, infects the lungs and invades the body, causing systemic infections that are very difficult to cure and are associated with an extremely high mortality rate," said Dr. David Johnston, Nektar Senior Vice President, Research and Development.

"Fungal spores are routinely inhaled. An immunosuppressed patient is susceptible to fungal infections, like aspergillosis, normally not seen in those with healthy immune systems. Nektar's approach delivers amphotericin B directly to the potentially vulnerable organ through inhalation in the same manner that the fungal spores are inhaled, and could represent a breakthrough in prevention of these infections with such high mortality rates," said Johnston.

The FDA granted orphan drug designation to Nektar's amphotericin B inhalation powder upon review of the application which included pre-clinical data presented at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in December 2005. These data indicated that the inhaleable amphotericin B provided a statistically significant improvement in survival of immunosuppressed rabbits challenged with a pulmonary dose of Aspergillus fumigatus spores. In separate toxicology studies, there was little or no pulmonary toxicity when animals were administered ten times or more than the expected amphotericin B powder dose for humans. Further, data indicated that there was no systemic toxicity and low amounts of the drug in the bloodstream -- less than the concentration generally regarded as toxic in blood in humans -- even when delivered at doses more than ten times the level expected for humans.

Data from the two clinical studies completed to date reinforce the pre-clinical results. Nektar scientists will present data from the first of these clinical studies at upcoming conferences, including: 2nd Advances Against Aspergillosis, Athens, Greece, February 22-25, 2006; and Focus on Fungal Infections 16, Las Vegas, Nevada, March 8-10, 2006. Pivotal trials are on target to begin in early 2007.

Nektar Amphotericin B Inhalation Powder

Amphotericin B is a potent, broad spectrum, fungicidal drug which has been used intravenously for decades for treatment and remains the "gold-standard" therapy for fighting fungal infections, limited only by its systemic toxicities. The Nektar amphotericin B inhalation powder product enables the inhalation of a therapeutic concentration of amphotericin B directly to the lungs, at levels similar to or greater than the lung concentrations achieved by intravenous dosing of amphotericin B or lipid-associated amphotericin B products. By delivering amphotericin B directly to the site of potential infection, Nektar's inhaleable amphotericin B will potentially eliminate life-threatening pulmonary fungal infections, while minimizing common dose-limiting toxicities associated with intravenous amphotericin B therapy. Nektar's unique delivery mode has been designed to encourage long-term compliance and may have significant cost benefits for this high-risk patient population.

http://www.genengnews.com/news/bnitem.aspx?name=1168959XSL_NEWSML_TO_NEWSML.xml

[SeriousMoney]

Merrill Lynch to Webcast Nektar Corporate Presentation
February 01, 2006 04:27 PM US Eastern Timezone
http://www.nektar.com/wt/page/investor_relations_

SAN CARLOS, Calif., Feb 01, 2006 (BUSINESS WIRE) -- Nektar Therapeutics (Nasdaq:NKTR) announced today that its corporate presentation will be webcast live from the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference, Wednesday, February 8, 2006 beginning at 9:20 a.m. Eastern Standard Time. The audio-only presentation may be accessed on Nektar's Investor Relations' page at http://www.nektar.com/wt/page/investor_relations_ and will be available within 24 hours following the live presentation until February 15, 2006.

Nektar Therapeutics develops and enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.

SOURCE: Nektar Therapeutics
http://www.nektar.com/wt/page/Press_Releases?rid=186281

[SeriousMoney]

Diabetics get some good news: FDA approves inhaled insulin
Pfizer and San Carlos company collaborate to produce powdered form of hormone
Justin Gillis, Washington Post
Saturday, January 28, 2006

Washington -- The Food and Drug Administration on Friday approved an inhaled form of insulin, the first new way to get that hormone into the body since it was discovered in 1921 -- and a new treatment option for many of the 21 million Americans with diabetes.

The approval fulfills an arduous scientific quest that spanned most of the 20th century and spilled over to the 21st. And it marks the biggest change in diabetes treatment in decades, one that doctors hope will lure a fair slice of the American population into their offices to talk about controlling blood sugar. The product poses long-term safety questions, though, and it's not clear whether it will be more expensive than standard insulin.

Millions of Americans need treatment with insulin but don't get it because it involves frequent, painful needle sticks and injections. About 5 million take the hormone, but a high proportion inject themselves too few times during the day because it's so inconvenient. Doctors hope inhaled insulin will overcome some of that resistance, helping diabetics ward off a slew of medical problems that afflict those who don't control their disease.

Studies show the new product, to be sold by Pfizer Inc. under the brand name Exubera, works and appears to be safe with short-term use. Patients who have used inhalers told researchers they prefer them to needles by a wide margin, according to studies sponsored by Pfizer.

"I'm just flabbergasted at the number of people who really do seem to want this, and want it substantially," said Jay Skyler, a University of Miami doctor and one of the nation's leading diabetes experts.

However, inhaled insulin causes minor declines in how much air the lungs can hold. Scientists consider that a signal that long-term use could pose risks, although that could take years to sort out. The FDA recommended that smokers and people with some types of lung disease, including asthma, avoid using the product. Exubera is approved only for people 18 or older, though studies in children are under way.

Pfizer said the product wouldn't be available in most pharmacies until June or July. Exact prices haven't been set, but Vanessa Aristide, a Pfizer spokeswoman, said the product would be "priced competitively" with injected insulin. Pfizer is first to market with such a product, but others are under development.

Pfizer's partner in the development of Exubera is a Bay Area biotechnology firm, Nektar Therapeutics of San Carlos. The technology to produce the inhalant, powdered form of insulin was the fruit of 20 years of research by scientists led by Nektar's co-founder, John Patton.

The team had to produce insulin particles small enough to be propelled by a hand-held inhaler and to penetrate deep into the lungs, where the drug could be absorbed into the bloodstream. The powdered drug also had to be stable at room temperature.

Nektar said it drew inspiration from engineering tactics used in food processing, the music industry, diesel carburetor design and scuba equipment manufacturing.

"Exubera would not have been possible without Nektar's innovative scientists and engineers and also our partner, Pfizer, who worked with us and remained committed to our original dream of delivering this medical breakthrough to patients," said Patton.

Friday's decision confronts millions of Americans -- diabetics make up 7 percent of the population -- with a complicated new strategic problem, requiring them to figure out how much long-range risk they're willing to incur for the convenience, and possibly greater disease control, of using inhaled insulin.

"The issue comes down to: How do we all deal with uncertainty?" said Robert Rizza, a diabetes specialist at the Mayo Clinic and president of the American Diabetes Association. "We just don't know what the long-run safety record will be. Each person will now need to think very carefully about the potential benefits and the risks for them."

The human body burns a simple sugar, glucose, in much the way a car burns gasoline. But the level of this essential fuel in the blood must be tightly controlled, because too much can wreck tiny blood vessels and cause other problems. The pancreas monitors glucose levels and releases insulin, a hormone that signals cells to absorb the sugar.

Diabetes is a pervasive group of diseases in which this fundamental life process has gone awry. Some people's bodies don't make insulin at all, and they must take it as a medicine or die. But the vast majority of diabetics have a milder form of the disease in which their bodies make too little insulin, resist its effects or both.

Diabetes can be controlled in both groups, but it isn't easy. Diet and exercise are important. Pills help some people, but many others need supplemental insulin, which cannot be given as a pill. They have to prick their fingers to test blood-sugar levels and inject themselves repeatedly throughout the day with insulin, or wear pager-sized insulin pumps that deliver the hormone through tiny needles.

The sheer tedium of the task gets diabetics down, and overall, they do poorly at it. A third of Americans with diabetes don't even know they have the disease, the government estimates, and many others fail to achieve adequate control of their blood sugar. The long-term result is a litany of severe medical problems: blindness, impotence, limb amputation, kidney failure, heart attack. The government pegs costs at more than $100 billion a year.

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/01/28/MNGAIGURAH1.DTL

[SeriousMoney]

Great homework, B!

Many diabetics will prefer inhalable delivery to needles. Ask your family, ask your friends, ask yourself... Oh, I see you already did!

And just like asthmatics, diabetics will carry their delivery system of choice like smokers their favorite cigs. I would expect that inhalable delivery systems will shrink with further development.

NKTR's EXUBERA is a bet on the looming diabetes epidemic as baby boomers enter their most susceptible years. Hey, we're already there!

AMLN's BYETTA is another but with needle injection delivery. http://www.investorshub.com/boards/read_msg.asp?message_id=9434496

Both should garner significant market share.

[bernoulli]

Good Morning, didn't know if you had seen this, interesting. Links below

http://www.nektar.com/wt/page/how_it_works_2 - > Photo of container like one would carry it in their purse, glovebox, briefcase, whatever.

http://www.nektar.com/wt/page/delivery_system_2 -> Photo of container in deliverable form.

http://www.nektar.com/wt/page/blister_pack_2 -> Photo of insulin in package which is inserted in container

http://www.nektar.com/media/inhale2.mpg -> movie of how to use delivery system

The latest naysayer from John Hopkins, is saying that the delivery system, is to bulky and people would not want to carry it around. They would prefer carrying the slim needles which are almost painless. The below is what a diabetic using needles needs to do including the equipment besides the needle they need to carry.


1. http://www.byetta.com/consumer/300_byetta_patient_information.jsp?reqNavId=3.1 -> Shows Byetta, click Byetta pen tutorial, then launch, then start, once finished with part 1, continue, to part 2, as though you needed to dose youself now, this is current best method movie instructions for type 2 diabetes hailed as best medical device of 2005. Notice, refrigeration required.

2. http://www.diabetesuffolk.com/Managing%20Diabetes/How%20to%20mix%20insulin%20in%20a%20syringe.asp ->( Type 1 or Type 2 if not using Byetta ) Preparing the dose, including mixing insulin in the container, needle disposal and the suggested container needed to dispose of needle.

3. http://www.diabetesuffolk.com/Managing%20Diabetes/Insulin%20needles.asp#_Toc55315063 -> General question and answer links for diabetics.

My opinion: I would choose Exubera any day over the above.

[SeriousMoney]

NEKTAR UPDATE - 1/27/06
ChangeWave Biotech Investor Alert

The FDA approved Nektar's (NKTR) inhalable insulin product Exubera after the close today and the approval was for both Type I and Type II diabetes in adults.

The product will be marketed by Pfizer (PFE). The press release on the FDA Web site indicated that Exubera would only require a typical FDA Medication Guide (i.e., instructions for use) and is not recommended for people with lung problems and lung diseases -- or for people who have quit smoking in the past six months.

I have taken a lot of flak about Exubera for several years. And there is still debate on Wall Street whether it will be a blockbuster drug. The debate is utter nonsense based on ChangeWave Alliance physician surveys and plain common sense. Would you rather inhale a medication or stick yourself with a needle?

I don't expect a big pop in the stock (mainly due to Wall Street's reaction), but given the power of the Pfizer's sales force you can expect serious sales results within six to nine months -- and good sales results will really put a fire under the stock.

[SeriousMoney]

Why the sell off on the news?

I believe it's only a buy-on-expectation (hardly a rumor, esp. after PFE CEO Hank McKinnell's gaff top of the morning), sell-on-the-news by speculators & momo players.

PFE recently bought Exubera world-wide rights for $1.3 billion. http://www.investorshub.com/boards/read_msg.asp?message_id=9243955

The analysts & talking heads should show up with their guessessments soon.

If this is a multi-billion dollar drug & NTKR is years ahead of the competition as they say, then NKTR goes much higher as Exubera hits the streets & lungs.

Toughest competitor Novo Nordisk is way behind on this one. http://www.investorshub.com/boards/read_msg.asp?message_id=9447409

[SeriousMoney]

Novo Nordisk Sales Climb
By Robert Steyer
TheStreet.com Staff Reporter
1/27/2006 3:18 PM EST

Novo Nordisk (NVO:NYSE ADR) , the world's biggest seller of insulin products, said Friday that it expects to resume late-stage clinical testing of its inhaled insulin device during the first quarter.

The Danish company's announcement comes one day after Pfizer (PFE:NYSE) and Nektar Therapeutics (NKTR:Nasdaq) received approval from the European Union for their inhaled insulin called Exubera. In addition, the Food and Drug Administration may rule today on Exubera.

Novo Nordisk's development of inhaled insulin has proceeded in fits and starts, punctuated with some setbacks. Even if the company's late-stage clinical research and regulatory efforts go smoothly in the future, analysts say a product probably wouldn't reach the market until the end of the decade. Novo Nordisk is using inhalation technology licensed from the U.S. company Aradigm (ARDMD:Nasdaq).

Novo Nordisk said improvements on its AERx inhaled insulin project are "almost completed," and that the company "expects to confirm" resumption of clinical trials during the first quarter. "This confirmation will be partly subject to FDA's acceptance of final specifications for the AERx system," the company said.

The announcement accompanied the release of full-year earnings. For the year ended Dec. 31, the company earned $978 million, or $2.97 a share. Net earnings rose 17% and earnings per share rose 20% vs. 2004.

Total sales rose 16% to $5.63 billion in 2005. Sales of diabetes-care products, which account for nearly three-fourths of corporate revenue, rose 17% to $4 billion.

"Novo Nordisk insulin now constitutes more than half of the insulin sold globally, and we expect the strong demand for our strategic products to continue in 2006 despite increased competition," said Lars Rebien Sorensen, president and CEO. In early afternoon trading, Novo Nordisk's stock was down 90 cents, or 1.6%, to $55.84.

http://www.thestreet.com/_yahoo/stocks/biotech/10264822.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite...

[SeriousMoney]

Talk about the power of suggestion... or me-too-ism!

[SeriousMoney]

Took slugs of MAR 22.5 & MAY 25.

[bernoulli]

Looks like I am a day late and a dollar short here. However, still a great long at this point. March 20 and Jan 20 calls look good to me.

[SeriousMoney]

Gonna be a big pop tomorrow a.m. FDA approval expected FRI! http://finance.yahoo.com/q?s=NKTR

http://www.investorshub.com/boards/read_msg.asp?message_id=9434176

[SeriousMoney]

Insulin Firms Waiting to Inhale
By Robert Steyer
TheStreet.com Staff Reporter
1/25/2006 7:14 AM EST

Investors should prepare for a chain reaction among several pharmaceutical stocks if the Food and Drug Administration delivers its verdict on the first inhaled insulin in a few days.

Pfizer (PFE:NYSE) and its partner Nektar Therapeutics (NKTR:NKTR) will benefit the most if the agency approves their drug Exubera.

But analysts also suggest that the stocks of many competitors could rise or fall on the decision, which is expected Jan. 27.

"Expected Exubera approval lifts all ships," says Andrew Forman of WR Hambrecht & Co. in a recent research report. "We believe that an approval for Exubera would be positive for all developers of pulmonary insulin ... in confirming [that] a path to market exists." Forman predicts the U.S. inhaled insulin market could reach $3.6 billion in sales by the end of the decade.

Big companies such as Eli Lilly (LLY:NYSE) and Denmark's Novo Nordisk (NVO:NYSE) will be watching closely.

So will smaller companies, including Alkermes (ALKS:Nasdaq) which is Lilly's partner, MannKind (MNKD:Nasdaq) , a solo act so far, and Kos Pharmaceuticals (KOSP:Nasdaq) , a company that's developing inhaled insulin on its own.

Although Pfizer recently bought out one inhaled-insulin partner, Sanofi-Aventis (SNY:NYSE ADR) , for $1.3 billion, some analysts suggest that the French drugmaker could get back in the game by making a deal with an unattached player.

Dual Use

Pfizer, Nektar and the other companies say inhaled insulin could improve patient compliance vs. injectable insulin. Assuming the FDA approves Exubera, Wall Street will be looking at several key issues: How many patients will switch to inhaled insulin? How quickly will they switch? What restrictions or warnings will the FDA impose on Exubera, especially in regard to potential lung problems? And how much will Pfizer and Nektar charge?

In September, an FDA advisory panel voted 7-2 to support Exubera as a treatment for type 1 and type 2 diabetes.

The following month, a medical advisory panel to the European Union's drug regulatory agency endorsed Exubera for both types of diabetes. Type 1 diabetes is caused by the body's inability to produce insulin, the protein hormone that helps turn sugar into fuel for the body's cells. Type 2 diabetes is caused by cells ignoring insulin or the body's failure to produce enough insulin.

However, it's never safe to make an assumption with regulators -- especially the FDA, and especially with a new class of a drug or device. The FDA was supposed to rule on Exubera in late October, but the agency asked for a 90-day extension.

Considerable Competition

Pfizer and Nektar have about a two-year lead over their competitors in the regulatory process, but analysts still believe that the inhaled insulin market could accommodate several players. Investors looking beyond Exubera should pay attention to upcoming announcements from several companies.

For example, Lilly, whose AIR insulin is considered in second place, will issue fourth-quarter earnings Jan. 26 and may discuss its product's progress. Lilly initiated a 24-month phase III clinical trial in July and a 12-month clinical trial in August. Phase III testing is the final clinical trial before a company seeks regulatory approval. Forman says the Lilly-Alkermes product appears on track for a 2009 launch.

Novo Nordisk, the world's leading seller of insulin, issues its fourth-quarter earnings report on Jan. 27. The company hasn't commented on whether it will take its AERx product to the final clinical trial stage.

"We expect the company to confirm that AERx is expected to move to phase III shortly," says Sachin Jain, of Merrill Lynch, in a Jan. 23 research report. Jain is neutral on the stock.

Moving ahead with the most time-consuming and expensive clinical trials isn't a slam-dunk. Novo Nordisk, which uses inhaler technology developed by Aradigm (ARDMD:Nasdaq) , employs a liquid form of insulin rather than the powdered form featured in most inhaled products.

Early clinical trials experienced some setbacks, and Aradigm's inhaler is considered cumbersome by some experts.

"Given the size of this device, we do not feel AERx will be a popular product," says Sagient Research Systems, a San Diego-based firm that analyzes biotechnology products.
International Ties

William Tanner of Leerink Swann recently told clients that Novo Nordisk "has significantly cut back development activities" on AERx, thus making the company "potentially interested" in MannKind's product called Technosphere Insulin. He says Sanofi-Aventis, as well as Japan's Sankyo or Takeda might be interested in making deal with MannKind, whose Technosphere appears "superior to other inhaled insulin formulations." Tanner has an outperform rating on MannKind.

Lack of a partner is one reason why some analysts have offered downbeat reviews of MannKind. The company did though deliver good news to investors Jan. 17, announcing favorable results for a phase II clinical trial. MannKind's product reduced blood sugar, didn't cause lung problems and didn't cause weight gain over 12 weeks of study. Two investment banks raised their ratings, and several others became more optimistic.

If Technosphere can repeat these results in future tests, it could become "best-in-class," says Thomas Wei, of Piper Jaffray, who elevated MannKind to outperform from market perform.

Wei says MannKind's stock will be helped by FDA approval of Exubera, favorable phase III results and a partnership agreement. Phase III results are due to be reported by midyear. So far, MannKind hasn't expressed an interest in a partner.

WR Hambrecht's Forman recently raised his rating on MannKind to hold from sell, echoing many of Wei's comments. Forman predicts that Kos Pharmaceuticals will seek a partner for its inhaled insulin product, which is still in phase II testing. Sagient Research says the Kos product differs from competitors because it features a canister that holds many insulin doses.

"Based on the characteristics of the device, this should be a popular product, but as a late entrant, we feel this product will lag slightly behind AIR Insulin and Technosphere," the research firm says.

http://www.thestreet.com/_yahoo/stocks/biotech/10263803.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite...

[SeriousMoney]

Inhaled Insulin Cleared in Europe
By Robert Steyer
TheStreet.com Staff Reporter
1/26/2006 7:08 PM EST

The European Union has given its approval to Exubera, an inhaled form of insulin developed by Nektar Therapeutics (NKTR:Nasdaq) and Pfizer (PFE:NYSE) .

The EU decision on Thursday came down just before the Food and Drug Administration is expected to make its own determination on Exubera's future in the U.S. Exubera, the first inhaled insulin approved for sale, will improve compliance among diabetics who now inject insulin to control blood sugar, the product's manufacturers say.

Shares of Nektar climbed $1.32, or 6.8%, to $20.62. Pfizer gained 22 cents, or 0.9%, to $25.05.

"Today's EU approval of Exubera is an important landmark in the treatment of diabetes, a disease that is growing at epidemic proportions," Dr. John Patton, co-founder and chief scientific officer of Nektar, said in a prepared statement.

Nektar developed the inhalation technology to administer a dry-powder form of insulin. Pfizer and Sanofi-Aventis (SNY:NYSE ADR) joined in the development and marketing partnership for Exubera, but Pfizer recently bought the French company's interest in the product for $1.3 billion.

Pfizer says it has invested more than $1 billion in the development of Exubera, including plants in Germany and Indiana. The European Union approved Exubera for both type 1 and type 2 forms of diabetes. Type 1 diabetes is caused by the body's inability to produce insulin, the protein hormone that helps turn sugar into fuel for the body's cells. Type 2 diabetes is caused by cells ignoring insulin or the body's failure to produce enough insulin.

The EU cleared the drug for treating people over age 18 whose type 2 diabetes isn't adequately controlled with other medications and who require insulin. Exubera also is approved for adults with type I diabetes, "in addition to long- or intermediate-acting injectable insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns," Pfizer says.

The concerns relate to the possibility of lung problems. "A small decrease in lung function may occur during Exubera treatment although symptoms might not be noticeable," Pfizer says. "This change occurs within the first months of treatment and should not worsen as treatment is continued."

Pfizer says patients should not take Exubera if they have "poorly controlled or unstable lung disease," if they smoke, or if they stopped smoking less than six months before taking the drug.

Before starting Exubera, patients must undergo a lung-function test. "This will help to find out if Exubera is the right treatment for individual patients," Pfizer says. Once a patient starts Exubera, Pfizer says a physician should recheck the patient's lung function after six months.

The safety requirements are "in line with our expectations," and there were "no unexpected surprises," says Andrew Forman of WR Hambrecht in a research note Thursday.

Forman says the news "bodes well for a formal FDA final approval." He doesn't follow Pfizer, but he has a buy rating on Nektar. " [The] label appears broad and positive." He doesn't own shares of the companies.

http://www.thestreet.com/_yahoo/stocks/biotech/10264548.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite...

[SeriousMoney]

Nektar Up on Pfizer Exubera Buyout
AP, Friday January 13, 2:05 pm ET
Nektar Shares Rise As Pfizer Buys Out World Rights to Exubera From Sanofi Aventis http://finance.yahoo.com/q/bc?s=NKTR&t=5d&l=off&z=m&q=l&c=

NEW YORK (AP) -- Shares of drug-delivery technology company Nektar Therapeutics jumped Friday after drug maker Pfizer Inc. said it would pay Sanofi Aventis SA $1.3 billion for global rights to the inhalable insulin the three companies developed.

Nektar shares rose $1.78, or 9.8 percent, to $19.89 in afternoon trading on the Nasdaq at more than seven times their average volume. Shares have traded between $13.32 and $21.52 over the past 52 weeks.

In a research note, investment firm Morgan Stanley said Pfizer's move shows that it is optimistic about the Food and Drug Administration's Jan. 27 decision due date for the product. The firm said the deal will not affect Nektar's 15 percent royalty from sales, but that the deal reflect Pfizer's commitment to the product.

The original due date for an FDA decision was Oct. 27, but the agency said it needed more time to review additional technical chemistry data on Exubera. In September, an FDA advisory panel recommended approval of the dry powder form of insulin that is inhaled rather than injected, but expressed safety concerns about some patients who experienced reduced lung function and coughing. Pfizer has promised to continue studying the drug's safety following approval.

Deutsche Bank agreed the action shows that Pfizer sees Exubera as a major driver for future growth, and expects positive near-term regulatory decisions in the United States and Europe.

The agreement settles legal action started by Pfizer in 2004 with the formation of Sanofi Aventis. Pfizer had originally been working on the product with Aventis, and Pfizer alleged that the merger had resulted in a change of control that violated the original contract.

Shares of Pfizer fell 5 cents to $24.53, and American depositary shares of Sanofi Aventis fell 3 cents to $46.93 on the New York Stock Exchange.

http://biz.yahoo.com/ap/060113/nektar_mover.html?.v=1

[SeriousMoney]

Pfizer to Buy Inhaled-Insulin Rights
Drug Maker Agrees to Pay Partner Sanofi $1.3 Billion To Gain Control of Exubera
By SCOTT HENSLEY, Staff Reporter of THE WALL STREET JOURNAL, January 13, 2006

Pfizer Inc. has agreed to pay $1.3 billion to Sanofi-Aventis SA for the world-wide rights to Exubera, an inhaled form of insulin the companies had previously planned to develop and market together.

The pact hands Pfizer of New York control of a drug that could be a hit, following a dispute with its French partner.

The Food and Drug Administration is expected to decide within weeks whether Pfizer can begin selling Exubera. In September, a panel of advisers to the FDA recommended the agency approve the drug. Sales forecasts for Exubera, which would be the first form of insulin taken without piercing the skin, vary because its main virtue is convenience. Some analysts expect the drug to be a modest seller while others project it could reap a billion dollars annually within a few years.

The agreement, announced last night, settles the commercial status of the experimental drug in the wake of Sanofi Synthelabo SA's acquisition of Aventis SA in 2004, creating Sanofi-Aventis.

Pfizer had teamed with Aventis to develop Exubera, and asserted that the merger triggered a change-of-control clause in their contract that opened the door to renegotiation of the agreement. Sanofi disputed that interpretation. Pfizer pursued the matter in U.S. and German courts, leading to the new deal reached yesterday, a company spokesman said.

Besides world-wide development and marketing rights, Pfizer will gain control of the manufacturing facilities for Exubera in Frankfurt that it previously owned jointly with Sanofi. Pfizer expects the deal to close by the end of February.

The new arrangement doesn't affect Nektar Therapeutics, Pfizer's other partner in the development. Nektar, San Carlos, Calif., remains entitled to royalties based on net sales of Exubera. Nektar provided technology to produce powdered insulin that could be inhaled.

The FDA review of Exubera has been delayed for years over concerns that the drug could hurt breathing capacity with long-term use. Pfizer and its partners studied Exubera in more than 3,500 patients, some who took it for as long as seven years. The declines in lung function appeared to be small and were reversible when patients stopped using the drug, according to data presented by Pfizer to the FDA advisory panel in September. If Exubera is approved, Pfizer pledged to study it further.

http://online.wsj.com/article/SB113711425479245490.html?mod=yahoo_hs&ru=yahoo

[SeriousMoney]

Toby on NKTR 12/1/005

NEKTAR (NKTR): This is essentially an inhalable insulin company and final FDA approval for Exubera, its product (marketed by Pfizer), is on the very near-term horizon.

* Recent Trends: Trading is all over the place and there is no clear trend in the stock.

* Upside Catalysts: An FDA approval is being taken more and more for granted, and may even prompt a sell-off in the stock, which happened when Amylin's Byetta was approved by the FDA. Assuming Exubera is available for sale for at least three months in the first half of 2006, that preliminary sales data will drive the stock.

* Downside Catalysts: An FDA rejection would be a total disaster. Should the FDA give a qualified approval with a narrow label (this would restrict the marketing of the product) that will hurt the stock and create a buying opportunity, because ChangeWave Alliance surveys show the product will be sell very well even with narrow FDA approval.

http://www.changewave.com/biotech/

[SeriousMoney]

Nektar Announces Third Quarter 2005 Financial Results
PR, Thursday November 3, 4:10 pm ET

SAN CARLOS, Calif.--(BUSINESS WIRE)--Nov. 3, 2005--Nektar Therapeutics (Nasdaq:NKTR - News):

Exubera® receives positive recommendations in Europe and US; FDA extends review period by 3 months;

Two proprietary products in clinic address unmet need for prevention of lung infections;

New high-value Baxter agreement to develop PEGylated therapeutic forms of blood clotting proteins;

Chiron and Nektar advance TIP to Phase III;

Aerogen acquisition broadens Nektar pulmonary leadership;

Company strengthens balance sheet.

Nektar Therapeutics (Nasdaq:NKTR - News) announced today its financial results for the third quarter ended September 30, 2005.

The Company reported total revenue of $36.4 million for the three months ended September 30, 2005 compared to $28.5 million for the three months ended September 30, 2004. In the third quarter of 2005, product and royalty revenue was $8.5 million compared to $5.0 million in the third quarter of 2004, and contract revenue totaled $23.7 million compared to $23.6 million in the third quarter of 2004. Nektar also reported that in the third quarter of 2005 the Company received $4.2 million from Pfizer for Exubera® (inhaled insulin) commercialization readiness for reimbursement of certain agreed upon operating costs related to the Exubera drug powder manufacturing facility in preparation for commercial production.

Nektar reported a net loss of $23.8 million or $(0.28) per share for the three months ended September 30, 2005 compared to a net loss of $20.5 million or $(0.24) per share for the three months ended September 30, 2004.

For the nine months ended September 30, 2005, Nektar reported total revenue of $93.4 million compared to $82.9 million for the nine months ended September 30, 2004. For the nine months ended September 30, 2005, product and royalty revenue was $20.3 million compared to $15.7 million for the nine months ended September 30, 2004, and contract research revenue totaled $62.7 million compared to $67.2 million for the nine months ended September 30, 2004. Exubera commercialization readiness totaled $10.3 million for the first nine months of 2005.

For the nine months ended September 30, 2005, Nektar reported a net loss of $76.9 million or $(0.90) per share compared to a net loss for the nine months ended September 30, 2004 of $82.6 million or $(1.08) per share.

As of September 30, 2005, the Company reported cash, cash equivalents and short-term investments of approximately $620.3 million compared to $378.5 million as of June 30, 2005. The cash, cash equivalents and short-term investments include the net proceeds from the sale of $315 million aggregate principal amount of its 3.25% convertible subordinated notes due 2012.

Substantial Progress Made

"This quarter Nektar achieved multiple milestones, including the recommendations for Exubera approval, announcement of two proprietary products, and new partner activities," said Ajit S. Gill, president and chief executive officer.

Exubera Approval Recommended in the EU and US; FDA Extends Review Period 3 Months

"The recommendations of the approval of Exubera in the US and the EU are significant milestones. The next steps for Exubera are final approvals from both regulatory agencies," said Gill.

On September 8, 2005, a US Food and Drug Administration (FDA) advisory committee panel recommended the approval of Exubera (insulin (rDNA origin) powder for oral inhalation), an inhaleable, rapid-acting powder insulin for the treatment of adults with type 1 and type 2 diabetes. While the FDA usually follows the advice of its advisory committees, it is not obligated to do so.

On October 13, 2005, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) issued a positive opinion recommending approval of Exubera. The European Commission is expected to act upon that recommendation early next year.

On October 28, 2005, the FDA notified Pfizer and sanofi-aventis that it is extending its original review period for Exubera by three months.

Nektar pioneered the advanced pulmonary technology for Exubera, including the inhaler, the formulation for the powdered insulin, and the manufacturing processes for making and packaging the powdered insulin.

Nektar Proprietary Products Target Local Lung Infections in Seriously Ill Patients; Aerogen Acquisition Broadens Pulmonary Leadership

"Nektar announced two proprietary products that highlight how our technology and expertise can generate unique product opportunities for Nektar that will enable us to build a high-value pipeline. These new products could help reduce mortality rates from fungal and bacterial lung infections while reducing the costs of patient treatment. Because they focus on improving existing medicines, they offer a lower risk profile with potential excellent returns-on-investment compared with typical new drug development programs," said Gill.

On September 29, 2005 at its Investor Day in New York, Nektar disclosed two anti-infective products targeted at preventing local lung infections in seriously ill patients.

Inhaled amphotericin B product is being developed for preventing fatal pulmonary fungal infections in immunosuppressed patients to reduce the incidence, morbidity, mortality and high cost of treating these infections. Using a small proprietary pocket size inhaler, the company has conducted two Phase I trials and has long-term toxicity studies underway to support the planned pivotal trials. More than 150,000 patients annually in the US and Europe are at risk of developing often fatal and costly fungal infections in the lungs. Nektar's inhaleable amphotericin B potentially could be the first prophylactic therapy to prevent these serious infections.

Inhaled ICU antibiotics product is being developed for the prevention of ventilator-associated pneumonia (VAP) in the intensive care unit (ICU). VAP is a form of hospital-acquired, or nosocomial pneumonia, occurring in patients on mechanical ventilators. Nektar's novel drug-device system uses a nebulizer and Nektar proprietary adapter technology, along with a unique formulation of liquid antibiotics, to target the lungs directly with preventative doses of medicine in a ventilated patient. More than 450,000 patients in the US are at the highest risk for this disease. A proof-of-principle study sponsored by Nektar demonstrated that aerosolized antibiotics reduce the persistence of VAP after its onset by approximately half as compared to placebo.
The acquisition of Aerogen, Inc., which closed on October 20, 2005, will broaden Nektar's pulmonary technology base by adding capabilities in aerosolized liquid drugs to Nektar's leadership position with inhaleable powdered drugs. Initially, Nektar will incorporate Aerogen technology into its proprietary inhaled ICU antibiotics product.

Partner Pipeline Progress: New Collaboration with Baxter; Advances in the Clinic

"We also saw progress in our partner pipeline. The new collaboration with Baxter exemplifies the higher value Nektar can gain through investment in early product concept work," said Gill. "The initiation of Phase III trials of tobramycin inhalation powder (TIP) by Chiron is an indication that our unique powder formulation and advanced inhaleable technologies may enable innovative therapeutics, such as TIP, to target local lung infections."

On September 29, 2005, Nektar announced an agreement with subsidiaries of Baxter International Inc. to develop PEGylated therapeutic forms of blood clotting proteins for patients with hemophilia, in order to reduce the frequency of injections required to treat blood clotting disorders such as hemophilia A. This agreement allows Nektar to capitalize on the internal work on PEGylated proteins to provide Baxter with a differentiated product.

On October 5, 2005, Chiron Corporation and Nektar announced the initiation of clinical testing in the Phase III program evaluating tobramycin inhalation powder (TIP), an investigational inhaled antibiotic. The TIP Phase III program includes two clinical trials and will evaluate the efficacy and safety of TIP in the treatment of lung infections caused by Pseudomonas aeruginosa in patients living with cystic fibrosis (CF). The first trial, called ASPIRE I, is underway.
Conference Call Information

Ajit S. Gill will host a conference call for analysts and investors today beginning at 2:00 p.m. Pacific Time, to discuss further the Company's performance.

Investors can access a live audio-only webcast through a link that is posted on the Investor Relations section of Nektar's website at http://www.nektar.com. The web broadcast of the conference call will be available for replay through November 17, 2005.

Analysts and investors can also access the conference call live via telephone by dialing [phone] (U.S.); [phone] (international). The passcode is 13029999 and the host is Mr. Ajit Gill. An audio replay will be available shortly following the call through November 17, 2005 and can be accessed by dialing [phone] (U.S.); or [phone] (International) with a passcode of 13029999. In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, 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.

About Nektar

Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.

This release contains forward-looking information about a product candidate which is under review by the United States Food and Drug Administration and the European Medicines Evaluation Agency that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when such regulatory authorities will approve the product candidate, their decisions regarding labeling and other matters that could affect its commercial potential as well as competitive developments.

http://biz.yahoo.com/bw/051103/35771.html?.v=1

[SeriousMoney]

Nektar Reports on Pfizer and Sanofi-Aventis Statement on Status of Exubera
PR, Friday October 28, 12:41 pm ET

SAN CARLOS, Calif.--(BUSINESS WIRE)--Oct. 28, 2005--Nektar Therapeutics (Nasdaq:NKTR - News) reported today that Pfizer and sanofi-aventis, a member of the sanofi-aventis Group, said today that the U.S. Food and Drug Administration has notified the companies that it is extending its original review period for Exubera® (insulin (rDNA origin) powder for oral inhalation) by three months to review additional technical chemistry data submitted by the companies.

In September, an FDA Advisory Committee recommended approval of Exubera for the treatment of adults with type 1 and type 2 diabetes. FDA is not obligated to follow the Advisory Committee's recommendation, but usually does so. Pfizer and sanofi-aventis continue to work closely with the FDA so that this important medicine can be made available for patients.

About Nektar

Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.

http://biz.yahoo.com/bw/051028/285399.html?.v=1

[SeriousMoney]

Nektar Announces Closing of Aerogen Acquisition
<PR, 10/20/05>

SAN CARLOS, Calif.--(BUSINESS WIRE)--Oct. 20, 2005--Nektar Therapeutics (Nasdaq:NKTR - News) announced today that it has closed the acquisition of Aerogen, Inc. (OTCBB:AEGN - News) under the definitive merger agreement announced on August 15, 2005. Aerogen stockholders approved the acquisition during a special meeting held October 19, 2005.

The acquisition will broaden Nektar's pulmonary technology base by adding capabilities in aerosolized liquid drugs to Nektar's leadership position with inhaleable powdered drugs. Initially, Nektar will incorporate Aerogen technology into its proprietary inhaled ICU antibiotics product, which is in clinical trials for the prevention of pneumonia in mechanically-ventilated patients. Nektar's inhaled ICU antibiotics program is designed to lower morbidity and mortality in ventilated patients and reduce the cost of care. The addition of Aerogen's technologies, people, products, and intellectual property, including a patent portfolio of more than 35 patents, will strengthen Nektar's pulmonary leadership position.

"We welcome and look forward to supporting Aerogen customers and to working with the Aerogen team to advance important therapies for intensive-care unit (ICU) patients," said Ajit S. Gill, Nektar president and CEO.

Aerogen products are based on its OnQ® Aerosol Generator technology to improve the treatment of respiratory disorders in the acute care setting. Aerogen has commercialized its Aeroneb® Micropump Nebulizer products for hospital, home and pre-clinical use through a network of world-class respiratory distribution partners that includes Puritan-Bennett, Respironics, Maquet, Cardinal Health, Evo Medical Solutions, and Drager Medical. The Aeroneb Professional Nebulizer is currently used in hospitals in more than 30 countries. Aerogen also has development collaborations with pharmaceutical and biotechnology companies for use of its technology in the delivery of novel compounds that treat respiratory and other disorders. In 2004, Aerogen reported revenue of $6.2 million and net loss of $10.1 million.

Former Aerogen stockholders who have questions about exchanging their shares of Aerogen capital stock for their portion of the merger consideration are advised to contact Mellon Investor Services LLC, the exchange agent for the merger, at [phone] (U.S.) toll free; or [phone] (outside the U.S.) collect.

About Nektar

Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance. For more information, visit www.nektar.com.

http://biz.yahoo.com/bw/051020/205923.html?.v=1

[SeriousMoney]

Nektar Shares Jump on EU Panel Recommendation for Exubera Inhalable Insulin
<AP, 10/13/05>

NEW YORK (AP) -- Drug maker Pfizer Inc. and drug delivery system developer Nektar Therapeutics said Thursday a European advisory panel recommended that regulators approve Exubera inhalable insulin on the heels of a similar recommendation made by U.S. counterparts a month ago.

Shares of Nektar, which helped develop Exubera with Pfizer and Sanofi Aventis SA, rose $1, or 6.7 percent, to $16.00, in afternoon trading on the Nasdaq. Shares hit a 52-week high of $21.52 in September after the U.S. panel meeting, after climbing from a 52-week low of $13.32 in March, and are down 21 percent so far this year.

The treatment is intended in Europe for Type 2 diabetics whose disease is not treated well enough with antidiabetic agents and who require insulin therapy, or for Type 1 diabetics in addition to their long-acting or immediate-acting insulin.

In September, a U.S. Food and Drug Administration advisory panel recommended 7-2 that the agency approve the product, but expressed concern about users' decreased lung capacity, which the companies promised to study.

Pfizer shares fell 33 cents to $24.51 and American depositary shares of Sanofi Aventis slipped 7 cents to $40.83 on the New York Stock Exchange.

http://biz.yahoo.com/ap/051013/nektar_mover.html?.v=1

[SeriousMoney]

Nektar Therapeutics Reports Exubera(R) Receives Positive Opinion from CHMP for the Treatment of Type 1 and Type 2 Diabetes
<PR, 10/13/05>

SAN CARLOS, Calif.--(BUSINESS WIRE)--Oct. 13, 2005--Nektar Therapeutics (Nasdaq:NKTR - News) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of Exubera® (insulin human), an inhaleable form of insulin for the treatment of type 1 and type 2 diabetes.

The proposed therapeutic indication for Exubera is for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy; and for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

Exubera, the product of a joint-development program between sanofi-aventis and Pfizer, is an inhaled rapid-acting insulin preparation that is inhaled into the lungs prior to each meal, using a proprietary inhalation device and powdered insulin formulation developed by Nektar Therapeutics. Exubera closely mimics the normal physiological insulin response to meals by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels in people with diabetes.

In Europe, approximately 22.5 million people suffer from diabetes. Type 2 diabetes accounts for 85 percent to 95 percent of all diagnosed cases. Although insulin is a very important treatment for diabetes, healthcare providers and patients are often reluctant to initiate or intensify insulin treatment. The reasons for this include concerns about lifestyle changes, compliance, disease progression and injection-related factors.

Complications commonly associated with uncontrolled or poorly controlled diabetes include cardiovascular disease, kidney failure and blindness. A large study in eight major European countries has shown that the total direct medical costs for type 2 diabetes are estimated to be (euro) EUR 29 billion each year, of which hospitalizations account for (euro) EUR 15.9 billion.

Pending approval of the European Commission, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in Europe since the discovery of insulin in the 1920s.

About Nektar Advanced Pulmonary Delivery Technology

Nektar Advanced Pulmonary Technology uses a portfolio of innovative formulations and novel delivery devices to improve or enable administration of medicines to and through the lungs for both lung diseases and systemic conditions. Exubera is the most advanced product using Nektar Pulmonary Technology.

Recently Nektar announced that it is developing two inhaleable products that use its Advanced Pulmonary Delivery Technology, including: an inhaled amphotericin B product for preventing fatal pulmonary fungal infections in immunosuppressed patients to reduce the incidence, morbidity, mortality and high cost of treating these infections; and inhaled ICU antibiotics for the prevention of ventilator-associated pneumonia (VAP) in the intensive care unit (ICU). Both are in clinical trials.

In addition, Nektar is partnered with Chiron to develop Tobramycin inhalation powder (TIP), a next-generation inhaled antibiotic in Phase III trials to treat lung infection in cystic fibrosis patients.

About Nektar

Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.

The information contained in this release is as of 13 October 2005. Nektar assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about a product candidate which is under review by the United States Food and Drug Administration and the European Medicines Evaluation Agency that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when such regulatory authorities will approve the product candidate, their decisions regarding labeling and other matters that could affect its commercial potential as well as competitive developments.

This release contains forward-looking statements that reflect management's current views as to Nektar's business strategy, product and technology development plans and funding collaborative arrangements, clinical trials, developments in connection with the regulatory approval process for Exubera. These forward-looking statements involve uncertainties and other risks that are detailed in Nektar's reports and other filings with the SEC, including its Annual Report on Form 10-K, as amended, for the year ended December 2004 and its Quarterly Report on 10-Q for the quarter ended June 30, 2005. Actual results could differ materially from these forward-looking statements.

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