Replies to post #18 on Nektar Therapeutics (NKTR)

[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.

[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]

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]

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