News***News***Nabi Biopharm... - 500 Beiträge pro Seite

[cbeck]

Nabi Biopharmaceuticals Signs Definitive Agreement to Sell PhosLo(R) to Fresenius Medical Care

2006-10-12 01:00 ET - News Release

BOCA RATON, Fla., Oct. 12 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals announced today that it has signed a definitive agreement to sell PhosLo(R) (calcium acetate) and the product's related assets to a US subsidiary of Fresenius Medical Care ("Fresenius") for consideration of up to $150 million in up front cash, milestone payments, and royalties on sales of a new product formulation under development.

Under the terms of the agreement, Fresenius will pay Nabi Biopharmaceuticals $65 million in cash at closing, and an additional $20 million upon the successful completion of certain milestones. Fresenius is also acquiring rights to a new product formulation currently under development, which Nabi expects will be submitted for licensure in the US during 2007. Following the successful launch of this new product formulation, Fresenius has agreed to pay Nabi Biopharmaceuticals royalties on incremental sales of the new product formulation for 10 years after the closing date until total consideration paid in the transaction reaches $150 million. In connection with the sale, Fresenius will assume the prosecution of the Roxane patent litigation initiated by Nabi. In addition, a number of Nabi Biopharmaceuticals' sales and marketing staff will move with PhosLo to Fresenius' team to continue to promote and market the product. Nabi Biopharmaceuticals will maintain an appropriately-sized sales force to meet the sales needs of the company's other products. Following the transaction, Nabi Biopharmaceuticals expects to realize a significant reduction in its selling, general and administrative expenses.

Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "PhosLo, while a valuable product, was no longer strategically aligned with our broader commercialization efforts. The PhosLo sale strengthens our financial position and will help reduce our selling, general and administrative expenses. Although the PhosLo transaction was initiated well before our recent announcement regarding the exploration of strategic alternatives, it demonstrates our commitment to evaluate and ability to pursue strategic transactions that we believe will enhance shareholder value. We will continue to focus on our core competencies and our most promising assets, including our nicotine addiction, organ transplant and Gram- positive infections programs, each of which represents a substantial commercial opportunity targeting unmet medical needs. Under the agreement with Fresenius, dialysis patients suffering from hyperphosphatemia will continue to have access to PhosLo and its demonstrated clinical benefits and we are committed to delivering a quick and seamless transition of the product to Fresenius."

The transaction is subject to customary closing and regulatory conditions including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and is expected to be completed within the next thirty days. Nabi Biopharmaceuticals' Board of Directors received an opinion, subject to various assumptions and limitations described therein, from Banc of America Securities LLC as to the fairness, from a financial point of view, of the consideration to be received by Nabi Biopharmaceuticals in the sale.

About PhosLo(R)

PhosLo(R) is administered orally, and when given with food, it combines with dietary phosphate to form insoluble calcium phosphate complexes that are eliminated from the body, thereby reducing phosphorus absorption, helping to prevent excess blood phosphorus levels. Patients should have serum calcium levels closely monitored and their dose of PhosLo adjusted or terminated to bring levels to normal. PhosLo is contraindicated in patients with hypercalcemia. No other calcium supplements should be given concurrently with PhosLo. PhosLo is well tolerated. Nausea, hypercalcemia, and pruritus (itching) have occasionally been reported during PhosLo therapy.

About Nabi Biopharmaceuticals

Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in our core business areas: Hepatitis and transplant, Gram-positive bacterial infections and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php." target="_blank" rel="nofollow ugc noopener">http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit our website: http://www.nabi.com.

Forward-Looking Statements

Statements in this press release about the company that are not strictly historical are forward-looking statements and include statements related to our plans to explore strategic alternatives and prospects. You can identify these forward-looking statements because they involve our expectations, beliefs, intentions, plans, projections, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to the company's ability to advance the development of products currently in the pipeline or in clinical trials; maintain the human and financial resources to commercialize current products and bring to market products in development; obtain regulatory approval for its products in the U.S., Europe or other markets; successfully develop, manufacture and market its products; successfully partner with other companies; realize future sales growth for its biopharmaceutical products; maintain sufficient intellectual property protection or positions; raise additional capital on acceptable terms; re-pay its outstanding convertible senior notes when due; and identify and complete transactions that represent strategic alternatives and opportunities. Many of these factors are more fully discussed, as are other factors, in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly Report on Form 10-Q for the Quarter ended July 1, 2006 filed with the Securities and Exchange Commission.

About the Conference Call

The live webcast can be accessed at: http://phx.corporate- ir.net/phoenix.zhtml?p=irol-eventDetails&c=100445&eventID=1401182 or via the Nabi Biopharmaceuticals website at http://www.nabi.com. If you do not have Internet access, the U.S./Canada call-in number is 866.202.4367 conference code 38407817, and the international call-in number is 617.213.8845 conference code 38407817. An audio replay will be available for U.S./Canada callers at 888-286-8010 conference code 34840919, and for international callers at 617- 801-6888 conference code 34840919.

An archived version of the webcast will be available at the same Internet address through October 19, 2006. The audio replay will also be available through October 19, 2006. The press release will be available on the company's website at http://www.nabi.com.

Nabi Biopharmaceuticals

CONTACT: Thomas E. Rathjen, Vice President, Investor Relations, of Nabi
Biopharmaceuticals, [phone]

Web site: http://www.nabi.com/
http://www.nabi.com/pipeline/index.php/

[GarfieldTrade]

Ich versuche zu kaufen!!


CBECK hat immer die besten Tips, die sind hammer.

Ich denke es heisst, kaufen was das Konto hergibt.

[Penny.Z]

Antwort auf Beitrag Nr.: 24.572.638 von GarfieldTrade am 12.10.06 09:25:25

Man so ein Honig Schmierer findet man selten.

Hast bestimmt auch viele Strohhalme und massenweise Puderzucker zur Hand.

Kopfschüttel!!!

[GarfieldTrade]

DU kannst es Dir nicht leisten CBECK zu verpassen

Ich habe echten Puderzucker! Und die Meldung und Tradingidee ist GUT!

[Penny.Z]

Antwort auf Beitrag Nr.: 24.572.888 von GarfieldTrade am 12.10.06 09:38:05

So dann vergess das Kaufen nicht. Ich sehe nur 500 Stücke wurden gehandelt.

cbecks oder deine???

[GarfieldTrade]

#2 von GarfieldTrade 12.10.06 09:25:25 Beitrag Nr.: 24.572.638
Dieses Posting: versenden | melden | drucken | Antwort schreiben

Ich versuche zu kaufen!!

Naseweiß Du

[Penny.Z]

Antwort auf Beitrag Nr.: 24.572.997 von GarfieldTrade am 12.10.06 09:43:09

Ja du versuchst zu kaufen, das kam schon an.

Benötigst du dazu erst eine Bedienungsanleitung oder muss du erst deinen Banker damit beauftragen???

[GarfieldTrade]

Doch kein exponentielles Wachstum Deiner Smilies!?

[Atheros]

!

Dieser Beitrag wurde vom System automatisch gesperrt. Bei Fragen wenden Sie sich bitte an [e-mail]

[Penny.Z]

Antwort auf Beitrag Nr.: 24.573.590 von Atheros am 12.10.06 10:06:15

Um mir das zu sagen hast du dir Heute deine ID zugelegt?

Mach das du Land gewinnst.

Solche User wie du die mag ich besonderst.

Wurden entweder gesperrt und kommen mit neuer ID wieder,
oder müssen sich zum stänkern neue ID´s anlegen.

Also wie gesagt ver..... dich wieder.

[cbeck]

Antwort auf Beitrag Nr.: 24.572.539 von cbeck am 12.10.06 09:21:05

Nabi Biopharmaceuticals Completes Enrollment in NicVAX Phase IIB 'Proof-of-Concept' Clinical Trial

2006-10-12 07:05 ET - News Release

BOCA RATON, Fla., Oct. 12 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced it has completed enrollment for its Phase IIB "proof-of-concept" study for NicVAX(R) (Nicotine Conjugate Vaccine), the company's novel, innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse. Enrollment for the trial was completed three months earlier than anticipated, paving the way for the release of trial results early in the second quarter of 2007.

Thomas H. McLain, chairman of the board, chief executive officer and president, Nabi Biopharmaceuticals, stated, "We are extremely pleased to have completed patient enrollment for this trial ahead of schedule and consider it a testament to the hard work and dedication of our clinical team and our ability to execute on the key milestones we have established for our company. The successful completion of patient enrollment also puts us in a highly advantageous position to rapidly advance partnering efforts for NicVAX. We look forward to sharing these trial results early in the second quarter of 2007."

Mr. McLain continued, "This achievement is also greatly supported by the physician and patient communities who maintain a strong interest in the development of a new and innovative smoking cessation approach such as NicVAX."

Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "According to the U.S. Centers for Disease Control and Prevention, tobacco use is the single leading preventable cause of death in the U.S. and is responsible for more than 440,000 deaths each year, and yet optimal treatments are still not available. We believe NicVAX is poised to address one of today's most pressing healthcare challenges, nicotine addiction, in a way that could offer distinct therapeutic advantages over both marketed and development-stage smoking cessation treatments. We look forward to advancing NicVAX to the next stage of development and to the continuing support of the physician and patient communities committed to innovative solutions for smoking addiction."

Dr. Rasmussen continued, "Completion of patient enrollment for this proof-of-concept Phase IIB trial is evidence that NicVAX is the most advanced smoking cessation vaccine in development. The clinical advancement of NicVAX is supported by both a strong and global intellectual property position and our ability to manufacture the vaccine at commercial-scale, a position unmatched by any other company with a smoking cessation vaccine in development. We believe the results of this Phase IIB trial will enable us to identify the optimal formulation for the upcoming Phase III pivotal trials, and allow us to initiate these trials with a development partner in the second half of 2007."

How NicVAX is Designed to Work

The main reason it is so difficult to stop smoking is that smokers crave the 'rush' they get when nicotine reaches and binds to receptors in the brain. That releases dopamine, which creates the positive stimulus in the brain and at the same time is very addictive. NicVAX is designed to prevent the 'rush' and the associated addiction by preventing nicotine from entering the brain. The vaccine stimulates the immune system to produce antibodies that bind to nicotine. Nicotine attached to the antibodies is too large to cross the blood brain barrier, preventing nicotine from reaching the receptors in the brain. The 'rush' that is normally caused by nicotine should no longer be present, thereby eliminating the addictive properties of nicotine and, consequently, helping people to quit. In essence, it is believed that these nicotine antibodies can act like a "sponge" soaking up nicotine as it circulates in the bloodstream and preventing it from reaching the brain.

Further, because the ability of the body's immune system to produce these antibodies is expected to be long lasting, it is believed NicVAX will also be effective in preventing smoking relapse. Relapse is a significant challenge with existing smoking cessation therapies and can range as high as 90% in the first twelve months after quitting. This is expected to be an important differentiator between NicVAX and existing smoking treatment options.

About the Phase IIB Study

The Phase IIB study for NicVAX was designed with extensive input from the U.S. Food and Drug Administration (FDA), the European Medicines Evaluation Agency (EMEA), the National Institute on Drug Abuse (NIDA) and leading external consultants. The study is a double-blinded, placebo-controlled dose ranging study comprised of approximately 300 patients, a large enough sample size to establish both "proof-of-concept" and optimal dose identification for the Phase III program. The primary endpoint of the study is the abstinence rate at six months. Abstinence will be evaluated by several measures, including reported cigarette consumption, chemical markers of nicotine in the bloodstream, and behavioral assessment. Secondary endpoints include the abstinence rate at 12 months, total cigarette consumption, titer levels, safety and nicotine dependency. The efficacy rates in this study will incorporate the benefits of other elements in smoking cessation programs, including counseling and behavioral modification. A previous Phase II study which demonstrated up to a 40 percent quit rate in smokers evaluated the vaccine-only benefits of NicVAX.

Development Progress to Date