United Therapeutics (UTHR) - 500 Beiträge pro Seite

[gholzbauer]

Jetzt haben sie sich einen offiziellen Thread verdient ....

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Thursday August 9, 7:25 pm Eastern Time
Press Release
SOURCE: United Therapeutics
FDA Advisory Committee Recommends Approval of Remodulin For Pulmonary Arterial Hypertension
SILVER SPRING, Md., Aug. 9 /PRNewswire/ -- United Therapeutics (Nasdaq: UTHR - news) announced today that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended approval of Remodulin (treprostinil sodium) Injection for the treatment of pulmonary arterial hypertension by a vote of 6 to 3. The Advisory Committee`s recommendation will be considered by the FDA in making its final market approval decision.

``We are very pleased that the Advisory Committee recommended approval of Remodulin,`` said Roger Jeffs, Ph.D., President and Chief Operating Officer of United Therapeutics. ``We refiled the Remodulin New Drug Application this afternoon and we look forward to working with the Agency in the coming weeks to finalize the labeling.``

Data was presented to the Advisory Committee by Stuart Rich, M.D., Professor of Medicine and Director, Rush Heart Institute Center for Pulmonary Heart Disease at Rush Presbyterian-St. Luke`s Medical Center, and Robyn Barst, M.D., Professor of Pediatric Cardiology and Director, Pulmonary Hypertension Center, of Columbia Presbyterian Medical Center. Drs. Rich and Barst were members of the steering committee for the Remodulin trials and are leading U.S. experts in the highly-specialized field of pulmonary hypertension.

Over 500 pulmonary arterial hypertension patients worldwide continue to use Remodulin in open label studies sponsored by United Therapeutics. Remodulin is administered subcutaneously via an infusion device developed by MiniMed, Inc. (Nasdaq: MNMD - news). In anticipation of final FDA approval of Remodulin, United Therapeutics entered into drug distribution partnerships in the United States with two companies: Priority Healthcare Corporation (Nasdaq: PHCC - news) and Gentiva Health Services, Inc. (Nasdaq: GTIV - news). United Therapeutics has also formed Remodulin distribution partnerships in Europe, Canada, Australia, South America and Israel. United Therapeutics also has a marketing application under review in France and expects action toward the end of this year. Additional international filings will occur upon approval in the U.S. and France.

[gholzbauer]

[erkilein]

500 patienet weltweit, das is nicht viel potential oder?

[puhvogel]

Wer sagt denn solches

[gholzbauer]

500 Patienten werden weiter getestet. Betroffen sind ca. 100.000 Menschen in Europa und USA zusammen (Quelle z.B. http://www.actelion.com/press/ActelionPressRelease35.pdf).

[erkilein]

oh wei, hab doch glatt zwei wörter überlesen (continue to) und eines ersetzt (potential statt studies)--ja, ja wenn man angst um seine frischen calls (MEDX) hat, sollte man sich wirklich 3 tage schlafen legen :O

[erkilein]

scheint bewegung reinzukommen, hier nochmal paar news zum querlesen

Thursday August 9, 1:40 pm Eastern Time
FDA panel backs United Therapeutics` Remodulin
BETHESDA, Md., Aug 9 (Reuters) - A U.S. advisory panel on Thursday backed United Therapeutics Corp.`s (NasdaqNM:UTHR - news) drug Remodulin for treating a chronic, life-threatening lung condition called pulmonary hypertension.


A Food and Drug Administration advisory committee voted 6-3 that Remodulin should be approved for treating the condition, which afflicts about 100,000 people worldwide.

Panel members said they believed that Remodulin therapy made patients feel better even though company studies did not statistically show a significant benefit.

``There are a lot of signals this drug is effective in a difficult population,`` said JoAnn Lindenfeld, a cardiologist at the University of Colorado.

The FDA usually follows its panels` advice.

Remodulin is a drug delivered under the skin through an external pump the size of a pager. Pulmonary hypertension, or high blood pressure in the lungs, causes fatigue and shortness of breath and can be fatal within two to three years if not treated.

The only approved therapy for the condition is GlaxoSmithKline Plc`s (quote from Yahoo! UK & Ireland: GSK.L) Flolan, which is delivered intravenously.

Remodulin is similar to Flolan but it lasts longer in the body, and its delivery under the skin makes infections less likely. Side effects include pain at the drug-delivery site, nausea and headaches.

On Friday, the FDA panel is scheduled to review another experimental treatment for pulmonary hypertension made by Actelion Pharmaceuticals AG.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

BETHESDA, Md. (Reuters) - A U.S. advisory panel on Friday backed Actelion Pharmaceuticals AG`s (ATLZn.S) drug Tracleer for treating a chronic, life-threatening lung condition called pulmonary hypertension.

The Food and Drug Administration (news - web sites) (FDA) advisory committee unanimously voted to recommend Tracleer, a twice-a-day pill for treating the condition, which afflicts about 100,000 people worldwide.

The FDA usually follows the advice of its panels.

``This is clearly a major therapeutic advance,`` said Steven Nissen of the Cleveland Clinic, a member of the FDA Cardiovascular and Renal Drugs Advisory Committee.

Pulmonary hypertension is high blood pressure in the lungs that can be fatal within two to three years if not treated.

On Thursday the same advisory panel voted 6-3 to recommend United Therapeutics Corp.`s (Nasdaq:UTHR - news) drug Remodulin for the condition. Remodulin is delivered under the skin through an external pump the size of a pager.

The only currently approved therapy for the condition in the United States is GlaxoSmithKline Plc`s (GSK.L) (NYSE:GSK - news) Flolan, which is given intravenously.

Advisory panel members said Tracleer was effective but that it posed several safety concerns.

Tracleer should carry a prominent warning that it can cause birth defects, and women should be warned not to get pregnant while taking the drug, said the committee.

Switzerland-based Actelion should also urge physicians to carefully monitor patients for elevated liver enzymes and to use caution when prescribing Tracleer because of its potential to interact with many other drugs, the panel said.

Tracleer was co-developed by Genentech Inc. (NYSENA - news) and is the first in a new class of medicines called endothelin receptor antagonists. It is also being tested for treating congestive heart failure and hypertension.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

United Therapeutics` Second Quarter 2001 Financial Results Demonstrate Continued Growth in Revenues and Improvement in Per Share Amounts
SILVER SPRING, Md., Aug. 10 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR - news) today announced financial results for the second quarter ended June 30, 2001.

``We are pleased to announce that United Therapeutics ended its second quarter in very strong financial condition. At June 30, 2001, United Therapeutics had $193.7 million of cash and investments and practically no debt. Revenues during the quarter were $1.3 million, up 240% from one year ago, and our loss of $.53 per share is down from $1.55 in the same quarter of last year,`` said Fred Hadeed, Chief Financial Officer. Martine Rothblatt, Chairman and CEO, added, ``We are very pleased that yesterday the Cardiovascular and Renal Drugs Advisory Committee of the FDA recommended approval of Remodulin for the treatment of pulmonary arterial hypertension by a vote of 6 to 3. Additionally, our second lead drug, Beraprost, is moving quickly through the clinic with approximately 800 patients scheduled to complete the six month final confirmatory pivotal study for peripheral vascular disease this month. We intend to formally present the Beraprost data at the upcoming American Heart Association meeting in November.``

Revenues in the second quarter of 2001 were $1.3 million as compared to revenues of $546,000 in the previous year. The increase was due primarily from the resales of pumps and supplies to distributors in connection with United Therapeutics` lead product, Remodulin, and sales by subsidiaries acquired late in 2000.

Research and development expenses were $9.6 million in the second quarter of 2001 as compared to $28.9 million in the previous year. The decrease was due primarily to the prior year expenditure of approximately $19.8 million in licensing fees to obtain the exclusive rights to the sustained release formulations of Beraprost. Sales and marketing expenses were $890,000 in the second quarter of 2001 as compared to none in the previous year. Cost of sales were $725,000 in the second quarter of 2001 as compared to $434,000 in the previous year. These increases were due primarily to expanded activities of subsidiaries.

Interest income was $2.5 million in the second quarter of 2001 as compared to $1.7 million in the previous year. This increase was attributable to an increase in the amount of cash available for investing resulting from sales of common stock since June 30, 2000, less amounts used for operations.

United Therapeutics is a biotechnology company focused on combating cardiovascular, inflammatory and infectious disease with unique therapeutic products. United Therapeutics is a member of the Russell 3000 Index and is included in the iShares Nasdaq Biotechnology Index Fund (IBB).


UNITED THERAPEUTICS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS DATA

Three months ended June 30, Six months ended June 30,
2001 2000 2001 2000


Revenues:
Sales $1,134,926 $496,303 $2,397,721 $755,700
Sales to
affiliates 135,666 - 355,386 -
Grant revenue 43,361 50,000 43,361 100,000
Total revenues 1,313,953 546,303 2,796,468 855,700

Operating
expenses:
Research and
development 9,597,049 28,935,915 18,065,902 34,712,664
General and
administrative 3,075,561 1,696,384 6,995,560 5,497,534
Sales and
marketing 889,778 - 1,733,889 -
Cost of sales 724,711 433,587 1,529,994 653,870
Total operating
expenses 14,287,099 31,065,886 28,325,345 40,864,068

Loss from
operations (12,973,146) (30,519,583) (25,528,877) (40,008,368)

Other income
(expense):
Interest income 2,453,681 1,712,868 5,738,208 3,270,726
Interest expense (54,245) (27,664) (93,423) (55,660)
Equity in loss
of affiliate (93,082) - (154,614) -
Other - net 19,855 24,063 (11,015) 71,389

Total other
income 2,326,209 1,709,267 5,479,156 3,286,455

Net loss before
income tax (10,646,937) (28,810,316) (20,049,721) (36,721,913)

Income tax - - - -

Net loss $(10,646,937) $(28,810,316) $(20,049,721) $(36,721,913)

Net loss per
common
share - basic
and diluted $(0.53) $(1.55) $(0.99) $(2.01)

Weighted average
number of
common shares
outstanding -
basic and
diluted 20,277,089 18,585,976 20,334,566 18,305,618

CONSOLIDATED BALANCE SHEET DATA

June 30, December 31,
2001 2000

Cash, Cash Equivalents, Marketable
Investments, and Certificate of Deposit $193,745,017 $215,990,326

Total Assets $229,840,557 $250,644,984

Total Stockholders` Equity $213,594,636 $234,737,782

SOURCE: United Therapeutics Corporation

scheisse, die zahlen sind arg verrutscht, aber wichtig eigentlich nur: knapp 200 mio cash und verlust von 1,50 auf 0,5... pro Aktie runtergefahren

[puhvogel]

Hmmm, ob solch eine Bekanntgabe im Vorfeld so gut ist?
United Therapeutics Anticipates FDA Nod for Hypertension Drug

By Adam Feuerstein
Staff Reporter
10/09/2001 12:31 PM EDT


United Therapeutics (UTHR:Nasdaq - news - commentary - research) CEO Martine Rothblatt is telling fund managers at a biotech conference that the company`s pulmonary arterial hypertension drug will receive an "approvable" letter from the Food and Drug Administration in the next week.
An FDA "approvable" letter means the regulatory agency will grant final approval to market a drug once the drug company takes care of relatively minor issues.
In a private meeting with fund managers, Rothblatt said the FDA has all but signed off on the approval of Remodulin, according to the managers. The meeting took place Monday afternoon at the UBS Warburg Global Life Sciences Conference, being held this week in New York. Rothblatt couldn`t be reached for comment.

"She told us that all major outstanding issues with Remodulin have been worked out between the FDA and the company, and that the drug will be approved," said one hedge fund manager attending the meeting.

FDA`s approval of Remodulin, if it does come, will be a big boost for United Therapeutics, which has more than its share of critics on Wall Street. Until now, predicting whether the drug would get approved has been one of the tougher calls in the biotech sector. Remodulin won`t be a huge seller -- analysts have pegged annual peak sales at between $100 million and $200 million. United Therapeutics has posted negligible revenue to this point; Remodulin would be its first approved drug.

Regulators seem split on the drug`s effectiveness and safety. On Aug. 8, FDA reviewers released a fairly scathing review of Remodulin in advance of an FDA advisory panel meeting. Investors fled the stock, fearing the drug`s rejection, pushing the company below $9 per share.

But when the advisory panel met the next day, it surprised many biotech observers by actually recommending Remodulin`s approval, bolstered by bullish comments from a top FDA official. Investors jumped back in, pushing United Therapeutics back above $14 per share. The stock was trading early Tuesday afternoon at $13.30, up 15 cents or 1.14%.

The company`s shares could move higher on a Remodulin approval, but expectations for the drug are fairly low. There aren`t many patients who suffer from pulmonary arterial hypertension. And Remodulin, which is injected, won`t get very far from the gate without encountering competition from drugs in oral form. Alexion and Genentech (DNA:NYSE - news - commentary - research) are expected to gain approval soon for one such drug, called Tracleer. Still other competing drugs are being developed.

But United Therapeutics will also give investors another reason to take a look at the company next month at the annual scientific meeting of the American Heart Association. There, United Therapeutics will present late-stage test results for Beraprost, an experimental oral drug to treat peripheral vascular disease. If the results are positive, an FDA filing for Beraprost is expected in the first quarter next year.

Beraprost, if eventually approved, could be a much bigger profit driver for United Therapeutics. There are 6 million patients in the United States who suffer from peripheral vascular disease, of which about 1.5 million could qualify for treatment with the drug, according to projections compiled by one hedge fund manager. The same manager has recently taken a long position in United Therapeutics.

"I think the real value in United Therapeutics is Beraprost," he says. "If the drug is approved and the company gets the [drug] label it wants, you could see peak sales of about $500 million."
http://www.thestreet.com/_yahoo/tech/adamfeuerstein/10002127…

[erkilein]

da scheint sich ein betonboden zu bilden...ich werd mir da mal welche in 3-4 wochen gönnen und liegen lassen...normalerweise werden solche statements nicht veröffentlicht, wenn nicht was dran wäre...dann würde man sich der strafbarkeit wegen und des images arg zurückhalten.
wird beraprost zugelassen, steht das ding wieder bei 40 $.

[puhvogel]

Da hast du genau meine Gedanken aufgegriffen, warum mir so ein Statement, und sei es inoffiziell, im Vorfeld überhaupt nicht gefällt.
In den üblichen News steht nämlich nicht zu unrecht drin, was alles möglich schief gehen kann, weil dann irgendein A....loch dann gleich klagt.
Ich habe mir übrigens die klinischen Daten von Tracleer und Remodulin genau angeschaut: Tracleer ist bei moderaten PPH im Vergleich überlegen, womöglich verliert sich der Vorteil bei schwereren Fällen. Remodulin muss sich vermutlich billiger verkaufen. Wenn die 100 Millionen $ in 2-3 Jahren umsetzen, wär das doch nicht schlecht bei der jetzigen Markkapitalisierung?

[puhvogel]

RESEARCH TRIANGLE PARK, N.C. and SILVER SPRING, Md., Oct. 15. /PRNewswire/
-- United Therapeutics (Nasdaq: UTHR) announced today the preliminary results
of a Phase III clinical trial investigating oral beraprost for the treatment
of intermittent claudication (pain when walking) resulting from peripheral
vascular disease. Beraprost was studied in approximately 750 patients in
60 centers in the United States in a trial that was designed to confirm the
significant efficacy results of the first Phase III trial of beraprost in
422 patients conducted by Hoechst Marion Roussel (now Aventis) in France and
Italy and published in the journal Circulation in July 2000.
While the preliminary data confirmed a trend toward fewer critical
cardiovascular events, the study did not confirm the positive results of the
European Phase III trial and statistical significance was not achieved in the
study`s endpoints relating to exercise.
"We are completely surprised by the discrepancy between the results
achieved in this study and the significant results achieved by the European
study," said Michael Wade, Ph.D., Associate Director, Research and Development
for United Therapeutics. "We are certainly disappointed that we were unable
to reproduce the European results in this larger confirmatory study,
particularly given that the entry criteria and study endpoints were nearly
identical."
"This study was one of the largest placebo-controlled studies ever
conducted in patients with intermittent claudication," said Emile R. Mohler
III, M.D., Director of Vascular Medicine at the University of Pennsylvania
Health System, and a member of the United Therapeutics` study Steering
Committee. "Perhaps the result is explained by the relatively limited
half-life of beraprost of 45 minutes. I remain hopeful that a longer acting
prostacyclin analog would provide a sustained increase in blood flow and
sustained benefit in patients with claudication."
Based on the study results, United Therapeutics expects to discontinue
development of beraprost for intermittent claudication, although it will
continue its Phase III clinical trial program for beraprost to treat pulmonary
arterial hypertension. In addition, United Therapeutics will evaluate whether
to continue development of a sustained release formulation of oral beraprost
which it in-licensed in July 2000. United Therapeutics is currently
developing a sustained release formulation of its lead drug Remodulin, which
has already demonstrated safety and efficacy in the treatment of pulmonary
arterial hypertension and demonstrated efficacy in a Phase II study of
advanced peripheral vascular disease.
"While we`re disappointed with the results of this study, we remain
committed to the development, approval and commercialization of our lead drug
Remodulin," said Roger A. Jeffs, Ph.D., President of United Therapeutics. On
August 9, 2001, the Cardiovascular and Renal Drugs Advisory Committee of the
U.S. Food and Drug Administration (FDA) recommended approval of Remodulin
(treprostinil sodium) Injection for the treatment of pulmonary arterial
hypertension and the Company is awaiting final action by the FDA.
United Therapeutics will host a teleconference on October 15, 2001 at
9:00 a.m. Eastern Daylight Time. The teleconference is accessible by dialing
1-800-997-8642. A rebroadcast of the teleconference will be available for
48 hours following the teleconference by dialing 1-800-428-6051 and using
access code 213633.

[gholzbauer]

Schade, schade.
Der Raketentreibstoff ist erstmal weg.
Remodulin ist mir egal.
Wenn die FDA hier noch Schwierigkeiten machen sollte, wäre es umso besser für Actelion.

[desastermaster]

So,
da hat sich die FDA doch wirklich mal wieder einen approvable letter abgerungen, diesmal fuer Remodulin.
Das ist zwar bei weitem kein Blockbuster, aber da uthr
bei $11.10 eine MK von $225 Mio aufweist und zum 30.9.
$203.5 Mio equity hatte(davon ein Grossteil fluessig)
gibts ja vielleicht doch etwas Potential nach oben.
Best
dm

Shares of United Therapeutics (UTHR) jumped $1.66, or 18 percent, to $11.10. The company said its treatment for pulmonary hypertension had been deemed "approvable" by the U.S. Food and Drug Administration. The designation means the company will be allowed to market the drug provided certain conditions are met.

Siehe auch
http://www.unither.com

[puhvogel]

Remodulin ist deren einziges Medikament, danach kommt eine ganz gähnende Leere in der Pipeline. Eigentlich müsste UTHR mit einer notleidenden Biotechfirma fusionieren, die eine volle Pipeline aber leere Kassen haben (Glia zum Beispiel, obwohl das nicht inhaltlich zusammen passt)
Dennoch ist die Zulassungerklärung der FDA keine Selbstverständlichkeit, denn die FDA-Gutachter hatte sich gegen eine Zulassung gestellt, das wissenschaftliche Kommittee dagegen eine Zulassung befürwortet.
Auch bei diesem Kommittee kam Actelions Bosentan deutlich besser an.
Allerdings hat es bisher keine lebensverlängernden Eigenschaften nachgewiesen, im Gegensatz zum Wirkstoff der sich hinter Remodulin verbirgt. So wird erst die Zukunft wie stark die Umsätze werden und hier ist noch echt Platz für Überraschungen.

[desastermaster]

Hallo Puhvogel,
du hast schon recht die pipeline von uthr ist voellig ausgebombt und ein Zukauf waere sicher sinnvoll. Eine weitere Biobude ohne cash waere endovasc mit MK $6 Mio (glia momentan $5 Mio). Die koennten im Sommer zwei Wirkstoffe die mir recht interessant erscheinen in Phase III Studien schicken. Aber wie sie sich finanzieren weis der Henker.
Best
dm

[gholzbauer]

UTHR ist z.Z. mein bester Biotechtitel.
Wer hätte das gedacht?

Mit dem AltaRex-Deal haben sie jetzt sogar eine nicht uninteressante Pipeline,
wenn auch die Entwicklung die Cashreserven schnell antauen wird.

[gholzbauer]

Die können ja doch zulassen



Wednesday May 22, 5:13 pm Eastern Time

Press Release

SOURCE: United Therapeutics Corporation

United Therapeutics Receives FDA Approval For Remodulin(TM) to Treat Pulmonary Arterial Hypertension

Commercial Drug Immediately Available

Conference Call Scheduled for Thursday, May 23, 2002, 8:30 a.m. Eastern Time

RESEARCH TRIANGLE PARK, N.C. and SILVER SPRING, Md., May 22


/PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR - News)
announced today that the U.S. Food and Drug Administration (FDA) has approved
Remodulin (treprostinil sodium) Injection as a continuous subcutaneous
infusion for the treatment of pulmonary arterial hypertension in patients with
NYHA Class II-IV symptoms to diminish symptoms associated with exercise.

The FDA approved Remodulin under its accelerated approval regulations based on the largest double blind placebo-controlled study ever conducted in pulmonary arterial hypertension, a disease in which blood pressure in the pulmonary arteries rises to life-threatening levels. In clinical trials, the most common side effects reported with Remodulin therapy included infusion site pain (85%) and infusion site reaction (83%). Other adverse events included headache (27%), diarrhea (25%), nausea (22%), rash (14%), jaw pain (13%), vasodilatation (11%), dizziness (9%), edema (9%), pruritus (itching) (8%) and hypotension (4%). Remodulin should be used only by clinicians experienced in the diagnosis and treatment of PAH.

Approximately 500 pulmonary arterial hypertension patients worldwide continue to use Remodulin in open label studies sponsored by United Therapeutics, with some patients on the drug for nearly four years. Approximately 50,000 people in North America and Europe are estimated to be afflicted with NYHA Class II-IV forms of the disease, most of whom are undiagnosed.

"We are pleased that our constructive work with the FDA has resulted in the approval of Remodulin for all symptomatic stages of the disease, including the first approved therapy for NYHA Class II pulmonary arterial hypertension patients," said Roger Jeffs, Ph.D., President and Chief Operating Officer of United Therapeutics. "We are committed to continuing clinical trials to further evaluate the benefit of Remodulin in the treatment of this devastating condition. We are grateful to the patients and investigators who have made this approval possible."

"There is a tremendous need to provide expanded treatment options to these patients and the approval of Remodulin is very encouraging news for patients and physicians alike," said Dr. Stuart Rich, Professor of Medicine and Director, Rush Heart Institute Center for Pulmonary Heart Disease at Rush Presbyterian St. Luke`s Hospital and a member of the Remodulin trial steering committee.

Commercial Remodulin Immediately Available

Remodulin is available immediately through United Therapeutics` U.S. distributors, Priority Healthcare Corporation (Nasdaq: PHCC - News) and Gentiva Health Services (Nasdaq: GTIV - News).

The recommended average wholesale price for Remodulin is $65 per milligram, with the medicine made available in an aqueous formulation in a 20 ml vial.

United Therapeutics has submitted Remodulin marketing applications to health authorities in France, Switzerland and Canada. Additional international filings will follow approval in the U.S. and France. United Therapeutics has also formed Remodulin distribution partnerships in Europe, Canada, Australia, Latin America and Israel.

Physicians or patients who have questions about Remodulin can call either Priority Healthcare at 1-866-4-PH-TEAM or Gentiva Health Services at 1-866-FIGHT PH.

Phase IV Post-Marketing Trial

United Therapeutics agreed as a condition of approval to conduct a post- approval controlled clinical trial to verify and further describe Remodulin`s clinical benefits. United Therapeutics will conduct a randomized transition of patients treated with Flolan® -- a synthetic form of prostacyclin delivered intravenously -- to either subcutaneous Remodulin or placebo. Outcome measures will include clinical deterioration, PAH symptoms and exercise performance.

Conference Call

United Therapeutics` CEO, Dr. Martine Rothblatt, and President, Dr. Roger Jeffs, will host a teleconference on May 23, 2002 at 8:30 a.m. Eastern Time to discuss the Remodulin approval, post-marketing study design and related business. The teleconference is accessible by dialing 1-800-997-8642 with international callers dialing 1-973-694-6836. A rebroadcast of the teleconference will be available for one week following the teleconference by dialing 1-800-428-6051, with international callers dialing 973-709-2089, and using access code 243902.

United Therapeutics is a biotechnology company focused on combating chronic and life-threatening cardiovascular, infectious and oncologic diseases with unique therapeutic products.

To the extent any statements made in this release deal with information that is not historical, these statements are necessarily forward-looking. As such, they are subject to the occurrence of events outside of United Therapeutics` control and are subject to various risks and uncertainties that could cause United Therapeutics` results to differ materially from those expressed in any forward-looking statement. These risk factors are described in United Therapeutics` reports on Form 10-K and Form 10-Q as filed with the Securities and Exchange Commission, including the 2001 Form 10-K, and include, without limitation, the risk of future clinical trial outcomes, regulatory risks and risks related to market acceptance and competitive products and pricing.

SOURCE: United Therapeutics Corporation



---------


Thursday May 23, 10:52 am Eastern Time

Press Release

SOURCE: Gentiva Health Services

Gentiva Health Services Begins Distribution of Newly-Approved Therapy For Pulmonary Arterial Hypertension

Product Portfolio to Include United Therapeutics` Remodulin(TM)

MELVILLE, N.Y., May 23 /PRNewswire-FirstCall/ -- Further building upon its reputation as a distributor of new generation pharmaceutical therapies, Gentiva Health Services (Nasdaq: GTIV - News), the nation`s leading provider of home health care and specialty pharmaceutical services, today announced that it is ready to begin commercial distribution of Remodulin(TM) (treprostinil sodium) Injection, for the treatment of certain symptoms associated with Pulmonary Arterial Hypertension.

Gentiva announced on March 21, 2000 the formation of a strategic alliance with United Therapeutics Corporation (Nasdaq: UTHR - News), the developer of Remodulin, in which Gentiva will provide clinical management, product distribution, reimbursement and patient support services for the therapy upon FDA approval. Gentiva will also provide patient education and compliance monitoring, as well as collection of drug utilization data.

Remodulin, which received FDA approval on May 22, 2002, has been indicated for the treatment of symptoms associated with Pulmonary Arterial Hypertension (PAH), New York Heart Association (NYHA) classes II, III and IV. It is the first treatment for PAH approved in the United States that is designed for continuous subcutaneous administration using a compact subcutaneous infusion pump device. Pulmonary Arterial Hypertension is a rare blood vessel disorder of the lungs in which the pressure in the pulmonary artery rises above normal levels and may become life threatening.

"We are excited to expand our product portfolio to include Remodulin therapy," said Bob Nixon, executive vice president and president of Gentiva Health Services Specialty Pharmaceutical Services division. "Our strategic alliance with United Therapeutics enables Gentiva to service the PAH community with every FDA-approved treatment for Pulmonary Arterial Hypertension. In addition, Remodulin will add a nice component to the combined product line offering that will result upon closure of the pending sale of Gentiva`s specialty pharmaceutical services business to Accredo Health, Incorporated (Nasdaq: ACDO - News)."

Gentiva Health Services (Nasdaq: GTIV - News), a Fortune 1000 company, is the nation`s leading provider of home health care and specialty pharmaceutical services. With more than 300 locations in the United States, the company had approximately $1.4 billion in 2001 net revenues. For more information, visit Gentiva`s Web site, http://www.gentiva.com .

"United Therapeutics is a biotechnology company based in Silver Spring, Maryland and Research Triangle Park, North Carolina focused on combating chronic and life-threatening cardiovascular, infectious and oncologic diseases with unique therapeutic products."

Information contained in this news release, other than historical information, should be considered forward-looking, and is subject to various risk factors and uncertainties. For instance, the company`s strategies and operations involve risks of competition, changing market conditions, changes in laws and regulations affecting its industries and numerous other factors discussed in this release and in the company`s filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those anticipated in any forward- looking statements.

Contact: Kimberly S. Herman
Vice President
Gentiva Health Services
3 Huntington Quadrangle, 2S
Melville, NY 11747
[phone]
[e-mail]

Investor Contact: John J. Collura
Executive Vice President,
Chief Financial Officer and Treasurer
Gentiva Health Services
[phone]


SOURCE: Gentiva Health Services

[desastermaster]

Hallo,
hier nun die ersten Quartalszahlen mit Umsaetzen von
remodulin. Ist aber durch die eindeckung der Grosshaendler
verzerrt und man wird sehen muessen wieviel wirklich in
den adern der patienten landet.
Drei Mio Spekulationsverluste hab sie auch gleich ausgebucht
und sich nun in den money market zurueckgezogen.
Best
dm


United Therapeutics Reports Second Quarter 2002
Financial Results
8/8/2002 6:07:00 AM
SILVER SPRING, Md., Aug 08, 2002 /PRNewsire-FirstCall via Comtex/ -- United Therapeutics Corporation
(UTHR) today announced financial results for the quarter ended June 30, 2002.

"We are pleased to report that United Therapeutics` total revenues for the quarter ended June 30, 2002 totaled
$11.6 million," said Fred Hadeed, United Therapeutics` Chief Financial Officer. "The majority of these revenues
were from the sales of newly approved Remodulin(TM) and related infusion pumps and supplies to our two
U.S. distributors." Remodulin (treprostinil sodium) Injection was approved by the FDA on May 21, 2002 as a
continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA
Class II-IV symptoms to diminish symptoms associated with exercise.

Approximately 500 patients are on Remodulin therapy worldwide, of which approximately 60 percent are
reimbursable patients. Based on the number of reimbursable patients on therapy, the current revenue run rate
is approximately $25 million per year.

"We are pleased with the results to date," said Martine Rothblatt, Ph.D., United Therapeutics` Chairman and
Chief Executive Officer. "Remodulin is a useful alternative for NYHA Class II-IV patients with Pulmonary
arterial hypertension for whom oral therapy is inappropriate or ineffective and for patients who are unable to
manage or accept the rigor and/or risks associated with intravenous therapy." Since FDA approval, the number
of U.S. medical centers with experience in transitioning patients from intravenous Flolan to Remodulin has
grown from three to eight, and the first IRB approval has been obtained for the Phase IV Flolan-to-Remodulin
transition study.

United Therapeutics manufactures Remodulin and sells the drug to its two U.S. distributors, Priority Healthcare
Corporation (PHCC) and Accredo Therapeutics, Inc. (formerly Gentiva Health Services, Inc.) (ACDO), who in
turn sell and market Remodulin and related infusion pumps and supplies to patients in the U.S. The timing and
extent of United Therapeutics` sales are based on the timing and extent of bulk orders from its distributors.
The initial shipments of Remodulin to United Therapeutics` U.S. distributors reflect the distributors` estimates
of the amount of Remodulin needed to provide for existing patients and to build an adequate inventory reserve
for new and continuing patients.

Revenues in the second quarter of 2002 were $11.6 million, as compared to revenues of $1.3 million in the
second quarter of 2001. Cost of sales in the second quarter of 2002 were $1.9 million, as compared to
$725,000 in the second quarter of 2001. Gross margin from sales was $9.7 million in the second quarter of
2002, as compared to gross margin of $589,000 in the second quarter of 2001.

A net loss of $3.2 million was incurred in the second quarter of 2002, compared to a net loss of $10.7 million in
the second quarter of 2001. This represents a loss of $.16 per share in the second quarter of 2002, as
compared with a loss of $.53 per share in the second quarter of 2001. A large component of the net loss in the
second quarter of 2002 was due to a write- down of marketable debt investments totaling $3.6 million. Had the
write-down not been necessary, United Therapeutics would have earned net income of $381,000 or $.02 per
share in the second quarter of 2002.

Research and development expenses in the second quarter of 2002 were $7.3 million as compared to $9.6
million in the second quarter of 2001. The decrease was due primarily to a reduction in expenses related to
patient enrollment in United Therapeutics` clinical trials, offset by an increase in expenses for United
Therapeutics` OvaRex ovarian cancer program. General and administrative expenses of $2.9 million in the
second quarter of 2002 were comparable to general and administrative expenses of $3.1 million in the second
quarter of 2001.

Sales and marketing expenses of $811,000 in the second quarter of 2002 were comparable to sales and
marketing expenses of $890,000 in the second quarter of 2001. Cost of sales were $1.9 million in the second
quarter of 2002 as compared to $725,000 in the second quarter of 2001. The increase in cost of sales was due
primarily to the increase in revenues from Remodulin and related infusion pumps and supplies.

Interest income was $1.9 million in the second quarter of 2002 as compared to $2.5 million in the second
quarter of 2001. This decrease was attributable to reductions in cash available for investing.

A write-down of marketable investments totaling $3.6 million was recorded in the second quarter of 2002
reflecting unrealized losses in the portfolio. The write-down at June 30, 2002 was necessary to reduce these
marketable investments to their fair values since they were sold shortly after June 30, 2002. Those sales
concluded in July 2002 and resulted in an additional loss of $3.3 million. The proceeds will be invested in
money market funds, commercial paper and U.S. treasury instruments. "In the face of a very volatile bond
market, we took this move to lock in the value of our portfolio and transfer that principal to stable investments
like money markets and U.S. treasuries," said Fred Hadeed. "Including the effect of these losses, we were still
able to earn an approximate 2.4% yield over the duration. Now we can continue investing our principal with less
volatility."

[gholzbauer]

Fragt sich nur, wieviel im Kurs enthalten ist.
Mkt Cap bei 17$ beträgt immerhin schon wieder 355 Mio $.



Press Release
Source: United Therapeutics Corporation

Remodulin Therapy Receives Nationwide Medicare Reimbursement Coverage
Monday September 23, 7:02 am ET

SILVER SPRING, Md., Sept. 23 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR - News) today announced that all four of the United States Medicare Durable Medical Equipment Regional Carriers (DMERCs) have now issued policies and procedures allowing for the nationwide reimbursement of Remodulin(TM) (treprostinil sodium) Injection therapy. Under each of the DMERC`s local medical review policy, Medicare coverage for Remodulin therapy is effective retroactively for all dates of service on or after May 21, 2002. In addition to coverage for Remodulin, Medicare will also provide reimbursement for the related infusion pumps and supplies. Generally, Medicare-eligible patients with all forms of pulmonary arterial hypertension for which Remodulin is indicated will be covered under the new DMERC policies.


Remodulin was approved by the FDA on May 21, 2002 for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. United Therapeutics estimates that approximately 30% of all patients with pulmonary arterial hypertension are Medicare eligible.






--------------------



Forbes Magazine
Biotech Buys
Monday September 16, 10:15 am ET

By Lisa W. Hess

This volatile sector has gotten killed this year, making it a very attractive play for people who want to take a chance on getting in on the next Amgen.

If you thought that investing in the S&P 500 was tough this year, welcome to the nightmare of biotech. Down 47% in 2002 (as measured by the Nasdaq biotech index), this is a sector that is nerve-racking in the best of times. To pick a stock intelligently you have to know about exotic areas of medical research that are unfamiliar to most doctors. Even pronouncing the names of a company`s products can be a challenge.

During a bear market, investors flee from biotech firms that are merrily burning through cash and are ten years away from having a commercially viable product. Doubts arise about whether they will ever be able to return to Wall Street for more capital--and even with all the capital in the world they may never turn their research into a usable drug. If the drug is a godsend to patients, it may still cost the discoverer several hundred million dollars to get it to market.

In an ideal world venture capitalists raise money for some smart biotech pioneers who are developing a plausible compound. Perhaps a giant drug outfit kicks in additional capital to get dibs on rights to market the potential new product. If scientific experiments pan out, the biotech firm launches an initial public offering and receives still more cash to carry it through patient trials. Next, the new drug receives Food & Drug Administration approval and starts generating sales and fat operating margins. Not many biotech firms get this far, but both Amgen and Genentech did. Another possible happy ending is that the fledgling business is bought out by the huge pharmaceutical company it partnered with earlier.

But this beneficent process has been spoiled lately. The new-issue market is moribund. Big pharma, suffering from expiring patents and criticism over rising drug prices, is less generous dispensing early-stage research money to biotechs. There`s an even worse problem: The Bush Administration`s shocking negligence in delaying naming an FDA chief. Without leadership, the FDA bureaucracy`s response to biotech innovations is to say either "No" or "Give me more information."

Despite all the current travails, though, you can make a strong case that the 21st century will be the age of biotechnology, just as the 20th century was the age of communications and the 19th the age of transportation.

First, the tools are available to create new wonder drugs by rapidly searching through tens of thousands of potential compounds: Biotechers now can employ extremely fast computing power and can decode any DNA sequence. Second, the aging baby boomers have created a demographic demand for new drugs to attack the chronic diseases of aging. Plus, the big pharmaceutical companies are starting to need fresh blockbuster products to replenish their patent portfolios.

Meanwhile, the present confluence of miseries has created a chance to buy into a great sector at some fabulous prices. For a passive play, buy an exchange traded fund. Biotech Holders Trust (AMEX:BBH - News) is down 37% this year and gives broad exposure to the group. This fund is weighted by market capitalization, so Amgen and Genentech represent 52% of the ETF`s portfolio.

Another way to participate in a broad-gauge fashion is to own an actively managed closed-end fund. H&Q Healthcare Investors (NYSE:HQH - News) is one you can buy cheaply, at a 19% discount to its net asset value. (Offsetting the bargain here is the expense drag: 1.5% of assets annually.) The Hambrecht & Quest closed-end owns stakes in 75 companies, including CV Therapeutics, maker of heart drugs, and Cytyc, provider of advanced Pap smear tests.

Investing in individual biotech companies is risky, of course, but for the courageous, such forays may yield a bonanza or two. A favorite of mine is Durect (NasdaqNM: DRRX - News) , which offers a series of drug delivery methods that automatically give patients medicine on a schedule. From biodegradable implants to matchstick-size titanium pumps inserted at the base of the spinal column, this company`s products deal with chronic ailments such as acute pain. This last system is now in Phase III trials, the final stage before the petition for an FDA permit. Durect`s $60 million in cash should last it through 2003.

Another biotech I like is United Therapeutics (NasdaqNM:UTHR - News) , one of the few to get FDA approval this year--for its lead drug, Remodulin, which treats pulmonary hypertension. With approximately $150 million in cash, and a yearly burn rate of $40 million, it has the financial stability to take on the sole existing drug for this illness, GlaxoSmithKline`s $200 million (annual revenue) Flolan. Remodulin will take a lot of patients away from Flolan within the next three years. *

Lisa W. Hess is a New York money manager. Visit her
homepage at www.forbes.com/hess


* Ein Hinweis auf Actelion wäre jedoch angebracht gewesen.

[puhvogel]

Der Kurs ist schon im Vorfeld recht stark ansgestiegen, am Freitag nochmal besonders. Jetzt kommt die Meldung dazu, meist ein klassischer Verkaufszeitpunkt.
Trotzdem eine gute, nicht selbstverständliche Meldung.
Actelion und Remodulin haben nicht zu 100 % die gleiche Schnittmenge, dennoch hat Actelion die besseren Karten. Es kann aber sein dass Remodulin billiger ist und deswegen durch Medicare gefördert wird.
Ich habe mich lang nicht mehr mit UTHR beschäftigt...