US-Biotechs: FDA macht Schlechtwetter - 500 Beiträge pro Seite

[Nachrichten [wO]]

Die nächste Ergebnissaison in den USA steht an. Die führenden Biotech-Unternehmen sind kaum von der aktuellen Konjunkturflaute betroffen – solide Zahlen werden erwartet. Dennoch machen einige Größen der Branche schwere Zeiten durch.

Die US-Zulassungsbehörde für Lebensmittel und Medikamente (FDA) macht dem Biotech-Sektor gehörig zu schaffen – die Wartezeiten bis zur Marktzulassung neuer Produkte steigen an und neuerdings hagelt es Absagen für experimentelle Heilmittel. Das kann für kleinere Unternehmen schnell den finanziellen Ruin bedeuten, aber auch die Branchenriesen haben daran zu knabbern.

Jüngstes Opfer der FDA ist Genentech, das zweitgrößte Biotech-Unternehmen der USA. Wegen nicht ausreichender Daten muss die Marktzulassung eines Allergiepräparates auf noch unbestimmte Zeit verschoben werden . Der Aktienkurs fällt daraufhin mehr als 10% und ein unheilvoller Schatten legt sich über die am Mittwochabend bevorstehende Verkündung des Quartalsergebnisses. Dabei wird eigentlich erwartet, dass Genentech die neue Quartalssaison mit einem guten Ergebnis einläutet.

Das Krebs-Medikament Rituxan soll Genentechs Garant dafür sein, den an der Wall Street erwarteten Gewinn von 19 Cent pro Aktie zu erreichen. Höhere Überlebensraten der Rituxan-Patienten haben den Umsatz des Präparats bereits im 1. Quartal in die Höhe geschraubt – für das 2. Quartal wird der Umsatz deutlich über 200 Mio.$ geschätzt. Außerdem sind die Verkaufszahlen der Brustkrebs-Arznei Herceptin zu beachten, die ebenfalls mit positiven Forschungsdaten glänzte.

Auch der Branchen-Gigant Amgen wird wohl weniger mit dem Erreichen der von Analysten prognostizierten 28 Cent Gewinn pro Aktie als mit der FDA zu kämpfen haben. Die Behörde hat den Zulassungsantrag für Plenaxis, ein experimentelles Medikament gegen Prostata-Krebs, abgeschmettert .

Bedeutender ist allerdings die Zulassungsverzögerung von Aranesp, dem potenziellen Nachfolger des Anämie-Präparats Epogen . Obwohl die Zahlen für das 2. Quartal davon noch nicht betroffen sind, könnten die Umsatz- und Gewinnprognose für das Gesamtjahr 2001 leiden. Es kommt darauf an, wie lange sich die Zulassung des Präparates, dass eigentlich schon auf dem Markt sein sollte, noch verzögern wird.

Das Sorgenkind unter den wichtigsten Namen der Biotechnologie ist ohne Zweifel Biogen. Avonex, das Top-Produkt des Unternehmens erfährt großen Konkurrenzdruck aus der Schweiz . Auch Amevive, ein bisher aussichtsreiches Produkt aus der Pipeline enttäuschte die Experten mit der neuesten Studie. Für die Aktie folgte ein düsteres 2. Quartal und auch die neuesten Analystenprognosen geben kaum Anlass zur Freude .

Es bleibt festzuhalten, dass die Ergebnisse des Biotech-Sektors im 2. Quartal wahrscheinlich kaum für negative Überraschungen sorgen. Allerdings werden die Branchen-Riesen von soliden Zahlen nicht unbedingt profitieren. Sollten Zulassungsverzögerungen tatsächlich die Ausblicke verhageln, könnte die schlechte Stimmung in den Vordergrund rücken.

[bigtime]

Die FDA macht das ganz richtig, daß so kritisch geprüft wird.

Immerhin wurde, so weit mir bekannt ist, das Schmerzmittel Contergan von der FDA in den USA nicht zugelassen und hat damit viel Leid erspart.

Für die Aktienkurse ist das leider nicht so schön, obwohl man dem auch positives abgewinnen kann, denn was will man mit einer Medikamentenschwemme, bei der kein Arzt mehr durchblickt und die für Margendruck sorgen.

Auch bieten die Kurse der Aktien, die von Zulassungverzögerungen betroffen sind auf längere Sicht gesehen gute Einstiegsmöglichkeiten.




Mfg bigtime

[Thierri]

Sehe das genauso!

So kommen die richtig innovativen Biotechs weiter! Die Spreu trennt sich vom Weizen!!

T.

[@CASH@]

Na dann überlegt mal WIE POSITIV es zu deuten ist das CALYPTE 909402 die FDA Zulassung bekommen hat.
FDA Approves Conversion of Calypte Urine Western Blot BLA to Premarket Approval Status
WEDNESDAY, JUNE 27, 2001 9:11 AM
- BusinessWire

ALAMEDA, Calif., Jun 27, 2001 (BUSINESS WIRE) -- Calypte Biomedical Corporation (Nasdaq:CALY) announced today that the United States Food and Drug Administration (FDA) has approved Calypte`s premarket approval application (PMA) for the Cambridge Biotech(TM) HIV-1 Urine Western Blot.

Calypte envisions a number of benefits arising from the new status, chief among which is the ability to significantly extend the product`s expiration dating. The Company believes that longer shelf life will improve manufacturing efficiency and better meet the needs of its international customers.

The approved product is intended for use as a supplemental, more specific test for urine samples that have been found to be reactive for antibody to HIV-1 using the company`s EIA screening procedure.

In the past, urine samples that required further testing as a result of a reactive urine screening procedure could be tested with the FDA-licensed serum Calypte Western Blot, which also had an FDA-approved claim for use with urine. The Calypte HIV-1 Urine EIA and Western Blot are approved for use in any professional laboratory setting with the exception of blood banks.

Nancy Katz, President, CEO, and CFO of Calypte said, "We are pleased to have received FDA approval of this PMA because it allows us to manufacture a urine-specific Western Blot much more efficiently than the original Western Blot with serum capability. The approval will eliminate costly duplicative testing, as well as the wasteful practice of providing kit controls for both urine and serum in the same kit."

"This outcome favorably impacts our ability to manage production costs and prices. Equally important, the conversion of the product`s approval status from a biologics license (BLA) to a PMA may give us additional benefits in terms of reduced regulatory burden and facilitated product improvements", continued Ms. Katz.

Calypte Biomedical Corporation (Nasdaq:CALY), headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte`s tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in over 40 countries worldwide through international distributors and strategic partners.

Statements in this press release that are not historical facts are forward-looking statements, including statement of plans regarding the effect of the FDA`s approval of the PMA for the Cambridge Biotech(TM) HIV-1 Urine Western Blot on market adoption of the Company`s products and on modifications of the Company`s cost structure. Such statements reflect management`s current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to the Company`s ability to obtain additional financing that will allow it to continue its current and future operations, its ability to draw down funds under its existing equity line of financing agreements and whether demand for its product in domestic and international markets will continue to expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company`s expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company`s success are more fully disclosed in its most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including the periodic report on Form 10-K for the year ended December 31, 2000 and other filings with the SEC.

CONTACT: Calypte Biomedial Corporation, Alameda
Nancy Katz, 510/749-5100

URL: http://www.businesswire.com
Today`s News On The Net - Business Wire`s full file on the Internet
with Hyperlinks to your home page.


Quelle:
http://www.bigcharts.com/news/articles.asp?newsid=781926694&…

MfG
CASH$

[erkilein]

@cash, das ist ein testprodukt und kein medikament, also wesentlich geringere margen zu erwarten, dazu ist caly aber mindestens genauso hoch verschuldet wie einige biotechs. das potential scheint bis 1 $ max 1,50 begrenzt.

[@CASH@]

@erkilein 1$ bis 1,5$ sehe ich als realistisches Ziel
Genau wie Du.
Man hat USD 7,3 MIO Umsatz für Q2 angekündigt.
Letzes Q lag bei USD 1,2 Mio

hier ist die Quelle:
http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7076655&…

MfG
CASH$

[Thierri]

Na, dann informiert Euch mal über Gilead Sciences [GILD/885823].

Deren Mittel gegen HIV namens Tenofovir zeigte so gute Ergebnisse, daß die FDA eine frühere Zulassung als geplant vorsieht.

Gilead hat eine umfassende Produktpipeline und ist schon seit Jahren erfolgreich. Dies u.a. mit dem Mittel Tamiflu, das in den USA einen Marktanteil von über 50% hat und nun auch in Europa und Asien zugelassen werden soll. Sehr interessantes Unternehmen: http://www.gilead.com

[erkilein]

@cash:
was verkaufen die so heftig innert 3 monate? hoffentlich keine beteiligungsumsätze oder ähnliches. ich glaub ich warte das delisting ab, dann wird das gap geschlossen und an diesem tag geh ich rein, war bei frtl auch so gelaufen
mit der cashsumme (89K) bleiben sie nie und nimmer im nasdaq.

[puhvogel]

@erki Die haben nochmal eine Geldspritze von 300 K (?)von einer Investorengemeinschaft bekommen, als der Kurs ganz unten war.
Schau mal unter www.secinfo.com nach

[erkilein]

danke puhvogel, 4mal das ganze und damit 850.000 $...schluck(april bis juno)

[erkilein]

ich glaub da waren sogar noch mehr transaktionen bis märz/april plus Pepgen-verkauf 500.000 $, ich schätze, die haben an die 1,7 mio cash. schau mal den monatschart an über 5 jahre...ich glaub, das isses

[puhvogel]

Die FDA als Jäger:
Momentan liegt die Zulassungsquote wohl eher bei 20 % als bei 70 %.

Pharmacia Shares Fall After FDA Rejects Painkiller (Update2)
By Kim Dixon
Frankfurt, July 16 (Bloomberg) -- Pharmacia Corp. shares fell as much as 6.6 percent in Germany after U.S. regulators rejected the drugmaker`s application for an injectable painkiller designed to reduce the need for morphine.
The Food and Drug Administration cited ``deficiencies`` in the application, Pharmacia spokesman Craig Buchholz said Friday. The shares fell as much as 3.60 euros to 50.90 ($43.63), after closing at $46.85 in the U.S. last week.
The drug was Pharmacia`s best bet for a new product this year, said Tim Anderson, an analyst with Prudential Securities. Pharmacia said Friday it will conduct new studies within 18 months to collect an unspecified amount of data that the FDA requested. ``This was supposed to be the one positive catalyst coming out in 2001, the one thing people were looking for this year,`` said Anderson, who had expected $60 million in worldwide revenue for the drug in 2001 and $216 million in 2002. The drug, known as parecoxib sodium, would be the first injectable form of a class of prescription painkillers known as Cox-2 inhibitors, which includes Pharmacia`s Celebrex and Merck & Co.`s Vioxx. Celebrex and Vioxx generated combined sales of $4.6 billion last year. Scientists designed the Cox-2 drugs to kill pain as well as older medicines, such as ibuprofen, without the gastrointestinal side effects of those treatments.
Peapack, New Jersey-based Pharmacia planned to sell the new medication for hospitalized patients with severe pain and those who have had surgery such as a hip replacement. The FDA`s rejection follows a series of setbacks for rivals.
Switzerland`s Novartis AG in June failed to win approval for its irritable bowel syndrome medicine Zelnorm and this month learned that its Xolair allergy and asthma treatment faces a delay because U.S. regulators need more information. Aventis SA, Roche Holding AG and Eli Lilly & Co. have also experienced delays.
Last year, the median review time for first-of-a-kind medicines rose for the first time in seven years. This year, the FDA has only cleared nine of the so-called new molecular entities, compared with about 18 by this time last year.
-----------------------------------------
Analyst Michael King said Chiron received a letter from the Food & Drug Administration last Thursday requesting more information before granting approval to its nucleic acid testing system (NAT) -- which tests donated blood for the HIV and hepatitis C viruses.

"We now assume that NAT will get approval at the end of 2001 and that [the company will] begin to see increased revenue in 2002," King said. The analyst noted that the decrease in revenue from the delay goes straight to Chiron`s pre-tax net income.
---------------------------------------------

[puhvogel]

Zieht Eure Schlüsse daraus:

Late Friday, the FDA failed to give its approval to Pharmacia`s new drug application for parecoxib sodium as a pain treatment. The company, however, stated that it does not believe there will be a financial impact for 2001 and reaffirmed its previous goal of 20 percent earnings-per-share growth for 2001. UBS Warburg called both the timing and the decision "a true surprise," noting that the FDA responded in 10 months rather than the 12 months typically expected for a standard review.
"We had viewed this drug as having a high probability of success given its demonstrated efficacy. The company has stated that it will likely take 12 to 18 months to refile, so a launch is now unlikely until mid-2003," analyst Jeffrey Chaffkin said in a research note.

[gholzbauer]

Wird auch Zeit.

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

Wednesday July 18, 4:32 pm Eastern Time
Transkaryotic, Merck executives said up for FDA post
By Lisa Richwine

WASHINGTON, July 18 (Reuters) - A biotechnology company lawyer and a Merck and Co. Inc. (NYSE:MRK - news) executive are candidates to become the new head of the Food and Drug Administration, industry and congressional sources said on Wednesday.


Michael Astrue, general counsel for Transkaryotic Therapies Inc. (NasdaqNM:TKTX - news), and Merck Senior Vice President Eve Slater are on the Bush administration`s list of potential nominees for FDA commissioner, said a congressional aide who declined to be named. The nomination must be confirmed by the Senate.

``We don`t speculate on personnel decisions,`` said White House spokesman Scott McClellan.

Astrue served as general counsel for the Department of Health and Human Services, which oversees the FDA, when President Bush`s father was president and also advised former President Reagan. Astrue also has worked for biotech company Biogen Inc.(NasdaqNM:BGEN - news).

Transkaryotic, based in Cambridge, Massachusetts, is developing gene therapy and other gene-related products.

Slater, who heads regulatory and clinical development for New Jersey-based drug giant Merck, has presented data on drug products to several meetings of FDA advisory panels.

An industry executive likely would be a controversial choice because some critics do not think a person with strong ties to drug makers should regulate them.

``You don`t want the fox guarding the chicken coop,`` Sen. Edward Kennedy, the Massachusetts Democrat who heads the committee that would hold hearings on a nominee, told Reuters.

Kennedy said he had talked with Health and Human Services Secretary Tommy Thompson about the qualifications needed to head the agency, which regulates more than $1 trillion worth of products including pharmaceuticals and most foods.

``I have not endorsed anyone. What we need is a good manager, a good scientist, someone who understands the agency and someone at the cutting edge of new kinds of science and technology to be able impact the agency in these new areas,`` Kennedy said.

Jeff Trewhitt, a spokesman for the Pharmaceutical Research and Manufacturers of America, said he had heard that Astrue and Slater were candidates but that the drug makers` lobbying group would not comment until Bush makes a nomination.

Neither Astrue nor Slater could be reached for comment and White House spokesman Scott McClellan said, ``We don`t speculate on personnel decisions.``

The FDA has been without a permanent leader since January, when former Commissioner Jane Henney left shortly before Bush took office. Bernard Schwetz, a veterinarian and former deputy to Henney, is serving as acting commissioner.

[puhvogel]

UPDATE-1 FDA advisory panel rejects Amylin`s diabetes drug
By Toni Clarke
NEW YORK, July 26 (Reuters) - Amylin Pharmaceuticals Inc.(NasdaqNM:AMLN - news) said on Thursday a panel of experts voted against recommending its experimental diabetes drug, Symlin, to regulators.
A nine-member panel voted eight-to-one against approving the drug for Type I diabetes, and three-to-six against approval for Type II diabetes. The first type of the disease affects about 1 million young people in the U.S. The second type affects about 10 million older people. Symlin is the company`s leading product candidate.
The panel requested that Amylin provide additional information about how physicians should prescribe the drug and in what quantities. The panel`s recommendation will now be passed to the U.S. Food and Drug Administration, which typically, but not always, follows the panel`s advice.
``I think the concerns of the committee are reasonable and addressable,`` said Daniel Bradbury, Amylin`s executive vice president. ``We will work with the FDA to define the scope of further studies to ensure these concerns are addressed.`` Prior to the committee meeting, one FDA medical reviewer said in a written report that while Symlin briefly reduces excessively high levels of glucose in the blood, it pushes levels too low over the long term.

``I am encouraged by the fact that the panel and the FDA agreed that Symlin showed efficacy,`` said Bradbury. ``And we showed the adverse events that they had concerns about were dose-dependent.`` The data suggests that it might be possible to avoid such episodes, Bradbury said, by testing patients on lower doses. ``Their concern was over safety in the first four weeks of therapy,`` Bradbury said. ``We had data showing no increase in risk after that,`` he said.
``Symlin has had a checkered history, so I`m not surprised the panel vote was negative,`` said Yi Ri, an analyst with Mehta Partners. ``This probably leaves Amylin in critical but stable condition.`` Data from Symlin trials have shown inconsistencies with both positive and negative results and Amylin`s shares have moved in tandem. The FDA panel`s decision is the latest blow Symlin has suffered on the road to seeking regulatory approval. In 1998, pharmaceuticals company Johnson & Johnson (NYSE:JNJ - news) dropped its three-year collaboration with Amylin to develop Symlin. It said Symlin didn`t fit into its portfolio.
In the meantime, the company plans to push ahead with several other products it has in the pipeline. Its cash is enough to fund its activities, including new clinical trials for Symlin, for a year, Bradbury said. The company had $60 million in cash at the end of the first quarter and raised an additional $35 million in a private placement. It`s burn rate for the quarter was $15 million. The company has said it doesn`t expect that figure to rise significantly in the second quarter.
The company plans to enter late-stage human trials of another diabetes drug, called AC2993, by the end of the year. The company is also working on a drug, currently in early stage human trials, to prevent the reblocking of arteries after heart surgery.

[puhvogel]

US panel not convinced spray flu vaccine safe
By Lisa Richwine
GAITHERSBURG, Md., July 27 (Reuters) - A U.S. advisory panel said on Friday it was not convinced that an experimental influenza vaccine sprayed into the nose was safe enough to win government approval.
The decision by a Food and Drug Administration committee prompted maker Aviron (NasdaqNM:AVIR - news) to announce it could not bring the vaccine to the market in time for the upcoming flu season. The product, called FluMist, could offer a pain-free alternative to annual flu shots. The FDA panel ruled that studies in 24,000 people showed the vaccine was effective in preventing the illness in kids as young as one year old and adults up to age 64.
But the panel voted 10-4 that information presented during a two-day meeting was insufficient to show FluMist was safe. Many members said further data might ease their concerns and they urged Aviron to continue development.
``I do think this vaccine will turn out to be safe but from the data we`ve seen ... I do think we need more information,`` said Judith Goldberg, director of biostatistics at New York University School of Medicine.
FluMist is key to the future of Aviron, which is trying to get its first product on the market. Industry analysts predict FluMist, which American Home Products Corp. (NYSE:AHP - news) would co-market, could generate $1 billion in annual sales in a few years if it gets FDA clearance.
Aviron Chairman and Chief Executive Boyd Clarke told reporters after the panel vote that, ``we will not be able to launch this vaccine in time to participate in the 2001-2002 flu season.``
The company had hoped to have limited quantities available for the upcoming flu season, which usually begins in the fall and peaks in the winter.
``Our primary objective still remains securing licensure of this vaccine in order to participate in a full launch for FluMist in 2002,`` Clarke said.
Aviron is continuing to provide data on FluMist`s safety to the FDA, he added. About 70 million people get flu shots each year to prevent the fever, aches and misery the illness brings. Flu complications kill 20,000 Americans each year and send 100,000 people to the hospital.
FluMist contains live, weakened flu strains that are sprayed up the nose to stimulate immunity against the virus at a place where it enters the body. Flu shots are made with killed flu viruses.
Panel members said they were concerned about a lack of information on how FluMist affected people with asthma or weak immune systems, as well as children who were given other immunizations at the same time.
Aviron said FluMist`s most common side effects were mild, such as a runny nose.
In one clinical trial, FluMist provided children with 95 percent protection from feverish illnesses and 97 percent protection from ear infections, a common flu complication.
Panelists said FluMist`s easy administration made it appealing for use in children, a group hard-hit by the flu, but not commonly vaccinated with shots.
``As a pediatrician, I am really very excited about the possibility of having an effective, relatively safe vaccine with ease of administration,`` Dr. Walter Faggett said.
Studies in adults were less successful, failing to show that FluMist reduced feverish illness during a flu outbreak compared with a placebo spray. Data did show FluMist cut rates of severe illness and upper respiratory infections.
Company studies did not compare FluMist to a flu shot.
Trading of Aviron shares was halted during the panel meeting. Aviron is based in Mountain View, California.

[erkilein]

AVANT Immunotherapeutics Reports Second Quarter 2001 Financial Results and TP10 Pediatric Phase IIb Studies Placed on Clinical Hold

NEEDHAM, Mass., Aug 1, 2001 /PRNewswire via COMTEX/ -- AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN chart, msgs) today reported financial results for the second quarter ended June 30, 2001. The Company reported a net loss of $5.7 million, or $.10 per share, for the second quarter of 2001 compared to a net loss of $2.7 million, or $.05 per share, for the second quarter of 2000. The results for the second quarter of 2001 primarily reflect a substantial increase in research and development expense compared to the same period in 2000. This increase resulted from increased clinical trials costs and clinical materials costs incurred in connection with the Company`s TP10 and CETi-1 clinical programs, as well as the addition of the operating costs of Megan Health, which AVANT acquired in December 2000. The Company ended the quarter with cash and cash equivalents of $40.7 million.

For the six months ended June 30, 2001, the Company reported a net loss of $9.7 million, or $.17 per share, compared to a net loss of $4.8 million, or $.10 per share, for the six months ended June 30, 2000. The six-month results for 2001 reflect an increase in net loss of $4.9 million compared to the same period in 2000. This increase in net loss primarily reflects a substantial increase in operating expense offset by an increase in revenue. The increase in revenue reflects differences in revenue recognized from the amortization of nonrefundable license fees received from our collaborators between the comparable six-month periods, revenue from SBIR grants recorded in 2001, and the addition of Megan Health revenue in 2001. The increase in operating expense is primarily due to increased clinical trials costs and clinical materials costs incurred in connection with the Company`s clinical programs. It also results from the addition of the operating costs of Megan Health in the six-month period in 2001 and an increase in the charges for amortization of acquired intangible assets related to the Megan Health acquisition in late 2000.

TP10 Pediatric Phase IIb Studies Placed on Clinical Hold

The Company suspended enrollment in its two Phase IIb studies of TP10 in infants undergoing cardiac surgery following receipt from the Data Safety Monitoring Board (DSMB) of a request for additional detailed information from these studies, including patient records for reported serious adverse events. The DSMB has met and reviewed the information requested, and has indicated that patient enrollment may be reinstated, with the recommendation to add additional laboratory tests to the study protocol. The U.S. Food and Drug Administration (FDA) has been notified that patient enrollment in the studies has temporarily been suspended. In response, the FDA has placed the pediatric programs on clinical hold, pending their review of these additional data. While the Company has not received written notification of the FDA`s specific questions and requests, it is working closely with the Agency to resolve this matter expeditiously. AVANT believes that this is a short-term situation and the Company is committed to complying with the FDA`s formal requests as soon as they are received. The Agency`s review of the pediatric TP10 studies does not affect the adult cardiac surgery program, which is continuing as planned.

"The infants in these studies are critically ill and are undergoing major reconstructive cardiac surgery that requires long times on cardiopulmonary bypass circuits which can result in considerable mortality and morbidity in this patient group," said Dr. Alistair Wheeler MD, Vice President, Medical Affairs of AVANT. "We have taken appropriate action to suspend enrollment in these trials pending review by the FDA of all data. We believe the serious adverse events reported by the investigators are consistent with those seen in this population of infants. We are very encouraged by the DSMB`s conclusion, after reviewing detailed data we provided them, that enrollment in the studies could be reinstated. We look forward to reviewing the data with the FDA."

Other Clinical Development Programs

AVANT remains focused on developing products that use novel applications of immunology to harness the human immune response to prevent and treat disease. The Company continues to make progress this year in advancing multiple products in its pipeline to later stages of clinical development.

During the quarter, AVANT announced results from the Phase IIb human challenge study of its single dose, oral cholera vaccine, Peru-15. Peru-15 showed 100% protection against moderate and severe diarrhea and 93% protection against any diarrhea. The study results suggest that, if confirmed by further investigation, Peru-15 may be an excellent candidate as a potential single dose, oral vaccine for travelers going to areas where cholera is endemic. AVANT also announced a manufacturing agreement with Bio Sidus S.A. of Buenos Aires, Argentina for the production of commercial quantities of Peru-15. AVANT will move rapidly to complete the manufacture of cGMP grade material this year and to initiate pivotal trials in the first half of 2002. Development of a safe, effective cholera vaccine is the first step in establishing AVANT`s travelers` vaccine franchise.

In addition to the two placebo-controlled Phase IIb studies of TP10 in babies (one in babies born with hypoplastic left heart syndrome, who often have high morbidity and mortality after heart surgery, and the second also in the pediatric cardiac surgery setting, but with a lower risk infant population), AVANT is actively enrolling a placebo-controlled Phase II trial of TP10 in approximately 600 adult patients undergoing cardiac surgery utilizing cardiopulmonary bypass. The objective of these three studies is to assess the ability of TP10 to mitigate the injury to the heart, brain and other organs that occurs when patients are placed on cardiopulmonary bypass circuits, thus potentially improving post-operative outcomes.

In February 2001, AVANT announced preliminary results from a double- blinded placebo-controlled extension of its earlier completed Phase I trial of its CETP vaccine (CETi-1) in healthy adult volunteers receiving a second dose of the vaccine. CETi-1 is being developed for the management of patients with low levels of HDL (high-density lipoprotein) cholesterol. Results from the extension study showed measurable antibody titers in all dose groups treated with the investigational vaccine and suggest a dose-response relationship. These data have been extremely helpful in designing a Phase II study, which AVANT plans to begin later this summer.

During the next twelve months, AVANT expects its partner, GlaxoSmithKline, to initiate Phase III studies of its investigational rotavirus vaccine, Rotarix(TM). This product is a two-dose oral rotavirus vaccine that has been shown to be helpful in preventing rotavirus gastroenteritis (RGE) disease in young children for at least two years following the vaccine`s administration. The design, timing and execution of the clinical program for Rotarix(TM) is the responsibility of GlaxoSmithKline.

[puhvogel]

Weekday Trader

--------------------------------------------------------------------------------
August 2, 2001
An FDA Boss Could Fast Track Drug Stocks
By Evelyn Ellison Twitchell

Lately, FDA drug approvals have been like a ride to the Hamptons on a humid Friday night in August: slow.
From October through June, the Food and Drug Administration`s median approval time for drugs climbed to about 16.9 months, from 15.6 months during the same period the year before, according to Schwab`s Washington Research Group. The sudden spike has caught Wall Street off guard. It reverses a trend in which the FDA slashed median approval times to 11.6 months in 1999 from 32.8 months in 1986. And it`s one contributor to the selloff in drug stocks this year: The group is down 13% in 2001, according to Thomson Financial/Baseline.
But approvals could pick up in the next several months because an FDA commissioner should be appointed this fall, and additional funding for the agency could kick in, some analysts suggest. The FDA has been leaderless since Jane Henney stepped down when President Bush took office. "The biotech and the pharmaceutical industries will breathe a sigh of relief when someone is actually nominated," says Joan Woodward, a political analyst at Goldman Sachs in Washington. There are many reasons for the sluggishness: Last month, the FDA delayed marketing of the asthma medication, Xolair, for example, because it wants developers Genentech and Novartis to produce more data on the product`s safety and mechanism of action. And the agency pushed back consideration of Eli Lilly `s Sepsis treatment, Xigris, citing concerns about manufacturing at Lilly`s partner, Catalytica Pharmaceuticals. In general, the trend seems to be the result of mounting concerns over safety, increasingly complicated drugs -- and the lack of an FDA commissioner.
"The fact that there isn`t somebody running the FDA would probably make people a little gun-shy about making controversial decisions," says Paul Heldman, a political analyst at Schwab. Woodward, however, believes President Bush could nominate a commissioner by September.
Until recently, the short list of candidates included Michael Astrue, general counsel for Transkaryotic Therapies , and Lynn Drake, a Harvard Medical School lecturer, she says. Just this week, two new names have surfaced: Thomas Caskey, CEO of Cogene Biotech Ventures, who taught at Baylor College of Medicine for 25 years, and Paul Yock, a Stanford School of Medicine cardiologist. The names were first reported by "The Pink Sheet," a trade publication. The emergence of new names "tells us that Bush`s people are aggressively trying to fill the post, " Woodward says. It also suggests that previously circulated names may have been rejected after Sen. Edward Kennedy (D-Mass.) discouraged the nomination of an industry insider, she says. Kennedy chairs the Senate Health, Education, Labor and Pensions Committee, which must approve the nominee. In reality, approval times may never return to the record pace of the late-1990s, when a backlog of drugs awaited review, says Linda Miller, manager of the John Hancock Health Sciences Fund. But simply having a commissioner in place to be accountable should speed things up somewhat, she says: "You just need somebody to be in charge and to take responsibility for decisions."
Meanwhile, the FDA could get a boost from a 10% increase in its budget, which has already passed the U.S. House of Representatives and is making its way through the Senate, Heldman says. That would be a jump from recent increases in the low-single digits. The FDA, for its part, doesn`t take responsibility for the slowdown. Instead, it blames a declining percentage of priority applications, which are reviewed in six months. Also, it suggests the small number of drugs that require additional data or label revisions are increasing the median approval time. Faster approvals would obviously be good for drug stocks. "There`s a real straight-forward correlation between new products and drug-stock performance," Miller explains.

[blabla]Companies such as Amgen and Schering-Plough , which are awaiting approval of potential blockbusters, stand to gain, she says. Amgen`s anemia product, Aranesp, could have peak annual sales of $1 billion to $2 billion, and Schering`s allergy drug, Clarinex, could top $1 billion per year. But Amgen still trades at a lofty 53 times expected 2001 profits, and Schering must resolve its own manufacturing problems. A more promising alternative: Lilly.
Lilly`s Xigris, which could be the first medicine approved to treat Sepsis -- severe infection that can cause organ failure and death, is a "very, very exciting product," says John Schaetzl, an analyst at GE Asset Management. It could produce sales of $2 billion annually within a few years. The manufacturing issue that has held up approval seems to be minor, compared with the situation at Schering, Schaetzl says. Lilly`s shares aren`t cheap. At 79.55 Thursday, they changed hands at 28x the $2.82 per share the company is expected to earn this year, according to First Call. The company`s anticipated secular growth rate is 14%. But the stock is trading slightly below its median multiple of 30x projected earnings over the past five years. And it is at just a 20% premium to the Standard & Poor`s 500 Index, vs. its more typical 40% premium, according to Baseline. Granted, even if drug approvals in general speed up, Xigris could fail for any number of reasons. And, more broadly, drug stocks could come under pressure as the national debate over drug prices heats up and investors get interested in other sectors again. [/blabla]

Nevertheless, a new leader of the FDA, combined with added agency funding, could spark speedier approvals. And that alone would be good medicine for the stocks.

[puhvogel]

Das Zulasssungsklima hat sich bedeutend verbessert, allerdings werden Studien aufgrund des Drucks der FDA und der Rechtsanwälte, die auf neue Lipobays geiern, immer teurer. Man muss sich nicht über teuer Medikamente beschweren.

NEW HIGH IN DRUG DEVELOPMENT COSTS.
The cost of developing a new prescription drug has jumped
to $802 million a new report said (The Tufts Center for the
Study of Drug Development, Boston), attributing most of the
increase to cost of clinical trials. The Center said it based this figure on information obtained from 10 drug firms. A decade ago, the estimated average cost were at $231 million.

[puhvogel]

Zur obigen Text muss man noch ergänzen, dass die Bush-Regierung die FDA -Gebühren um 60 % erhöhen will.

FDA slows down, frustrating biotechs
Joel Ozretich Staff Writer

After seven years of improving the pace of new-drug approvals, the U.S. Food and Drug Administration has slowed its reviews of therapies such as one developed by Seattle-based Corixa Corp. to treat an intractable form of non-Hodgkin`s lymphoma.

The FDA recently postponed an expected February review of Corixa`s drug candidate, acknowledging it simply didn`t have the time or reviewers available to study the requisite documents. Now the agency is expected to miss by three months its self-imposed 12-month timetable for evaluating such drugs.

The delay for Corixa`s drug Bexxar is symptomatic of a larger problem affecting pharmaceutical and biotechnology companies nationwide.

The FDA is receiving an increasing number of applications for new drugs without any increase in its budget or staff. At the same time, the agency has been without leadership for more than two years, since President George W. Bush took office and removed former FDA Commissioner Jane Henney.

"We have what I would call a headless horseman," said John McCamant, editor of the Medical Technology Stock Letter, a Berkeley, Calif.-based newsletter to advise biotechnology investors. "At a critical time for the FDA, no one is running the show."

The Biotechnology Industry Organization, a Washington, D.C.-based lobbying group, estimates there are more than 350 drug candidates in development by biotechnology companies alone. That does not include those in development by pharmaceutical companies.

"They`re a bit overwhelmed with the number of applications," said Thomas Dietz, a biotechnology analyst at Pacific Growth Equities of San Francisco.

As a result of this heavy workload, the biotechnology trade group notes that the FDA approval process has slowed in the past year. The number of new biotech drug and vaccine approvals decreased to 24 in 2001, from a high of 36 in 2000. Overall, 66 drugs from pharmaceutical and biotechnology companies were approved in 2001, compared to 98 in 2000 and a peak of 131 in 1996, according to FDA statistics.

To make matters worse, President Bush`s $2.13 trillion budget proposal this week did not include any increases for the two FDA divisions that deal with drug approvals, the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research, McCamant said.

In response to these problems, the Washington Biotechnology and Biomedical Association and its national counterpart are pushing for changes at the FDA.

The biotech industry organizations would like to see funding increases for the FDA and the appointment of a new commissioner as soon as possible. The groups are also supporting reauthorization of the Prescription Drug User Fee Act, which expires this fall. The act allows the FDA to charge filing fees to pharmaceutical and biotech companies, with proceeds going to help speed up the approval process.

Since 1993, the year the act first went into effect, the median review time for standard drug applications fell from 26.9 months to a low of 12 months in 1998. But last year, the median review time increased to 14 months, according to FDA statistics.

"(Approval times) are obviously a lot better than they were in the early 1990s. It was up to about three years and they got that down to about one year," said Eric Earling, director of public and government affairs for the state biotechnology association. "Now, that`s creeping up to 14 or 15 months, or even longer. So that`s obviously an issue."

Most industry analysts do not see a direct correlation between the lack of an FDA commissioner and additional resources, and the time it takes companies to get drugs approved.

But the agency`s workload clearly affected its decision not to review Corixa`s leading product, Bexxar, this month.

"We understand that (the FDA) has to balance the risk and the reward," McCamant said. "But we believe in the area of cancer, you can take more risk in the benefit of saving more lives. (Potential Bexxar) patients are dying while Bush is not making this move."

Corixa will most likely have to wait until the FDA`s next scheduled cancer drug meeting in June.

So far, Corixa is the only local biotech company directly affected by the FDA`s lagging approval process, but Bothell-based Icos Corp. is also awaiting approval for its erectile dysfunction drug, Cialis, which will compete with Pfizer Inc.`s Viagra.

Analysts expect Icos will hear back from the FDA in June, about one year after the company filed its new drug application with the agency.

But the company`s stock could be punished by investors if the drug`s approval is delayed too long. Shares of Icos stock dropped 5 percent on Jan. 30, when the company estimated wider than expected losses as the company prepares to launch Cialis.

"Icos took a big hit last week," said McCamant, whose investment group owns stock in both Corixa and Icos.

The company`s losses could continue to mount if approval of Cialis is delayed beyond the company`s anticipated time frame of the second half of this year. In the long run, however, the approval date will not affect the value of the company, said Andrew Heyward, an analyst at Seattle-based investment firm Ragen MacKenzie Inc.

"Whether it gets on the market in May or June or August or September doesn`t make a whole lot of difference," Heyward said. "It certainly doesn`t say anything about Cialis` effectiveness or safety."

[puhvogel]

!!!
FDA Nominee Confirmed by Senate

WASHINGTON (Reuters) - President Bush`s nominee to head the U.S. Food and Drug Administration, Mark McClellan, won unanimous confirmation by the U.S. Senate on Thursday, filling an important U.S. health position open for nearly two years.

McClellan, 39, is a Harvard University-trained physician with an economics doctorate now on Bush`s Council of Economic Advisers

Bush nominated him last month to head the FDA, a huge agency that regulates more than $1 trillion worth of pharmaceuticals, medical devices, foods, cosmetics and other products. The agency is now also at the forefront of the effort to defend against bioterrorism and potential threats to the food supply.

``Dr. McClellan has the training, the experience, and the stature to serve as the head of the country`s most important public health regulatory agency -- an agency that serves as the gold standard for the rest of the world,`` said Sen. Edward Kennedy, a Massachusetts Democrat who presided over the quick and cordial confirmation hearings as chairman of the Senate Health committee.

As the first physician on the three-member Council of Economic Advisers, McClellan has a voice in a large range of health policy issues.

McClellan has no ties to the pharmaceutical industry -- a prerequisite for winning support for some Senate Democrats. He is generally well-regarded on Capitol Hill and among economists, although some lawmakers and interest groups had voiced concern at his lack of regulatory experience.

Before taking his job at the White House, McClellan was an associate professor of medicine and economics at Stanford University and worked in the treasury under former President Bill Clinton.

His younger brother, Scott, is a White House deputy press secretary and his mother, Carole Keeton Rylander, is a former mayor of Austin, the capital of Bush`s home state of Texas.

[puhvogel]

!!! Ein Muß für jeden Biotechinvestor!

Decline in New Drugs Raises Concerns FDA Approvals Are Lowest in a Decade

By Marc Kaufman
Washington Post Staff Writer
Monday, November 18, 2002; Page A01


New drugs to treat and cure sick patients are coming into the market in the United States at the slowest rate in a decade, despite billions invested by pharmaceutical companies on research and a costly expansion by the federal agency that reviews new medicines.

The decline in the number of new drugs is most pronounced in the category considered by the Food and Drug Administration to have the greatest promise for patients -- those listed as breakthrough "priority" drugs and "new molecular entities" that are different from any others on the market.

The slowdown is troubling to many because it is largely unexpected. The drug industry now invests three times as much money in research as it did a decade ago, and the FDA has already undergone a major revamping to become more efficient and prompt -- an expansion funded largely by user fees from the drug makers. Yet the number of industry applications for innovative new drugs is down significantly, and the average time needed by the FDA to review applications is moving up.

The net result of both trends is a steep drop in the number of new drugs coming to the market to help cure and treat illnesses, and growing disappointment among many patients and their families and advocates.

"We hear talk all the time from the drug makers of the great drugs waiting in line, but the reality doesn`t seem to match the facts," said Ellen Stovall, director of the Cancer Leadership Council, a patients advocacy group. "There`s been a lot of hope about new drug cures and treatments and we`ve seen some progress, but lots more disappointment."

The possible reasons for the decline -- whether it is a function of FDA caution after some high-profile drug withdrawals, industry shortcomings and strategies, or a troublesome combination of both -- is the subject of an increasingly urgent debate. Some believe the drop is a relatively short-term development that will resolve on its own, while others believe there is a deeper and more fundamental problem. (Ich auch)

"Industry was trying to hit home runs, and it struck out a lot," Henry McKinnell, chief executive of the largest pharmaceutical company, Pfizer Inc., said in an interview. "Added to that, the [FDA] is giving greater scrutiny to each drug application. The result is that we are spending more time on each drug, spending much more on research, but seeing a definite drop in the number of new drugs."

Like many drug industry leaders, McKinnell still sees a "golden period" for new drug discovery ahead. But he acknowledges it may be further off than once predicted.

The newly confirmed commissioner of the FDA, Mark McClellan, has said that getting more drugs into and through the FDA review process is a top priority. McClellan was sworn in last week, filling a leadership void at the agency that had lasted 20 months.

The number of new drugs coming onto the market peaked in the mid-1990s, when the FDA approved more than 120 new drug applications in both 1996 and 1997 after being criticized for being too slow. Among the breakthrough drugs approved in that period are the cholesterol-lowering Lipitor, the novel osteoporosis medication Fosamax, and the protease inhibitors that revolutionized treatment of AIDS. But by 2001, the number of annual new drug approvals had dipped to 66, and for 2002 stood at 46 at the end of September.

But followers of the drug industry generally look to the smaller category of "new molecular entities" (NMEs) -- chemicals never before used as medications -- to assess how well the drug development and review process is working. In that group, the decline was even steeper. The annual number of NMEs approved went from an all-time high of 53 in 1996 to 24 approvals in 2001. By the end of this September, the number of NMEs approved was only 11 -- a pace that could result in the lowest yearly total of NME approvals since the 1980s.

Equally worrisome, the number of new drug industry applications for "priority" new drugs -- the ones that the FDA concludes are most likely to be breakthrough, potentially life-saving treatments -- has declined precipitously. Although there were 32 priority applications in 1997, there were only six in 2001. So far this year, there have been five.

Pharmaceutical industry officials say the slowdown can be at least partially explained by the fact that companies are making a major shift from developing new drugs through traditional chemistry to instead using cutting-edge biotechnology. Reflecting that change, a recent report from the Pharmaceutical Research and Manufacturers of America (PhRMA) found that a record 116 medicines made through biotechnology are now in the last phase of clinical testing or awaiting FDA review.

While the drug industry has been struggling with these research obstacles, many also believe the FDA has become notably more cautious in its review of new drug applications -- largely in response to the 10 drugs withdrawn from the market between 1998 and 2001 for safety reasons.

Most of those drugs had been approved by the FDA in the mid- 1990s, when the number of new drug approvals skyrocketed after the creation of an industry-funded program that expanded and streamlined the review process. None of the withdrawn drugs was life-saving, yet all proved fatal to some users and the agency was criticized for being too lenient in allowing new drugs on the market.

Although agency officials disagree with the assessment that there was a problem with drug approvals during the mid-1990s, they do acknowledge that they became more sensitive in recent years to some better understood potential problems with new drugs.

"As we identify safety concerns with one product or area, that can lead to a need to evaluate another new product more closely than we would have if we didn`t have that knowledge," said John Jenkins, the director of the office of new drugs for the FDA`s Center for Drug Evaluation and Research. "It would be irresponsible for us not to do that."

But Jenkins said the primary reasons there are fewer drugs being approved is that there are fewer applications from industry.

Nonetheless, Kenneth Kaitin, director of the Tufts University Center for the Study of Drug Development, said that FDA review was having an impact. "The FDA is clearly showing the stress of maintaining the torrid pace it set in the mid-1990s," he said.

But Kaitin said the FDA is not necessarily responsible for the low number of drug approvals. "It`s ludicrous to say the FDA is making it too hard," he said. "The industry pipeline is dry." A-Ha, das klang ja vor zwei Jahren ganz anders

And those that are being submitted are increasingly "me-too" versions of popular medications already on the market. The National Institute for Health Care Management, a nonprofit research group associated with the Blue Cross system, reported earlier this year that although the number of standard drugs being approved by FDA has remained relatively steady, the more innovative "priority" drugs have plummeted.

The last FDA commissioner, Jane Henney, said that she was concerned by the declining number of new drug applications when she was in office. She said it was a problem that needed to be addressed on a national, public-private basis.

She denied there was any conscious decision to slow down the review process during her tenure, though she acknowledged that the average review time for standard drugs was on the rise. She said, however, that reviews of exciting new drugs -- such as the recently approved cancer medication, Gleevec -- are still being regularly approved within six months, the time period allowed for review of a "priority" drug.

But McKinnell of Pfizer said the regulatory atmosphere clearly changed, and that it has had a chilling effect on drug makers.

He said, for instance, that drug companies may decide not to file an application for new drug approval even though they found a medication to be effective in their trials. He said that after the recalls of the late 1990s, the FDA began requiring more testing for drug-to-drug interactions, for potential liver toxicity and for cardiac risk, and that some companies "look at that burden and decide not to file."

Further complicating the FDA-drug industry relationship is the brain drain and employee burnout that has been widely reported at the agency. After Congress passed the Prescription Drug User Fee Act (PDUFA) in 1992 (and reauthorized it in 1997), the agency committed to performance standards that dictated how long a new drug application should take.

A recent GAO report concluded that PDUFA "has resulted in increased reviewer workload" and may be contributing to increased attrition among staff responsible for reviewing new drugs and biologics.

In an effort to further expedite the FDA drug review process, Congress passed a new PDUFA reauthorization this summer that will bring in $1.2 billion in industry user fees over five years. The stated goal was, again, to speed more drugs to the market.

[puhvogel]

FDA Seeks to Speed New Drug Development

WASHINGTON -- Worried about a serious slowdown in the creation of novel drugs, the government is taking steps it hopes will speed medical innovation, largely by making clearer how companies can prove a new product works before they waste time researching the wrong thing.

Atop the Food and Drug Administration`s priority list being announced Friday are guidelines to speed treatments for cancer, obesity and diabetes -- three of the country`s leading ailments.

The main issue is not how quickly FDA scientists review treatments -- that has sped up greatly in recent years -- but the time it takes to research and develop new medications and medical devices, FDA Commissioner Mark McClellan said.

That work can take over a decade and cost hundreds of millions of dollars. McClellan`s hope is that by making FDA`s requirements for approval more clear from the start, that research could be performed better and faster -- and companies might not be as reluctant to take a chance on novel treatments instead of financially safer copycats.

McClellan said that does not mean the agency is relaxing its requirements.

"If the drugs don`t meet the standards for approval, they`re not going to get through," McClellan told reporters Thursday. "But it`s in everybody`s interest to figure out more quickly and at a lower cost."

Drug companies are sending the government fewer groundbreaking medications each year. The FDA approved just 17 never-before-seen chemicals last year, down from 24 in 2001, said drug chief Dr. Janet Woodcock. The agency received 23 applications for those novel drugs last year, down from 30 the year before and a high of 60 in 1995.

Similarly, the FDA approved 32 novel medical devices last year, down from 56 in 2001.

McClellan`s plans are more a repackaging than a completely new approach. For years, the FDA has encouraged companies to seek its advice early in a product`s development.

But too few do, said veteran FDA watcher Ira Loss of Washington Analysis. He cited ImClone, a biotechnology company that imploded after the FDA rejected its potential cancer treatment Erbitux in December 2001, citing shoddy science that failed to tell if the drug had any effect. The company`s top executive later was charged in an insider-trading scandal.

"At some point, you have to hold the industries accountable for not taking advantage of the opportunities presented to them," Loss said.

Drug discovery is cyclical and dependent on far more -- scientific serendipity and financial investments, for example -- than the FDA, Loss noted. But McClellan`s plan "can`t hurt. If it will help (with speed), we`ll have to wait and see."

Among the FDA`s plans:

* Help companies understand what is needed for quality applications so that more approvable treatments get the FDA`s OK on the first try. The FDA rejects half of all novel medications and 93 percent of cost-saving generic drugs on the first try.

Too often the FDA discovers companies had data that would have cleared up concerns yet did not think to provide it at first, said medical device chief Dr. David Feigal. That can delay marketing at least six months.

* Developing special guidelines for brand-new technology, such as gene therapy, bioengineered tissue or drug-and-device combinations so companies can design the right studies from the beginning.

* More training of FDA reviewers and consistency in requirements for each application.

The medical device industry welcomed the news.

"The more innovators can know what the requirements are at the beginning of the process, the more quickly we can get those kinds of breakthroughs to patients," said Randy Burkholder of the Advanced Medical Technology Association.

The drug industry`s Pharmaceutical Research and Manufacturers of America declined comment, but noted that over 1,000 experimental medications are in development, and almost 4,000 studies of those potential drugs are under way in patients.

[Big Charly]

von wann ist die Mitteilung ????

schau mal hier im Bord unter FDA ERGREIFT INITIATIVE

neuste News vom 31.01.03. FDA gibt Gas

[puhvogel]

Die Nachrichten sind aktuell und doch alles andere als schlecht.