Sepracor (SEPR) - 500 Beiträge pro Seite

[gholzbauer]

Infos zu SEPR`s neuer Claritin-Version:

FEATURE-Claritin countdown puts Schering-Plough on tightrope
By Ransdell Pierson

NEW YORK, Aug 25 (Reuters) - Will the demise of Claritin give Schering-Plough Corp. (NYSE: SGP) runny eyes?

Some analysts predict the nation`s No. 8 drugmaker will shrug off the U.S. patent expiration on its best-selling allergy medicine -- slated for December 2002 -- and continue its 14-year trend of double-digit earnings growth.

But others are less optimistic, saying the company has an anemic pipeline unlikely anytime soon to produce new blockbusters to compensate for potential declines in sales of Claritin once the drug faces generic competition.

"Claritin is 30 percent of Schering-Plough`s sales. No other U.S. drugmaker is so dependent on a single drug, so the patent expiration could spell trouble," said Mario Corso, a pharmaceuticals analyst for Dutch bank ABN Amro.

Indeed, Claritin chalked up U.S. sales of $767 million in the second quarter, 29 percent of the company`s total global revenues of $2.64 billion. The non-sedating antihistamine, whose chemical name is loratadine, had global sales of $2.7 billion in 1999, including $2.3 billion in the United States.

Prescription drugs typically lose up to 80 percent of their sales within a year after their patents expire and cheaper generic versions enter the market.


HIGH-STAKES WEAPON TO SAVE FRANCHISE


But Schering-Plough has a plan to keep its allergy drug franchise from going down the drain when generics hit the scene. Its ace in the hole is desloratadine.

It is a metabolite, or derivative, of loratadine that the company has said is a "superior product" to Claritin and a potential means of wooing millions of allergy patients even before Claritin`s patents expire.

The company has a U.S. patent through April 2004 on the desloratadine compound itself. What`s more, it has licensed from Sepracor Inc. (NASDAQ: SEPR) other U.S. patent rights -- which extend to 2014 -- related to certain uses of the metabolite.

Schering-Plough plans to make desloratadine and sell it as a prescription drug under a different brand name than Claritin. It has already asked U.S. regulators to approve the metabolite and expects to have the agency`s answer by November.

If approval comes, the company plans to launch desloratadine by early next year and is expected wage a vigorous campaign to switch patients to it from Claritin.

Desloratadine is cloaked in mystery. Schering-Plough has divulged very little about it, except that in clinical trials the pill significantly reduced symptoms of hay fever, appeared safe and seemed to work somewhat more quickly than Claritin.

"It doesn`t appear to offer any significant advantages over Claritin. So I believe Schering-Plough will have a hard time self-cannibalizing Claritin by luring patients to desloratadine," said Mara Goldstein, a pharmaceutical analyst at CIBC World Markets. The switchover campaign would become even more difficult once cheaper generic substitutes for Claritin became available, she added.


SKEPTICISM OVER MYSTERY-CLOAKED DRUG


ABN Amro`s Corso also expressed skepticism about desloratadine`s presumed potency and safety advantages over Claritin.

"Schering-Plough has released just little bits of data, but it`s all very vague. Based upon what we know, it doesn`t seem desloratadine will be a major improvement," Corso said.

Another concern is that even without generic rivals, Claritin`s sales growth has already begun to taper amid competition from such allergy drugs as Aventis SA`s Allegra and Pfizer Inc`s (NYSE: PFE) Zyrtec.

Claritin, whose annual global sales had routinely jumped 20 percent in recent years, has chalked up sales gains averaging only about 13 percent in the past four quarters.

"So even if desloratadine works perfectly, it doesn`t appear obvious to me that it will grow Schering-Plough`s overall allergy franchise at all," Goldstein said.

Barbara Ryan, an analyst for Deutsche Bank Alex. Brown, said Wall Street is far from convinced the company`s desloratadine strategy will pan out.

"Desloratadine is largely a defensive move; it`s not meant to attract new business but to protect the company`s allergy business from generics. The company has a lot riding on it and there`s a lot of risk associated with it," Ryan said.


CONCERNS DAMPEN SHARE PRICE


Such concerns have dampened Schering-Plough`s stock price, which is at about a 20 percent discount to those of other large U.S. drugmakers, based on the company`s expected earnings per share this year of $1.65. Shares were trading on Friday morning at 42, a shade below their 1999 closing price of 42-3/16 and well off their price of 55-1/4 at the end of 1998.

Schering-Plough has other weapons, including its drug pipeline and planned improvements of existing drugs, to maintain competitive earnings growth regardless how desloratadine fares. But analysts sharply disagree on the prospects for the drug lineup.

The company`s second biggest franchise is its injectable drug Intron A (interferon alfa-2b) for treatment of certain cancers and hepatitis C. Intron A is also taken with the antiviral pill ribavirin, in a combination product sold under the brand name Rebetron, for treatment of hepatitis C.

Total global sales of Intron A and Rebetron jumped 56 percent in 1999 to $1.1 billion and will likely hit $1.5 billion this year, according to Sergio Traversa, pharmaceuticals analyst for ING Barings.

European regulators in May approved Peg-Intron, a longer-acting form of Intron A, for hepatitis C. The drug, which Schering-Plough says is twice as active and as well tolerated as Intron A, is now awaiting U.S. approval and is also being studied as a potential cancer therapy.

If cleared in the United States, Traversa said, the improved version of Intron A and Rebetron together could claim annual sales of $3 billion by 2005, double expected 2000 sales of the franchise.

There`s also Remicade (infliximab), which Schering-Plough sells in Europe for treatment of Crohn`s disease and rheumatoid arthritis. Traversa forecast that it will have European sales of $60 million this year, growing to $500 million by 2006.

Integrilin (eptifibatide), which prevents platelets from clumping together to form blood clots, had sales of about $55 million in 1999 but could jump to $500 million by 2004, said PaineWebber drug analyst Jeffrey Chaffkin.


ROOM FOR DEBATE ON PIPELINE


Another hope is Asmanex (mometasone), an experimental inhaled steroid for asthma that is awaiting U.S. and European marketing approval. Although Traversa predicts it could rack up annual global sales of $1 billion by 2005, other analysts such as Chase Hambrecht & Quist`s Alex Zisson have forecast more modest sales, in the $200 million to $300 million range.

Caelyx, a liposomal form of the drug doxorubicin, is awaiting approval in Europe for treatment of advanced ovarian cancer and unlikely to be a big money-maker, according to Zisson. "It could break $100 million (a year) in Europe."

"All things considered, I like Schering-Plough`s pipeline
and think its current stock price is reasonable," said Zisson,
who cited the company`s marketing prowess and tight rein on
finances as great strengths. "They`re a tightly managed ship."
Traversa said the company was his "top pick" among large U.S. drugmakers, although he rates its pipeline "not great."

Others, such as ABN Amro`s Corso and CIBC`s Goldstein have "hold" ratings on Schering-Plough shares and described its pipeline as one of the weakest in the industry in terms of innovation and revenue prospects.

"Schering-Plough is really just a two-drug company, Claritin and Rebetron, and hasn`t launched any major drugs in the last few years. They spend a lot on research and development, $1.4 billion slated for this year, but certainly haven`t gotten much out of it in my view," Corso said.

"With such a weak pipeline, the generic situation with Claritin becomes more threatening," Corso said.

Goldstein said Claritin became a blockbuster because of Schering-Plough`s aggressive sales force and its decision to invest heavily in direct-to-consumer advertising to promote the brand. "They did a beautiful job building the franchise."

"But marketing and advertising can carry you only so far. New drugs have to get you through, and Schering-Plough is not in the top of the industry in terms of R&D ability. For them, it`s sort of a long time between products," Goldstein said.

Schering-Plough spokesman William O`Donnell said neither Chief Executive Richard Jay Kogan nor other officials of the company were available for comment.

[gholzbauer]

Sepracor completes efficacy trial for insomnia drug
MARLBOROUGH, Mass., Aug 28 (Reuters) - Drugmaker Sepracor Inc. (NASDAQ: SEPR) said Monday that it successfully completed a 400-patient clinical efficacy trial for its insomnia treatment zopiclone.

The company, which takes drugs nearing patent expiration and tries to reduce their side effects and improve their efficacy, said it was on track to advance the sleep disorder drug into Phase III clinical studies, which are slated to begin during the third quarter.

The drug, which has been marketed by Rhone Poulenc-Rorer, now part of Aventis SA (NYSE: AVE), under the brand names of Imovane and Amoban, is available in about 80 countries and has never been submitted for approval in the U.S.

In this recent efficacy study, patients treated with zopiclone successfully fell asleep and stayed asleep through the night.

Sepracor shares took a hit earlier this month after a court ruling shortening Eli Lilly`s (NYSE: LLY) patent on its anti-depressant Prozac endangered the success of Sepracor`s licensing agreement with Lilly to develop a successor to Prozac.

Shares of Sepracor closed at 105-47/64 on Friday, off a 52-week high of 140, up from a low of 33-1/2.

[gholzbauer]

Sepracor Completes Large-Scale Efficacy Study for (S)-Zopiclone (S)-Zopiclone Demonstrates Significant Improvement in Sleep Maintenance
MARLBOROUGH, Mass., Aug 28, 2000 /PRNewswire via COMTEX/ -- Sepracor Inc. (Nasdaq: SEPR chart, msgs) announced today that it has successfully completed a 400-patient clinical efficacy trial for (S)-zopiclone in the treatment of insomnia. The Company is on track to advance (S)-zopiclone into Phase III clinical studies, which are expected to begin during the third quarter.
Racemic zopiclone is a non-benzodiazepine, rapid-acting hypnotic indicated for the treatment of sleep disorders. Racemic zopiclone, marketed by Rhone Poulenc-Rorer under the brand names of IMOVANE(R) and AMOBAN(R), is available in approximately 80 countries worldwide and has never been submitted for approval in the U.S.
In Sepracor`s recently completed large-scale efficacy study in transient insomnia, patients treated with (S)-zopiclone successfully achieved all efficacy endpoints, including rapid onset of action and long duration of activity, resulting in patients falling asleep and staying asleep through the night. All endpoints were clinically relevant and statistically significant (p<0.05). Additionally, (S)-zopiclone was well tolerated in this study.
According to the National Sleep Foundation, sleep disorders affect approximately 84 million people in the United States. The U.S. market for prescription sleep products is approaching $1 billion and growing at a rate of 20 percent per year. Insomnia may be caused by a number of factors including stress, anxiety, environmental temperatures, change in the surrounding environment, sleep/wake schedule problems such as those due to jet lag, and medication side effects.
Sepracor is a specialty pharmaceutical company that develops and commercializes potentially improved versions of widely-prescribed drugs. Referred to as Improved Chemical Entities ("ICE"), Sepracor`s ICE(TM) Pharmaceuticals are being developed as proprietary, single-isomer or active-metabolite versions of these leading drugs. ICE Pharmaceuticals are designed to offer meaningful improvements in patient outcome through reduced side effects, increased therapeutic efficacy, improved dosage forms, and in some cases, the opportunity for additional indications.
This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of, and development timetable for, the Company`s ICE Pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the timing of filing and approval of NDAs, the results of the Company`s clinical trials with respect to its products under g transferred around a switchboard, and never getting a response from e-mail inquiries. Web180 was created to be customer-focused and accessible."
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Tel: [phone]

[gholzbauer]

Sepracor Advances (S)-Zopiclone Into Phase III Studies Company Expects To Complete Pivotal Trials By Mid-2001
MARLBOROUGH, Mass., Sep 6, 2000 /PRNewswire via COMTEX/ -- Sepracor Inc. (Nasdaq: SEPR chart, msgs) announced today that it has begun Phase III patient enrollment for (S)-zopiclone for the treatment of insomnia. A second Phase III clinical study, which will run in parallel, is planned to begin in October, bringing total Phase III enrollment to approximately 300 patients. (S)-Zopiclone is a single-isomer version of racemic zopiclone, a non-benzodiazepine, rapid-acting hypnotic prescribed worldwide for the treatment of insomnia.

Racemic zopiclone is marketed by Rhone Poulenc-Rorer in approximately 80 countries worldwide under the brand names of IMOVANE(R) and AMOBAN(R), and has never been submitted for approval in the United States. In 1999, racemic zopiclone was the leading treatment for sleep disorders outside the United States.

In Sepracor`s recently completed, large-scale efficacy study in transient insomnia, patients treated with (S)-zopiclone successfully achieved all efficacy endpoints, including rapid onset of action and optimal duration of activity, resulting in patients falling asleep and staying asleep through the night. All endpoints were clinically relevant and statistically significant (p<0.05). Additionally, (S)-zopiclone was well tolerated in this study.

"(S)-Zopiclone has the potential to be the first non-benzodiazepine to provide rapid onset of sleep and an improvement in sleep maintenance without exhibiting residual, next-day hangover effects," said Peter Powchik, M.D., Senior Medical Director at Sepracor.

According to the National Sleep Foundation, sleep disorders affect approximately 84 million people in the United States. The U.S. market for prescription sleep products is approaching $1 billion and growing at a rate of 20 percent per year. Insomnia may be caused by a number of factors including stress, anxiety, environmental temperatures, change in the surrounding environment, sleep/wake schedule problems such as those due to jet lag, and medication side effects.

"The recently completed efficacy study, which displayed hypnotic effect at multiple doses, allows the Company to choose a dose with the optimal therapeutic index. We are hopeful that the results obtained from the trials will indicate that (S)-zopiclone will provide an important therapeutic advance in the treatment of insomnia," said Paul D. Rubin, M.D., Executive Vice President of ICE Research and Development at Sepracor.

(S)-Zopiclone is Sepracor`s third self-managed Phase III program. The Company has recently completed Phase III clinical studies and is in the process of compiling data necessary for the New Drug Application (NDA) filing with the U.S. Food and Drug Administration for norastemizole, a new antihistamine. Sepracor plans to expand its 150-person sales organization in support of the expected launches of norastemizole, (S)-zopiclone, and its other primary care products such as (S)-oxybutynin, for urinary urge incontinence, (R)-DDMS for central nervous system disorders, and (S)-DDMS for urology indications.

Sepracor currently markets XOPENEX(R) (levalbuterol HCl) inhalation solution, a beta-agonist for the treatment and prevention of bronchospasms, for patients 12 years of age and older with reversible obstructive airway disease, such as asthma. XOPENEX is commercialized through a co-promotion agreement with the Ross Products Division of Abbott Laboratories.

In addition to the several products that the Company expects to self- market, Sepracor also develops and licenses franchise management candidates to pharmaceutical companies to expand and improve upon existing product lines. Schering-Plough is currently awaiting NDA approval for desloratadine, a new antihistamine for the treatment of allergies, which is an active metabolite of CLARITIN(R). UCB Farchim SA has filed in Europe a Marketing Authorization Application (MAA), the European equivalent of an NDA, for levocetirizine, a single-isomer version of ZYRTEC(R). Eli Lilly and Company is in large-scale efficacy studies for (R)-fluoxetine, a modified form of an active ingredient found in PROZAC(R). Additionally, R149524 ((+)-norcisapride), a potentially safe, active metabolite of Janssen Pharmaceutica`s gastroesophageal reflux disease (GERD) drug, PROPULSID(R), is in Phase II studies.

Sepracor is a specialty pharmaceutical company that develops and commercializes potentially improved versions of widely-prescribed drugs. Referred to as Improved Chemical Entities ("ICE"), Sepracor`s ICE(TM) Pharmaceuticals are being developed as proprietary, single-isomer or active- metabolite versions of these leading drugs. ICE Pharmaceuticals are designed to offer meaningful improvements in patient outcome through reduced side effects, increased therapeutic efficacy, improved dosage forms, and in some cases, the opportunity for additional indications.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy and potential benefits of, and development timetable for, the Company`s ICE Pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the timing of filing and approval of NDAs, the results of the Company`s clinical trials with respect to its products under development; the scope of the Company`s patent protection with respect to such product candidates; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in the Company`s periodic reports filed with the Securities and Exchange Commission.

Imovane and Amoban are registered trademarks of Rhone-Poulenc Sante.
Xopenex is a registered trademark of Sepracor Inc.
Claritin is a registered trademark of Schering-Plough Corporation.
Zyrtec is a registered trademark of UCB Farchim SA.
Prozac is a registered trademark of Dista.
Propulsid is a registered trademark of Janssen Pharmaceutica.


To receive a copy of this release or any recent release via fax, call Sepracor`s automated news fax line at 1-800-758-5804 ext. 780960, or visit our web site at www.sepracor.com.

[gholzbauer]

Gefunden bei Siliconinvestor im SEPR-Thread, reply # 4544

Has everybody seen the ML opinion posted in the YC?
"Desloratine could be approved by Oct. 21."

From todays ML research online.
"Aventis announced that Allegra has been approved in Japan, which is ahead of our
expectations. sepr receives royalties on the product , so this bodes well for Sepr. For now, our
estimates and ratings are unchanged. this is good news for the stock in terms of sentiment."
Royalties are in the high single digits and he understands Aventis will launch the product early
next year.
Seldane is marketed in Japan and may be removed from the market when Allegra is launched. If
that is true Allegra has an opportunity to capture sales(about 100 million) quickly.
Royalty assumtions are 4 million for 2000 climbing to $40 million in 2004(not including Japan).
Desloratine could be approved by Oct. 21.
R.R fluxetine could be filed late next year.
"Perhaps most importantly, an NDA for norestemizole should be filed by year end...we believe
that Sepr could announce a marketing partner in the next 6-12 months."

[gholzbauer]

Sepracor
Product
Candidate Parent Drug 1999 Worldwide Estimated Sales (mil)
(parent drug) Potential Benefits
of Sepracor Drug
Candidate Drug
Status
Respiratory Diseases
Levalbuterol (XOPENEX™) Ventolin®/
Proventil® $1,400 Potential for improved safety and efficacy Launched
(R,R)-formoterol Foradil®/
Atock® $250 Potential for rapid onset, longer duration Phase IIB
Levocetirizine Zyrtec® $1,000 Potential for reduced sedation Phase III (Europe)
Norastemizole Hismanal® $100 Potential for improved potency, rapid onset, longer duration, reduced cardiovascular side effects Phase III
Desloratadine Claritin® $2,700 Potential for improved potency NDA Filed
Urological Disorders
(S)-oxybutynin Ditropan® $160 Potential for reduced side effects including: dry mouth, dizziness, nausea and palpitations Phase IIB
(S)-doxazosin Cardura® $850 Potential for reduced orthostatic hypotension and improved potency Phase I
(-)-DDMS Meridia® erectyle disfunction, stress incontinence 2000 IND Candidate
Psychiatry/Neurology
(R)-fluoxetine Prozac® $2,600 Potential for shorter washout and increased flexibility in treating depression Phase II
(+)-Zopiclone Imovane® $150 Potential for reduced anticholinergic side effects, including dry mouth Phase II
(+)-DDMS Meridia® N/A Potential for reduced anticholinergic side effects including dry mouth and constipation Phase I
Hydroxy bupropion Zyban™ $800 Potential for reduced incidence of seizures, dry mouth and insomnia Preclinical
Gastroenterology
(+)-norcisapride Propulsid® $1,000 Potential for improved potency without the adverse side effects of cardiac toxicity Phase II
(R)-ondansetron Zofran® $700 Potential for reduced cardiovascular side effects and improved efficacy Preclinical
(S)-lansoprazole Prevacid® $3,000 Potential for improved dosing consistency and efficacy Preclinical
(-) pantoprazole Pantozol™ $350 Potential for consistent plasma levels that may lead to better efficacy and safety Preclinical

[puhvogel]

Wow...
Stammen die Zahlen von ML Research?

[gholzbauer]

UPDATE 1-Euro panel supports altered form of Claritin
(new throughout, adds quotes, background)
By Ransdell Pierson


NEW YORK, Oct 10 (Reuters) - Schering-Plough Corp. (NYSE: SGP) said on Tuesday a key European regulatory committee has recommended approval of desloratadine, an allergy pill meant to replace the company`s blockbuster Claritin whose U.S. patent could expire by 2002.

The New Jersey drugmaker said the Committee for Proprietary Medicinal Products (CPMP) has issued a "positive opinion" on desloratadine, a once-a-day treatment for seasonal allergic rhinitis, commonly known as hay fever.

The European Agency for the Evaluation of Medicinal Products (EMEA) relies on the committee`s advice in deciding whether to approve new medications and typically makes its decision within three months.

Shares of Schering-Plough, which is also awaiting approval of the experimental antihistamine in the United States, rallied after the announcement -- gaining 2-1/8, or 4.5 percent, to $49-1/8 in early afternoon trade on the New York Stock Exchange.

Massachusetts biotech firm Sepracor Inc (NASDAQ: SEPR), which has licensed rights to desloratadine to Schering-Plough, saw its share price jump $3-5/8 to $113-3/8 on the Nasdaq.

"The committee`s recommendation of approval brings Wall Street a major sigh of relief because it is a good indication that U.S. regulators are also close to approving desloratadine, perhaps by the first quarter of 2001," said David Saks, manager of the Saks Gruntal MedScience Fund.

If EMEA follows its committee`s advice and grants final approval to desloratadine, it would become available in all 15 member countries of the European Union and be sold in most markets under the brand name Aerius, Schering-Plough said.

Claritin, whose chemical name is loratadine, had global sales of $2.7 billion in 1999, including $2.3 billion in the United States. Some Wall Street analysts have nicknamed desloratadine "Son of Claritin" because it is a chemically similar second-generation form of Schering-Plough`s flagship medicine.

The drug is a metabolite, or derivative of loratadine. Schering-Plough, the nation`s No. 8 drugmaker, has said it is a "superior product" to Claritin and a potential means of wooing millions of allergy patients before Claritin`s U.S. patents begin to expire as soon as 2002.

Prescription drugs typically lose most of their sales once copycat generic drugs hit the market, a key reason Schering-Plough licensed from Sepracor the U.S. patent rights to desloratadine which extend to 2014.

By selling a similar allergy drug with long patent life, analysts say Schering-Plough could protect its profitable antihistamine franchise, assuming that desloratadine is more effective or safer than future generic forms of Claritin.

Saks said Schering-Plough has not yet disclosed what benefits, if any, desloratadine may have over Claritin.

"We don`t know for sure because they won`t say until they get final approval of the drug. But you could assume the new drug must have benefits over Claritin although it might not be revolutionarily different," Saks said.

Schering-Plough added on Tuesday that the European advisory panel gave it another bit of good news -- recommending approval for expanded use of the company`s treatment for rheumatoid arthritis, Remicade.

Remicade had received European approval in June for signs and symptoms of rheumatoid arthritis, an inherited form of arthritis in which the immune system attacks the body`s own joints. The expanded application would be to improve physical function and rate of joint damage in patients, a spokesperson for the company said.

[gholzbauer]

!

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[dosto]

die zahlen aus der post vom 25.09 sind so oder so übertrieben,
einiges hat sich erledigt.
neues nachdenken über SEPR ist angesagt.
übrigens auch über MLNM, ICOS, VRTX, MEDX; MEDIGENE so oder so.
vor allen dingen sollten mal die zeitabläufe für die pipelines,
und die wirtschaflichkeit der firmen, wieder mal unter die lupe genommen werden, dann werden sich einige zahlen relativieren, die kurse so oder so.

[dosto]

die zahlen aus der post vom 25.09 sind so oder so übertrieben,
einiges hat sich erledigt.
neues nachdenken über SEPR ist angesagt.
übrigens auch über MLNM, ICOS, VRTX, MEDX; MEDIGENE so oder so.
vor allen dingen sollten mal die zeitabläufe für die pipelines,
und die wirtschaflichkeit der firmen, wieder mal unter die lupe genommen werden, dann werden sich einige zahlen relativieren, die kurse so oder so.

[Neemann]

Rülps

[gholzbauer]

Hallo, Neemann, schon wieder etwas sauer aufgestoßen?
Du wirst doch nicht ohne SL und Put auf SEPR gesetzt haben?
Obwohl - das würde manches erklären ...

[Pritzel]

Wenn ich meine Aktien im Amiland verkaufen möchte fahre ich dort schlechter durch den Euro ???

Danke für eure Nachricht !!!

[unicum]

Sepracor hat in letzter eine deutliche Aufwertung seitens der Analysten erfahren: aktuell 1,5.
Auch wenn man die Meinungsäußerungen von Analysten mit Vorsicht genießen muß, ein schlechtes Zeichen ist das nicht.

Gruß unicum

[dosto]

zu spät
schon wieder ein verkauf.

[gholzbauer]

bin z.Z. nicht übermäßig optimistisch für SEPR
spätestens über 80$ werden wieder Puts zur Absicherung gekauft
Pharma sucks
small cap is beautiful

[Cargospezialist]

@dosto
Besteht nicht doch ein kleiner Funke Hoffnung dass wir hier die nächsten Wochen wenigstens keine weiteren Rückschläge erwarten können - vielleicht seitwärts? Bin leider schon vor über einem Jahr bei 80E rein und möchte wenigstens meine Kohle wieder!
Gruß Cargo

[unicum]

Naja, technologisch kenne ich mich natürlich nicht aus, die Konsensus-Schätzung liegt momentan immerhin bei 1,5. Sie muß in der letzten Zeit deutlich angehoben worden sein (verfolge das nicht mehr regelmäßig, war aber glaube ich schon auf 2,8 runter) der Chart ist ja auch nicht schlecht und Sepr hat in den letzten 6 Monaten den AMEX Biotechnology um 30% übertroffen. Auf ein Jahr sieht´s da aber anders aus.
Habe mit Sepr seinerzeit mein großes Geld verdient und bin zum Teil immernoch drin. Mit der Pipeline habe ich mich schon lange nicht mehr beschäftigt.

Gruß unicum

[unicum]

Tach allerseits !

Sepracor hat ja in den letzten Wochen deutlich Gas gegeben. Heute erreichte mich ein Schreiben meiner Depotbank. Darin ist zu lesen, dass gegen Sepracor eine Sammelklage erhoben wurde (nur für Käufe zwischen 14.4.00-6.3.02 - da gehöre ich eh nicht zu).
Anfragen an folgende Adresse:

Law Offices J.Piven, P.A.
Charles J. Piven
Tel: [phone]
E-Mail: [e-mail]

Kennt jemand die Hintergründe und die Seriösität der Kanzlei?

Gruß unicum

[Cargospezialist]

Hallo unicom,

wurde auch mal wieder Zeit (nach einem Jahr) in diesem Thread zu scheiben. Was die mit einer Sammelklage wollen weiß ich leider nicht, wurde aber von meiner Bank angeschieben (reines Infoschreiben). Habe die Unterlagen angefordert, mal sehen was die machen wollen.
Der Kursverlust für mich war ziemlich erschreckend, aber vielleicht wird´s ja wieder, schaut im Moment Charttechnisch nicht schlecht aus.

Grüße Cargo

[Cargospezialist]

Sepracor scheint zur Zeit zu den wenigen Bio´s zu gehören, die keinen Urlaub im Süden machen werden:

Update Sepracor Inc.: Overweight
24.02.2003 13:17:27
Die Analysten von SunTrust Robinson Humphrey bewerten in ihrer Analyse vom Freitag, 21. Februar 2003 die Aktie von Sepracor Inc. nach wie vor mit dem Rating "Overweight". Ein Kursziel geben die Analysten nicht an.

ESTORRA wird´s schon richten!

Gruß Cargo

[Cargospezialist]

Vielleicht hat es sich ja doch gelohnt das Papierchen zu halten!?

ESTORRA(TM) NDA Filed By FDA



MARLBOROUGH, Mass. -(Dow Jones)- Sepracor Inc.(NASDAQ-NMS:SEPR) (SEPR) announced that the Food and Drug Administration has filed the company`s New Drug Application for Estorra brand eszopiclone 2 mg and 3 mg tablets for the treatment of transient and chronic insomnia.

In a press release Wednesday, the pharmaceutical company said Estorra was studied in the 3 mg dosage strength for adults and in the 2 mg dosage strength for the elderly population.

Sepracor submitted the NDA on January 31, after which the FDA had 60 days to review the submission before officially accepting it for filing.

The company`s shares closed Tuesday up 59 cents, or 4.4%, to $14.13.

-Thomas Gryta; Dow Jones Newswires; 201-938-5400

Wir werden sehen!

[blb]

Bin seit gestern wieder im Plus bei SEPR! Toller Kursverlauf über die letzten Monate...

[Cargospezialist]

Das macht ja richtig Spass, Kursziel auf Jahresende dürfte sogar bei 50$ liegen.

[721hh]

griazzli aus austria!

bin seit knapp einem jahr in sepracor investiert und kann´s nicht glauben! die aktie klettert und klettert!

hab sepracor mit 24 euro gekauft, mit 14 euro nachgekauft und dann einfach tatenlos zugesehen wie diese aktien seit ihrem 4 euro tiefstand in neue höhen klettert!

es bewahrheitet sich einmal mehr! wenn man an eine aktie glaubt dann heisst es drann bleiben und kaufen, auch wenn der kurs fällt!

ich darf gar nicht überlegen welche gewinne ich eingefahren hätte wenn ich (getreu meiner linie aktien auch bei fallenden kursen nachzukaufen) sepracor zu 4 euro erworben hätt...

lg 721hh

[unicum]

Kann mich jemand kurz updaten, bezüglich der Frage warum Sepracor in den letzten Wochen und heute so gut läuft?
Danke!

Gruß unicum

[721hh]

ESTORRA(TM) One-Year Data Presented At Associated Professional Sleep Societies Meeting


MARLBOROUGH, Mass., June 9 /PRNewswire-FirstCall/ -- Sepracor Inc. (Nasdaq: SEPR) today announced the presentation of data from the first successful, long-term, placebo-controlled study conducted with a non-benzodiazepine for the treatment of chronic insomnia. Data from this large-scale study of eszopiclone in which patients 21-69 years of age received nightly treatment of either placebo (n=195) or eszopiclone 3 mg (n=593) were presented at the annual meeting of the Associated Professional Sleep Societies (APSS) in Chicago. The study was designed to evaluate safety and efficacy over 12 months of treatment: the first six months of the study were placebo- controlled and the second six months were open-label. In this study, subjective sleep maintenance, sleep latency (onset of action), total sleep time and sleep quality were reported weekly and safety was evaluated monthly.

According to Wallace Mendelson, M.D., Professor of Psychiatry and Clinical Pharmacology of the University of Chicago, "The practice of medicine for the treatment of insomnia has suffered due to the lack of data from rigorous, placebo-controlled studies on the long-term treatment of insomnia. This has resulted in lack of evidence on whether or not sleep agents lose effect and patients develop tolerance over time, thereby requiring higher doses to achieve sleep. The long-term study with eszopiclone is the type of clinical trial the sleep medicine field needs to better understand the long-term treatment of insomnia."

"In my opinion, eszopiclone is an exciting insomnia treatment candidate," said Andrew Krystal, M.D. of Duke University Medical Center in North Carolina. "I believe that eszopiclone could be considered an anti-insomnia agent because this study suggests unprecedented potential to address the entire syndrome of insomnia, including problems of falling asleep and maintaining sleep, as well as complaints of poor sleep quality and daytime function. In particular, addressing problems with daytime functioning is an essential, though rarely addressed, aspect of this disease."

In the long-term study of chronic insomnia presented at the APSS meeting, insomnia patients treated with eszopiclone showed statistically significant improvements over the six months of double-blind treatment in sleep maintenance measures (wake-time after sleep onset, referred to as WASO, and number of awakenings), sleep latency, total sleep time and sleep quality, relative to placebo (p<0.01). No decline in therapeutic effect was observed on any outcome parameter over the course of the trial, and eszopiclone was well tolerated. In addition, patients on eszopiclone reported improved daytime alertness (p<0.005) and improved daytime ability to function (p<0.001).

In new data presented at the APSS meeting by Dr. Krystal, eszopiclone sustained the therapeutic effect for one year of nightly treatment on all outcome parameters including sleep onset and sleep maintenance. In addition, improvements in daytime alertness and daytime functioning were sustained for 12 months. There was no evidence of loss of effect, or the development of tolerance, in patients who received eszopiclone.

"I believe this is a landmark study for the treatment of insomnia," said Dr. Krystal. "Eszopiclone is the first non-benzodiazepine to complete a twelve-month chronic insomnia study that provides a full six months of data from the placebo-controlled, blinded phase. The fact that nearly 300 patients took this medication nightly for one year provides an unprecedented wealth of data. In these patients, eszopiclone demonstrated sustained therapeutic effect for the full twelve months of this study. The therapeutic effect was also achieved for sleep maintenance measures including WASO, and this is particularly notable since the population was not enriched with patients suffering from sleep maintenance problems. This study sets a new standard for assessing efficacy and safety of insomnia medications."

To access the eszopiclone abstracts presented at the APSS meeting, please visit the APSS web site at www.apss.org, accessing "Abstract Information". Abstracts can be found via the "2003-Chicago" link.

According to the National Institutes of Health web site, insomnia affects more than 70 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.

According to the National Sleep Foundation (NSF) Sleep in America Poll 2003, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of a host of common, serious, age-related medical conditions, from arthritis to diabetes, heart and lung disease and depression. The NSF`s new poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67%) report frequent sleep problems, only about seven million elderly patients have been diagnosed.

The New Drug Application (NDA) for ESTORRA brand eszopiclone was submitted to the U.S. Food and Drug Administration (FDA) on January 31, 2003 and accepted for filing by the FDA on April 1, 2003. The NDA contains a total of 25 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies, including one with a positive control, for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package. ESTORRA is the only non-benzodiazepine anti-insomnia agent that has completed a long-term, six-month, placebo-controlled trial for safety and efficacy and is currently under FDA review.

The U.S. market for prescription sleep products, not including off-label use of central nervous system agents not indicated for the treatment of insomnia, was approximately $1.4 billion in 2002. The U.S. prescription sleep agent market grew at a rate of almost 25 percent for the past two years, according to IMS Health information.

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor`s drug development program has yielded an extensive portfolio of pharmaceutical compound candidates, including candidates for the treatment of respiratory, urology and central nervous system disorders. Sepracor`s corporate headquarters are located in Marlborough, Massachusetts.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits and successful development and regulatory approval of ESTORRA brand eszopiclone and Sepracor`s other pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of clinical trials with respect to ESTORRA and Sepracor`s other products under development; the timing and success of submission, acceptance and approval of regulatory filings; the scope of Sepracor`s patents and the patents of others; the commercial success of Sepracor`s products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor`s licensees; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in Sepracor`s quarterly report on Form 10-Q for the quarter ended March 31, 2003 filed with the Securities and Exchange Commission.

In addition, the statements in this press release represent Sepracor`s expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor`s expectations or beliefs as of any date subsequent to the date of this press release.

Although Sepracor has referred you to the APSS web site in this press release, Sepracor does not control or maintain such web site. Therefore, Sepracor assumes no responsibility for information or statements on the APSS web site.

Estorra is a trademark of Sepracor Inc.

For a copy of this release or any recent release, visit
http://www.prnewswire.com/comp/780960.html or www.sepracor.com.


SOURCE Sepracor Inc.

*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X**X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X*X


ESTORRA(TM) Six-Week Phase III Study Presented At Associated Professional Sleep Societies Meeting


MARLBOROUGH, Mass., June 9 /PRNewswire-FirstCall/ -- Sepracor Inc. (Nasdaq: SEPR) today announced the presentation of data from a pivotal six-week, placebo-controlled Phase III clinical trial conducted with ESTORRA(TM) brand eszopiclone at the annual meeting of the Associated Professional Sleep Societies (APSS) in Chicago.

Results of the large-scale, randomized, double-blind, multicenter, placebo-controlled, parallel-design study in adult patients 21-64 years of age, were presented by Gary Zammit, Ph.D., of the Sleep Disorders Institute at St. Luke`s/Roosevelt Hospital in New York. This study was designed to investigate safety and efficacy of eszopiclone following nightly dosing over a period of six weeks and to assess the potential for next-day residual effects versus placebo. Patients received a nightly dose of either placebo or eszopiclone 2 mg or 3 mg. Efficacy and potential for rebound insomnia were measured using both objective polysomnography measures and subjective patient reports, and next-day residual effects were measured using digit-symbol substitution tests (DSST). Assessments were performed at baseline, after the first dose, and at weeks 2, 4 and 6.

According to Mark Corrigan, M.D., Executive Vice President of Research and Development at Sepracor, "Given the need to ensure that objective evidence of efficacy is achieved with sleep drugs, we believe it is critical to confirm their effects via polysomnography, in addition to subjective reports from patients. Further, because insomnia patients may experience worse sleep symptoms upon abrupt discontinuation of therapy -- which is referred to as rebound insomnia -- it is important to evaluate potential sleep agents for this effect. Many insomnia patients also suffer withdrawal effects so patient symptoms should be evaluated upon discontinuation of drug therapy. In addition to discontinuation symptoms, patients may also experience next-day residual or hangover effects and, in my opinion, it is essential to evaluate potential new products on this parameter."

Relative to placebo, eszopiclone at both 2 mg and 3 mg significantly improved latency to persistent sleep (LPS) and sleep latency, both measures of sleep onset (p<0.0001); sleep efficiency and total sleep time (p<0.0001); and the quality and depth of sleep (p<0.05). Eszopiclone at 3 mg significantly improved objective and subjective wake time after sleep onset (WASO) versus placebo (p<0.05). Evaluation of potential residual effects by DSST showed a comparable degree of improvement over baseline scores in both the placebo and eszopiclone groups. Further, there was no decline in efficacy (i.e., no evidence of tolerance) with eszopiclone. In addition, no rebound was observed compared to baseline on either sleep onset or sleep maintenance parameters upon discontinuation of eszopiclone. There were no apparent adverse events associated with withdrawal when patients ended treatment with eszopiclone.

"I believe the parameters studied in this trial are important for evaluating a new medicine for sleep. Improvements in sleep onset, sleep duration and sleep maintenance were achieved on both objective and subjective endpoints. There was no evidence of tolerance or rebound insomnia. Next-day effects as measured by DSST, the accepted standard for objective measurement of next-day effect, were comparable to placebo," said Gary Zammit, Ph.D. "These results suggest that this compound could provide insomnia sufferers with an important new treatment option."

To access the eszopiclone abstracts presented at the APSS meeting, please visit the APSS web site at www.apss.org, accessing "Abstract Information". Abstracts can be found via the "2003-Chicago" link.

According to the National Institutes of Health web site, insomnia affects more than 70 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.

According to the National Sleep Foundation (NSF) Sleep in America Poll 2003, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of a host of common, serious, age-related medical conditions, from arthritis to diabetes, heart and lung disease and depression. The NSF`s new poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67%) report frequent sleep problems, only about seven million have been diagnosed.

The New Drug Application (NDA) for ESTORRA(TM) brand eszopiclone was submitted to the U.S. Food and Drug Administration (FDA) on January 31, 2003 and accepted for filing by the FDA on April 1, 2003. The NDA contains a total of 25 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies, including one with a positive control, for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package. ESTORRA is the only non-benzodiazepine anti-insomnia agent that has completed a long-term, six-month, placebo-controlled trial for safety and efficacy and is currently under FDA review.

The U.S. market for prescription sleep products, not including off-label use of central nervous system agents not indicated for the treatment of insomnia, was approximately $1.4 billion in 2002. The U.S. prescription sleep agent market grew at a rate of almost 25 percent for the past two years, according to IMS Health information.

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor`s drug development program has yielded an extensive portfolio of pharmaceutical compound candidates, including candidates for the treatment of respiratory, urology and central nervous system disorders. Sepracor`s corporate headquarters are located in Marlborough, Massachusetts.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits and successful development and regulatory approval of ESTORRA brand eszopiclone and Sepracor`s other pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of clinical trials with respect to ESTORRA and Sepracor`s other products under development; the timing and success of submission, acceptance and approval of regulatory filings; the scope of Sepracor`s patents and the patents of others; the commercial success of Sepracor`s products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor`s licensees; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in Sepracor`s quarterly report on Form 10-Q for the quarter ended March 31, 2003 filed with the Securities and Exchange Commission.

In addition, the statements in this press release represent Sepracor`s expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor`s expectations or beliefs as of any date subsequent to the date of this press release.

Although Sepracor has referred you to the APSS web site in this press release, Sepracor does not control or maintain such web site. Therefore, Sepracor assumes no responsibility for information or statements on the APSS web site.

Estorra is a trademark of Sepracor Inc.

For a copy of this release or any recent release,
visit http://www.prnewswire.com/comp/780960.html or www.sepracor.com.


SOURCE Sepracor Inc.

[Cargospezialist]

Korrektur mit einer guten Nachricht beendet, es geht wieder
Richtung Norden:

Company News


SEPR
Sepracor Inc. Nasdaq-NM


Back to Headlines | Previous Story



Sepracor Xopenex Study Yields Positive Results



MARLBOROUGH, Mass. (Dow Jones)--Sepracor Inc.(NASDAQ-NMS:SEPR) (SEPR) reported positive results from its Phase III clinical program of the Xopenex metered-dose inhaler for asthma patients.

In each of the three, large-scale pivotal Phase III trials, the Xopenex hydrofluoroalkane metered-dose inhaler was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma, the research-based pharmaceutical company said in a press release Tuesday.

In the primary airway function measure - or a test of lung function - the Xopenex HFA MDI produced statistically and clinically significant improvements relative to placebo, the company said.

Sepracor said its metered-dose inhaler development program includes more than 1,800 pediatric and adult subjects in 12 clinical studies.

The company has completed all clinical studies that it plans to include in the Xopenex HFA MDI New Drug Application submission to the Food and Drug Administration. The company plans to submit the NDA by the end of the first quarter of 2004.

3M Co. (MMM) will manufacture the metered-dose inhaler system.

Xopenex inhalation solution revenue for the nine months ended Sept. 30 was about $186.6 million, up 50%. The product is currently used via a nebulizer.

On Monday, Ivax Corp. (IVX) said it received notice from the FDA that its new drug application for a CFC-free version of the asthma medicine albuterol in a metered dose inhaler is approvable.

Shares of Sepracor closed Monday at $24.98, up 20 cents, or 0.8%.

Company Web site: http://www.sepracor.com

-Jenny Park; Dow Jones Newswires; 201-938-5400

Order free Annual Report for Sepracor

Visit http://djnewswire.ar.wilink.com/?link=SEPR or call 1-888-301-0513


Dow Jones Newswires
12-02-030830ET
Copyright (C) 2003 Dow Jones & Company, Inc. All Rights Reserved.

[blb]

Bin immer noch dabei!

Heute wurde zwar Soltara endgültig aufgegeben, erste Gewinne sind aber Ende 2004 möglich...

[Cargospezialist]

04.12.2003
Sepracor "overweight"
SunTrust Robinson Humphrey

Die Analysten der Investmentbank SunTrust Robinson Humphrey stufen die Aktie von Sepracor (ISIN US8173151049/ WKN 882759) unverändert mit "overweight" ein.

Sepracor habe positive Ergebnisse der drei Phase III Studien für Xopenex MDI (Asthma) bekannt gegeben. In allen drei Schlüsselstudien sei Xopenex MDI gut vertragen worden. Daneben sei in FEV1 gegenüber Placebos bei Erwachsenen und Kindern eine statistisch deutliche Verbesserung gezeigt worden. Damit seien alle klinischen Arbeiten abgeschlossen worden. Separcor erwarte den Zulassungsantrag im ersten Quartal 2004, was sich im Rahmen der Erwartungen befinde. Die Zulassung dürfte gegen Ende 2005 erteilt werden.

Die Entscheidung von Sepracor, die Entwicklung der Allergietherapie Soltara nicht weiter fortzusetzen und die R&D-Ressourcen auf andere Pipelineprojekte zu verlagern, beeinflusse die EPS-Schätzungen vor 2007 nicht wesentlich.

Vor diesem Hintergrund bewerten die Analysten von SunTrust Robinson Humphrey die Aktie von Sepracor weiterhin mit dem Votum "übergewichten".



Weitere Analysen zur ISIN US8173151049 alle
02.12.2003 Sepracor "buy" Merrill Lynch
17.11.2003 Sepracor kaufenswert sunday-biotech
13.11.2003 Sepracor "buy" Merrill Lynch

[blb]

SEPR mit guten Zahlen heute! Ist noch wer dabei?

[Cargospezialist]

Sepracor Announces Fourth Quarter and Full Year 2003 Operating Results



Fourth Quarter 2003 XOPENEX(R) Revenues Increased 53% Compared to the Fourth Quarter 2002 and Full Year 2003 XOPENEX Revenues Increased 51% Compared to the

Full Year 2002
MARLBOROUGH, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Sepracor Inc.(NASDAQ-NMS:SEPR) (Nasdaq: SEPR) today announced its consolidated financial results for the fourth quarter and full year 2003. For the three months ended December 31, 2003, Sepracor`s consolidated revenues were approximately $112.3 million, of which revenues from pharmaceutical product sales (XOPENEX(R) brand levalbuterol HCl) were approximately $100.2 million. The net loss for the fourth quarter of 2003 was approximately $33.9 million, or $0.40 per share. These consolidated results compare with consolidated revenues of $78.9 million, of which revenues from pharmaceutical product sales (XOPENEX) were approximately $65.6 million, and a net loss of $44.3 million, or $0.53 per share, for the three months ended December 31, 2002.

For the year ended December 31, 2003, Sepracor`s consolidated revenues were approximately $344.0 million, of which revenues from pharmaceutical product sales (XOPENEX) were approximately $286.8 million, and the net loss was approximately $135.9 million, or $1.61 per share. This compares with consolidated revenues of $239.0 million, of which revenues from pharmaceutical product sales (XOPENEX) were approximately $190.2 million, and a net loss of $276.5 million, or $3.34 per share, for the year ended December 31, 2002.

As of December 31, 2003, Sepracor had approximately $840.4 million in cash and short- and long-term investments.

Commercial Operations

XOPENEX brand levalbuterol HCl -- XOPENEX brand levalbuterol HCl inhalation solution is marketed through Sepracor`s 450-person sales force. XOPENEX is a short-acting bronchodilator indicated for the treatment or prevention of bronchospasm in patients 6 years of age and older with reversible obstructive airway disease, such as asthma. XOPENEX is available for use in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for routine treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12 years of age and older.

Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. According to the American Lung Association, approximately 26 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects approximately 8.6 million children in the U.S. under the age of 18. Short-acting beta-agonists are the most-prescribed asthma therapy among primary care physicians and pediatricians in the U.S., according to IMS Health information.

ASTELIN(R) brand azelastine HCl -- Through a co-promotion agreement with MedPointe Inc., Sepracor`s sales force details ASTELIN brand azelastine HCl, a nasal-spray antihistamine, to pulmonologists, allergists, pediatricians and primary care physicians in the U.S. ASTELIN is the only antihistamine that has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptoms of both seasonal allergic rhinitis in adults and children 5 years of age and older and non-allergic vasomotor rhinitis in adults and children 12 years and older.

ALLEGRA(R) brand fexofenadine HCl -- Sepracor earns royalties from Aventis for sales of ALLEGRA, a nonsedating antihistamine, in the U.S. and other countries where Sepracor holds patents relating to fexofenadine (including Japan, Europe, Canada and Australia).

CLARINEX(R) brand desloratadine -- Sepracor earns royalties from Schering- Plough Corporation(NYSE:SGP) on sales of all formulations of CLARINEX brand desloratadine in the U.S. and in other countries where Sepracor holds patents relating to desloratadine. CLARINEX is indicated for the treatment of allergic rhinitis and chronic idiopathic urticaria (CIU), also known as hives of unknown cause, in patients 12 years of age and older.

XYZAL(R)/XUSAL(TM) brand levocetirizine -- Sepracor earns royalties from UCB on sales of levocetirizine in European countries where the product is sold. Levocetirizine is marketed as XUSAL in Germany and is marketed under the brand name XYZAL in other E.U. Member States. A single isomer of ZYRTEC(R), levocetirizine is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis and CIU, in adults and children aged 6 years and older.

Sepracor New Drug Application (NDA)-Track Programs

ESTORRA(TM) brand eszopiclone -- Sepracor submitted its NDA to the FDA for ESTORRA brand eszopiclone for the treatment of transient and chronic insomnia on January 31, 2003. ESTORRA was studied at a 2 mg dosage strength for treatment of the elderly population and at a 3 mg dosage strength for treatment of adult subjects. The FDA officially accepted the NDA for filing on April 1, 2003.

In November 2003, the FDA notified Sepracor of an extension to its review of the ESTORRA NDA, and the FDA indicated that the new target date for completing its review is on or before February 29, 2004.

ESTORRA Scientific Meetings/Publications:

During 2003, Phase III data of ESTORRA in adult and elderly patients were presented at the following medical meetings:

-- The American Psychiatric Association meeting in May;
-- The annual meeting of the Associated Professional Sleep Societies
(APSS) in June; and
-- The Eleventh International Congress of the International
Psychogeriatric Association in August.

Among the data presented were the results of a Phase III, 231-patient, multi-center, randomized, double-blind, placebo-controlled, parallel-group trial in elderly patients; a pivotal six-week, 308-patient placebo-controlled Phase III polysomnography study in adults; and the first successful, long- term, 788-patient, placebo-controlled study conducted with a non- benzodiazepine for the treatment of chronic insomnia in which safety and efficacy were evaluated over 12 months of treatment, the first six months of which were placebo-controlled and the second six months were open-label.

Data from the six-month, Phase III, 788-patient, randomized, double-blind, placebo-controlled parallel-group safety and efficacy study were also published in the November issue of the journal SLEEP, the official publication of the APSS.

For further information regarding previously presented ESTORRA data, please refer to Sepracor`s press releases and past webcasts, which can be accessed on the Sepracor web site at www.sepracor.com.

ESTORRA Phase IIIB Program

A comprehensive Phase IIIB clinical program for ESTORRA began in the fourth quarter of 2003 and includes the following:

-- A double-blind, placebo-controlled, 8-week study for the treatment of
insomnia in patients suffering from depression, with a target
enrollment of 600 patients;
-- A double-blind, placebo-controlled, 4-week study for the treatment of
insomnia in patients suffering from rheumatoid arthritis, with a target
enrollment of 440 patients;
-- A double-blind, placebo-controlled, 4-week study for the treatment of
insomnia in women experiencing perimenopause, with a target enrollment
of 440 patients; and
-- A double-blind, placebo-controlled, 6-month safety and efficacy study
for the treatment of chronic insomnia, with a target enrollment of 780
patients.

These studies are being conducted on Sepracor`s initiative to provide further clinical information on the effects of ESTORRA in the treatment of insomnia in these patient populations.

The ESTORRA NDA contains a total of 24 clinical trials, which include more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies, including one with a positive control, for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package. ESTORRA is the only non-benzodiazepine anti-insomnia agent that has completed a long-term, six-month, double-blind, placebo-controlled trial for safety and efficacy, and is currently under FDA review.

According to the National Institutes of Health web site, insomnia affects more than 70 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.

According to the National Sleep Foundation (NSF) Sleep in America Poll 2003, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of several other medical conditions, from arthritis to diabetes, heart and lung disease and depression. This NSF poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67%) report frequent sleep problems, only about seven million elderly patients have been diagnosed.

The U.S. market for prescription sleep products, not including off-label (not indicated for the treatment of insomnia) use of central nervous system agents for the treatment of insomnia, was approximately $1.5 billion in 2002. The U.S. prescription sleep agent market grew at a rate of almost 25 percent for the past two years, according to IMS Health information.

XOPENEX MDI -- Sepracor and 3M Drug Delivery Systems Division are collaborating under an agreement that includes scale-up and manufacturing for the XOPENEX (levalbuterol tartrate) hydrofluoroalkane (HFA) metered-dose inhaler (MDI). The collaboration combines Sepracor`s short-acting bronchodilator, XOPENEX, and 3M`s expertise in manufacturing MDIs, the device most commonly used by patients for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

In 2003, Sepracor completed its Phase III studies of the XOPENEX MDI. In each of the three, large-scale pivotal Phase III trials conducted by Sepracor, the XOPENEX HFA MDI was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma. In the primary airway function measure, FEV1 (a test of lung function that measures the amount of air forcefully exhaled in one second), the XOPENEX HFA MDI produced statistically and clinically significant improvements relative to placebo (p<0.001).

Sepracor`s MDI development program includes over 1,800 pediatric and adult subjects in 12 clinical studies. All clinical studies that Sepracor plans to include in the XOPENEX HFA MDI NDA submission to the FDA have been completed. The U.S. short-acting bronchodilator MDI market potential at branded prices, assuming parity pricing to branded PROVENTIL(R) HFA, is approximately $1.6 billion.

Arformoterol -- Sepracor has completed more than 100 preclinical studies and has initiated or completed 15 clinical studies for arformoterol, formerly known as (R,R)-formoterol, inhalation solution for the treatment of bronchospasm in patients with COPD. Sepracor has recently completed a Phase III study of arformoterol and a second pivotal Phase III trial continues.

In Sepracor`s Phase II program, arformoterol demonstrated a significant improvement in FEV1 immediately after dosing and duration of action of up to 24 hours.

Bronchodilators have the potential to improve lung function, decrease symptoms, help increase mucus clearance and reduce the number of exacerbations in patients suffering from COPD. The U.S. market for long-acting bronchodilators was approximately $2 billion in 2002, according to IMS Health information.

Sepracor`s Phase I/II Clinical Candidates

Sepracor intends to allocate additional resources in 2004 to advance and develop the following existing and new clinical candidates.

(S)-Amlodipine -- In 2001, Sepracor submitted an Investigational New Drug Application (IND) to the FDA for (S)-amlodipine. Sepracor is investigating (S)-amlodipine as a potential treatment for hypertension and has conducted both Phase I and Phase II studies. Amlodipine, marketed by Pfizer Inc.(NYSE:PFE) as NORVASC(R), is the leading calcium antagonist approved for use for the treatment of hypertension and angina. Preclinical studies conducted by Sepracor have suggested that (S)-amlodipine may provide potential improvements over existing therapies. The evolving paradigms for hypertension treatment are focusing on the use of multiple mechanistic approaches as initial therapy, such as the use of calcium channel blockers (CCBs) with ACE (angiotensin converting enzyme) inhibitors or ARBs (angiotensin II receptor blockers). In 2004, Sepracor plans to expand the (S)-amlodipine program to include development of (S)-amlodipine in combination with other mechanistic approaches for the treatment of hypertension.

SEP-0226330 -- SEP-0226330 is a norepinephrine and dopamine reuptake inhibitor (NDRI). In 2001, Sepracor submitted an IND to the FDA, and in 2002, the company completed a Phase I clinical study of SEP-0226330. In 2004, Sepracor intends to conduct a Phase II proof-of-concept study in support of SEP-0226330 for the treatment of restless leg syndrome, a sleep disturbance that is reported to afflict up to 15 percent of the U.S. adult population. This compound may have advantages over currently used dopamine agonists in the treatment of restless leg syndrome.

SEP-0226332 -- SEP-0226332 is an antagonist of the 5-HT3 receptor, a serotonin receptor subtype in the brain. Sepracor intends to conduct a Phase II proof-of-concept study in support of SEP-0226332 for the treatment of sleep apnea. Obstructive sleep apnea (OSA) is a serious and potentially life- threatening condition. Sleep apnea affects approximately 15-20 million Americans and is characterized by brief interruptions of breathing during sleep, with in some cases, as many as 60 interruptions per hour. Currently, there are no pharmacological therapies indicated specifically for the treatment of sleep apnea. However, the pathogenesis of the disorder, which includes altered serotonin activity, suggests that patients with OSA may respond to drug therapy.

With the development of SEP-0226330, SEP-0226332 and ESTORRA, Sepracor is seeking to establish a strong portfolio of candidates for the treatment of sleep disorders.

SEP-174559 -- SEP-174559 is a GABA-A agonist with a selectivity profile that favors the alpha2 subunit of the GABA receptor. The term "GABA-A" refers to a specific neurotransmitter receptor in the central nervous system. In 2001, Sepracor submitted an IND to the FDA, and in 2002, the company completed a Phase I clinical study for SEP-174559. In 2004, the company intends to conduct Phase II proof-of-concept studies, which are expected to include trials for the treatment of anxiety, muscle spasm and spasticity. Preclinical data suggest that SEP-174559 has the potential to provide a rapid onset of action with less sedation than currently marketed anxiolytics for acute anxiety. It is estimated that 39 million adults in the U.S. suffer from some form of anxiety disorder and approximately 37 million Americans suffer from back or neck pain, two-thirds of whom may also suffer from muscle spasm. An estimated 3 million Americans suffer from spasticity, a condition in which a patient`s muscles are in a state of continuous contraction, usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement.

Corporate Update

In December 2003, Sepracor announced the discontinuation of clinical development of tecastemizole for the treatment of allergic rhinitis. Following a meeting with the FDA in the fourth quarter 2002, Sepracor initiated several preclinical and clinical studies. Contingent upon favorable results from these trials, Sepracor had intended to amend the tecastemizole NDA and seek marketing approval. Evaluation of the preliminary results from some of these preclinical and clinical trials indicated that the company would need to conduct additional studies, delaying the timing of a possible amendment to the NDA. After taking into consideration the results from recent tecastemizole trials, evaluating the changing dynamics of the U.S. antihistamine market, and thoroughly assessing the potential of all clinical candidates in Sepracor`s portfolio, the company decided to discontinue development of tecastemizole.

As a result of the discontinuation of further development of tecastemizole, Sepracor incurred a non-cash charge of approximately $19 million in December 2003. The charge represents the carrying value of all patent and intangible assets associated with tecastemizole.

In the first quarter 2004, Sepracor completed the redemption of $430.0 million aggregate principal amount of its 5.75% Convertible Subordinated Notes due November 15, 2006 ("5.75% Notes"). Sepracor redeemed the 5.75% Notes, pursuant to their terms, on January 9, 2004 at 100% of the principal amount, plus accrued but unpaid interest from November 15, 2003 to, but excluding, the redemption date. The total aggregate redemption price for the 5.75% Notes was approximately $433.7 million, including approximately $3.7 million of accrued interest. The 5.75% Notes redeemed by Sepracor represented all of the remaining outstanding 5.75% Notes.

In the fourth quarter 2003, Sepracor completed a $600 million aggregate principal amount 0% Convertible Senior Subordinated Note offering (the "0% Notes"), including $200 million of 0% Series A Convertible Senior Subordinated Notes due 2008 (the "Series A Notes") and $400 million of 0% Series B Convertible Senior Subordinated Notes due 2010 (the "Series B Notes"). In January 2004, the initial purchasers of the $600 million aggregate principal amount of the 0% Notes exercised their option to purchase an additional $50 million principal amount of the Series A Notes and $100 million principal amount of the Series B Notes.

In 2003, Sepracor reduced its convertible subordinated debt outstanding through the redemption of $111.9 million aggregate principal amount of its 7% Convertible Subordinated Debentures due December 15, 2005 ("7% Debentures"). Sepracor redeemed the 7% Debentures, pursuant to their terms, on July 10, 2003 at 103% of the principal amount, plus accrued but unpaid interest from June 15, 2003 to, but excluding, the redemption date. The total aggregate redemption price for the 7% Debentures was approximately $115.8 million, including approximately $0.5 million in accrued interest. The 7% Debentures redeemed by Sepracor represented all of the remaining outstanding 7% Debentures.

Sepracor Inc.(NASDAQ-NMS:SEPR) is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor`s drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. Sepracor`s corporate headquarters are located in Marlborough, Massachusetts.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits and successful development and regulatory approval of the company`s pharmaceuticals under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the results of clinical trials with respect to products under development; the submission, acceptance, and approval of regulatory filings; the scope of Sepracor`s patents and the patents of others; the commercial success of Sepracor`s products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor`s licensees and other collaboration partners; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in the company`s current report on Form 8-K filed with the Securities and Exchange Commission on December 8, 2003.

In addition, the statements in this press release represent Sepracor`s expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor`s expectations or beliefs as of any date subsequent to the date of this press release.

Soltara and Estorra are trademarks and Xopenex is a registered trademark of Sepracor Inc.(NASDAQ-NMS:SEPR) 3M is a trademark of 3M Company(NYSE:MMM) . Astelin is a registered trademark of Wallace Laboratories. Clarinex and Proventil are registered trademarks of Schering Corporation. Allegra is a registered trademark of Merrell Pharmaceuticals. Xusal is a trademark and Xyzal and Zyrtec are registered trademarks of UCB, Societe Anonyme. Norvasc is a registered trademark of Pfizer, Inc.(NYSE:PFE)

To receive a copy of this release or any recent release via fax, call Sepracor`s automated news fax line at 1-800-758-5804 ext. 780960 or visit the web site at www.sepracor.com.

In conjunction with this fourth quarter and full year 2003 press release, Sepracor will host a conference call and live webcast beginning at 8:30 a.m. ET on January 22, 2004. To participate via telephone, dial [phone]. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com and access the Investor Information section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A replay of the call will be accessible by telephone after 12:00 p.m. ET and will be available for approximately one week. To replay the call, dial [phone], access code 716160. A replay of the webcast will be archived on the Sepracor web site in the Investor Information section. Condensed, consolidated statements of operations and consolidated balance sheets follow.

Contact:
David P. Southwell
Executive Vice President
Chief Financial Officer

Jonae R. Barnes
Vice President
Investor Relations
Sepracor Inc.(NASDAQ-NMS:SEPR)

[phone]


Sepracor Inc.(NASDAQ-NMS:SEPR)

Condensed Consolidated Statements of Operations
(Unaudited)

(In thousands, except per share amounts)

Three months ended Twelve months ended
December 31, December 31,
2003 2002 2003 2002

Revenues:

Product sales $100,216 $65,570 $286,819 $190,227
Royalties and other 12,079 13,337 57,221 48,741
Total revenues 112,295 78,907 344,040 238,968

Cost of revenue 9,608 8,470 30,219 24,609

Gross margin 102,687 70,437 313,821 214,359

Operating expenses:
Research and development(A) 78,083 61,217 220,224 243,797
Sales and marketing 57,802 43,767 172,762 155,204
General and administrative
and patent costs 6,684 5,124 24,158 22,659
Total operating
expenses 142,569 110,108 417,144 421,660

Loss from operations (39,882) (39,671) (103,323) (207,301)

Other income (expense):
Interest income 1,238 3,300 6,179 15,553
Interest expense (11,687) (13,683) (50,907) (63,720)
Other income (expense),
net (B) 16,653 497 18,681 (515)
Gain on early
extinguishment of debt (C) - 5,315 - 44,265
Loss on debt redemption (D) - - (4,645) -
Debt conversion expense (E) - - - (63,258)
Total other income
(expense) 6,204 (4,571) (30,692) (67,675)

Equity in investee (loss) (220) (13) (1,921) (1,514)

Net loss $(33,898) $(44,255) $(135,936) $(276,490)

Basic and diluted net loss per
common share $(0.40) $(0.53) $(1.61) $(3.34)

Shares used in computing basic
and diluted
net loss per common share: 84,955 84,230 84,639 82,899


(A) Included in amounts for the three and twelve months ended December 31,
2003 is a non-cash charge of $18,814 related to the discontinuation of
further development of tecastemizole.
(B) Other income (expense), net includes gains of $16,297 and $18,552
related to the sale of Vicuron stock for the three and twelve months
ended December 31, 2003, respectively.
(C) Represents the net gain on the 2002 cash repurchase of Sepracor 7%
convertible subordinated debentures due 2005.
(D) Represents the loss on the redemption of the remaining outstanding
$111.9 million face value of Sepracor 7% convertible subordinated
debentures due 2005.
(E) Represents non-cash inducement costs incurred from the exchange of
convertible subordinated debt into shares of Sepracor common stock.


Sepracor Inc.(NASDAQ-NMS:SEPR)

Condensed Consolidated Balance Sheets
(Unaudited)

(in thousands)


December 31, December 31,
ASSETS 2003 2002

Cash, short and long-term investments (A) $840,388 $556,434
Accounts receivable, net 50,591 21,654
Inventory 6,866 7,960
Property, plant and equipment, net 66,428 72,522
Investment in affiliate 3,019 4,940
Other assets 52,933 63,603

Total assets $1,020,225 $727,113


LIABILITIES AND STOCKHOLDERS` EQUITY (DEFICIT)

Accounts payable and accrued expenses $139,542 $121,001
Other liabilities 28,976 14,430
Debt payable 918 1,992
Convertible subordinated debt (A) 1,470,000 981,870
Total stockholders` equity (deficit) (619,211) (392,180)

Total liabilities and
stockholders` equity (deficit) $1,020,225 $727,113

(A) In January 2004, the Company redeemed its $430,000 5.75% Convertible
Debentures for approximately $433,700, including accrued interest, and
received net proceeds of approximately $145,875 from the exercise of
an additional $150,000 of its 0% Convertible Debentures.


SOURCE Sepracor Inc.(NASDAQ-NMS:SEPR)

[blb]

Entscheidung der FDA soll noch im Februar kommen.

[blb]

Estorra wurde am Wochenende so gut wie zugelassen!

FDA Notifies Sepracor of Approvable Action for ESTORRA(TM) Brand Eszopiclone for the Treatment of Insomnia
SATURDAY, FEBRUARY 28, 2004 9:00 AM
- PR Newswire

MARLBOROUGH, Mass., Feb 28, 2004 /PRNewswire-FirstCall via COMTEX/ -- Sepracor Inc. (SEPR) today announced that it has received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for ESTORRA(TM) brand eszopiclone 2 mg and 3 mg tablets for the treatment of insomnia characterized by difficulty falling asleep, and/or difficulty maintaining sleep during the night and early morning for adult and elderly patients, and a 1 mg tablet for elderly patients whose primary complaint is difficulty falling asleep. The FDA has not requested additional clinical or preclinical trials for final approval.

"We are very excited to have received an approvable letter from the FDA for ESTORRA," said Mark H.N. Corrigan, M.D., Executive Vice President of Research and Development at Sepracor. "The draft labeling is consistent with our proposals regarding indication and intended use. We are particularly pleased that the results of our six-month study are included in the draft labeling."

Contingent upon the outcome of our expected discussion with the Agency and their assessment of our resubmission of the NDA, the company believes it is on track for an approval and launch of ESTORRA mid-2004 if the resubmission is categorized as Class One, which would involve a two-month FDA review. Sepracor would anticipate an approval and launch during the second half of 2004 if the resubmission is categorized as Class Two, which would involve a six-month FDA review.

The NDA, which was submitted to the FDA on January 31, 2003, contained a total of 24 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies, including one with a positive control, for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package.

According to the National Institutes of Health web site, insomnia affects more than 50 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.

According to the National Sleep Foundation (NSF) Sleep in America Poll 2003, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of several other medical conditions, from arthritis to diabetes, heart and lung disease and depression. This NSF poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67%) report frequent sleep problems, only about seven million elderly patients have been diagnosed with sleep problems.

The U.S. market for prescription sleep products, not including off-label (not indicated for the treatment of insomnia) use of central nervous system agents for the treatment of insomnia, was approximately $1.5 billion in 2002. The U.S. prescription sleep agent market grew at a rate of almost 25 percent for the past two years, according to IMS Health information.

Conference Call and Webcast

Sepracor will host a live conference call and webcast on Monday, March 1, 2004 at 8:30 a.m. ET to discuss the approvable letter for ESTORRA and provide an update of Sepracor`s sales force expansion plan. To participate via telephone, dial [phone]; [phone]; [phone]; (612) 326- 1013; [phone]; [phone]; [phone]; [phone]; [phone]; [phone]; [phone]; [phone]; or [phone]. Reference the "ESTORRA FDA Action" conference call. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com. The webcast will be accessible from either the homepage or the Investor Information section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A replay of the call will be accessible by telephone after 12:00 p.m. ET on March 1, 2004 and will be available for approximately one week. To replay the call, dial [phone] using access code 722906.



Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor`s drug development program has yielded an extensive portfolio of pharmaceutical compound candidates, including candidates for the treatment of respiratory and central nervous system disorders. Sepracor`s corporate headquarters are located in Marlborough, Massachusetts.

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the anticipated regulatory approval, potential benefits and successful development and commercialization of ESTORRA. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the timing and success of submission, acceptance and approval of regulatory filings; the scope of Sepracor`s patents and the patents of others; the commercial success of Sepracor`s products; the ability of the company to attract and retain qualified personnel; the performance of Sepracor`s licensees; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in Sepracor`s current report on Form

8-K filed with the Securities and Exchange Commission on December 8, 2003.

In addition, the statements in this press release represent Sepracor`s expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor`s expectations or beliefs as of any date subsequent to the date of this press release.


Estorra is a trademark of Sepracor Inc.


For a copy of this release or any recent release, visit http://www.prnewswire.com/comp/780960.html or www.sepracor.com.

SOURCE Sepracor Inc.

David P. Southwell, Executive Vice President and Chief Financial
Officer, or Jonae R. Barnes, Vice President of Investor Relations, both of
Sepracor Inc., [phone]
/Company News On-Call: http://www.prnewswire.com/comp/780960.html


http://www.sepracor.com


Copyright (C) 2004 PR Newswire. All rights reserved.

[blb]

Aktuell 30% im Plus, Tendenz steigend. Keiner dabei? Das waren Schnäppchenkurse heute vormittag!

[perry2]

Hätte ich nie gedacht, dass meine Depotleiche ersten Ranges noch einmal auf Wiederbelebungsversuche reagiert. Das Teil besaß für mich nur noch nostalgischen Wert. Man lernt eben nie aus!
Perry

[Cargospezialist]

Geht doch

[721hh]

toll ...

mein erstinvestment in sepracor war zu 20.- euro etwa im frühjar 2002, hab zu 14.- dann nachgekauft...
jedoch bei 6.- euro tiefstand mich statt den cost average zu nützen mich für einen urlaub mit meiner freundin entschieden...
verkauft hab ich letzten sommer zu 24.-...wiederum weil ein urlaub anstand...

was lernen wir daraus? lass dich niemals von einer frau beeinflussen...

lg 721hh aus austria

[blb]

Bin heute raus. Knapp 150% Gewinn. War ne lange Zeit mit vielen Ups and Downs. Aktuell erscheint mir Konkurrent Neurocrine mehr Potenzial zu haben.

[goldmaki]

hallo blb,

du scheinst ja auch überall investiert zu sein.
ich behalte meine sepracor noch eine weile, denn der 3 jahres chart zeigt noch "luft" bis in den raum 60 ff....

gruß goldmaki

[blb]

@goldmaki:

Ja, bin v.a. in den Großen drin. Aktuell noch in PDLI, MLNM und leider halt auch VRTX.

Das it den 60$ halt ich auch für machbar, allerdings ist mir das Chance/Risikoverhältnis aktuell zu niedrig.
Viel Glück weiterhin!

Grüße
blb

[unicum]

Sepracor ist jetzt auch im Portfolio von BBBiotech.

[blb]

@unicum: Ja, aber auch schon ne ganze Weile jetzt. Hab sie weiterhin auf der Watchlist, meine Gewinnmitnahmen waren aber im Nachhinein erstmal richtig!

Grüße
blb

[unicum]

@blb

kann ja nicht überall immer up to date sein

Bin auch erstmal draußen, aber leider zu früh ausgestiegen, aus meiner guten alten Sepracor.

[blb]

Heute wurde Estorra endgültig zugelassen!

Mal schaun wie der Kurs heute reagiert. Bei neuen Hochs kauf ich mir evtl. wieder ein paar!

Grüße
blb

[Frank888]

wenn wir über 60 gehen, sind ganz schnell die 80 da, aber vielleicht gibt es nochmal eine Kaufchance bei 54. Mal schaun.

Frohes Fest für alle

[Cargospezialist]

17.02.2005 15:03:
SEPRACOR - Biotech-Momentumplayer zieht durch

SEPRACOR (Nachrichten) (SEPR) : 63,20$ (+7,76%)

Wochenchart (log) seit März 2002 (1 Kerze = 1 Woche)

Diagnose: Gewinner ist vorbörslich heute die Aktie von Sepracor. Eine starke Rally wurde hier ab Anfang 2004 innerhalb einer breiten Tradingrange zwischen 41,90 und 54,00$ auskonsolidiert. Der Ausbruch daraus nach oben ist Mitte Dezember erfolgt. Nach dem Erreichen des bei 60,00$ liegenden Widerstands fiel die Aktie zunächst zurück, konnte sich aber mit einem bullischen Pullback auf den gebrochenen Widerstand bei 54,00$ fangen. Vorbörslich erfolgt jetzt der Ausbruch über 60,00$.

Prognose: Aus der Tradingrange lässt sich bei SEPR weiterhin ein Ziel im Bereich 66,00$ ableiten, welches auch kurzfristig erreicht werden kann. Mittelfristig bietet sich nach Bestätigtem Ausbruch nach oben durchaus weiteres Kurspotenzial. Oberhalb des bei 51,00$ liegenden mittelfristigen Aufwärtstrends wird ein anstieg bis in den Bereich 90,50$ auf längerfristige sicht möglich. Gefährdet wird das bullische Szenario bei einem klaren Rückfall unter 54,00$.





Chart erstellt mit Qcharts

[blb]

Glückwunsch allen, die noch dabei sind!

Grüße
blb

[borazon]

Sepracor jumps on takeover talk



By Russ Britt & Val Brickates Kennedy, MarketWatch
Last Update: 4:38 PM ET Feb. 17, 2005

LOS ANGELES (MarketWatch) -- Shares of Sepracor jumped more than 8 percent Thursday on reports that the drugmaker could be the target of a buyout and is evaluating strategic options.
Sepracor (SEPR: news, chart, profile) closed up 8.4 percent at $63.60 after Bloomberg reported that the company has retained Morgan Stanley to explore future opportunities, citing unnamed sources.

Company executives were not immediately available for comment.

In December, Marlborough, Mass.-based Sepracor received Food and Drug Administration approval for Lunesta, a sleeping pill that it says could bring in up to $1 billion sales. Unlike other insomnia drugs, which can be addictive, Lunesta can be prescribed for long-term use.

The launch of Lunesta has been delayed while the Drug Enforcement Agency finishes its classification review of the drug. Sepracor announced in January that the sleeping pill should be on the market by the end of the first quarter.

Sepracor already markets Xopenex, a treatment for asthma. The drug firm has been marketing it by itself and plans to do the same for Lunesta. Sepracor also earns royalties on sales of Sanofi-Aventis` (SNY: news, chart, profile) Allegra and Schering-Plough`s (SGP: news, chart, profile) Clarinex.

The emerging pharmaceutical company continues to operate in the red, however. For the quarter ended Dec. 31, Sepracor reported a loss of $33.7 million, or 33 cents per share, compared with a loss of $33.9 million or 40 cents a share for the same period last year.

As of the end of 2004, Sepracor had $833.9 million in cash and securities.

[borazon]

Sepracor hires banker to review options - report
Thu Feb 17, 2005 08:53 AM ET

NEW YORK, Feb 17 (Reuters) - Sepracor Inc. (SEPR.O: Quote, Profile, Research) has hired Morgan Stanley (MWD.N: Quote, Profile, Research) to advise it on "strategic options" that may include a sale, Bloomberg reported on Thursday, citing people familiar with the matter.

Officials for Sepracor, which recently had its insomnia drug Lunesta approved by U.S. regulators, were not immiedately available for comment.

Morgan Stanley would not comment on the report.

[perry2]

Wollte das gute Stück mal wieder aus der Versenkung hervorholen - den Thread meine ich. Die Aktie hat das nicht nötig!
Der Chart sieht übrigens lecker aus. Kenne nicht viele der Biotechüberflieger anno 2000, die wieder 50% ihrer Höchststände erreicht haben bzw. über 1000% von den Tiefsständen entfernt sind.
Interessant erscheint mir die Abkopplung von der Entwicklung des Branchenindex.
Perry

[perry2]

Schade, dass Sepracor von dem Amgen-Hype nicht profitiert.
Liegt wohl mal wieder an der Einschätzung eines Analysten:
http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yh…
Noch liegen sie im Aufwärtstrend, aber viel Platz nach unten ist nicht mehr.
Perry

[blb]

Neurocrine gefällt mir zur Zeit besser, perry2!
Sepracor ist schon ziemlich teuer. Trotzdem natürlich langfristig noch lange nicht ausgereizt.

Grüße
blb

[blb]

Zahlen waren gut!

Sepracor Announces Second Quarter 2005 Operating Results
TUESDAY, JULY 19, 2005 7:00 AM
- BusinessWire

MARLBOROUGH, Mass., Jul 19, 2005 (BUSINESS WIRE) -- Sepracor Inc. (SEPR) today announced its consolidated financial results for the second quarter of 2005. For the three months ended June 30, 2005, Sepracor`s consolidated revenues were $185.1 million, of which revenues from pharmaceutical product sales were $166.7 million ($83.2 million for sales of XOPENEX(R) brand levalbuterol HCl Inhalation Solution and $83.5 million for sales of LUNESTA(TM) brand eszopiclone, which was launched in April 2005). The net loss for the second quarter of 2005 was $7.4 million, or $0.07 per share. These consolidated results compare with consolidated revenues of $70.0 million, of which revenues from pharmaceutical product sales (XOPENEX Inhalation Solution) were $57.5 million, and a net loss of $81.1 million, or $0.93 per share, for the three months ended June 30, 2004.

For the six months ended June 30, 2005, Sepracor`s consolidated revenues were $304.1 million, of which revenues from pharmaceutical product sales were $273.4 million ($189.9 million for sales of XOPENEX Inhalation Solution and $83.5 million for sales of LUNESTA), and the net loss was $30.0 million, or $0.29 per share. These consolidated results compare with consolidated revenues of $169.4 million, of which revenues from pharmaceutical product sales (XOPENEX Inhalation Solution) were $142.5 million, and a net loss of $131.6 million, or $1.53 per share, for the six months ended June 30, 2004.

As of June 30, 2005, Sepracor had approximately $920 million in cash and short- and long-term investments.

Commercial Operations

LUNESTA brand eszopiclone - During the quarter, Sepracor began full-scale commercial launch of LUNESTA 1 mg, 2 mg and 3 mg tablets for the treatment of insomnia. Marketed through Sepracor`s 1,250-person sales force, LUNESTA is available by prescription in the U.S.

Also during the quarter, Phase III and IV data related to LUNESTA were presented at the annual meetings of the Associated Professional Sleep Societies, the American Psychiatric Association and the International Society for Pharmacoeconomics and Outcomes Research. Among the data presented were:

-- Forecasting the Impact of Adding a New Drug on Formulary Using Medical Claims Data and Clinical Literature: A Case Study of Insomnia Treatment

-- Adjunctive Eszopiclone With Fluoxetine for Major Depressive Disorder (MDD) and Insomnia: Sleep Effects

-- Adjunctive Eszopiclone With Fluoxetine for MDD and Insomnia: Depression Effects

-- Analysis of the Treatment Effect of Eszopiclone on Sleep Parameters That Affect Next-Day Function in the Elderly

-- A Crossover Study of Eszopiclone in the Treatment of Primary Insomnia

-- Eszopiclone Co-Administered With Fluoxetine for Insomnia Associated With MDD: Effects Following Eszopiclone Discontinuation

-- Trajectory Analysis of Treatment Response Across a Twelve-Month Study of Nightly Eszopiclone in Patients With Chronic Insomnia

-- A Dose-Response Efficacy and Safety Study of Eszopiclone in the Treatment of Primary Insomnia

-- Evaluation of the Safety and Efficacy of Eszopiclone in Patients With Obstructive Sleep Apnea

In July 2005, Sepracor announced results from its Phase IIIB/IV, 410-patient, four-week, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of LUNESTA for the treatment of insomnia in perimenopausal and menopausal women suffering from insomnia. The results of this study will be presented at The North American Menopause Society`s annual meeting in San Diego on Sept. 30, 2005.

In this study, nightly use of LUNESTA 3 mg resulted in statistically significant improvement (p<0.01) compared with placebo in patient-reported measures of sleep latency (onset of sleep), wake time after sleep onset (WASO; a sleep maintenance measurement of the amount of time spent awake after initially falling asleep), and total sleep time for each week of the four-week study. LUNESTA was well tolerated over the treatment period.

Compared to baseline and averaged over the double-blind period, women treated with LUNESTA reported fewer nocturnal awakenings due to hot flashes than those treated with placebo (p<0.003). A physician global assessment, which evaluated the overall change in menopausal symptoms, was statistically significantly improved (p<0.0001) for women treated with eszopiclone 3 mg compared with those treated with placebo.

Perimenopause in women is the transition period from normal reproductive function to complete cessation of the menstrual period, or menopause. During this transition, which can be years in duration, and continuing through to the post-menopausal period, the body experiences both physical and hormonal changes, which can be associated with a variety of symptoms. Problems sleeping and the resulting fatigue may occur due to waking up in the middle of the night because of hot flashes or the need to go to the bathroom, which can lead to trouble falling back to sleep. During this time, women may also experience trouble falling to sleep or waking up early in the morning. According to the Agency for Healthcare Research and Quality, up to 40 to 60 percent of perimenopausal, menopausal, and postmenopausal women experience sleep disturbances.

Insomnia can include difficulty falling asleep as well as difficulty maintaining sleep through the night. The recommended dosing for LUNESTA to improve sleep onset and/or maintenance is 2 mg or 3 mg for adult patients (ages 18 to 64). In older adult patients (ages 65 and older), 2 mg is recommended for improving sleep onset and/or maintenance, while the 1 mg dose is recommended for improving sleep onset in older adult patients whose primary complaint is difficulty falling asleep.

An estimated 100 million adult Americans suffer from either chronic or occasional insomnia.(a) Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed. Insomnia can be a serious condition. If left untreated, it may become progressively worse and in turn potentially affect a person`s emotional, mental and physical health.

XOPENEX(R) brand levalbuterol HCl - Marketed through Sepracor`s sales force, XOPENEX Inhalation Solution is a short-acting bronchodilator indicated for the treatment or prevention of bronchospasm in patients 6 years of age and older with reversible obstructive airway disease, such as asthma. XOPENEX is available for use in a nebulizer at 0.31 mg and 0.63 mg dosage strengths for routine treatment of children 6 to 11 years old, and in 0.63 mg and 1.25 mg dosage strengths for patients 12 years of age and older.

Asthma is a chronic lung disorder characterized by reversible airway obstruction and the pathologic finding of airway inflammation. According to the American Lung Association, approximately 26 million Americans have been diagnosed with asthma in their lifetime. It is the most common childhood illness and affects approximately 8.6 million children in the U.S. under the age of 18.

ALLEGRA(R) brand fexofenadine HCl - Sepracor earns royalties from Aventis for sales of ALLEGRA, a nonsedating antihistamine, in the U.S. and other countries where Sepracor holds patents relating to fexofenadine (including Japan, Europe, Canada and Australia).

CLARINEX(R) brand desloratadine - Sepracor earns royalties from Schering-Plough Corporation on sales of all formulations of CLARINEX brand desloratadine in the U.S. and in other countries where Sepracor holds patents relating to desloratadine. CLARINEX is indicated for the treatment of allergic rhinitis and chronic idiopathic urticaria (CIU), also known as hives of unknown cause, in patients 12 years of age and older.

XYZAL(R)/ XUSAL(TM) brand levocetirizine - Sepracor earns royalties from UCB on sales of levocetirizine in European countries where the product is sold. Levocetirizine is marketed as XUSAL in Germany and is marketed under the brand name XYZAL in other member states of the European Union. A single isomer of ZYRTEC(R), levocetirizine is indicated for the treatment of symptoms of seasonal and perennial allergic rhinitis and CIU, in adults and children aged 6 years and older. XYZAL is also indicated for persistent allergic rhinitis, which is characterized as allergic symptoms that are present for at least four days per week, and last at least four consecutive weeks.

XOPENEX HFA(TM) (levalbuterol tartrate) MDI - On March 11, 2005, the U.S. Food and Drug Administration (FDA) approved Sepracor`s New Drug Application (NDA) for XOPENEX HFA (hydrofluoroalkane) MDI (metered-dose inhaler) for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease. Reversible obstructive airway disease includes respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). An MDI is a portable, hand-held device consisting of a pressurized canister containing medication and a mouthpiece through which the medicine is inhaled.

Sepracor continues to work to resolve outstanding manufacturing issues and complete process validation work relating to XOPENEX HFA. Sepracor is targeting launch of XOPENEX HFA by the end of the year. Upon launch, Sepracor`s sales force will promote XOPENEX HFA to primary care doctors, specialists including allergists and pulmonologists, and hospitals in the U.S.

The MDI development program included approximately 1,870 pediatric and adult subjects and 54 studies (preclinical and clinical). In each of the three, large-scale, pivotal Phase III trials that Sepracor conducted, the XOPENEX HFA MDI was well tolerated and met the targeted efficacy endpoints in both adults and children with asthma. In the primary airway function measure, FEV(1) (a test of lung function that measures the amount of air forcefully exhaled in one second), the XOPENEX HFA MDI produced statistically (p<0.001) and clinically significant improvements relative to placebo.

Approximately 96 percent of the short-acting beta-agonist inhalers sold in 2004 contained chlorofluorocarbon (CFC) propellants, according to IMS Health information. Under provisions in the Montreal Protocol on Substances that Deplete the Ozone Layer, an international agreement that requires the phase-out of substances that deplete the ozone layer, MDIs containing CFC propellants would qualify for removal from the marketplace. In March 2005, the FDA issued its final rule for the removal of the essential use exemption for albuterol, which currently permits the use of CFC-containing albuterol inhalers despite environmental concerns. Under the rule, all production and sales of albuterol CFC MDIs in the U.S. must cease by the end of 2008. The XOPENEX MDI uses HFA technology and does not contain a CFC propellant.

Currently, the U.S. short-acting bronchodilator MDI market potential at branded prices, assuming parity pricing to branded PROVENTIL(R) HFA, is approximately $1.8 billion.

NDA-Preparation Program

Arformoterol - Sepracor has completed more than 100 preclinical studies and 16 clinical studies for arformoterol inhalation solution as a maintenance treatment for COPD. In 2004, Sepracor completed Phase III studies for arformoterol in which patients treated with arformoterol demonstrated a significant improvement in FEV(1) after dosing with a duration of action of up to 24 hours, versus those taking placebo.

Sepracor is currently preparing the arformoterol NDA and is targeting submission of the NDA to the FDA in the fourth quarter of 2005.

Bronchodilators have the potential to improve lung function, decrease symptoms, help increase mucus clearance and reduce the number of exacerbations in patients suffering from COPD. The U.S. market for long-acting bronchodilators, including the combination product ADVAIR(R), was approximately $4.2 billion in 2004, according to IMS Health information.

Sepracor`s Phase II Programs and Additional Clinical Candidates

SEP-226330 - SEP-226330 is a norepinephrine and dopamine reuptake inhibitor (NDRI). Sepracor initiated a Phase II study of SEP-226330 for the treatment of restless legs syndrome in the fourth quarter of 2004. This compound may have advantages over currently used dopamine agonists in the treatment of restless legs syndrome, which is a movement disorder that is reported to afflict approximately 16 percent of the U.S. adult population.(b) Sepracor is also conducting preclinical evaluations of SEP-226330 as a potential novel mechanistic approach for the treatment of Parkinson`s disease.

(S)-Amlodipine - Sepracor has conducted both Phase I and Phase II studies of (S)-amlodipine for the treatment of hypertension. Amlodipine, marketed by Pfizer Inc. as NORVASC(R), is the leading calcium channel antagonist approved for use for the treatment of hypertension and angina. The evolving paradigms for hypertension treatment are focusing on the use of multiple mechanistic approaches as initial therapy, such as the use of calcium channel blockers (CCBs) with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs).

SEP-225289 - Sepracor plans to submit an Investigational New Drug (IND) application to the FDA and begin a Phase I clinical study for SEP-225289, a norepinephrine, dopamine and serotonin reuptake inhibitor, for the treatment of depression, in 2005. According to the National Institutes of Mental Health, in a given year, approximately 18.8 million Americans have a depressive disorder.

SEP-227162 - SEP-227162 is a serotonin and norepinephrine reuptake inhibitor that Sepracor plans to investigate for the treatment of depression. Other dual reuptake inhibitors have been shown in studies to be successful in the treatment of depression.

Important Safety Information - LUNESTA

LUNESTA works quickly and should only be taken immediately before bedtime. Be sure you have at least eight hours to devote to sleep before becoming active. You should not engage in any activity after taking LUNESTA that requires complete alertness, such as driving a car or operating machinery. You should use extreme care when engaging in these activities the morning after taking LUNESTA. Do not use alcohol while taking any sleep medicine. All sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Side effects may include unpleasant taste, headache, drowsiness and dizziness.

For more product information or for the full prescribing information, please refer to the Sepracor web site at www.sepracor.com.

About Sepracor

Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and commercialization of innovative pharmaceutical products that are directed toward serving unmet medical needs. Sepracor`s drug development program has yielded an extensive portfolio of pharmaceutical compound candidates with a focus on respiratory and central nervous system disorders. The company`s commercialization efforts are carried out by its U.S.-based, 1,250-person, primary care and specialty-oriented sales force. Sepracor`s corporate headquarters are located in Marlborough, Massachusetts.

Forward-Looking Statement

This news release contains forward-looking statements that involve risks and uncertainties, including statements with respect to the successful development and expected commercial launch of XOPENEX HFA MDI, arformoterol and the company`s other pharmaceuticals under development, the safety, efficacy, potential benefits and commercial success of LUNESTA brand eszopiclone, XOPENEX Inhalation Solution, XOPENEX HFA MDI and all of the company`s pharmaceutical candidates, and expectations with respect to collaborative agreements. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: unexpected delays in commercial introduction of Sepracor`s products; Sepracor`s ability to fund and the results of further clinical trials with respect to products under development; the timing and success of submission, acceptance, and approval of regulatory filings; the scope of Sepracor`s patents and the patents of others; the clinical benefits of the company`s products; the commercial success of Sepracor`s products; changes in the use and/or label of LUNESTA; the ability of the company to attract and retain qualified personnel; the performance of Sepracor`s licensees and other collaboration partners; the availability of sufficient funds to continue research and development efforts; the continued ability of Sepracor to meet its debt obligations when due; and certain other factors that may affect future operating results and are detailed in the company`s quarterly report on Form 10-Q for the quarter ended March 31, 2005 filed with the Securities and Exchange Commission.

In addition, the statements in this press release represent Sepracor`s expectations and beliefs as of the date of this press release. Sepracor anticipates that subsequent events and developments may cause these expectations and beliefs to change. However, while Sepracor may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Sepracor`s expectations or beliefs as of any date subsequent to the date of this press release.

(a) Extrapolated to current population from 2000 census based on Ancoli-Israel et al. SLEEP. 1999;22 (suppl 2):S347-S353

(b) Data Monitor, October 2004

Lunesta and Xopenex HFA are trademarks and Xopenex is a registered trademark of Sepracor Inc. Clarinex and Proventil are registered trademarks of Schering Corporation. Allegra is a registered trademark of Merrell Pharmaceuticals. Xusal is a trademark and Xyzal and Zyrtec are registered trademarks of UCB, Societe Anonyme. Norvasc is a registered trademark of Pfizer, Inc. Advair is a registered trademark of Glaxo Group Limited.

For a copy of this release or any recent release, visit Sepracor`s web site at www.sepracor.com.

In conjunction with this second quarter 2005 press release, Sepracor will host a conference call and live webcast beginning at 8:30 a.m. ET on July 19, 2005. To participate via telephone, dial [phone]. Please call ten minutes prior to the scheduled conference call time. For live webcasting, go to the Sepracor web site at www.sepracor.com and access the For Investors section. Click on either the live webcast link or microphone icon to listen. Please go to the web site at least 15 minutes prior to the call in order to register, download, and install any necessary software. A .pdf file of the slides will also be made available in the For Investors section of the web site just prior to the start of the webcast. A replay of the call will be accessible by telephone after 12:00 p.m. ET and will be available for approximately one week. To replay the call, dial [phone], access code 787022. A replay of the webcast will be archived on the Sepracor web site in the For Investors section.

Condensed, consolidated statements of operations and consolidated balance sheets follow.

Sepracor Inc.
Condensed Consolidated Statements of Operations
(Unaudited)

(In thousands, except per share amounts)

Three months ended Six months ended
June 30 June 30
2005 2004 2005 2004
--------- --------- --------- ----------

Revenues:

Product sales $166,743 $57,450 $273,391 $142,506
Royalties and other 18,321 12,517 30,718 26,939
--------- --------- --------- ----------
Total revenues 185,064 69,967 304,109 169,445

Cost of revenue 14,655 6,930 24,895 16,030
--------- --------- --------- ----------

Gross margin 170,409 63,037 279,214 153,415

Operating expenses:
Research and development 37,132 45,077 65,701 82,373
Sales and marketing (A) 130,148 86,355 223,320 170,789
General and
administrative and
patent costs 9,848 7,899 18,329 14,933
--------- --------- --------- ----------
Total operating
expenses 177,128 139,331 307,350 268,095

--------- --------- --------- ----------
Loss from
operations (6,719) (76,294) (28,136) (114,680)

Other income (expense):
Interest income 5,422 1,424 10,670 2,679
Interest expense (5,839) (5,830) (11,681) (11,954)
Other income (expense),
net 36 (71) (357) (88)
Loss on redemption of
debt (B) - - - (7,022)
--------- --------- --------- ----------
Total other income
(expense) (381) (4,477) (1,368) (16,385)

Equity in investee (loss) (300) (358) (468) (505)

--------- --------- --------- ----------
Net loss $(7,400) $(81,129) $(29,972) $(131,570)
========= ========= ========= ==========

Basic and diluted net loss per
common share $(0.07) $(0.93) $(0.29) $(1.53)
========= ========= ========= ==========

Shares used in computing basic
and diluted net loss per
common share: 104,686 86,797 104,118 86,006
========= ========= ========= ==========

(A) Included in the expenses for the six months ended June 30,
2004 is a charge of $30,671 related to the termination of the
Ross agreement for the co-promotion of Xopenex.

(B) Represents the loss for write-off of deferred finance costs
resulting from the redemption of our $430,000 5.75%
convertible subordinated notes, due 2006.


Sepracor Inc.
Condensed Consolidated Balance Sheets
(Unaudited)


(in thousands) June 30, December 31,
2005 2004
----------- -----------
ASSETS

Cash, short and long-term investments $920,367 $833,912
Accounts receivable, net 111,220 68,914
Inventory 18,969 13,086
Property, plant and equipment, net 70,966 70,860
Investment in affiliate 5,067 5,535
Other assets 48,255 46,811
----------- -----------

Total assets $1,174,844 $1,039,118
=========== ===========



LIABILITIES AND STOCKHOLDERS` EQUITY
(DEFICIT)

Accounts payable and accrued expenses $114,389 $132,473
Other liabilities 97,485 72,485
Debt payable 3,438 4,455
Convertible subordinated notes 1,160,820 1,160,820
Total stockholders` equity (deficit) (201,288) (331,115)
----------- -----------

Total liabilities and
stockholders` equity (deficit) $1,174,844 $1,039,118
=========== ===========


SOURCE: Sepracor Inc.

Sepracor Inc.
David P. Southwell
Executive Vice President
Chief Financial Officer
or
Jonae R. Barnes
Vice President
Investor Relations
508-481-6700


Copyright Business Wire 2005

[perry2]

Analysten sind schon eine besondere Sorte Menschen.
Prudential F.: Underweight
Lehman B.: Overweight
...und das innerhalb von 2 Tagen. So unterschiedlich kann die Perspektive gar nicht sein.
Auf jeden Fall ist Bewegung hinein gekommen. Luft bis 62$.
Perry

[blb]

Morgan Stanley analyst Marc Goodman maintained an "overweight" rating and $70 price target on Sepracor (nasdaq: SEPR - news - people ) on the heels of an "excellent" fourth quarter with higher-than-expected earnings and strong guidance.

"[Sepracor`s] stars were aligned for a great quarter," wrote the analyst in a research note Wednesday. "We remain committed to the stock."

Goodman believes that investors will increasingly return to Sepracor as its Lunesta sleep-aid continues its ramp in the face of new product launches, Xopenex franchise continues to grow, and arformoterol is approved by year-end 2006 or early 2007.

Sepracor reported fourth-quarter earnings of 32 cents per share, 30 cents higher than Goodman`s estimate and 27 cents higher than consensus. Management guided its 2006 sales estimate for Lunesta to $650 million, a number Goodman deemed "doable, even if [competitor] Indiplon enters the market in mid-2006."

The analyst adjusted his 2006 and 2007 earnings-per-share estimates for the Sepracor to $1.50 and $2.96, respectively, from $1.26 and $3.28.

In his coverage of specialty pharmaceuticals, Goodman has "overweight" ratings on Adams Respiratory Therapeutics (nasdaq: ARXT - news - people ), Advanced Medical Optics (nyse: EYE - news - people ), Barr Pharmaceuticals (nyse: BRL - news - people )and Barrier Therapeutics (nasdaq: BRTX - news - people )among others.