Sepracor unter 50$ - 500 Beiträge pro Seite

[dohanics]

Hi Leute,
was ist mit Sepracor los???????????????

[gholzbauer]

Thursday February 15 5:40 PM ET
Schering-Plough:Plant Issues May Hit Earns

NEW YORK (Reuters) - Schering-Plough Corp. (NYSE:SGP - news) said on Thursday it expects first-quarter earnings to drop as much as 15 percent from the 2000 quarter after U.S. regulators required the drug company to correct manufacturing problems, thus disrupting production.

Full-year 2001 sales and earnings will also be lower than expected as plants are taken off line following inspections by the U.S. Food and Drug Administration (news - web sites) of the company`s plants in New Jersey and Puerto Rico, it said.

The problems involve the failure to adhere to ``Good Manufacturing Practices, primarily relating to production processes, controls and procedures,`` the company said without elaborating.

Schering-Plough said the deficiencies must be corrected before it can receive FDA approval for desloratadine -- a key experimental allergy drug that the company had hoped to ship to drug stores for the coming allergy season that begins next month.

Schering-Plough, which earned 42 cents per share in the first quarter of 2000, said the FDA had expressed concern after inspecting the Kenilworth, N.J.-based company`s manufacturing plants.

Analysts polled by First Call/Thomson Financial expect the firm to earn 48 cents per share in the current quarter and $1.90 a share for full-year 2001.

Schering-Plough said in a statement that its drug production and shipments would be hurt by the ``temporary interruption of some production lines to install system upgrades and further enhance compliance, and other technical production and equipment qualification issues.``

The firm said the FDA recently inspected the New Jersey and Puerto Rico plants in a follow-up to manufacturing problems spotted in the fall of 1999. The company said it has been working to correct the earlier problems with the help of outside consultants and has committed to spend over $50 million for new equipment, process and system improvements.

Schering-Plough did not say when it expects to begin shipping desloratadine, the successor to the company`s $3 billion-a-year allergy treatment Claritin, which is facing possible generic competition when its U.S. patent expires in December 2002.

It hopes to switch over Claritin users to desloratadine well before the patent expires late next year, a mission that will be more difficult to accomplish with any delay in getting desloratadine to market.

The FDA has given a so-called ``approvable letter`` to desloratadine, indicating the drug has satisfied most of the requirements for final approval. But the drug, which is a derivative of Claritin (loratadine), has not yet received a final green light from the agency.

The stock closed down 70 cents to $48.32 on the New York Stock Exchange (news - web sites) Thursday. Its 52-week trading range is $60 and $30.50.

[rockdj]

Was ist denn mit Sepracor ?

Der heutige Tag war doch soweit okay.

[gholzbauer]

Jetzt immerhin wieder 53$.
Die drohende Verschiebung des Marktstartes von Desloratadine, das Schering-Plough von Sepracor lizensiert hat, kommt natürlich nicht gut an.

[fadosa]

Bitte um Übersetzung.
Danke
fadosa

[gholzbauer]

SGP wird natürlich alle Hebel in Bewegung setzen, um Desloratadine so bald wie möglich zu etablieren, da der Patentschutz für das Vorgängerprodukt Loratadine 12/2002 ausläuft, und SGP die zu erwartenden Umsatzverluste aufgrund generischer Konkurrenz mit dem überlegenen Desloratadine kompensieren will. SGP macht ca. 25-30% des Gesamtumsatzes mit Loratadine.
SGP soll nachbörslich von 48$ unter 40$ gefallen sein.
SEPR jetzt laut Island wieder 55.50$.

[gholzbauer]

Schering-Plough Says Quality Flaws to Hurt Earnings (Update2)
By Brian Reid

Kenilworth, New Jersey, Feb. 15 (Bloomberg) -- Schering- Plough Corp. said first-quarter profit
will drop as much as 15 percent, and approval of the successor to its Claritin allergy drug will be
delayed, as it works to fix manufacturing flaws.

The U.S. Food and Drug Administration is withholding approval of the new drug, known as
Clarinex or desloratadine, until the deficiencies are corrected, the company said. Claritin,
Schering- Plough`s biggest product and the world`s top-selling allergy drug, starts losing patent
protection next year.

Schering-Plough said it had to stop some production lines and install new equipment to fix quality
control flaws the FDA found at plants in New Jersey and Puerto Rico. The delay may prevent
Schering-Plough from introducing Clarinex before the spring allergy season in the U.S., when
sales of allergy drugs pick up.

``If the FDA is linking the approval for Clarinex to Schering- Plough`s ability to fix these problems,
then they`re out of the spring allergy season. These problems don`t get quick fixes,`` said Chris
Delpi, an analyst with Glenmede Trust, which doesn`t hold a major position in Schering-Plough
shares.

The announcement came after the close of trading on U.S. markets. In after-hours trading
Schering-Plough shares fell 17 percent to $40 from their close of $48.32. Shares of Sepracor,
Inc., which developed Clarinex with Schering-Plough, fell as much as 23 percent in after-hours
trading to $50.25 from their close of $64.88.

Claritin made up about 31 percent, or $3 billion, of Schering- Plough`s $9.8 billion in 2000 sales.
The drug already has competition from Zyrtec, a UCB SA drug that Pfizer Inc. markets, and
Aventis SA`s Allegra.

The FDA last month issued a so-called approvable letter on Clarinex. Such a letter spells out the
final steps a company must take before the agency will approve a drug. Neither the FDA nor the
company divulged the contents of the letter.

`In the Penalty Box`

Schering-Plough is ``in the penalty box`` with the FDA, said Ira Loss, an analyst with Washington
Analysis, who noted that the release didn`t say how long it would take to correct the problem.
``Those things make for major downdrafts in stock prices.``

Generic competition for Claritin could begin in 2002, meaning Schering-Plough would have only
one allergy season to convert patients to the newer drug, said Delpi.

Schering-Plough said fixing the manufacturing problems would ``negatively affect earnings for
the full year 2001.``

The company said the quality of drugs on pharmacy shelves hasn`t been affected by the flaws
cited by the FDA, which dealt primarily with manufacturing procedures and controls. The
company said it would spend more than $50 million in new equipment and other improvements.

`Full Responsibility`

``I am taking full responsibility for resolving these matters in a timely manner and securing FDA`s
confidence in the quality and reliability of our manufacturing systems and controls,`` said Richard
Jay Kogan, the company`s chief executive, in a statement.

Schering-Plough has had a history of quality control lapses. The FDA has sent the company at
least three warning letters in the last two years noting lapses in quality control procedures at
both New Jersey and Puerto Rico facilities.

The most recent letter publicly available, issued last May, detailed improper testing of some of
the Schering-Plough`s antibiotics and allergy drugs at its plant in Puerto Rico.
-------------------------------------------------------

Die von mir herausgehobenen Konkurrenzprodukte sind natürlich auch von Sepracor in Lizenz vergeben.

[gholzbauer]

Ach ja, bid/ask zuletzt 56$/57.75$.
Alles wird gut.
Zumindest langfristig.

[pixelpaxel]

Hallo gholzbauer,
jetzt wird alles gut,zumindest für diejenigen die in sepracor short sind,mein Kursziel von 10$ ist ja jetzt
in greifbarer Nähe,hoffentlich werdet ihr an eurem
Optimismus nicht alle aufgehängt und noch viel Spass mit
eurer Superseifenblase sepr.