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[homerle]

War das jetzt der Durchbruch ?
Gute Testergebnisse mit Plecanatide (SP-304).

Riesen Umsätze gestern Abend, + 50 %.

Und ich Trottel habe die Hälfte meiner Callisto-Aktien für 0,20 ct vor Kurzem verschleudert. Hoffe wenigstens, jemand von euch hat zugeschlagen.

Könnte jetzt echt die Unsicherheit nehmen und Callisto wieder an 1 Euro ranführen.

Hier der Bericht:

NEW YORK--(BUSINESS WIRE)-- Synergy Pharmaceuticals, Inc. (OTCBB:SGYP.ob - News), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today positive results in a Phase IIa clinical trial of plecanatide (SP-304) in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg gave improved bowel function in patients with chronic constipation. Benefits were observed in increased frequency of bowel movements, decreased straining and abdominal discomfort, and improvement in other associated clinical measures. Plecanatide treatment exhibited an excellent safety profile. No severe adverse events were observed, and notably no patients receiving plecanatide reported diarrhea. Additionally, no systemic absorption of plecanatide was detected in patients at any of the dose levels studied. The clinical data will be presented on Monday, October 18, 2010 (Poster Number P762; 10:30 AM to 4:00 PM) at the American College of Gastroenterology Annual Scientific meeting in San Antonio, Texas. Plecanatide is a member of a new class of non-systemic drugs, referred to as GC-C receptor agonists, for treatment of chronic constipation, irritable bowel syndrome with constipation (IBS-C) and other GI diseases.



“We are very pleased with the superb safety profile that plecanatide exhibited in this trial,” said Gary S. Jacob, Ph.D., President and CEO of Synergy. “Along with the clear trend in improvement of bowel function in patients treated with plecanatide compared to placebo, there was a complete absence of reported diarrhea, which bodes well for our plan to initiate a 450 patient, dose-ranging Phase IIb trial in chronic constipation in December, 2010, and our Phase II program in IBS-C in 2011.”


“The successful completion of this Phase IIa trial represents a major milestone in the development of plecanatide to treat GI disorders,” said Mr. Gabriele Cerrone, Chairman of Synergy. “Millions of patients worldwide suffer from chronic constipation and other human GI conditions for which there are limited treatment options currently available.”



Study Design and Results


The Phase IIa, randomized, double-blind, placebo-controlled, dose-escalation, cohort-design, multi-center clinical trial in patients with chronic constipation, using modified Rome III criteria for enrollment, was designed primarily as a safety study, but with the inclusion of measures of bowel function and patient-reported symptoms to provide information on the pharmacodynamic effects of plecanatide on patients with chronic constipation. Seventy eight evaluable patients were enrolled and dosed with placebo or plecanatide once-daily for 14 consecutive days at oral doses of 0.3 mg, 1.0 mg, 3.0 mg or 9.0 mg, respectively. Patients were monitored for number of spontaneous and complete-spontaneous bowel movements, stool consistency using the Bristol Stool Form Scale, and ease of stool passage, abdominal discomfort, constipation severity and overall relief.



About Plecanatide


Plecanatide (formerly called SP-304) is a member of a new class of non-systemic drugs for treatment of CC, IBS-C and other GI diseases. Plecanatide is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered plecanatide binds to and activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut, facilitating bowel movement. In animal models, oral administration of plecanatide promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.



About Chronic Constipation (CC)


CC is a very common gastrointestinal disorder. Up to 26 million Americans suffer from the disorder, and of this population about 5 million have a severe condition necessitating intervention. The prevalence of the disorder is similar in other developed countries. Patients with CC often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with CC can experience serious discomfort which adversely affects their ability to work and their quality of life.



About Irritable Bowel Syndrome (IBS)


Up to one sixth of adults experience irritable bowel syndrome (IBS), a condition marked by disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder (IBS-M). The split in prevalence between the forms is about 1/3rd each. In addition, most patients suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated 10 million people in the US and an additional 10 million people in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of adult visits to primary care physicians in the US.



About the American College of Gastroenterology Annual Scientific Meeting


The American College of Gastroenterology (ACG) Scientific Meeting is one of the premier GI clinical events of the year, playing a major role in educating GI professionals regarding gastroenterological disorders, and delivering the latest clinical updates on common and not-so-common GI disorders.



About Synergy Pharmaceuticals, Inc.


Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's proprietary drug plecanatide is a synthetic analog of the human gastrointestinal hormone uroguanylin, and functions by activating the guanylate cyclase C (GC-C) receptor on epithelial cells of the GI tract. Plecanatide has just completed a Phase IIa clinical trial in patients to treat chronic constipation. The Company plans to initiate a Phase IIb 28-day repeated-oral-dose, placebo-controlled trial in chronic constipation patients in late 2010. More information is available at http://www.synergypharma.com.



Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Synergy does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.

[Loserin]

Antwort auf Beitrag Nr.: 40.286.075 von homerle am 08.10.10 01:04:08

Was hat SGYP mit Callisto zu tun ?

[suuperbua]

Antwort auf Beitrag Nr.: 40.286.441 von Loserin am 08.10.10 08:39:43

genau schatzi

[Peederwoogn2]

Antwort auf Beitrag Nr.: 40.286.441 von Loserin am 08.10.10 08:39:43

@m schatz,

was läuft da zwischen dir und dem greifswalder

[suuperbua]

Antwort auf Beitrag Nr.: 40.288.864 von Peederwoogn2 am 08.10.10 13:39:32

das geht doch Dich nix an

bleibt unser geheimnis

@schatzi (Loserin)

vielen dank nochmal, Du warst großartig

[homerle]

Antwort auf Beitrag Nr.: 40.286.441 von Loserin am 08.10.10 08:39:43

SGYP ist eine 100%-ige Tochter von Callisto !!!

[homerle]

Antwort auf Beitrag Nr.: 40.299.439 von homerle am 11.10.10 16:20:40

Jetzt schlummert sie wieder vor sich hin, bis zur nächsten Meldung. Komisch, am Tag der positiven News sind knapp 200000 Aktien gehandelt worden (Schnitt: 11000) und jetzt wieder Stillstand.
Egal, meine Restposten werde ich aussitzen (hoffentlich erlebe ich noch den Durchbruch)

[homerle]

Antwort auf Beitrag Nr.: 40.303.112 von homerle am 12.10.10 09:46:18

Jetzt kommt sie doch in Fahrt. Die Meldung scheint jetzt erst richtig anzukommen.
In den USA immer größere Umsätze (> 300000) und steigende Kurse.
Werden wohl bald die 40ct sehen.

[massny]

gestern wurden über 2 millionen shares gehandelt, hat jemand infos was los ist..?

habe nichts gefunden..

[homerle]

So, das war dann wohl der Durchbruch.

Über 2 Mio gehandelte Aktien. Kursziel von Callisto wird mit 7 Dollar angegeben. Gestern plus 64 %.

Könnte mich in den A.... beißen, dass ich zum Teil verkauft habe.
Jetzt stehen sie im Fokus undes wird weiter aufwärts gehen.


Hier der Experten-Tip, der wohl die Kursralley eingeläutet hat:
I'm on a constant hunt for stocks with potential for 10x returns. I first started writing about Dendreon (DNDN) when it was below $5, Genworth Financial (GNW) at $1.00, and more recently Pharmathene (PIP) at $1.90 as examples. All have had significant gains. When I wrote the book, "Trade Like Warren Buffett" I learned that Buffett's primary trade when he was building his initial wealth was to find very safe arbitrage opportunities: stocks that had assets significantly greater than what their market cap was worth. Many of the situations I focus on and like to own for myself are arbitrage opportunities where you can buy a $1 bill for 50 cents. Then you know your downside is protected with the potential for significant gain.
Callisto Pharmaceuticals (CLSP.OB) is the best and clearest arbitrage opportunity I've seen in a long time. There are two arbitrages at play here.
The basic arbitrage:
CLSP owns 48% of Synergy Pharmaceuticals (SGYP.OB). I'll describe Synergy in a second and why Synergy itself could be a strong buy at these levels. But even without that, here's the basic math: Synergy has a market cap of about $380mm. Callisto owns 48% of SGYP. That 48% this moment is worth $182mm. So CLSP has an asset worth $182mm.
CLSP's market cap is $86mm. (155mm shares outstanding fully diluted, price of 0.56). If the market was to fully value CLSP given its $182mm asset, then the stock price would be about 1.20, an immediate return of over 110% from today's price.
But wait, the story gets even better with a relative value arbitrage that exists between Synergy and Ironwood Pharmaceuticals (IRWD) a $1.1bb market cap company that was the hottest biotech IPO of the year.
The real arbitrage
Synergy (whose Chairman is an ex-SIGA 13G shareholder) is in the same business as Ironwood Pharmaceuticals (IRWD). Both companies develop a drug for IBS (irritable bowel syndrome). Over 100mm people on the planet suffer from some form of IBS (primarily severe constipation). Both companies have had great clinical data. On November 2, Ironwood reported good Phase III results. On October 6, Synergy reported positive phase IIa results which had (as we'll see below) better safety results than Ironwood's drug in the same phase and similar efficacy results. Ironwood's drug and Synergy's drug are very similar. In fact, the scientistis for each company that developed their respective drugs both came out of the same laboratory in Monsanto (MON).
There are two key differences though:
Ironwood's drug has a potentially very negative side effect: diarrhea. According to a Merrill Lynch report written by their research analyst Rachel McMinn on October 6, about the Synergy drug: "The one specific detail noted is that none of the patients experienced diarrhea, a side effecte noted with [the Ironwood drug]." She also notes, "the mechanism of action of the two drugs is identical." In other words, we have a potential $20bb market with two drugs that act the same, except one drug causes "Montezuma's revenge" (Ironwood) and the other doesn't (Synergy).
Ironwood has sold off 50% of its royalties in the US and Europe. Why is this significant? Ironwood's primary asset is this drug, which they've sold off 50% of their potential gains. With a $1.1bb market cap, its as if the market is valuing the value of the drug at $2.2bb. Synergy, with a $380mm market cap, owns 100% of its drug. There's an enormous arbitrage between Synergy's $380mm market cap and the $2.2bb technical value of Ironwood's drug. Both companies have the same asset, but with wildly different valuations, and with a significant side effect on the Ironwood drug.
So you could make the argument that Synergy could have a 2.2B value down the road which would be north of $22/share which would result in CLSP being worth 1.1B or nearly $7/share. I like to have as much margin of safety as possible in an investment. In this case we have two arbitrages: At current market caps, the value of Synergy suggests that CLSP should trade closer 1.20 per share, an immediate improvement of 114% over current levels. As the market begins to value Synergy's drug closer to Ironwood's drug (and research firm, Global Hunter, has already assigned a price target of $5.50 on Synergy based on catalysts they expect to happen in the next few months), CLSP can trade as high as $7 / share (although that is certainly over time). So at a current level of $0.56 share its a great immediate opportunity as an arbitrage play and a long-term deep value play eventually heading towards $7/share.

Disclosure: Long CLSP