Aeterna Zentaris Inc.

Aeterna Zentaris kündigt Übernahme von Rechten in Bezug auf Herstellung Cetrotide ® von Merck KGaA

http://finance.yahoo.com/news/...ransfer-manufacturing-113000530.html

lle Beträge sind in US-Dollar (wenn nicht anders erwähnt)

Québec City, 17. April 2013 / PRNewswire / - Aeterna Zentaris Inc. ( AEZS ) ( AEZ.TO ) (das "Unternehmen") gab heute bekannt, dass ihre deutsche Tochtergesellschaft hat in verbindliche Vereinbarungen mit verschiedenen Partnern und Lizenznehmern in Bezug auf die Herstellung eingegeben Rechte und Pflichten für seine Cetrotide ® Produkt. Der wichtigste Effekt solcher Vereinbarungen ist die Fertigung Rechte zu übertragen und eine Lizenz zur Herstellung von Cetrotide ® an eine Tochtergesellschaft der Merck KGaA, Darmstadt, Deutschland ("Merck Serono") zu gewähren, in allen Ländern. Vorbehaltlich der Erfüllung der üblichen Closing-Bedingungen, wird die Transaktion voraussichtlich am oder um den 1. Oktober 2013 abgeschlossen werden, zu welchem ​​Zeitpunkt Aeterna Zentaris würde eine einmalige Zahlung von 2,5 Mio. € bzw. rund $ 3.200.000 und bestimmte andere Zahlungen erhalten. Darüber hinaus hat das Unternehmen auch in einer Übergangszeit-Services-Vertrag mit der Merck KGaA, unter denen die Gesellschaft, während eines 36-Monats-Zeitraum, bieten verschiedene Dienstleistungen an Übergang Merck KGaA in die Verantwortung für die Herstellung von Cetrotide unterstützen eingegebenen ® als Gegenleistung für die Zahlung einer monatlichen Gebühr für die Gesellschaft während dieses Zeitraums.

Cetrotide ® (Cetrorelixacetat zur Injektion) wird verwendet, um Antworten Hormon bei Frauen mit der Behandlung der Unfruchtbarkeit zu regulieren. Merck Serono, ein führendes Unternehmen auf dem Gebiet der Behandlung der Unfruchtbarkeit, vermarktet derzeit Cetrotide ® weltweit mit Ausnahme von Japan.

Das Unternehmen hatte zuvor den passenden Stream im Zusammenhang mit Cetrotide ® im November 2008 in einer Transaktion mit HealthCare Royalty Partners LP (vormals Cowen Healthcare Royalty Partners LP) monetarisiert. Mit der Übertragung der Rechte auf Herstellung Merck Serono bleibt Aeterna Zentaris auf seine Phase-3-Studie in Endometrium-und Phase-2-Studien bei Brust-, Prostata-und Blasenkrebs mit AEZS-108, seine bevorstehende Zulassungsantrag für AEZS-130 als orale Diagnostik konzentriert Test für Wachstumshormonmangel bei Erwachsenen, sowie seine früheren Stadium onkologische Wirkstoffe, einschließlich AEZS-120.

Die Verwendung des Namens "Merck" und "Merck Serono" in dieser Pressemitteilung beziehen sich auf die Merck KGaA, Darmstadt, Deutschland. In Nordamerika betreibt Merck KGaA unter der Dachmarke EMD.

Über Aeterna Zentaris

Aeterna Zentaris ist ein Onkologie und Endokrinologie Medikamentenentwicklung Unternehmen untersucht derzeit verschiedene Behandlungen für unerfüllte medizinische Bedürfnisse. Die Pipeline des Unternehmens umfasst Verbindungen, in allen Phasen der Entwicklung, von der Wirkstoffforschung bis hin zu vermarkteten Produkte. Für weitere Informationen besuchen Sie bitte www.aezsinc.com .

Forward-Looking Statements

Diese Pressemitteilung enthält zukunftsgerichtete Aussagen gemäß den Safe-Harbor-Bestimmungen des US-amerikanischen Securities Litigation Reform Act von 1995. Zukunftsgerichtete Aussagen unterliegen bekannten und unbekannten Risiken und Unsicherheiten, aufgrund derer die tatsächlichen Ergebnisse wesentlich von jenen abweichen, die in den zukunftsgerichteten Aussagen abweichen. Solche Risiken und Unsicherheiten zählen unter anderem die Verfügbarkeit von Finanzmitteln und Ressourcen, um FuE-Projekte zu verfolgen, die erfolgreiche und zeitgerechte Abschluss von klinischen Studien, das Risiko, dass die Sicherheit und Wirksamkeit von Daten aus einem unserer Phase-3-Studien möglicherweise nicht mit den Daten Analysen überein von bisher Phase 1 und / oder Phase 2 der klinischen Studien, die Fähigkeit des Unternehmens, Vorteile aus den Geschäftschancen in der pharmazeutischen Industrie nehmen, Unsicherheiten bezüglich der Zulassungsverfahren sowie allgemeine Veränderungen der wirtschaftlichen Bedingungen berichtet. Anleger sollten zur Klärung der Gesellschaft vierteljährlichen und jährlichen Einreichungen bei den kanadischen und US-amerikanischen Börsenaufsichtsbehörden für zusätzliche Informationen über Risiken und Ungewissheiten in Bezug auf zukunftsgerichtete Aussagen. Investoren werden darauf hingewiesen, sich nicht auf diese zukunftsgerichteten Aussagen verlassen. Die Gesellschaft übernimmt keinerlei Verpflichtung, solche zukunftsgerichteten Aussagen zu aktualisieren. Wir übernehmen keine Verpflichtung, solche Faktoren zu aktualisieren oder öffentlich zu verkünden das Ergebnis allfälliger Berichtigungen zu einem zukunftsgerichteten Aussagen hierin zukünftigen Ergebnissen, Ereignissen oder Entwicklungen widerzuspiegeln enthalten, es sei denn, dazu verpflichtet die von einer staatlichen Behörde oder durch geltendes Recht .  

Aeterna Zentaris Newly Appointed CEO, David A. Dodd, to Host Introductory Analyst and Investor Conference Call on Thursday, April 25, 2013

http://finance.yahoo.com/news/...s-newly-appointed-ceo-201000604.html  

As I noted 10 weeks ago, cancer statistics are both staggering and disappointing. Although cancer deaths per 100,000 people have been on the downswing since 1991 thanks to access to more effective medications and better awareness about the negative health effects of smoking, there is still a lot of research and progress yet to achieve. My focus in this 12-week series is to bring to light both the need for continued research in these fields, as well as highlight ways you can profit from the biggest current and upcoming players in each area.

Over the past nine weeks, we've looked at the nine cancer types most expected to be diagnosed this year:

Prostate cancer
Breast cancer
Lung cancer
Colorectal cancer
Melanoma
Bladder cancer
Non-Hodgkin's lymphoma
Thyroid cancer
Kidney cancer
Today, we'll turn our attention to the projected 10th-most diagnosed cancer: endometrial cancer.

The skinny of endometrial cancer
Endometrial cancer is the most common type of uterine cancer and is most often found in the endometrium, or lining of the uterine walls. This year, just shy of 50,000 cases of endometrial cancer are expected to be diagnosed, with nearly 8,200 women expected to pass away as a direct cause of this disease.

Although there are no early detection tests to help diagnose endometrial cancer, many cases (68% to be exact) are diagnosed in the early stage of the disease thanks to fairly easily identifiable symptoms including post-menopausal bleeding, as well as pain during urination, intercourse, or in the pelvic area, according to the American Cancer Society (link opens PDF file).

But just because there are easily identifiable factors that help women recognize the need to go and see their doctor, it doesn't mean there isn't a laundry list of potential risk factors. In fact, obesity (specifically in the abdominal area), diabetes, estrogen exposure, never having children, and medical conditions such as Lynch Syndrome are all factors that increase a woman's risk of getting endometrial cancer. Not to mention that women who took breast cancer therapy Tamoxifen, which was developed by AstraZeneca (NYSE: AZN  ) , have also been shown to run a higher risk of developing endometrial cancer, since it delivers an estrogen-like effect on the uterus, which can encourage tumor growth.

What's even scarier is that five-year survival rates have actually declined since 1975-1977 from 88% to just 83% in 2002-2008. Furthermore, endometrial cancer has been on the rise in African American women, increasing at a rate of 2.2% per year between 2005 and 2009.


Source: Surveillance, Epidemiology, and End Results Program, and National Center for Health Statistics.

There also exists a stark difference in five-year survival rates between white women (85%) and African-American women (63%), as noted by the ACS.

Where investment dollars are headed
Now that you have a better understanding of what endometrial cancer is, what its risk factors are, and who it's affecting, let's look at some of the ways physicians go about treating the disease.

Commonly, endometrial cancer will involve surgery, radiation, or perhaps hormone therapy and/or chemotherapy, depending on the stage of the disease. Despite the numerous treatment options, the investments in advancing chemotherapy agents to treat endometrial cancer simply haven't been there over the past three decades. Here's a closer look at the most common treatments.

Cisplatin + Paclitaxel: I know this is brutally unexciting from a treatment and investment standpoint, but the global treatment of cisplatin and paclitaxel is still one of the standards in treating late-stage disease where surgery is not an option. More interestingly, a study presented at the Society of Gynecologic Oncology's annual meeting last year revealed that the pairing of cisplatin with paclitaxel over a four-year study period proved just as effective and delivered far fewer side effects than a control arm of patients receiving the doublet and doxorubicin as well.
Depo-Provera: While not necessarily a "treatment" in the sense of the term, this contraceptive injection developed by Pfizer (NYSE: PFE  ) has been shown to reduce the risk of developing endometrial cancer by nearly 80%, according to a study by the World Health Organization, since it contains no estrogen. That's a significant figure, and certainly worth mentioning.
Megestrol + Tamoxifen: That's right; you guessed it! Tamoxifen has been shown to slightly increase endometrial cancer risk, but it's also been shown to be extremely useful as a hormone therapy in partially or completely reducing tumors in combination with Par Pharmaceuticals' Megace ES (Par was purchased last year by private-equity firm TPG Capital). Par's Megace provides the antineoplastic growth inhibiting/spreading effect, while Tamoxifen handles the reduction in hormones that can help to starve the tumor.
What's coming down the pipeline
As we saw with the current treatment options, the endometrial cancer pipeline isn't filled with a lot of choices, but they are at least more encouraging than the standard care treatments we've seen over the past three decades.

Avastin: Surprise: It's Roche's (NASDAQOTH: RHHBY  ) wonder drug yet again! Roche's Avastin is in the process of being tested as a treatment for recurrent endometrial cancer and demonstrated promising results in a mid-stage trial according to the Journal of Clinical Oncology. Avastin, which is an angiogenesis inhibitor (a fancy way of saying it inhibits blood vessel growth), was tested on 52 evaluable patients and delivered a progression-free survival of at least six months for 21 of them. Overall median PFS was 4.2 months, and median overall survival came in at 10.5 months. Don't be surprised if Roche decides to pursue further studies of Avastin in recurrent endometrial cancer with these results.
AEZS-108: Currently in late-stage development by Aeterna Zentaris (NASDAQ: AEZS  ) , a holding in my own portfolio, AEZS-108 is an intravenous treatment composed of a synthetic peptide carrier and doxorubicin that targets Luteinizing Hormone Releasing Hormone-receptor expressing tumors. That series of scientific jargon simply means it targets cancer cells with minimal healthy cell death relative to the current standards of treatment. In mid-stage trials, AEZS-108 delivered an overall response rate of 30.8% and a clinical benefit rate of 74.4%. These figures were enough to get AEZS-108 a special protocol assessment (SPA), which should streamline its approval if these results stay consistent in late-stage studies.
Your best investment
With very few investable options to choose from, since many of these treatments are off patent as they're decades old, I'm going to split my decision this week between Roche and Aeterna Zentaris for obvious reasons.

With regard to Roche, the company has a very diverse pipeline that's headlined by blockbuster Avastin, which is seemingly adding new indications all the time. Even when Avastin's patents begin to expire, Roche's staggered FDA approvals for its tumor-inhibiting drug are bound to keep its revenue stream steady.

As you might have properly guessed as well, since I personally own Aeterna Zentaris, I think it makes for a speculative, but interesting, buy. The company's endometrial drug, AEZS-108, wasn't the only product that initially drew me to the company; but with one FDA approved treatment, seven clinical trials, and four preclinical studies under its belt, there appear to be a lot of opportunities for success for this tiny biotechnology company. With AEZS-108 receiving an SPA, its pathway to approval has been made even easier.

Stay tuned next week, when we tackle the current and upcoming therapies for the treatment of leukemia in this "Tackling Cancer" series.

While you can certainly make huge gains in biotech and pharmaceuticals, the best investing approach is to choose great companies and stick with them for the long term. The Motley Fool's free report "3 Stocks That Will Help You Retire Rich" names stocks that could help you build long-term wealth and retire well, along with some winning wealth-building strategies that every investor should be aware of. Click here now to keep reading.  

 

 

May 16 2013, Disclosure: I am long OESX. (More...)

During a bull market many investors often comb through the underachievers looking for companies that are full of potential, exhibit steady growth or have terrific fundamentals. The following four small companies have some of these elements and offer terrific value for investors, but have share valuations that don't reflect their great mechanics. One of these companies, National American University, even pays out a dividend with a 4.9% yield! Sometimes it might take a while to realize a return with these smaller companies while other times their stock might soar given just a little positive news. Some small companies can be associated with the failure of a highly touted drug, others a troubled industry but most often investors simply consider these smaller companies to be too much of a risk. Here are four small companies that you might want to consider:

Aeterna Zentaris (AEZS) - Market Cap $48.38 million (5/14)

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I have already mentioned the case for Aeterna Zentaris after it came crashing down in early March. Aeterna's stock is still reeling from the effects of failure from Perifosine, but that is something investors have been aware of for quite some time now. Currently, Aeterna has some positive signs of life coming from an agreement with Merck Serono and others for the manufacturing rights and obligations for Cetrotide along with a partnership with Ergomed to co-develop AEZS-108 which is entering Phase III trials for endometrial cancer. Cetrotide is the first luteinizing hormone (LHRH) antagonist treatment developed for use in in-vitro fertilization. AEZS-108 is a hybrid molecule composed of a synthetic peptide carrier and doxorubicin which basically acts to bind the compound to cancerous tumor cells allowing doxorubicin to accumulate in the malignant tissue and target the tumor cells.

Aeterna also has much more with AEZS-130 in Phase III trials for stimulating the secretion of growth hormone and also in Phase II trials for the treatment of cachexia. AEZS-108 is also in Phase II trials for the treatment of ovarian, prostate, bladder and breast cancers. Another candidate, Ozaralix, is in Phase II trials for the treatment of sexual hormone dependent malign and benign tumors like prostate cancer and endometriosis. This enormous pipeline also includes five more candidates in either pre-clinical stages or Phase I trials. For a company that has taken its share of bumps and bruises with Perifosine, there is plenty left for investors to get excited about.

Can Aeterna last long enough to get AEZS-108 and AEZS-130 to the endpoints of their trials? That is a big question, but Aeterna currently has about $33.2 million in cash and equivalents with a cash burn that was only $1.9 million last quarter. Revenue was up to $16.6 million for the first quarter of 2013 compared to only $9.5 million a year ago reflecting progress from the sale of Cetrotide. The partnership with Ergomed to develop AEZS-108 will have Ergomed reimbursing Aeterna with 30% of the clinical trial costs for endometrial cancer (up to $10 million) to help advance the drug through trials. The deal with Merck Serono and others will also add about $3.2 million with an upfront charge as well as other payments related to the transfer of manufacturing. These two moves bring in more money and helps Aeterna focus attention on developing more of its pipeline. Shares of Aeterna are currently trading at $1.91 a share (May 14th) and are down over 41% from a year ago and barely above the 52-week low of $1.70 a share. The 52-week high of Aeterna shares is $5.64 a share which was attained September of last year. The stock has room to move minus the issues with Perifosine and now might be a great time to take notice.  

 

Ende Mai Anfang Juni wirds spannend!!  

die 2,10 sollte was drin sein die nächsten tage  

Was ist denn hier eigentlich so los?
Wieso tut sich hier absolut nix.
Hat jemand ein paar Infos über das Unternehmen und wieso der Kurs so eingebrochen ist?  

5,2 Mio. Aktie x 1,50 $ pro Aktie = 7,8 Mio. $

http://www.finanznachrichten.de/...registered-direct-offering-008.htm  

http://www.boerse-online.de/aktie/empfehlung/650037.html?p=6#a

Pennystock-Empfehlung in Börse-Online

 

 

 

aber Interesse hält sich in Grenzen. Wir ja vielleicht bald abgehen wue Keryx  

und schöner Umsatz  

http://www.aezsinc.com/pdfdyn/..._November_12_2013-FINAL%20Public.pdf  

haben ja auch nicht die schlechteste pipeline  

http://www.ariva.de/news/...ing-of-Common-Shares-and-Warrants-4852304  

eingestiegen...von ARIA nach hier etwas umgeschichtet...
Sieht mir hier nach einem sehr soliden Invest aus...nach dem Closing des Public Offering
sollte es nun langsam wieder anziehen bis $ 1,50 - wenn dann noch News kommen gerne
etwas mehr...  

....mal schaun was draus wird :-)  

 

Anstieg?  

Umsätze bei steigendem Kurs!  

Ich denke langsam aber sicher geht es Richtung 2 Dollar und dann weiter. Ich denke negative News sind erstmal nicht zu erwarten