Ich meine, das keine Gewinne erzielt werden ist klar.
Aber keinen Hinweis, das der Staat nochmal einspringen müsste, keine Insolvenz.
Ist doch eigentlich ein Hoffnungsschimmer, das die Bank of Ireland es schaffen
kann.
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Hana Biosciences - Product Pipeline Review - Q4 2010 provides data on the company's research and development focus. The report includes information on current developmental pipeline, complete with latest updates, and features on discontinued and dormant projects.
It also gives a complete picture of the company's future therapy areas of focus.
This report is built using data and information sourced from proprietary databases, primary and secondary research using the company's corporate website, SEC filings, investor presentations and featured press releases, both from company and industry-specific third party sources, put together with in-house analysis, by a team of industry experts.
Scope
- Hana Biosciences - company overview including business description, key employees, and other facts.
- Review of current pipeline of Hana Biosciences human therapeutic division.
- Overview of pipeline therapeutics across various therapy areas.
- Coverage of current pipeline molecules in various stages of drug development, including the combination treatment modalities, for the pharmaceutical markets across the globe.
- Product profiles for late stage and clinical stage products of Hana Biosciences with complete description of the product's developmental history, mechanism of action, clinical trials, major milestones and others.
- Recent updates of the Hana Biosciences's pipeline in the last quarter.
- Key discontinued and dormant projects.
- Latest news and deals relating to the products.
Reasons to buy
- Evaluate Hana Biosciences's strategic position with total access to a detailed intelligence on its product pipeline.
- Assess the growth potential of Hana Biosciences in its therapy areas of focus.
- Identify new drug targets and therapeutic classes in the Hana Biosciences's R&D portfolio and develop key strategic initiatives to reinforce pipeline in those areas.
- Exploit in-licensing opportunities by identifying windows of opportunity to fill portfolio gaps.
- Exploit collaboration and partnership opportunities with Hana Biosciences.
- Avoid Intellectual Property Rights related issues.
- Explore the dormant and discontinued projects of Hana Biosciences and identify potential opportunities in those areas.
- Do deals with an understanding of the mergers and partnerships that have shaped the sector.
http://www.companiesandmarkets.com/...eline-review-q4-2010-395852.asp
Written by Grant Zeng, CFA
Hana Biosciences Inc. ( HNAB ) A decent pipeline with late stage candidates…
South San Francisco, CA based Hana Biosciences, Inc. (Hana) is a late development stage biopharmaceutical company which is focused on two cancer care areas: cancer therapeutics and cancer supportive care.
The company’s lead cancer therapeutic candidate is Marqibo (vincristine sulfate liposome injection), a novel, targeted Optisome encapsulated formulation product candidate of the FDA-approved anticancer drug vincristine, for the treatment of relapsed/refractory adult acute lymphoblastic leukemia (ALL).
Hana presented results from the registration-enabling Phase II clinical trial (rALLY) of Marqibo for ALL in June 2010 at the ASCO meeting. The data were compelling. Marqibo was administered as third-, fourth-, fifth-, and sixth-line single-agent therapy for ALL patients. The trial achieved 35% overall response rate with a predictable and manageable toxicity profile. The complete response (CR) and CR with incomplete blood count recovery (CRi) were 20%. The median CR/CRi duration was 5.3 months, and median survival in responders was 7.4 months.
Based on the above encouraging Phase II results, Hana completed the pre-NDA meeting with the FDA in April 2010 and plans to start the rolling NDA filing process soon. The rolling NDA filing will be completed by the first half of 2011. Hana has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the FDA. Marqibo has also received orphan drug designation from the European Medicines Evaluation Agency in adult ALL. We estimate Marqibo will get the FDA approval in the second half of 2011. Submission of Marqibo for EU approval is planned to happen in 2011.
Marqibo remains both a near term and long term value for Hana. The drug candidate represents a large opportunity. Marqibo is intended to replace standard vincristine chemotherapy. Vincristine is widely and globally used to treat lymphomas, leukemias, myeloma, solid tumors, and childhood cancers. Vincristine is a major component of highly effective combination chemotherapy regimens such as R-CHOP, R-CVP, CVAD, VAD, and VP. It’s estimated that more than 2.4 million doses of Vincristine were sold in the US and Europe per year. However, although Vincristine is used in a broad range of chemotherapies, it is limited by its pharmacokinetics and toxicity profile. Individual doses (1.4 mg/m2) are limited to 2.0 mg regardless of patient size. Frequent, early onset peripheral neuropathy limits cumulative dosing in lymphoma and leukemia induction to approximately 6-8 total mg and rarely more than 12 mg.
Marqibo is a high concentration vincristine loaded into sphingomyelin and cholesterol liposome nanoparticles (Optisomes). Marqibo facilitates individual vincristine doses of 2.8 to 5.5 mg and cumulative induction dosing up to 70 mg. Marqibo’s formulation optimizes vincristine pharmacokinetics by prolonging circulating half-life as an encapsulated drug, by targeting delivery to tumors, bone marrow, lymph nodes, liver, and spleen, by enhancing disease penetration and up to 10x drug concentration in target tissues.
We estimate peak sales of Marqibo for the ALL indication only could be well above $100 million per year. In addition to ALL indication, Hana is also expanding Marqibo label into other indications including front line aggressive NHL, front line elderly Ph (-) ALL, front line non-elderly Ph (-) ALL, pediatric cancers and multiple myeloma. If all of, or even part of these label expansions are successful, Marqibo could represent a $5 billion market opportunity.
Another important drug candidate is Menadione for cancer supportive care. Menadione is a novel topical lotion being developed for the prevention and/or treatment of the skin toxicities associated with the use of epidermal growth factor receptor inhibitors (EGFRI) in the treatment of certain cancers. Rash is a common, painful and treatment-limiting skin toxicity side effect of all approved EGFR inhibitors such as Tarceva, Iressa, Erbitux, Vectibix, and Tykerb with incidence rates as high as 90 percent. EGFR inhibitor-associated rash can lead to reduced compliance and cause dose reductions, delays or discontinuation of EGFR inhibitor therapy in a significant portion of affected patients. Currently, there are no FDA-approved products or therapies to treat these skin toxicities.
Hana has completed a Phase I study of Menadione topical lotion in healthy volunteers, which demonstrated delivery of Menadione into the skin without appreciable systemic absorption. In addition, Menadione topical lotion was generally well-tolerated. The company has recently completed enrollment of a proof-of-concept study of Menadione topical lotion in cancer patients receiving EGFR inhibitors for anti-cancer therapy. This study assessed both treatment potential in patients with new onset rash and prophylactic potential in those about to begin an EGFR inhibitor. Data from this study will be available in late 2010.
In addition to current focus on Marqibo and Menadione, Hana is also developing Alocrest (vinorelbine liposome injection, Phase I) for the treatment of solid tumors; and Brakiva (topotecan liposome injection, Phase I) for the treatment of solid tumors including small cell lung cancer and ovarian cancer. The company is exploring options for further development of these two drug candidates beyond the Phase I trial.
In early June 2010, Hana entered into an Investment Agreement with Warburg Pincus and Deerfield Management for the sale of up to $100 million in preferred stock. Warburg Pincus, the lead investor in the financing, is a new investor in Hana, and Deerfield is the company’s largest existing shareholder prior to this financing.
The Warburg Pincus deal further validates Hana’s technology and clinical efforts
Hana intends to use the net proceeds from the financing to advance its clinical development and commercialization programs, including regulatory activities related to Marqibo’s New Drug Application preparation and submission, and for general corporate purposes. Hana expects that the financing will provide the funds needed to develop Marqibo to approval and commercialization for relapsed/refractory adult ALL patients; to study Marqibo in front-line adult ALL and lymphoma patients; and to unlock the full potential of Menadione topical lotion.
On June 7, 2010, the investors purchased 400,000 shares of Series A-1 Preferred Stock, at a per share sale price of $100. In conjunction with the signing, the investors have the right to purchase up to $60 million of additional Preferred Stock under certain circumstances. The original conversion price for the Preferred Stock to be converted to common stock will be: $0.184 for the first $60 million purchased by the investors and $0.276 for the additional $40 million of Preferred Stock that the investors may have the right to purchase. After the 4-to-1 reverse stock split, the conversion price has increased to $0.74 and $1.10 respectively. The Preferred Stock would accrete at the rate of 9% per annum.
We see the Warburg Pincus deal very as a very positive step for Hana. The deal not only provides vital, necessary funds for the company’s operations, it also further validates the company’s technology and the potential of its pipeline of drug candidates.
Some investors may fear the dilution of existing shareholder base
http://markets.hpcwire.com/taborcomm.hpcwire/...FO&ChannelID=6552
Kann jemand bitte meine falsch gepostet einträge Melden und löschen lassen?
ich habs versuchs aber leider komme ich nicht durch... Danke..
Endlich kommt BOI wieder in fahrt ;-)
Wegen steigender Kosten für die Staatshilfe und geringerer Einnahmen befürchtet die Bank of Ireland in diesem Jahr einen heftigen Gewinneinbruch. Das bereinigte Betriebsergebnis vor Wertberichtigungen werde wohl bis zu 40 Prozent unter den 1,5 Mrd. Euro aus dem Vorjahr bleiben, teilte das nach Marktwert größte irische Geldhaus am Freitag mit.
Die Kosten für die Staatsgarantien, die erst kürzlich bis Juni verlängert wurden, stiegen in der zweiten Jahreshälfte um 150 Prozent auf rund 380 Mio. Euro von 151 Mio. Euro in den ersten sechs Monaten. Einen Lichtblick sieht die teilverstaatlichte Bank am Hypothekenmarkt. Dort habe sich die Lage stabilisiert.
Die Bank of Ireland war das erste Institut des Landes, das seine Kapitaldecke auch wieder mit Hilfe privater Investoren stärken konnte. Dadurch ging der Staatsanteil auf rund 36 Prozent zurück. Anders auch als seine Rivalen brauchte die Bank bei der jüngsten Runde staatlicher Finanzhilfen im September keine Kapitalspritze
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| 47 | 9.487 | (BOI)denbildung abgeschlossen, | weltumradler | Judas | 25.04.21 00:01 |