Kommt bei Hana Bioscience ein möglicher Rebound?
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Data From Pivotal Phase 2 RALLY Trial Show Marqibo Produced Compelling Single-Agent Anti-Leukemic Efficacy in Advanced Relapsed/Refractory Adult Ph(-) Acute Lymphoblastic Leukemia
SOUTH SAN FRANCISCO, Calif., Jun 7, 2010 (GlobeNewswire via COMTEX News Network) --
-- Marqibo administered as third-, fourth-, fifth-, and sixth-line single-agent therapy -- 35% overall response rate with a predictable and manageable toxicity profile -- 20% complete response (CR) and CR with incomplete blood count recovery (CRi) rate -- 5.3 month median CR/CRi duration and 7.4 month median survival in respondersHana Biosciences Inc., (OTCBB:HNAB), today announced complete data from its pivotal, Phase 2 RALLY clinical trial for Marqibo(R) (vincristine sulfate liposome injection) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Results from the RALLY trial demonstrated compelling evidence of single-agent, anti-leukemic activity in an advanced, heavily pre-treated, adult ALL population.
An analysis of the 65 evaluable subjects demonstrated an overall response in 35 percent of the subjects and a complete response (CR) or CR with incomplete blood count recovery (CRi) in 20 percent of the subjects. The estimated median overall survival in complete responders was 7.4 months, with five patients having an overall survival greater than one year. The estimated median duration of CR/CRi was 5.3 months. Ten patients treated with Marqibo went on to receive a potentially life-saving stem cell transplant. There were no unexpected toxicities.
"We believe these data position Marqibo as an effective treatment for relapsed/refractory adult ALL patients with limited to no current options, as efficacy was demonstrated in second and third salvage settings, as third- through fifth-line therapy, and in both B- and T-lineage ALL," said Anne Hagey, M.D., Chief Medical Officer of Hana Biosciences. "Based upon these data, we are moving forward with our plan to initiate a rolling NDA submission with the hopes of bringing a much needed therapy to patients with no standard treatment options. In addition, the complete RALLY results reinforce our belief that Marqibo has the potential to be an important and useful stand-alone therapy in relapsed adult leukemia. We look forward to additional and continued development in combination therapy in leukemia and lymphomas."
"The results of the RALLY trial demonstrate a clinically meaningful benefit for patients who have relapsed multiple times or who have progressed following two or more prior lines of therapy," said Susan O'Brien, M.D., Professor of Medicine in the Leukemia Department at the University of Texas, MD Anderson Cancer Center and RALLY study lead investigator. "Based on historical data with single-agent therapy, one would have expected no more than a 4 percent CR/CRi rate in such an advanced leukemia population. Marqibo's CR/CRi rate of 20 percent would be an extremely important step forward in the treatment of adult ALL"
Phase 2 RALLY Clinical Trial Design and Results
The pivotal Phase 2 RALLY clinical trial enrolled a total of 65 evaluable patients at 22 sites in the United States, Canada, Germany, and Israel. The primary objective of the RALLY clinical trial was to assess the efficacy of single-agent, weekly Marqibo (2.25 mg/m2 with no dose cap) as assessed by achievement of CR or CRi. Secondary objectives included assessments of duration of CR/CRi, overall survival (OS), safety and pharmacokinetics. Independent response assessment remains ongoing at the present time. Marqibo was dosed weekly based on actual body surface area without the dose capping applied to standard vincristine sulfate. The study population is defined as Philadelphia chromosome-negative adult patients in second or greater relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who have previously undergone stem cell transplantation.
An overall response rate (ORR) as determined by CR, CRi, partial remission, and bone marrow blast count normalization without blood count recovery was reported by investigators in 23 of 65 subjects for an ORR of 35 percent, with 13 of 65 subjects (20 percent) experiencing a CR or CRi. Marqibo enabled successful stem cell transplantation in 10 patients after dosing. The median OS in the 65 subjects is estimated to be 4.6 months (range 0.1-21.6) using Kaplan-Meier methodology. The safety profile of Marqibo is predictable, manageable, and similar to standard vincristine sulfate. The early death rate, defined as death occurring within the first 14 days on study, was 4.6 percent (3 of 56 subjects) and occurred due to progressive ALL.
The Company anticipates locking the data base and commencing a rolling NDA submission in the near future.
ASCO Presentation
The complete data from the pivotal Phase 2 RALLY trial will be presented in an oral podium presentation by Susan O'Brien M.D. (Abstract #6507) at 11:45 am on Monday, June 7 at the American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago, Illinois, June 4-8, 2010.
About Marqibo(R) (vincristine sulfate liposome injection)
Marqibo is a novel, targeted, Optisome(TM) encapsulated formulation of vincristine sulfate, a widely-used chemotherapy, which has shown promising anti-cancer activity in patients with ALL, non-Hodgkin's lymphoma, Hodgkin's disease, and melanoma in several clinical trials. Marqibo is designed to enhance the penetration and concentration of vincristine sulfate at sites of active cancer and facilitate dose-intensification compared to standard vincristine formulations. Unlike standard vincristine, Marqibo is dosed based on actual patient body surface area without the need for dose capping.
Hana Biosciences has received orphan drug and fast track designations for Marqibo for the treatment of adult ALL from the U.S. Food and Drug Administration. Marqibo has also received orphan drug designation in adult ALL from the European Medicines Evaluation Agency.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing, progress and anticipated results of Hana's planned development and regulatory activities relating to Marqibo, including its proposed NDA filing and whether such filing will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Hana Biosciences, Inc.
CONTACT: Hana Biosciences, Inc. Investor & Media Contacts: Investor Relations Team (650) 588-6641 investor.relations@hanabiosciences.com
(C) Copyright 2010 GlobeNewswire, Inc. All rights reserved.
News Provided by COMTEX
http://ir.hanabiosciences.com/releasedetail.cfm?ReleaseID=476923
Liberty Analytics Co. Initiates Independent Research Coverage on Hana Biosciences, Inc.
CALGARY, Alberta, June 10, 2010 (GLOBE NEWSWIRE) -- Liberty Analytics Co., a leading provider of large, small- and micro-cap independent investment research, today initiated coverage on Hana Biosciences, Inc. (OTCBB:HNAB - News). Liberty Analytics is currently offering a complimentary trial subscription. To view our research, go to: http://www.libertyanalyticsco.com/
About LAC:
Liberty Analytics Co. is a leading provider of independent investment research in North America. Our services include research analysis on the large, small- and micro-cap markets, real-time news and financial data, market commentary and the LAC newsletter. Liberty Analytics' staff of large and small-cap investment professionals is dedicated to providing the market's investment community with the tools and avenues necessary to make the important investment decisions. To view our research reports on a complimentary trial basis and take advantage of our other services, go to http://www.libertyanalyticsco.com/ and click on the complimentary trial subscription button on our home page, or go directly to our registration page at www.libertyanalyticsco.com/signup.php
About Hana Biosciences, Inc. (OTCBB:HNAB - News):
Hana Biosciences, Inc. (OTCBB:HNAB - News) is a biopharmaceutical company. It is engaged in developing and commercializing cancer therapies designed to enable current standards of care.
LAC Disclosure:
Libertyanalyticsco.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. Liberty Analytics has not been compensated by any of the above-mentioned companies. Please read our report and visit our Web site, http://www.libertyanalyticsco.com/, for complete risks and disclosures.
Contact:
Kevin Mix
480-626-1850
info@libertyanalyticsco.com
http://finance.yahoo.com/news/...s-Co-pz-1493195526.html?x=0&.v=1
11-Jun-2010
Entry into a Material Definitive Agreement, Unregistered Sale of Equity Secu
Item 1.01. Entry into a Material Definitive Agreement.
Investment Agreement
On June 7, 2010, Hana Biosciences, Inc. (the "Company") entered into an Investment Agreement (the "Investment Agreement") with Warburg Pincus Private Equity X, L.P. and Warburg Pincus X Partners, L.P. (together, the "Warburg Purchasers"), and Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Special Situation Fund, L.P., and Deerfield Special Situations Fund International Limited (collectively, the "Deerfield Purchasers," and together with the WP Purchasers, the "Purchasers"). Pursuant to the terms of the Investment Agreement, on June 7, 2010, the Company issued and sold to the Purchasers an aggregate of 400,000 shares of the Company's newly-designated Series A-1 Convertible Preferred Stock, stated value $100 per share (the "Series A-1 Preferred Stock"), at a per share purchase price of $100 for an aggregate purchase price of $40,000,000. Collectively, the Warburg Purchasers purchased 360,000 shares of Series A-1 Preferred Stock at an aggregate purchase price of $36,000,000, and the Deerfield Purchasers purchased 40,000 shares at an aggregate purchase price of $4,000,000. Prior to the entry into the Investment Agreement, the Company had no prior relationship with the Warburg Purchasers. Prior to the entry into the Investment Agreement, the Company and the Deerfield Purchasers had previously entered into a Facility Agreement dated October 30, 2007 (the "Facility Agreement") that provided for the Company to borrow from the Deerfield Purchasers up to an aggregate of $30,000,000, of which the principal amount of $27,500,000 is currently outstanding and is secured by a senior security interest in all Company assets. In addition, prior to June 7, 2010, the Deerfield Purchasers beneficially owned approximately 18.9 million shares of the Company's common stock, par value $0.001 per share (the "Common Stock"), representing approximately 22.4% of the outstanding Common Stock.
The Investment Agreement provides that the Purchasers have the right, but not the obligation, to make additional investments in the Company in the event the Company obtains Stockholder Approval (as defined below) of certain amendments to its certificate of incorporation by December 7, 2010 (the "Stockholder Approval Outside Date"), as follows:
� At any time prior to the date the Company receives marketing approval from the U.S. Food and Drug Administration for any of its product candidates (the "Marketing Approval Date"), the Purchasers may purchase up to an additional 200,000 shares of Series A-1 Preferred Stock at a purchase price of $100 per share for an aggregate purchase price of $20,000,000 (the "Additional Series A-1 Investment"), which purchases shall be in tranches of at least 100,000 shares; and
� At any time beginning 15 days and within 120 days following the date of the Marketing Approval Date, the Purchasers may purchase up to an aggregate of 400,000 shares of the Company's newly-designated Series A-2 Convertible Preferred Stock, stated value $100 per share (the "Series A-2 Preferred Stock" and together with the Series A-1 Preferred Stock, the "Series A Preferred Stock"), at a per share purchase price of $100 and an aggregate purchase price of $40,000,000 (the "Series A-2 Investment"), which purchases shall be in tranches of at least 100,000 shares.
If the Company does not receive Stockholder Approval by the Stockholder Approval Outside Date, then the Investment Agreement provides that the Purchasers have the right, but not the obligation, to purchase up to an additional 200,000 shares of Series A-1 Preferred Stock at any time prior to Marketing Approval, and up to an additional 400,000 shares of Series A-1 Preferred Stock at any time beginning 15 days and within 120 days following the Marketing Approval Date, in each case at a per share price of $100 (each a "Subsequent Series A-1 . . .
Item 3.02. Unregistered Sales of Equity Securities.
On June 7, 2010, pursuant to the terms of the Investment Agreement, the Company sold 400,000 shares of Series A-1 Preferred Stock to the Purchasers at a price per share of $100, for aggregate proceeds of $40,000,000. The offer and sale of such shares constituted a private placement under Section 4(2) of the Securities Act of 1933, as amended, in accordance with Regulation D promulgated thereunder. The information set forth under Item 1.01 is incorporated herein by reference.
Item 5.01. Changes in Control of Registrant
The disclosures set forth above under Item 1.01 of this report are incorporated by reference hereto. As further described in Item 1.01 above, in accordance with the terms of the Investment Agreement, the Warburg Purchasers purchased 360,000 shares of Series A-1 Preferred Stock, each of which is currently convertible into Common Stock at a rate determined by dividing the stated value of $100 by the Initial Series A-1 Conversion Price, subject to limitations on the number of shares of Common Stock available for issuance, which shall not be less than 90,000,000 shares. As of June 7, 2010, there were 84,844,815 shares of Common Stock outstanding.
Item 5.02. Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
The disclosures set forth above under Item 1.01 of this report are incorporated by reference hereto. As described above, on June 7, 2010, Dr. Weiser and Ms. Wiesinger resigned from the Board and Messrs. Leff, de Silva and Ferrer were appointed directors of the Company. No determinations have been made with respect to the committees of the Board on which any of Messrs. Leff, de Silva and Ferrer will serve. Each new director will be entitled to the compensation applicable to the Company's non-employee directors.
Upon the closing of the initial sale of 400,000 shares of Series A-1 Preferred Stock to the Purchasers, the Company granted to each of Steven R. Deitcher, its President & Chief Executive Officer, and Craig W. Carlson, its Chief Financial Officer, 10-year stock options to purchase 350,000 and 250,000 shares of Common Stock at an exercise price of $0.23 per share. The stock options are evidenced by a form of stock option agreement between the Company and each of Dr. Deitcher and Mr. Carlson in the standard form of agreement for use under the Company's 2010 Stock Incentive Plan, a copy of which was filed as Exhibit 10.2 to the Company's Current Report on Form 8-K filed on February 22, 2010.
Item 5.03. Amendments to Article of Incorporation or Bylaws; Change in Fiscal Year.
The disclosures set forth above under Item 1.01 of this report are incorporated by reference hereto. Effective June 7, 2010, the Board adopted an amendment to the Company's Amended & Restated Bylaws by deleting the existing Section 3.12 and replacing it with the following provision:
"3.12 Quorum of Directors. The presence in person of a majority of the Directors at any time in office, provided, however, that such number of Directors shall in no event constitute less than one third (1/3) of the number of members of the Entire Board, shall be necessary and sufficient to constitute a quorum for the transaction of business at any meeting of the Board."
Item 8.01. Other Information
On June 7, 2010, the Company issued a press release announcing data from its pivotal Phase 2 rALLy trial of Marqibo. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. The following exhibits are filed herewith.
| Exhibit No. Description 3.1 Certificate of Designation of Series A-1 Convertible Preferred Stock 3.2 Certificate of Designation of Series A-2 Convertible Preferred Stock 10.1 Investment Agreement dated June 7, 2010 among the Company and the Purchasers named therein. 10.2 Form of Indemnification Agreement dated June 7, 2010 between the Company and each of Jonathan Leff, Nishan de Silva and Andrew Ferrer. 10.3 Registration Rights Agreement dated June 7, 2010 among the Company and the Holders identified therein. 10.4 First Amendment dated June 7, 2010 to Facility Agreement dated October 30, 2007 among the Company and the Lenders identified therein. 99.1 Press release of Hana Biosciences, Inc. dated June 7, 2010 announcing Investment Agreement. 99.2 Press release of Hana Biosciences, Inc. dated June 7, 2010 announcing data from Phase 2 study. |
Was meint Ihr?
Es schaut so aus das bei Hana sich endlich was tut ;-)
Eure Meinung würde mich interesieren
Grüß Prinz ;-)
MFG
Chali
Optionen
| Boardmail an "Chalifmann3" |
Wertpapier: Hana Biosciences old |
n065.gif
noch ein starker Rebound richtung norden kommen wird..
Es dauert noch ein wenig halt, bist die erste geschichte mit Marqibo ins laufen kommt..
Geduld ist angesagt... Und ich hoffe sie wird an Ende belohnt werden ;-)
Gruß Prinz :-)))
MFG
Chali
Optionen
| Boardmail an "Chalifmann3" |
Wertpapier: Hana Biosciences old |
Optionen
| Boardmail an "Chalifmann3" |
Wertpapier: Hana Biosciences old |
habe ich im Wallstreet Forum gefunden
ref.: http://www.themarketfinancial.com/...ence-investment-opportunity/2691
Amidst an uncertain market, Hana Biosciences has positioned itself nicely for the upcoming ASCO conference on June, 7th, 2010, where it will present its phase 2 rALLy results of the additional 9 patients requested by the FDA, with the general consensus being that the results are highly positive for Marqibo, a revolutionary drug that hopes to replace the use of generic vincistrine for acute lymphoblastic lukemia (ALL). The company has stated that an NDA is to be followed once the promising results are showcased. Many investors have placed the focus on the company’s flagship product while ignoring the potential of its oncology pipeline in Alcotrest (Breast and Lung Cancer), and Brakiva (Small-Cell and Ovarian Cancer), both of which are in phase I and could be initiated for phase II once the FDA makes its decision on Marqibo. With market cap of only $17.63M, a low float of 81 million shares, while currently sitting on only 92 million shares outstanding. For more information on Hana’s pipeline and potential, read the corporate presentation from January 11, 2010. Additionally, there are rumours that the company is coming close to becoming elligible for the recently announced Small to Mid-Sized $1B Biotech Grant. For these reasons, we believe Hana’s binary events will culminate into the perfect storm, leading to handsome gains in the next couple of weeks.
At the forefront of the storm lies their NDA submission, as Hana looks to capitalize on their unique situation revolving Marqibo and the FDA’s requirements. Hana is benefiting from the fact that the Marqibo NDA has already been submitted by Inex Pharmaceuticals in the past resulting in a non-approval, thus requiring the additional 9 patient rALLy study to satisfy the FDA’s conditions. Due to Inex’s inability to foster the necessary cash to conduct the additional trials, they decided to pass over this novel drug to Hana. The general concensus among the biotech industry is that most drugs never make it on their first try with the FDA, especially smaller players, and when Hana bought Marqibo from Inex they got a big bonus, a CRL where “the FDA provided a list of deficiencies that needed to be addressed prior to re-applying for approval”. For more information, visit this article courtesy of BioSpace.com.
Sign-up for Free to Receive Future Commentary and Trading Alerts on HNAB.
If all goes as it should, Hana could be one of the biggest “BioShockers” of the year.
It looks like the perfect storm is now brewing for Hana Biosciences (OTC:HNAB). In December, this penny bio stock took a major hit for no reason other than an impatient investor sell off.
Despite the negative afterthoughts of a possible dilution following the NDA submission, the company should have more cash available through Deerfield Management, who has a seat on the board of directors. There is chatter amongst several trusted expert sources that a partnership or private / institutional investor financing could be on the way should results be highly positive, especially considering the predicted market potential of its flagship product is$2.5B annually.
Going into what should be a very positive year with a new drug application (NDA) filing for their drug Marqibo after successful trial results, this stock is prime for some major movement in the near future; first a reset to the $60-80 cent level, then a move higher as the NDA is filed. We have big expectations as this meeting at the ASCO will most likely be the binary event that decides the company’s survival, and several sources have confirmed that the data should be positive.
The December publication of results from the rALLy trial in acute lymphoblastic leukemia (ALL) in second relapse shows that the drug was highly efficient as a single-agent in a very sick patient population who have few other options. There are no safety concerns beyond what is expected for this type of drug. The FDA has a history of approving ALL treatments based on phase II single-arm clinical trials, and Hana intents to use the results of the rALLy trial in their NDA filing later on this year.
SOUTH SAN FRANCISCO, Calif., Sept. 10, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences, Inc. (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that it has filed a certificate of amendment to its certificate of incorporation to effect a 1-for-4 reverse split of its common stock. The company expects the reverse split will become effective for trading on Monday, September 13, 2010. The reverse split was authorized by Hana's stockholders at a special meeting held September 2, 2010.
Details of Reverse Split
As a result of the reverse split, every four shares of Hana's pre-split common stock was automatically reclassified as and combined into one share of post-split common stock. As a result, the number of outstanding shares of common stock is approximately 21.2 million, excluding outstanding stock options and warrants to purchase common stock and subject to adjustment for fractional shares. The reverse stock split does not affect any stockholder's ownership percentage of Hana's common stock, except to the extent that the reverse split would result in any stockholder holding a fractional share.
Effective on September 13, 2010, it is expected that a "D" will be added to Hana's ticker symbol, making it HNABD.OB for a period of 20 trading days. Thereafter, the ticker symbol will revert to HNAB.OB. Shares of Hana's common stock will also trade under a new CUSIP number effective September 13, 2010.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding, the timing of the effectiveness of proposed reverse split for purposes of trading in Hana's common stock. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements.
http://finance.yahoo.com/news/...erse-pz-3678621686.html?x=0&.v=1
Form 8-K for HANA BIOSCIENCES INC
14-Sep-2010
Unregistered Sale of Equity Securities, Material Modification to Rights of S
Item 3.02. Unregistered Sales of Equity Securities.
As previously disclosed in its Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") on June 11, 2010, the contents of which are incorporated by reference herein, on June 7, 2010, Hana Biosciences, Inc. (the "Company") entered into an Investment Agreement (the "Investment Agreement") with Warburg Pincus Private Equity X, L.P., Warburg Pincus X Partners, L.P., Deerfield Private Design Fund, L.P., Deerfield Private Design International, L.P., Deerfield Special Situations Fund, L.P., and Deerfield Special Situations Fund International Limited (collectively, the "Purchasers"), whereby the Company issued and sold to the Purchasers an aggregate of 400,000 shares (the "Initial Shares") of the Company's Series A-1 Convertible Preferred Stock, stated value $100.00 per share (the "Series A-1 Preferred Stock"). On September 10, 2010, following approval of the Charter Amendment (as defined below under Item 3.03 of this report) by the Company's stockholders, the Company and the Purchasers completed a second closing (the "Second Closing") pursuant to the terms of the Investment Agreement.
At the Second Closing, the Purchasers were issued an aggregate of 12,562 additional shares (the "Accretion Shares") of Series A-1 Preferred Stock, in satisfaction of approximately $1.26 million in accretion that had accrued on the Initial Shares between June 7, 2010 and the Second Closing. The offer and sale of the Accretion Shares constituted a private placement under Section 4(2) of the Securities Act of 1933, as amended, in accordance with Regulation D promulgated thereunder. No general solicitation was involved in connection with the offer and sale of the Accretion Shares, and each of the Purchasers has represented to the Company that it is an "accredited investor."
Also at the Second Closing, the Series A-1 Preferred Stock automatically became subject to the terms (the "Revised Series A-1 Terms") described in Annex II of the Certificate of Designation filed with the Secretary of State of Delaware on June 7, 2010 (the "Series A-1 Certificate"), whereas the Series A-1 Preferred Stock had previously been subject to the terms (the "Initial Series A-1 Terms") described in Annex I of the Series A-1 Certificate. As described in more detail in the Company's Form 8-K filed with the SEC on June 11, 2010, the Revised Series A-1 Terms are more Company-favorable than the Initial Series A-1 Terms.
The Revised Series A-1 Terms provide that the Series A-1 Preferred Stock is convertible into shares of the Company's common stock, par value $0.001 per share (the "Common Stock") at a conversion price of $0.736 per share (after giving effect to the Reverse Stock Split, as defined below under Item 3.03 of this report), subject to adjustment in certain circumstances (the "Revised Series A-1 Conversion Price"). Under the the Revised Series A-1 Terms, the stated value of each share of Series A-1 Preferred Stock accretes at a rate of 9% per annum, compounded quarterly, for a five-year term; thereafter cash dividends become payable at a rate of 9% of the accreted stated value per annum, payable quarterly. Upon the occurrence and during the continuance of certain material breaches by the Company of its obligations under the Investment Agreement, Series A-1 Certificate and related transaction agreements (referred to in the Series A-1 Certificate as "special triggering events"), the accretion rate and the dividend rate on the Series A-1 Preferred Stock would increase to 12% per annum, compounded quarterly. Upon any liquidation of the Company, holders of the Series A-1 Preferred Stock would be entitled to receive a liquidation preference per share equal to the greater of (i) 100% of the then-accreted value of the Series A-1 Preferred Stock and (ii) the amount which the holder would have received if the Series A-1 Preferred Stock had been converted into Common Stock at the Revised Series A-1 Conversion Price immediately prior to the liquidation. Similar rights would apply upon any change of control in the Company (although the liquidation preference would be calculated assuming the liquidation occurred on the fifth anniversary of the date of issuance). Unlike under the Initial Series A-1 Terms, the Series A-1 Preferred Stock is not redeemable under the Revised Series A-1 Terms.
The foregoing summary of the terms of the Series A-1 Preferred Stock is qualified in its entirety by reference to the Series A-1 Certificate, a copy of which was attached as Exhibit 3.1 to the Company's Form 8-K filed with the SEC on June 11, 2010.
Item 3.03. Material Modification to Rights of Security Holders.
On September 8, 2010, the Company amended its Amended and Restated Certificate of Incorporation to: (i) increase the number of authorized shares of its Common Stock from 200,000,000 to 350,000,000; (ii) effect a combination (reverse split) of the Common Stock at a ratio of one-for-four (the "Reverse Stock Split"); and
(iii) include a provision that the number of authorized shares of Common Stock may be increased or decreased by the affirmative vote of the holders of a majority of the Company's issued and outstanding Common Stock and preferred stock, voting together as one class, notwithstanding the provisions of Section 242(b)(2) of the Delaware General Corporation Law (collectively, the "Charter Amendment").
The Company's Board of Directors approved the Charter Amendment on June 25, 2010, and the Company's stockholders approved the Charter Amendment at a special meeting on September 2, 2010, as reported in the Company's Current Report on Form 8-K filed with the SEC on September 3, 2010. A copy of the Certificate of Amendment of the Company's Amended and Restated Certificate of Incorporation, as filed with the Secretary of State of Delaware on September 8, 2010, is attached hereto as Exhibit 3.1 and is incorporated herein by reference.
As a result of the Reverse Stock Split, which was effective as of the close of business on September 10, 2010 (the "Effective Time"), each share of the Common Stock was automatically combined into one-fourth of a share of Common Stock. No fractional shares will be issued as a result of the Reverse Stock Split, but instead stockholders will receive cash in lieu of any fractional shares to which they would otherwise have been entitled, based upon the last quoted bid price of the Common Stock on September 10, 2010, as reported on the OTC Bulletin Board.
The Reverse Stock Split does not change the proportionate ownership interest of any holder of the Common Stock, except to the extent any stockholder receives cash in lieu of fractional shares. Following the Reverse Stock Split, the number of outstanding shares of Common Stock is approximately 21,234,309, excluding outstanding stock options and warrants to purchase Common Stock and subject to adjustment for fractional shares. All stock options and warrants outstanding at the Effective Time will be appropriately adjusted to give effect to the Reverse Stock Split.
As of the Effective Time, the Common Stock will trade under a new CUSIP number (40963P 204). The Common Stock began trading on the OTC Bulletin Board on a post-split basis on September 13, 2010 under the temporary ticker symbol "HNABD.OB". After a period of 20 trading days, the ticker symbol for the Common Stock will revert to "HNAB.OB". Each holder of Common Stock will be receiving a letter of transmittal from the Company's transfer agent, Corporate Stock Transfer, Inc., which will explain the process by which certificates representing pre-split shares of Common Stock may be exchanged for new certificates representing post-split shares. Such exchange is not mandatory.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
The disclosures set forth above under Item 3.03 of this report are incorporated by reference hereto.
http://biz.yahoo.com/e/100914/hnabd.ob8-k.html
Form 8-K for HANA BIOSCIENCES INC
22-Sep-2010
Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement.
Pursuant to an Amended and Restated License Agreement dated April 30, 2007, as amended effective May 27, 2009 (the "License Agreement"), between Hana Biosciences, Inc. (the "Company") and Tekmira Pharmaceuticals Corporation ("Tekmira"), the Company holds exclusive, worldwide rights to develop and commercialize three oncology drug candidates, Marqibo� (vincristine sulfate liposomes injection), Brakiva� (topotecan liposomes injection), and Alocrest� (vinorelbine liposomes injection). On September 20, 2010, the Company and Tekmira entered into Amendment No. 2 to the License Agreement (the "Amendment"), which amends the License Agreement as follows:
� The Company's maximum aggregate obligation for milestone payments to Tekmira for all three product candidates was decreased from $37.0 million to $19.0 million. All of the affected milestone payment obligations relate to amounts triggered by the achievement of regulatory milestones for the Company's Marqibo drug candidate.
� The Amendment modified the royalty rates payable by the Company for net sales of Marqibo by eliminating a tiered royalty rate structure based upon the amount of net sales and instead provides for a single royalty rate without regard to the amount of net sales.
� In consideration of the foregoing, the Company agreed to make a one-time payment to Tekmira of $5.75 million.
The foregoing description of the Amendment does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the full text of the Amendment that will be filed as an exhibit to the Company's Quarterly Report on Form 10-Q for the quarter ending September 30, 2010. The Company intends to submit a Confidential Treatment Request to the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, requesting that it be permitted to redact certain portions of the Amendment.
Marqibo® geschätzter Potential100 Millon $ ;-))
http://www.hanabiosciences.com/pipeline-o.html
Marqibo® (vincristine sulfate liposomes injection, OPTISOME™)
A Novel Targeted Nanoparticle-encapsulated Anti-Cancer Compound currently for Acute Lymphoblastic Leukemia (ALL) and Melanoma. Marqibo® has a robust safety database (over 600 patients) and has been extensively evaluated in lymphoid blood cancers such as non-Hodgkin’s lymphoma (NHL) and ALL. Hana has ongoing (or planned) clinical trials which may enable an accelerated approval in 2 indications. Future clinical trial development possible in multiple indications including NHL and melanoma. More Details »
Alocrest™ (vinorelbine liposomes injection, OPTISOME™)
A Novel Targeted Anti-Cancer Compound for Breast and Lung Cancer. Alocrest™ has completed a Phase I dose-escalation trial demonstrating promising anti-cancer activity as well as acceptable and predictable toxicity. More Details »
Brakiva™ (topotecan liposomes injection, OPTISOME™)
A Novel Targeted Anti-Cancer Compound for Small-Cell Lung Cancer and Ovarian Cancer. Preclinical data demonstrate the value of Brakiva™ over conventional topotecan. More Details »
Menadione Topical Lotion - A Topical Compound for Skin Rash Associated with EGFR Inhibitors. Treatment with EGFR inhibitors such as Tarceva®, Erbitux® and Vectibix® are associated with an acne-form rash involving the face, neck and upper torso in approximately 75% patients. 50% of patients who manifest skin toxicity experience significant discomfort. This results in drug discontinuation or dose reduction in at least 10% and up to 30% of all subjects. Drug delivery is targeted to the normal location of the EGFR-containing skin cells at the dermal/epidermal junction without interfering with EGFR inhibition systemically at the level of the tumor. More Details »
sehr Bald Geplanter Markteinführung ;-))
Hana Biosciences Corporate Presentation
http://files.shareholder.com/downloads/HNAB/...86932C/HNAB_081408.pdf
Hana BioscieHana Biosciences: Accelerating Product Development
• Late‐stage, well‐capitalized, biopharmaceutical company focused on
the development and commercialization of novel, improved cancer
therapeutics and compounds that reduce cancer therapy toxicity
• Marqibo® (vincristine sulfate liposome injection)
Lead asset that demonstrated compelling single‐agent, anti‐leukemic
efficacy in a heavily pre‐treated, advanced adult ALL population
– 35% ORR in the third‐, fourth‐, fifth‐, and sixth‐line treatment setting
– 20% CR/CRi rate with impressive median response duration and survival
– Rolling NDA submission seeking accelerated approval to be initiated 2H 2010
Langsam fangen viele an sich zu positionieren bevor es loss geht ;-)
Also Hana schön in Auge halten ;-)
http://finance.yahoo.com/...ohlcvalues=0;logscale=on;source=undefined
Written by Grant Zeng, CFA
Hana Biosciences Inc. (OTC BB: HNAB.OB - News) 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 by the deal, but we have different opinion. We think there is nothing to worry about the deal, especially by Warburg Pincus. Warburg Pincus is a sophisticated institutional investor in the pharma/biotech space. We believe the investment in Hana by Warburg is a long term investment as with its investments in other biotech companies. This can be evidenced by the biotech portfolio held by the investor. Warburg has been a long term investor in Inspire Pharmaceuticals, Allos Therapeutics, ZymoGenetics, Eurand, WuXi Pharma, and ev3 which was recently bought by Covidien at $2.6 billion.
At the current trading price of about $0.55 per share, we don’t see any short term dilutive effect as the conversion price has increased to $0.74 and $1.10 after the reverse stock split for Hana. Anything under $0.74 at this time should be a gift. Even if the share price increases to $1, we don’t believe that Warburg is willing to sell for about 15 or 20 cents profit. That makes no sense at all for an investor like Warburg.
The bottom line……
We think Hana in entering a transition period from a pure development stage company into a commercialization concern. With an appropriate growth strategy in place, the company is well positioned to deliver shareholder value in the next few quarters.
Although it’s always difficult to value a development stage biotech company like Hana, we think Hana’s shares are undervalued based on the company’s fundamentals. Currently, the company shares are trading at about $0.55 per share which values the Company at about $11.5 million. This is certainly a huge discount compared to its peers. One example is Cell Therapeutics (CTIC). This company is similar to Hana in terms of business, pipeline and development stage. Cell Therapeutics also has one candidate Pixantrone under the FDA review for the treatment of NHL and other early to middle stage candidates. However, Cell Therapeutics’ market cap is about $314 million. Another similar company is Allos Therapeutics (ALTH). Allos’ Pralatrexate received the FDA accelerated approval in late September 2009 for second line peripheral T-Cell lymphoma. Currently, Allos is valued at about $457 million. One more similar example is Bioenvision which was sold to Genzyme in 2007 for $345 million. Bioenvision had only one product Clofarabine approved for the third line treatment of pediatric ALL patients when it was bought by Genzyme.
We understand that the Street discounts Hana because of the uncertainty of Marqibo’s marketing authorization. However, we think Marqibo has a high probability to get the FDA nod in the second half of 2011. We believe Hana should be valued at least $100 million at current stage which translate into a share price of about $5 per share. Investors should pay attention to the following near-term catalysts:
- Presentation of Marqibo integrated efficacy data and PK 4Q10
- Generate Menadione Topical Lotion Phase II plan 4Q10
- Initiation of Marqibo NDA rolling submission to FDA 4Q10
- Seek EU EMA formal Scientific Advice for Marqibo 1H11
- Complete Marqibo NDA rolling submission to FDA 1H11
- ODAC meeting in support of Marqibo NDA 2H11
- FDA accelerated approval of Marqibo 2H11
HANA BIOSCIENCES INC (HNAB): Read the Full Research Report
http://finance.yahoo.com/news/Hana-Bioscience-Poised-To-zacks-1220037434.html?x=0
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.
http://finance.yahoo.com/news/...ence-Poised-To-zacks-1220037434.html
kann sich das schnell nach oben arbeiten jetzt ;-)
shares of common stock is approximately 21.2 million
http://ir.hanabiosciences.com/releasedetail.cfm?ReleaseID=506570
ist nicht mehr lange her also dürfte der kaufdrück steigen...
Ich hoffe sie schaffen es und dan winken satte Gewinne..
Zulang haben die long Aktionäre auf diesen Moment gewartet...
Allen viel Glück ;-))
quelle ihub
und einige scheinen sich zu positionieren
good luck
Wenn man bedenkt das sie schon bei 38 Euro lagen...
Bin mal gespannt ws der CEO heute mitzuteilen hat..
bei ganz gute News können wir vor der Marqibo zulassung bis mitte juni 2011 ein vielfaches höher liegen
und dazu kommen die andere Medikamente...
Das könnte sich zu eine Goldgrube Entwickeln ;-)
diese Bio Aktien sind sehr Extrem-springer, kein Wunder bei einen Potenzial von $5 billion market opportunity.
mal schauen was heute gesagt wird ;-)
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
- Market: Healthcare and Medical
- Published Date: 15 Nov 2010
- Report Type: Company Profile
- Country: Global
- Number of Pages: 40
- View Table of Contents
Hana Biosciences - Product Pipeline Review - Q4 2010
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