Kommt bei Hana Bioscience ein möglicher Rebound?

Sieht ja doch nicht so gut aus bei den Amis...
Hat jemand eine Erklärung?

Wollte den Wert fast in mein Depot nehmen.
Bin zum Glück nicht vor Eröffnung der US Börsen eingestiegen, puhhh....  

gabs ne konferenz
vielleicht waren die erwartungen zu hoch,oder nix neues
muss mich erst belesen,grad erst rein

 

Hana Biosciences Reports Third Quarter 2010 Financial Results                                

SOUTH SAN FRANCISCO, Calif., Nov. 12, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences, Inc. (OTCBB:HNAB - News),  a biopharmaceutical company focused on strengthening the foundation of  cancer care, today reported financial results for the three and nine  months ended September 30, 2010, and provided a corporate update.

"During the third quarter of 2010, our focus was on preparation of the 5  modules that make up the NDA submission for Marqibo(R)" stated Steven  R. Deitcher, M.D., President and Chief Executive Officer of Hana  Biosciences. "An analysis of data from the Menadione Topical Lotion  Phase 1 program showed that it was generally safe and well tolerated. In  addition, the dose limiting toxicity and apparent maximum tolerated  lotion strength were identified. Our strategy is to seek a partner to  enhance and accelerate the continued development of Menadione Topical  Lotion."

Recent Clinical and Corporate Highlights:

• Intensive data collection and verification efforts in the third  quarter led to completion of the database lock for the primary Phase 2  Marqibo clinical trial in October 2010.
• Completed data analysis of Menadione Topical Lotion Phase 1 study.
• Dr. Robert Spiegel, former Chief Medical Officer of Schering Plough, joined the Hana Board of Directors.
• Obtained stockholder approval of certain amendments to the Company's  certificate of incorporation, which led to an adjustment to the  Company's recent Convertible Preferred financing transaction to more  Company-favorable terms.
• Amended its License Agreement with Tekmira Pharmaceuticals Corporation  resulting in an aggregate reduction of $18 million in Hana's potential  milestone obligations in exchange for a one-time payment to Tekmira of  $5.75 million.

Three Months Ended September 30, 2010 Financial Results

For the three months ended September 30, 2010, the Company reported a  net loss of $7.9 million and deemed dividends on preferred stock of  $22.1 million, which when combined, resulted in a net loss applicable to  common stockholders of $30.0 million, or $1.41 per share. The deemed  dividends on preferred stock had an impact of $1.04 per share for the  three months ended September 30, 2010. This compares with a net loss of  $5.7 million, or a loss per share of $0.70, for the three months ended  September 30, 2009. There were no deemed dividends on preferred stock  for the three months ended September 30, 2009.

Total operating expenses for the three months ended September 30, 2010,  were $10.3 million, including the one-time payment to Tekmira of $5.75  million, compared with $4.4 million for the three months ended September  30, 2009. Research and development expenses were $9.0 million for the  three months ended September 30, 2010, compared with $3.5 million for  the three months ended September 30, 2009. General and administrative  expenses were $1.3 million for the three months ended September 30,  2010, compared with $0.9 million for the three months ended September  30, 2009.

As of September 30, 2010, the Company had cash, cash equivalents and  available-for-sale securities of $27.7 million. Cash used in operations  was $10.2 million for the three months ended September 30, 2010 compared  with $5.2 million for the three months ended September 30, 2009.

Nine Months Ended September 30, 2010 Financial Results

For the nine months ended September 30, 2010, the Company reported a  net loss of $19.7 million and deemed dividends on preferred stock of  $31.4 million, which when combined, resulted in a net loss applicable to  common stockholders of $51.1 million, or $2.48 per share. The deemed  dividends on preferred stock had an impact of $1.52 per share for the  nine months ended September 30, 2010. This compares with a net loss of  $19.1 million, or a loss per share of $2.36, for the nine months ended  September 30, 2009. There were no deemed dividends on preferred stock  for the nine months ended September 30, 2009.

Total operating expenses for the nine months ended September 30, 2010,  were $19.3 million, including the $5.75 million one-time payment to  Tekmira, compared with $14.2 million for the nine months ended September  30, 2009. Research and development expenses were $15.0 million for the  nine months ended September 30, 2010, compared with $10.7 million for  the nine months ended September 30, 2009. General and administrative  expenses were $4.3 million for the nine months ended September 30, 2010,  compared with $3.5 million for the nine months ended September 30,  2009.

Cash used in operations was $20.6 million for the nine months ended  September 30, 2010 compared with $16.0 million for the nine months ended  September 30, 2009.

The per share results for all periods have been adjusted to reflect the  impact of the Company's 1-for-4 reverse stock split that occurred at  the close of business on September 10, 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,  progress and anticipated results of Hana's planned NDA filing relating  to Marqibo, including whether such NDA submission 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;  and statements regarding the timing, progress and anticipated results of  the clinical development, clinical trial and data analysis timelines,  development plans and strategies and the anticipated benefits of  Menadione Topical Lotion. 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 a partner  with which to develop Menadione Topical Lotion. Additional risks that  may affect such forward-looking statements include Hana's need to raise  additional capital to fund its product development programs 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 period ended March 31,  2010. Hana assumes no obligation to update these statements, except as  required by law.



HANA BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
	September 30, 2010	December 31, 2009
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$8,669,331	$9,570,453
Available-for-sale, equity securities	64,000	68,000
Available-for-sale, debt securities	18,981,752	--
Prepaid expenses and other current assets	107,074	114,067
Total current assets	27,822,157	9,752,520
Property and equipment, net	135,266	252,455
Restricted cash	125,000	125,000
Debt issuance costs	938,109	1,193,594
Total assets	$29,020,532	$11,323,569
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable and accrued liabilities	$4,024,057	$4,027,075
Other short-term liabilities	6,479	43,586
Total current liabilities	4,030,536	4,070,661
Notes payable, net of discount	23,188,508	22,597,050
Other long-term liabilities	5,253	6,540
Investors' right to purchase future shares of Series A-1 and A-2 preferred stock	6,239,000	--
Warrant liabilities, non-current	692,271	2,145,511
Total long term liabilities	30,125,032	24,749,101
Total liabilities	34,155,568	28,819,762
Commitments and contingencies:
Redeemable convertible preferred stock; $100 par value:
10 million shares authorized, 0.4 million and 0 shares issued and  outstanding at September 30, 2010 and December 31, 2009, respectively;  aggregate liquidation value of $41.5 million and $0 at September 30,  2010 and December 31, 2009, respectively	30,643,219	--
Stockholders' deficit:
Common stock; $0.001 par value:
350 million and 200 million shares authorized, 21.2 million and 19.9  million shares issued and outstanding at September 30, 2010 and  December 31, 2009, respectively	21,234	19,912
Additional paid-in capital	119,071,635	117,632,111
Accumulated other comprehensive income	(29,532)	(24,000)
Accumulated deficit	(154,841,592)	(135,124,216)
Total stockholders' deficit	(35,778,255)	(17,496,193)
Total liabilities, redeemable, convertible preferred stock and stockholders' deficit	$29,020,532	$11,323,569

HANA BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
	Three Months Ended	Nine Months Ended
	September 30,	September 30,
	2010	2009	2010	2009
Operating expenses:
General and administrative	$1,253,194	$932,221	$4,299,929	$3,504,895
Research and development	9,002,798	3,506,920	14,966,768	10,701,473
Total operating expenses	10,255,992	4,439,141	19,266,697	14,206,368
Loss from operations	(10,255,992)	(4,439,141)	(19,266,697)	(14,206,368)
Other income (expense):
Interest income	37,514	470	38,020	12,626
Interest expense	(856,050)	(935,993)	(2,881,369)	(2,496,143)
Other expense, net	(3,511)	--	(3,511)	(4,908)
Change in fair value of warrant liabilities	348,717	(292,111)	(34,819)	(2,449,220)
Change in fair value of investors' right to purchase future shares of Series A-1 and A-2 preferred stock	2,809,000	--	2,431,000	--
Total other income (expense)	2,335,670	(1,227,634)	(450,679)	(4,937,645)
Net loss	$(7,920,322)	$(5,666,775)	$(19,717,376)	$(19,144,013)
Deemed dividends attributable to preferred stock	(22,059,541)	--	(31,366,973)	--
Net loss applicable to common stock	(29,979,863)	--	(51,084,348)	--
Net loss per share applicable to common stock, basic and diluted	$(1.41)	$(0.70)	$(2.48)	$(2.36)
Weighted average shares used in computing net loss per share, basic and diluted	21,233,804	8,145,034	20,570,038	8,123,541
Comprehensive loss:
Net loss	$(7,920,322)	$(5,666,775)	$(19,717,376)	$(19,144,013)
Unrealized holdings gains (losses) arising during the period	(13,532)	(20,000)	(5,532)	(24,000)
Comprehensive loss	$(7,933,854)	$(5,686,775)	$(19,722,908)	$(19,168,013)

                                                                       

Hana Biosciences, Inc. Investor & Media Contacts: Investor Relations Team (650) 588-6641 investor.relations@hanabiosciences.comhttp://finance.yahoo.com/news/Hana-Biosciences-Reports-pz-1088605335.html?x=0&.v=2

 

 

doch so läuf es leider nicht ;-)

Ein wenig Warten und Geduld ist angesagt ;-))

 

Marqibo ist in ein paar Monate dran und bist dahin wird hier sich noch vieles tun ;-))

 

kauf ich die dips
good luck

Interessant ;-))

http://www.thecleverbull.com/articles/view/article/14/Pullback-Opportunity-exclusive-interview-with-Hana-Biosciences-OTCHNAB

 

     

Pullback Opportunity, exclusive interview with Hana Biosciences (OTC:HNAB)

Posted on Nov 13, 2010, 9:30 pm  Author: The Clever Bull

Hana Biosciences provided a business update about the progress made during the third quarter. link to Nov. 12th CC: ir.hanabiosciences.com/eventdetail.cfm Complete original NDA will be submitted in first half of 2011. This change in process is not expected to effect the timing of submission completion, review or potential approval.   "During  the third quarter of 2010, our focus was on preparation of the 5  modules that make up the NDA submission for Marqibo(R)" stated Steven R.  Deitcher, M.D., President and Chief Executive Officer of Hana  Biosciences. "An analysis of data from the Menadione Topical Lotion  Phase 1 program showed that it was generally safe and well tolerated. In  addition, the dose limiting toxicity and apparent maximum tolerated  lotion strength were identified. Our strategy is to seek a partner to enhance and accelerate the continued development of Menadione Topical Lotion. While  this should have been considered as good news, some impatient investors  have taken their profit off the table after the recent rise of the  share price, +50% in one month (While HNAB was down 28% after the CC, it  is good to note that the volume was very low). We think the potential  is still here and this might represent a good buy opportunity since the  submission of the NDA is just few months away and it will be submitted  as a complete original NDA with all the modules. During the CC Dr. Deitcher was very confident that the NDA will be submitted in the first half of 2011. He stated "We are well on the way to accomplishing that goal..." Hana  Biosciences was working on preparing the 5 modules during the third  quarter and this will carry on through the end of the year, almost all  of the modules will be completed before the end of 2010, we believe a  change for a full submission rather than module by module might be a  good strategy and Dr. Deitcher mentioned during the CC that it was  suggested and recommended by the FDA, it is most convenient for them. As  of September 30, 2010, the Company had cash, cash equivalents and  available-for-sale securities of $27.7 million. With the recent $40M  financing round, that brings the market cap of Hana Biosciences to  around $50M, which we consider to be still very low regarding the  pipeline, and the long term potential for Marqibo in other indications. The  Clever Bull has conducted an exclusive interview with Hana Biosciences  to highlight more specific points such as the NDA application, the  potential for Marqibo in other indications, Menadione, Warburg financing  deal. Here is the interview: 1-    You are  about to fill the rolling NDA for Marqibo, are you confident to get an  accelerated approval review? You said the NDA will be filled before end  of 2010, are you still on track with this time frame? Response:   On November 8, 2010 we held a pre-NDA follow-up meeting with the FDA.  At that meeting we and the FDA agreed that Hana would submit all of the  NDA modules simultaneously instead of following a rolling submission  process. This change in process is not expected to effect the timing of  submission completion, review or potential approval. We anticipate  submitting the completed NDA in the first half of 2011. We are pursuing  an accelerated approval of Marqibo and the program already has  Fast-Track and Orphan Drug designations from the FDA. 2-     Can you confirm that other applications with Marqibo such as Front-line  NHL and Front-line Ph-ALL which represent a total market of around 5B  will both only require Phase III studies? Are they already started or  when do you plan to start them? Response:   We expect that studies such as the ones you indicated will only require  Phase III studies. However, until a Phase III trial protocol is  approved by the FDA there is not 100% certainty. No Phase III clinical  trials of Marqibo have commenced. The logical strategy is to receive the  FDA’s approval decision on Marqibo’s current indication before  committing funds to a large, expensive, label expansion trial. 3-     Are those other applications with Marqibo already founded or do you  plan to partner with the classic method of upfront payment and royalties  system? Response:  For large,  expensive, multi-national, Phase III clinical trials, it is common for  small companies to seek to share costs with another entity. We are  keeping all our options open.   4-    Marqibo has  been granted EMA Orphan Drug designation in Europe and you said you are  exploring the potential for an authorization under exceptional  circumstances. Can you tell us more about this process and does it mean  Marqibo may be approved in Europe in 1H11? Response:   Hana will seek formal Scientific Advice from EMA in 2011. Approval in  Europe will require a full regulatory submission.  The approval decision  in Europe is anticipated to follow the approval decision in the US. 5-     There is actually one clinical trial that is ongoing with the NCI with  respect to pediatric cancers ALL, when will we have some data about this  promising indication? Response:   The pediatric oncology branch of the NCI will be conducting a Phase 1  pharmacokinetic and dose finding study. The study could take up to 2  years to fully enroll. 6-    Now, with respect  to Menadione, we are waiting for Top-line data and the start of the  Phase II before end of this year. The focus is on Marqibo for now and  investors have yet to discover the potential of this topical cream.  Since it has the potential to prevent the rash in chemotherapy treated  patients and it is also effective to treat psoriasis, can you tell  enlighten us about the market potential in term of numbers? Response:   First, we have no clinical data demonstrating the efficacy of Menadione  Topical Lotion for treating psoriasis. We recently completed the Phase 1  program.  The Phase 1 program has successfully demonstrated that MTL is  generally safe and well-tolerated.  The dose limiting toxicity, skin  irritation and redness, was only observed at the 0.2% lotion strength.   The apparent maximum tolerated lotion strength is 0.1%.   MTL applied  twice daily at all strengths, including the highest lotion strength  tested (0.2%) resulted in no appreciable systemic exposure. Due  to the fact that there are no comparable lotions indicated for the  treatment of EGFR rash, there is no empirical data establishing the size  of the opportunity.  It is estimated that there are approximately  45,000 to 50,000 people undergoing EGFR therapy annually in the U.S and  Europe. 7-    Since Menadione is a topical  cream, does it need to go through a classic FDA review process with a  NDA filling? You said you plan to find a partner for Menadione, you  mentioned discussions with partners are ongoing, can you tell us more  about this? Response:  Menadione  Topical Lotion requires the completion of the standard FDA clinical  trial process. We are unable to comment on discussions with potential  partners. 8-    You recently signed a financing  deal with Warburg Pincus for up to $100M. While many investors fear  dilution to come, can you explain the Warburg’s strategy with your  company? Do you feel it’s a long term partner that will push Hana  Bioscience to a bigger company? Response:   Warburg Pincus has a track record as a long-term investor seeking to  generate significant value but we are unable to predict how things will  progress with Hana at this time. 9-    There has  been some misunderstanding with the convert prices post R/S. Can you  confirm that convert prices did increase 4X also with the R/S and are  now at $0.72 and $1.10? We have seen that Warburg is a long term partner  with companies they invest on, do you think they will convert and sell  their shares on the market or rather they will wait to get the full  potential in the coming years before selling any? Response:   The new conversion prices are $0.736 for the Series A-1 Preferred Stock  and $1.104 for the Series A-2 Preferred Stock. Based on the Investment  Agreement, the preferred shareholders have options for how they may  choose to create liquidity for their preferred shares, including  converting to common shares or, if there is an acquisition, preferred  shareholders may opt to receive proceeds in cash without converting into  common shares. We are unable to predict if or when preferred  shareholders may choose to convert their preferred shares to common  shares. 10-    We know that Warburg has a large  portfolio of biotech companies that are almost all traded on the NASDAQ  with a market cap of over $500M, do you think we might see HNAB back to  the NASDAQ in early 2011? Response:   There are certain requirements to be listed on exchanges such as Nasdaq  and Amex. Among the requirements are share price, stock holder equity,  and market cap, as well as others. We are unable to predict when Hana  may meet the necessary requirements, if at all.   Forward-Looking Statement This  document 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 NDA filing relating to Marqibo, including  whether such NDA submission will be accepted for review or approved by  the FDA; statements regarding the timing and progress of proposed  clinical trials; 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;  statements regarding our ability to secure a development partner for  Menadione Topical Lotion; and statements regarding the Menadione Topical  Lotion regulatory approval process. 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; and that Hana will be able to secure a development  partner for Menadione Topical Lotion. 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 period ended March 31,  2010. Hana assumes no obligation to update these statements, except as  required by law.   Full Disclosure: -Long position on HNAB -The  Clever bull has NOT been compensated in any way by Hana Biosciences or Warburg Pincus to  promote or write this article.   The Clever Bull team. By  reading The Clever Bull you agree to the disclaimer,       and  thereby will not hold The Clever Bull accountable for any       transactions  or decisions you make. It is up to you to do your own  due      diligence. TheCleverBull.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.  The Clever Bull  has   not   been compensated by any of the above   mentioned companies.   Please  read   our report and visit our Web site,  www.thecleverbull.com,  for complete risks and disclosures.

 

bis auf 2 -3 Euro hochgehen wird ;-)

habe ein wenig der Aktienverlauf zurückgeschaut und es können Extrem große Sprünge geben bald :-)

 

http://finance.yahoo.com/...ohlcvalues=0;logscale=on;source=undefined

 

Mit ein Potenzial  von 5 Millarden USD sind hier bald ganz andere Preiße zu ewarten ;-)

Mein rat haltet eure shares fest ;-)

 

Hana Biosciences recovering from recent price drop

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Written by Eric Sebastien

Wednesday, 17 November 2010 03:21

 

Hana Biosciences, Inc. (OTC:HNAB) has been busy getting ready to submit- in first half of 2011- a complete original NDA. 
"During the third quarter of 2010, our focus was on preparation of the 5 modules that make up the NDA submission for Marqibo" stated Dr. Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences during a recent conference call. "An analysis of data from the Menadione Topical Lotion Phase 1 program showed that it was generally safe and well tolerated. In addition, the dose limiting toxicity and apparent maximum tolerated lotion strength were identified. Our strategy is to seek a partner to enhance and accelerate the continued development of Menadione Topical Lotion.

While some investors considered this positive news, others simply took their profits off the table after the recent rise in share prices (+50% in one month) and wlaked away.  HNAB was suddenly down 28% on low volume. Now some are re-considering HNAB and its potential as a "good buy opportunity", especially since the complete submission of the NDA is just months away.

Hana Biosciences was working on preparing the 5 modules during the third quarter and this will carry on through the end of the year, almost all of the modules will be completed before the end of 2010, we believe a change for a full submission rather than module by module might be a good strategy and Dr. Deitcher mentioned during the CC that it was suggested and recommended by the FDA, it is most convenient for them.

As of September 30, 2010, the Company had cash, cash equivalents and available-for-sale securities of $27.7 million. With the recent $40M financing round, that brings the market cap of Hana Biosciences to around $50M, which we consider to be still very low regarding the pipeline, and the long term potential for Marqibo in other indications.

I recenlty conducted an exclusive interview with Hana Biosciences:

Question:  You are about to fill the rolling NDA for Marqibo, are you confident to get an accelerated approval review? You said the NDA will be filled before end of 2010, are you still on track with this time frame?

Craig Carlson, CFO of Hana Biosciences:  On November 8, 2010 we held a pre-NDA follow-up meeting with the FDA. At that meeting we and the FDA agreed that Hana would submit all of the NDA modules simultaneously instead of following a rolling submission process. This change in process is not expected to effect the timing of submission completion, review or potential approval. We anticipate submitting the completed NDA in the first half of 2011. We are pursuing an accelerated approval of Marqibo and the program already has Fast-Track and Orphan Drug designations from the FDA.
 

Question: Marqibo has been granted EMA Orphan Drug designation in Europe and you said you are exploring the potential for an authorization under exceptional circumstances. Can you tell us more about this process and does it mean Marqibo may be approved in Europe in 1H11?

Craig Carlson, CFO of Hana Biosciences:  Hana will seek formal Scientific Advice from EMA in 2011. Approval in Europe will require a full regulatory submission.  The approval decision in Europe is anticipated to follow the approval decision in the US.

Question: There is actually one clinical trial that is ongoing with the NCI with respect to pediatric cancers ALL, when will we have some data about this promising indication?

Craig Carlson, CFO of Hana Biosciences:  The pediatric oncology branch of the NCI will be conducting a Phase 1 pharmacokinetic and dose finding study. The study could take up to 2 years to fully enroll.

Question: Now, with respect to Menadione, we are waiting for Top-line data and the start of the Phase II before end of this year. The focus is on Marqibo for now and investors have yet to discover the potential of this topical cream. Since it has the potential to prevent the rash in chemotherapy treated patients and it is also effective to treat psoriasis, can you tell enlighten us about the market potential in term of numbers?

Craig Carlson, CFO of Hana Biosciences:  First, we have no clinical data demonstrating the efficacy of Menadione Topical Lotion for treating psoriasis. We recently completed the Phase 1 program.  The Phase 1 program has successfully demonstrated that MTL is generally safe and well-tolerated.  The dose limiting toxicity, skin irritation and redness, was only observed at the 0.2% lotion strength.  The apparent maximum tolerated lotion strength is 0.1%.   MTL applied twice daily at all strengths, including the highest lotion strength tested (0.2%) resulted in no appreciable systemic exposure.

Due to the fact that there are no comparable lotions indicated for the treatment of EGFR rash, there is no empirical data establishing the size of the opportunity.  It is estimated that there are approximately 45,000 to 50,000 people undergoing EGFR therapy annually in the U.S and Europe.

Question: Since Menadione is a topical cream, does it need to go through a classic FDA review process with a NDA filing? You said you plan to find a partner for Menadione, you mentioned discussions with partners are ongoing, can you tell us more about this?

Craig Carlson, CFO of Hana Biosciences:  Menadione Topical Lotion requires the completion of the standard FDA clinical trial process. We are unable to comment on discussions with potential partners.

Question: You recently signed a financing deal with Warburg Pincus for up to $100M. While many investors fear dilution to come, can you explain the Warburg’s strategy with your company? Do you feel it’s a long term partner that will push Hana Bioscience to a bigger company?

Craig Carlson, CFO of Hana Biosciences:  Warburg Pincus has a track record as a long-term investor seeking to generate significant value but we are unable to predict how things will progress with Hana at this time.

Question: There has been some misunderstanding with the convert prices post R/S. Can you confirm that convert prices did increase 4X also with the R/S and are now at $0.72 and $1.10? We have seen that Warburg is a long term partner with companies they invest on, do you think they will convert and sell their shares on the market or rather they will wait to get the full potential in the coming years before selling any?

Craig Carlson, CFO of Hana Biosciences:  The new conversion prices are $0.736 for the Series A-1 Preferred Stock and $1.104 for the Series A-2 Preferred Stock. Based on the Investment Agreement, the preferred shareholders have options for how they may choose to create liquidity for their preferred shares, including converting to common shares or, if there is an acquisition, preferred shareholders may opt to receive proceeds in cash without converting into common shares. We are unable to predict if or when preferred shareholders may choose to convert their preferred shares to common shares.

Question: We know that Warburg has a large portfolio of biotech companies that are almost all traded on the NASDAQ with a market cap of over $500M, do you think we might see HNAB back to the NASDAQ in early 2011?

Craig Carlson, CFO of Hana Biosciences: There are certain requirements to be listed on exchanges such as Nasdaq and Amex. Among the requirements are share price, stock holder equity, and market cap, as well as others. We are unable to predict when Hana may meet the necessary requirements, if at all.

Writer Eric Sebastien is the managing editor of TheCleverBull.com
Disclosure: Long HNAB

http://biomedreports.com/2010111760228/...ering-from-recent-drop.html

 

Business

Market Report, "Hana Biosciences - Product Pipeline Review - Q4 2010", published

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Author: Bill Thompson e-mail Web: www.fastmr.com Phone: 18008448156 http://www.pr-inside.com/market-report-hana-biosciences-r2256935.htm

 

PROTOX CLOSES FIRST $10 MILLION TRANCHE OF WARBURG PINCUS INVESTMENT

Mr. Jonathan Leff is a Managing Director of Warburg Pincus where he focuses on investments in healthcare. Prior to joining Warburg Pincus, he was a consultant at Oliver, Wyman & Co. Mr. Leff received an A.B. in government from Harvard University and an M.B.A. from the Stanford University Graduate School of Business. Mr. Leff is a director of Allos Therapeutics, Inc., Hana Biosciences, Inc., Inspire Pharmaceuticals, Inc., InterMune, Inc. and Rib-X. Mr. Leff also serves on the Board of Directors of the Biotechnology Industry Organization,

http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7959520

Hana Biosciences, Inc.

Hana Biosciences, Inc. (Nasdaq: HNAB) is a biopharmaceutical company dedicated to developing new, differentiated cancer therapies designed to improve and enable current standards of care. The Company has two lead product candidates that target large markets and are in pivotal and/or proof-of-concept clinical trials. Marqibo(R) is being developed to treat lymphoid cancers such as ALL and lymphomas. Menadione topical lotion is a first-in-class compound being developed as a prevention and/or treatment of skin toxicity associated with epidermal growth factor receptor inhibitors like Erbitux(R) and Tarceva(R). The Company has additional pipeline opportunities that, like Marqibo, improve delivery and enhance the therapeutic index of well characterized, proven chemotherapies. Further information on Hana Biosciences can be found at www.hanabiosciences.com.

http://www.bioportfolio.com/corporate/company/...Biosciences-Inc.html

 

Hallo liebe Mitstreiter.
Ich habe Interesse an einer Position HANA, jedoch fällt es mir schwer, mich hierfür zu entscheiden. Die News sind toll, Bodenbildung meines Erachtens erreicht und FinRes Report ist auch ok. Bin aber durch Oscient und Genta ein gebranntes Kind. Von Bio- bzw. Pharmawerten halte ich aktuell nur Prometic, welche nach vielen positiven News auch mal an die Decke gehen könnte (tut's aber noch nicht, das elende Teil).
Aus diesem Grund: Ist hier jemand weiter in der Materie vorangeschritten und kann mir näheres zu 1. EMA Orphan Drug designation in Europe; 2. dem Fast-Track Status  bezüglich Marquibo erzählen? Danke im voraus und Thumbs Up! bei HANA  

Hana Biosciences to Present Data on Marqibo(R) at the 2010 American Society of Hematology Annual Meeting and Exposition

 

SOUTH SAN FRANCISCO, Calif., Nov. 29, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that data regarding Marqibo for treatment of adults with relapsed/refractory acute lymphoblastic leukemia (ALL) will be the subject of two presentations at the 2010 Annual Meeting and Exposition of the American Society of Hematology (ASH) being held in Orlando, Florida from December 4-7, 2010.

 

 

Presentation details are as follows:

 

 

Abstract: 2142: Marqibo(R) (vincristine sulfate liposomes injection; VSLI) Optimizes the Dosing, Delivery, and Pharmacokinetic (PK) Profile of Vincristine Sulfate (VCR) In Adults with Relapsed and Refractory Acute Lymphoblastic Leukemia (ALL)

 

 

Abstract: 2143: Marqibo(R) (vincristine sulfate liposomes injection; VSLI) In the Treatment of Adult Patients with Advanced, Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL): A Combined Analysis of the VSLI-06 and RALLY Studies

 

Date/Time/Place:	Sunday, December 5, 2010, 6:00PM -- 8:00PM
	Orange County Convention Center, Orlando, FL
Poster Boards:	II-22 & 23

 

The abstracts are available online at:

 

 

http://ash.confex.com/ash/2010/webprogram/Paper33455.html
http://ash.confex.com/ash/2010/webprogram/Paper34609.html

 

 

About Marqibo(R) (vincristine sulfate liposomes 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 clinical development of Marqibo, the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL and other diseases 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.

http://finance.yahoo.com/news/...sent-pz-2333698019.html?x=0&.v=1

 

Hast du noch ander aktien,ausser Hana,BOI und YRCW ?  

Chalifmann3: was ist loss? gefallen sie dir nicht? Naja man sollte auf Long gehen finde ich...

Bio Aktien sind nicht einfach, aber können auch sehr Extreme Gewinne bringen,

 wenn natürlich an Ende alles Stimmt...

Jeder muss selber wissen was er tut und dafuer auch die Verantwortung übernehmen...

 

der mit der erste Zulassung der Durchbruch schaffen sollte winken schon mal 5$

bei der Ganze Marqibo(R) Palette 5 Milliarde USD Umsatz..

Das wäre ja ein Traum Gewinn je Aktie..

Der kaufdrück wird Automatisch steigen be so eine Schanze...

Und später kommen ja noch andere Medikamente..

Diese Aktie könnte sich in den nässten 7 Monate zu eine Goldmine Entwickeln.

Daumen drücken ist angesagt jetzt ;-)

 

Hana Biosciences to Change Name to Talon Therapeutics

 

SOUTH SAN FRANCISCO, Calif., Dec. 1, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, announced that its board of directors has approved changing its name to Talon Therapeutics, Inc. The name change will become effective on Thursday, December 2, 2010.

"The change in corporate name from Hana Biosciences to Talon Therapeutics reflects the Company's culture of seizing upon medical opportunities, efficiently and expertly leading product candidates through clinical development, and transferring value to patients, patient care providers, shareholders, corporate partners, and employees," stated Steven R. Deitcher M.D. President and Chief Executive Officer of Hana Biosciences. "Other than the name change, there is no fundamental change to the Company. Marqibo(R) is our lead product candidate and we anticipate submitting our NDA to the FDA during the first half of 2011."

The Company's ticker symbol on the OTC Bulletin Board will be TLON.OB effective at the commencement of trading on December 2, 2010. The Company's new corporate website is www.talontx.com.

About Marqibo(R) (vincristine sulfate liposomes 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.

The Company 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 Us

We are 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, 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.

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 clinical development of Marqibo, the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL and other diseases compared to existing therapies, and the timing for NDA submission. Such statements involve risks and uncertainties that could cause the Company'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/...ange-pz-4001940225.html?x=0&.v=1

 

über Marqibo das sie schon die weichen setzen für eine bessere Mark Einführung

The abstracts are available online at:

http://ash.confex.com/ash/2010/webprogram/Paper33455.html
http://ash.confex.com/ash/2010/webprogram/Paper34609.html

Officer of Hana Biosciences. "Other than the name change, there is no fundamental change to the Company. Marqibo(R) is our lead product candidate and we anticipate submitting our NDA to the FDA during the first half of 2011."

The Company 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.

 

 

Last Trade:	0.75
Trade Time:	9:55AM EST
Change:	0.19 (33.93%)

http://finance.yahoo.com/q?s=TLON.OB

 

Last Change Volume Last-Trade Time Open High    Low
      0.58                         5,700§12/2/10 10:37:29   00,58   0,75     0,58      

Form 8-K for TALON THERAPEUTICS, INC.

2-Dec-2010

Amendments to Articles of Inc. or Bylaws; Change in Fiscal Year, Financi

 

 

http://biz.yahoo.com/e/101202/tlon8-k.html

 

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