Sie sind auf Seite 1von 8

Junta de accionistas para 19 junio de 2015

Se planta la aprobacin de 75 millones de acciones ms de acciones ordinarias (de 200 millones a


275), adems de las de bonus y dems

Estimacin: $3.47

million in Q1 or $3.81 million in Q2 Consensus is -$0.09 EPS or a loss

of $13.58 million.
23-4-2015
http://seekingalpha.com/article/3092776-galena-biopharma-is-a-worthwhile-gamble-for-the-shortor-long-term
10-4-2015

Folate Binding Protein and Anagrelide Control Release Data In May/June


Possible Early FDA approval
Anagrelide CR - A better reformulated, patented version of Anagrelide Instant
Release. Anagrelide IR causes many serious side effects and still garners
almost $500 Million in annual revenues. Gale's CR Version has proven to
work, provide an equal drug benefit without the many serious side effects
and also allows for greater dosage for those patients who require it.
These Mid Stage Results are out in May/June as well - I expect sooner as the
Phase 2 trials enrolled a full 6 months early due to very strong patient
demand. Additionally, Shire (who owns the IR version) has been rumoured
to be eyeing this drug for buyout / partnership while they are on their recent
buying binge
Se esperan datos top-line para mediados de 2015 . Earnings 7 de mayo
Phase 2a GALE301
Phase 1 GALE401
Phase 2 GALE401
Deficiencias comunicadas en farmacovigilancia por la FDA (11-12-2013) que lo peor es que no han
incluido en el informe trimestral ni han respondido a la FDA adecuadamente. No son de
fiar.
24-11-2015
En dilucin ATM con Lincoln entrada 1,60

http://www.thestreet.com/story/12963541/1/galena-shunned-by-wall-street-forced-to-seek-priceyvulture-financing.html?puc=yahoo&cm_ven=YAHOO

5-2-2015

Galena Biopharma Announces Orexo's Filing of a Patent


Infringement Lawsuit Against Actavis Concerning
Abstral(R) (fentanyl) Sublingual Tablets in the U.S.
PORTLAND, Ore., Feb. 5, 2015 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc.
(Nasdaq:GALE), a biopharmaceutical company developing and commercializing
innovative, targeted oncology treatments that address major medical needs across the
full spectrum of cancer care, today announced that its partner, Orexo AB, has filed a
patent infringement lawsuit in United States District Court for the District of New
Jersey, against Actavis Laboratories FL, Inc., Andrx Corporation, Actavis, Inc. and
Actavis Pharma, Inc. (collectively "Actavis").
The lawsuit was filed in response to the Abbreviated New Drug Application ("ANDA")
filed by Actavis. In its application, Actavis seeks to market and sell generic versions of
Abstral (fentanyl) sublingual tablets in the U.S. prior to the expiration of Orexo's U.S.
patents for Abstral listed in the FDA's Orange Book. The listed patents are U.S. patents
6,759,059, 6,761,910 and 7,910,132 with expiration dates in September 2019. Galena
currently markets Abstral and is the owner of the New Drug Application in the United
States.
Because Orexo initiated a lawsuit against Actavis in a timely manner, the FDA is
statutorily precluded from approving Actavis' ANDA for 30 months, or until a district
court decision finding the patents invalid or not infringed, whichever occurs earlier. The
30-month stay period began as of the date Orexo received the Notice Letter from
Actavis that notified Orexo of the ANDA filing.
Mark W. Schwartz, Ph.D., President and Chief Executive Officer of Galena Biopharma,
commented, "We are confident in the patents listed in the FDA's Orange Book and fully
support our partner, Orexo, as they vigorously enforce the intellectual property rights
around Abstral. Given the significant sales growth and future market potential for
Abstral, ANDA filings of generic versions are not entirely unexpected. Our overall
strategy and revenue projections for Abstral are unchanged, and we look forward to
continued growth and increased market penetration during 2015."

15-01-2015

Competencia, deduzco y cay en AH.


Galena Biopharma and its partner, Orexo AB (Orexo) have received a "Paragraph IV"
patent certification notice from Actavis Laboratories, FL (Actavis). The Notice Letter
advises Galena of Actavis filing of an Abbreviated New Drug Application (ANDA)

with the U.S. Food and Drug Administration seeking approval of generic versions of
Abstral (fentanyl) sublingual tablets prior to the expiration of Orexos patents listed in
the Orange Book. Galena currently markets Abstral and is the owner of the New Drug
Application in the United States.
Galena is working closely with its partner Orexo to review the details of this Notice
Letter and decide on the response within the statutory timeline of 45 days from receipt
of the Notice. Together with our partner Orexo, Galena intends to vigorously enforce the
intellectual property rights around Abstral.

18-11-2014
Roth Capital affirms Galena Biopharma (Nasdaq: GALE) at Buy with a price target of $8
following an update on Phase 2 GALE-401 enrollment.
Reclutamiento completado GALE-401 (Anagrelide Controlled Release) Phase 2 Clinical Trial
11-11-2014

Galena Biopharma Doses First Patient in Phase 2 Clinical


Trial With NeuVax(TM) (nelipepimut-S) in
Combination With Herceptin(R) (trastuzumab) to
Treat High-Risk HER2 3+ or HER2 Gene-Amplified
Breast Cancer Patients

Datos presentacin oncolgica 7-11-2014

Phase 1/2a trial of GALE-301, a Folate Binding Protein (FBP)-derived immunotherapy.


Buenos datos de seguridad y eficacia. Adems, el compuesto consigue un 38% de
reduccin de reaparicin de tumores en los ovarios.
After a median follow-up of 13 months, there have been 11/22 (50%) recurrences in the
control group compared to 9/29 (31%) recurrences in the vaccine group, a 38%
reduction in relative risk of recurrence. The study was not powered for efficacy but
rather, a clinical proof of concept study. GALE-301 generates a long lasting immune
response, which generates tumor lysing CD8 T cells, bypassing the need for active
receptor or ligand binding to generate efficacy.
http://www.streetinsider.com/Corporate+News/Galena+Biopharma+%28GALE
%29+Issues+Encouraging+Update+on+GALE301+Phase+12a+as+Ovarian+Cancer+Treatment/9988362.html?si_client=intbro
Informe 6-11-2014
On January 12, 2014, we acquired exclusive worldwide license to develop
and commercialize GALE-401 (anagrelide CR), a patented, controlledrelease formulation of anagrelide, through our acquisition of Mills
Pharmaceuticals, LLC (Mills) under a unit purchase agreement.

Under the terms of the unit purchase agreement, we made an up-front


cash payment of $2 million to the former Mills owners and also agreed
to make additional contingent payments to the former owners upon
the achievement of certain development milestones relating to
GALE-401, including 2,000,000 shares of our common stock upon
initiating the first clinical trial of GALE-401 in patients with essential
thrombocythemia, or ET, and an additional 2,000,000 shares upon
initiating a Phase 3 clinical study of GALE-401. The number of shares
issuable upon the milestones is subject to increase based on a formula
specified in the purchase agreement, up to a maximum of 3,000,000
shares for each milestone, in the event the five-day average trailing
closing price of our common stock (the Average Price) is less than
$4.84 at the time the applicable milestone is achieved. Similarly, the
number of shares issuable upon achievement of the milestones is
subject to decrease based on such formula if the Average Price
exceeds $6.84 at the time of achievement of the applicable milestone.

We achieved the milestone relating to the initiation of the first clinical trial of
GALE-401 in the third quarter of 2014 and issued 3,000,000 shares of common
stock to the former owners, the maximum under the unit purchase agreement as
our five-day average trailing close price of our common stock was less than the low
end of the collar of $4.84 . We will record as an addition to the GALE-401 intangible
asset the fair value of the shares delivered in payment of each milestone under the
Mills unit purchase agreement. The addition to the intangible asset for the fair value
of the shares will increase our additional paid-in capital by the same amount, less
the par value of the milestone shares. As a result of the achievement of the
initiation of the first clinical trial of GALE-401, we recorded an addition to GALE-401
asset and additional paid in capital in the amount of $6.8 million , or the fair value
of the shares issued. The milestone payments will have no effect on our net loss.
On July 17, 2014, we entered into a definitive license and supply agreement
with MonoSol Rx, LLC (MonoSol) for the U.S. commercial rights to Zuplenz
(ondansetron) Oral Soluble Film, an FDA approved product for the prevention of
highly and moderately emetogenic chemotherapy-induced nausea and vomiting
(CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative
nausea and vomiting (PONV). Refer to Note 12 for details of the transaction.
In conjunction with the acquisition of NeuVax TM , the company acquired rights
and assumed obligations under a license agreement among Apthera and The
University of Texas M. D. Anderson Cancer Center (MDACC) and The Henry M.
Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) which
grants exclusive worldwide rights to a U.S. patent covering the nelipepimut-S
peptide and several U.S. and foreign patents and patent applications covering
methods of using the peptide as a vaccine. Under the terms of this license, we are
required to pay an annual maintenance fee of $200,000 , a milestone payment of
$200,000 upon commencing the Phase 3 PRESENT trial of NeuVax and other clinical
milestone payments, as well as royalty payments based on sales of NeuVax or other
therapeutic products developed from the licensed technologies.
On March 18, 2013, we acquired Abstral (fentanyl) Sublingual Tablets for sale
and distribution in the United States from Orexo AB (ORX.ST), an emerging specialty
pharmaceutical company based in Sweden. Abstral has been approved by the U.S.

Food and Drug Administration (FDA) and is a transmucosal immediate-release


fentanyl (TIRF) product.
Under our agreement with Orexo, we assumed responsibility for the U.S.
commercialization of Abstral and for all regulatory and reporting matters in the U.S.
We also agreed to establish and maintain through 2015 a specified minimum
commercial field force to market, sell and distribute Abstral and to use commercially
reasonable efforts to reach the specified sales milestones. Orexo is entitled to
reacquire the U.S. rights to Abstral from us for no consideration if we breach our
obligations to establish and maintain the requisite sales force throughout the
marketing period. We expect to maintain our sales efforts beyond this date. We
officially launched U.S. commercial sales of Abstral in October 2013.

Preferred Stock The company has authorized up to 5,000,000 shares of


preferred stock, $0.0001 par value per share, for issuance. The preferred stock will
have such rights, preferences, privileges and restrictions, including voting rights,
dividend rights, conversion rights, redemption privileges and liquidation
preferences, as shall be determined by the companys board of directors upon its
issuance. To date, the company has not issued any preferred shares.
Common Stock The company has authorized up to 200,000,000 shares of
common stock, $0.0001 par value per share, for issuance.

3-11

Galena Biopharma (NASDAQ:GALE): Q3 EPS of -$0.05 beats by $0.06.


Revenue of $1.6M (+36.8% Y/Y) misses by $1.06M.
Press Release

http://investors.galenabiopharma.com/secfiling.cfm?filingid=1390478-14-58&CIK=1390478
23 octubre
S3 de 2 millones de acciones para el colocador a un precio mximo de 1,66. Dilucin ATM
Octubre
Patentes:

1. Galena Biopharma (Nasdaq: GALE) announced the Notice of Allowance of a U.S.


patent application covering methods of treating patients having any HER2/neu
expressing cancer by administering NeuVax (nelipepimut-S) in combination with
Herceptin (trastuzumab; Genentech/Roche)
2. Aprobada la misma en Japn

http://www.streetinsider.com/Litigation/Galena+Biopharma+%28GALE
%29+Receives+NeuVaxRelated+Patent+Notice+of+Allowance+from+USPTO/9895115.html?
si_client=intbro
Septiembre 2014. Sobre las acusaciones de manipulacin
Comunicado sobre la historia de los artculos de pumpeo. Resumo: que ellos no tuvieron nada que ver,
que fue la empresa Lidingo. El CEO de GALE resulta que actu al margen y contrat a dicha
empresa para comprar a los articulistas y como pago a la empresa se le dio un puado de acciones de
GALE. Vamos, que no, que ellos no fueron.
9-9

Galena Biopharma Doses First Patient in GALE-401 (Anagrelide Controlled Release)


Phase 2 Clinical Trial
GALE-401 in Phase 2 Study in Patients With Elevated Platelet Counts in
Myeloproliferative Neoplasms (MPNs) Including Essential Thrombocythemia (ET)
Agosto 2014

Abstral sales in the second quarter were flat sequentially and weren't down
only because of a large order from a single customer. Galena warned third-quarter sales
of Abstral could be negatively affected by this large order. Looking ahead, Abstral sales
will also be hurt by Express Scripts (ESRX_) adding the cancer painkiller to its 2015
formulary exclusion list.
http://finance.yahoo.com/news/galena-biopharma-reports-second-quarter-203500437.html
Ventas de Monosol no irn a ningn lado segn el BAstardo
http://www.thestreet.com/story/12781204/1/galena-gives-sales-team-another-useless-product-topromote.html?puc=yahoo&cm_ven=YAHOO
13 enero 2014 Compra Acquires Mills Pharmaceuticals y sube

Entra en el Russell junio 2013


Funcionamiento de NeuVax en video
http://www.globenewswire.com/NewsRoom/Attachment/18614

While improved diagnostics and targeted therapies have decreased breast cancer mortality in
the United States, metastatic breast cancer remains incurable. Up to 25% of resectable node-positive
breast cancer patients having no radiographic evidence of disease following surgery and adjuvant

chemo/radiation therapy still relapse within three years following diagnosis. These cancer patients
presumably still had isolated, undetected tumor cells also known as circulating tumor cells (CTCs) which,
over time, led to a recurrence of cancer, either in the breast area (local recurrence) or at a remote location
(metastatic disease).
Galena is developing peptide vaccine (off-the-shelf) cancer immunotherapies, which address
major patient populations of cancer survivors to prevent recurrence. These therapies work by harnessing
the patients own immune system to seek out and attack any residual cancer cells. Using peptide
immunogens has many clinical advantages, including an excellent safety profile, as these drugs lack the
toxicities typical of most cancer therapies. They also feature long-lasting protection through immune
system activation and convenient delivery.
Abstral
On March 18, 2013, we acquired the rights to sell and distribute Abstral (fentanyl)
sublingual tablets in the United States from Orexo AB (ORX.ST), an emerging specialty pharmaceutical
company based in Sweden. Abstral has been approved by the FDA and is the transmucosal immediaterelease fentanyl (TIRF) market leader in Europe by ProStraken/Kyowa Hakko Kirin.
Abstral is an important new treatment option for inadequately controlled breakthrough cancer
pain (BTcP) in opioid-tolerant cancer patients. The innovative Abstral formulation delivers the
analgesic power of fentanyl in a convenient and easy to use sublingual tablet, which dissolves within
seconds. Abstral provides rapid relief of BTcP, predictable dosing, and is convenient and easy to use.
Under our agreement with Orexo, we assumed responsibility for the U.S. commercialization of Abstral
and for all regulatory and reporting matters in the U.S. We also agreed to establish and maintain from
January 1, 2014 through December 31, 2015, which we refer to as the marketing period, a specified
minimum field sales force to market, sell and distribute Abstral and to use commercially reasonable
efforts to reach the specified sales milestones. Galena intends to launch U.S. commercial operations for
Abstral in 2013.
In exchange for the U.S. rights to Abstral, (1) we paid Orexo $10 million in cash from our
cash on hand, and (2) we agreed to pay to Orexo: (a) $5 million in cash upon the earlier of (i) the
approval by the FDA of a specified U.S. manufacturer of Abstral and(ii) the first anniversary of the
closing; (b) three one-time future cash milestone payments based on our net sales of Abstral; and (c) a
low double-digit royalty on future net sales. No further milestone or royalty payments will be due after
the date on which all claims of the last remaining licensed patents expire (currently 2019) or become
invalidated by a governmental agency.

http://marketplayground.com/2013/04/20/galena-biopharma-inc-nasdaqgale-behind-theanalyst-ratings/
PRESENT study, which will report interim data in 4Q13 or 1Q14. We believe adjuvant
vaccine therapy will ultimately become standard of care for many cancer types, and we
view NeuVax as one of the leading new product candidates for this revolutionary
treatment modality. Galena also recently acquired an approved product for breakthrough
cancer pain, giving the company near-term revenue potential and a commercial presence
in oncology.
http://clinicaltrials.gov/ct2/show/NCT01479244?term=nelipepimut&rank=1
GALE:
http://clinicaltrials.gov/ct2/show/NCT01570036?term=Galena+Biopharma&rank=2
http://clinicaltrials.gov/ct2/show/NCT01479244?term=Galena+Biopharma&rank=1

El estudio que tienen entre manos mola mucho, pero es ingente y no acabar hasta 2017
(mayo 2022 sale ahora en los estudios; preliminares en mayo 2015), con lo que entre
medio s podran necesitar pasta si no encuentran socios o alguna fuente de financiacin.
http://clinicaltrials.gov/ct2/show/NCT01479244?term=nelipepimut&rank=1

Das könnte Ihnen auch gefallen