Beruflich Dokumente
Kultur Dokumente
Estimacin: $3.47
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
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
15-01-2015
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
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.
3-11
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:
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
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
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