Farmas USA

Pues seria un corto muy goloso del -15% o asi , eh??? ( en caso de irse a por el gap )

HZNP

Novavax Initiates Pivotal Phase 3 Trial of the RSV F Vaccine in Older Adults
GAITHERSBURG, Md., Nov. 09, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the initiation of a Phase 3 clinical trial, known as Resolve™, of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).

The Resolve trial is a randomized, observer-blinded, placebo-controlled trial designed to enroll up to 11,850 older adults at 60 sites in the United States. Participants are being enrolled and vaccinated in advance of the 2015-16 RSV season, with top-line results expected in the second half of 2016.

The primary efficacy objective of the Resolve trial is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. The trial’s objectives, endpoints and statistical approach were finalized based on the FDA’s recommendations during the recent End of Phase 2 meeting. The results of a Phase 2 trial in older adults, reported by Novavax in August 2015, provided the basis for the Phase 3 trial design, including the determination of the attack rate, vaccine efficacy and case definitions.

“We have taken advice and recommendations from the FDA, along with numerous key opinion leaders and clinical experts, to design the Resolve trial to align with and build on the strength of our previous clinical results,” said Stanley C. Erck, President and CEO. “The primary objective of this clinical trial captures moderate-severe RSV disease that drives an estimated annual economic burden of more than $24 billion in the United States alone. The Resolve trial takes Novavax one step closer to bringing this important vaccine to licensure, years ahead of other RSV vaccine development efforts.”

About RSV

Respiratory syncytial virus, commonly referred to as RSV, is a respiratory infectious disease that causes serious infection of the respiratory tract, similar to influenza. For some, RSV may progress in severity, and lead to hospitalization or even death. The spread of RSV occurs annually, with an incidence rate of 2.5 million infections per year in the United States, RSV is increasingly being recognized as a significant cause of morbidity and mortality in the population of 64 million older adults.1,2 The U.S. Centers for Disease Control and Prevention (CDC) reports that each year the disease causes 177,000 hospitalizations and 14,000 deaths among adults older than 65.3 Annually, there are approximately 900,000 medical interventions directly caused by RSV disease.4,5 Currently, there is no approved RSV vaccine available.

El report financiero Q3
http://ir.novavax.com/phoenix.zhtml?c=71178&p=irol-newsArticle&ID=2110290

GALE

data from the Company's GALE-301 and GALE-302 clinical programs were presented at the Society for Immunotherapy of Cancer (SITC) 30th Anniversary Annual Meeting in National Harbor, Maryland. The data presented was on the primary vaccine series (PVS) from a randomized Phase 1b trial with GALE-301 (E39) and GALE-302 (E39' - variant of E39; previously named J65) that are folate binding protein-derived (FBP) peptides.

Poster #166 (abstract #156) entitled, "Preliminary report of a clinical trial supporting the sequential use of an attenuated E39 peptide (E39') to optimize the immunologic response to the FBP (E39+GM-CSF) vaccine," details the results of a randomized trial comparing three PVS sequences of E39 and E39' in ovarian and breast cancer patients to optimize the ex vivo immune responses, local reactions (LR), and delayed type hypersensitivity (DTH) reactions. This preliminary analysis revealed both agents are immunogenic and well tolerated with no differences in toxicities between PVS sequences. The study demonstrates that the in vivo immune response is enhanced with the use of the attenuated E39' (GALE-302) after E39 (GALE-301). The optimal vaccination sequence utilizing three inoculations of GALE-301 followed by three inoculations of GALE-302 produced the most prominent and statistically significant LR and DTH responses.

"We are pleased with the outcomes we observed in this trial as we evaluate strategies to optimize the immune response from our two clinical programs targeting folate binding protein," said Mark W. Schwartz, President and Chief Executive Officer. "Folate binding protein is a highly expressed tumor-associated antigen in many cancers making it a very logical treatment target for active immunotherapy. It also results in immunogenic peptides that have led to the development of a potentially very potent vaccine. It is theorized that this potency could lead to T-cell burn-out in patients over time, so we are assessing whether incorporating an attenuated version of the vaccine into the treatment regimen will provide a better immune response. The data derived from the DTH reactions indicate that treating patients first with the strong vaccine followed by a weaker version may provide a longer lasting effect. As the data continues to mature we will consider the outcomes as we plan the next stages for our GALE-301 and GALE-302 programs."

The Phase 1b is a single-center, randomized, single-blinded, three-arm study in patients with breast (n=35) or ovarian cancer (n=4) diagnosis who have been treated by standard of care and are without evidence of disease. The primary endpoint of the trial is immunologic and designed to determine which of the three PVS strategies maximizes short and long-term specific immunity defined as the number of E39-specific CTLs one and six months, respectively following completion of the PVS.

"The data presented confirms our assumption that sequencing the delivery of peptides provides varied immune responses and that the delivery can be optimized to potentially provide improved patient outcomes. Most importantly, we achieved a statistically significant increase in LR and DTH when delivering E39 followed by E39' in the PVS (p < 0.001). We are currently implementing a booster program and continued analysis of immunologic responses will further elucidate the optimal vaccination series for the prevention of recurrence in breast and ovarian cancer," commented Doreen O. Jackson, M.D., post-doctoral fellow with the Cancer Vaccine Development Program and the San Antonio Military Medical Center, and the poster presenter.

HLA-A2-positive breast or ovarian cancer patients were enrolled after completion of standard of care. The PVS includes six inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus 500mcg peptide in the first five patients per arm and 250mcg GM-CSF + 1000mcg of peptide in the second five patients. Thirty-nine patients were randomized into three arms with 30 patients completing the PVS:

E39 (GALE-301) x 6 inoculations (n=12)
E39 (GALE-301) x 3 inoculations followed by E39' (GALE-302) x 3 inoculations (n=14)
E39' (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=13)

Ex vivo immune response was measured via dextramer assay for E39-specific CD8+ T-cells at pre-vaccine (R0), then 1 and 6-months after the PVS (RC1, RC6). To assess the in vivo immune response, LR was measured 48 hours after each inoculation, and DTH reactions were measured at R0, RC1, and RC6. Statistical analyses included descriptive statistics, 2-tailed t-test, Chi-squared, Fisher's exact test and ANOVA as appropriate.

INO

beats by $0.03, revenue in-line

HZNP

Horizon's Q3 revenues and EPS came in significantly above the analyst consensus. Q3 revenues increased 202% to $226.5 million, which was $40 million above views while EPS came in at $0.70, or $0.30 ahead of the consensus.

The company also purchase $71.8 million worth of Depomed (NASDAQ:DEPO) shares in Q3 and this has brought down the level of cash in Q3. Luego el articulista dice que ve difícil que haya adquisición de DEPO

Sobre el escándalo de las farmacias: "These pharmacies are not owned by Horizon Pharma; we do not have any type of ownership stake, we do not have any options to purchase them in the future. These pharmacies solely dispense the prescriptions that physicians prescribe and we work to ensure that patients receive what his or her physician has prescribed. And these pharmacies are not involved in changing prescriptions or disrupting the healthcare system, that is a fallacy created in that market just - to justify other's motivations."

http://seekingalpha.com/article/3665016-horizon-pharma-business-as-usual?app=1&auth_param=7ib4d:1b413a3:db80a6f0adb17a8c11571500b18b5575&uprof=44

Bajada de 1$ o más??? Uffff no creo