Farmas USA

Articulo comentando el inicio de la Fase 3

http://www.fiercevaccines.com/story/novavax-kicks-phiii-trial-its-rsv-vaccine/2015-11-10

NVAX

HZNP

Recién salido en SA. Copio lo interesante de Horizon. También hay tela para Valeant

Express Scripts takes action against Horizon Pharma in a big way.

Horizon Pharma has half its revenue coming from specialty pharmacies.

Valeant and Horizon may not be able to use copay waivers to sell overpriced drugs if other PBMs follow.

Horizon's Vimovo and Duexis had been dropped from formularies, because they were just combinations of ancient generics.

Horizon has just been reminded that specialty pharmacies were for medications that required special handling and refrigeration, such as injections. Specialty pharmacies were not supposed to be used for copay subversion for ancient generics.

"If our strategies to mitigate formulary exclusions are not effective, these events may reduce the likelihood that physicians prescribe our products and increase the likelihood that prescriptions for our products are not filled."

Horizon's financial position

At least half of Horizon's revenue came through its specialty pharmacy program. In their Q3 earnings call they said:

We anticipate PME penetration for our primary care products to be in the 65% to 75% range. In the second quarter, PME penetration for Duexis, Vimovo and Pennsaid 2% were 71%, 61% and 69%, respectively, well within our expected range.

Horizon had $226 million of product revenue in Q3, of which $148 million was primary care. If primary care revenue was 70% PME, it works out to $104 million. But it was not just primary care that used PME:

And then on Rayos, PME penetration increased from 36% to 60% which drove an 88% increase in prescriptions in the quarter and gross to net increased from 40% to 55%.

Rayos was $12 million, so PME Rayos revenue would be around $7 million. Adding it all up, in my opinion, Horizon Pharma's debt holders will be in big trouble if other PBMs follow Express Scripts. Horizon's stock price had nearly doubled from the post-Philidor low, driven in part by the idea that Horizon did not own its specialty pharmacies.

Horizon has debt of $858 million. When such a huge chunk of revenue is at risk, the EBITDA drop is left to the imagination. In its latest earnings release, Horizon claims adjusted EBITDA of $239 million in the first nine months of 2015. Its hard to estimate just how bad the EBITDA can get without knowing the fixed costs at Horizon.

http://seekingalpha.com/article/3675356-horizon-hit-by-express-scripts-valeant-back-to-square-one?app=1&auth_param=7ib4d:1b46fr7:450c1159b3255f5bea6bfc2ccc485b7a&uprof=44

CYTX me refiero a esto Ana

en febrero se fue de 0,5 aprox a 1,4 aprox no se si por ese days to cover o por qué razón

Necesitamos superar los 335 en el IBB para romper bajista ...

NVAX

No specific vaccines and no product specific data will be presented and/or discussed at the Vaccines and Related Biologic Products Advisory Committee (VRBPAC)meeting. However, in light of the above challenges, the committee will be asked to opine on the appropriate clinical study designs to support the safety and effectiveness of investigational vaccines,as well as study designs of licensed vaccines that are recommended for use in pregnancy to protect the infant. For example, on the issue of demonstrating effectiveness, the committee will be asked to discuss considerations regarding the potential use of immune marker(s)in lieu of clinical endpoint efficacy trials. Regarding safety the committee will be asked to discuss safety endpoints to be evaluated in both the mother and the infant, as well as the duration of follow-up for infants born to mothers immunized during pregnancy. In addition, the committee will be asked to discuss approaches to evaluating interference with immune responses to vaccination among infants born to mothers immunized during pregnancy.

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM471661.pdf

CYTX

Pues el mayor fue justo antes de la gran noticia del pivotal y designación de huérfano el 22 de febrero

Cytori Receives Positive European Opinion on Orphan Drug Status
http://finance.yahoo.com/news/cytori-receives-positive-european-opinion-130000207.html

Should the pivotal STAR study be successful, CYTX would file a PMA for approval in the U.S.

received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. The STAR study is an 80 patient pivotal clinical trial approved by FDA in January 2015 to study the effects of Cytori’s lead drug ECCS-50 for treatment of patients with hand manifestations of Scleroderma.

http://www.streetinsider.com/Analyst+Comments/Roth+Positive+on+Expansion+of+STAR+Study+Sites%3B+Afforms+Cytori+%28CYTX%29+at+Buy/10317060.html?si_client=intbro

NVAX
El volumen flojo pero al menos en verde
Y aquí otro día más haciendo de coche escoba
http://www.ftportfolios.com/Retail/Etf/EtfHoldings.aspx?Ticker=FBT

HZNP

Joer, palizón gitano le están dando.