Farmas USA

BLUE

Update de goldman sachs.

Prepare for flight, adding to the conviction list. Buy, Target $135

https://pbs.twimg.com/media/CsYvWt6WAAAzkr-.jpg

AERI
no he seguido los msjes sobre ésta, pero si subió un +7% no paséis por alto que ITEK subió un +12%. ambas tienen el pipeline fármacos para tratar la presión intra ocular

AERI

http://www.nasdaq.com/es/symbol/aeri/after-hours

+62% en AH

AERI

Creo que esta hija de puta me pilló justo el año pasado en estas mismas fechas en un corto. Los datos eran discutibles y creo que lo siguen siendo por lo que dice el Bastardo:

Is the $AERI safety & tolerability issue resolved in its favor w/ Roclatan data? I’m not sure everyone will be convinced.

Entre eso y la ATM solo hay que buscar el punto para corto, pero con cuidado, que es una puta bestia y leo por ahí que las opciones indican muy para arriba.

Artículo de hace un año:
http://www.xconomy.com/new-york/2015/09/16/with-revamped-trial-aerie-glaucoma-drug-bounce-back/#

¿Alguna más apetecible?

ARNA

FBR inits with Outperform PO $6

AERI

Además han recibido algún upgrade de PT. Yo ni tocarlas con un palo, la locura ya la hice ayer con ARLZ (que por cierto lleva una hora en HALT esperando news y no sale nada de nada...). Igual ésta te da cierto juego si sale PR de esas ambiguas y tu que eres como un lince interpretas mejor que el mercado esos resultados ;-)

Es interesante el documento. Gracias. Lo del post marketing no creo que se aplique en este momento a NVAX, pero igual sí pueden ir los tiros por lo de unir cepas de RSV + gripe o sencillamente por lo de la validación de los lotes que habíamos dicho.

To be considered for accelerated approval, a BLA for a pandemic influenza vaccine should include results from one or more adequate and well-controlled studies designed to meet immunogenicity endpoints and a commitment to conduct confirmatory post-marketing studies. Since each vaccine candidate is unique (e.g., particular product characteristics, manufacturing process, etc.
), we recommend that you discuss with CBER early in development the adequacy of the manufacturing methods and product testing and the extent of the clinical data need ed to license your candidate vaccine.

1.
Effectiveness
This section describes possible approaches for establishing effectiveness based on
immune responses under an accelerated approval.
a.
A placebo-controlled immunogenicity trial in which HI antibody responses to
the new vaccine are assessed may be supportive of accelerated approval if the
study was adequately powered to assess the co-primary endpoints: 1)
seroconversion rates, and 2) percent of subjects achieving an HI antibody titer
≥1:40.

b .If a U.S. licensed pandemic influenza vaccine exists against a strain for which the sponsor is seeking licensure of a new vaccine, a non-inferiority comparison, as assessed by HI antibody responses, to the U.S. licensed pandemic influenza vaccine may support accelerated approval. The study should be adequately powered to assess the co-primary endpoints: 1) GMT, and 2) seroconversion rates.

c. Alternative study designs that assess different endpoints
and/or other immune responses will be reviewed by CBER and may be accepted in support of an accelerated approval. CBER would need to determine that the study design is acceptable and the proposed surrogate endpoint(s) is reasonably likely to predict clinical benefit.

2. Safety
Safety data should be collected from subjects enrolled in pre-licensure clinical trials intended to support the accelerated approval of a pandemic vaccine. The monitoring of these subjects should follow the outline described in section III.A.2. above. In addition, safety laboratory tests, to include hematologic and clinical chemistry evaluations, should be obtained pre- and post-vaccination in the first clinical study(ies). A total safety database large enough to rule out a serious adverse event that occurs at a rate of 1 in 300 may be adequate. The size of the pre-licensure safety database warrants discussion with CBER, especially for vaccines manufactured using novel processes and for adjuvanted pandemic vaccines. This determination would be influenced by factors such as the nature of the new manufacturing process and available clinical data. Safety data to support use in pediatric populations would also be needed and should be submitted as part of the BLA or as a supplement if the indication is sought at a later time.

3. Post-marketing Confirmatory Studies
a.
Confirmatory studies if a sponsor pursues U.S. licensure of an annual TIV
vaccine Sponsors seeking approval of a pandemic influenza vaccine strain are encouraged to pursue development of a trivalent inactivated influenza vaccine using the same manufacturing process as used for the pandemic influenza vaccine (see footnote
3). Approval of the trivalent inactivated vaccine, other than through accelerated approval, may help fulfill the post-marketing requirement to verify the clinical benefit of the pandemic influenza vaccine.

b. Confirmatory studies if a sponsor does not pursue U.S. licensure of annual
trivalent inactivated influenza vaccine
The sponsor would need to conduct one or more post-marketing field
effectiveness studies to verify the clinical benefit of the vaccine. The sponsor should discuss its plans with CBER and include its plan or a
pproach to conduct a study with its BLA application

AERI

PT 48 de Raymond James

RoclatanTM dosed once daily achieved the primary efficacy endpoint of demonstrating statistical superiority over both latanoprost and RhopressaTM at the primary endpoint range of baseline IOPs from above 20 to below 36 mmHg for each of the nine measured time points.
IOPs were measured at 8 a.m., 10 a.m., and 4 p.m. at week 2, week 6, and day 90. RoclatanTM IOP lowering exceeded that of latanoprost in a range of 1.3 to 2.5 mmHg, and exceeded RhopressaTM IOP lowering in a range of 1.8 to 3.0 mmHg. Efficacy levels were consistent across the 90-day period for all arms in the study.
RoclatanTM mean diurnal IOP-lowering exceeded that of latanoprost by an average across the study duration of 1.9 mmHg and exceeded RhopressaTM by 2.6 mmHg.
RoclatanTM reduced mean diurnal IOPs to 16 mmHg or lower in 61 percent of patients, a significantly higher percentage than observed in the comparator arms.
The most common RoclatanTM adverse event was hyperemia, or eye redness, which was reported in approximately 50 percent of patients, or 30 percent above baseline, and was scored as mild for the large majority of these patients. There were no drug-related serious adverse events for any of the comparators in the trial.

http://investors.aeriepharma.com/releasedetail.cfm?ReleaseID=989137

mean diurnal IOP-lowering “exceeded that of latanoprost by an average across the study duration of 1.9 mmHg and exceeded Rhopressa by 2.6 mmHg.” The combo “reduced mean diurnal IOPs to 16 mmHg or lower in 61 percent of patients, a significantly higher percentage than observed in the comparator arms.”

The combo, though, was also linked with a high rate of eye redness among patients, a trait also tied to Rhopressa. About half of the patients suffered from hyperemia, linked to a high number of dropouts in its studies. This new combo will also have to significantly outperform the generic if it expects to win over US payers.

It hasn’t all been smooth sailing for Aerie in recent years. The biotech had to get the FDA’s permission to change the endpoint for its second late-stage study of Rhopressa in order to avoid back-to-back failures.

they expect the agency will allow Aerie to launch that drug in early 2018 while Roclatan may arrive a year later.

Aerie CEO Vicente Anido, who’s already touted Rhopressa as a likely blockbuster able to earn more than $1 billion a year,

http://endpts.com/aerie-shares-rocket-up-as-glaucoma-combo-drug-scores-positive-data/

ARLZ

Gracias. Ahora me la miro un poco a ver...

Edito: tiene restricción de cortos hasta mañana