I think your not seeing the value x Hep-Lisa-V
Todays MK 560M, That's today we have 10 months to go
I see MK 1.5 by years end
frequency of adverse drug reactions ADR's
. Very common 1/10
. Common ( Frequent ) 1/100 & 1/10
. Uncommon ( Infrequent ). 1/1000 & 1/100
. Rare 1/10000 & 1/1000
. Very Rare 1/10000
If approved, Heplisav would compete with vaccines in a global market with estimated annual sales of $750 million. This market is growing, too. The Centers for Disease Control has recommended increased prophylactic dosing for diabetics, which could add incremental sales of up to $300 million per annum.
If a larger cohort represented by a more diverse ethnic sampling is necessary, how come an under-represented enrollment of blacks (about nine-percent) was sufficient when the FDA positively reviewed GlaxoSmithKline’s other adjuvant vaccines, like the Hep-A drug Havrix and the combination DTP-HBV vaccine Infanrix?
Agency reviewers who voted against the safety profile also criticized the company for perceived flaws in study-design, complaining about sample size – one member suggested enrollment of 10,000 patients would be more satisfactory -- and study duration (more than one year was desirable).
Heplisav supporters on the advisory board did suggest that larger and longer – including surveillance safety monitoring – studies could be conducted after marketing approval.
There was consensus among the committee that there is a medical need for more HBV vaccines, as efforts to inoculate persons in high at- risk groups (prisoners, IV drug users, diabetics, etc.) have had limited success. Compliance problems with vaccination schedules is a likely culprit as global health agencies struggle to eliminate the transmission of HBV and the incidence of HBV-associated chronic liver disease.
Unlike currently licensed HBV vaccines from GlaxoSmithKline and Merck’s (MRK) Recombivax-HB, immune responses with Dynavax’s proprietary adjuvant technology is achieved faster, resulting in the need for only a two-dose schedule (administered one month apart), compared to existing guidelines of three-to-four doses given up to a year between first and final dosing.
Only approval and post-marketing surveillance studies, however, can factually address whether ease of administration with Heplisav might increase adherence and decrease the incidence and prevalence of HBV. Ergo, there is still hope for Hepsilav approval.
Heplisav may come with a higher price tag than current vaccines. As a result, the $700 million market may expand beyond $1 billion if Heplisav gets approved.
Assuming a $1 billion sales base and 15% operating margins, DVAX would be poised for $150 million in annual profits. The company would likely be worth 10 times that peak profit forecast, or $1.5 billion. The company's current market value is below $500 million, so shares appear to have 200% to 300% upside if both the U.S. and Europe approve Heplisav.
Understand that these are rough estimates, and the ultimate market value will be easier to determine once the company's pricing strategies are better articulated. (More than likely, DVAX would be acquired by a large drug company before actual drug sales took place.)
A theoretical concern exists that vaccines containing adjuvants (pharmacological agents added to enhance seroprotection) might induce autoimmune diseases, such as multiple sclerosis. Dynavax’s drug contains the same Hep-B surface proteins (antigen) as currently marketed HBV vaccines. Heplisav enjoins a first-in-class adjuvant, which activates immune responses by specifically targeting Toll-like Receptor 9 (TLR-9), found on a specialized subset of immune cells.
However, Pooled results from two pivotal late-stage trials demonstrated the relative risk of developing a serious adverse event in patients treated with Heplisav was no greater than the group injected with the comparator vaccine Engerix-B, marketed by GlaxoSmithKline (GSK).
The risk of African-Americans contracting HBV is three times greater than that of whites. Committee chair Robert Daum, MD, expressed concern “that there’s not enough data from different ethnic groups to be sure the immunogenetic response [of heplisav] is adequate.”
On average, the ethnicities in the two phase-3 trials containing 4,800 participants were White (87.8%); Black (8.8%); and Hispanic (4.3%). However, it’s important to remember that last year blacks and those of Hispanic or Latino origin comprised only 13.1% and 16.7% of the U.S. population, according to U.S. Census Bureau data.
To ask Dynavax – or any company — to power the study design specifically tailored to those at minority groups at higher-risk would be cost prohibitive. The biotech has spent more than $300 million (in just the last five years) to move the drug through the pipeline approval process.
We should expect the same outcome
from the second Phase III
The overall safety across studies didn't reveal significant imbalances in important adverse events. No significant differences in ANA titers,ANCA or anti - ds DNA levels were detected between recipients of Heplisav or Engerix-B. Subgroups analysis for AEs did not identify subgroups of subjects the exhibited higer rates of AEs than other groups.
The CBER reviewers concluded summary of safety did not reveal any significant differences in safety between HEPLISAV & Engrix-B Less
According to the World Health Organization, asthma affects 300 million people worldwide. Asthma is a chronic disease of the lungs and is caused primarily by allergic inflammation of the airways. In addition, 210 million people worldwide are affected by COPD, a term used to describe chronic lung diseases that limit airflow in the lungs. Analysts estimate the current worldwide market opportunity for asthma and COPD therapies to be over $15 billion annually.
Yes, it was the answer and funds put out contract for shares.
It was held down to attain cheap shares. In all fairness that's the facts.
These same funds will make sure it pays off.
2 EZ *
I would love to hear from fellow Long Dyanvax share holders
What to make of our R&D regarding this so far Promising drug.
last bit of news we received was of a good nature.
But no other news regarding Follow up or other trials? What have I missed other than the obvious, we are trying to get our hep B Vac in order. It has been dropped from our web site as a drug in development.
Well Mr. Tang *
Another 5% makes for 12% in two days after tomorrow we should be trading up over the 20.00 bucks.
A lot of your friends are leaving, Do you need a ride?
Of course you never had any doubt........LOL