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.)
The good news is that the company shored up its balance sheet and shares have finally begun to rebound. And, with a few breaks, DVAX looks poised to rise to $3, $4 or even $5. Pre any approval.
The Vaccines and Related Biological Products board voted its confidence in the immunogenicity of Heplisav by a 13 – 1 vote; however, the committee said in an 8 – 5 decision, with one abstention, that it could not recommend the vaccine for approval to the FDA due to insufficient clinical safety data, especially in certain minority groups.
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. What has some panel members worried, however, is that 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, briefing documents posted by the regulatory agency failed to demonstrate a mechanistic link between the company’s TLR-9 agonist and autoimmune response: 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.
The Advisory Committee did not vote against the approval of the vaccine.
The Advisory Committee voted 8 to 5 that the safety data is insufficient. So there were 5 members that voted clearly for the approval. From the 8 members that voted against the safety data, there were some that voted that a further test could be made POS-approval. I do not know the exact number who voted for that, but I remember to see at least 2 of them. If from 8 members, 2 voted against but accept a POS-approval test, that means that 5+2=7 member are for the approval of the vaccine even if a test is further necessary. That would mean that at maximum 8-2=6 members requested tests pre-approval. In other words the result of the voting was at least 7 for the approval and at maximum 6 against the approval.
In my World EU is a Shoe in*
I see Blue Birds. ... make that ....Green Birds
You see we never should have been at this low valuation
For the EU to validate our Science will open the flood gate of VALUE
The Science is Proven and agreed by the FDA
So look at the Blue Sky's I'm pointing at and stop looking at the tip of my finger *
More on RA because you need to know more about these guys
RA Capital, we take an evidence-based approach to investing globally in innovative healthcare and life sciences companies. We strive to recognize success early and to appreciate the full extent of value creation of which a company is capable.
Our breadth of research and unique business structure, which accommodatboth public and private investments, helps our portfolio integrate what we believe are the most compelling opportunities for value creation in our industry. Our understanding of scientific and business risks and best practices is derived from our well-curated collection of thousands of case studies that document the impact of clinical trial design, partnership structures, public market dynamics, and many other factors on valuation and business viability.
We make our knowledge base available to our portfolio companies and, through our outreach efforts, to the broader healthcare and life science community
This is your FUEL
With in One years time Dynavax Potentially becomes A CANCER for GSK
We'll have a product to compete in the Hep B, UK market place that GSK Dominates
Sir Grey's " GGP " has Accomplished Several Things
Enough Cash to carry us through a Third Hep Lisa V trial
Prepare for Marketing of the drug
Cover staff and operations over the trial period
BUT the Best part of the " GGP " and this is *speculation on my part *
He Sold what must be the ( Magic Beans ) to RA Cap
Who In their right mind would put up so much Capital with out a Nugget
That nugget must be Give me the Leverage Cap and I hand you a Deal with GSK
Amazing Prep and Cred of our new Staff in regards to
being prepared to launch in short order after a EU approval.
Mr. Gray served as the President of Pharmaceuticals Europe at GlaxoSmithKline
Senior Vice President and General Manager of Pharmaceuticals
In both roles, he was instrumental in the launch, commercialization and strategic development of GSK’s vaccine portfolio.
Vice President and Director of the Vaccines Business Unit in the US, and Vice President and General Manager of Pharmaceuticals in Canada. GSK
Mr. Nat Ricciardi was appointed to our Board in June 2013. Mr. Ricciardi
Held the position of President, Pfizer Global Manufacturing, and Senior Vice President of Pfizer Inc,
Nat was directly responsible for all of Pfizer’s internal and external supply organization,
Mr. Ricciardi maintained responsibility for global manufacturing activities from 2004 through 2011.
RA Capital, we take an evidence-based approach to investing globally in innovative healthcare and life sciences companies. We strive to recognize success early and to appreciate the full extent of val
From the current Q
In Europe, our Marketing Authorization Application for HEPLISAV is currently under review by the European Medicines Agency’s (“EMA”). In late 2012, we received the 120-Day List of Questions which relate to Suitability of different patient populations, Safety database, Good Manufacturing Practices (“GMP”) and Good Clinical Practices (“GCP”) matters. In the early summer EMA added to the list of questions, resetting the clock for our response. EMA has also inspected several study sites, Dynavax and our clinical contract research organization. The focus of the GCP inspection was HBV-17, a 500 patient study in CKD patients that is part of the EMA application but not the US application. We are currently preparing our response to the 120-Day Questions and expect to submit the response before the end of 2013. EMA will consider our responses and in the first quarter of 2014 is expected to issue the 180-Day List of Outstanding Issues (“LOI”). We anticipate that the discussion regarding the patient group who would most likely benefit, and some of the GMP/GCP matters will need to be resolved following issuance of the 180-Day LOI.
I don't know for a fact but Grey told us the EMA 120 day letter will be late in Q4,
Will this POP the Stock don't know, Will it drop the stock I Doubt it.
Bagged Shorts Might be a nice Gift*