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The 180 degree turn-around seems very unlike the FDA. Glad they are doing an about-face, though! The FDA does seem much harder to get a drug passed through than in Europe...and I agree, they don't really seem to care if Europe uses it or not. But in this case, at least they will allow patient and physician experience with the drug to serve as a response to the CRL.
Happy holidays to you as well.
Now we know why the price jumped up really quickly on 11/26/13 (message#346) and why it has been climbing on increasing volume the past few days. Glad I bought more yesterday after I could no longer ignore that something was going on in the background! I knew about the ad com meeting for Jan 27th, but I couldn't figure out what was going on in the background one month PRIOR to the mtg...now we know it's b/c no mtg is needed! This is great news.
What Is Next For pSivida?
new article on Seeking Alpha
seekingalpha.com/article/1905581-what-is-next-for-psivida?source=email_rt_article_readmore&%3bapp=1
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Editors' Note: This article covers a stock trading with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
pSivida (PSDV) and its holders have had a pretty hard time over the last 2-3 months. Nevertheless, despite twists, turns, rockets and crashes, the stock up is still up nearly 133% on its year to date opening price, primarily driven by speculation as to the approval of its Diabetic Macular Edema [DME] treatment, Iluvien. On October 17, the FDA issued a complete response letter stating it could not approve the treatment in its current form, and the stock crashed. To add insult to injury, the stock fell considerably before the announcement had been made, leaving some holders with the feeling that they may have been at some unfair disadvantage as far as information is concerned. Though one could always say follow the insider moves and assume all information leaks. With this in mind, and with many holding PSDV stock and wondering whether to cut or hope, what is next for pSivida?
(click to enlarge)
Advisory Meeting
The first thing pSivida holders should look to is an advisory meeting between Alimera (ALIM), the manufacturer of Iluvien, and the FDA. The meeting will take place on January 27, and will effectively be the watershed moment for Iluvien in the US. As Larry Smith explains, the driving factor behind the most recent, and subsequent, FDA non-approvals of the treatment is an imbalance between efficacy and harmful side effects. Among the patient group targeted, chronic DME sufferers in the latest application, there is simply not enough incentive to undergo treatment in the face of its potential for harm. The meeting will no doubt explore the possibility of Iluvien treatment among extreme sufferers-the more chronic the DME the fewer the available alternatives-which, while vastly reducing the potential market for the treatment, would at least enable the drug to move forward.
European Sales
Despite the failure of Iluvien three times when faced with the FDA approval process, the treatment has to date received marketing authorization in the UK, Austria, France, Germany, Portugal and Spain and is pending in Italy. It is currently commercially available in both the UK and Germany. Announced two weeks prior to the FDA complete response, and somewhat ignored since, was the UK National Institute for Health and Care Excellence (NICE) issuance of a final draft guidance that recommends Iluvien as an option for the treatment of chronic DME. In the UK, the Department of Health, which is the government arm of the national healthcare system, refers treatments to NICE for recommendation. Any treatment or drug that received NICE recommendation (unofficially) becomes an almost standard of care treatment for the condition in question. The reason I say unofficially, is because National Health Service [NHS] doctors are under no obligation to administer recommended treatments. Having said this, and the reason I can make this claim, is that NHS hospitals are quality checked based on their doctors' adherence to NICE guidelines.
What is the market potential in the UK? This is difficult to estimate, as figures concerning the exact number of chronic DME sufferers are not available. Having said this, the company has received over $30M so far from Alimera Sciences under the terms of the Iluvien collaboration even before any profit split on sales. Factor in the UK NICE recommendation, and the remaining four or five European markets yet to be addressed, and Europe alone could be enough to fund pSivida's pipeline. Which brings me to my next point…
Medidur
The company's current lead candidate is Medidur for posterior uveitis, which is now in phase III trials. Posterior uveitis has a prevalence of 38 per 100,000 in the US and is difficult to treat. It is the third largest cause of blindness in the US, being the direct cause of nearly 30,000 cases. Medidur is similar to Iluvien, in that it is a sustained release technology that is inserted into the back of the eye. The drug delivered is fluocinolone acetonide, which is the same drug used in Retisert, pSivida's treatment collaboration with Bausch and Lomb. Retisert is already approved by the FDA for uveitis that affects the posterior segment of the eye, which is the same indication the company is seeking for Medidur. The concern with Medidur is that its risk profile is similar to that of Iluvien. It increases intra-ocular pressure considerably and causes cataracts in almost all patients treated. The difference between Medidur and Iluvien however, is posterior uveitis is considered much more serious than DME. Therefore, although the risk profile of the two treatments is similar, the benefit gained compared with risk of undergoing the treatment to the patient is larger.
Finances
Iluvien's failure to gain approval has had a dramatic effect on the financial position of the company. Success would have meant an instant and guaranteed milestone payment of $25M, which at its current price is just under one third of its total market capitalization. This would have accelerated the Medidur trial, and allayed pSivida investors' fears of further dilution. Instead these fears remain. As of September 30, the company reported cash holdings just shy of $15M. Current burn rate is a little over $4M, with revenues of around $600,000. With this in mind, the company expects to be able to fund current and planned operations through calendar year 2014. This funding derives from a combination of existing capital resources together with expected royalty income and other expected cash inflows under existing collaboration and evaluation agreements.
Risks
The recent activity in this stock means two things. The first, that the pSivida holders who suffered post October 17, will likely need no lesson-much less to be preached to-as far as the risks involved with investing in development stage biotech companies are concerned. The second, that the recent events serve to illustrate the danger in doing so, and the way in which speculator perception as to the likelihood of a particular event can often be completely wrong. pSivida is a company that, all else aside, has just enough cash to survive 2014. Yes, it has what seems to be a strong candidate in its pipeline, but without successful financing, and the dilution that financing will bring with it, coupled with a statistically unlikely FDA approval, that product will never reach market. Investors must consider this before risking their capital. Nevertheless, this all can change if Medidur meets approval and PSDV can rocket back up once again. Those who got in early on this one are still quite happy with 133% gains.
Conclusion
So, with all this said, what does the next year look like for pSivida? I would estimate a range between its current $2.50-2.60 and $3.50-$3.60 between now and at least the end of January. If the advisory meeting between the FDA and Alimera is successful, I imagine the market will forgive pSivida somewhat and there is a chance it could be trading at its pre-October $5 before the end of next year. The focus then, of course, will be on Medidur.
Good volume here today with nice move in PPS. Wonder if there is more going on behind the scenes than we know. The price jumped up after the announcement of the NEJM article, but this spike doesn't seem to be related to that bit of news a few days ago.
Which financing deal fell through?
And how is it that there is no PR regarding this? We only get notice of this from a poster on iHub?
New England Journal of Medicine Publishes Positive Data From Clinical Trial of Novavax' Vaccine Against H7N9 Avian Flu
Data are industry's first from clinical trial of vaccine against A(H7N9) strain of influenza
81% of 5ug adjuvanted vaccine recipients had protective HAI levels
97% of 5ug adjuvanted vaccine recipients had anti-neuraminidase antibody responses
Protective levels achieved from vaccinations within 116 days of the announced outbreak of novel lethal H7N9 virus
Dose-sparing formulation shows significant potential utility in the event of a pandemic
Vaccine safety consistent with previously tested adjuvanted pandemic vaccines
Novavax, Inc. (Nasdaq:NVAX) today announced that positive clinical data for the company's virus-like particle (VLP) vaccine candidate against A(H7N9) influenza were published online in the Correspondence section of The New England Journal of Medicine. The correspondence can be found at: http://www.nejm.org/doi/full/10.1056/NEJMc1313186 and will appear in the December 26, 2013 print edition.
The study, conducted in 284 adult male and female subjects, examined the safety and immunogenicity of two administrations of Novavax' A(H7N9) VLP vaccine candidate on day 0 and day 21. Subjects were administered either placebo, 15 or 45 ?g of vaccine alone, or 5 or 15?g of vaccine with either 30 or 60 ISCO? units of the saponin-based ISCOMATRIX? adjuvant, developed by CSL Limited in Australia. Serology was assessed at Days 0, 21 and 35 post-first immunization.
The Novavax A(H7N9) VLP vaccine candidate was generally well tolerated, and the safety was in line with the company's previous findings with its influenza VLP antigens using ISCOMATRIX? adjuvant. Overall, as with other adjuvanted influenza vaccines, there was an increase in transient local and systemic reactions in the adjuvanted in contrast to the non-adjuvanted formulations, but there were no treatment-related SAEs in the active groups. The A(H7N9) VLP vaccine candidate induced hemagglutination-inhibition (HAI) antibody titers of ?1:40 (seroprotection) and a four-fold HAI antibody rise (serconversion) against H7N9 in 81% of subjects at the 5mg dose of A(H7N9) antigen with 60 ISCO? units of adjuvant, and 73% of subjects receiving 5mg dose of A(H7N9) antigen with either adjuvant dose level. The vaccine also elicited anti-neuraminidase (NA) antibodies against N9 in 92 to 97% of subjects receiving 5mg with either adjuvant dose level.
The A(H7N9) influenza strain has emerged recently as a potential pandemic concern. Less than ten (10) days after the Chinese Health authorities announced an outbreak of this novel avian influenza in humans (137 total confirmed cases, including 45 deaths, to date), Novavax obtained the genetic sequence of the strain and commenced production of a recombinant vaccine. Clinical trial material was manufactured and released in late June 2013 with the first doses injected in humans in early July 2013. Less than four months after the novel A(H7N9) virus had been identified and sequenced, Novavax' H7N9 VLP vaccine, with the higher-dose of ISCOMATRIX? adjuvant, has achieved immune responses likely to be protective in 81% of recipient subjects with as little as 5?g of antigen.
"The production and testing of a vaccine for a novel, lethal influenza virus in such a short time period validates the agility of Novavax' technology in addressing pandemic threats," said Dr. Lou Fries, the company's Vice President of Clinical and Medical Affairs. "The performance of our vaccine candidate is particularly important in light of the speed with which pandemic outbreaks can unfold. Often, an initial outbreak of a novel influenza virus is followed by a more severe and widespread outbreak at the onset of the next fall and winter respiratory virus season, as seen in 2009 with H1N1. Unfortunately, vaccine makers in 2009 were unable to produce vaccine in advance of the second wave and there was little impact of vaccine upon H1N1 disease in the first year. Past H7-based vaccine candidates have been poorly immunogenic and thus could not be advanced as viable vaccine candidates. This risk appears to have been overcome by our H7N9 adjuvanted VLP vaccine."
Stanley C. Erck, President and Chief Executive Officer of Novavax, added, "As evidenced by our correspondence in The New England Journal of Medicine, this is a critical accomplishment for pandemic preparedness. Building on the positive clinical results with our H5N1 VLP vaccine candidate from last October, these recently gathered data from our A(H7N9) influenza vaccine give further confirmation that the Novavax vaccine platform deserves to play a key role in addressing evolving pandemic threats. We have used recombinant VLP technology to demonstrate that timely responses are possible, and we are proud to be the first company to produce a viable H7N9 vaccine. Furthermore, we are pleased that HHS-BARDA has recognized this achievement and asked us to focus our pandemic vaccine development under our HHS-BARDA contract on our H7N9 vaccine candidate."
About H7N9 Avian Flu
Following recognition of the first human infections with avian-origin influenza A(H7N9) and their attendant severity in March 2013, public health officials from around the world called for immediate and preemptive development of surveillance, diagnostic and clinical intervention tools in the event that the A(H7N9) virus becomes transmissible among humans. According to Keiji Fukuda of the WHO, there is high concern over potential for A(H7N9) to gain sustainable person-to-person transmissibility. He noted that over a two-month period in China, as many H7N9 cases occurred as caused by H5N1 cases over 10 years. Additionally, molecular genetic changes occurred, suggesting adaptation of the virus to humans. After a quiescent period during the summer months, four new cases of human A(H7N9) disease have been reported since October 7, prompting concerns and expectations over the virus reemerging in human populations in the coming winter season.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
About ISCOMATRIX? adjuvant
ISCOMATRIX? adjuvant is made from saponin, cholesterol and phospholipid which, under defined conditions, form cage-like structures typically 40-50nm in diameter. The optimized ISCOMATRIX? adjuvant is well defined, has minimal impurities and does not use any materials of animal origin. Additionally, improvements have been made to the manufacturing processes to ensure it can be reproduced on a large scale. ISCOMATRIX? adjuvant is currently manufactured at commercial scale at CSL's facility in Kankakee, Illinois.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012,and Form 10-Q for the period ended June 30, 2013, both filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
CONTACT: Barclay A. Phillips
Senior Vice President, Chief Financial Officer
Novavax, Inc.
240-268-2000
David Schull or Andrea Flynn, Ph.D.
Russo Partners, LLC
212-845-4271
David.schull@russopartnersllc.com
Andrea.flynn@russopartnersllc.com
LOL. yup, too bad nobody holding shares (besides insiders) in it could have sold them, though.
I think it was related to the fact that most people's shares were locked up due to the name change. I wonder if it was just getting run up by insider selling/market makers (and maybe to retail people who saw the stock going up over the past couple of weeks). Now that everyone's shares are starting to clear (mine cleared today), the market is heading back down, more in line to where it started before the name change/CUSIP change.
Not 100% sure about all that, of course, but that was my feeling this whole time that it ran up. I didn't expect the price to stay there that long once shares cleared in people's brokerage accounts. There was no real good reason for it to have gone up with the fact that the EPC report was delayed again and no bonds would be sold this year.
FWIW, this is the PR they put out in August explaining name change:
www.bionitrogen.com/2013/08/28/bionitrogen-corporation-announces-name-change-and-cusip-change/
My second account was updated late last night to show that the shares in that retirement acct were also paid out. Good timing b/c now I can buy some more stocks in the down market.
Just noticed at end of day that my shares in my personal brokerage account got paid out; and now the CVRs are there, too.
The shares in my retirement account have not yet been paid out, but maybe those are coming soon, though.
None of my shares were tendered, so it sounds like those who tendered their shares got paid a lot quicker, which makes sense.
Too bad about your short-term vs. long-term capital gains. To have missed it by that little amount of time is annoying to say the least.
I'm with you, BTW, definitely taking advantage of the down market right now to get more of my fave biotechs. I'll look into the ones you mentioned. After TSRX, my largest holdings are NVAX, PSDV, ARRY, SRPT, and SSH.
I'm in the same boat as you...didn't tender...didn't get paid yet.
I am wondering if the people who tendered their shares are getting paid yet. I contacted one of my brokers and they said it should start getting paid out Oct 2, so I was hoping that now, a week later, I would have gotten mine. I'm assuming people who tendered are getting preference and getting theirs paid out first, but I wish the whole thing would happen quicker. I want to use those funds for other biotechs, which are taking a nosedive right now.
Woops...just noticed that I had a typo in my last post about the price the secondary offering was set at. It was $3.15, but I typed $2.15 on my phone for that post. Sorry about any confusion there.
But, yes, the gov't shutdown could very well be the issue here as people are all de-risking in their stocks right now and could be the reason for the sell-off (including all these biotechs going down yesterday and today). At this point, I didn't expect NVAX to keep dipping as much as it has today already, so I wouldn't venture to guess where it's going to stop from here, but I'm ready to buy more at $2.75 or lower if it gets there.
Good luck, Stockwinner and all longs.
Has anybody who tendered their shares seen their shares paid out yet?
Also, has anybody who DIDN'T tender their shares seen their shares paid out yet?
TIA.
Agree completely. I think it was a great value buy as well.
I'm glad the biotech industry took a nosedive today because I was able to make two more purchases on NVAX and another purchase in ARRY. Not sure what caused the dip on most biotechs today except maybe that they have been hot lately and maybe they're giving some gains, but because I'm planning on holding a handful for quite some time, I'll take advantage of the dips and add more when I can.
Today NVAX went below the price that they just offered the secondary at ($2.15), and I don't think it'll stay down below it too long. If it goes into the $2.75 range for some reason, I'll happily add again.
Not sure why specifically; but it seems there is a blood bath for most biotechs right now.
I picked up some more ARRY and others today because of this.
I think this is more a general biotech effect rather than specific reason for this company b/c as I mentioned, almost all the biotech stocks I track are red by a good amount (only 3 of the 43 biotechs I watch are green).
Also, here's another Seeking Alpha article just out.
This author's belief is more in line with what I believe regarding Iluvien (i.e. 60% chance of approval in the US this time around for Iluvien) vs. the other SA article earlier this morning where that author felt there was a 95% chance of approval and that it would be a "slam dunk." I'm far from believing it's a slam dunk but do feel it's more likely than not.
The article info is below if anyone is interested in reading it.
PSivida: Previewing The Possible Effect On The Stock Of The October 17th PDUFA Date For Iluvien
seekingalpha.com/article/1733322-psivida-previewing-the-possible-effect-on-the-stock-of-the-october-17th-pdufa-date-for-iluvien?source=email_rt_article_readmore&app=1
Disclosure: I am long PSDV. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.
Investment Scenarios: The Positive and Negative Case
pSivida (PSDV) has a very important binary event upcoming on October 17, 2013; this is the PDUFA date for Iluvien, an ocular implant for diabetic macular edema that was licensed to Alimera (ALIM). I cannot answer the question of whether the government shutdown might delay the PDUFA date and if so, how long.
Approval would trigger a $25 million milestone payment to pSivida and potentially could expedite the approval of Medidur as early as 2016. Medidur is an ocular implant that uses the same insert device as Iluvien and the same dose of the same drug. Iluvien is indicated for diabetic macular edema (DME) and Medidur, if approved, would be indicated for the different indication of posterior uveitis; commercial potential may be comparable for these indications. Iluvien's approval could allow pSivida to file an NDA on the basis of a single phase III trial that is now underway. The company has profit sharing rights that provide it roughly 20% of Iluvien's operating profits in the US; this is based on sales minus cost of goods sold and direct selling expenses.
The $25 million milestone payment would put the company in a comfortable cash position with about $41 million on its balance sheet as of year-end 2013. This would be enough to take the company through the possible approval of Medidur in 2016 and might put pSivida in the position of being able to market Medidur in the US entirely on its own. This would dramatically change the business model from a licensing business to a much more attractive specialty pharmaceutical model.
This would also allow pSivida to adequately fund new ocular drug delivery products based on Tethadur. The company's current ocular implants do not degrade once they are implanted in the eye and can only deliver small molecule drugs. Tethadur is based on a new biodegradable technology that can potentially deliver biologics such as Lucentis or Eylea to the back of the eye. If successful, this would be a major technology and commercial advance. Tethadur is in pre-clinical testing and is currently being evaluated for an undisclosed product under a funded evaluation agreement with a leading global biopharmaceutical company.
If Iluvien is approved on October 17th, investors will focus on the potential approval of Medidur in 2016 and the evolution to a specialty pharmaceutical model. I expect a very slow sales ramp for Iluvien in the US, but with time it probably has sales potential of $100 to $200 million of sales, perhaps by 2019. This could result in $15 to $30 million of revenues for pSivida with no offsetting costs. Iluvien has already been approved in Europe and has similar sales prospects in the same timeframe in Europe. Topping off this very positive investment scenario is the significant promise of a new technology, Tethadur.
So far, I have laid out the positive case for pSivida. If this comes to be, I could see a significant move in the stock. Its current fully diluted share count is 31.3 shares if every outstanding option and warrant is included; by GAAP accounting the fully diluted share count is about 27.0 million. Based on 31.3 million shares and the recent price of $4.50, the current market capitalization is $140 million. If the positive case prevails, I think that it could drive market capitalization to $280 to $350 million or $9 to $11 based on valuations of similar companies.
This potential 100% to 150% upside must be weighed against what would likely be s sharp downside move of 40% to 50% in the negative case. There would be no $25 million milestone payment, Medidur would require another phase III trial pushing approval to 2018 and no payments based on Iluvien's US sales could be expected. While there would still be promise for pSivida based on Medidur, Tethadur and European sales of Iluvien, the investment potential would be meaningfully diminished.
So what are the odds of an approval for Iluvien, which has previously received two complete response letters from the FDA? In the last CRL, the FDA asked Alimera to conduct two new phase III trials which would be extremely expensive and could take three to four years to complete. Alimera believed that the information that the FDA needed to approve Iluvien could be provided from the data already compiled for the previous NDA filings. Alimera hired a consulting company to reorganize the NDA paying them $4 million and potentially another $2 million upon approval. Encouragingly, the FDA accepted the refiling and set the October 17th PDUFA date. This along with the previous approval of Iluvien in seven European countries suggests that there is a reasonable chance for approval.
I place the upside as potentially $9 to $13 with Iluvien's approval and $2.25 to $2.50 if it is not approved. I place the odds for approval as better than 60%. The approval by European regulatory agencies indicates to me that there is a persuasive case for approval based on the data in the NDA. I am inclined to think that the format of the initial NDA filing was flawed and with a better presentation of the underlying data that the US may follow Europe in approving Iluvien. I want to caution investors that these are guesses on my part meant to convey magnitude of the potential upside and downside. They convey more precision than is actually the case. Based on this reasoning, I think that the potential upside in the case of approval substantially offsets the downside if Iluvien is rejected.
More Detailed Analysis of pSivida and Alimera
I wrote a more detailed analysis of pSivida and Alimera on May 31, 2013. I would suggest that investors interested in pSivida carefully read that report. This note is only a brief summary and update of that earlier, more in-depth report.
The European Launch of Iluvien Has Been Slow and Disappointing So Far
pSivida receives 20% of net profits of Iluvien in Europe using the same determination previously described for the US; sales minus cost of goods sold minus direct sales expenses on a country by country basis. Iluvien has been approved in seven European countries and has been going through the slow and rigorous process of gaining satisfactory reimbursement in the three major markets: Germany, the UK and France. Work continues on pricing and reimbursement in Italy, Spain, Portugal and Austria. However, Alimera does not currently plan to commercialize Iluvien in those countries until it achieves positive cash flow in Germany, the United Kingdom and France.
Germany is most advanced in terms of commercialization, but progress has been slow. In Germany, reimbursement requires individual negotiations with over 20 health insurers and associations and reimbursement is gained one at a time. Without such approvals, patients must file individual requests to be reimbursed. This is a tedious, slow process. Alimera reported that nearly 90 individual funding requests have been made and of these less than one third of patients have been treated. This has obviously slowed the commercial launch in Germany.
The launch in the UK has been greatly affected by determination of the National Institute for Health and Care Excellence, or NICE, not to recommend Iluvien for DME. However, NICE's Appraisal Committee has since recommended Iluvien for the treatment of pseudophakic patients with chronic DME considered insufficiently responsive to available therapies. Alimera hopes that this will lead to pricing approval in this indication in 4Q, 2013. The Transparency Commission of the French National Health Authority issued a favorable opinion for the reimbursement and hospital listing of Iluvien by the French National Health Insurance. The commercial launch could begin in early 2014.
Iluvien was initially rejected by NICE in the UK as being not cost effective for use in diabetic macular edema, which meant that it would not be reimbursed by the National Health Service, which is responsible for reimbursement for 90% of UK patients. This meant that only private pay patients could be addressed. However, NICE has recently found Iluvien to be cost effective for pseudophakic patients and this opens up a not insignificant opportunity.
Alimera began realizing Iluvien revenues in the second quarter of 2013 from operations in Germany and the UK as 18 units (90% in Germany) were implanted leading to revenues of $179,000. As of the quarterly conference call on August 12th 2013, Iluvien had been used by 14 physicians in the U.K. and Germany to treat a total of 30 patients with chronic diabetic macular edema. Initially patients are treated in one eye, but the company reports that good outcomes have led to some patients being treated in the second eye.
The European uptake has been slower than management expected primarily because of these reimbursement hurdles. Looking ahead, they cautioned that demand could flatten in the 3Q and early 4Q as physicians assess the first patients treated before some upward inflection occurs in late 2013. By that time they hope that most of the reimbursement issues will be behind them. It seems to me that sales will probably be about $1 million in 2013. I would expect some significant improvement in 2014, but I can't give anything more than an outright guess of perhaps $5 to $10 million. I do believe that Iluvien has an important role to play in DME patients who have failed both VEGF and laser therapy and also in pseudophakic patients.
Novavax Initiates Dose-Confirmatory Phase 2 Clinical Trial of its RSV Vaccine Candidate
ih.advfn.com/p.php?pid=nmona&article=59514971&symbol=NVAX
Novavax, Inc. (Nasdaq:NVAX) today announced that enrollment has begun in a Phase 2 dose-confirmatory clinical trial of its respiratory syncytial virus (RSV) vaccine candidate in women of childbearing age.
This randomized, blinded, placebo-controlled Phase 2 study will evaluate the immunogenicity and safety of multiple formulations of Novavax' RSV-F protein nanoparticle vaccine candidate with aluminum phosphate as an adjuvant. The study is scheduled to enroll 720 women of childbearing age who will receive either one or two intramuscular injections at each dose level of vaccine or placebo at days 0 and 28. Immunogenicity and safety will be evaluated over three month and six month periods, respectively.
"This trial represents important progress for our RSV vaccine, which is being developed to protect young infants through maternal immunization," said Gregory Glenn M.D., Senior Vice President and Chief Medical Officer of Novavax. "This study will help define the dose and dose regimen and expand the safety database for our maternal immunization strategy. These are all essential steps in the advancement of this important vaccine towards licensure."
About RSV
RSV is a respiratory pathogen that afflicts all humans regardless of age. In healthy adults, RSV infections are generally mild to moderate in severity, but may be more severe in infants and young children as well as the elderly and adults with underlying chronic cardiac or pulmonary disease. Globally, RSV is a common cause of childhood respiratory infection, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease results in 3.4 million hospital admissions per year globally and disproportionately affects infants below six months of age. It is estimated that between 11,000 to 17,000 elderly and high risk adults die of RSV infection annually in the U.S., with up to 180,000 hospitalizations for serious respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available for either of these populations.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2012,and Form 10-Q for the period ended June 30, 2013, both filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
I do think that it'll be approved this time. I wish more studies or info had been done to show the FDA that the side effect profile isn't as bad as they seem to think. I'm assuming that PSDV really thinks that it'll get approved this time by narrowing the patient population like they did. This is obviously the less expensive route for PSDV just to change the patient population rather than conducting more studies. So for shareholder value, I guess, getting approval this way will be better in the long run. I don't think it's a slam dunk, but I do think it'll get approved.
Take care and good luck.
New Seeking Alpha article out on PSDV.
pSivida Corporation: Strong Takeover Target, October 17th PDUFA Date Make It A Buy
seekingalpha.com/article/1731522-psivida-corporation-strong-takeover-target-october-17th-pdufa-date-make-it-a-buy
Some info is similar to his article he presented earlier:
pSivida Corporation And Trius Therapeutics: Takeover Targets In 2013
seekingalpha.com/article/1505612-psivida-corporation-and-trius-therapeutics-takeover-targets-in-2013
Efficacy didn't outweigh the side effects of increased intraocular pressure in their (FDA) mind. Now PSDV is resubmitting with target population changed to be smaller population and those with more severe disease...the hope being that the drug will be approved now given poor treatment options for that specific patient population and the likelihood that patients and clinicians will tolerate side effect profile because they need something to treat them.
Here is the link to that Jim Cramer segment on ARRY from 9/27/13 you are referencing. FWIW, he also recommended it back in July.
www.millionaireby33.com/2013/09/jim-cramer-array-biopharma-ron-squarer.html
CEMP - Does anybody know what is going on with the share price on CEMP that past 10 trading days? It has been on a nice steady climb w/out significant news (from $8.53-ish to 12.52-ish)? I think the float is pretty small given the small outstanding share count coupled with heavy inside ownership, but does somebody think there is something brewing over there?
TIA
Very nice day today here. I'm still long all my shares, holding out for more because I believe in the company's pipeline. Almost couldn't resist the jump in share price, but didn't cave in to temptation. Maybe this retraces tomorrow, but maybe it keeps running, too. I saw the PR come out last night about the news in UK, and I expected bump in share price this moving but never to this magnitude. Makes me wonder if there is more going on behind the scenes that we aren't privy to...maybe deals/partnerships or something MORE than just running up based on that most recent PR or expectations leading up to PDUFA.
Wow. Wish I was able to buy some more when it dropped for that short period after financials release. I had money tied up elsewhere, though. PSDV looking really strong today!
Is that from Adam at Bionitrogen's IR? If so, that's great news.
Great Reward Must Come With Great Risk? Sunshine Heart May Be An Exception
seekingalpha.com/article/1713232-great-reward-must-come-with-great-risk-sunshine-heart-may-be-an-exception?source=email_rt_article_readmore
Article from Seeking Alpha, link above, text below:
Disclosure: I am long SSH. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Sunshine Heart (SSH) announced a public offering of 3.8M shares at $10.5/share last week. SSH now has about $54.4 million cash after the offering. Given its current cash burn rate at $4.2M per quarter, the company is funded well into late 2016. Currently the intuitional ownership is about 44.2%. After the offering, the institutional ownership could be well above 60%.
The multi-billion market potential of C-pulse has been elaborated upon several times by different SeekingAlpha authors. You may think that such huge potential reward in Sunshine Heart must come with great risk as well. It appears so on surface. Up to today all we have are the data from 20-patient feasibility study. The study is not a randomized trial and has no control arm. How could we, as skeptical biotech investors that have seen so many failures in bio-land, have much faith in the future success of this device? In this article, I will try to make a comprehensive analysis of the clinical risks of C-pulse and you may be surprised that the clinical risks may not be as high as you originally thought.
Efficacy
Although it's a small 20-patient trial, there is little doubt about the efficacy:
Among the responders, 4 Class III improved to Class I, 7 Class III to Class II, and 1 Class IV to Class II;
3 inteterminate patients are those non-complaint with device use < 80%;
0% re-hospitalization rate within first 30 days, 5% at 6 months, and 15% at 12 months. The increase of hospitalization rate was actually due to patient non-compliance;
MLWHF (quality of life score): 100% responder rate at 12 months;
6-minute hall walk: 83% responder rate at 12 months;
Two super responders permanently weaned from C-pulse;
Two additional super responders have been identified for weaning.
Among the above evidences, 4 super responders out of 20 patients are the definitive signal of efficacy. These patients improved so much that they became asymptomatic and returned to all their normal activities in their daily livings. "Patients with chronic heart failure that is severe in nature after many years of development just don't suddenly get well on their own", said Dr. William Abraham, the PI of the feasibility trial and the U.S. pivotal trial, "such dramatic improvement can't be attributable to placebo effects or spontaneous recovery." As the matter of fact, the C-Pulse design is based on proven balloon counter-pulsation technology that has been used in 1960's. The mechanism is well studied and understood. Efficacy is the least thing I worry about among all the clinical risks.
Safety
Now let's turn to safety. C-pulse is not a drug, but a mechanical device. This would make safety analysis a bit easier, as we all know simple physical process usually is more predictable and transparent than chemical reaction. I will try to make a comprehensive list of potential sources of risks and analyze each of them one by one.
1) Risks of implantation operation.
During the feasibility trial, Sunshine Heart improved the implantation procedure by moving from open chest operation, or full sternotomy, to minimally invasive procedure. This minimally invasive procedure only takes 2-3 inches of incision among the ribs and doctors can implant the cuff through the incision. This new procedure shortened the hospital stay and reduced the infection risks. I see little risk involved in the implantation operation. According to Dr. Thoralf Sundt in Mayo Clinic, with today's technology, even the sternotomy incision is generally well tolerated, and patients are surprised a day or two after surgery that they really are not having much discomfort at all from it.
2) Risks of device failure/loss of power.
Although C-pulse is a new device, each of its component has been around for many years. The inflation/deflation is synchronized to the patients ECG, just like a pacemaker. The balloon counter-pulsation technique has been used in intra-aorta way for many decades. These are all mature technologies. Even if C-pulse stop working for some reason, it does not pose any immediate threats to patients, as the device does not replace the heart functions like LVAD device. The device can be turned on/off at will. In my view, C-pulse has a much larger margin for error/failure than LVADs.
3). Risks of infections at exit site.
This risk is real and very common for devices with exit through the skin. 8 patients had infections in the feasibility trial. The company gave very close attention to this issue. After the feasibility trial, they re-designed the device by adding a so-called "C-Patch" that mobilize the tube to reduce or minimize the gap between the tube and the skin when patients pull the tube. They even formed a special committee to oversee this issue. They asked patients to take pictures of the exit site once in a while and send them back to doctors to preempt the potential infections. I believe with such aggressive infection management strategies, this risk can be minimized.
4). Risks of Neurological events
This is actually the strength of C-Pulse. So far there has been zero neurological events recorded that is related to the device. C-Pulse is non-blood contacting and no need for blood thinning medication. All these reduced the risk infection and potentially stroke risk.
5). Risks of aorta damage/disruption
Based on recent interview with the company's CEO, two physicians that took tissue samples from patients right underneath the balloon and the samples 1cm to the right and 1cm to the left. They compare the tissues and found there were no differences. The earliest patients in the feasibility trial have been using the device safely for over 2-3 years. It appears that at least in short term, the cuff and balloon show no sign of damage to the wall of aorta. There has been no long term study of the effect on the aorta. Honestly, the long term aorta safety issue is the only issue I am not highly confident about. But we need to put this issue in the perspective. In the long run, we are all dead. The 5-year mortality rate for Class III/IV heart failure patients is over 50%. These late stage patients are usually very old already. For them, "long term" may be as long as you think. If C-pulse can give them over 5 years' high quality of life with improved heart function, I would say it is well worth the potential "long term" aorta risk.
6) Risks of other unidentified risks?
Maybe. Any MAJOR unidentified risks? I don't think so. Again, this is a mechanical device that just has so many touch points to patients body. It's not like a drug with unknown mechanism of actions.
To summarize, Sunshine Heart offers the best risk/reward ratio that I have not seen in biotech companies for many years. It's critical for investors to understand the clinical risks involved in the device, particularly as we are entering the phase that we will frequently get updates on European Option HF trial from Sunshine Heart. On Oct 28, the company will present initial EU clinical data at TCT conference in San Francisco. Even though this clinical update will probably only cover 4-5 patients, it's still a highly significant catalyst. According to 2nd quarter earning call, Germany reimbursement decision only requires clinical data from 5 patients. If the data are good, the company will very likely get favorable reimbursement decision in Feb 2014. That would mark the official start of the commercialization of C-pulse in Europe.
Caution: Please do your own research before any buy or sell decisions. Use of information and research in the article above is at your own risk. It's always risky to invest in development stage micro-cap biotech companies. SSH is a highly illiquid public company. The share price could be very volatile. Please check the full list of risk factors in the company's annual report.
Novavax: A Vaccine Company On The Rise
seekingalpha.com/article/1713182-novavax-a-vaccine-company-on-the-rise?source=email_rt_article_readmore
Another Seeking Alpha article just out, link above, text below:
Disclosure: I am long NVAX. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Company overview and opportunity
Novavax, Inc. (NVAX) is a clinical-stage biopharmaceutical company that uses recombinant nanoparticle technology to develop vaccines for a wide variety of infectious diseases. The company presently has six vaccine candidates undergoing clinical trials, with a seventh (rabies) being readied for a Phase-1 study later this year. Of the six vaccine candidates in active clinical trials, the most advanced are the Respiratory Syncytial Virus (RSV) and Seasonal Quadrivalent Influenza vaccines, both of which are in advanced Phase 2 trials. Getting down to brass tacks, the RSV vaccine is believed by analysts to be the most important short-term value driver for the company, with Lazard Capital recently placing an eye-popping $11 target on shares of NVAX based on this candidate alone.
To provide some context, RSV is a common virus that infects the lungs and breathing passages. Although healthy adults generally recover within a week's time, the infection can be deadly in infants and elderly patients with compromised immune systems. An effective prophylactic medication (Palivizumab) is presently available for preterm babies born prior to 35 weeks, but there isn't an FDA approved vaccine for any other demographic. Because of the global nature of RSV and the enormity of this unmet medical need, an effective vaccine that treats a wide variety of potential patients could be valued well into the billions.
Analysts are optimistic about Novavax's RSV vaccine candidate for two reasons. Firstly, the potential market for a successful RSV vaccine is easily worth 3-4X times Novavax's current market cap of $490M. Secondly, Novavax has repeatedly announced top-line results from its host of Phase 2 clinical trials aimed at creating a broad-based RSV vaccine.
Fundamental and Technical Perspective
As of June 30th, 2013, the company had $40.6 M in cash and cash equivalents, $30M of which was raised through the sale of common stock between 2011-2013. Yesterday, the company announced that it had raised an additional $82.6 M via a public offering (net proceeds) of > 27 M shares at $3.14, giving the company approximately $120 M in cash and cash equivalents. Because of increased expenses related to the company's advancing clinical trials, Novavax's cash burn rate has increased to approximately $3M a month this year, up $1.4 M compared to the same period in 2012.
Revenue generated from the BARDA contract and the PATH clinical development program came in at $7.4M for the first six months of 2013, which is a 37% decrease in revenue from these agreements year-over-year. To provide some context, the HHS BARDA contract was awarded in 2011 for the development of Novavax's seasonal and pandemic (H5N1) influenza vaccines. At the company's recent investor and analyst update, Novavax announced that the company will move forward with the clinical programs funded through BARDA, which is a major achievement both financially and scientifically for Novavax. Specifically, the continuation of this agreement will provide much needed revenue, and it signals that the company is steadily progressing towards a pivotal Phase III study for its nanoparticle vaccine platform. Overall, the company is now on financially stable footing and should have no reason to raise additional capital through dilutive measures within the next three years.
Shares of NVAX are now up approximately 70% year to date, despite more than 10% of the float still being short. The Relative Strength Index (RSI) stands at 56 at the time of writing this article, suggesting the shares are neither overbought nor oversold. Even so, NVAX is trading 13% higher than its 50 day SMA, and almost 42% higher than its 200 day SMA. From a purely technical perspective, NVAX would appear to be ready for a consolidation phase to form a new base near all-time highs for the stock. As such, I believe now is a good time to begin building a long term position in NVAX.
Conclusions
Companies developing the next generation of vaccines, like Inovio Pharmaceuticals (INO) and Novavax, have unquestionably caught the eye of investors in recent years. While these cutting-edge vaccine makers are certainly not the first companies to try to tackle global pandemics with novel technological approaches, they may be among the first in actually succeeding. Simply put, the technology behind non-protein based vaccines appears to have finally caught up with the hype of the past decade, evinced by the plethora of top-line results emanating from synthetic vaccine makers of late. Within this exciting subsector, I believe Novavax is an intriguing speculative play that could easily double in PPS over the next few months if the company continues to report positive clinical data. Backing this claim, the company currently has enough cash where dilution shouldn't be a major risk factor in the short-term, insiders have bought over 300k shares on the open market in the past 12 months, and the company's market cap is markedly lower than what a successful RSV vaccine would be worth (i.e., billions). In sum, Novavax looks to be a rising star in this up and coming sector, and offers investors an excellent risk-to-reward ratio going forward.
Novavax: Why Investors Are Excited Now
seekingalpha.com/article/1712842-novavax-why-investors-are-excited-now?source=email_rt_article_readmore
Article from the Seeking Alpha link above is copied/pasted below:
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Novavax, Inc. (NVAX) describes itself as a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases.
On Tuesday September 24, Novavax released a lot of information that has investors excited. Novavax has been working to bring its manufacturing platform and production process out of the Phase I and II stage into a process that it considers locked and suitable for Phase III and commercialization. My attempt with this article is to highlight for investors the important data points.
1. Game on
Novavax announced today it is preparing for the next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), for its quadrivalent seasonal influenza vaccine and its pandemic influenza vaccine. This is an important step toward ultimate commercialization and shareholder value.
2. Well financed
Novavax also announced a public offering of $82.6 million in equity priced at $3.14 per share, near its 52-week high of $3.50 per share. It's always a good sign that large investors are willing to pony up so much money despite a stock trading near its high. The PR was vague on details as to the extent this funding will secure Novavax, but the CEO spilled the beans during the Q&A session of the presentation that followed:
We're looking to fund the program in ways that we have our flu program to the extent that we can with non-diluted financing, but it also requires investor participation. This money that we raised is designed to take us into 2016, which will get us a long way on all 3 different programs, and then, we'll see where we go from there.
Looks like investors don't have to worry about any more dilution or capital concerns or anything else financial for quite a while.
3. Possible stockpile purchase coming for Novavax H7N9 vaccine
Novavax's CEO deep in the Q&A session gave a cautionary yet eye-opening response to an analyst question:
It's somewhat difficult to predict the actions of the U.S. government or other governments. But if history prevails, BARDA and the U.S. government have, in the past, stockpiled hundreds of millions of dollars of H5N1 vaccine. They have purchased, as I think Gale pointed out, over $1 billion worth of H1N1 - Lou pointed out the H1N1, and I think that the government does stockpile. Having said that, there is not a stockpile plan in action like this minute for H7N9, but I would be surprised if there weren't at some point.
Over $1 billion in possible orders for just one vaccine for a company excited to have $80 million in financing would likely have investors causing a stampede to get into the stock. As the CEO pointed out there's no such order yet, but he would be surprised if one doesn't come.
Most of the presentation was filled with complex details about the science behind what Novavax is doing. I won't try to bore you with the details. It's the results that are exciting for the investment thesis. Financially, Novavax is very sound with plenty of cash in the bank, its programs moving forward, and it's sitting on a wild card of a possible government order to stockpile one of its vaccines. Investors can now sit back and watch the events and developments unfold, be they positive or negative, attempt to study the science and get an edge if they wish and not have to worry about the funding angle of Novavax. Often funding is a worry that eats up most of the time, research and concern of investors in development-stage biotechs. Novavax investors: worry no more.
I'm holding. Hopefully the financials will be ok, given that they just had a secondary. Either way, it's a small cap biopharm, so I'm not going to go crazy myself about financials and sell my shares that are green now, as I believe in their products. How about you?
Good luck.
Also, this is the link to that small blurb I copied/pasted.
The link in the last post was to the full article.
This is the link to the blurb:
seekingalpha.com/currents/post/1298042
Infinity Pharmaceuticals slides as Hsp90 inhibitor misses in Phase 2 NSCLC study
Infinity Pharmaceuticals' (INFI) Hsp90 inhibitor retaspimycin hydrochloride missed its efficacy endpoints in a Phase 2 non-small cell lung cancer study. That's it for retaspimycin HCl apparently: "The company will not initiate any new trials."INFI will focus on IPI-145 (the PI3K inhibitor) going forward. (PR)INFI -3% premarket. Keep an eye on Synta Pharmaceuticals (SNTA) — ganetespib is an Hsp90 inhibitor.
www.seekingalpha.com/news-article/7676692-infinity-reports-topline-data-from-phase-2-study-of-retaspimycin-hydrochloride-its-hsp90-inhibitor-in-patients-with-non-small-cell-lung-cancer
Wow, rockin and rollin now.
Some large orders earlier seemed to have taken out a lot of limit orders. Now there seems to be blue skies ahead of us.
Looking at all the pre-market activity, the immediate reaction to RNA's failure was very positive for SRPT share price, but then as it sunk in, the reaction turned, as investors realize maybe SRPT's drug will have the same failure.
I'm hoping not...
Prosensa's data was released, which was that they did not meet their Phase III primary end point for their drug drisapersen. It was suspected that very good Prosensa (RNA) Phase III news or very bad Phase III news would be bad for SRPT.
Good RNA PhIII data would be bad for SRPT for the obvious reasons.
Bad RNA PHIII data would cast doubt on axon-skipping technology and the use of dystrophin as a clinical surrogate.
I'm not sure if it "validates" the conversion process, but at least they have a patent so the technology is theirs.
Now that is some good news.
Just saw that PR come out myself.
Very nice news, indeed.
No longer a patent application, but a full-fledged patent.
Congrats!
So if that's the Doral office (assuming the Wauchula office is staying put near the proposed plant site), then a West Palm Beach office is closer but still the commute is approx. 2 hr 50 min vs. 3 hr 30 min. Closer but still not an easy commute. I think the Wauchula office is going to be the main hub for construction, assuming it ever gets going.
Still waiting on uplisting that was supposed to be so easily done in May.
Fast track status and it goes from green to red. Crazy.