This just came out today. It explains why though this week is all about Iluvien, next week will be all about Tethadur. Don't worry longs about how a small microcap gets manipulated before an FDA decision. If you really believe in PSDV's pipeline.....buy more and cost average....and just hold on to your seat.
ZURICH—Roche Holding AG is to invest 800 million Swiss francs ($877 million) in four facilities to boost global production of biologic therapies, underscoring the company’s belief that its future rests in the fast-growing class of drugs.
The Basel-based drug maker said Monday that the investment would be spread across manufacturing sites in Germany, the U.S. and Switzerland over the next five years. The investments, designed to expand the company’s ability to supply biologic therapies, will create an additional 500 jobs world-wide, the company added.
Three facilities in California and Germany already produce Roche’s biologic therapies, complex medicines that are derived from living organisms. The company will add a production site in Basel.
The investment will help solidify Roche’s position as a leader in biologic therapies, which often carry higher margins than conventional medicines and are more difficult to copy when they lose patent protection. Many of the Swiss company’s new products, such as breast cancer treatments Kadcyla and Perjeta, are biologics. The class of treatments accounted for 86% of the 26.783 billion Swiss francs in revenue that Roche’s 10 biggest-selling drugs generated in 2012.
Roche said the investment would support rising demand for biologic medicines that are already on the market, as well as help it develop 39 biologic medicines that are currently in its pipeline.
“Investing 800 million Swiss francs in biologics manufacturing capability underscores Roche’s supremacy in this area of medicine,” Andrew Weiss, an analyst at Vontobel, said in a research note. Mr. Weiss has a buy rating on Roche stock.
Sales of biotechnology products are expected to account for 25% of the world’s pharmaceutical market in 2018, compared with 21% last year, according to data from EvaluatePharma, a health-care industry research company. Roche is set to remain the biggest player, with sales reaching $35.3 billion in 2018 from $26.7 billion in 2012.
Roche’s investment program stands in contrast to many of its peers, which have been slashing jobs and cutting costs amid weakening sales.
You guys don't get it. Retail traders are giving shares away. You should be buying, not selling. I know it's hard to see, but Biologic delivery is what PSDV will be doing going forward. Roche is picking up shares right now, that they won't have to pay handsomely for later.
Regeneron posted upbeat earnings this morning largely due to its blockbuster eye drug Eylea. Lucentis is lagging a bit in sales, which is why I believe Roche is the "Global" pharma looking to PSDV for sustained release of Lucentis. "IF", we can assist Roche in competing with Eylea on efficacy with a 4-6 month sustained delivery of Lucentis (hello, Tethadur).......patients will quickly have a change of heart on which drug they prefer.
Some other quarterly reports this season have given some hints on the performance of Eylea, Regeneron's treatment for age-related vision loss. European marketing partner Bayer (BAYRY) reported last week that its cut of Eylea's sales rose 16% over the second quarter, when it was launched in Europe. RBC Capital Markets analyst Adnan Butt wrote in a research note that the $115 million in Q3 sales topped analysts' consensus of $106 million.
Butt also saw positive signs in Roche's (RHHBY) comments earlier this month about Lucentis, the Eylea rival that Roche co-markets with Novartis (NVS). Roche said Lucentis uptake was strong for its newer indication of diabetic macular edema (DME), and that Roche expects to get competition on this front from Eylea in mid-2014. Butt wrote that this is ahead of his expected timeline for Regeneron's own filing for a DME indication, but that when it does come out its uptake pattern will probably mimic Lucentis'.
The blockbuster launch of Eylea over the last two years has sent Regeneron stock on a bull run that peaked at 319.83 on Sept. 30. In midday trading in the stock market Monday, Regeneron was down 1%, near 283.
These guys are already behind in their trade and very scared. They'll be moving into their cars on Friday morning, low on gas, with a big bill due the broker. Their urgency is represented with caps throughout their messages. Pretty unusual for this board.
Obviously, today's action is about a great technology and company to back it up. I don't get too excited, I've picked up my shares on the dip, like everyone should've done. Happy to see a bit of movement back up. Just mention license deal for Tethadur and we'll be double digits, I'm holding through thick and thin, because the Tethadur platform should take PSDV to very high levels. A license deal will prove it, because the company doing it will be global in it's influence and it's pocketbook.
As Avid Research stated pretty clearly, the pipeline is worth $7.50/sh. Naturally, I agree. When we get data from our CEO regarding Tethadur, we'll then start rockin'. Can you say
"License deal for Billion dollar drugs"? Many longterm longs can.
For all those new to holding PSDV: Just pull up the 5 year folks and take a deep breath. This company trades like this and who knows why, it does at time seem like it is manipulated. But just remember the core PSDV fundamentals are "technology" based. It's never really about earnings, and PSDV has moved a long way from Iluvien in it's evolution. It's most advanced product is Tethadur, not the Iluvien insert. Any acquisition that may or may not be pending will be in large part due to it's Tethadur technology. There have been many days where the stock was $1.35 and no volume in my memory. When it drops on days like this.....just take a deep breath and either believe in the technology or sell. I still buy a little on dips. Good luck.
The FDA will make a decision to approve a drug for which there are no "OTHER" therapies that seem to work. More importantly, the "DATA" supports it, very well I might add. "Chronic" DME does not respond to VEG-F therapy, and the FDA "Adores" Lucentis and Eylea. So, as Balram repeatedly states and I support, Iluvien is a "Second Line" of very effective therapy. The FDA will recognize it and approve it. Then, on a very close side note, Roche will acquire PSDV based on Iluvien's approval. It's price was to be negotiated on such approval; $20 to $24/ share......It's a bargain, not because of Iluvien but because of the very fragile science of biologic delivery, I've preached about it for years...."TETHADUR" Don't sell your shares on the pop, a bigger one will closely follow.
IB, You've got it right. There is 2.5 years worth of data being held in relative secret. Although, Iluvien is PSDV's late stage product, it is "not" their most advanced technology. The stuff happening right now is pure manipulation by market makers, and they faired fairly well today. We do not know of the FDA decision regarding Iluvien, but we do know that PSDV has the Tethadur platform, that has shown to deliver Roches biologic drugs at least 2 months (this already competes with REGN's Eylea). Today's manipulation was frustrating, but PSDV's future will not be dictated by Iluvien, it's just one simple drug for Chronic DME. Look at the bigger picture and trust that when this FDA decision is behind us, we'll have that drug to sell in the US. If they go thumbs down, buy the livin' hell out of the big dip and hold till the end of the year. I do know that we'll soon announce data regarding Tethadur, and it will be huge. I'm sitting on shares with a very low basis, I suggest that you buy them when they are low, if they go any lower. I'm poised to do the same and hold long and strong. We are a huge target for large Pharma, keep the faith and try not to get too twisted if the FDA is dumb enough to screw this up. Don't panic if we see a dip, we will recover for very "BIG" reasons.
Tro, You've been around the longest on this board, that I know of. This company is moving rapidly toward big biologic delivery. The only ones that seem to know about it are today's buyers. It's a bit of short covering, but that stopped long ago. Today's volume indicates to me a big Pharma "FRENZY FEED".
PFE owns 7% of outstanding shares. Look at key statistics in Yahoo finance page/PSDV. Roche is presumed to be a potential buyer due to PSDV's pre-clinical data with Tethadur, showing very strong results in sustained release of Roche drugs; Lucentis, Avastin and the breast cancer drug Herceptin. Sustained release (6 months) and bioerodible formats a very important factor in gaining market share against Eylea(REGN's veg-F) These drugs get injected every month without a sustained release platform.
I'm watching to pick up more shares on a big dip.....but there seems to be support at around $2.50. We're all waiting for news on Tethadur and perhaps some POC/Latanoprost data. News on this level can push the pps much higher. Volume is subtly good for post Iluvien CRL. Remember longs, PSDV has moved so far beyond the Polyimide tubes to deliver a steroid. We're all now waiting for news regarding data on Tethadur, this could possibly be the most widely used platform for sustained release for biologics in medicine. It'll make Iluvien seem trite.
In reading and re-reading the latest transcript of Paul Ashton's words, he obviously is looking forward to license deals with Tethadur. Hopefully, before years end, Dr. Ashton will show some of the cards he's been holding, relative to pre-clinical Tethadur data. To me, this is data long awaited and hopefully worth the wait. If it's as good as I believe it will be, it'll be putting Pharma large and small on notice to get on board:
"We are continuing to invest in collaborations and partnerships as part of our strategy. Even as we move to a specialty pharma model developing our own products. There are several reasons for this. First, collaborations provide us with leverage. It can be preferable for a small company like us to team up with a large potential big pharma partner to take on another big pharma competitor "NO MATTER HOW GOOD OUR TECHNOLOGY MAY BE".
Just got this link from Beverly at PSDV , Investor Relations
10/1/2013] In the absence of either an FY 2014 appropriation or a Continuing Resolution for FDA, beginning on October 1 and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution ("lapse period"), agency operations will be limited to the following:
Emergency work involving the safety of human life or the protection of property;
Criminal law enforcement work; and
Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.
Sure, there's a PDUFA date upcoming. Yes, we'll get 25M upon approval. Yes, it's going to happen, we'll get the 25M. But remember, PSDV is on the threshold of biologic drug delivery. That's how we'll transition into a "specialty pharma", it's not possible without Tethadur. Retail traders are going to make a few bucks here, but if you held for Tethadur data and soon to follow license deals, you'll make a killing. Tethadur is the promise of broad spectrum biologic drug delivery throughout the body in "SUSTAINED RELEASE". So, go ahead RETAILERS.....sell your shares.
You know little about anything going on in this company. It's not about Ilvien, it's about Tethadur. He who possesses this platform delivery system, owns biologic delivery for the next 10 years.
Kelly, Tom has owned a piece of this company for over 7 years. Tro' has owned it a bit longer. I'm a newb at 3 and change and will hold as long as it takes for biosilicon to get into the right hands. It will be a game changer. Tom is so right about the new limited label regarding the FDA decision. The data really does support it's passage and approval. The price fluctuation in this stock has always been puzzling, yet the CEO owns 5% of outstanding shares. The success of this company is his success. If you've done your DD as you say, you should be telling friends about the company. Ninety days from now will be a whole different deal, we long, longs promise you that. Good luck and thanks for bringing a little sanity to the boards.