Bohn, Disagree. Revenues are growing pushing 40% quarter over quarter. At the current stock price, it's a perfect time to cost average. The shorts will cover in next two quarters to more reasonable numbers. Even though there is a concern about cash on hand, there will be ample ways to raise cash with increasing sales vs. dilution.
Kool, Were they not talking about the cancer TKI inhibitors for "dry AMD"? The wet AMD thing has got me puzzled, with a bio-erodible Durasert insert....what small molecule? ......that's different for pSivida. Is Roche or Genentech working with them on the wet AMD , now that the word is out that after 5 years the VEGF's have real limits? Very interesting things coming to light regarding VEGF's and wet AMD. Is it that there is too much dosing? To big a dose? Are they reaching the limits of the VEGF's for wet AMD. The last NIH article that was just posted stated at the end that they are looking for different ways to administer these drugs. Well, that's what I've been wanting to hear for a long time.! GLTA!
Hey pSIvida investors, This scientific paper was presented at this past weeks ARVO conference in Seattle. Why is it important? Because it illustrates these particular facts regarding VEGF therapy for wet AMD: 1.) After 2 years of VEGF therapy 21% of patients start to lose vision due to geographic atrophy. After 5 years, 41% lose vision to geographic atrophy. Here is a copy of the study from the NIH that address these particular points. So, what does this have to do with pSivida? Well, sustained release platforms do not bombard the eye with drug, And now that we know pSivida is working with wet AMD, and pre-clinical work shows similar efficacy to Eylea in treating wet AMD, we can hope that a sustained release platform delivers a more appropriate dosage to alleviate some of the catastrophic atrophy associated with heavy dosing........read on and chime in.
The Comparison of AMD Treatments Trials (CATT) began in 2008 and was designed to compare the anti-VEGF drugs Avastin and Lucentis. VEGF is important in the growth and development of new blood vessels in normal and cancerous tissues. Avastin* (bevacizumab) was approved by the Food and Drug Administration in 2004 for the treatment of metastatic colon cancer. Other drugs were later developed specifically to target blood vessels in the retina, with Lucentis (ranibizumab) coming to the market in 2006 and Eylea (aflibercept) in 2011. For treating AMD, the drugs are injected into the eye. Before Lucentis was available, many ophthalmologists began treating the disease with Avastin, which appeared to have similar benefits, at least in the short-term. The difference in the cost of the drugs also made Avastin appealing; the approximate per-dose price was $50 for Avastin and $2000 for Lucentis.
In the trial, more than 1200 participants with neovascular AMD were randomly assigned to receive either Lucentis or Avastin for two years, through monthly or as-needed injections. During that time, the two drugs were equally effective at preserving visual acuity. These results were later confirmed in five multicenter clinical trials around the world.
The current study followed up with CATT participants between March 2014 and 2015, an average of 5.5 years after enrollment in the trial. After two years on their assigned drug, participants were free to work with their eye care providers to choose their own course of therapy. During that 3.5-year period, more than half received at least one treatment with a drug or therapy other than the drug assigned to them. The investigators obtained visual acuity measurements for 647 of 914 participants who were still living.
In addition to the overall effects of anti-VEGF therapy at five years, the investigators compared the outcomes of participants who received Avastin or Lucentis during the trial.
“Some experts had speculated that two years of treatment with ranibizumab might have long-term benefits superior to bevacizumab. However, at five years, there were no differences in visual acuity between the two drugs,” said Daniel F. Martin, M.D., chair of the Cleveland Clinic Cole Eye Institute and CATT study chair.
The study also found that after five years, participants assigned to Lucentis during the trial had a higher rate of strokes and heart attacks (7.6 percent) than those assigned to Avastin (4.5 percent). Since most participants received treatments other than their assigned drug after the two year-trial, the investigators are cautious about attributing this difference to the study drugs.
Finally, the study provides information on the general course of AMD with treatment. It was already known that many people with neovascular AMD eventually develop geographic atrophy, which has no treatment. In the trial, participants were more likely to develop geographic atrophy when they received monthly, rather than as-needed injections of Avastin or Lucentis. After the trial, almost all participants stopped monthly injections in favor of as-needed treatment, with an average of 4-5 injections per year. By five years, the rate of geographic atrophy increased from 20 percent of participants at two years to 41 percent at five years. The fraction of participants with geographic atrophy was similar between the Avastin and Lucentis groups.
“Although anti-VEGF treatment has greatly improved the prognosis for patients overall, we still need to find ways to avoid poor vision in these patients and to decrease the burden of ongoing treatment,” said Maureen G. Maguire, Ph.D., the study’s principal investigator and a professor of ophthalmology in the Perelman School of Medicine at the University of Pennsylvania in Philadelphia.
You and your 5 alias portfolio need therapy. Get help. What you think you might be accomplishing.......isn't working.
You'll have to give the CC a listen. Paul Ashton was very careful to say that some pre-clinical work was showing that "a small molecule" on a bio-erodible Durasert platform was showing similar efficacy to Eylea.on the long acting platform. And, let's think back about the latest Durasert Evaluation agreement with a "global pharma in ophthalmology". Could it be that this Pharma was pursuing a long term solution for "wet AMD'', that not only doesn't work for half of the patients, but needs to be administered every 6-8 weeks? Ashton was careful to mention in past CC's that Dry AMD is going to be pSivida's pursuit. So, now we hear about a "Wet AMD" gig? I say it's the big Pharma evaluation agreement that's driving the interest here. Eylea is huge for REGN. But for almost half the patients that receive it, it is ineffective. And over time Eylea and the other veg-f's show diminished efficacy over time. Well.....this is what sustained release of micrograms (millionth of a gram) of a drug is all about. And this is why this pSivida will be nicely positioned going forward.
Not a bad thought either. Just thought is was odd that OPHT SP was stout at $44/sh. as it loses 3 bucks a share per year.
OPHT has a MC of 1.5 Billion and loses 3 bucks a share per year, vs. 60 cent loss for pSivida. However, with 34 M shares outstanding for PSDV, I'd say Medidur and Iluvien will turn this one profitable first.
Just look at the two companies and how their MC's differ. Which company has more upside? Just curious.
Here's a look at OPHT's profile:
Ophthotech Corporation, a biopharmaceutical company, develops novel therapeutics to treat diseases of the back of the eye. Its principal product candidate, Fovista, an anti-platelet derived growth factor, is in Phase III clinical development for use in combination with anti-vascular endothelial growth factor drugs for the treatment of wet age-related macular degeneration (AMD). The company is also developing Zimura, an inhibitor of complement factor C5, for the treatment of dry AMD and wet AMD. Ophthotech Corporation was founded in 2007 and is headquartered in New York, New York.
Interesting points JD. But I think each and every indication out there may benefit from sustained release drugs. pSivida has made a very clear point to distance itself from the Iluvien and Alimera issues. This is not to say that Iluvien won't play a big role in revenue going forward, it will. But should Tethadur be the golden egg that I think it will, there is little chance that pSivida will group the technologies in any one deal or for any one big pharma.....this naturally changes if pSIvida is acquired...and it's still on the table. Tethadur needs to go into the clinic and fast, with a stated partner and drug (Abbvie's Humira) perhaps then the big boys take notice.
I know it's been tough for all of us watching the bio's get hammered; especially pSivida always being ignored and undervalued. However, it seems as though many on this MB are still around hoping our day , and pSivida's will come for all the recognized reasons. GL
That's annually too Kool and 30K going blind from the disease. With no approved drug (other than Retisert) pSivida will have a really big advantage in the space. It really will be an attractive gig for a partner. Even if there a pretty good split, pSivida stands in a good spot here. It just seems that EU approval comes before a partnership will be announced.
I didn't think we'd hear any news prior to the upcoming call. This shows some idea of how the EU will handle
the Medidur insert prior to approval. All things point to just that. Now, if the FDA would pull its head out and let pSivida file for an NDA on one very good PIII study. GL to all.
I noticed "strong sell" on your sentiment. Really? Naturally, I did read the Stonegate coverage, I own ALIM; underwater there too. I'm confident that both of these company's will grow and excel. We wll however have to wait until they are ready to announce; partnerships, IND's NDA's and milestones. Until then, we hope and pray......and wait.
I know......our catalysts are coming. It just seems we've waited years for
any news that might be just around the corner. If I knew then what I know now
I'd still own the company, but I'd own perhaps a bit less. I look forward to
taking this statement back. With 34M shares outstanding, there are no anxious
owners "running for the doors". Comforting? maybe.
Makes us all scratch our heads and wonder.......Are we starting our comeback from the oversold pharma
hangover? Not getting too excited, but the ride continues. Now, let's hear from the FDA about the stellar Uveitis data and let's move this company into the well deserved category.
I've been interested in the M&A discussion of Allergan and PFE. Obviously, the US is not going to let the
mergers of the US Big Pharmas continue , by allowing them to move to some other country in a merger. We'll see.....Many pSivida longs know the value of PSDV is huge should big pharma acquire and then accelerate the pSivida pipeline; Durasert and Tethadur. Time will tell and by years end with Tethadur going into the clinic, it may be time to see someone like Allergan show some interest. After all, the Uveitis drug of pSivida's is just the tip of the Iceberg. Ozurdex will lose most of its market share for the indication, to pSivida. Worth a watch.
There are many fascinating story lines in biotech and pharma as both sectors start to recover from deep bear market declines. Some of the more interesting ones involve Ireland-based drug giant Allergan (AGN). Earlier this month, on the third try, the Treasury Department successfully bypassed Congress to rewrite the rules to combat "tax inversion," an issue much in the headlines this election year. This finally made Pfizer(PFE) and Allergan realize they were playing against a stacked deck and call off their $150 billion merger.
The thwarted tie-up obviously put a large monkey wrench in Allergan's plans, but I also expect it to result in a plethora of smaller deals that could help perk up tepid M&A activity in these sectors. Allergan -- a holding in Action Alerts PLUS -- has already made a few smaller moves and I expect it to be very active once the $40 billion sale of its generic business to Teva Pharmaceutical (TEVA) is completed. Allergan should receive about $33 billion in cash and just south of $7 billion in Teva stock, greatly bolstering its balance sheet and allowing it to hunt for some smaller fish. The transaction will also likely boost its stock price once official approval is given, seeing how many deals regulators have foiled lately.
Meanwhile, Valeant Pharmaceuticals (VRX) has brought in investment bankers to look at strategic divestures the company could make to pay down its $30 billion debt load, and I would expect Allergan to take a close look at some those potential asset sales. Allergan could be particularly interested in some of Valeant's gastrointestinal product lines if they are put on the block.
One of these Valeant assets is the marketing and distribution rights to a compound called Relistor, which is a treatment for opioid-induced constipation and chronic non-cancer pain. The drug has shown solid initial growth. Earlier this month, the PDUFA (Prescription Drug User Fee Act) for the oral version of Relistor was pushed back 90 days mainly due to the Valeant "overhang." However, it is very likely to be approved in July and should do much larger sales than the injectable version of the compound already on the market. The two versions of the drug could eventually hit peak sales of more than $1 billion, making it a potentially good strategic pick-up.
No worries Vero. All day trading below 30K. I wouldn't jump to conclusions about the FDA either. The Medidur data for the first PIII should be in for the whole year now. March marked the point where all patients in the first PIII have a year with the insert. That means additional full year data is now being evaluated. From what it appears, Medidur for Uveitis gets better with time. If the FDA snubs this data, the whole system is *&^%