So we have the Tethadur poster and oral presentation on July 16th. Delivering biologics to make biobetters is a billion dollar gig, to say the least. Then Durasert's ability to deliver TKI's for Wet AMD is showing similar efficacy to the anti Veg-f's...only with a more patient friendly dosing profile. So, let's now hear some Dry AMD preclinical work, my guess it gets announced this year too. There are no approved treatments for Dry AMD. Each of these platforms and indications are billion dollar gigs. I think I'm sticking around for it.
" Research continued in its evaluation of off-patent or soon-to-be off-patent anti-cancer drugs that inhibit VEGF and PDGF to treat wet and dry age-related macular degeneration "
pSivida hasn't missed a primary end point with any clinical trial yet, elevated IOP being the exception . My guess is that should continue and the company valuation will start to reflect their ability to design products around the science of sustained release.
Vero, I think the institutional investors are playing this thing like a fiddle. When they start bailing........you might want to reevaluate. But until then....the retailers are losing money., because they're selling out of fear , and that's the way the tutes like it. Show me another company that has an effective DME drug and then tell me their market cap...Any questions? Just wait ....it's an $8 stock controlled by the tute's who are all in.
Nord, Humira for RA is administered every two weeks with an injection . Should a sustained release version of Humira be available it would obviously be patient friendly and potentially as or more effective. Plus, the big deal is that Abbvie is more able to compete with biosimilars ready to come to market....like Amgen's news today of its biosimilar. So, Abbie competes with a biobetter of its original drug through better delivery. To me, this is the real market value of the Tethadur technology.
Saw that too Alyn. I guess that's what "new science" means. Sometimes it needs tweaking. I sure like the "non-ophthalmic" idea. Expand with partners outside of the eye space. The reason we have little market participation in this company has always been because pSivida had no initial public offering. As IR puts it "we're an orphan company". I'd say not for long with a valuation of 100 Million.
Kool. I think Paul Ashton has mentioned 6 months, which would be huge for ophthalmology. But non ophthalmic applications will be the eventual winner with Tethadur, in my opinion. I still think Humira has a place and look forward to seeing the eventual partnerships when more news comes out.
Looks like the world of biosimilars is officially open. Now, wouldn't these biologics like Humira be even better delivered in pSivida's Tethadur matrix, with injections every couple of months instead of every two weeks? That would be a yes.
Humira, with annual sales of $14 billion, accounts for 60 percent of AbbVie's revenue. Like Amgen's Enbrel and Johnson & Johnson's Remicade, it works by blocking a protein called tumor necrosis factor.
Investors are nervous because Humira's main patent lapses in December, opening the drug up to potential competition from cheaper biosimilars being developed by companies that also include Coherus Biosciences Inc and Germany's Boehringer Ingelheim. But Amgen, which was first to seek U.S. approval, has the inside track to become the first to market.
AbbVie says numerous company patents will stave off introduction of biosimilar forms of Humira until at least 2022, allowing the drug's U.S. sales to continue jumping in the meantime.
Even as Amgen pushes its copy of Humira to market, it is fighting to fend off biosimilar competition for Enbrel. The same FDA advisory panel will decide on Wednesday whether to recommend Novartis AG's cheaper version of the drug, which brings Amgen annual U.S. sales of more than $5 billion.
Great point Alyn. Think about the OA applications in dog hips alone. As a life long Labrador owner, quality of life issues hit them with hip pain by the age of 7. An OA insert might just do the trick to manage pain and improve life quality. Hadn't even thought of that.
Kool, I recall Paul Ashton stating in one of his last calls, that "they would be taking Tethadur into the clinic, sometime this summer". I'll try to pull the call up and nail that statement down.
Good points Pat. The Durasert delivery platform alone can deliver small molecules on a sustained basis for years. So it will be interesting to see who lines up for other tech agreements, to see if their drug might apply to broad treatments. Nobody mentions cancer, but it's possible the Dursert platform might deliver cancer drug small molecules, like TKI's into solid tumors in smaller concentrations, but large for the tumors. Very exciting stuff, but all the while the sp languishes into bio-space no man's land.
OK, let's do the math. The TKI inhibitor pre-clinical work looks great. Enough so that pSivida announced a pending trial based on comparable efficacy to the Anti Vegf's but with longer duration at 6 months. Then, we have the OA gig..with HSS/pSivida and an already filed IND for chronic pain management of the knee using Durasert and an unnamed steroid. Last but not least we have the Tethadur gig for biologics with an as yet unnamed drug or indication. With these things having been mentioned by management, and management rarely says a word about anything, there are 3 IND's with trials pending. Then let's not forget Medidur which has it's insert ready for a partnership in the EU for posterior Uveitis. So am I getting ahead of myself with "FOUR" potential partnerships? It's pretty simple math.
Now, as REGN and/or Roche is watching on the sidelines while one or the other evaluates Tethadur, this company is quietly developing products that will compete with their own products in Eylea and Lucentis, only with a better release profile. The partnerships are coming and my guess is that they won't be $100M companies. Each of these will move the needle fellow investors.
No one is going bankrupt here. Should there be a bankruptcy, Iluvien would revert back to pSivida....and that ain't going to happen; no way no how. Sales of Iluvien are ramping up. Alimera has restructured their debt agreement with Hercules and the coming quarters will show real growth. It's pretty simple. You've lost it Bohn.
Alyn, So, if REGN or Roche are watching carefully, and one of them is in the Tethadur evaluation agreement, so we can assume one is watching closely. This little company is showing early signs of improving the treatment of their billion dollar Wet AMD market. And if Abbvie is jumping into the Uveitis market with Humira....I'd say pSivida is getting noticed with their Durasert platform. Still it's a waiting game. C'mon OA and HSS.
So, I kept wondering....How in the world is Humira....the best selling biologic on the planet....being administered to the eye. So, I contacted Bev at pSivida IR...I got this reply..
Humira it's is administered systemically and has some significant side effects (increased risk of cancer etc).
It has been used off label in uveitis for quite some time (it's expensive, approx $100k/year). It tends to be used by rheumatologist a who sometimes treat uveitis (who are ok with handling these kind is side effects) rather than ophthalmologists (who very rarely are). Ophthalmologists are our audience so I don't think that getting the uveitis label will change prescribing practices at all and I don't see it as a competitor for us.
We all recall Dr. Jaffe of Duke. He's the doc that is doing the ongoing study of 11 diverse patients with Uveitis and Medidur. I also believe he was the Chief Investigator for the first PIII trial of Medidur for Uveitis. Well here he is once again working with Humira for the same indication.
NORTH CHICAGO, Ill., June 30, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. HUMIRA is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for HUMIRA in the United States for immune-mediated diseases.
This month, the European Commission also approved HUMIRA in the European Union for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
"We are pleased to provide patients with the first FDA-approved non-corticosteroid treatment option for certain types of uveitis, an eye disease that can flare and impact vision," said Mike Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "These approvals reflect our ongoing focus on continuing to innovate with HUMIRA to address critical unmet needs of patients living with serious immune-mediated diseases."
"These approvals provide a valuable option for patients experiencing flare and vision impairment associated with this group of inflammatory diseases of the eye," said Glenn J. Jaffe, M.D., Duke University, Durham, N.C. "Data from the robust VISUAL clinical trial program demonstrate the value of HUMIRA as a treatment option for patients with these serious diseases."
Vero, The TKI's are small molecules from what I understand. Avastin is a biologic, which is a large molecule. The Durasert platform carries the small molecules. Anyone else can chime in on this too. Though Avastin was a cancer drug initially.
So, Wet AMD potentially managed with TKI's for 6 Months on one injection? Look's like REGN and Roche will be watching closely....as will all investors. Now, should we get the HSS gig going? I'd call that a milestone too. Looks like the ball might be rolling a bit....and forward I might add.