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Today gonna be intresting snup.
There is this guy on stocktwits with crazy info about the investigation of that orchestraded short attack 2 weeks back
David Cohn,John Zaro III,Adam Feurstein and one other person who will be known here shortly make up,"The Inner Circle"...The conversation between Adam feuerstein and the Author of the short report "Art Doyle" will be published and has already been forwarded to The District Attorney,SEC as well as his current employer..."Biotechhack"is the only one left who's identity is unknown
A group of 40 individuals had omeros in a basket of short positions for 1 1/2 year but got surprised by the breaktrough therapy designation news and turned to a more agressive way to bring it down.
Join stocktwits, lot more info posted last night, read it dor yourself, gonna be a fun week
thought I had the short term lows,
ouch, better keep my day hobbies :-}
no hurrys, no worries
omer easy double if one has patience.
snupDAWGoled
Thanks Thorfin, we dodged one not chasing cara...omer runup from just under 15 to just over 27 came back to right at the big fibonacci at 19.70 where all the hammering could not break it..now we need to break this downtrend tomorrow and head up...understand Doyle article has been removed...
You forgot the most important part, that this 15yo girl was dying because threatment with soliris,omeros only competition, failed to do so. Not only did oms721 saved her life but i believe she is also of dialyse now after beeing threated further under compasionate use
snupoled - one patient was dying too sick for kidney transplant and 721 use recovers enuogh for transplant, success and life saved ! Ask him if it works....we need to brosdcast that one fact loudly plus breaktrough from FDA is data based and much harder to get, another important fact needed to be broadcast...
1h,
I have , thanks for posting insights,
I also read company disturbed by a short seller, and
raising awareness etc. so hopefully bottom is in.
omer I think should double fairly quickly, [ years time or
less}
snup
Should work Snup ! congrats...I had minor low due today on market so we should pick up next week pretty strong signs bottom in for omer if you read my few posts past few days.
bought 2500 omer today
hopefully hold for a year, anticipating
a double.
Snup
SPHS upcoming like this one check it out.
Dr. Thorfin -omer gift from financial gods today as I finally found there was one of those ignorant hit pieces out and it hit near 19 on big volume bar and turned up there...lucky for me i go in gradual and had way out feb 30's so got to pile into some aug and more feb even 25's here !!! what a gift...omer is not like the little biotechs these guys hit...it has approved product growing sales fast now and I know science and as you do the kidney breakthough from FDA is real, they can't lie about that stuff so shorts should get cooked pretty fast when people realize why it dropped...and shoot normal fibonacci .618 of 12.20 runup was at 19.75 area so pretty normal correction anyway but without the bloggers horsefeathers probably would not have come under .382 to 1/2 before heading back up..nice to know ahead of time there are idiots that will pick on this one after big runups.
dr thorfin, we think alike. I amost grabbed cara options when it stirred up some about 19 but didn't then the huge opiad drug article nationally like you noted gapped it up about 3 which i hated because not chasing it...
Thank goodness for a stop loss.
Sold 1/2 my shares yesterday at 24.
Crazy stock
Thanks. I agree and it will provide $74 million when they exercise.
finally getting a correction now and I am adding back some now.
I'm not an expert on share structure, but Employees will have one year to exercise shares of omeros at around 20 buck, when price keep climbing it will be a nice bonus for their hard work, they are worth it. Exercised shares will be counted into the float
It is imo a great way to show respect to the ones that make omeros the company its becoming today and in same time fund pipeline. Getting employees involved in the finaceial side of the company will get them even more stoked.
Been thinking its gonna stabilize for a few days now,but this bull just keeps going
Still undervalued by 200% imo
Dr. Thorfin, think I mixed up the s-8 with the s-3...s-3 would be to sell stock to public but S-8 is for use for employees like options I guess to exercise no Higher than 20.69 so if this is correct that is pretty bullish long term...
dr. Thorfin, They filed an S-8 to sell 3.6 million shares at not OVER 20.69 to raise $74,400,000. But no announcement yet...can you tell me about the S-8? That does not mean they have placed that size privately and are reporting it does it? that would be very bullish to me but I assume it is what is called a shelf filing meaning they can execute that at any time up to a year or whatever time limit is if there is one....can you update me on that? Thanks!
Doc thorfin - looks like they filed to sell some stock.. 3.6 million shares at no MORE than 20.69 for $74 million
when I wore a young man's clothes one would say
hub ba hub ba HUB BAAAA when an attractive female walked by
OMer has had Quite the move in the past few months
congrats to all who held! it really feels like she is just
getting started, if all goes well this easily could be above
50-bucks by years end.
Hub BA HUB BA Hubb BBAAAA
snup
When fda rule it has to be bundeled with surgery there is a chance omidria becomes standard, profit may be less, but number of clients can go up 50fold
Oh yeah, i am a much a doctor as Dr Dre is one
Lol
Just been investing in pharma for over 15 years
Gltu
Thanks again Dr. Thorfin....both NASDAQ and two other sources, one was fidelity research link, all three show as of Dec. 2016 he was at 1.800,000 million shares...so thanks for your direct link...since it lists he CONTROLS the 3,825,000 shares then he must have about 2,000,000 in family trust or something...so great DD. Also, I was asking you if you have any insight into the fact they are billing for eye product separately til Dec 31 but have applied to continue that way Jan 1, 2018 going forward and may hear soon ?! My understanding is the fda can rule it is to be bundled with surgery and would cut revenue significantly - like 40% = maybe even half..as doctor does your experience include any of that billing detail?
Ceo owns 3.825.000 shares or 8,4% of the company
Big reason to NOT dilute
https://www.sec.gov/Archives/edgar/data/1285819/000119312517043752/d335669dsc13ga.htm
I think old short from 14 level getting out but new ones at 23 getting in, so maiby short numbers are the same. Hope they are up, the higher , the better
Thanks doc...assume short interest off but June 15 figures not out yet...
Maiby they already made sweet deal with euro partner, waiting on milestone payment to make the announcement? Or they have a few more aces up their sleeves and wait till it reached 50 to dilute a mil.
We can only guess what they know.
And for buyout, I believe it was in Q2 or 3 2016 earnings call ceo stated he want to make from omeros the biggest pharma out there , and he believed he can do it allone. Not selling for 5 billion when he can turn it in a 100billion dollar company
Today alxn presents at JPM conference, sure competition from omeros will be mentioned, to have 1 whale like morgan start buying shares would be realy bullish,at this price its easy for them to buy 5 to 10 mil shares, their fleet of followers would gobble up the rest , and those 9 mil shorts will provide some animation
Dr. Thorfin, presently I believe they are paid separately for the eye product until Dec 31 this year. They expect to get approved for J code (or is it C code for medicare) to continue that way and I saw something about them hearing that decision soon?! which if positive should at least add a point or two but if the FDA rules against that and it has to be bundled in with the surgery then it could cut revenue by a lot, even maybe 40%. With politics on costs what it is I will be glad when we know that decision is out in our favor..also,
while I get the math on no secondary it does make me a bit concerned that sometimes with this kind of jump they just HAVE to take advantage of it and raise some amount as smallish amount should not dilute much. Personally I would want to if in their shoes...to take advantage of this run they will need to do it soon UNLESS they know pretty immediate news will be out like EU partner....interesting to see. Also, REALLY want your opinion on buyout possiblities too doc. Thanks !
doc, home stretch time 3:30 failed twice at 24.80 resistance and had perfect breakout pullback to just under the 24.40-24.50 resistance first half of day so three pullback lows at 24.35 on 11,000 volume 5 minute bar, then 24.41 on 9,000 volume bar and then 24.45 on 13,000 bar so three ascending lows and best sign so far is extreme volume shrinkage on pullbacks....would love to see it blow to or through 25 on close and gap up tomorrow for new daily breakout which would imply 27-29 quickly....if we fail and break back off late then as long as we hold 24 area tomorrow we will set up an ascending triangle on the DAILY basis like we did on the 5 minute chart today but it has larger target implications on the daily of course...
doc - sorry on typo, that was apple of course not apply !
Doc, while I was typing a while ago the omer broke out to the upside so put up a bar chart with a bar every 5 minutes just for the fun of it - We are both long term but it is fun to watch it work on even very short term techicals to me anyway....in fact when it started moving from 15 towards 16 on way to 17 on pickup in volume = and I know context which helps greatly often = when market was weak with apply off 7 and 5 and google over 30 down two days also and biotechs weak this was swimming opposite direction and allowed me to grab a bunch extra because it was clear somebody knew something great was to be out soon....mainly doc look at volume on five minute chart when it just broke out above 24.50..so now we challenge 24.80-25 between now and close...
Doc Thorfin...Thanks for reply and stock as of about 1 pm est has a short term ascending triangle on just the daily chart which is not a certainty but great majority of time will break to upside ---with three highs at the 24.50 level so it has to break through and challenge 25 high or break daily uptrend and correct back some...question....Bret Jensen has been extremely bullish since way back at 5-7 area and put out an extremely bullish update a few weeks back when it was consolidating between about 15-17. He also has stated he believes it will be bought out before yearend...along those lines doc with all the medical evidence you kindly shared and I too knew about the eye and kidney part alone to be worth over 100 if they don't share part of it ----I don't see how a number of big pharmas are not drooling over this soon and one or more will make offers? Or do you think they will stick with offering partnerships?
I know its 5% , 10% is the total shares held by insiders
Saw it when re-reading message
About options,,,,,
Zero undertanding of that
Cant help you
Lots of bullish info posted on stocktwits this evening
Doc Thorfin, Thanks! I agree on your assessments basically....in my question to you Sat. morning I estimated market for first kidney disease in clinical now should put market cap to 6 or 7 times the 24 price or over 100 on that alone plus eye product sales for this year....I do show ceo with just under 2 million shares which would be near 5% instead of 10%...am I off on his amount or total shares out? ....it makes no difference to your point he would not want to dilute but I just like to have my facts in line...since we knew the kidney clinical worked it was just a matter of time and breaktrough gets us off and running again..thanks for your insights on all the medical potentials you understand so well....keep up the great work...oh, did see where four more officers or directors filed with sec friday and looks to me like they each exercised options to buy 10,000 shares each but at 23.75 which I don't get since they don't expire until next year..am I reading that wrong on sec forms...maybe it just was awarding them the options at this price but I don't think so..anybody help on what they did? thanks
And the 2 billion from soliris (ahus) is just topping , Igan is an easy double on that number, no real approved therapy and 5 billion potential, Igan,Ahus and omidria potential is close to 8 billion comming to market between now and same time next year
The 23 dollar pps right now is still cheap , add to that the rest of the pipelines potential and its dirt. dirt cheap
About dilution,Ceo owns close to 10% of this company, he will do everything it takes to minimalize diluting his own stake, they will announce Euro partner for Omidria real soon so that will bring in extra cash and vallue to our shares, they now have 20mil in cash and another 25 mil in august, that and growing omidria sales is enough to fund pipeline another year
AHUS and Igan are no large scale phase 3's
Maiby 40 patients or so due to rare disease,the U.S.,Euro and Asia market value for IgA nephropathy is +$5B
At the ERA-EDTA meeting in Mardrid last week European & Asian institutions asked Omeros to participate in the phase 3 trial, so worldwide partnerships are already beeing forged. Next in pipeline is Immunotherapy and their addiction program, if they , in time , need to dilute for those it would be few 100k shares,They don't need that much. OMS527 would be phase 1. Those are cheap. And by then price could be 50 to 75
After phase 1 revenue will be sufficient to fund the rest of the trials
Yesterday was a shareholders meeting, not a CC , so imo no transcripts or replay
Over 90% of the outstanding shares were represented at the meeting
Quote from someone who was there
"Meeting was insanely positive. FDA basically begged them to go fast track for IGAN. Also, removed criteria that would make it take 2-3yrs for drug to market. Could be on market in a year. With 150k potential patients in US, cost of 70-100k per patient annually. Addiction drug potential unreal. Would be largest drug ever to come to market, 1-2 years aways from trials. 906 for arthritis scaling up for clinical trials. DR D believes recognition of OMER only beginning, wanted to be biggest pharma out of NW ever, thinks that now is conservative."
We also reached $1B market cap, the minimum m. Cap for some large institutions before they start buying,also 20% still shorted, if price continue to climb we will see a few squeezes in the proces
So to scale things up,2 five billion dollar products about to be launched between year end and half 2018 , start of Immunotherapy and 906 trials very soon and start trials for the MASSIVE OMS527 next year will make this a multi year runner
Addiction drug potential is beyond believe,Would be largest drug ever to come to market, pre trials were promising
$1000 company within 5 year
Sorry for the gramatical errors, i'm flemmish
Gltu
Doc, Looks they will need capital raise on this surge since they do not seem interested in partnerships and noticed a VP sold stock this week at about 19 and 23 in some size - think I figured he held about 25% of what he exercised on options at aroung 9 and 11. They do have access I believe to 25 million they can bring in before sometime in August...missed conference call and replay not up yet so do you have any insights into a capital raise?
Looks to me that they should get 2 billion or more of Soliris present 3 billion sales and with a billion market cap it about values ratio of sales on the eye product...so even 3 or 4 times the 2 billion should allow for a six to eight times run of the 24 unless they partner and give some up or dilute...your opinion please on this...thanks
Hey, almost $1800 profit on the first 10 calls, and decided to wait until
Friday for the other 10. Could see another $5 grand on a $150 gamble.
The one thing I didn't really think about was the possible short covering that's been happening. It's all good
--------------------
sorry I cost you more coin, hoping you didn't need it?
nailing it down however was safe way to go, your other half
is a wow!
beats a cd 10year cd :--]
Thanks, got lucky fda is on their side
$20 still a bargain few months from now
Congrats and nice play on OMER. You have nailed this stock for quite awhile now. Solid DD throughout.
Underdog,
sorry I cost you more coin, hoping you didn't need it?
nailing it down however was safe way to go, your other half
is a wow!
beats a cd 10year cd :--]
are you still in school? best to you!
snup
Doc,
that you did!
wow, omer is red hot good healthy volume [buys]
snup
Gave eltp longs the tip when it was @8
They ridiculed me and deleted my posts
Tried a few more times around 9 and 11 but got angry pm's
Just tried to help them recoup some cash
Hope sequestOX is a succes one day
For us and them both
Gltu
underdog,
Why not ? Good for you! that was fast coin!
snup
I sold 10 contracts at $1.80 for an $1800 profit a few minutes ago.
I'll hold the last 10 to see if this closes above $20 by Friday.
Doc,
should have had your vision! you handed it to me and I settled
for pizza and beer monies,
oh well, from the little I know I see this above 60 bucks
in a few years so getting funds that I can sink into it
I will.
snup
Hold until chart says waaay overbought, then maiby i flip 50% but hold until a few of the 721 indications are approved few years from now
Bought 18k at 8.2
Sold at 13 and rebought at 10
Under,
I say lock it down .
but
stock itself a couple of years out could very well be
70 bucks a share! this is one to buy and hide away if you
can!
I need to take my own advise as I let this one get away
but long term look, it really wont matter.
nail it down, quick cash esp. since your not talking a lot
but profit is profit a couple of bucks for the news paper too
thus this is my advise.
snup
$$OMER$$
FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor OMS721 for the Treatment of IgA Nephropathy
BOOM 8 MILL SHORT POSTION COULD GET EXCITING
https://www.otcmarkets.com/stock/OMER/news
FDA Grants Breakthrough Therapy Designation to Omeros’ MASP-2 Inhibitor OMS721 for the Treatment of IgA Nephropathy
- Omeros’ Second Phase 3 Clinical Program for OMS721 Slated to Begin this Year -
SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (NASDAQ: OMER) today announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
Breakthrough therapy designation was granted based on data from Omeros’ Phase 2 clinical trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases. The data were recently presented at the 54th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Madrid. Proteinuria is an important marker for disease progression in patients with IgA nephropathy, and improvement in proteinuria is associated with improved clinical outcomes. The clinical trial data show unprecedented improvement in proteinuria following only 12 weeks of OMS721 treatment, with a 77-percent mean reduction in urine albumin-to-creatinine ratios (p = 0.026) and a 73-percent mean reduction in 24-hour urine protein levels (p = 0.013). In response, many physicians attending ERA-EDTA in Madrid and representing centers across Europe, the U.S. and Asia that manage large numbers of IgA nephropathy patients asked to participate in Omeros’ planned Phase 3 clinical trial. These physicians have been added to the ongoing clinical site evaluation for the Phase 3 clinical program.
FDA’s breakthrough therapy designation enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease. Preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies is required. Benefits of breakthrough therapy designation include the eligibility for priority review of the application and rolling submission of portions of the application. FDA personnel, including senior management, provide guidance to the company to determine the most efficient route to approval. OMS721 is the only drug candidate in development for the treatment of IgA nephropathy that has been granted breakthrough therapy designation by FDA.
“We are pleased that FDA has granted breakthrough designation to OMS721 for IgA nephropathy and appreciate the Agency’s recognition of the potential importance of OMS721 in the treatment of this disease,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “OMS721 appears to be helping IgA nephropathy patients with a rapidity and magnitude not previously seen with any other therapy, and we look forward to working closely with the FDA to accelerate its development.”
There is no approved treatment for IgA nephropathy. The most common primary glomerulopathy globally, it accounts for up to 10 percent of all dialysis patients. In the U.S. alone, an estimated 120,000 to 180,000 patients have this disease. Approximately 40 percent of IgA nephropathy patients develop end-stage renal disease, a life-threatening condition, within 20 to 30 years following diagnosis.
OMS721 is also being evaluated in a Phase 3 clinical program for atypical hemolytic uremic syndrome and in a Phase 2 clinical program for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
About Omeros’ MASP Programs
Omeros controls the worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a novel pro-inflammatory protein target involved in activation of the complement system, which is an important component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage or microbial infection. MASP-2 is the effector enzyme of the lectin pathway, one of the principal complement activation pathways. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, which is a critical component of the acquired immune response to infection, and its abnormal function is associated with a wide range of autoimmune disorders. MASP-2 is generated by the liver and is then released into circulation. Adult humans who are genetically deficient in one of the proteins that activate MASP-2 do not appear to be detrimentally affected by the deficiency. OMS721 is Omeros’ lead human MASP-2 antibody.
Following discussions with both the FDA and the European Medicines Agency, a Phase 3 program for OMS721 in atypical hemolytic uremic syndrome (aHUS) is in progress. Also, two Phase 2 trials are ongoing. One is evaluating OMS721 in glomerulonephropathies, which has generated positive data in patients with immunoglobulin A (IgA) nephropathy and with lupus nephritis; the other has reported positive data both in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TMA) and in those with aHUS. One or more additional OMS721 Phase 3 clinical programs are planned to initiate this year in IgA nephropathy and in stem cell transplant-associated TMA. OMS721 can be administered intravenously, and Omeros also expects to commercialize OMS721 for one or more therapeutic indications as a subcutaneous injection. In parallel, Omeros is developing small-molecule inhibitors of MASP-2. Based on requests from treating physicians, Omeros has established a compassionate-use program for OMS721, which is active in both the U.S. and Europe. The FDA has granted OMS721 breakthrough therapy designation for IgA nephropathy, orphan drug status for the prevention (inhibition) of complement-mediated TMAs and fast track designation for the treatment of patients with aHUS.
Omeros also has identified MASP-3 as responsible for the conversion of pro-factor D to factor D and as a critical activator of the human complement system’s alternative pathway. The alternative pathway is linked to a wide range of immune-related disorders. In addition to its lectin pathway inhibitors, the company is advancing its development of antibodies and small-molecule inhibitors against MASP-3 to block activation of the alternative pathway. Omeros is preparing to initiate manufacturing scale-up of its MASP-3 antibodies in advance of clinical trials.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Part of its proprietary PharmacoSurgery® platform, the company’s first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a proprietary G protein-coupled receptor (GPCR) platform and controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, risks associated with product commercialization and commercial operations, unproven preclinical and clinical development activities, regulatory oversight, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2017. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
http://cts.businesswire.com/ct/CT?id=bwnews&sty=20170613005978r1&sid=acqr7&distro=nx&lang=en
View source version on businesswire.com: http://www.businesswire.com/news/home/20170613005978/en/
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations
360.668.3701
jennifer@cwcomm.org
Source: Omeros Corporation
Doc,
congrats! Do you take a few off the table? or is it
a long term hold? Your in sub 7 ? and 9 range?
snup
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http://www.omeros.com/
http://finance.yahoo.com/q/ks?s=OMER+Key+Statistics
Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system. Our most advanced product candidates are derived from our proprietary PharmacoSurgery® platform designed to improve clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical and medical procedures. Our PharmacoSurgery platform is based on low-dose combinations of therapeutic agents delivered directly to the surgical site throughout the duration of the procedure to inhibit preemptively inflammation and other problems caused by surgical trauma and to provide clinical benefits both during and after surgery. Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, the first commercial product from Omeros’ PharmacoSurgery platform, was approved by the FDA in May 2014. Omidria is also currently under review for marketing approval by the European Medicines Agency (EMA). Omeros’ six other clinical programs are focused on schizophrenia, Huntington’s disease, and cognitive impairment; addictive and compulsive disorders; complement-related diseases; and preventing problems associated with surgical procedures. Two additional programs are expected to advance into the clinic next year – one for the control of blood loss during surgery or resulting from trauma and the second for the treatment of a wide range of addictions and compulsions as well as any movement disorder. Omeros also has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development. |
Omeros is developing a deep pipeline of small-molecule and protein therapeutic candidates targeting inflammation, coagulopathies, and disorders of the central nervous system. Our twelve programs include those focused on inflammation, coagulopathies, and multiple CNS disorders, as well as our three platform programs: PharmacoSurgery®, antibody and G protein-coupled receptor all targeting both large-market and exciting orphan opportunities. Products from our proprietary PharmacoSurgery platform, which yielded our first commercial product Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, for use during cataract surgery and other lens replacement procedures, are designed to improve the clinical outcomes of patients undergoing arthroscopic, urological, and other surgical and medical procedures. Our MASP program is in clinical development to treat thrombotic microangiopathies, including atypical hemolytic uremic syndrome, and a wide range of inflammatory disorders. Our two PDE10 clinical programs for the treatment of schizophrenia and Huntington's disease, our clinical program for the treatment and prevention of addictions and compulsions and our preclinical programs targeting other CNS disorders and coagulopathies further strengthen our pipeline and help create multiple opportunities for commercial success. Our GPCR platform is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and our antibody platform enables the discovery of novel, high-affinity monoclonal antibodies. For each of our product candidates and programs, we have retained all manufacturing, marketing and distribution rights. | ||
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Our proprietary PharmacoSurgery® products are designed to improve the clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical and medical procedures. Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, is the first approved drug from our PharmacoSurgery platform |
We have multiple programs focused on central nervous system (CNS) disorders, all targeting large markets. Our most advanced CNS programs include our phosphodiesterase 10 (PDE10) program, focused on developing drugs for the treatment of schizophrenia, Huntington's disease and other cognitive disorders; our PPARγ program, focused on developing proprietary compositions that include peroxisome proliferator-activated receptor gamma (PPARγ) agonists for the treatment and prevention of addiction to substances of abuse (e.g., opioids, nicotine and alcohol); and our PDE7 program for the development of drugs for the treatment of movement disorders, such as Parkinson's d |
We are developing antifibrinolytic agents for the control of blood loss during surgery or resulting from trauma. Excessive bleeding during cardiac surgery is known to increase overall morbidity and mortality. In an attempt to control this bleeding, patients undergoing cardiac and other extensive surgery often receive antifibrinolytic compounds. These drugs inhibit plasmin, an enzyme present in blood that degrades fibrin clots. Because plasmin degrades fibrin clots, an agent that inhibits plasmin may have potential utility for reducing blood loss due to trauma or surgery. Prior to withdrawal from the market in 2008 for safety concerns, the antifibrinolytic Trasylol® (aprotinin) had been shown in a number of studies to be more effective at reducing blood loss than the other two most commonly used antifibrinolytics on the market today, tranexamic acid and epsilon aminocaproic acid. While Trasylol® is a potent inhibitor of plasmin, it is non-selective. In addition to plasmin, it significantly inhibits kallikrein and Factor XIa, two enzymes important in promoting clotting, and their inhibition can increase bleeding. Trasylol® was found to be associated with a number of safety issues, including increased mortality. Further, it is a bovine protein associated with anaphylactic reactions. While the specific cause of increased death remains unknown, an often-cited explanation is the lack of specificity of Trasylol®. Our proprietary agents also inhibit plasmin but, unlike Trasylol®, they do not significantly inhibit kallikrein and Factor XIa. Additionally, our agents are derived from human protein, which may reduce immunological side effects. The properties of our proprietary agents are described in a peer-reviewed article titled "Engineering Kunitz Domain 1 (KD1) of Human Tissue Factor Pathway Inhibitor-2 to Selectively Inhibit Fibrinolysis: Properties of KD1-L17R Variant" that was published in the February 11, 2011 issue of the Journal of Biological Chemistry. We believe the efficacy and improved selectivity of our proprietary agents provide a novel approach to the control of bleeding from surgery and trauma. We have selected a lead clinical candidate and are manufacturing pre-clinical supplies to enable the initiation of GLP toxicology studies intended to support the submission of an IND or clinical trial application and subsequent clinical trials. We plan to be in clinical trials with our anti-plasmin molecule in 2015. Patent Position As of February 15, 2014, we owned one issued patent and three pending patent applications in the U.S. and seven issued patents and 26 pending patent applications in foreign markets directed to our recent discoveries linking PPAR? and |
G protein-coupled receptors (GPCRs), which mediate key physiological processes in the body, are one of the most valuable families of drug targets. According to Insight Pharma Reports, GPCR-targeting drugs represent 30 to 40 percent of marketed pharmaceuticals. Examples include Claritin® (allergy), Zantac® (ulcers and reflux), OxyContin® (pain), Lopressor® (high blood pressure), Imitrex® (migraine headache), Reglan® (nausea) and Abilify® (schizophrenia, bipolar disease and depression) as well as all other antihistamines, opioids, alpha and beta blockers, serotonergics and dopaminergics. The industry focuses its GPCR drug discovery efforts mostly on non-sensory GPCRs. Of the 363 total non-sensory GPCRs, approximately 240 have known ligands (molecules that bind the receptors) with nearly half of those targeted either by marketed drugs (46 GPCRs) or by drugs in development (about 70 GPCRs). There are approximately 120 GPCRs with no known ligands, which are termed "orphan GPCRs." Without a known ligand, drug development for a given receptor is extremely difficult. Omeros uses its proprietary high-throughput cellular redistribution assay (CRA) to identify small-molecule agonists and antagonists for orphan GPCRs, unlocking them to drug development. Omeros believes that it is the first to possess the capability to unlock orphan GPCRs in high-throughput, and that currently there is no other comparable technology. Unlocking these receptors could lead to the development of drugs that act at these new targets. There is a broad range of indications linked to orphan GPCRs including cardiovascular disease, asthma, diabetes, pain, obesity, Alzheimer's disease, Parkinson's disease, multiple sclerosis, schizophrenia, learning and cognitive disorders, autism, osteoporosis, osteoarthritis and several forms of cancer. Omeros has begun screening orphan GPCRs against its small-molecule chemical libraries using its proprietary, high-throughput CRA. In addition to Class A orphan GPCRs, we have also begun screening orphan and non-orphan Class B receptors. Class B GPCRs have large extracellular domains and their natural ligands are generally large peptides, making the development of orally active, small-molecule drugs against these receptors, such as glucagon and parathyroid hormone, a persistent challenge. Omeros has announced that it has identified and confirmed sets of compounds that interact selectively with the following orphan receptors: | The GPCR family represents an important source of drug discovery. Of the 363 characterized GPCRs, only about 46 are currently targeted by marketed drugs, yet GPCR-targeted drugs account for 30-40% of all drugs sold worldwide. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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In parallel, Omeros is executing on its intellectual property strategy to protect each unlocked target through a multipronged approach directed to compound structures, uniquely identified signaling pathways and associated therapeutic indications. Collectively, this approach provides Omeros the opportunity to establish broad and enforceable protection for each unlocked receptor. GPR17We are optimizing compounds against GPR17, a G protein-coupled receptor (GPCR) which is linked to myelin formation. Myelin is an insulating layer rich in lipids and proteins that forms a sheath around the nerve fibers, which is essential for the proper functioning of the nervous system. Loss of the myelin sheath is the hallmark of several diseases, including multiple sclerosis, acute disseminated encephalomyelitis, Neuromyelitis Optica, transverse myelitis, chronic inflammatory demyelinating polyneuropathy, Guillain-Barré syndrome, central pontine myelinosis, inherited demyelinating diseases such as leukodystrophy, and Charcot-Marie-Tooth disease. We believe GPR17 inhibitors have the potential to promote remyelination and improve the outcome of these diseases as well as traumatic brain injury and spinal cord injury, conditions that have been associated with GPR17. Discovering GPR17 inhibitors has previously been challenging to the pharmaceutical industry because this receptor is an orphan GPCR. However, using our proprietary CRA, we have been able to identify over 100 compounds that functionally interact with GPR17. We are now in the process of developing lead molecules targeting GPR17, which we intend to evaluate in remyelination assays in cell culture systems as well as in animal models. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Patent Position As of February 15, 2014, we owned five issued patents and 10 pending patent applications in the U.S., and 43 issued patents and eight pending patent applications in foreign markets , which are directed to previously unknown links between specific molecular targets in the brain and a series of CNS disorders, our cellular redistribution assay and other research tools that are used in our GPCR program and to orphan GPCRs and other GPCRs for which we have identified functionally interacting compounds using our cellular redistribution as |
Our proprietary ex vivo platform for the discovery of novel, high-affinity monoclonal antibodies utilizes a chicken B-cell lymphoma cell line and has demonstrated potential for the generation of diverse antibodies that can be readily engineered. This platform offers several advantages over other antibody platforms. The ex vivo immunizations of our proprietary cell line are significantly more rapid than whole animal immunizations and conventional hybridoma technology. By avoiding immunization of mice or other animals, we believe that the antibodies we generate from this platform are not limited by immunological tolerance. Our platform is capable of producing novel antibodies against difficult targets, such as highly homologous proteins, enzymes, and receptors with short extracellular domains. Chicken antibodies also have unique features that enable binding capabilities distinct from mammalian antibodies. We have generated antibodies to several clinically significant targets, and our platform continues to add antibodies against additional important targets to our pipeline. Patent Position As of February 15, 2014, we owned and/or held worldwide exclusive license rights from the University of Washington to three pending U.S. Patent Applications, four foreign patent applications and one International Patent Cooperation Treaty Patent Application directed to our antibody platform. Additionally, we owned one issued U.S. Patent, two pending U.S. Patent Applications and eight pending foreign applications directed to antibodies generated |
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