Catalyst = approval of passthrough Medicare/insurance reimbursement of $465 per single use Omidria vial outside of the standard eye surgery bundle.
And then there's OMER's strong pipeline.
FWIW, I just found Omidria info on Drugs.com. You may have seen it before. It's like the micro-print fact sheet contents that come with all prescription drugs. It even shows the vial packing box layout. I had to zoom to 300x+ to read that.
Go to Drugs.com and search for Omidria
How do you spell skweez?
OMS721 Inhibits Thrombus Formation in Sera from aHUS Patients
- Data Bode Well for Success of Ongoing Phase 2 Trial in Thrombotic Microangiopathies -
SEATTLE, Nov. 19, 2014 /PRNewswire/ --Omeros Corporation (NASDAQ: OMER) today announced positive data using OMS721, the lead human monoclonal antibody for its mannan-binding lectin-associated serine protease-2 (MASP-2) program, to inhibit thrombus formation in an ex vivopathophysiologic system of human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain. OMS721 is currently in a Phase 2 clinical program evaluating the drug's efficacy in treating TMAs, including aHUS.
The data announced today resulted from studies in a well-established experimental model of TMA aimed at assessing the potential therapeutic benefits of OMS721 in TMA using serum samples from aHUS patients with different etiologies obtained during the acute phase of disease as well as during remission. The studies were conducted by Prof. Giuseppe Remuzzi and colleagues Marina Noris and Miriam Galbusera at the Mario Negri Institute for Pharmacological Research in Bergamo, Italy, and the Clinical Research Center for Rare Diseases "Aldo e Cele Dacco" of the same institute, a European center for the study of TMA. The experimental model is based on the finding that sera from aHUS patients promote the formation of thrombi on human microvascular endothelial cells, the defining pathological feature of TMA.
(More in the full news release)
On their website and in yesterday's 10-Q, OMER said, ""OMS103, a PharmacoSurgery product candidate, is being developed for use during arthroscopic procedures, including partial meniscectomy surgery. Our Phase 3 clinical program in arthroscopic partial meniscectomy surgery may be redesigned to include reduction of early postoperative pain as the primary endpoint. In addition, we are evaluating alternative approaches for making OMS103 commercially available, such as through a registered outsourcing facility without the need to conduct any additional clinical trials."
Apparently OMS103, a blend of FDA-approved constituents, is being considered as a marketing candidate without the need for ANY additional trials or FDA approvals.
Think about it ...... Reducing inflammation and post-op pain at surgical sites sure sounds like quite a good thing.
And not just in knees!
inVentiv's initial 20 dedicated Omidria sales reps have been knocking on ophthalmologist and surgical center doors since August.
Just two months later, in October 2014, they entered into an amendment to the agreement with inVentiv for twenty additional sales reps in the USA, doubling the sales force. It seems very likely that the negotiations for this amendment occurred before the October 29th pass-through reimbursement notification.
IMO, this indicates the Omidria rollout is going extremely well. While not wanting to be, or sound, overconfident, Greg Demopulos said on the CC, "we frankly could not have scripted a better scenario than the one into which we are launching".
Also IMO, the folks with the six million short OMER shares have to be very uneasy. They may look in the mirror soon and think $18+ would have been a smart place to cover.
"Every year, more than 800,000 people in the U.S. suffer a stroke, almost 90 percent of which are ischemic, and approximately one out of six are fatal. A leading cause of serious long-term disability, the cost of stroke in the U.S. is estimated at $37 billion annually"
Omeros Announces Positive Data for MASP-2 Inhibitor in Experimental Model of Stroke
-- Lectin Pathway Identified as Key Contributor to Stroke Sequelae --
SEATTLE, Nov. 6, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced positive data using a derivative of OMS721 in a well-established animal model of stroke. OMS721 is the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2). MASP-2 is critical to the function of the lectin pathway, one of the principal components of the complement system, a key part of the immune response. Omeros controls the worldwide rights to MASP-2 inhibition and to all therapeutics targeting MASP-2.
The study evaluated the effect of MASP-2 blockade on neurological deficits and the size of brain infarcts 48 hours after induction of an ischemic stroke. Compared to control antibody-treated mice, mice treated with MASP-2 antibody demonstrated significantly reduced neurological deficits 48 hours after an ischemic stroke. In addition, the infarcted area of the brain was significantly smaller in MASP-2 antibody-treated mice. A similar degree of protection was also observed in gene-targeted MASP-2-deficient mice, which showed significantly lesser neurological deficits and infarct sizes compared to wild-type control mice.
...... "The data from this study clearly identify the lectin pathway as a central contributor to the damage and disability resulting from the ischemic injury of stroke," stated Dr. de Simoni. "Our findings are consistent with human clinical data supporting the importance of the lectin pathway in stroke and underscore the attractiveness of MASP-2 as a potential target for the treatment of stroke patients."
(More in the news release)
Omeros Corporation to Announce Third Quarter 2014 Financial Results on November 10, 2014
SEATTLE, Nov. 4, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER), a 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, today announced that the company will issue its third quarter 2014 financial results for the period ended September 30, 2014, on Monday, November 10, 2014, after market close. Omeros management will host a conference call and webcast that day at 4:30 p.m. Eastern Time to discuss the financial results.
Conference Call Details
To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 31107196. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 31107196.
To access the live and subsequently archived webcast of the conference call, go to the Company's website at www.omeros.com and go to "Events" under the Investors section of the website. Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
They WILL use it, tredleon. It will become the standard of care now that it has approved reimbursement at $400+ per surgery starting 1/1/15 in the USA .... that's just nine weeks away.
Do the math. About 4 million applicable surgeries per year in the USA. About 4 times as many, total, for the developed world. Standard of care. $400+/surgery. The annual revenues from Omidria alone can EASILY top OMER's current market cap.
Yesterday's share price increase is totally justified.
And then there are still all those millions of short shares ........
...... On InvestorVillage and Silicon Investor message boards
A snippet from WBB's .....
"In our opinion, CMS pass-through reimbursement is a seminal moment in the OMER franchise history. While FDA approval of Omidria was absolutely necessary for launch of the product, we now believe that Omidria will more quickly become the standard of care as a fully reimbursed product that will supplant non-reimbursed compounded products. With nearly 4 million US lens and ocular procedures a year, it would behoove administrators and surgeons to use Omidria instead of compounded products that could be problematic and are not reimbursed.
Whereas no one could dispute that FDA approval of Omidria had significant healthcare value, the financial impact of pass-through approval now makes this a pre-eminent pharmaco-economic proposition. Investors also should take great interest in the January 1, 2015 pass-through date. Looking at drugs that were recently awarded January 1 pass-through approval shows that such a start date provides for three years of pass-through reimbursement, which would extend through 2017. As such, the financial advantages granted through CMS reimbursement aligns perfectly with the intended launch plans for Omidria.
We typically refrain from commentaries on market ownership or short sales of securities, however given the egregiously large open short position on OMER, we expect to see lively trading patterns as the potential for a short squeeze becomes self-evident. According to Nasdaq as of October 15, there were more than 6.5 million shares of OMER reported short with more than 27 days to cover given present volume. Taking all of this into consideration, we reiterate our Strong Buy of OMER with a $60 price target."
Omidria™ Granted Pass-Through Reimbursement Status from CMS
-- Unique Billing Code Allows Separate Payment for Omidria --
SEATTLE, Oct. 30, 2014 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) announced today that it has received transitional pass-through status for its lead product Omidria™ (phenylephrine and ketorolac injection) 1%/0.3% from the Center for Medicare & Medicaid Services (CMS), the federal agency that administers the Medicare program. Approved earlier this year by the U.S. Food and Drug Administration (FDA) for use during cataract surgery or intraocular lens replacement (ILR), Omidria is the only FDA-approved product for intraocular administration that prevents intraoperative miosis (pupil constriction) and reduces postoperative pain, providing consistent and predictable management of these problems for ophthalmic surgeons and their patients. A large and growing market, cataract and other ILR procedures are among the most common surgical procedures performed in the U.S. with approximately four million expected in 2015.
Transitional pass-through status will allow ambulatory surgery centers and other outpatient facilities to bill Medicare and other insurance providers for Omidria using a temporary Healthcare Common Procedure Coding System (HCPCS) code unique to Omidria. Pass‑through status allows for separate payment for new drugs and other medical technologies that meet specific clinical-value and cost requirements. Pass‑through remains in effect for a period of two to three years, after which time CMS and other insurance providers make a new reimbursement determination. Pass‑through status for Omidria will become effective on January 1, 2015, and reimbursement will be based on the product's wholesale acquisition cost of between $400 and $500 per single-use vial.
(More in the full OMER press release)