Omeros Corporation Announces Independent Studies with OMIDRIA® to Be Presented at Upcoming Ophthalmology Congresses
26-Apr-2016 7:00 AM
-- Studies Assessed Key Surgical Outcome Measures Including Complication Rates --
SEATTLE--(BUSINESS WIRE)--Apr. 26, 2016-- Omeros Corporation (NASDAQ: OMER), 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, today announced that new research related to the clinical utility of OMIDRIA (phenylephrine and ketorolac injection) 1% / 0.3% and the importance of preempting intraoperative miosis and inflammation during cataract surgery will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting in Seattle, Washington, May 1 - 5, 2016, and the American Society of Cataract and Refractive Surgery (ASCRS) Congress in New Orleans, Louisiana, May 6 - 10, 2016. Presentations will address the beneficial effects demonstrated in case-controlled studies of OMIDRIA on complication rates, on use of pupil-expanding devices, on surgical times and on postoperative visual acuity.
"As utilization of OMIDRIA in cataract surgery continues to grow, we are accumulating a wealth of data across varied ophthalmic conditions, clinical settings and practice patterns," said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "These findings underscore the important benefits of OMIDRIA to both patients and surgeons - improving outcomes, streamlining procedures and reducing risks."
(News release lists all of the studies)
It's on the website people...
Omeros Corporation (NASDAQ:OMER) today announced that it has closed a non-dilutive senior credit facility with Oxford Finance and East West Bank. The new credit facility consists of a $50.0 million term loan drawn by the company at closing and the ability, subject to the satisfaction of certain conditions including achievement of certain net revenue milestones for the company’s product Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, to access up to an additional $20.0 million in two tranches until June 30, 2017. The credit facility requires interest-only payments through July 2017, following which monthly principal and interest payments will be due through the January 1, 2020 maturity date. The company used a portion of the loan proceeds to repay its obligations under its prior loan and security agreement with Oxford Finance and MidCap Financial (the Prior Agreement), and expects that the remaining net proceeds of approximately $22.3 million, as well as any of the additional $20.0 million if borrowed, will be used for general corporate purposes and working capital. During the interest-only period, the company’s cash debt service obligation will be reduced by $11.4 million as compared to the aggregate principal and interest payments that would have been payable during the same period under the Prior Agreement, which terminated December 30, 2015. The company anticipates recognizing a loss on debt extinguishment of approximately $1.3 million in its financial statements for the fourth quarter of 2015. The credit facility requires Omeros to achieve certain minimum net revenue amounts from Omidria through the end of 2018 and to maintain at least $10 million in cash and cash equivalents during its term. As required by the loan agreement, the company is also required to establish an at-the-market equity facility of up to $100 million.
It was just a condition of the loan agreement that they have an active shelf registration... the people on these boards shouldn't be investing
Well...it's certainly not helping.... I believe any threat of dilution is somewhat baked in to the PPS at this point.
Hopefully, this is just Dr. D being prudent.
manipulation in small biotechs is rampant. long term fundamentals will drive valuation, just need to have the stomach for it until they do. GLTA
Nice over view of our Company. An om4carley you should take the time if it's not to above you. My big question is how can we be trading at $13.70 with our product Omidria and the pipe line as it is ,When a lot of bio companies with no product and in phase triles be selling for $30---$40 even $50 per share.
Sentiment: Strong Buy
It was sponsored for phase 2 by a NY hospital. They aren't going to handle phase 3 costs though if it's good.
The Roth Capital Partners analyst that formerly covered OMER recently left the firm. Elemer Piros is now managing director at Cantor Fitzgerald.
the dosage is for 12 weeks. So this patient should be off dosage by the end of july (unless there is a request from the doc to keep the patient on the drug).
my guess the latest we will hear about the patient(s) that started today by Q2 CC during August. That should give the docs enough time with the 10-12 week dosage to gather the information for a number of patients. If the drug does not work we would hear about it sooner.
if I am not mistaken omeros is not responsible for the phase 2 costs related to 405 (have not seen costs in the last annual financial statements). if this is the case the phase 3 costs may be picked up by the partner.
Also, as Dr. D had said before they control the costs determining the progress of the pipeline. 201 is on hold (they may be looking for a partner for 201)
Yes because Alexion using their resources to destroy the stock price so Omeros can't raise funds is going to send the price up.
I have not read all this but did a basic search, the NIH fact sheet for chronic kidney disease (if it works can be expanded)
Chronic Kidney Disease and Kidney Failure
One third of diabetic patients were destined to develop kidney failure.
Two lifesaving renal replacement therapies, dialysis and renal transplantation, developed through fundamental NIH research in the 1960s, were increasingly available; however, neither was ideal.
Dialysis left patients feeling washed out and unable to work. Patients suffered from disabling bone disease, dementia caused by aluminum intoxication, and severe fatigue from uncontrollable anemia. High cardiovascular disease death rates limited life expectancy.
Some patients were lucky enough to get a kidney transplant, which greatly improved their quality of life and life expectancy. However, transplantation was not common, and acute rejection resulted in transplantation failure rates of 30 to 50 percent.
No methods were available to screen diabetic patients for early signs of kidney injury, so preventive treatments were not possible.
Few treatments for kidney disease were available, and the importance of controlling blood sugar and blood pressure was not recognized.
Kidney failure was increasing at epidemic rates. Through the 1980s and 1990s, the number of patients developing end-stage kidney failure nearly doubled each decade.
An estimated 23 million American adults have chronic kidney disease. Currently the NIH spends $655 million on kidney disease research.
With good care, fewer than 10 percent of diabetics develop kidney failure.
Management of complications has markedly improved the quality of life of dialysis patients. Dialysis dementia due to aluminum toxicity no longer occurs.
Premature death due to cardiovascular disease and all other causes are higher in adults with chronic kidney disease. Individuals with chronic kidney disease are 16 to 40 times more likely to die than to progress to kidney failure. High cardiovascular death rates in dialysis patients are also a serious problem.
Transplantation is widely available, although limited organ availability has resulted in longer waiting times.
Transplant failure due to acute rejection is much less common, with one-year success rates exceeding 90 percent.
Kidney disease can be detected earlier by standardized blood tests to estimate renal function and monitoring of urine protein excretion. New drugs better control blood pressure and slow the rate of kidney damage by about 50 percent. An NIH education campaign informs patients and their doctors about the importance of early detection of kidney disease http://www.nkdep.nih.gov/.
The disease pathways that cause damage to the kidney filter (glomerulus) are becoming better understood.
Because kidney disease often runs in families, the NIH has carried out several genetic studies of kidney disease. Researchers are learning how to identify genetic markers that might predict who will get kidney damage, especially in African-Americans.
As a result of improved treatment, the number of new dialysis patients has stabilized.
The savings to Medicare for each patient who does not progress to dialysis is estimated to be $250,000 per patient. Overall estimated Federal savings from recent improvements in preventing kidney disease is approximately $1 billion per year.
The Medicare program spends approximately $24 billion per year for care of the over 525,000 U.S. patients with end-stage kidney failure. This represents nearly 6 percent of Medicare expenditures. Including the cost to other payors and out-of-pocket expenses, the total annual bill for treating kidney failure is over $35 billion.
The continued development and testing of new detection strategies, therapies, and community education will result in fewer people developing advanced chronic kidney disease and kidney failure, requiring less need for dialysis and transplantation. The NIH is conducting research that will help us realize these benefits for patients.
As researchers pinpoint additional genetic variants, they are learning how to identify genetic markers that might predict who will get kidney damage, identify key disease pathways, and new drug treatment strategies. These genetic studies are yielding clues about how to intervene earlier in disease progression and to intervene more effectively. We want to extend the success in preventing or delaying progression to end-stage kidney disease in people with diabetes to other common causes of kidney injury such as high blood pressure, glomerulonephritis, and cystic disease.
Accelerated cardiovascular disease is the main cause of death in kidney disease patients. Ongoing longitudinal studies will determine new risk factors for accelerated cardiovascular disease, and may permit individualized prevention strategies.
If detected sufficiently early, it may be possible to restore lost kidney function. More aggressive management of diabetes and high blood pressure, as well as drugs that target kidney fibrosis, may give patients additional years of life without dialysis.
For those patients who need dialysis, NIH is studying whether more frequent dialysis improves physical function and cardiovascular health. Studies are also underway to examine the factors that influence the functioning of fistulas—a surgically-created site used to access blood—in patients undergoing hemodialysis.
Despite our best immunosuppressant therapies, a number of patients with kidney transplants still lose their transplanted kidney due to chronic rejection. Better strategies to maintain the function of transplanted kidneys and prevent chronic scarring are likely to emerge from on-going basic research and improved imaging methods.
The best hope for reducing the human and economic costs of chronic kidney disease and end-stage renal disease lies in prevention. The NIH’s National Kidney Disease Education Program works to bridge the gap between scientific evidence and clinical practice by focusing on the minority communities at highest risk of kidney disease and the healthcare professionals who serve these patients http://www.nkdep.nih.gov/.
While every application use for a drug is good, does anyone have any concrete number of patients suffering from this condition. Is it very rare like aHUS or is it a more common ailment?