New/excellent article by Alan Ross at Trust Intelligence
Post #14 on his Omeros thread, title as above.
Lead in points .......
-Omeros has been increasingly volatile lately, at least partly due to a large short position.
-Lead product, Omidria sales exceeded analyst consensus expectations in Q2’15
-Analyst consensus is that Omeros has more than enough cash to finance activities through Q1 2016
-Analyst cash flow projections and current cash position indicate Omeros has no need to raise cash this year
-Analyst sum of the parts valuation estimate pipeline and the development platform is worth more than the current share price
-Omeros has a number of pending 2015 catalysts that can provide more cash and move the market
Look for PR: "Omeros Announces Additional Positive Data in OMS721 Phase 2 Clinical Trial"
In the mid-dose cohort, the two patients with plasma therapy-resistant aHUS demonstrated:
•47% increase in mean platelet count, resulting in both patients having counts in the normal range
•86% decrease in mean schistocyte count, with schistocytes disappearing in one patient
•71% increase in mean haptoglobin with both patients reaching the normal range during treatment, one slipping slightly below normal at one week following the last dose
•5% decrease in the mean levels of LDH, with levels in both patients remaining slightly elevated above normal range
The mid-dose-cohort patient with TTP required repeated plasma infusion therapy prior to entering the study. Laboratory parameters did not show consistent improvement, but the patient did not require plasma therapy during treatment with OMS721 and, to date, has not required it since completing treatment.
The first patient in the high-dose cohort - a plasma therapy-resistant aHUS patient with additional complicating disorders including hepatitis C, cryoglobulinemia and lymphoma - has also completed treatment with OMS721. Prior to OMS721 treatment, the patient required repeated dialysis. Throughout treatment and following completion of the OMS721 course, the patient to date has remained off dialysis. Hematological and renal parameters showed:
•63% improvement in platelet count, returning to normal levels
•100% decrease in schistocytes
•Haptoglobin increased from an undetectable level and normalized
•43% decrease in LDH, resulting in a level just slightly above normal
•24% reduction in creatinine level
As expected, patients with aHUS in the mid- and high-dose cohorts demonstrated more consistent and robust improvement in efficacy measures than patients in the low-dose cohort. As in the low-dose cohort, the drug was well tolerated by all patients in the mid- and high-dose cohorts throughout the treatment period.
08/17/2015 -- Omeros is planning to file a patent infringement lawsuit against Par Pharmaceutical over its plans to market a generic version of its Omidria drug, used during cataract surgery or intraocular lens replacement to maintain pupil size by preventing pupil constriction and to reduce postoperative ocular pain.
(Much more info in OMER's news release)
Omidria® Approved for Commercialization Throughout the European Union and Additional Countries
Date(s): 3-Aug-2015 7:00 AM
-- Approval by the European Commission Follows Unanimous Recommendation by the EMA --
SEATTLE, Aug. 3, 2015 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that the European Commission (EC) has granted marketing authorization for Omidria (phenylephrine and ketorolac injection) 1% / 0.3% in the European Union (EU) for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain. This approval allows for the marketing of Omidria in all EU member states plus Iceland, Lichtenstein, and Norway. Cataract surgery and lens replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015.
"European ophthalmic surgeons are excited by the approval of Omidria in the EU," said Roberto Bellucci, MD, professor of ophthalmology at the University of Verona, Italy, director of the Ophthalmic Unit at the Hospital of Verona, and current president of the European Society for Cataract and Refractive Surgeons. "For the first time, we will have a product that provides consistent and predictable management of intraoperative miosis - a problem that can be challenging for surgeons. I expect that use of Omidria will translate into better outcomes for our patients and, together with the drug's ability to reduce postoperative pain, will improve patient satisfaction following cataract surgery."
(More info in the news release)
Alan is for real. I've known him for years. Peter is involved with the software setting up the hosting of Trust Intelligence.
Depends on your point of view. I've accumulated OMER over 5+ years and am up over 150%. I wish all of my stocks were that bad. :-)
You have less than two weeks to wait to learn the Q2 Omidria revenue numbers. I'm thinking those who expect poor sales data may be in for an eye-opening day.
Maybe we won't have to wait long for a decision. I've been digging into the EMA. It that apparently operates continuously, unlike the monthly-meeting CHMP (with August off). The EMA's Commission will make Omidria's EU authorization decision.
This site indicates the continuous EMA activity .....
http://www.ema.europa.eu/ema/index.jsp? … ts_new.jsp
Since we didn't hear about EMA approval, I checked the EMA "Pending Decisions" website and found there are 22 drugs that got CHMP positive opinions in May and earlier (back to December 2014) that have not been approved yet, so the 67 day rule appears to be "soft". Specifically, 11 drugs that got CHMP positive opinions on May 21st still do not have EC approval.
....... which is truly bizarre, since OMS721 has Alexion's blockbuster Soliris in its crosshairs. A big chunk of ALXN's $47B market cap is ascribed to Soliris' aHUS revenues. Alan Ross posted an interesting article on his OMER blog on Trust Intelligence (Google that), saying that Alexion should buy OMER.
The CUP is already underway ...... " Earlier this year, Omeros announced positive data from the Phase 2 trial and commencement of an investigator-requested compassionate use program for OMS721 to allow extended treatment of patients who completed the trial's four-week dosing."
"17th World Congress of Gastrointestinal Cancer17th World Congress of Gastrointestinal Cancer
July 1-4, 2015
The International Convention Center of Barcelona - Barcelona, Spain
Eric Wachter, PhD will present on July 2 at 10:30am and 4:55pm local time. [4:30am and 10:55am EDT]"
From PVCT .....
"Once the poster has been presented at the Congress [5:00am EDT?], Provectus will provide full details of its contents to the public."
Potential for early news Thursday?