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Omeros Corporation (OMER)

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Last Post: 2/16/2021 10:52:58 AM - Followers: 37 - Board type: Free - Posts Today: 0



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.



Omeros is one of the first companies to recognize that, in a wide range of pathologic conditions, a combination of agents acting on multiple molecular targets is required for optimal therapeutic effect. Our PharmacoSurgery® products are combinations of targeted therapeutic agents designed to modulate the molecular mechanisms of pathologic conditions rather than just treating their symptoms.

Surgical procedures cause extensive trauma at the surgical site. This trauma produces a complex cascade of molecular signaling and biochemical changes, resulting in a number of unintended problems. These problems are currently treated postoperatively in an attempt to "undo" them after they have started.

Omeros believes that there is a better way: deliver our PharmacoSurgery products throughout the duration of surgical trauma directly to the surgical site and preemptively — before the problems can begin — to provide clinical benefits both during and after the procedure.

Our first commercial PharmacoSurgery product is Omidria™ (phenylephrine and ketorolac injection) 1%/0.3%, an ophthalmologic product approved in May 2014 by the U.S. Food and Drug Administration (FDA). Our additional PharmacoSurgeryproducts, OMS103 - Arthroscopy and OMS201 — Urology, are currently in clinical development.


Patent Position

As of May 23, 2014, our patent portfolio included 18 U.S. and 75 foreign issued or allowed patents, and eight U.S. and 30 foreign pending patent applications, directed to our PharmacoSurgery products and development programs. These patents include claims directed to broad therapeutic classes (e.g., mydriatic, anti-inflammatory, analgesic, etc.) from which unique combinations of agents are drawn for local and perioperative delivery to the site of a wide range of medical and surgical proce



A discovery by researchers at the University of Leicester led to the identification of mannan-binding lectin-associated serine protease-2 (MASP-2), a novel pro-inflammatory protein target in the complement system. Omeros holds worldwide exclusive licenses to rights related to MASP-2, the antibodies targeting MASP-2 and the therapeutic applications for those antibodies from the University of Leicester and from its collaborator, Medical Research Council at Oxford University, as well as Helion Biotech ApS.

MASP-2 is a key protein involved in activation of the complement system, which is a critical component of the immune system. The complement system plays a role in the inflammatory response and becomes activated as a result of tissue damage (e.g., trauma) or infection by microbial pathogens. MASP-2 appears to be unique to, and required for the function of, one of the principal complement activation pathways, known as the lectin pathway. Importantly, inhibition of MASP-2 does not appear to interfere with the antibody-dependent classical complement activation pathway, a central component of the acquired immune response to infection. If the classical pathway is caused to function abnormally, a wide range of autoimmune disorders can result.

Our preclinical data suggest that antibody-blockade of MASP-2 may have a preventive or therapeutic effect in the treatment of a wide range of complement-related diseases and disorders, including thrombotic microangiopathies (TMAs, e.g., atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenic purpura (TTP), etc.) and neovascular age-related macular degeneration (AMD).

OMS721 has received Orphan Drug Designation from the FDA for prevention of complement-mediated TMAs. We are completing a Phase 1 trial in Europe evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of OMS721 in healthy subjects. In this trial, OMS721 administration was well tolerated in all subjects, there were no drug-related adverse events, and no clinically significant abnormalities on laboratory tests or electrocardiograms have been observed. In the Phase 1 trial, both subcutaneous and intravenous routes of administration resulted in a high degree of lectin-pathway inhibition and successfully achieved the pharmacologic target of sustained inhibition for at least one week. We submitted an Investigational New Drug application to the FDA in March 2014 for our Phase 2 clinical program, and we expect begin enrolling subjects in the Phase 2 trial in the third quarter of 2014 to evaluate OMS721 for the prevention of complement-mediated TMAs.

We also believe that we have identified the proteins that activate the complement system's alternative pathway in humans, which is linked to a wide range of immune-related disorders, and we are establishing a broad intellectual property position around these discoveries. Therefore, in addition to our lectin pathway inhibitors, such as OMS721, we are advancing the development of antibodies that would block activation of the alternative pathway alone or in combination with the lectin pathway.

Patent Position

As of February 15, 2014, we exclusively controlled seven issued patents and 17 pending patent applications in the U.S. and 16 issued patents and 90 pending patent applications in foreign markets related to our MASP pr





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

Bleeding Disorders

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:

GPCR Metabolic Indications GPCR Oncology Indications
GPR12 Obesity, Cognitive Impairments, Motor Disorders GPR19 Metastatic Melanoma
GPR21 Obesity, Diabetes GPR39 Esophageal Cancer
GPR25 Arterial Stiffness GPR65 Cancer
GPR37L1 Hypertension, Cardiac Hypertrophy GPR80 Hepatocellular Carcinoma
GPR50 Metabolic Disorders GPR87 Squamous Cell Carcinoma
GPR82 Appetite, Body Weight GPR150 Ovarian Cancer
GPR132 Atherosclerosis GPR161 Metastatic Epithelial Cancers, Cancer Stem Cells
GPR176 Atherosclerosis GPR174 Melanoma, Grave’s Disease
GPR101 Eating Disorders LGR4 Cancer Stem Cells, Bone Diseases
SREB1/GPR27 Obesity, Schizophrenia LGR5 Cancer Stem Cells, Esophageal Adenocarcinoma
SREB2/GPR85 Obesity, Schizophrenia OGR1/GPR68 Ovarian, Prostate Cancers
SREB3/GPR173 Obesity, Schizophrenia P2Y8 Acute Lymphoblastic Leukemia
GPCR CNS Indications GPCR Miscellaneous Indications
GPR17 Multiple Sclerosis GPR15 HIV Enteropathy, Rheumatoid Arthritis
GPR31 Anxiety Disorders GPR22 Osteoarthritis
GPR37 Parkinson’s Disease GPR32 Acute Inflammatory Responses
GPR52 Schizophrenia GPR183 Humoral Immunity
GPR63 Autism CCRL2 Rheumatoid Arthritis, Immune Disorders
GPR78 Bipolar Disorder, Schizophrenia LGR6 Hair Follicle Stem Cells, Wound Repair
GPR83 Memory and Inflammatory Conditions Orphans Unlocked with No Known Indictations
GPR139 Motor Disorders GPR20, GPR45, GPR135, GPR141, GPR171, GPR182, OPN5
GPR151 Cognition; PTSD  
GPR153 Schizophrenia
GPR162 Neuropsychiatric Disorders
MAS1 Cognitive Impairments
OPN4 Circadian Rhythm, Sleep Disorders

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.


We 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

Bleeding Disorders

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


In the news:  http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-news&nyo=0


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OMER News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 03/01/2021 05:22:43 PM
OMER News: Omeros Corporation Reports Fourth Quarter and Year-End 2020 Financial Results 03/01/2021 04:02:00 PM
OMER News: Omeros Corporation to Announce Fourth Quarter and Year-End Financial Results on March 1, 2021 02/25/2021 09:37:00 AM
OMER News: Statement of Changes in Beneficial Ownership (4) 02/23/2021 06:44:22 PM
OMER News: Statement of Changes in Beneficial Ownership (4) 02/17/2021 05:16:32 PM
#453   Tute ownership up to 78% been hovering around umiak 02/16/21 10:52:58 AM
#452   Not new news but I like the smart umiak 01/28/21 03:55:03 PM
#451   Have you looked at NLST? Short story: umiak 01/22/21 07:20:31 PM
#450   umiak 01/22/21 07:17:56 PM
#449   I think that's realistic. umiak 01/22/21 07:03:47 PM
#448   I am a newbie in term of having Dartgator 01/22/21 03:44:35 PM
#447   LOL!!! That's awesome! I thought you were a umiak 01/22/21 03:02:55 PM
#446   I tried to find the link to the umiak 01/22/21 03:00:44 PM
#445   Thanks for the link. OMER is my biggest Dartgator 01/22/21 02:57:51 PM
#444   I can't give you a %. What I umiak 01/22/21 02:31:54 PM
#443   What are the chances of getting an approval Dartgator 01/21/21 06:35:09 PM
#442   OMER- Acceptance with Priority Review and JPM link: umiak 01/19/21 06:16:33 PM
#441   About Narsoplimab umiak 12/30/20 11:33:27 PM
#440   Imo, they sold because of narsoplimab. I don't umiak 12/30/20 11:27:39 PM
#439   Alexion bought for 173$/share. What does that do to qi 12/14/20 07:40:45 AM
#438   Today— CMS has now approved Omidria as a umiak 12/02/20 11:47:58 PM
#437   News; $OMER Omeros Schedules Webcast to Present Final whytestocks 10/15/20 08:00:25 PM
#436   News: $OMER Omeros Announces Proposed Public Offerings of whytestocks 08/10/20 04:30:33 PM
#435   * * $OMER Video Chart 08-10-2020 * * ClayTrader 08/10/20 04:21:59 PM
#434   News: $OMER Omeros Corporation Reports Second Quarter 2020 whytestocks 08/10/20 04:15:50 PM
#433   News: $OMER Omeros Corporation Reports Recovery and Survival whytestocks 08/10/20 10:15:19 AM
#432   Omeros shares are trading higher after the company umiak 08/10/20 09:28:12 AM
#431   OMER Test on intubated covid patients . All narsoplimab-treated Dr_Thorfin 08/10/20 01:48:37 AM
#430   FLY, ROBIN, FLY. $20 Monday. hitekmastr 05/08/20 12:02:48 AM
#429   As reminder , omeros holds worldwide rights to Dr_Thorfin 04/27/20 07:20:32 AM
#428   I hope you are well . lovethatgreen 04/18/20 06:02:56 PM
#427   Yeah umiak 04/16/20 09:37:24 AM
#426   Nice move. hitekmastr 04/13/20 05:09:26 PM
#425   * * $OMER Video Chart 03-03-2020 * * ClayTrader 03/03/20 05:53:11 PM
#424   Omeros Corporation Appoints Former Amazon Treasurer Kurt Zumwalt umiak 02/11/20 07:49:52 PM
#423   PIOE/OMER P was my best stock in 2019. umiak 01/29/20 11:51:47 AM
#422   https://investor.omeros.com/news-releases/news-release-details/mytomorrows-and-o umiak 12/18/19 10:39:23 AM
#421   Also means higher % tute ownership, for now. umiak 12/18/19 10:38:58 AM
#420   For us shareholders it means 7% dilution , Dr_Thorfin 12/13/19 10:05:38 AM
#419   Wat does that mean for us shareholders? Dilution? qi 12/05/19 12:36:09 AM
#418   News: $OMER Omeros Announces Proposed Public Offering of whytestocks 12/04/19 06:30:24 PM
#417   News: $OMER Omeros Reports Positive Data Across Primary whytestocks 12/04/19 11:15:33 AM
#416   Yeah , from alan , he did nice Dr_Thorfin 11/22/19 09:24:53 AM
#415   GPR174 13 indications(?) umiak 11/21/19 03:47:54 PM
#414   This is from a knowledgeable long. I have not umiak 11/21/19 03:36:48 PM
#413   Sure , you need strong data as ammo Dr_Thorfin 11/21/19 01:31:22 AM
#412   Probably any number of deals they could workout. umiak 11/20/19 09:02:00 PM
#411   Ha! Just signed up for alerts. Be harder umiak 11/20/19 08:58:28 PM
#410   If you were a big pharma and you Dr_Thorfin 11/20/19 04:39:32 PM
#409   Cms can change rule at meeting within 2 Dr_Thorfin 11/20/19 04:35:57 PM
#408   For those following OMER, here is a link umiak 11/20/19 02:50:52 AM
#407   OMER - GPR174 https://investor.omeros.com/news-releases/news-release-details/o umiak 11/20/19 01:55:23 AM
#406   $OMER short squeeze https://news.squeezereport.com/short-squeeze/ome whytestocks 11/12/19 11:40:25 AM
#405   https://flashalert.me/?symbol=OMER&source=PR&referer=https://stocktwits.com/&url umiak 10/28/19 09:52:51 AM
#404   *OmerosL Rolling Submission of the Remaining BLA Sections umiak 10/28/19 09:16:56 AM
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