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Omeros Corporation (OMER)

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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.


Pipeline

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.


antibody

PharmacoSurgery

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


antibody

MASP

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

Inflammation

 

 

PharmacoSurgery®

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

cns

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

GPCR

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
MRGE Pain
MRGF Pain
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.

GPR17

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

http://investor.omeros.com/phoenix.zhtml?c=219263&p=irol-irhome

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

 

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OMER
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Option Chain for OMER
OMER News: Statement of Changes in Beneficial Ownership (4) 06/24/2014 07:00:28 PM
OMER News: Confidential Treatment Order (ct Order) 06/16/2014 02:31:37 PM
OMER News: Statement of Changes in Beneficial Ownership (4) 06/04/2014 06:51:49 PM
OMER News: Current Report Filing (8-k) 06/02/2014 07:06:18 AM
OMER News: Omeros Receives FDA Approval of Omidria™ for Use in Cataract and Other Intraocular Lens Replacement Procedures 06/02/2014 07:00:00 AM
PostSubject
#170   Recent short #'s goodplenty100 06/26/14 11:23:22 AM
#169   There actually seems to be an untapped market goodplenty100 06/25/14 03:07:23 PM
#168   Very nice Form 4 filling goodplenty100 06/24/14 07:39:37 PM
#167   New 52wk hi.......Blue skies ahead goodplenty100 06/24/14 10:35:34 AM
#166   Is news forthcoming goodplenty100 06/23/14 10:18:24 AM
#165   Confidential treatment order goodplenty100 06/16/14 08:37:19 PM
#164   Zack's........A sure sign sh are difficult to acquire goodplenty100 06/12/14 09:56:44 AM
#163   None that I'm aware of UD. goodplenty100 06/10/14 07:29:44 PM
#162   Who is calling for a pr? underdog150 06/10/14 05:55:27 PM
#161   What catalyst if any would deploy/constitute a PR today? goodplenty100 06/10/14 02:31:17 PM
#160   New 52 week high! underdog150 06/10/14 11:16:02 AM
#159   TY chops, my best to you as well. goodplenty100 06/08/14 09:51:50 PM
#158   Nice strategy. Hope your come out on top. lambchops 06/08/14 08:29:33 PM
#157   One example would be OMER just made a goodplenty100 06/08/14 09:04:39 AM
#156   Thanks for the thoughtful response, GP100. Also, thanks lambchops 06/08/14 08:28:43 AM
#155   Chops, I have been into Bio's for over goodplenty100 06/07/14 11:27:32 AM
#154   Love your analysis. Don't know much about this lambchops 06/07/14 10:24:07 AM
#153   Yes, +10% in 2 days since last post. goodplenty100 06/06/14 05:13:19 PM
#152   Good post underdog, it really looks ripe for goodplenty100 06/04/14 06:32:04 PM
#151   Price target raised to $44 from $37 underdog150 06/02/14 07:01:44 PM
#150   Made a killing on Bios in the last underdog150 06/02/14 08:41:17 AM
#149   Thumbs up to Surf and AFXM as well. goodplenty100 06/02/14 07:58:55 AM
#148   Outstanding! underdog150, I was so confident that Omeros goodplenty100 06/02/14 07:51:12 AM
#147   Omeros Receives FDA Approval of Omidria™ underdog150 06/02/14 07:15:46 AM
#146   Omeros Corporation June 1st goodplenty100 06/01/14 08:40:56 AM
#145   OMER Omeros reports positive results from phase 2 trial [SMART MONEY] 03/07/14 08:07:03 AM
#144   $14.60 Pre-Mkt afxm 02/27/14 09:15:41 AM
#143   Ready to say hello to $15+ :) afxm 02/26/14 08:57:24 AM
#142   7:03AM Omeros: FDA grants Fast Track designation to surf1944 02/05/14 08:28:08 AM
#141   Headed for $13+ Wednesday... it's going to $16+ afxm 01/21/14 11:01:58 PM
#140   How is level 2 looking this morning ? afxm 01/21/14 09:15:57 AM
#139   OMER @ Stockcharts Investor100 01/04/14 10:13:18 PM
#138   Looks like OMER is getting ready to take goodplenty100 01/03/14 12:33:54 PM
#137   Sorry.... posted on wrong board, please delete afxm 12/27/13 08:41:48 AM
#136   Lots of benefits there, soounds good afxm 12/27/13 04:55:17 AM
#135   Sorry about that, this was supposed to be goodplenty100 12/23/13 08:55:29 AM
#134   This was in the news section on my goodplenty100 12/23/13 08:53:15 AM
#133   OMER @ Stockcharts Investor100 12/19/13 10:15:30 PM
#132   7:03AM Omeros announces FDA granted orphan drug designation surf1944 12/18/13 09:44:51 AM
#131   BINGO $10 OMER [SMART MONEY] 12/18/13 09:41:43 AM
#130   here it comes...................... [SMART MONEY] 12/18/13 09:31:59 AM
#129   OMER $10 comin [SMART MONEY] 12/18/13 08:20:59 AM
#128   OMER News : FDA Grants Orphan Drug Designation to [SMART MONEY] 12/18/13 07:08:12 AM
#127   Baker Bros have started a position in OMER. Bickema 11/21/13 09:15:49 PM
#126   I briefly had hope afxm 11/20/13 07:21:20 PM
#125   7:04AM Omeros announces FDA acceptance of Omidria as surf1944 11/20/13 09:08:44 AM
#124   Is this going to tank until thier new afxm 11/15/13 02:52:11 PM
#123   7:34AM Omeros announces positive data in Phase 1 surf1944 11/07/13 09:32:20 AM
#122   did anybody knows why this company goes down Eagle eyes24 10/21/13 10:40:50 AM
#121   7:04AM Omeros reports additional positive clinical data for surf1944 10/17/13 02:19:46 PM
PostSubject