StemCell Therapy

Omeros Corporation (OMER) is a biopharmaceutical company which develops and commercialize both small-molecule and protein therapeutics for the treatment of inflammation, coagulopathies and disorders of the central nervous system. Omeros has one of the most diverse pipelines and recently emerged as a strong investment target. The company has one marketed product and four drug candidates in clinical stage with various others in preclinical stage in their pipeline. A company with 12 drug candidate under development in their clinical and pre clinical pipeline has lot of potential and could turn out to be a company with blockbuster portent in the next couple of years.

Omeros first marketed product Omidria, a 1% phenylephrine and 0.3% ketorolac injection is a part of its proprietary PharmacoSurgery platform. It is primarily designed to prevent the intraoperative miosis (pupil constriction) during cataract surgery or intraocular lens (IOL) replacement and to reduce postoperative ocular pain. The main benefit from Omidria is that it prevents damage to the ocular structures, especially the iris, during surgery as a result of smaller pupil size.

Omidria is a pupil dilator that helps eye surgeons operate on lenses with fewer complications. In 2016, Omidria generated over $41 million in total sales, and in Q1 2017, it generated $12.3 million in sales. At present, nearly 3 million cataract surgeries are performed each year in the U.S. alone and assuming that it works better than any other traditional method of maintaining pupil dilation during surgery, this drug has billion dollar potential.

The pipeline for Omeros is diverse and quite extensive. OMS721 is the lead product candidate most likely to hit the market next. Currently, OMS721 is being tested in three areas; atypical hemolytic uremic syndrome (aHUS, which is a rare life threatening disorder resulting in blood clot throughout the body), hematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA, a disorder triggered by stem cell transplant surgery), and immunoglobulin A nephropathy (IGAN, a disease where IgA antibodies build up in the kidneys leading to inflammation and possible kidney failure). OMS721 for treating Atypical Hemolytic Uremic Syndrome is already in the Phase 3 stage.

OMS721 is a human monoclonal antibody targeting a protein called "MASP-2.", which when inhibited can help prevent damaging immune reactions seen in the above disorders. OMS721 recently received the breakthrough therapy designation from the FDA for treating IgA Nephropathy and other renal diseases. FDAs breakthrough therapy designation enables expedited development and review of a drug candidate for the treatment of a serious or life-threatening disease. Proteinuria (uACR) is an important marker for disease progression in patients with IgA nephropathy, and improvement in proteinuria is associated with improved clinical outcomes. The company announced positive data from its Phase 2 clinical trial of OMS721 for the treatment of serious kidney disorders, including IgA nephropathy. As reported for the three patients who completed treatment, mean improvement in uACR values was 76% and mean decrease in 24-hour urine protein levels was 66%. Concurrently, daily steroid doses for all patients were substantially reduced or completely eliminated.

Omeros also is pursuing accelerated approval for OMS721 in aHUS. The FDA has already granted fast track designation for OMS721 in patients with aHUS and orphan designation for OMS721 in patients with complement-mediated TMAs, including aHUS and HSCT-TMA. The potential of the lead pipeline candidate OMS721 of Omeros seems to be even more exciting than Omidrias. Its lead clinical-stage candidate OMS721 has shown positive data from Phase 2 clinical trials in both renal disorders and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). If the results achieved in small and mid-stage clinical trials can be repeated in late-stage studies, which are currently underway, Omeros could have a second drug with $1 billion per year sales potential.

A success from the company's first drug, and encouraging clinical trial results from the lead product candidate OMS721 which is in late-stage development, has produced strong movements in the company stock in the recent past. It gained close to 150 percent this year. The company has multiple drugs in its pipeline, which means that the company needs to have a steady cash flow to ensure that the development work is carried out without any hindrance.

The company has several upcoming catalysts as it progresses with the clinical trial of its lead drug candidates . The companys lead product candidate OMS721 is in Phase 3. Any positive news on this candidate will help propel the stock further. Omeros Corporation's market cap has more than doubled this year to about $1 billion but there is plenty of potential still left. If Omidria and OMS721 continue on their success to blockbuster status, the stock could give huge incentives over the next couple of years.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Excerpt from:
Omeros: Next Big Thing In Biotech - Seeking Alpha

This entry was posted on July 5, 2017 at 8:41 pm and is filed under Stem Cell kidney Failure. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |