Without knowing anything about a biotech's pipeline or indications, an investor can review the company's stock chart and ascertain that something big is happening or coming. Omeros Corporation (OMER) shareholders have enjoyed a more than 150% stock price run-up with a recent dip back down to $9.2 from its peak of more than $10 after trading at about $4.00 in early January. Speculation can drive any biotech up for a brief period; however being able to hold those gains for over three months typically requires something more substantial than only speculation. Omeros' lead drug candidates utilize their proprietary PharmacoSurgery platform to improve patients' recovery from arthroscopic, urological, ophthalmological and other surgical and medical procedures. Using therapeutics already approved, the technology involves administering these therapeutics agents in pre-dosed, pre-formulated and single-use containers that are easily incorporated into standard surgical irrigation solutions without surgeons making any changes to their operating procedures. These drugs, which are usually used to reduce inflammation and other side-effects, are applied preemptively to ward off problems rather than their normal system of treating them after they have occurred. These conditions include inflammation, spasms, pain, loss of function and other problems all of which cause discomfort and even slow the healing process as the patients are often unable to keep the wounds or incisions from being disrupted due to movement.
With the obvious huge marketing potential for the indication, it's little wonder why investors are beginning to take note of the company. Omeros has two drugs in Phase III trials currently, OMS302 and OMS103HP. OMS302 is intended for use in surgical irrigation solutions for patients undergoing cataract or refractive lens replacement procedures. The company recently completed the first Phase III trial in which the therapy proved to be highly effective and demonstrated statistically significant superiority over placebo in maintenance of intraoperative mydriasis (p<0.00001) and reduction of postoperative pain (p<0.00001). It has since began enrollment in a second Phase III trial for the same indication, and the company is preparing to begin operating as a revenue generating company rather than just a development Phase company. Data from this trial is expected in 2H 2012 for its 400 patient set, giving testament to this huge area of need as enrollment completion is expected to happen quickly with the trial data following. OMS103HP is intended for use in patients undergoing arthroscopic surgery and uses anti-inflammatory/analgesic active ingredients to improve post-operative joint function and reduce pain. The Phase II OMS103HP trial yielded favorable results with the company reporting "clinically meaningful and significantly greater efficacy than vehicle as measured by VAS pain scores, passive knee flexion and patient-reported functional scores using the KOOS. The patient-reported outcomes scores showed a sustained benefit through postoperative Day 90 across all five KOOS subscales." The Phase III OMS103HP trial has competed enrollment and data is expected in 2H 2012 as well. With 2 Phase III data sets expected in 2H 2012, a scale up for production scale batches of OMS302 likely coming soon, and with its recent news on its GPCR program and its implications, Omeros has an exciting 2012 ahead of it and could be a nice addition to a biotech investor's portfolio.