Omeros negotiated a $40 million equity financing facility with Azimuth Opportunity. Under the terms of the agreement Omeros has the option to sell up to $40 million-worth of its shares to Azimuth over a two year period and will be able to decide on the timing, dollar amount, and floor price per share for any draw subject to certain limitations. A contractual formula will determine the number and prices of shares sold in each draw and a prenegotiated discount will apply to the volume-weighted recent average price of Omeros’ common stock.
The firm says it will use proceeds from the sale of any shares to Azimuth for general corporate services. “This financing vehicle provides flexibility and potentially strengthens our position as we pursue strategic opportunities,” states Gregory A. Demopulos, M.D., chairman and CEO.
Biopharmaceutical firm Omeros is developing a pipeline of candidates for the treatment of inflammation and CNS disorders. The firm’s lead clinical-stage anti-inflammatory candidates have been developed using its PharmacoSurgery platform and comprise FDA-approved generic drugs that are added to standard surgical irrigation fluids during surgical procedures in ophthalmology, urology, and arthroscopy.
The lead PharmacoSurgery drug, OMS103HP, is in Phase III development for use in joint surgery. The candidate is composed of anti-inflammatory agents that each act on discrete molecular targets involved in the acute inflammatory response, Omeros claims. The Phase III study is evaluating the ability of OMS103HP to improve postoperative joint function and reduce pain following arthroscopic anterior cruciate ligament reconstruction surgery. A Phase II program is evaluating the product’s safety and ability to reduce pain and improve postoperative joint function following arthroscopic meniscectomy surgery. Positive data from a Phase II study in the arthroscopic meniscectomy surgery trial were reported in March and May.
OMS302 is in Phase II development for use during ophthalmological procedures including cataract and other lens-replacement surgeries. The drug combination comprises an anti-inflammatory agent and an agent that causes pupil dilation. Earlier this week the firm reported the start of a Phase IIb trial evaluating OMS302 in patients undergoing cataract surgery.
Urology candidate OMS201 is a combination of an anti-inflammatory agent and a smooth muscle relaxant. Currently in Phase I/II development, OMS201 is in development for inhibiting surgically induced inflammation, pain, and smooth muscle spasm resulting from uroendoscopic procedures such as bladder endoscopy, minimally invasive prostate surgery, and ureteroscopy,.
The lead candidate in Omeros’ CNS pipeline is a Phase II-stage PPARγ agonist candidate for the potential treatment and prevention of addiction to substances of abuse including opioids, nicotine, alcohol, and amphetamines as well as other compulsive behaviours. A Phase II opioid addiction trial is being funded by the National Institute on Drug Abuse.
Omeros also has a phosphodiesterase-7 (PDE7) program centered on developing candidates for the treatment of movement disorders such as Parkinson disease and restless legs syndrome. The firm claims it has demonstrated a previously unknown link between PDE7 and movement disorders. In March it negotiated an exclusive license to compounds from Asubio Pharma for use in its PDE7 therapuetics pipeline. Clinical trials are expected to start in 2011.
Omeros is also progressing a GPCR program that has arisen from the firm’s technology for carrying out high-throughput de-orphanization of orphan GPCRs. Using this platform Omeros claims to have identified a subset of GPCRs expressed exclusively or preferentially in brain regions involved in the regulation of specific behaviors. The firm generated 61 strains of knock-out mice that each lack one of these GPCRs. Studies with the knock-outs have now led to the discovery of what Omeros believes are previously unknown links between specific molecular targets in the brain and a series of CNS disorders.