Phase III and NDA filings are what keep biotech investors on their toes for a surge in share value. Much like mining plays, biotech stocks can be very cyclic with latent periods during research, but rapid movements at periods just before major milestones. For example, moving close to a production stage can boost shares for miners. In the pharma world, commencement and completion of phases are generally share price moving events as investors prepare for decisions from the Food and Drug Administration.
Toronto, Canada-based Trimel Pharmaceuticals Corp. (TSX:TRL) is honing-in on a New Drug Application (NDA) for its medication CompleoTRT™, a bio-adhesive intranasal Testosterone gel currently in Phase III clinical testing in the United States. CompleoTRT™ is under investigation for the treatment of male hypogonadism, or low testosterone, a condition when the sex glands (located in the testes and called “gonads”) produce little or no hormones and commonly referred to as "Low T". The primary end-point for the Phase III study is based on achieving certain testosterone blood level parameters.
Today, Trimel reported that it has completed the treatment phase of a special population study that will be included in the CompleoTRT™ NDA. The Allergic Rhinitis / Drug-Drug interaction (AR/DD) study involves the assessment of CompleoTRT™'s relative bioavailability, safety and tolerability when administered to patients suffering from seasonal allergic rhinitis, an allergic inflammation of the nasal airways. The completed results are expected by the end of June 2012 and represent an essential part of the NDA for CompleoTRT™, according to Bruce D. Brydon, CEO at Trimel Pharma.
Trimel took over development of CompleoTRT™ nearly three years ago and has optimized the treatment to meet FDA requirements with more than 3,500 drug exposure studies completed.
There is not a shortage of biotechs pursuing the hormone replacement therapy market, but Trimel may have an advantage over other drug makers because its application technology avoids exposure of the drug to other people. Belgium pharmaceutical company Solvay had a black box warning on its AndroGel because of women and children having adverse effects as a result of inadvertent exposure. The popular television show “House” even had an episode revolving around trying to diagnose a girl’s symptoms that eventually were tagged to handling of the father’s medication containing testosterone. Trimel’s CompleoTRT™ avoids this with a gel that is safely applied and absorbed through the lining of the nose. Moreover, CompleoTRT™ is designed to avoid the negative effects from first-pass metabolism on the product, liver, or both.
For the sake of brevity, the other products in Trimel's pipeline will not be discussed in this article, but it is notable that the company has several other candidates being developed and in clinical trials for different indications utilizing their gel technology.
Shares of TRL have been holding a steady upward pace since October of 2011 when a share was only bringing about $1.00. Touching $5.11 two weeks ago, shares are retracing a bit and back down to around $4.00 each currently. The final phase of this biotech cycle is nearly complete for CompleoTRT™ as Phase III is nearing an end which will put investors on the lookout for a decision from the FDA regarding bringing the product to market. Proper due diligence is, as always, encouraged.
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