The holy grail of any biotechnology pharmaceutical company is final FDA approval. Once the approval is granted, the real work of making it pay begins.
MiddleBrook Pharmaceutical, a biotechnology research and development company, has received its first FDA approval. This first approval is for a “step throat” product which can be taken once-a-day. The approved once-a-day dosage betters the numerous times per day for other treatments such as penicillin. Currently, the medication is only approved for patients over the age of 12 but further diligence will likely lead to children’s dosages in the form of a “sprinkle” product of the medication. The company is currently in Phase II trials for this particular formulation of the product.
Moving quickly after the approvals for the medication, the company announced (January 25, 2008) that it has signed definitive agreements for the private placement of 8.75 million shares to be listed at $2.40 per share. The company indicates that the proceeds from the private placement will be used in support of the “strep throat” MOXATAG ™ product.
Perhaps being overshadowed by the excitement of the company’s first FDA approval is the success of the delivery system that makes MOXATAG attractive. The proprietary mechanism that makes the drug able to be used once per day, as opposed to 4 times a day for Penicillin, is called a pulsatile delivery system. MiddleBrook refers to the delivery system as PULSYS ™ but does not necessarily promote it as a potential revenue source when it may, in fact, be a rather large “time release” revenue asset. Currently, information regarding the company’s product development pipeline is limited although some have indicated that a structural analysis of the company is ongoing and that sale opportunities are always an interesting idea.
Let us hear your thoughts below: