Alitair develops respiratory products for orphan diseases and Rx/OTC cough products. The Alitair management team has a successful track record in product development and commercialization. Alitair became operational in July of 2010. The Company currently has one issued patent and five additional patents filed; two executed development and license agreements, and is the recipient of a federal grant.
Alitair’s business strategy is focused on developing orphan drugs and innovative cough and cold products. Our drug development strategy is focused on proven molecules that are lower-risk and can be brought to market much more quickly than new chemical entities.
Our orphan drug product is both currently approved and marketed outside the United States which should reduce time and costs for approval in the United States. Our strategy of licensing compounds approved outside the United States provides access to products that have significant amounts of development work completed. A typical license opportunity would have a complete and up-to-date toxicology package, dose ranging studies, special populations and full scale clinical trials already completed. However, the company expects to carry out at least one late stage trial here in the United States to get this product approved.
Alitair has received written confirmation from FDA that all its cough products can be can submitted for FDA approval through 505(b)(2) New Drug Applications (NDAs). These NDAs will require only pharmacokinetic trials - no clinical, safety or pre-clinical trials are required, and these products will be eligible for patent protection
Alitair has no outside investors. Since founding the Company, the management team has executed rapidly on its business plan and has achieved the following important milestones:
- Received a patent from the USPTO on its ion exchange resin platform drug delivery technology, REA™
- Entered into two licensing and development transactions related to the Company’s intellectual property with large pharmaceutical companies that provide $6 million in milestone payments over the next four years with additional royalty payments
- In-licensed an orphan drug product approved outside the United States
- Received a federal grant in the amount of $244K to research overdose reduction
- Has four important patents pending with more planned filings
- Commissioned third-party market research among doctors, patients and managed care directors related to the company’s products
- Commissioned the analysis and design of a specialty sales force to market our prescription cough products
- Put in place all the resources to develop candidate products for FDA approval