Our company has a strong focus on value creation, and expanding our drug product portfolio. Partnership with other members of the industry is one means of achieving this. If you are looking for a strategic US partner or seeking to increase your current sales volume, Micelle BioPharma has the initiative and expertise to help you achieve your drug development, filing, sales and distribution goals. We have ample experience in successful tech transfer, and we are poised to collaborate via in-licensing of your potential drug product or out-licensing our proprietary technology.
Micelle BioPharma is an integrated pharmaceutical company with a dedicated team of specialists driven to take your drug product from early development to market. Our regulatory team has the experience to assist with your New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) filings, ensuring timely and effective navigation of the FDA filing process. Our on-site Clinical team can support your clinical strategy, and our full suite of laboratory, manufacturing, and quality services can provide the necessary Chemistry, Manufacturing, and Controls (CMC) solutions for your drug.
Once your drug is approved in the US, Micelle BioPharma has an established, unique distribution channel to provide upside volume sales that typically does not infringe on traditional US distribution and marketing models. Micelle BioPharma has an inside call center, warehousing, pick and pack and distribution to eliminate the need for third-party logistics services.
Our business development activities are focused on:
- ANDA products that are in late-stage development or currently approved for the US;
- Assisting partners with the US filing of drug products approved outside of the US; and
- Life cycle management of existing commercial products through the application of our proprietary formulation platform Advance Lipid Technologies® (ALT®) to be filed as a 505(b)(2) NDA.
Micelle BioPharma is one of only three approved contract US manufacturing facilities for soft gel drug products. We are the only FDA-inspected drug manufacturing facility in the United States that can manufacture and package your soft gel product into bottles at the same facility. Micelle BioPharma offers complete end-to-end services from analytical development and validation, pre-formulation, deformulation, and formulation development to cGMP manufacturing and quality control testing of clinical supplies, and commercial pharmaceutical products, as well as stability storage and testing at our facility in Riviera Beach, Florida.
We will consider in-licensing, acquisition, co-promotion, revenue-sharing, and other partnering opportunities.
ADVANCED LIPID TECHNOLOGIES® TECH TRANSFER
Micelle BioPharma maintains a team of highly specialized scientists who focus on developing cutting-edge formulations and technologies and have had more than a decade of research in the field of lipophilic compound formulation. Micelle BioPharma has a dossier of trade secreted information including laboratory data, diversified expertise, and competitive intelligence which contribute to our Advanced Lipid Technologies (ALT) platform. Micelle BioPharma’s ALT platform provides a systematic approach, based on cummulative laboratory data and significant scientific expertise, specifically designed to enhance the bioavailability of lipophilic compounds. Although only a fraction of the ALT information has been released into the public domain, unleashing the power of ALT has resulted in over 50 issued patents.
The novel formulation technology has clinically been demonstrated to:
- Create engineered micelles in vivo, allowing for improved lipid API absorption
- Enhance bioavailability of lipid and lipophilic materials
- Allow for lower dosing, up to 50% less than competitors, potentially smaller and easier to swallow capsules than currently available treatment
- Reduce or eliminate the food effect
- Enhance consistency of efficacy of lipids and lipophilic materials
We believe ALT’s mechanism of action has demonstrated the ability to increase the bioavailability of previously insoluble or poorly absorbed compounds, including hormones, Omega-3 ethyl esters, and other lipid-based or lipid-soluble compounds, thereby potentially increasing efficacy and patient compliance.
Current ALT Applications that have been clinically tested:
- Essential Fatty Acids: customized ratio for global applications
- Hormone: individual or in combination
- Antibiotic (under development)
If you seek the expertise of a solid scientific partner to help advance the IP portfolio of your lipophilic drug compound, Micelle BioPharma should be your partner of choice. Our ALT platform is the ideal solution to overcome low bioavailability, food effects, liver toxicity, first pass effects, and other significant challenges faced by lipophilic APIs. We also have significant experience with non-lipophilic compounds. If you would like to grow the IP portfolio of your API while improving the likelihood of success in product commercialization in today’s ever more competitive market, please contact us today for a free evaluation.