Eastgate Biotech Corp. Ticker Symbol (ETBI)
https://finance.yahoo.com/quote/ETBI?ltr=1
EastGate Biotech Corp. (OTC: ETBI), a pharmaceutical company that focuses on innovative technological developments specifically in insulin drug delivery for the treatment of type 2 diabetes, signed a definitive agreement effective August 10th, 2018 with Nico Innovagroup S.r.l. with its principal headquarters in Brescia, Italy. The definitive agreement encompasses the license of the company's liquid insulin mouth rinse solution for a period of 15 years in the European market in exchange for milestone payments and a royalty up to a 10% of the drug sales.
The terms of the definitive agreement mirror the previously announced Memorandum of Understanding and are related to the European licensing and distribution of the liquid insulin mouth rinse. The European license included 28 countries. Additionally, Nico Innovagroup will be responsible for the manufacturing and distribution of EastGate's nutraceutical products. Nico Innovagroup's licensing agreement is assignable, and Nico Innovagroup is already proceeding to transfer the agreement to the new incorporated subsidiary company Nico Innovapharma S.r.l., that will operate with a consortium of several mid-sized European pharmaceutical companies with the aim to approach much larger pharmaceuticals and to form a distribution framework capable of quickly bringing to market the oral insulin mouth rinse after receiving regulatory approval.
According to the terms of the definitive agreement, milestone payments will commence immediately.
The first milestone payment is an equity offering for 2.0 million preferred stock with priority position in the intellectual property of the liquid insulin mouth rinse. The preferred stock pays no dividend and simply gives the preferred shareholders priority treatment in the event of dissolution of the company and is convertible into common on a 1 for 1 basis. $2.0 million is due within 60 days of signing in exchange for 2.0 million preferred shares of ETBI at a price of $1.00/ share.
$8.0 million upon the successful completion of a phase 2 study on the liquid insulin mount rinse from the Philippines or any other market in which EastGate or is partner are able to conduct a trial.
$20 million investment for the purposes of funding the clinical trial expenses necessary to secure EMA regulatory approval. In the event the budget exceeds $20 million Nico Innovagroup will be granted additional shares at the price of $.50/share.
$8 million milestone payment no later than 60 days after EMA approval of a marketing license provided the budget is not exceeded. In no case will the milestone payments be less than $4.0 million
This is a 15-year agreement
Up to 10% Royalty Fee
"We are pleased to be working with Nico Innovagroup S.r.l, a private European investor, who recognizes the important role that oral insulin will play increasing patient compliance," said Anna Gluskin, CEO of EastGateBiotech. "We think we have found the ideal partner that can not only go after the underserved markets in the European region, but also go after the mainstream market controlled by big pharma. These entrenched relationships with big pharma are immeasurable. This sort of blanket coverage should have a profound impact on market penetration and patient compliance. The only real way existing pharmaceuticals can grow the diabetes market is through patient compliance. Studies have shown that patient compliance which results in glycemic controls is only 55%*. This means that 45% of type 2 diabetes (T2D) patients fail to achieve glycemic control and are primarily not taking their medicine as directed. With our oral insulin mouth rinse our partners feel confident that they will be able to target this non-compliant market including those with needle phobia. In general needle phobia effects over 20%** of the general population and our partners recognize the paradigm shift that will occur when oral insulin is available."
Rose, President of EastGate said, "Our overall game plan for the global market is growth through licensing and we believe this investment validates our licensing strategy going forward. The International Diabetes Foundation estimates that 66 million people in Europe have diabetes and 41 million people have impaired glucose intolerance. This is a very serious market and our partners are resolute that after 90 years trying to come up with an oral version of insulin that the timing is perfect for a widespread rollout of the oral Insulin mouth rinse should we achieve regulatory approval. Details of our clinical development are soon to follow."
Stock Ticker : ETBI,OTC PINK: ETBI