Strategy

Strategy

Anew Biotechnology Inc.’s partnership with Reliance Life Sciences (RLS) provides the company with Phase III-ready Monoclonal Antibodies (mAbs) that were successfully developed by RLS and approved for marketing in India and other major countries as a highly similar biosimilar. Anew Biotech has licensed exclusive rights to the RLS data and the processes for making the mAbs in our territories of North America, Europe, Israel, and emerging market countries. After a “gap analysis”, the experts at Anew Biotech meet with the European EMA and U.S. FDA regulatory authorities to review the data and provide comments on Anew’s clinical and statistical plan for the Phase III pivotal international study. Anew Biotech then hires a contract research organization (“CRO”) to file the IND and implement the Phase III study plan, while Anew prepares for commercial launch in emerging markets using the RLS dossier and in-country marketing and distribution expertise. Then, Anew will prepare for market launch and education in the major markets of the U.S., Europe, Israel, and other highly regulated markets. Other expert global partners are hired for unique functional expertise, including a strategic partnership with a sterile fill and finish contract manufacturing organization (“CMO”) and ex-U.S. in-country consulting experts to provide local clinical, regulatory, marketing and distribution support in emerging markets. Thus, Anew Biotechnology Inc. will commercialize follow-on biologics in ex-U.S. territories through licensing and partnerships, while retaining commercialization rights in the U.S. and Canada. This licensing structure will provide a long-term, self-sustaining profit stream.

Anew Biotechnology Inc.  employs a highly efficient and proven business model. The essence is the utilization of experts in manufacturing, testing, logisitics, regulatory affairs, clinical trials, and key opinion leaders on a contract service basis. The CROs provide defined and detailed activities in a pre-agreed timeline and budget, and with well vetted deliverables. The Management Team closely manages each CRO’s activities and defines and “de-risks” each potential hazard along the way. When activities or deliverables are not required, the service provider “goes away” and is not salaried or retained on a permanent basis. Thus, each entity – consultant or CRO – is an independent consultant and is not “carried” by the Company as far as benefits, bonuses, or equity ownership. In some cases, CROs or service providers may take equity instead of cash payments for services, but this is limited and not common to our service providers. The Company will utilize contract sales organizations (CSOs) in the U.S., Japan and Europe to train their staff to detail our products. Oncology focused CSOs are common and highly experienced in the processes of product launch, marketing, sales, and follow-up for oncology drugs and biologics. Likewise, logistics providers in the medical product distribution area are utilized to ship product under appropriate temperature requirements, as all of these products require refrigeration and are not stable at room temperature or at elevated temperatures, nor are they stable when frozen.

Our Strategy ProcessOur business model is highly cost-efficient, and capital is not required to build manufacturing infrastructure saving Anew hundreds of million of dollars in construction and ongoing maintenance, and saves us years of time. Likewise, we do not have teams of scientists and technicians and support people that are a drain on resources on an ongoing basis. We do not have a full time medical and clinical CRA staff of 30-40 people running studies as this is done by the CROs. Regulatory affairs staff are contracted for auditing, documentation, dossier submissions and follow-up, and communications with regulatory agencies. By eliminating this “full-time” burn rate paying a staff of hundreds, by proper scheduling of activities and deliverables, and with low overhead, our profit margins and expenses have been minimized for efficiency.

 

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