Dawah Pharmaceuticals Inc. is envisioned to be a state-of-the-art pharmaceutical facility for sterile injectables and sterile ophthalmics, with adjoining development laboratories and pilot plants. Its founders and senior associates bring to the endeavor cumulative experience of over 200 years in top-tier pharmaceutical establishments in the US, Europe, and India.
Currently, in the United States, there is a rampant shortage of critical drugs, many of them in sterile dosage space. Interestingly, the same situation prevails in Europe, GCC / MENA countries, and the Far East. Dawah plans to engage in this area, with a view to ameliorate the shortages and gain faster regulatory approvals, which FDA typically grants for drugs in shortage. Addressing these shortages will help regions and people in need of these important medications.
Complex sterile generics, liposomals, and biosimilars are very challenging to develop, scale-up and manufacture. Typically, there are few competitors for this class of drugs. These call for a high level of technical skills to develop and state-of-the-art manufacturing capability. In the next ten years or so, complex generics with cumulative revenue potential in the tens of billions of dollars are expected to come off patent. Dawah has laid out plans to enter complex generics and take advantage of this market. The disease states we plan to address are GERD, Oncology, Antifungal, Antipsychotic, and Paralytic.
Ophthalmics is in an area in which there are only a limited number of competitors. One newer development in this area is the use of patented delivery devices (dropper bottles), which enable the delivery of ophthalmic drugs without using anti-microbial preservatives. Drugs for indications like glaucoma, which require life-long therapy, are ideal candidates for preservative-free presentations. Preservatives over extended use cause irritation of the eye and often cause corneal damage. Dawah will enter this segment from the very outset.
The Dawah business plan is three-pronged. Licensing currently approved products will help market entry with minimal delay. The use of CMOs, while Dawah facility is being built and validated, will shorten time-to-market by at least 2-3 years. Dawah’s own facility (feasibility study completed) will form the third prong in the business plan. The facility project is ready to go. With the feasibility study complete we are able to proceed with hiring an engineering firm to start and complete construction.
The key to high-tech products is talented and experienced personnel. Dawah will select a facility site where there are major pharmaceutical companies with labs and manufacturing, from which Dawah plans to recruit top-tier talent.
Dawah will market and distribute products by availing highly experienced Commercial Sales Organizations (CSOs), which have access to virtually thousands of hospitals, Group Purchase Organizations (GPOs) and wholesalers.
We are very excited about Dawah Pharmaceuticals' future prospects.
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