Levolta Pharmaceuticals
A company
that reformulates products to enhance their customer value
Presenter: Ketan Desai MD, PhD,
Wednesday, January 17, 2018
Embassy Suites, Chesterbrook, Pennsylvania (directions)
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About
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Levolta Pharmaceuticals reformulates products to enhance their customer value. The Company uses existing therapies, such as zoledronic acid, and modifies them to improve the overall effectiveness of the therapy. VOLT01 (zoledronic acid), the Company’s lead product to test this platform, has demonstrated superior efficacy and safety in patients with knee osteoarthritis and has advanced to phase III clinical trials. It has the potential to be the first disease modifying treatment for osteoarthritis with blockbuster sales. Mission - Overcome current treatment barriers by reformulating late-stage products, resulting in significantly less development costs and an enhanced therapeutic index.
The current problem within the pharmaceutical industry is two-fold; 1) new drug development is lengthy and very expensive, leading to 2) a lack of effective new therapies to treat the ailments of consumers. Pharmaceutical development is risky due to the high upfront costs to develop, test and release new products. Many potential products fail in the clinical trials stage, or do not gain FDA approval, causing companies to absorb the sunk costs associated with product development.
The pharmaceutical industry continues to experience a high degree of clinical development failures and corresponding costs, which drive escalating consumer costs upon product approval. These risks have led to big pharmaceutical companies scaling down on R&D investments and evaluating business development opportunities for portfolio growth. The Generic industry is also experiencing risk, as profit margins have sunk to all-time lows which has led to M&A's with "Ethical / Branded" pharmaceutical companies.
To overcome these problems inherent in the industry, Levolta has created a re-formulation platform to enhance a product’s probability of success (testing and development), provide an enhanced therapeutic index and significantly reduce the development time lines by using 505(b)(2) regulatory filings, thus decreasing time lines by 8-10 years.
Levolta Pharmaceuticals, Inc. was incorporated in October, 2013 in the state of Pennsylvania as a C-corporation. It is located within the Ben Franklin Technology Partners, Northeastern PA TechVentures Facility at 116 Research Drive, Bethlehem, PA 18015. The Company was formed through the collective mergers of IMC Biotechnology and Renascence Pharmaceuticals. The Company has three founders: Ketan Desai (former CEO of Renascence), Renee Stewart (former CEO of IMC Biotech.) and Richard P. Becker Jr. (CEO of Levolta). All three of the founders also represent the current number of employees within the Company.
3 Major Issues
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- Currently, there is a great deal of excitement around immuno-oncology, much less around reformulation/recombination therapies (e.g. osteoarthritis). What can we do to generate excitement and enthusiasm for VOLT01 and osteoarthritis.
- Potential investors and partners ask about a physician work around in which the physician uses the two available generic products and infuses them together. Our answer has been that neither component is approved for treatment of OA, so the work around would expose the physician to regulatory, legal, reimbursement and medical risk, with little gain. This response assumes a pricing structure for VOLT01 that is not egregious.
A. How can we effectively address this concern? and
B. Since we receive this question fairly often, should we address it upfront in the presentation?
- In our current Phase II plan we have two cohorts - VOLT01 and placebo. Is there any reason to think the FDA would require a cohort of zoledronic acid and/ormethylprednisolone? As mentioned in Q#2, neither are approved for treatment of osteoarthritis.
Program:
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6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)
8:00 - Ketan Desai MD, PhD, CMO of Levolta will deliver "Elevator" Pitch to the Group
8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.
9:00 - Open discussion: members and guests
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 Slides
None available at this time
 Audio
None available at this time
 Video
None available at this time
 Webcast
Levolta Webcast - 01/17/18
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