UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_______________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________________________________________
`
`TWI PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`MERCK SERONO SA,
`Patent Owner.
`_________________________________________________
`
`Case IPR2023-00049
`Patent 7,713,947
`
`Case IPR2023-00050
`Patent 8,377,903
`____________________________________________________
`
`DECLARATION OF YOGESH DANDIKER, Ph.D.
`
`Merck 2055
`TWi v Merck
`IPR2023-00049
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`

`

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`
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`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947, 8,377,903
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`I, Yogesh Dandiker, declare as follows:
`
`I.
`
`INTRODUCTION
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`1.
`
`I am over eighteen years of age, and I am competent to testify as to
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`the matters set forth herein if I am called upon to do so.
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`2.
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`I have prepared this Declaration for consideration by the Patent Trial
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`and Appeal Board in the following Inter Partes Review proceedings: IPR2023-
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`00049 (“’049 IPR”) and IPR2023-00050 (“’050 IPR”). I understand that the
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`subject of the ’049 IPR is U.S. Patent No. 7,713,947 (“the ’947 patent”) and the
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`subject of the ’050 IPR is U.S. Patent No. 8,377,903 (“the ’903 patent”).
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`3.
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`I am a named inventor of U.S. Pat. No. 7,888,328 (“Bodor ’328”), as
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`well as PCT Application, WO 2004/087101, “Oral Formulations of Cladribine”
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`(“Bodor PCT”), which Bodor ’328 claims priority to. I understand Bodor ’328 has
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`been numbered Ex. 1029 and the Bodor PCT has been numbered Ex. 1007, in both
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`the ’049 IPR and in the ’050 IPR. I have been asked to provide a declaration as an
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`inventor of Bodor ’328.
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`4.
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`I am being compensated for my time in preparing this declaration at
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`my usual consulting rate of $800.00/hour. My compensation is in no way
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`contingent on the substance of my testimony or the outcome of this or any other
`
`proceeding. I have no interest in this proceeding.
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`1
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`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947, 8,377,903
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`5.
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`I have personal knowledge of the facts stated herein and can testify
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`competently to those facts.
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`II. BACKGROUND
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`6.
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`I am the CEO of Celista Pharmaceuticals, a start-up company based in
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`Minnesota. My professional qualifications are stated more fully in my curriculum
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`vitae, which is attached as Appendix A. Below is a brief summary of my relevant
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`education, work experience, and other qualifications.
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`7.
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`I received my B.S., M.S., and Ph.D. all from the University of Salford
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`in the United Kingdom. I received my B.S. and M.S. in 1979 and 1981,
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`respectively, in biochemistry. During my M.S. studies I was involved in the
`
`development of a diagnostic radiotracer for a company in the UK; the company
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`was later acquired by GE Healthcare. I received my Ph.D. in Physical Chemistry
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`in 1984. My Ph.D. research focused on polymers for applications including dental
`
`fillings and drug delivery systems.
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`8.
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`After graduating with my Ph.D., I joined Pfizer as a research scientist,
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`where I researched liquid formulations of drugs including prostaglandins and
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`cytotoxic drugs. I worked at Pfizer until 1987. Then, from 1987 to 1997, I worked
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`at GlaxoSmithKline (GSK), where I held several positions and ultimately became a
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`project team leader. At GSK, I was involved in the development of the Accuhaler
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`range of respiratory devices and researched a number of new drugs, including
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`ranitidine. In 1997, I moved to Roche to be the Head of Pharmacy Research &
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`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947, 8,377,903
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`Development. At Roche, I worked on the first protease inhibitors and combination
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`therapy for HIV and many other products, including Tamiflu. I was also on a
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`committee which selected drugs from screening to be progressed for development.
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`9.
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`In 2001, I joined IVAX as Director of R&D. When I joined, IVAX
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`was a generic manufacturer accustomed to conducting bioequivalence studies for
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`generic drugs. IVAX did not have the capability to conduct the more onerous
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`Phase II and Phase III clinical trials required for the approval of a drug. At IVAX,
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`I worked on the development of an oral formulation of cladribine as a treatment for
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`multiple sclerosis (MS), in partnership with Serono. Cladribine ultimately was
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`approved by the FDA as an oral treatment for multiple sclerosis, which is sold
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`under the brand name Mavenclad®.
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`10.
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`I left IVAX in 2004 to join Apotex as Vice President of Product
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`Development. In 2008, I joined Paddock Laboratories where I led research and
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`development, leading to the successful sale of Paddock to Perrigo in 2012.
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`11.
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`In 2012, I started my own pharmaceutical company, named Celista
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`Pharmaceuticals LLC, where I am developing several orphan drugs in the areas of
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`oncology and infectious diseases. Celista has successfully developed multiple
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`drugs which have orphan drug designation from the FDA. We are also working on
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`several women’s health products for conditions for which there are currently no
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`
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`3
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`effective treatments, such as cervical cancer. I am also running clinical trials for
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`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947, 8,377,903
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`products to treat neurogenic orthostatic hypotension, another orphan drug
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`indication.
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`III. DEVELOPMENT OF CLADRIBINE FORMULATION
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`12. Cladribine is a chlorinated purine analog, 2-chloro-2’-deoxyadenosine
`
`(“2-CdA”). I joined IVAX in the UK in 2001, after IVAX licensed the right to
`
`develop cladribine for treating MS from the SCRIPPS Research Institute and
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`Johnson & Johnson. As director of R&D at IVAX, I was responsible for managing
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`the development of formulations for cladribine. My colleagues at IVAX included
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`Dr. Nicholas Bodor, who was IVAX’s Chief Scientific Officer and my co-inventor
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`of Bodor ’328; Dr. Stephen Marcus; and other team members.
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`13. Ultimately, my team at IVAX focused on developing an oral
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`cladribine formulation, while we partnered with Serono to design and conduct
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`Phase III clinical trials for MS patients, as discussed below. My team at IVAX
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`investigated many potential formulations of cladribine. We particularly
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`investigated cyclodextrin-cladribine complexes, which resulted in our invention of
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`an oral formulation of cladribine including a cladribine-cyclodextrin complex, as
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`described in Bodor ’328.
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`4
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`IPR2023-00049, IPR2023-00050
` U.S. Patent Nos. 7,713,947, 8,377,903
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`A.
`
`IVAX PARTNERSHIP WITH SERONO
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`14. Because IVAX lacked the funding, clinical, regulatory, and marketing
`
`expertise to design and conduct Phase II or III clinical trials to obtain regulatory
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`approval for cladribine to treat MS, IVAX needed to partner with another company
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`to complete the development and seek approval for cladribine. In 2002, IVAX
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`entered into an exclusive worldwide product development and license agreement
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`with Ares Trading, S.A., an affiliate of Serono, S.A., (collectively, “Serono”) to
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`develop and commercialize cladribine for treating MS. Under our joint research
`
`and development agreement with Serono, IVAX was responsible for developing a
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`suitable oral formulation of cladribine. Serono’s role was to design and develop a
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`dosing regimen for treating MS with cladribine, design and conduct Phase III
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`clinical trials, obtain regulatory approval, and market and sell the final product.
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`15. Under the joint research and development agreement, the IVAX and
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`Serono teams communicated frequently and confidentially. That included frequent
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`meetings and emails to share information in support of IVAX’s development of
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`cladribine tablets, Serono’s design and development of cladribine dosing regimen,
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`and Serono’s planning for Phase III clinical trials. I sometimes emailed directly
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`with Dr. Munafo. These confidential communications included IVAX’s progress
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`on oral cladribine compositions and related pharmacokinetic studies as well as
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`Serono’s progress on designing a safe and effective cladribine dosing regimen for
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`proposed Phase III clinical trials for treating MS patients amongst other aspects of
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`IPR2023-00049, IPR2023-00050
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`the clinical design.
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`16. For example, in August 2003, I and several of my colleagues attended
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`a meeting with the Serono team in Amsterdam. I have been provided a copy of
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`minutes from that meeting by Patent Owner’s counsel. Ex. 2050.1 It appears to me
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`that those minutes accurately summarize the meeting, and I am not aware of any
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`inaccuracies in those minutes.
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`17. At that meeting, members of both teams presented their progress.
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`That included my colleague, Dr. Stephen Marcus, who presented on IVAX’s Phase
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`I studies of oral formulations of cladribine. Ex. 2050, 2-3. I gave a presentation
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`on four formulations we had developed and were investigating. Ex. 2050, 3-4. Dr.
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`Maria Lopez-Bresnahan from Serono presented a Phase III study design. Ex.
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`2050, 4-5. And other individuals from Serono presented on regulatory strategy.
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`Ex. 2050, 5-6.
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`18.
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`In December 2003, I recall receiving a draft regulatory Briefing
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`Document from Serono. I was asked to review the Chemistry, Manufacturing, and
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`Controls section of that document, and I believe I did. I have been provided a copy
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`1 All citations to Patent Owner’s exhibits are in reference to Patent Owner’s
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`exhibits filed contemporaneously in IPR2023-00049 and IPR2023-00050.
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`
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`of a regulatory Briefing Document dated December 2003 by counsel. Ex. 2049. It
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`IPR2023-00049, IPR2023-00050
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`appears to be the document I received in December 2003, and I am not aware of
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`any differences between this document and what I received at that time.
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`B.
`
`INVENTION OF THE COMPLEX CLADRIBINE-
`CYCLODEXTRIN COMPLEX
`
`19. My team at IVAX filed several patent applications related to our work
`
`on oral formulations of cladribine. I understand that IVAX filed U.S. Provisional
`
`Patent Application Nos. 60/458,922, 60/484,756, and 60/541,247 between March
`
`24, 2003 and February 4, 2004. Ex. 2044; Ex. 2045; Ex. 2046. I understand all
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`three were directed to aspects of Dr. Bodor’s work on cladribine-cyclodextrin
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`complexes and all three named only Dr. Bodor as an inventor.
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`20.
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`I understand that on March 25, 2004, IVAX also filed two provisional
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`patent applications entitled “Cladribine Regimen for Treating Multiple Sclerosis.”
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`’049 Ex. 1007, 23:24-29; ’050 Ex. 1007, 23:24-29. I was not aware of either
`
`application. I do not believe either Dr. Bodor or I was named an inventor. I am
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`unaware of the content of either application. I am not aware of anyone at IVAX
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`who was working on developing or researching a cladribine dosing regimen for
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`treating MS, nor anyone at IVAX who invented a cladribine dosing regimen for
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`treating MS. Indeed, I understand that during the prosecution of a U.S. patent
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`related to the Bodor PCT and Bodor ’328, the references to these two provisional
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`IPR2023-00049, IPR2023-00050
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`applications were deleted from the patent specification, and it was stated that:
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`These were provisional applications which were abandoned without
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`the filing of non-provisional applications based thereon. Further, they
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`were not for inventions of the present inventors and belonged to a
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`former assignee. They were not made available to the public. In the
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`parent case, now patented (Application No. 12/986, 310), the sentence
`
`in question was deleted during prosecution, by an amendment made
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`October 3, 2008. Accordingly, page 23 of the specification has been
`
`amended to delete the final sentence on page 23, consistent with the
`
`parent.
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`Ex. 2047, 10. I have no reason to doubt the amendment is accurate. The reference
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`to these two provisional patent applications was similarly removed from Bodor
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`’328. Ex. 2072, 3.
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`21. On March 26, 2004, IVAX filed the Bodor PCT, later published as
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`WO 2004/087101, which named me and my colleague Dr. Bodor as inventors.
`
`The Bodor PCT was directed to oral formulations of cladribine IVAX was
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`developing—solid oral dosage forms containing particular amorphous mixtures of
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`cladribine-cyclodextrin complexes.
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`8
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`IPR2023-00049, IPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
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`22. On November 14, 2006, IVAX filed Bodor ’328. Bodor ’328 claimed
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`priority to the Bodor PCT and named me and my colleague Dr. Bodor as inventors.
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`Bodor ’328 was directed to oral formulations of cladribine IVAX was
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`developing—solid oral dosage forms containing particular amorphous mixtures of
`
`cladribine-cyclodextrin complexes. It contains essentially the same disclosure as
`
`the Bodor PCT.
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`23. Bodor ’328 and the Bodor PCT describe amorphous cladribine-
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`cyclodextrin complexes that contain an “amorphous admixture of (a) an
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`amorphous inclusion complex of cladribine with an amorphous cyclodextrin and
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`(b) amorphous free cladribine associated with amorphous cyclodextrin as a non-
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`inclusion complex.” ’049 Ex. 1007 [Bodor PCT], 14-16, 33-39; ’050 Ex. 1007,
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`14-16, 33-39. Because this formulation contains both an inclusion complex and a
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`non-inclusion complex of cladribine, it is described as a “complex cladribine-
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`cyclodextrin complex.” ’049 Ex. 1007, 16; ’050 Ex. 1007, 16. This complex
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`cladribine-cyclodextrin complex can “be saturated with cladribine.” ’049 Ex.
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`1007, 14, 16; ’050 Ex. 1007, 14, 16. For example, an amorphous form of this
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`composition can be created by freeze drying (lyophilizing) a solution of
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`cyclodextrin that is saturated with cyclodextrin at high temperature. ’049 Ex.
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`1007, 12-21, 26-33; ’050 Ex. 1007, 12-21, 26-33.
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`9
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`IPR2023-00049, IPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
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`24.
`
`I understand that certain disclosures in Bodor ’328, which are similar
`
`to disclosures in U.S. Provisional Application No. 60/541,247 (“the ’247
`
`Provisional”) and the Bodor PCT, are at issue in the inter partes review
`
`proceedings. Specifically, Bodor ’328 states:
`
`At the present time, it is envisioned that, for the treatment of multiple
`
`sclerosis, 10 mg of cladribine in the instant complex cladribine-
`
`cyclodextrin complex in the instant solid dosage form would be
`
`administered once per day for a period of five to seven days in the
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`first month, repeated for another period of five to seven days in the
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`second month, followed by ten months of no treatment.
`
`’049 Ex. 1029, 13:19-25; ’050 Ex. 1029, 13:19-25. The Bodor PCT
`
`contains the same language. ’049 Ex. 1007, 23:15-20; ’050 Ex. 1007,
`
`23:15-20. The ’247 Provisional contains similar language:
`
`At the present time, it is envisioned that, for the treatment of multiple
`
`sclerosis, 10 mg of cladribine in the instant complex cladribine-
`
`cyclodextrin complex in the instant solid dosage form would be
`
`administered once per day for one week in the first month, repeated
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`for another week in the second month, followed by ten months of no
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`treatment.
`
`Ex. 2046, 20:6-10.
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`10
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`IPR2023-00049, IPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
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`25.
`
`I did not invent the dosing regimen disclosed in Bodor ’328, the
`
`Bodor PCT, and the ’247 Provisional. Nor, to the best of my knowledge, did
`
`anyone else on my team at IVAX, including Dr. Bodor. In fact, to the best of my
`
`knowledge, no one on my team at IVAX developed, researched, or invented any
`
`cladribine dosing regimen for treating MS. I am not aware of anyone at IVAX
`
`who was working on developing or researching a cladribine dosing regimen for
`
`treating MS. And I am not aware of any cladribine dosing regimen invented by
`
`any member of the IVAX team. We did not claim the above identified regimen in
`
`Bodor ’328, and we did not claim it in the BODOR PCT or the other related U.S.
`
`patent, No. 8,785,415. Ex. 1029; Ex. 1007; Ex. 2029.
`
`26.
`
`Serono was responsible for any research and development regarding
`
`proposed dosing regimens to be used in Phase III clinical trials of the oral
`
`cladribine formulation that my team and I developed. I believe Serono and IVAX
`
`followed that division of responsibilities. This division represented our respective
`
`organizational expertise. To the best of my knowledge, Serono was the only group
`
`developing a dosing regimen for cladribine between 2002 and 2004.
`
`27. Between 2002 and 2004, the IVAX and Serono teams met regularly to
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`discuss the development of cladribine for treating MS, and we also communicated
`
`via e-mail. Because Serono researchers, and not IVAX, were working on
`
`developing proposed dosing regimens of cladribine for treating MS, I believe that,
`
`11
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`IPR2023-00049, IPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
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`as part of the joint research and development agreement, Serono communicated the
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`dosing regimen disclosed in Bodor ’328, the ’247 Provisional, and the Bodor PCT
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`to me, Dr. Marcus, and other members of the IVAX team.
`
`28.
`
`I note that the August 2003 meeting minutes and the December 2003
`
`Briefing Document provided to me by counsel describe dosing regimens that are
`
`substantially the same as the dosing regimen described in Bodor ’328 (and the ’247
`
`Provisional and the Bodor PCT). Those documents include the disclosure of at
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`least (1) a “low dose” arm with a dosing regimen of 10 mg cladribine tablets each
`
`day for 5 consecutive days each month for 2 months; (2) a yearly dosing regimen
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`including a 6-month dosing phase with 6 dosing cycles (one each month) and a 6-
`
`month non-treatment period; and (3) a 6 monthly dosing cycle that administers the
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`“low dose” arm through 2 months of cladribine, followed by 4 months of placebos
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`to “fill out high dose cycles.” Ex. 2050, 4; Ex. 2049, 47-51. In particular, the
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`December 2003 Briefing Document discloses a regimen including 2-months of
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`cladribine, 4-months of placebos, then 6-months where no pills were administered,
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`i.e., a 2-month cladribine dosing period followed by a 10-month cladribine-free
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`period. Ex. 2050, 4; Ex. 2049, 47-51. I recall attending the August 2003 meeting
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`and receiving the December 2003 Briefing Document, and both appear to be
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`accurate.
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`12
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`IPR2023-00049, IPR2023-00050
`U.S. Patent Nos. 7,713,947, 8,377,903
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`believe that the Serono team communicated additional details about
`29,
`their dosing regimen to me andthe rest ofthe IVAX team in additional other
`
`meetings and emails before February 2004.
`30.
`In signing this declaration,I understandthat the declaration will be
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Patent and Trademark Office.
`
`I acknowledgethat I may be
`
`subject to cross-examinationin this case and that cross-examination will take place
`within the United States. If cross-examination is required of me, I will appear for
`
`cross-examination within the United States during the time allotted for cross-
`
`examination.
`
`31.
`
`I declare that all statements made herein of my knowledgeare true,
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`and that all statements made on information and belief are believed to be true, and
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`that these statements were made with the knowledgethat willful false statements
`
`and the like so madeare punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code.
`
`
`
`Dated: February22, 2024 By:YDeer
`
`
`
`
`
`Yogesh Dandiker, Ph.D.
`
`13
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`

`APPENDIX A
`APPENDIX A
`
`

`

`NAME: Yogesh Dandiker
`
`POSITION TITLE: CEO, Celista Pharmaceuticals LLC
`
`CURRICULUM VITAE
`
`
`
`EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing,
`include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)
`DEGREE
`Completion Date
`(if applicable)
`MM/YYYY
`
`FIELD OF STUDY
`
`
`Biochemistry
`Biochemistry
`Physical Chemistry
`
`Business
`
`
`
`INSTITUTION AND LOCATION
`
`University of Salford, UK
`University of Salford, UK
`University of Salford, UK
`
`Open University Business School, UK
`
`
`
`
`
`
`
`B.Sc.(Hons)
`M.Sc.
`Ph.D.
`
`MBA
`
`
`
`1979
`1981
`1984
`
`1993
`
`
`
`
`
`A. Personal Statement
`
` I
`
` am the CEO of Celista Pharmaceuticals, a start-up company based in Minnesota. I have extensive
`experience in drug development. During my M.Sc., I was involved in the development of a diagnostic
`radiotracer for a company in UK, the company was later acquired by GE Healthcare. During my P.hD, I worked
`on polymers, applications for which include dental fillings and drug delivery systems. I have developed a large
`number of pharmaceutical products for various pharmaceutical companies, for instance I developed the range
`of Accuhaler respiratory devices for GSK, I worked on the first protease inhibitors and combination therapy for
`HIV and Tamiflu when at Roche. At Ivax, I worked on Movenclad, the first oral treatment for multiple sclerosis.
`At Paddock Laboratories, I led Research and Development, leading to the successful divestment of Paddock to
`Perrigo.
`
`At Celista, I am developing several orphan drugs in oncology and anti-infectives areas for which I have orphan
`drug designations from FDA. I am also working on several women’s health products for conditions for which
`currently, there are no effective treatments, for example, we have developed a product for cervical cancer.
`
`More recently, we are running clinical trials for a product for neurogenic orthostatic hypotension.
`
`
`Publications:
`
`Cundall, R. B., Dandiker, Y. M., Davies, A. K., and Salim M. S., 1987, Radiation Curing of Polymers, D. R.
`Randell, ed., Royal Society of Chemistry, London, p. 172–183.
`
`Geraghty, P. B., Attwood, D., Collett, J. H., Sharma, H., and Dandiker, Y. (1997). An investigation of the
`parameters influencing the bioadhesive properties of Myverol 18–99/water gels. Biomaterials 18, 63–67. doi:
`10.1016/s0142-9612(96)00087-7
`
`Davies AK, Cundall RB, Dandiker Y, Slifkin MA. Photo-oxidation of tetracycline absorbed on hydroxyapatite in
`relation to the light-induced staining of teeth. J Dent Res. 1985;64:936-939.
`
`
`
`
`i
`
`

`

`Bennett, F.S., Carter, P.A., Rowley, G., and Dandiker, Y. Modification of electrostatic charge on inhaled carrier
`lactose particles by addition of fine particles. Drug Dev Ind Pharm. 1999; 25: 99–103
`
`Malton A, Sumby BS, Dandiker Y. A comparison of in vitro drug delivery from salbutamol Diskus and
`terbutaline Turbohaler inhalers. J Pharmacol Med. 1996;6:35–48.
`
`Geraghty PB, Attwood D, Collett JH, Dandiker Y. The in vitro release of some antimuscarinic drugs from
`monoolein/water lyotropic liquid crystalline gels. Pharmaceutical Research. 1996;13(8):1265–1271.
`
`Salim MS, Cundall RB, Davies AK, Dandiker YM, Slifkin MA. Application of Photoacoustic spectroscopy to UV
`systems. Technical Paper - Society of Manufacturing Engineers.
`
`Cundall, R. B., Dandiker, Y. M., Davies, A. K., and Salim M. S., 1987, Radiation Curing of Polymers, D. R.
`Randell, ed., Royal Society of Chemistry, London, p. 172–183.
`
`(Having worked in industry, the objective is to develop and commercialize products, hence publications are
`discouraged when intellectual property is involved)
`
`Patents:
`
`
`• Dandiker, Huckle PD, (1995), Controlled Release pharmaceutical compositions. US Patent 5425950
`• Price PT, Davies MB, Rand PK, Dandiker Y, Heppenstall CR, Huckle PD, (1997), Depression for a
`tablet, US Patent D377977.
`• Dandiker Y, Huckle PD, Multi-layered compositions containing histamine or serotonin antagonists,
`(1997), EU Patent EP0546593
`• Woolfe JA, Dandiker Y, Elchidana P, (2005), Stable Gabapentin Compositions, WO 2005072736
`• Bodor NS, Dandiker Y, (2011), Oral formulations of Cladribine, US Patent 7888328.
`• Bodor NS, Dandiker Y, (2011), Oral formulations of Cladribine, US Patent 8785415.
`• Dandiker, Y.; Panchal, M.; Yu, X. (2018), Composition of Midodrine and Methods of Using the Same.
`Patent Application WO 2018/064490 A1.
`• Dandiker, Y, Panchal M, Yu, X. (2018) Droxidopa Compositions ad Methods. Patent Application WO
`2018/119323 A1.
`• Dandiker Y, Panchal M, (2019), Testosterone Transdermal spray with film, Patent Application
`PCT/US/2019/013047
`• Dandiker Y, (2019), Testosterone and Estradiol Spray, Patent Application US 62/694,365
`• Dandiker Y, Panchal M, Yu Y, (2019), Oxycodone and Methylnaltrexone Multiparticulates and
`suspensions containing them, Patent application PCT/US19/20010
`• Dandiker Y, Panchal M, Yu X, (2019), Atomoxetine Hydrochloride Extended Release Compositions and
`Methods of Use, US Application 62/866,837
`• Dandiker Y, (2019), Sprayable Lidocaine Solution, US Application 62/902,543
`• Dandiker Y.; Panchal, M.; Yu, X. (2020) Composition of Midodrine and Methods of Using the Same.
`Patent Application US 2020/0022919 A1.
`• Dandiker Y, Wong P, (2020), Application for Topical Composition. US Patent 10555592.
`• Dandiker Y, Dandiker S, (2020), Nasal lmmunotherapy for Covid-19, US Application 63/042704.
`• Dandiker Y, Imiquimod Co-Crystals, (2020) US Application 63/054019.
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`• Dandiker Y, Topical Atomoxetine and Oxybutynin for Obstructive Sleep Apnea, (2023) US Application
`63/446,083
`• Dandiker Y, Topical Treatment of Arboviral Infections, USA Application (2023) 18/223,678
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`Jan. 2012-
`Present
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`Positions and Employment
`
`Celista Pharmaceuticals
`CEO, Minneapolis, MN
`
`
`Paddock Laboratories, Inc.; Minneapolis MN
`Senior Vice President.
`
`Member of the Executive management team leading Paddock’s R&D
`efforts culminating in divestment of Paddock Labs to Perrigo.
` Provided leadership of the Pharmaceutical Development and Program
`Management.
` Assured continued growth in resources and capabilities within R&D.
` Collaborated closely with Business Development to provide scientific
`guidance to development partners and key contributor to the Product
`Selection Process.
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`Aug. 2008-
`Oct. 2012
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`March 2004 -
`July 2008
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`July 2001-
`Feb. 2004
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`Apotex, Inc.; Toronto Canada
`Vice President, Product Development
`
`Responsible for Development for Toronto-based sites.
` Directed personnel at India and New Zealand R&D site.
` Directed development activities of groups based in Brazil,
` Member of several management committees that served the wider Apotex
`business.
`
`
`
`IVAX Pharmaceuticals Ltd; UK
`Director, R&D, UK, Ireland & India
`
`
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` Managed generic product development from product selection to API
`selection, to formulation and analytical development, to conducting
`biostudies, input of submissions and launch of products both in Europe
`and the U.S. on patent expiry.
` Responsible for R & D groups based in UK, Ireland and India.
` Spearheaded proprietary medicine development in Europe.
` Significant input in patent and business development strategies.
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` Responsible for pharmaceutical research and development and early clinical studies.
` Extensive interaction with personnel at all levels; particularly with staff
`in marketing, research, primary and secondary production sites and
`regulatory authorities. Developed the first combination HIV drugs and anti-virals for Roche,
`e.g.Tamiflu
`
`
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`November 1987-
`May 1997
`
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`
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`Glaxo Ltd, UK
`
`Project Team Leader (September 1995-May 1997)
`Research Leader (February 1994-September 1995)
`Project Leader (February 1989-February 1994)
`Senior Research Scientist (November 1988-July 1989)
`Research Scientist (November 1987-July 1988)
` Worked with several NCE’s and line extension projects.
` Sustained and modified release oral drug delivery systems.
` Development activities related to compounds for gastric disorders, in particular Ranitidine
`and its successors.
` Developed several multi-dose dry powder inhalation systems for use in asthma e.g.
`Accuhaler and Diskhaler.
` Responsible for formulation, analytical development, scale-up and technology transfer.
` Responsible for selection and early development of pipeline compounds.
` Completed MBA while at Glaxo-Wellcome.
`
`
`Pfizer, UK
`
`Roche, UK
`
`Head of Pharmacy Research & Development
`Formulation/Analytical/Clinical Trials /Drug Delivery
`
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`May 1997-
`July 2001
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`February 1985-
`November 1987
`
`Formulation Research Scientist
`Parenteral/Controlled Release Systems
`
`
` Worked primarily with liquid formulations of NCE’s, mostly prostaglandins and cytotoxic
`drugs.
` Conducted significant amount of work on transdermal and semi-solid (emulsions and gels)
`controlled release systems.
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`B. Contributions to Science
`
`When at GSK, I was involved in the development of a number of dry powder multi-dose products for asthma, in
`particularly the Accuhaler range of products (Flixotide, Seretide, Serevent), which were launched by GSK for
`marketing worldwide. Amongst other projects, at Roche I was involved principally in the development of the
`first HIV combination therapy drugs (Invirase and AZT for example) and other anti-virals (Tamiflu).
`
`More recently, I have filed patents for Midodrine ER Tablets for symptomatic neurogenic orthostatic
`hypotension (nOH). nOH is an orphan condition as it affects < 200,000 people in the US. Similarly, we have
`developed a once-a-day Droxidopa suspension for nOH. Droxidopa is a prodrug, which is converted to
`norepinephrine, increases BP, and improves symptoms of nOH. The drug is indicated largely for Parkinson’s
`patients and therefore we have developed an extended release suspension which is easy to swallow, the
`suspension is housed in a novel patentable bottle which has been developed so that Parkinson’s patients can
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`easily open the bottle. The type of packaging developed for this project may be useful for the elderly population
`for other products too.
`
`
`• Dandiker, Y.; Panchal, M.; Yu, X. (2018), Composition of Midodrine and Methods of Using the Same.
`Patent Application WO 2018/064490 A1.
`• Dandiker, Y, Panchal M, Yu, X. (2018) Droxidopa Compositions ad Methods. Patent Application WO
`2018/119323 A1.
`Other products recently developed: Around 40% of cancer patients are administered opioids for pain. However,
`within a week of administering the medication, patients become constipated. I have developed an opioid
`medicine which addresses mu receptors for both pain and constipation, is easy to swallow and has been
`especially developed for cancer patients.
`
`
`• Dandiker Y, Panchal M, Yu Y, (2019), Oxycodone and Methylnaltrexone Multiparticulates and
`suspensions containing them, Patent application PCT/US19/20010
`I have also developed a Testosterone / Estradiol spray product to address hypoactive sexual desire disorder
`(HSDD) in post-menopausal women and have obtained positive FDA feedback for the required studies. This is
`the the first product for HSDD for post-menopausal women, potentially, a large group of patients with an unmet
`medical need.
`
`
`• Dandiker Y, (2019), Testosterone and Estradiol Spray, Patent Application US 62/694,365
`
`
`Besides contributions to the science, I have served in senior management positions in a number of
`pharmaceutical companies which has enabled me to learn about the commercial aspects of getting a product
`to the market.
`
`C. Additional Information: Research Support and/or Scholastic Performance
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`I serve as a Scientific Advisor for Nanocopoeia, a nanoparticle drug delivery company.
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