Managing Joint Venture Arrangements Between Two Biotech Companies: A Case Report. Dr. Jan Mous Midatech / PharMida May 21 st 2014

Transcription

1 Managing Joint Venture Arrangements Between Two Biotech Companies: A Case Report Dr. Jan Mous Midatech / PharMida May 21 st

2 Midatech Ltd. Corporate verview Founded 2000 in xford, England Drug development subsidiary in witzerland, PharMida AG Accredited cgmp manufacture of Investigational Medicinal Products in pain, Midatech-Biogune Focus on Diabetes, Peptide Delivery, ncology and Infectious Diseases Advanced program in field of Diabetes JV Collaboration with Monool Rx, Inc. focusing on transbuccal delivery of Insulin and GLP-1 JV Collaboration wit Immunotope Inc. focusing on therapeutic cancer vaccines 2

3 Gold Nanoparticle (GNP) Technology Midatech Ltd. is at the forefront of the design, development, synthesis and cgmp manufacture of nanomedicines based on proprietary, self-assembling and biocompatible gold nanoparticles 3

4 Nanotechnology / Nanometer Nano-scale science/technology deals with very small objects: atoms, molecules, aggregates and surfaces, for which new instruments have to be used so that these objects can be studied, touched and structured for specific applications. 4

5 Midatech Technology The design, development and synthesis of GNPs are based on Midatech s proprietary, one step, self-assembling technology. The successful employment of MidaForm platform and know-how has led to discovery of practical nanomedicine applications through in-house and partnered drug development programs. 2 ~ 5 nm diameter NPs which allow rapid targeting of drugs/drug combinations to specific tissues or cells as well as potentially enabling transport across the blood brain barrier. First in class NPs covered by a comprehensive patent estate with global utility for pharmaceutical applications. Noble Metal Core Corona H H HH H HH H H H H H H H H H H H H H H H H H H H H H H H H H H H H HH Linkers H H HH H H H H H H H H H H H H H Compounds N H H H H H H H H H

6 PharmFilm Technology MNL TECHNLGY Patent protected film product which utilizes polyethylene oxide (PE) as a base polymer to form a content uniform dose for the sublingual, buccal, and/or enteral delivery of pharmaceutical drugs. Best-in-class film delivery technology with over $400mm in commercial pharmaceutical sales to date. PharmFilm is the first commercial stage solid dose technology to allow for the delivery of appropriately sized proteins and peptides via absorption in the oral cavity. PharmFilm provides mucoadhesion upon contact, flexible residence times & release characteristics, along with a flexible platform for meeting complex dosing requirements. Insulin PharmFilm (buccal delivery)

7 From Partnership to JV Early 2009 Midatech Ltd. and Monool Rx formed partnership dedicated to the development of a novel drug delivery platform to treat diabetes. Transbuccal delivery of insulin identified as priority project. Immediate success by demonstrating in animals that the concept was of potential commercial value. Rapid expansion of the insulin project led to multiple project considerations for the field of diabetes. The partners formed Midaol Therapeutics, a 50:50 JV, in late 2011.

8 Platform Breath and Value ynergistic Technologies = A Platform with Broad Application Combining the technologies of Midatech and Monool Rx has resulted in the creation of a delivery platform applicable to insulin, GLP-1, a combination of both insulin and GLP-1 as well as other peptides and proteins. What does this mean? Promotes the use of natural peptide hormones ffers ultra-fast delivery to blood circulation Changes the therapeutic paradigm administering peptide combinations delivered by one carrier

9 Partnership Focus MidaForm Insulin & GLP-1 ourced from Midatech 2 nm gold nanoparticles are produced using a patented self-assembly process. The insulin is conjugated with the GNPs with the result being uniform particles about 5 nm in diameter. The GNPs are then added to the formulated PharmFilm. PharmFilm ourced from Monool Rx Commercial stage company with a proprietary polymeric matrix based film which adheres to the buccal mucosa and allows for precise content uniform dosing and absorption through the buccal lining. Diabetes Focus Technology Applications 1. Insulin and analogues 2. GLP-1 and analogues 3. Fixed and Variable combinations of Insulin and GLP-1

10 Midatech Technology Converting Peptides Into Globular Proteins (MidaForm ) Insulin Carbohydrate containing Corona Gold Core ~1.7nm ~200 Units insulin/mg Au ~6.0nm toichiometry: 16 insulin molecules (monomers) / gold particle Globular insulin protein same size as HRP (Horse Radish Peroxidase) 10

11 MRx Bi-Layer PharmFilm 11

12 Project tatus Demonstrated in animal studies therapeutic levels of insulin and retention of insulin biological activity equivalent to sc injection. Completed full set of pre-clinical tox studies with no issues. Validated the production process for MidaForm Insulin and final dosage form with the ability to manufacture under cgmp. A First in Human study of MidaForm Insulin in PharmFilm was successfully completed in March This study in healthy volunteers confirmed safety of the GNP-insulin films, which showed a bioavailability of 25% and elicited pharmacodynamic responses similar to subcutaneously injected NovoRapid. A Phase 2a study in Type 1 diabetes patients is scheduled to start in Q3, Midaol started partnering discussions with global companies which have strong presence in the diabetes market.

13 ther Diabetes Projects MidaForm GLP-1 alone and MidaForm Insulin GLP-1 combo have been created and delivered in PharmFilm bservations: Increased stability of GLP-1 when attached to NP after iv injection. Achieved PM with MidaForm GLP-1 in PharmFilm in mini-pigs demonstrating strong and immediate insulinotropic effect. Combination of MidaForm Insulin + MidaForm GLP-1, and both peptides on one NP drastically reduces blood glucose peak height after IVGTT. Combination of MidaForm Insulin and MidaForm GLP-1 induces a glucagon response following IVGTT, which is not observed with MidaForm Insulin alone

14 14 Management of the Midaol JV

15 Joint Venture Wikipedia Definition: A joint venture (JV) is a business agreement in which the parties agree to develop, for a finite time, a new entity and new assets by contributing equity. In a joint venture, both parties are equally invested in the project in terms of money, time, and effort to build on the original concept. ince the cost of starting new projects is generally high, a joint venture allows both parties to share the burden of the project, as well as the resulting profits. 15

16 Midaol Therapeutics LP Midaol has its registered office on the Cayman Islands. It is a non-operational organisation. The JV has been formed to own, manage and commercialise its license in intellectual property. The business is managed by appointed Directors, representing the partners and constituting the Board of Directors. tatutory documents include a Memorandum of Association, Articles of Association, and a hareholder Agreement between the partners. The Board of Directors meets every second week by teleconference, and four times per year in a face-to-face meeting. 16

17 perational Management The JV partners share the operational management and the product development work according to the required technology, internal expertise and the status of the project. External costs are shared 50/50. The operational and budget responsibility is in the hands of a Joint teering Committee consisting of two members of each partner organisation. The JC meets every two months in a face-to-face meeting, or ad hoc by TC when project or budget decisions are to be taken. The joint project team is responsible for managing day-to-day activities and meets every week by teleconference. 17

18 Working with External ervice Providers Each partner manages the respective service providers that support the respective technology and manufacture activities. Animal experiments and pre-clinical toxicology testing is commissioned to CR s. Pre-clinical development work as well as the clinical development is managed by PharMida AG, the wiss subsidiary of Midatech Ltd, on behalf of Midaol. The FIH clinical study performed between December 11 and April 12 has been commissioned to a CR in Basel (CH), who supported CTA filing, Regulatory interactions, clinical study performance and management, study monitoring and document filing. Pharmida AG is currently organizing a second Phase 2a study, planned to start during H

19 Take Home Messages uccessful collaborations between business partners are build on mutual respect and trust. Frequent and open communication between partners on various levels (executive, operational, business) is key. mall Biotech s seldom have all expertise in house needed for a professional (pre-clinical and) clinical development. ne stop shop CR s are therefore very attractive for small Biotech s to help their clinical development. Cost awareness and budget discipline are vital. 19