Your path toward successful allergy drug development

Transcription

1 Your path toward successful allergy drug development

2 Ora has a proven track record of 19 anti-allergic product approvals from the FDA, EMA, and PMDA over the past 30 years.

3 Ora is a drug development company that has been operating in the greater Boston area for the past 35 years. We provide a complete range of development services, including preclinical models, clinical research and development, regulatory strategy, statistics and data management, medical writing, and marketing & advertising services. At Ora, we believe that our success originates from the quality of our services and the relationships we foster with our clients. The development of the next generation of anti-allergic bio-pharmaceuticals will rely on the ability to define the proper clinical and regulatory pathways, together with a precise understanding of the proper endpoints, timepoints, and therapy mechanics. At Ora, our approach is to tighten standard deviations through an enhanced level of scientific rigor, the addition Ora s success in helping to achieve new drug approavals is based on the foundation of the high level of scientific rigor that they apply to the entire drug development process to the drug development process ~Paul Ratner, MD, MBA of objective assessments, and employing stringent controls in our models. We study the underlying science of allergic disease, with a specific focus on how potential therapeutic agents may benefit our patients. Ora s pre-clinical and clinical models, unique methodologies, and regulatory strategies have been refined across thousands of projects across the globe, including hundreds of multicenter studies and dozens of phase III pivotal trials. Ora s Rhinitis and Rhinoconjunctivis models, including the Boston Chamber, Nasal Allergen Challenge (NAC), and EnviroNAC, enable the enrollment of an enriched homogeneous population. Our extensive allergy site network consists of both large population and specific-population enriched sites. This site diversity allows us to execute trials within short timelines through increased efficiency while reducing variability across different environments. When it comes down to it, no one in the world has seen or tested more allergy clinical trial participants than us.

4 Models and Methods Allergen Chambers Proprietary methods of allergen distribution ensure full dilution into the air, mitigating failures caused by inconsistent allergen exposure in studies. Accordingly all patient locations within Ora s exposure chambers are fully validated for consistent allergen levels, not just select spots within the room. No other chambers in existence are subject to such Air Inlet rigorous control of allergen levels. Pollen Flow In order to meet the demands of the various stages of drug development, we have built and validated numerous chamber configurations. Air Exhaust Adhesive Surface Air Exhaust Our 7 seat chamber is ideal for Proof of Concept, Observational, and Phase IV marketing studies. This model can quickly highlight the efficacy of a proven therapeutic, such as fluticasone propionate. The Boston Chamber, our 25 seat configuration, is ideal for integration into multi-center Phase III programs, Onset of Action and Duration of Action Studies, and High Throughput Screening. In addition to our stationary units in the Boston area, we also have the ability to conduct multi-center studies by employing our Mobile Chambers. Similar to the stationary units, we have developed an 8 seat and a 25 seat configuration to best fit the needs of your study design. We have also formed strategic partnerships to allow for the use of other stationary units around the globe, including the original Allergy Chamber at Queens University in Kingston, Ontario.

5 Nasal Allergen Challenge (NAC) Ora s standardized NAC processes include the diluation of allergen formulations and titration to ensure the safe, precise, and reproducible instillation of allergen directly to the nasal mucosa to allow for standardization across study sites. Up to ten different concentrations of allergen are applied to the nasal mucosa in order to replicate the level of reaction observed in the environment during an allergic response. The reaction caused by the NAC is subjectively scored by study subjects, in conjunction with clinician-graded objective measures including nasal mucosa inflammation, PEFR, and PNIF. Enviro-NAC Environmental/Field studies have been the standard for the approval of allergic rhinitis therapies. In order to enrich the study population with subjects that are demonstrated to be highly sensitive to the specific allergen(s) being studied, knowing the relative sensitivity of the study subjects is crucial. The utilization of the NAC as a screening tool in environmental studies is an essential component in the development of allergen specific immunotherapies. Nasal Inflammation Scale (NIS) Objective measurements such as the NIS provide quantifiable measurements, thus reducing patient bias and ensuring a visibly moderate level of disease. Within the screened patient population, the NIS is correlated with PNIF and symptomatology scores. The NIS can be incorporated as an objective endpoint in Chamber, NAC, and Traditional Environmental protocols. Pre-treatment baseline Post-treatment effect Pre-treatment baseline Post-treatment effect In a recent Boston Chamber study of 21 allergic rhinitis patients, we sought to evaluate a currently marketed nasal steroid versus placebo. Patient reported symptom scores and objective Ora Nasal Inflammation Scale scores were collected. We saw statistically significant results in both the objective and subjective measurements as seen to the right. In addition, we saw a high correlation of the Nasal Inflammation Scale with the TNSS scores.

6 Allergy System Ora s Allergy System is optimized to decrease timelines to regulatory filings; the ultimate increased value results in a product that is generating revenue potentially years before traditional studies are completed. Clinical Strategy Regulatory Expertise Pre- Screened Patients Optimal Sites Subject Recruiting Ora provides turnkey Allergy Drug Development and Commercialization services from product inception to post marketing approval. Our Allergy team is at the ready to execute with our disease-categorized and pre-qualified site network (OraNet), actively maintained patient databases, and SMO feet-on-the-ground approach to conducting clinical research studies. We bring together an extensive and experienced Efficient Execution network of therapeutic experts, investment partners, and industry-leading companies in order to bring new drugs, drug delivery systems, and medical devices to market. Proper Planning Monitoring Logistics QA Oversight Training Project Mgmt Sr. Mgmt Oversight Ora Field Ops Trained Site Staff Standardizing Graders Trained Investigators Selected Publications Lanier, Abelson, Berger, et al. Comparison of the efficacy of combined fluticasone propionate and olopatadine versus combined fluticasone propionate and fexodenadine for the treatment of allergic rhinoconjunctivitis induced by conjunctival allergen challenge. Clin Ther 1002;24(7): Spangler, Abelson, Ober, Gomes. Randomized, doublemasked comparison of olopatadine ophthalmic solution, mometasone furoate monohydrate nasal spray, and fexofendine hydrochloride tablets using the conjunctival and nasal allergen challenge models. Clin Ther 2003;25(8): P. Gomes, M.B. Abelson, K. Lane, E. Angjeli. Development of a Standardized Clinician-Graded Scale for Assessment of Nasal Turbinate Inflammation Induced by Exposure to the Allergen BioCube Journal of Allergy and Clinical Immunology, Volume 127, Issue 2, Supplement, February 2011, Page AB53. M.B. Abelson, P. Gomes, K. Lane, N. Arenas. Signs and Symptoms of Allergic Rhinitis Produced by the Allergen BioCube Compared to the Environment: A Validation Study Journal of Allergy and Clinical Immunology, Volume 127, Issue 2, Supplement, February 2011, Page AB253. Berger, Abelson, Gomes, et al. Effects of adjuvant therapy with 0.1% olopatadine hydrochloride ophthalmic solution on quality of life in patients with allergic rhinitis using systemic or nasal therapy. Ann Allergy Asthma Immunol 2005;95(4):

7 World Class Experts. Mark B. Abelson MD, CM, FRCSC Founder + Chairman Dr. Abelson is a Clinical Professor of Ophthalmology at Harvard Medical School and Senior Scientist at the Massachusetts Eye and Ear Infirmary. During his 35+ years of experience in allergy research, Dr. Abelson has developed clinical models used for international approvals in both allergy and dry eye. His expertise includes regulatory interface, study execution, clinical strategies, and data interpretation. Paul Ratner, MD, MBA Dr. Ratner has been conducting allergy clinical research for nearly 30 years. He maintains one of the largest Texas Mountain Cedar research sites and has also been involved with over 570 clinical trials phases I-IV in the respiratory therapeutic area. Dr. Ratner has been asked to lecture worldwide on six continents on allergy, asthma, and immunology to many different professional associations. He is the author of 60 articles published in peer review journals. Anne Ellis, MD, MSc, FRCPC Dr. Ellis is an Associate Professor and Chair of the Division of Allergy & Immunology in the Department of Medicine with a crossappointment to the Department of Biomedical and Molecular Sciences at Queens University. With over 13 years experience conducing clinical trials at the first North American Environmental Exposure Unit in Kingston, Ontario, and having led NAC studies (both single and multi-centre) over the past three years, Dr. Ellis is at the forefront of the rhinitis challenge research arena. She and her group have worked with national and international regulatory agencies to gain acceptance of Exposure Units for Phase II- IV studies, and the standards set by her research group are considered to be of the highest degree of scientific rigor and ethical conduct. Paul Gomes MS Vice President, Allergy Mr. Gomes has more than 15 years of experience in successfully executing allergy programs and providing clinical regulatory strategy. He has overseen over 100 allergy clinical trials, published numerous articles on specific drugs, and helped approve six allergic conjunctivitis treatments. Mr. Gomes is generally regarded as one of the world s experts in clinical strategy in allergy drug development and has presented on the topic for numerous biotech and pharmaceutical companies. Keith Lane Director, Rhinitis R+D Mr. Lane has spent the past 7+ years working on the identification and development of clinical models, with a special focus on sub-population response to allergic insult and therapeutic intervention. He led the team that developed the Boston Chamber and has project managed all of the validation and verification studies related to our Allergy Chambers to date. Liz Peoples Director, Rhinitis Services Prior to joining Ora, Ms. Peoples had been working in various roles of increasing responsibility in the fields of Oncology and Women s Health for the past 20 years. As Director of Rhinitis Services, she is the main point of contact for existing and potential clients. Our core staff includes MDs, Allergists, PhDs, experienced clinical trial managers, and a staff of 14 clinical research associates that focus soley on allergy clinical trials.

8 (978) Ora is your value-added partner from molecule to marketplace: Strategic Consulting Formulation/CMC Management Preclinical Models Regulatory Submissions and FDA Interface Medical Writing and Publication Support Study and Clinical Program Design Pharmacology/Toxicology Clinical: Phase I IV Biostatistics and Data Management Marketing, Advertising, and Product Commercialization