Novel Drug Evitar™-“Sentinel Moment in Surgery”
 
Unprecedented Clinical Data in Adhesion Prevention Could Capture $3B Uncontested Market

 

Prevention of Adhesions following abdominal / pelvic surgeries

Market

Evitar™ Positioned to Capture Large Uncontested Adhesion Prevention Market

  • Significant market development completed and medical need established by Sanofi-Genzyme, Johnson and Johnson over last 15-30 years with global sales of $200M (est)
  • Novel drug Evitar™ unrivaled clinical efficacy (>83-90%) and safety stands to capture uncontested $2.5-$3B US market
  •  “Evitar™ offers a potential therapeutic option for preventing adhesion formation based on sound scientific principles with the exciting triad of Efficacy, Safety and Ease of Use.”-Dr. Greenberg
  • Temple's patent family extends to orthopedics--frozen shoulders, knee replacement surgery, spinal surgery and other related joint surgery where scarring inhibits recovery and rehab

Milestones

  • Q3'16 - FDA pre-IND meeting completed
  • Q4'17 - ICH-GCP Compliant double blind placebo controlled randomized study completed
  • Q1'18 - Temple announces on March 13, 2018 Unrivaled Clinical Efficacy
  • Q1'18 - Temple presents groundbreaking mechanistic data March 9, 2018 at SRI in San Diego
  • Q2'18 - Mechanistic data accepted for publicaiton in top ranked & highly cited Ob/Gyn Journal
  • 2018 - EMA IMPD & US FDA IND meeting request - start pivitol trials in 2018 for lead in Europe for Evitar™ and 2019 Expected for USA with other regional markets

Technology

Current literature suggests that addressing hypoxia and shifting anaerobic metabolism to aerobic metabolism could be a viable strategy to preventing post surgery adhesions. (ASRM) (Awonuga AO) (Diamond MP) (Duron) (Valerie I. Shavell) Evitar™ is a proprietary aqueous formulation of naturally occurring amino acids. In preclinical models, when it is administered into the peritoneal cavity at the time of surgery it has been demonstrated, through the use of known peritoneal inflammatory biomarkers (Vero´nica Go´mez-Gil), to prevent post-surgery adhesions or fibrosis.

Market: limited options for laparoscopic surgeries

Post operative adhesions or fibrosis/scar tissue is a major medical problem with no current viable solution for laparoscopic surgeries.  It leads to reduced clinical outcomes, high hospital readmission rates, reduced quality of life for patients and is a leading cause of medical lawsuits. In the case of OB GYN, can lead to serious and societal expensive complications such infertility, intestinal obstruction and pelvic pain.

Reversing Hypoxia and Restoring Homeostasis May Prevent Adhesions

(Valerie I. Shavell)

Evitar™ addresses this unmet medical need by preventing post-surgery adhesions in both laparoscopic and laparotomic procedures. Management has a well crafted strategy to bring this First in Class Drug pharmaceutical approach to market that deals safely and effectively with post-operative fibrotic or scar tissue. This type of scarring occurs in 93% of procedures and is a worldwide major concern for surgeons, patients and the health care system. (Menzies) (Koji Okabayashi) (Trew)

EASY TO USE, QUICK TO APPLY & NO ADVERSE EVENTS REPORTED  IN CURRENT TRIAL

Medical devices based on untargeted mechanisms of action (e.g. “barrier”-type, colloid osmotic agent) currently serve the market for open surgery. However, market leaders Seprafilm® (Genzyme) and Interceed® (Ethicon) are not adapted for or approved by the FDA for laparoscopic surgery, are known to extend mean operation time and difficult to handle. (Trew)

Burden Still an Unmet Medical Need

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Works Cited

ASRM. "Pathogenesis, Consequences, and Control of Peritoneal Adhesions in Gynecologic Surgery." Fertility and Sterilty 99.6 (2013).

Awonuga AO, Fletcher NM, Saed GM, Diamond MP. "Postoperative adhesion development following cesarean and open intra-abdominal gynecological operations: a review." Reproductive Sciences 18.12 (2011): 1166-1185.

Diamond MP, Freeman ML. "Clinical implications of postsurgical adhesions 2001." Hum Reprod Update 7 (2001): 567-576.

Duron, Jean-Jacques. "Postoperative intraperitoneal adhesion pathophysiology." The Association of Coloproctology of Great Britain and Ireland 9 (2007): 14-24.

John R Lue, Louise S Boyd and Michael P Diamond. "Pelvic Adhesive Disease: Current Approaches to Management." Journal of Women's Health,Issues and Care 3.3 (2014).

Koji Okabayashi, Hutan Ashrafian, Emmanouil Zacharakis, Hirotoshi Hasegawa, Yuko Kitagawa, Thanos Athanasiou, Ara Darzi. "Adhesions after abdominal surgery: a systematic review of the incidence, distribution and severity." Surgery Today (2013).

Menzies, D. "Peritoneal adhesions. Incidence, cause, and prevention." Surgery Annals 24(Pt1) (1992): 27-45.

Trew, Geoffrey. "Consensus in adhesion reduction management-Supplement." The Obstetrician and Gynecologist 6.2 (2004).

Valerie I. Shavell, Ghassan M. Saed, and Michael Diamond. "Cellular Metabolism:Contribution to Postoperative Adhesion Development." Reproductive Sciences 16 (2009): 627-634.

Vero´nica Go´mez-Gil, Gemma Pascual, Ba´rbara Pe´rez-Ko¨hler, Alberto Cifuentes, Julia Buja´n and Juan M. Bello´n. "Involvement of transforming growth factor-b3 and betaglycan in the cytoarchitecture of postoperative omental adhesions." Journal of Surgical Research 187 (2014): 699-711.

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