ASHBURN, Va., Dec. 17 /PRNewswire-FirstCall/ -- Innocoll, Inc., a privately held specialty pharmaceutical company, announced that it has closed an equity financing investment to raise $30 million through the sale of convertible preferred stock in a private placement with three institutional investors led by Camulos Capital LP together with NewSmith Asset Management LLP and Morgan Stanley & Co, Incorporated. The existing principal shareholders, Rolf and William Schmidt, also converted existing loans totaling approximately $16 million into convertible preferred stock. The financing will be used to fund a series of phase 2 and phase 3 clinical trials for Innocoll's lead product development programs, payment of financing fees, and general corporate purposes.
Commenting on the equity financing, Dr. Michael Myers, President and CEO said, "We are delighted to have attracted three institutional investors of the caliber of Camulos, NewSmith and Morgan Stanley to make a significant financial investment in our business. In 2007, we have seen the approval of three INDs for products which are now in active clinical development and, according to market research performed by L.E.K. Consulting, have combined annual sales projections of approximately $800 million in the U.S. alone. Having secured the necessary funding, we are well placed to move forward aggressively with the clinical development of our lead pharmaceutical products."
Mr. Rolf Schmidt, Chairman of Innocoll's Board of Directors at the time of the transaction added "We are excited to be working with a group of highly knowledgeable investors who bring many years of healthcare industry experience and can ably assist us in the development and commercialization of our pipeline of innovative products."
"This investment is an opportunity to finance the U.S. development of several late stage products that have proven efficacy and safety in Europe. We look forward to working with Dr. Myers and his team on the product portfolio, which has both compelling therapeutic benefits and strong commercial potential" said Courtney Carson, an analyst at Camulos Capital LP and a newly appointed Director of Innocoll, Inc.
NewSmith Financial Products LLP and Sudbrook Associates LLP acted as financial advisor to Innocoll in this transaction.
About Innocoll, Inc.
Innocoll is a privately held, specialty pharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. It develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx(R) and Liquicoll(R). The Company is internationally-based with Corporate Headquarters in the United States, Research & Development and Product Commercialization Divisions in Ireland, and manufacturing facilities in Germany and South Africa.
Innocoll's lead product, GENTAMICIN SURGICAL IMPLANT, is a fully biodegradable, leave-behind surgical implant impregnated with the broad spectrum aminoglycoside antibiotic, gentamicin. It was developed using Innocoll's proprietary collagen-based drug delivery technology, CollaRx, and is designed to provide a high localized concentrations of gentamicin at the target tissue. The product is indicated as an adjunct to systemic antibiotic therapy for the prevention of surgical site infections and for the treatment of deep, localized infections in both hard and soft tissues. There are more than 60 prospective clinical trials and published case reports totaling over 7,500 patients documenting safety and efficacy over a broad range of orthopedic, colorectal, cardiothoracic, vascular, and neurosurgical procedures. The product is already approved for sale in 49 countries spanning Europe, Latin America, Middle East, Africa and Asia and is marketed under the following trade names; COLLATAMP(R) G, COLLATAMP(R) EG, SULMYCIN(R) IMPLANT, GARAMYCIN(R) SCHWAMM, DURACOL(R), DURACOLL(R), GENTACOL(R), GENTACOLL(R), GARACOL(R), GARACOLL(R), and CRONOCOL(R). In 2005, Innocoll acquired the worldwide marketing rights from Essex Chemis AG, an affiliated company of Schering Plough Corporation (NYSE: SGP) and in August 2007 sold its marketing rights, with the exception of the U.S., to EUSA Pharma. GENTAMICIN SURGICAL IMPLANT is currently in phase 3 clinical development in the U.S. for the prevention of surgical site infections. Innocoll will conduct two US multi- centered phase 3 clinical trials; one in cardiac surgery patients at higher risk of surgical site infection and the other in patients undergoing open colorectal surgery. Innocoll has appointed Duke University's Duke Clinical Research Institute (DCRI) as the Study Co-ordinating Center for both trials. Independent market research recently performed by L.E.K. Consulting has projected peak U.S. sales of GENTAMICIN SURGICAL IMPLANT at more than $200 million per annum.
Other late stage pharmaceutical products in Innocoll's development pipeline include CollaRx GENTAMICIN TOPICAL for the treatment and prevention of infected diabetic foot ulcers and CollaRx BUPIVACAINE IMPLANT for the management of post-operative pain, which are both in Phase 2 clinical trials.
CollaRx GENTAMICIN TOPICAL represents the clinical development of the marketed GENTAMICIN SURGICAL IMPLANT for the topical treatment and prevention of infection in chronic skin ulcers, such as diabetic foot. A high proportion of chronic wounds become clinically infected requiring treatment with antibiotics. Orally administered and injected antibiotics are often associated with systemic side effects and widespread use can lead to development of bacterial resistance. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow (ischemia), which may render systemically acting antibiotics less effective. Innocoll plans to investigate CollaRx GENTAMICIN TOPICAL for the localized treatment and prevention of diabetic foot infections in patients with moderately infected, mildly infected and uninfected ulcers in a parallel series of three phase 2 multi-centered clinical trials. Currently, there are no topically applied antibiotics marketed in the U.S. that are specifically indicated for the treatment of infected diabetic foot ulcers and recent market research independently performed by L.E.K. Consulting forecast peak annual revenues approaching $270 million for the diabetic foot indication in the U.S. alone.
BUPIVACAINE SURGICAL IMPLANT has been specifically developed and formulated using Innocoll's proprietary CollaRx sponge technology for the management of post-operative pain following moderate/major abdominal, gynecological, thoracic, and orthopedic surgeries. Post-operative pain is typically controlled with narcotic analgesics such as morphine, but systemic administration of these drugs can result in unfavorable side effects including suppression of breathing, sedation, nausea and vomiting; and can also affect patient recovery. BUPIVACAINE SURGICAL IMPLANT is designed to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery. The collagen matrix naturally biodegrades over a few days and the bupivacaine is released to provide local analgesia for up to 96 hours post-operatively, as demonstrated by the results of an initial clinical study performed at Wexham Park Hospital, Slough, UK, in patients undergoing hysterectomy surgery. Starting later this month, Innocoll plans to conduct a series of phase 2, multi-centered, controlled clinical trials in various soft tissue and orthopedic surgeries. The product is believed to have broad utility spanning a wide variety of surgical procedures and independent market research recently performed by L.E.K. Consulting has projected peak U.S. sales nearing $310 million
For more information about Innocoll, its technologies and products, please visit www.innocoll.com.
SOURCE Innocoll, Inc.
