News
- Sale will result in profitable exit for iCeutica investors
- Sale positions Iroko with strong pipeline and unique technology
- Combined company has capital and experience to be dominant in pain and inflammation therapeutic space
Thursday 28th April, 2011
Australian pharmaceutical reformulation company iCeutica Inc (‘iCeutica’) today announced that it has finalised the sale of all of its shares to Iroko Holdings S.A, the parent company of its US-based partner, Iroko Pharmaceuticals, LLC (‘Iroko’).
The sale price was not disclosed, but iCeutica confirms that the price was more than 10 times the closing valuation of its first fundraising round for the Company in July 2005.
The existing management team, including CEO Mr Matt Callahan and CSO Dr Bill Bosch, will continue to lead the company after the acquisition.
“We are very pleased to have closed the sale of iCeutica to our long-time partner Iroko,” Mr Callahan commented. “This represents a very profitable exit for our investors and an exciting path to market for our pipeline products, given Iroko’s track record, management capability and depth of funding.”
iCeutica, which is based in Philadelphia, USA and Perth, Australia is using its unique SoluMatrix® reformulation platform to develop a range of pharmaceutical products aimed at delivering significant performance improvements over existing marketed versions of those drugs. iCeutica’s internal clinical pipeline currently includes reformulations of pain and inflammation drug meloxicam and muscle relaxant metaxalone.
Iroko is a Philadelphia-based international pharmaceutical company committed to the development and commercialization of a range of products in the pain and inflammation therapeutic space. Recently completed Phase 2 clinical trials of Iroko’s three leading products show tremendous potential to dominate the $7 billion global market for non-steroidal anti-inflammatory drugs (NSAIDs).
“The acquisition of iCeutica was a natural fit for Iroko,” said Iroko CEO John Vavricka.
“Bringing together the SoluMatrix platform and iCeutica’s clinical and development pipeline alongside Iroko’s advanced clinical programs creates a robust pipeline with the, capital and capability to compete globally.”
iCeutica licensed three products reformulated utilising its SoluMatrix platform to Iroko in 2007. Each of these products have recently successfully completed Phase 2 clinical trials and two of these products are scheduled to enter Phase 3 clinical trials later in 2011.
iCeutica Director and Ausbiotech Board Member Dr Stewart Washer added: “The management team should be commended for achieving this result for shareholders and showing that it is possible to successfully develop and profitably exit life sciences companies in Australia.”
The combined iCeutica/Iroko company will boast five clinical stage products, with three products having completed Phase 2 trials, one entering Phase 2 trials and one entering Pilot PK trials in the coming 12 months. Four of these products are reformulations of the popular NSAID class of pain and inflammation products, which dominate the prescription and OTC markets in the USA and globally.
Matt Callahan, iCeutica CEO added: “SoluMatrix is an enabling tool which has been applied to a range of different drugs to solve their solubility problems. Our reformulations provide a range of benefits to patients such as allowing them to take lower doses of drugs, significantly reducing side effects or making the drugs much faster acting.”
“An additional attraction of the business is that we avoid many of the commercial challenges that face other biotechnology companies in bringing their products to market. By concentrating on the reformulation of existing drugs, we avoid much of the time, risk and cost of the traditional new drug discovery and development process.”
“We also expect the successful improvement of an existing drug will lead to a strong competitive advantage in the market place for the reformulated superior product, as well as new patent protection.”
iCeutica will be operated as a stand-alone company within the Iroko group and will continue to develop new products for patients via traditional oral and inhalable delivery routes. These products will be developed either by iCeutica, or in conjunction with external partners.
Osagie Imasogie, iCeutica Chairman said: “This is a great example of the world class intellectual property being developed in Australia and making a real impact on the global pharmaceuticals market. There is a wonderful opportunity to repeat this success with other Australian technologies and companies, given the depth of research and talent in Australia.”
Philadelphia, PA, June 19, 2008: iCeutica, Inc. announces that the first GMP clinical supplies have
been manufactured for its partner, Iroko Pharmaceuticals, utilizing iCeutica’s proprietary nano-sizing technology. The completion of the manufacturing campaign represents an important technical and commercial validation of the iCeutica platform.
“We are very pleased to achieve this significant milestone for iCeutica. Our nano-sizing technology has progressed from pilot plant scale to commercial operation inside a GMP facility and is producing the consistent, quality products that we projected,” said iCeutica President and CEO, Matt Callahan. Iroko and iCeutica are collaborating on the application of iCeutica’s nano-sizing platform to reformulate certain proprietary Iroko products. Iroko is guiding the progression of these reformulated products through the regulatory process, clinical trials and ultimate commercial launch.
“The products Iroko is developing with iCeutica will have significant and relevant benefits for
patients, with enhanced onset of action, reduction in food-fast effects and potentially reduced side effects,” said Iroko President and CEO, John Vavricka.
“iCeutica’s nano-sizing platform is broadly applicable to a wide range of poorly soluble drug
compounds and provides a novel and exciting approach to formulation development and drug product manufacturing. We look forward to working with our partners and on our internal pipeline in maximizing the potential of this important new technology,” said Mr. Callahan.
About iCeutica: iCeutica commercializes products developed utilizing its proprietary nano-sizing
platform. The technology is an enabling reformulation platform, which provides simple and scalable processes to reformulate development stage and marketed products with solubility, delivery or bioavailability challenges.
About Iroko Pharmaceuticals LLC: Iroko is a pharmaceutical company focused on specialty
therapeutic areas. The company acquires, develops and maximizes the potential of currently marketed pharmaceutical products. Iroko increases the revenues of acquired products through focused selling and marketing efforts and product life cycle management activities including development of relevant formulations to improve patient treatment.
Philadelphia, PA, May 16, 2009. iCeutica, Inc. today announced a reformulation agreement with a leading ‘Big Pharma’ company. The agreement provides for iCeutica to reformulate a number of new chemical entities for the partner utilizing iCeutica’s SoluMatrix™ Technology. Upon successful reformulation, the partner intends to guide progression of these reformulated products through the development and regulatory process and ultimate launch.
“This transaction represents iCeutica’s first transaction with a Big Pharma and further validates the value proposition of the SoluMatrix™ Technology platform. While we are cautiously approaching the new programs with our partner, we are keen to see the new candidates progress through clinical development and ultimately to launch,” stated iCeutica CEO, Matt Callahan.
The agreement comes on the back of the recent completion of the first human trials using SoluMatrix™ Technology formulated product in the United States and anticipates the commencement of a further two clinical trials in coming months. The iCeutica internal pipeline of products is progressing strongly and additional licensing activity is expected in Q3 of this year.
“We are pleased to be able to work with solid global companies and continue to generate revenue from the select partner we have chosen to pursue at this stage of our development”, Mr Callahan said, “our own pipeline is progressing through the clinic in parallel as we prove the broad application of the SoluMatrix™ Technology for a range of products and delivery routes.”
About iCeutica: iCeutica commercializes products developed utilizing its proprietary SoluMatrix™ Technology platform. The technology is an enabling reformulation platform, which provides simple and scalable processes to reformulate development stage and marketed products with solubility, delivery and/or bioavailability challenges.
September 2007
Philadelphia, PA, September 12, 2007 iCeutica, Inc. announces nano-pharmaceuticals industry
leader Dr William Bosch has joined iCeutica Inc. Dr Bosch was until recently a senior member of
the research and development management team at Elan Corporation responsible for Elan’s
NanoCrystal® Technology and the related drug reformulation and delivery business.
Dr Bosch brings more than fifteen years of scientific innovation, leadership, and team-building
experience in pharmaceutical product development and drug delivery, having been a co-inventor,
or played a key role in the development of four of the five nano-particulate based drugs approved by the FDA in the last decade. His roles at Elan have encompassed basic research into nanopharmaceuticals production, formulation science, regulatory strategy and IP prosecution. Dr
Bosch is widely regarded as a leader in the fields of drug delivery and manufacturing of nanoparticles for pharmaceutical applications.
Dr Bosch joins the team which is advancing a number of reformulated products into the clinic
which utilize iCeutica’s proprietary Encapsulated Organic Nanoparticle (EON™) Platform. In
addition to iCeutica’s pipeline, these products include drugs reformulated under the recent
collaboration with Iroko Pharmaceuticals as well as those being developed by iCeutica’s spin-off
company Spree Pharmaceuticals.
“We are very pleased to secure the services of Dr Bosch at this exciting period of the Company’s
growth as iCeutica scales up the EON platform in preparation for clinical trials and commercial
manufacturing. Dr Bosch’s unrivalled experience with nano-reformulation technologies will
provide a significant boost to our regulatory and customer engagements,” stated iCeutica CEO,
Matt Callahan.
“iCeutica’s EON platform will be broadly applicable to a wide range of poorly soluble drug
compounds and provides a novel and exciting approach to formulation development and drug
product manufacturing. I am delighted to be joining the iCeutica team and look forward to
working with them and our partners to maximize the potential of this important new technology,” said Dr. Bosch.
About iCeutica: iCeutica commercializes products developed utilizing its proprietary EON™
Platform. EON is an enabling reformulation technology, which provides simple and scalable
processes to reformulate development stage and marketed products with solubility, delivery or
bioavailability challenges.
