OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces today that it has signed a feasibility agreement with a top-5 generics company to develop a generic formulation of an existing injectable specialty pharmaceutical product.
Under the terms of the contract that was announced earlier today, OctoPlus will develop up to the phase of preparation for small-scale production, a generic copy of one of the major injectable specialty pharmaceuticals. If the project is successful, the contract may progress to a full process development and manufacturing agreement. Financial terms of the current agreement have not been disclosed.
What are specialty generics?
Specialty generics are generic versions of long-acting injectable drugs. Several blockbuster injectable specialty pharmaceuticals are coming off patent in the coming years, which opens the way to develop competitive products without infringing on the original patents. The development process and market introduction of specialty generics is significantly less expensive and shorter than for new medicines, yet their commercial opportunity remains large. In short, these are commercially very attractive opportunities.
Why we see an important role for OctoPlus in specialty generics
Although the commercial attractiveness of specialty generics is high, few competitors have entered this market due to the specialized and complex development and manufacturing process. It requires state-of-the-art equipment and in-depth knowledge on developing, manufacturing and lyophilizing microspheres. OctoPlus has gained over 16 years of experience and has built an impressive infrastructure to work on these types of formulations. As one of the few companies to combine microsphere formulation with manufacturing expertise, we have a competitive edge in this market.
Specialty generics partnerships
Our efforts in specialty generics can either be structured through a fee-for-service arrangement or by investing with our own financial resources. The latter scenario allows us to participate more significantly in the commercial upside of these products in the form of royalties, milestones and manufacturing revenue upon commercialization. The contract announced today will initially be structured on a fee-for-service basis.
Jan Egberts, CEO of OctoPlus: "Development of complex long-acting generic products, so-called specialty generics, is a strategic focus for OctoPlus. Our expertise in the development of these formulations is unique, and the combination of our formulation development and our manufacturing expertise really fits our sweet spot. This is the second specialty generic project which we have initiated and we look forward to putting our expertise to use for this project."
For further information, please contact:
Rianne Roukema, Corporate Communications: telephone number +31 (71) 524 1071, or send an e-mail to Investor Relations at IR@octoplus.nl.
About OctoPlus
OctoPlus is a specialty pharmaceutical company focused on the development and manufacture of improved injectable pharmaceuticals based on our proprietary drug delivery technologies that exhibit fewer side effects, improved patient convenience and a better efficacy/safety balance than existing therapies. OctoPlus also focuses on the development of long-acting, controlled release versions of known protein therapeutics, peptides and small molecules, including specialty generics.
The clinically most advanced product incorporating our technology is Locteron®, a controlled release formulation of interferon alpha for the treatment of chronic hepatitis C. OctoPlus licensed Locteron exclusively to Biolex in October 2008. Locteron is being manufactured for Biolex by OctoPlus and has completed Phase IIb clinical studies with superior clinical data versus current treatment.
In addition, OctoPlus is a leading European provider of advanced drug formulation and clinical scale manufacturing services to the pharmaceutical and biotechnology industries, with a focus on difficult-to-formulate active pharmaceutical ingredients.
OctoPlus is listed on NYSE Euronext in Amsterdam under the symbol OCTO. For more information about OctoPlus, please visit our website www.octoplus.nl.
This document may contain certain forward-looking statements relating to the business, financial performance and results of the Company and the industry in which it operates. These statements are based on OctoPlus N.V.'s current plans, estimates and projections, as well as its expectations of external conditions and events. In particular the words "expect", "anticipate", "predict", "estimate", "project", "plan", "may", "should", "would", "will", "intend", "believe" and similar expressions are intended to identify forward-looking statements. We caution investors that a number of important factors, and the inherent risks and uncertainties that such statements involve, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements. In the event of any inconsistency between an English version and a Dutch version of this document, the English version will prevail over the Dutch version.
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Source: OctoPlus N.V. via Thomson Reuters ONE
