Novuspharma To Co-Develop Micromet's Human Antibody MT201 For The Treatment of Cancer
Monday September 2, 2:51 am ET
BRESSO, Italy, and MUNICH, Germany, Sept. 2 /PRNewswire/ -- Novuspharma SpA (Nuovo Mercato: NOV.MI) and Micromet AG announce today that they have entered into an alliance to co-develop Micromet's proprietary drug candidate MT201, a fully human antibody targeting the Ep-CAM molecule, which is currently in Phase I studies in patients with hormone-refractory prostate cancer.
Under the terms of the agreement, the partners will pursue a broad Phase II program with up to 1,000 patients in major cancer indications. The program, consisting of several trials, will be rolled out during 2003. Both parties will share future costs and revenue streams from a joint development and commercialization strategy. In addition, Micromet will receive euro 4 million in an upfront fee as well as annual and milestone payments.
MT201 has shown potential to improve efficacy and safety of carcinoma treatment in a broad range of indications (promising preclinical results were published in April 2002.(1) To date, it is the only fully human antibody against the Ep-CAM target in clinical development. Ep-CAM is an acknowledged anti-cancer target present in the majority of epithelia-derived tumours and increased expression correlates with decreased overall survival and tumour progression.
The Phase II program will benefit from the joint expertise of two experienced clinical development teams, combining Novuspharma's specific oncology know-how with Micromet's capabilities in the field of novel antibody therapeutics. The cooperation is aimed at building maximum value into the development candidate while retaining full commercial flexibility. Potential indications include prostate, breast, lung, stomach, ovarian and head & neck cancer. The companies will jointly decide on the selection of a licensing partner for the drug depending on its clinical profile.
Dr. Silvano Spinelli, Chief Executive Officer of Novuspharma, commented: "With MT201, Novuspharma gains access to an innovative drug candidate which is already in the clinic. Based on an impressive set of preclinical data and preliminary Phase I results we are convinced of its outstanding therapeutic and commercial potential. Micromet is a leading player in the field of antibody therapeutics and this agreement will extend our broad oncology portfolio from chemotherapeutics into the highly promising field of biologics."
Christian Itin, Chief Business Officer of Micromet, said: "We are looking forward to teaming up with Novuspharma, an oncology specialist with a successful track record of maturing anti-cancer drugs through Phase II and into pivotal trials. We will maximize the value of MT201 through a broad Phase II program covering major carcinoma indications while fully retaining all commercialization options for the two parties."
Erich Felber, Chief Executive Officer of Micromet, added: "This is a landmark collaboration with a deal structure that allows biotech companies to finance state-of-the-art clinical development programs and postpone the selection of a marketing & sales partner until the drug's potential is clear. It will allow for selection of partners with the appropriate clinical, marketing and financial muscle. In this way, Micromet and Novuspharma are building options to broaden their pipelines and secure a substantial participation in future sales revenues."
A conference call for analysts will be held today at 11.00 CET, 10.00 UK time. For further details please call Claire Rowell on +44 20 7269 7285.
* Notes to Editors
* Background on Micromet AG
* Micromet, a privately held, Munich-based biotechnology company, designs
and develops innovative antibody-based drugs for the treatment of cancer,
autoimmune and inflammatory diseases. The Company is building a broad
pipeline of drug candidates on the basis of proprietary technologies, with two
candidates being in Phase I clinical trials. Fundamental to Micromet's
therapeutic strategy is the elimination of cells playing a pivotal role in the
pathogenesis of human diseases by recruiting and activating immune effector
cells. The Company has established the BiTETM technology ("Bispecific T cell
engagers"), a unique drug format that leverages the outstanding cytotoxic
potential of T cells, the most powerful 'killer cells' of the human immune
system. Micromet has integrated expertise and infrastructure in key drug
development disciplines.
The Company has investments from leading international life science investors with a cumulative financing volume in excess of 77.5 million Euros.
For further information, please visit the Company's web site at micromet.de.
Background on Novuspharma SpA
Novuspharma, based in Bresso, Milan, is an emerging biopharmaceutical company leveraging its expertise in the field of oncology to discover and develop innovative new treatments for cancer. It has four products in clinical development and a dynamic research programme. Novuspharma's leading anti-cancer drug, BBR 2778, has recently begun Phase III clinical trials in indolent Non-Hodgkin's Lymphoma. Novuspharma was established in 1998 following the merger of Boehringer Mannheim and Hoffmann-LaRoche to exploit the R&D team's proven track record in product development. Novuspharma makes use of a complete range of discovery and development platforms and focuses its specific expertise on the most critical part of the development process from the initial identification of leads to late clinical development stages as far as New Drug Application. Novuspharma was listed on the Nuovo Mercato of the Borsa Italiana in November 2000.
For further information, please visit the Company's web site at novuspharma.com.
# (1) Naundorf, S., Preithner, S., Mayer, P., Lippold, S., Wolf, A., Hanakam, F., Fichtner, I., Kufer, P., Raum, T., Riethmuller, G., Baeuerle, P., Dreier, T. 2002. In Vitro and In Vivo Activity of MT201, a Fully Human Monoclonal Antibody for Pancarcinoma Treatment. Int. J. Cancer: 100, 101-110 |
