On January 29, 2007 Micromet reported in the British Journal of Cancer on proceedings from an international symposium on EpCAM (CD326). EpCAM is one of the most frequently and intensely expressed tumor-associated antigens known. EpCAM overexpression is linked to poor survival in several tumor types including breast, ovarian and pancreatic cancer; is associated with increased metastatic potential; and is found on tumor stem cells. Micromet has two product candidates targeting EpCAM in development which target EpCAM: adecatumumab, a human antibody, which is in clinical development, and MT110, a BiTE molecule, which is in formal preclinical development.
Morphotek License
On February 12, 2007, Micromet and Morphotek Inc., a privately held biopharmaceutical company focused on the discovery and development of therapeutic monoclonal antibodies, announced that Morphotek exercised its option under a 2004 agreement to obtain an exclusive worldwide license for an antibody targeting an antigen with potential activity for the treatment of certain cancers, including melanoma. Under the terms of the agreement with Morphotek, Micromet has received a payment in connection with the exercise of the option by Morphotek and is eligible to receive development milestone payments and royalties on net sales. Morphotek is planning to file an investigational new drug (IND) application later this year and to commence clinical trials in 2008.
TRACON License
Today, Micromet announced an agreement granting TRACON Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of products for cancer treatment, the exclusive worldwide rights to develop and commercialize Micromet's D93 antibody with a novel mode of action for the treatment of cancer. Under the terms of the agreement, TRACON will be responsible for all development and commercial activities and plans to initiate a phase 1 clinical trial in the second half of this year. Micromet will receive license fees and milestone payments from TRACON of US$100 million, if D93 is successfully developed and commercialized. In addition, we will receive royalties on worldwide sales.
Summarizing the events, Christian Itin, Ph.D., President and Chief Executive Officer of Micromet said: "We are well on track with the post-merger integration and continue to make progress with our entire product pipeline. On the clinical development front, we have reported interim phase 1 results for the MT103 NHL program at the recent ASH meeting in Orlando and phase 2a results at the San Antonio Breast Cancer Meeting for adecatumumab and look forward to continuing to move these programs forward. Our financial position was further strengthened with the receipt of the US$10 million milestone payment from Merck Serono on the adecatumumab program in the fourth quarter of 2006. Furthermore, we expect to announce additional results of our clinical and preclinical programs, as well as business development efforts during the first half of 2007."
2007 Outlook:
-- Micromet and its partner MedImmune plan to initiate a first clinical
trial with MT103/MEDI-538 in non-Hodgkins lymphoma patients in the
U.S. and a phase 2 clinical trial in acute lymphatic leukemia in
Europe.
-- Micromet and its partner Merck Serono will continue their ongoing
phase 1b trial in metastatic breast cancer with adecatumumab in
combination with docetaxel and are planning to initiate a phase 1
clinical trial to test adecatumumab in other solid tumors.
-- Micromet plans to advance its preclinical development program for
MT110 towards an IND/IMPD filing in 2007, and is evaluating strategic
corporate collaborations with this program.
-- Micromet and its partner TRACON Pharmaceuticals plan to initiate a
phase 1 clinical trial for D93 in the second half of 2007.
-- Micromet is continuing its outlicensing activities with respect to
MT203 and MT204.
-- Micromet will continue its research and development programs for the
discovery of new BiTE product candidates.
Conference Call and Audio Webcast Today, March 16, 2007, at 9:00am Eastern Time
Micromet will host a conference call and audio webcast today to discuss these financial results at 9:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-866-713-8565 (U.S.) or +1-617-597-5324 (international), passcode: Micromet. The audio webcast can be accessed at: www.micromet-inc.com.
A replay of the call will be available from 12:00 pm Eastern Time on March 16, 2007 (5:00 pm Central European Time) through Wednesday, March 21, 2007. The replay number is +1-888-286-8010 (U.S.) or +1-617-801-6888 (international), passcode: 53343055.
About Micromet, Inc. (www.micromet-inc.com)
Micromet, Inc. is a biopharmaceutical company focusing on the development of novel, proprietary antibody-based products for cancer, inflammatory and autoimmune diseases. Two product candidates are currently in clinical trials. MT103 (MEDI-538), which is the first product candidate based on Micromet's proprietary BiTE(R) product development platform, is being evaluated in a phase 1 clinical trial for the treatment of patients with non-Hodgkins lymphoma. The BiTE(R) product development platform is based on a unique, antibody-based format that leverages the cytotoxic potential of T cells, the most powerful 'killer cells' of the human immune system. Adecatumumab (MT201), a recombinant human monoclonal antibody which targets EpCAM expressing tumors, has completed two phase 2a clinical trials, one in patients with breast cancer and the other in patients with prostate cancer. In addition, a phase 1b trial evaluating the safety and tolerability of adecatumumab in combination with docetaxel is currently ongoing in patients with metastatic breast cancer. Micromet has established collaborations with MedImmune, Inc. and Merck Serono.
Forward-Looking Statements
This release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the efficacy, safety, and intended utilization of Micromet's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research, discovery of new product candidates, and clinical trials, and plans regarding partnering activities, outlicensing activities, and the establishment and growth of key management functions in the U.S. Factors that may cause actual results to differ materially include difficulties encountered in integrating CancerVax and Micromet AG, the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that the Company will not obtain approval to market its products, the risks associated with reliance on outside financing to meet capital requirements, the risks associated with reliance on collaborative partners for future revenues under the terms of its existing collaboration agreements, further clinical trials, development and commercialization of product candidates, and the risks associated with recruiting, incorporating and retaining individuals to fill key management functions. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed in Micromet's periodic reports and other filings with the SEC, including the "Risk Factors" sections of such reports.
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