Review Zanolimumab Program to be Discontinued and Headcount to be Reduced Summary: Genmab Announces the Results of its Portfolio Review; Zanolimumab
Program to be Discontinued and the Company Will Reduce the Number of
COPENHAGEN, October 8 /PRNewswire-FirstCall/ -- Genmab A/S (OMX: GEN) announced today that it is discontinuing development of zanolimumab (HuMax-CD4(R)). In addition, as a result of a portfolio review and assessment of the organization, Genmab is reducing its headcount by 101 positions.
As the company approaches potential commercialization, the need to establish a sustainable level of R&D investment is a key priority. Genmab has conducted a review of its portfolio and organization to establish priorities that will build the greatest potential value. The company will sharpen its focus on cancer therapeutics and a less broad, but higher potential portfolio.
Zanolimumab is currently in a Phase III pivotal study to treat cutaneous T-cell lymphoma (CTCL). As Genmab has previously indicated, patient recruitment into the zanolimumab pivotal study has been slow which the company believes is due to the relatively small market potential in CTCL, the introduction of a new CTCL therapeutic to the market and numerous competing clinical trials. In the light of these issues, Genmab considers that the significant investment required to take the product through to approval is no longer a good use of its resources.
Genmab will also aim to out-license three of its early stage development programs that fall outside the focus area: HuMax-HepC(TM), HuMax-IL8(TM) and HuMax-TAC(TM).
In addition, Genmab will wind down the zalutumumab (HuMax-EGFr(TM)) early stage studies in colorectal and lung cancer. This decision is based on new information about the role of K-RAS mutations and appropriate therapeutic regimens. Genmab will continue its development of two Phase III and two earlier stage studies with zalutumumab in head and neck cancer.
Genmab will be reducing staff across its international locations in an effort to match the number of programs to the resources needed to carry them out. One hundred and one of the company's employees will be affected.
These decisions are not expected to have a material effect on this year's guidance.
"The Board and management of Genmab deeply regret the need to reduce our workforce, all of whom have been valued members of our team. However, the changes are necessary to ensure that we have the correct level of staff for the planned development programs. The need to make these changes has taken on a special urgency in the current economic climate," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We are grateful to all our employees for their contributions and are committed to assisting those that are leaving in finding new positions. With a broad development program including 6 ongoing Phase III studies, we must prioritize spending to ensure that we can continue to invest effectively for the future."
Conference Call Genmab will hold a conference call to discuss the outcome of the portfolio review today, October 8, 2008 at:
4:00 pm CEST 3:00 pm BST 10:00 am EDT
The conference call will be held in English.
The dial in numbers are as follows:
+1-877-879-6207 (in the US) and ask for the Genmab conference call +1-719-325-4798 (outside the US) and ask for the Genmab conference call
A live and archived webcast of the call will be available at http://www.genmab.com.
About Genmab A/S Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for unmet medical needs. Using cutting-edge antibody technology, Genmab's world class discovery, development and manufacturing teams have created and developed an extensive pipeline of products for potential treatment of a variety of diseases including cancer and autoimmune disorders. As Genmab advances towards a commercial future, we remain committed to our primary goal of improving the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit http://www.genmab.com.
This press release contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's Annual Report, which is available on http://www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this press release nor to confirm such statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM) and UniBody(R) are all trademarks of Genmab A/S.
Contact: Helle Husted, Sr. Director, Investor Relations, T: +45-33-44-77-30, M: +45-25-27-47-13, E: firstname.lastname@example.org
Stock Exchange Release no. 46/2008
|SOURCE Genmab A/S|
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