Healthcare Industry News: hepatitis B virus
News Release - July 31, 2012
Idenix Pharmaceuticals Announces Restructuring of Development and Commercialization Collaboration With Novartis Pharma AGIdenix Regains Worldwide Rights to Pipeline and Gains Flexibility in Future Potential Collaborations for All-Oral Combination HCV Therapies
CAMBRIDGE, Mass., July 31, 2012 -- (Healthcare Sales & Marketing Network) -- Idenix Pharmaceuticals, Inc. (IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that Idenix and Novartis Pharma AG (Novartis) entered into a termination and revised relationship agreement that restructures the development and commercialization collaboration that was established in May 2003. Idenix will host a conference call this morning at 8:00 a.m ET to discuss this agreement.
KEY TERMS OF THE TERMINATION AND REVISED RELATIONSHIP AGREEMENT
* Under this agreement, Novartis' option right to license Idenix's current and future development-stage drug candidates in any therapeutic area has terminated. In exchange, Idenix has agreed to pay Novartis a royalty based on worldwide product sales of Idenix's future hepatitis C virus (HCV) drugs, unless they are used in combination with drugs from Novartis. The royalty percentage will vary based on the commercialized Idenix HCV drug.
* Further, Novartis has a non-exclusive option to conduct clinical trials evaluating a combination of any of Idenix's and Novartis' HCV drug candidates, subject to the drug candidates meeting several criteria. Novartis' ability to initiate combination trials expires on the seven year anniversary of the execution of the termination and revised relationship agreement.
* Idenix will no longer receive royalty or milestone payments from Novartis based upon worldwide product sales of Tyzeka(R)/Sebivo(R) (telbivudine) for the treatment of hepatitis B. Novartis is committed to reimburse Idenix for payments to third-parties in connection with intellectual property related to Tyzeka/Sebivo.
* Novartis will retain the right to designate one member of the Idenix Board of Directors, reduced from two members, so long as it continues to own at least 15% of Idenix's equity ownership. Novartis has relinquished all other corporate governance rights, including approval rights over the authorization or issuance of additional shares of capital stock as well as significant acquisitions and dispositions. Novartis currently holds a 31% equity position and continues to have the right to participate in future public or private offerings of Idenix securities in order to maintain its ownership.
"This agreement affords Idenix increased flexibility to optimize the value of our pipeline for the benefit of Idenix, our shareholders and ultimately HCV patients. By regaining the worldwide rights to develop, commercialize and license all of our drug candidates, we believe Idenix will be well-positioned to develop pan-genotypic all-oral direct-acting antiviral combination treatments with potential collaborators," said Ron Renaud, Idenix's President and Chief Executive Officer.
ABOUT THE IDENIX/NOVARTIS COLLABORATION
In May 2003, Idenix and Novartis entered into a collaboration relating to the worldwide development and commercialization of Idenix's drug candidates. In May 2003, Novartis also purchased approximately 54% of Idenix's common stock. Novartis had certain corporate governance rights including approval rights over the authorization or issuance of additional shares of capital stock as well as significant acquisitions and dispositions.
Under the original development and commercialization agreement, Novartis had the option to license any of Idenix's development-stage drug candidates after demonstration of activity and safety in a proof-of-concept clinical trial, so long as Novartis maintained at least 30% ownership of Idenix's common stock. If the option were exercised, Novartis would have exclusive worldwide rights to co-develop and co-commercialize the licensed drug candidate with Idenix, and financial terms were to be based upon certain contractual obligations and future negotiations.
Novartis licensed telbivudine from Idenix in 2003 and the companies co-developed and co-launched Tyzeka(R) /Sebivo(R) for the treatment of hepatitis B virus. In September 2007, Idenix transferred to Novartis all worldwide development, commercialization and manufacturing rights and obligations pertaining to telbivudine in exchange for royalties based on net product sales of Tyzeka(R) /Sebivo(R) from Novartis.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 8:00 a.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 15948331. Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.
A replay of the conference call and webcast will be available until August 7, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 15948331.
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with HCV. For further information about Idenix, please refer to www.idenix.com.
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates; and the successful development of novel combinations of direct-acting antivirals for the treatment of HCV. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the Company's ability to obtain additional funding required to conduct its research, development and commercialization activities; the Company's amended relationship with Novartis; the Company's expectations regarding the benefits of the restructuring of its collaboration with Novartis; changes in the Company's business plan or objectives; the ability of the Company to attract and retain qualified personnel; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q for the quarter ended March 31, 2012, as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.
All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
Source: Idenix Pharmaceuticals
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