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Spectrum Pharmaceuticals (SPPI) Licenses A Fourth-Generation Phase 2 LHRH Antagonist From Zentaris GmbH (AELA)


10/19/2005 5:11:07 PM

IRVINE, Calif., Aug. 12 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. announced today that it has acquired certain rights to D-63153, a fourth generation LHRH (Luteinizing Hormone Releasing Hormone, also known as GnRH or Gonadotropin Releasing Hormone) antagonist, which has been in clinical trials in Europe, from Zentaris GmbH, a wholly owned subsidiary of AEterna Zentaris Inc. (Nasdaq: AEZS; TSX: AEZ). D-63153 has the potential to treat hormone-dependent cancers as well as benign, proliferative disorders (such as benign prostatic hypertrophy and endometriosis). The combined U.S. market opportunity for the potential initial indications (hormone-dependent prostate cancer, benign prostatic hypertrophy and endometriosis) is estimated to exceed $4 billion.

Under the terms of the agreement, Spectrum acquired an exclusive license to develop and commercialize D-63153 for all potential indications in North America (including Canada and Mexico) and India. Zentaris received an upfront payment of cash and equity, and is eligible to receive payments upon achievement of certain development and regulatory milestones, in addition to royalties on potential net sales. Zentaris retains exclusive rights to the rest of world, but will share with Spectrum upfront and milestone payments, royalties or profits from potential sales in Japan. Financial details were not disclosed.

"The acquisition of rights to this compound, which has so far been in clinical trials in Europe, represents an important milestone in expanding Spectrum's product portfolio," stated Luigi Lenaz, M.D., President of Oncology Division, Spectrum Pharmaceuticals. "We are delighted to have the opportunity to work with AEterna Zentaris team as well as someone of Professor Engel's caliber and look forward to developing and commercializing D-63153. Based on clinical data accumulated in the past several years on D-63153, we believe that this 4th generation LHRH antagonist may unlock the commercial potential of this class of agents. The discovery of LHRH and its antagonists was the subject of a Nobel Prize in Medicine in 1977. We plan to expand the development of D-63153 by initiating additional trials in one or more indications as soon as feasible, possibly before the end of 2004."

"We are extremely pleased to establish this alliance," stated Rajesh Shrotriya, M.D., Chairman of the Board, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "The acquisition of this oncology asset is an important step in implementing our strategy and achieving one of our stated goals for 2004. Our overall strategy is to build an extensive portfolio of anti-cancer and related compounds that span all stages of development and that can be used either as a single agent or in combination with other currently marketed anti-cancer treatments to enhance their safety and efficacy."

"We are delighted to have a collaborator with the drug development expertise of Spectrum's management and the financial strength that Spectrum possesses," stated Professor Juergen Engel, Chairman and Managing Director of Zentaris GmbH and Chief Operating Officer of AEterna Zentaris. "We believe that this is the beginning of a long-term, productive relationship. Our complementary skills and experience should enhance and expedite the development of this promising compound."

About Spectrum Pharmaceuticals

Spectrum Pharmaceuticals is an oncology-focused pharmaceutical company engaged in the business of acquiring, developing and commercializing proprietary drug products which have a primary focus on the treatment of cancer and related disorders as well as generic drug products for various indications. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug being co-developed with GPC Biotech AG for its initial indication, second-line chemotherapy for hormone-refractory prostate cancer and has been granted fast-track status by the FDA. Elsamitrucin, a phase 2 drug, will initially target non-Hodgkin's lymphoma. EOquin(TM), a phase 2 drug, is being studied in the treatment of superficial bladder cancer. In addition, the Company has filed with the FDA three Abbreviated New Drug Applications for the generic drugs ciprofloxacin, carboplatin and fluconazole.

For additional information, including SEC filings, visit the Company's web site at http://www.spectrumpharm.com/.

About AEterna Zentaris Inc.

AEterna Zentaris Inc. is a biopharmaceutical company focused in oncology and endocrine therapy. Its extensive portfolio, from drug discovery to marketed products, includes perifosine, an orally-active AKT inhibitor in several Phase II trials for multiple cancers, and cetrorelix, an LHRH antagonist already marketed for in vitro fertilization under the brand name Cetrotide(R), and also in advanced clinical development for the treatment of uterine myoma, endometriosis and benign prostatic hyperplasia (BPH).

AEterna Zentaris also owns 62% of Atrium Biotechnologies Inc., which develops, distributes and markets active ingredients, specialty fine chemicals, cosmetic and nutritional products for the cosmetics, chemical, pharmaceutical and nutritional industries.

News releases and additional information about AEterna Zentaris are available on its new Web site http://www.aeternazentaris.com/.

Forward-looking statements

This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, our financial position, our plans for the commercialization of our drug candidates, including D-63153, the ability of D-63153 to unlock the commercial potential of LHRH antagonists, the timing and success of our clinical trials, including the timing of initiation of additional clinical trials on D-63153, the success of our drug candidates in their initial indications and other potential indications, including the success of D-63153 in and the combined market opportunity for the potential initial indications of hormone-dependent prostate cancer, benign prostatic hypertrophy and endometriosis, the success of our regulatory filings, the acquisition of additional drug compounds to build an extensive portfolio of anti-cancer compounds, our drug development expertise, the ability to enhance and expand the development of D-63153 and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our efforts to acquire or in-license and develop additional oncology drug candidates to build an extensive portfolio of anti-cancer and related compounds may fail, the possibility that our existing and new drug candidates, including D-63153, may not prove safe or effective in their initial indications or other potential indications, the possibility that our existing and new drug candidates may not receive approval from the FDA in a timely manner or at all, the possibility that our existing and new drug candidates including D-63153, if approved, may not be more effective, safer or more cost efficient than competing drugs and therefore may not be successfully commercialized, our dependence on third parties for clinical trials, our management's limited experience in working together and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.

For further information, please contact: Rajesh C. Shrotriya, M.D., CEO and President, +1-949-743-9295, or Anna Kazanchyan, M.D., +1-949-743-9215, both of Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, Inc.

CONTACT: Rajesh C. Shrotriya, M.D., CEO and President, +1-949-743-9295,or Anna Kazanchyan, M.D., +1-949-743-9215, both of Spectrum Pharmaceuticals,Inc.


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