found this at www.bioportfolio.com/news/btech march 3 2009
Aventis and Genta Partner To Develop Genasense
Biotech companies are holding on to drugs longer and longer before partnering with a pharmaceutical or larger biotech company to co-market the drug. ImClone (NASDAQ: IMCL) was almost ready to file its ill-fated BLA for Erbitux when it announced a $2 billion deal with Bristol-Myers Squibb (NYSE: BMY). With three phase III trials well underway, Genta (NASDAQ: GNTA) announced yesterday that it would co-develop and co-market Genasense with Aventis (NYSE: AVE).
Although not approaching the value of the Erbitux deal, Genta touted the Genasense partnership, valued at $480 million, as the second largest single-drug deal in biotech history. Genta will receive a $10 million licensing fee, $75 million in convertible debt ($65 million of which is contingent on Genasense achieving certain clinical milestones), a $75 million equity payment, $40 million in cash prior to Genasense's first approval, and $280 million in cash after Genasense is approved. Aventis will also pay for certain development costs associated with Genasense. Genta and Aventis will jointly handle regulatory submissions and Aventis will finance Genta's sales force for Genasense. The two companies will split U.S. revenue from Genasense roughly equally. Aventis will market the drug in non-U.S. markets and Genta will receive a royalty.
The deal is important for the biotech sector because it demonstrates that pharmaceutical companies are still willing to pay significant amounts for biotech drugs, even after the problems that Erbitux has caused for Bristol-Myers. Given the extensive due diligence that Aventis must have demanded in the current biotech climate, the deal is also a significant validation of Genasense and antisense technology in general.
Genasense is an antisense therapeutic that inhibits production of the Bcl-2 protein, an anti-apoptotic factor that protects many tumor cells from programmed cell death. By making cancer cells generally more sensitive to killing by both natural mechanisms and by chemotherapy or radiotherapy, Genasense has promise to treat a broad range of cancers in combination with many types of therapy. In fact, two of the most promising therapeutics being tested with Genasense - Taxotere and Campto - are sold by Aventis.
Aside from the obvious synergy between Genasense and Aventis's chemotherapeutic drugs, Aventis has strong expertise in oncology that should complement Genta's developmental program and marketing of Genasense. Highlights from Aventis's oncology platform include:
* Taxotere (docetaxel)
* Campto (irenotecan in Europe)
* Advexin (with Introgen), a gene therapy construct in phase III clinical trials for head and neck cancer and multiple earlier stage trials in various solid tumor indications
* MLN-341 (with Millennium), a proteosome inhibitor in phase II clinical trials for multiple myeloma
Given this oncology expertise, Aventis should help Genta execute in four areas:
* Prioritizing the initiation and successful accomplishment of clinical trials in cancers of greatest incidence such as those of the lung, colon, breast, and prostate, as well as lymphoma
* Completing ongoing phase III trials in melanoma, multiple myeloma, and chronic lymphocytic leukemia
* Aligning with European interests for expanding development in other conditions not yet clinically examined
* Accelerating the regulatory process to enable early initiation of clinical trials in Japan
In contrast to ImClone's approach, Genta has been very conservative about projections for Genasense development. Data from phase III trials, expected this summer, should indicate which of the three indications being tested will become the basis for Genasense's initial regulatory submission.
Full analysis of Genasense, Genta's pipeline, and other antisense therapeutics can be found in the Nov. 9, 2001 Btech Report: Fighting Disease with DNA and RNA.
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