主页 > 医学讨论 >
【drug-news】Celgene为什么急于并购 Vidaza?
The drugs that are driving two of the latest M&A deals in biotech attracted a great deal of attention at the annual American Society of Hematology (ASH) conference in Atlanta last week, giving investors the opportunity to scrutinize them more closely.
For starters, Celgene Corp. is after Vidaza, an up-and-coming cancer therapy owned by Pharmion Corp. (a company in which Celgene already has a minor stake). Vidaza, a DNA demethylating agent, is FDA-approved for subcutaneous or IV administration to patients suffering from all subtypes of myelodysplastic syndrome (MDS), a condition in which the bone marrow does not function normally. As such, Vidaza will join Celgene’s own MDS drug Revlimid, a thalidomide analog approved in late 2005 for treating patients with transfusion-dependent anemia due to MDS.
Revlimid is also approved for use in combination with dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy. And Celgene’s got another thalidomide-based drug – Thalomid – which can be used in combination with dexamethasone to treat patients with newly diagnosed multiple myeloma, the second most common blood cancer in the U.S. That means Revlimid and Thalomid are already generating serious revenues. (Sales of the two products in 2006 amounted to $754 million.) It also puts Celgene on a collision course with Millennium Pharmaceuticals Inc., a situation we’ll explore next.
Although its sales in 2006 totaled a mere $142 million, Celgene has high hopes for Vidaza’s future. And it’s no wonder: In Phase III trials, this drug extended overall survival in high-risk MDS patients by 74 percent as compared to conventional care. That translates into a median survival benefit of 9.4 months. Pharmion presented the complete Phase III trial data at the ASH conference and intends to file for European approval of Vidaza in high-risk MDS patients by year’s end, followed by a U.S. filing in 2008.
Through its $2.9 billion acquisition of Pharmion, which will close next year, Celgene also gets full marketing rights to thalidomide, which it licensed to Pharmion in November 2001 to develop and sell in Europe, Japan, China and a few other countries. Pharmion’s thalidomide is currently under review for use in patients with newly diagnosed multiple myeloma.
Even with its undeniably strong position in the multiple myeloma market, Celgene is still vulnerable to competition from Millennium Pharmaceuticals’ Velcade, a small molecule drug that inhibits the proteasome, a housekeeping enzyme complex present in all cells that plays an important role in numerous biological pathways, including the growth of cancer cells.
Velcade garnered its first FDA approval in May 2003 for treating patients with relapsed and refractory multiple myeloma. And data presented at this year’s ASH conference demonstrated that Velcade is very effective in patients newly diagnosed with multiple myeloma, as well. In fact, Velcade was able to quadruple complete remission rates in this setting – a finding that enchanted Millennium’s backers while forcing Celgene’s supporters to reevaluate their positions, even though results presented at the same meeting showed that Revlimid also increased overall survival and response rates as a first-line therapy for multiple myeloma.
Revlimid and Velcade are being positioned by their sponsors as initial therapies for multiple myeloma. But one study presented at the ASH conference combined the two (with dexamethasone) for dosing newly diagnosed multiple myeloma patients. Investigators from the Dana-Farber Cancer Institute showed that the three-drug combo achieved an overall response rate of 98 percent in an ongoing Phase I/II trial. More than half of the 42 patients evaluated so far had very good partial responses or better, with 30 percent achieving a complete response.
Revlimid, when combined with Rituxan, also seems to work in patients with relapsed/refractory mantle cell lymphoma. Results from a Phase I/II study presented at ASH showed that the drug combo elicited a 70 percent overall response rate in these patients, and 30 percent of them achieved complete responses. (Here again, Velcade represents a potential threat: It received FDA approval in December 2006 for use in patients with mantle cell lymphoma.)
Celgene also faces competition in the market for drugs to treat myelodysplastic syndromes (MDS) from MGI Pharma Inc.’s product Dacogen, an antimetabolite drug that inhibits DNA methylation. Dacogen, which MGI licensed from SuperGen Inc. in September 2004, garnered FDA approval for use in MDS in May 2006. Shortly thereafter, MGI Pharma licensed ex-North American rights to Cilag GmbH, a Johnson & Johnson company.
But Dacogen is about to change hands once again: In early December 2007, MGI announced that it had agreed to be acquired by Japanese giant Eisai Co. Ltd. for $3.9 billion. The deal, expected to close in the first quarter of 2008, includes MGI’s brain cancer drug Gliadel, post-chemotherapy anti-nausea/vomiting drug Aloxi, ovarian cancer drug Hexalen, and dry mouth drug Salagen as well as Dacogen.
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-07-09 17:14
医学,生命科学网