|ImmunoGen Confirms Approval of Kadcyla by FDA; Elan Provides Update of Tysabri Collaboration|
|By Staff and Wire Reports|
|Friday, 22 February 2013 19:55|
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its TAP technology, today announced that Roche has reported the U.S. FDA has granted marketing approval to Kadcyla for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy.
“This is a big day for the patients with this cancer and for ImmunoGen,” commented Daniel Junius, President and CEO. “In clinical testing, the findings with Kadcyla in this patient population have been impressive, and we're delighted the product can now be used by practicing oncologists across the US. In addition to its importance from a medical perspective, commercialization of Kadcyla also marks the start of ImmunoGen earning royalty income.”
Mr. Junius continued, “The efficacy and tolerability seen with Kadcyla underscores the transformative potential of our technology. Kadcyla is the most advanced of ten compounds with our TAP technology already in the clinic, with more in earlier stages of development. We are hopeful that in the future many different types of cancers will be routinely treated with TAP compounds.”
Kadcyla has gained FDA approval for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin and a taxane chemotherapy. People should either:
* Have already been treated for their metastatic cancer, or * Have had their early-stage cancer come back during or within six months after they completed a course of treatment following surgery.
FDA approval of Kadcyla triggers a $10.5 million milestone payment to ImmunoGen. The Company also earns royalties on commercial sales of Kadcyla. Genentech is prepared to launch the product imminently.
“I am thrilled to see our concept of a trastuzumab-DM1 conjugate become a reality today,” commented John Lambert, Ph.D., Executive Vice President and Chief Scientific Officer. “We have always believed this product could make an enormous difference for appropriate patients and are delighted to see it move into the hands of practicing oncologists.”
Elan Corporation, plc (NYSE:ELN) provides an update to the market post the February 6, 2013 announcement regarding the restructuring of the Tysabri® collaboration with Biogen Idec. As previously announced, under the terms of this agreement, Elan will move from the current 50:50 business collaboration to an upfront payment of $3.25 billion and a double digit tiered royalty structure for the life of the complete Tysabri asset.
Mr Kelly Martin, CEO commented, “Understandably, many market participants are looking forward to further clarity around how we intend to deploy the significant upfront payment we will be receiving from Biogen Idec upon the close of our transaction. The goal of this communication is to provide additional information to our investors.” Mr Martin continued, “We have been making significant progress in this regard and are prepared to move expeditiously, upon close, on the redeployment of capital.”
The Board of Directors, executive management and a number of our key advisors have been working on a possible restructuring of the Tysabri relationship for many years. The unlocking of a portion of the Tysabri asset value provides Elan with significant strategic flexibility and a unique opportunity to reset the company along a number of dimensions.
Upon the closing of the Tysabri transaction Elan will, in accordance with applicable law and regulation (including by obtaining any required consents or approvals), execute along three dimensions:
I. Strategic Initiatives: A portion of the $ 3.25 billion will be invested into a variety of business assets. From a portfolio point of view, these assets will, characteristically, diversify Elan from a product, science/clinical, therapeutic, and geographic point of view. As mentioned previously, in anticipation of agreeing to the Tysabri restructuring, we have spent significant time evaluating assets around the world and establishing relationships that might ultimately lead to constructive strategic transactions. We are pleased with our progress along these lines. We are enthusiastic about the opportunities that exist and we expect to be in a position to announce a number of strategic transactions upon or following the close of the Tysabri restructuring.
II. Debt Refinancing: Following closing of the Tysabri transaction, Elan will refinance its outstanding debt. We have worked closely with the credit markets over the past ten years and value the access to capital and long standing relationships that we have with our creditors. Details regarding the refinancing will be made public following the close of the Tysabri restructuring.
III. Share Repurchase: Following closing, we will institute a share repurchase program by utilizing $1 billion of the upfront proceeds from the Tysabri restructuring, with the method to be detailed following the transaction closing. This enables a significant portion of the unlocked value of Tysabri to be returned to shareholders directly. Additionally, and as outlined previously, the upfront cash payment to Elan will have little to no tax burden and part of our objective is to enable shareholders to benefit directly from that structural advantage. Following this transaction, Elan retains over $1.5 billion in accumulated tax losses and other structures as well as our favorable Irish tax structure. We greatly value our shareholder relationships and the access to equity capital these relationships give us and we appreciate the time horizon of many of our long term holders. We will continue to work on ways to unlock incremental value to their direct benefit.
In closing, Kelly Martin concluded, “Our actions over the past years have been consistent in theme and execution. We have reduced risk (financial, asset concentration, infrastructure burden) while, at the same time, preserving the upside from future advancement of science, clinical or commercial products. By unlocking a portion of the Tysabri asset value while retaining a significant earnings upside, we have a unique opportunity to reward shareholders, diversify our business and create a highly distinctive business platform upon which to advance to the benefit of shareholders and patients around the world.”
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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla™ (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy.
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops anticancer therapeutics using its TAP technology, today announced that Roche has reported that the U.S. Food and Drug Administration (FDA) has granted marketing approval to Kadcyla for the treatment of people with HER2-positive metastatic breast cancer who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy.
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