Millennium Pharmaceuticals Inc. decided to let someone else drive, or at least pay for the gas, in the development of its cardiovascular product, MLN519.
Cambridge, Mass.-based Millennium and Paion GmbH will collaborate on the compound, formerly called LDP519, with a joint project team drawing up plans for Phase II trials. But Paion, of Aachen, Germany, shoulders responsibility for MLN519’s development, including all costs, although Millennium has the option to get back in, all the way up to approval. MLN519 is designed to treat patients with stroke and certain other neurological conditions.
It’s a nice way of getting a compound developed without allocating the resources.
“This is part of a proven strategy that others have used,” she told BioWorld Today. “If you follow Genentech [Inc., of South San Francisco], it’s done this extensively. We think it is a sound strategy because it helps us accelerate the development of the product and it allows us to leverage the external expertise of our partners while we focus our internal resources on nearer-term opportunities.”
Millennium was “clearly thinking” about locating the right partner for just this type of deal, Protopapas said, and discovered that Paion has a sizable amount of that external expertise it was looking for.
“Paion is very well known in the stroke area that’s their area of focus and they have a seasoned team,” she said, adding that the team has moved a thrombolytic agent for the treatment of ischemic injury in stroke into worldwide Phase II trials.
Although stepping back for now, Millennium retains exclusive commercial rights in North America and parts of Asia and would receive royalties on European sales. Paion has rights in Europe and certain Asian countries, for which Millennium will receive option payments, and Paion will receive royalties in all other major markets. Millennium will receive milestone payments for clinical achievements.
Also, Millennium will make a convertible loan to Paion before Paion’s next equity financing and will make a “minority interest” equity investment in Paion at the conclusion of the round, Protopapas said.
Dan Curran, senior director of business development and the man who brokered the deal, said the companies will “move aggressively,” giving Millennium a chance for evaluation.
“The plan is to put this into patients as soon as possible,” he said. “[Millennium] can look at the Phase II or we can allow the program to blossom into Phase III and then look. We’ll judge that as we go along.”
MLN519 is a proteasome inhibitor with anti-inflammatory properties. It is designed to act on an intracellular mechanism that controls the activation of inflammatory molecules.
Through the closure of the acquisition of COR Therapeutics Inc., of South San Francisco, and the taking on of its cardiovascular product, Integrilin, Millennium believes it is “the leading franchise in the cardiovascular area,” Protopapas said. Integrilin is approved for patients with acute coronary syndrome including patients who are to be managed medically and those undergoing percutaneous coronary intervention. The product also is indicated for use at the time of percutaneous coronary interventions, including procedures involving intracoronary stenting. Integrilin is in multiple Phase II and Phase III trials to broaden its label. (See BioWorld Today, Dec. 7, 2001.)
Separately, Millennium announced the details of its cash offer to holders of its outstanding 4.5 percent converitble senior notes due June 15, 2006, and 5 percent convertible senior notes due March 1, 2007. The offered cash amount equals 100 percent of the principal amount of the notes plus interest accrued and unpaid through April 28. The offers and withdrawal rights expire at 9 a.m. April 29. Millennium assumed the $600 million in notes in connection with its merger Feb. 12. The notes are now convertible into Millennium stock.
But if Integrilin is the staple in Millennium’s cardiovascular portfolio, the portfolio itself is gathering speed. Millennium, in collaboration with XOMA Ltd., of Cambridge, Mass., is developing MLN01, a humanized monoclonal antibody, for cardiovascular uses. The product is in Phase II trials. Its preclinical programs include a Factor Xa inhibitor program and a platelet ADP receptor blocker program.
The deal with XOMA, signed in November, is structured similarly to the deal with Paion, Protopapas said. It’s the kind of deal Millennium likes. (See BioWorld Today, Nov. 27, 2001.)
“This is the strategy we’ve used in the past that will allow us to continue to develop multiple products,” she said. “I think this is yet another step in the strategy we have to enter alliances where appropriate to accelerate the development of our pipeline. I think you will see other deals like this in the future.”
Millennium’s stock (NASDAQ:MLNM) fell 57 cents Thursday to close at $24.20.