Alkermes Inc.'s confidence in its proprietary sustained-release drugdelivery technology paid off in a collaboration with Germany-basedBoehringer Mannheim GmbH.

Alkermes, of Cambridge, Mass., signed a deal worth up to $10million to apply its ProLease technology to an undisclosedBoehringer Mannheim molecule. The deal allows for the companiesto work together on three other molecules, which would benegotiated separately.

Rather than asking for upfront funding from Boehringer Mannheim,Alkermes "chose to work with them on their molecule of interest onan [unfunded] scientific basis to show them our capabilities,"Michael Landine, the company's chief financial officer, toldBioWorld Friday. "Given the partnering market out there now, wethought it might be inappropriate to ask someone to spend a lot ofmoney upfront."

Now Alkermes will be reimbursed for the feasibility work it did withBoehringer Mannheim, which dates back to May. It also will getmilestone payments in addition to sales royalties. BoehringerMannheim will fund all clinical development.

ProLease uses polyactic glycolic acid (PLGA) polymers toencapsulate proteins and peptides. By adjusting the formulation ofthe microcapsules, sustained delivery ranging from days to monthscan be achieved, depending on how quickly the polymer is designedto disintegrate, Landine said. "Under ideal circumstances, it isreleased equally over a period of time," he said. "As a practicalmatter, you get a small amount of burst _ 5 to 10 percent initially_ then the balance is released equally over the rest of the period."

Advantages to the delivery method include less-frequentadministration, presumably resulting in reduced cost of service, and"in some instances it may even have increased clinical benefit,"Landine said.

Boehringer Mannheim is the first corporate partner for the ProLeasetechnology, but isn't expected to be the last.

"This is the first of the scientific collaborations we've had that wasconverted into a funded development agreement," Landine said."The sustained delivery of proteins and peptides is an extremelydifficult technical challenge. We're very confident of ourtechnology. We think we're the world's best in sustained delivery."

Alkermes is working with two other companies in "scientificcollaborations," at least one of which Landine expects to beconverted into a funded agreement.

Boehringer Mannheim, a private company, does not want to discloseits target focus. But Landine said the technology could be beneficialin any kind of protein application that requires frequent injection.

The feasibility study, started last May, is expected to be completed inmid-1995. At that time Boehringer Mannheim will decide whether tocontinue the collaboration.

Last month Alkermes initiated what it called a "proactive" move inwhich it cut back on development efforts and staff to reduce netlosses by $1 million per year. (See Today, Sept. 21, 1994,p.6.)

The goal was to focus on the nearest-term programs, or the ProLeaseand RMP-7 (receptor-mediated permeabilizer) efforts.

Phase I/II trials of RMP-7, in combination with the chemotherapeuticagent carboplatin, are ongoing for treatment of brain tumors. Two ofthe trials, including one in the U.K., involve intravenousadministration. In the other trial the agent is being administeredintra-arterially. Landine said he expects to begin Phase II trials ofRMP-7 around the end of March 1995. RMP-7 results are expectedto be presented at an oncology meeting in the spring.

Preclinical studies demonstrated that RMP-7 selectively increasedpermeability of the blood-brain barrier in animals with brain tumorsor radiation injury.

The company, in announcing its cutbacks, said two programs wereput on hold. One, the carrier program, uses an antibody to deliverlarge molecules to the brain. The other involves calpain inhibition,dealing with neurodegeneration in the brain. Preclinical data fromthose programs will be presented this week in Miami at the Societyof Neuroscience meeting. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.

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