SAN FRANCISCO _ Alkermes Inc. landed Genentech Inc. as itssecond partner in one of its drug-delivery programs, and is makingplans to advance into Phase II trials with another.
The Cambridge, Mass., company is announcing the developments inboth programs today at the 13th Annual Hambrecht & Quist Inc. LifeSciences Conference here. Both of the announcements concern theareas Alkermes decided to focus on when it restructured inSeptember.
The company will receive a $3.5 million, five-year loan _ payableat any time during that period with stock or cash _ from South SanFrancisco-based Genentech, said Richard Pops, CEO of Alkermes.The deal involves Alkermes' ProLease micro-encapsulationtechnology, which allows for sustained release of injectable proteins.
The companies will test a ProLease formulation of Genentech'shuman growth hormone and an undisclosed protein. The deal isworth up to $20 million in payments and milestones to Alkermes, notincluding potential royalties and manufacturing revenues.
"Genentech is the most sophisticated consumer of this technology,"Pops told BioWorld. "They have a deep understanding of sustained-release formulations of proteins. It was gratifying for us to pass thescientific scrutiny of Genentech."
In November, Germany-based Boehringer Mannheim GmbH agreedto pay Alkermes $3 million, in a deal worth up to $10 million withmilestones, to apply ProLease to one of its molecules.
In both cases Alkermes worked with the companies on unfunded,scientific collaborations, to show ProLease's capabilities. Two othercompanies might come aboard under similar arrangements, Popssaid.
ProLease uses polyactic glycolic acid polymers to encapsulateproteins and peptides. By adjusting the formulation, sustaineddelivery ranging from days to months can be achieved. Pops saidGenentech's growth hormone, injected in children daily, is an idealcandidate for the technology.
Separately, Alkermes said it completed patient enrollment in threePhase I/II studies of RMP-7 (receptor-mediated permeabilizer) incombination with chemotherapy drugs in patients with brain tumorsand cryptococcal meningitis. The company also said it completed aPhase I study of RMP-7 that showed an effect on increasing the braintumor permeability.
Pops said it was the first time the blood-brain barrier opening inhumans has been quantitatively shown.
RMP-7, a peptide formulated for injection, will be tested in Phase IItrials starting this quarter, the company said. RMP-7 and carboplatinwill be tested in the U.S. and Europe in patients with recurrentglioma. The U.S trial will be a controlled, double-blinded studycomparing carboplatin and RMP-7 against carboplatin alone. TheEuropean study will be an open-label trial testing RMP-7 andcarboplatin. Alkermes expects to complete the trials in one to twoyears, Pops said.
Carboplatin was the drug used in two of the Phase I/II trials.Amphotericin B was used in the cryptococcal meningitis indication,which won't be pursued because of the decline in the disease.
"Our intention is to craft partnerships with pharmaceuticalcompanies in upcoming months," said Pops, adding that it remains tobe seen whether the deal will be exclusive. n
-- Jim Shrine
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