18 Biotechnology Law Report 422Number 5 (October 1999)Mary Ann Liebert, Inc.

Licensing and Collaborations

{BLR 2987} Anti-Angiogenesis Agents-Cancer-CocaineToxicity-DrugAbuse Sciences-EntreMed-Tetrionics-Therapeutic Antibodies.

CONTRACTS SIGNED FORMANUFACTURE OF TWOPOTENTIAL PRODUCTS

—Anti-Cocaine Antibody,Antiangiogenesis Drug

SUMMER 1999-Two products in developmenthave found manufacturers to provide the consider-able amounts needed for final preclinical and clini-cal testing.

TREATMENT FOR COCAINE TOXICITY

On June 29, DrugAbuse Sciences, Inc. (MenloPark, Cal.) announced that it had signed an exclu-sive agreement with Pasteur Merieux Connaught(Lyon, France) to manufacture DAS's proprietarypotential treatment for cocaine toxicity. That prod-uct, COC-AB, is a purified antibody fragment di-rected against cocaine and its active metabolites. Asfree drug in the blood becomes bound by the anti-body, cocaine is released from the brain and heart,to be similarly taken up and prevented from furtherinteractions with tissues. Such therapeutic antibod-ies already are in use to treat overdoses of two clas-sic plant-derived drugs, the heart stimulant digitalisand the anti-gout agent colchicine. Pasteur Merieuxhas extensive experience in antibody manufacturingand has been working with DAS for 18 months toproduce the COC-AB used in preclinical studies.DrugAbuse Sciences hopes to file an Investiga-

tional New Drug Application for COC-AB in thefirst quarter of 2000.In 1998, an estimated 250,000 emergency de-

partment visits in the U.S. and Europe were causedby cocaine toxicity.

ANTIANGIOGENESIS DRUG

On July 13, Tetrionics, Inc. (Madison, Wise.) re-ported that it had agreed to manufacture 2-methoxyestradiol for EntreMed, Inc. (Gaithersburg,Md.). A hormonally inactive estrogen derivative,2ME kills rapidly dividing cells and inhibits the for-mation of new blood vessels. Thus, it may mount atwo-pronged attack on cancers. EntreMed expectsto submit an IND before the end of the year. Thecompany is developing 2ME under a CooperativeResearch and Development Agreement with the Na-tional Institutes of Health.Tetrionics, which is privately held, manufactur-

ers the active pharmaceutical ingredient for severalmarketed and developmental biotechnology prod-ucts.

{BLR 2988} Bostwick Laboratories-Cytogen-Pro-genics-Prostagen-Prostate Cancer.

CYTOGEN, BOSTWICK TO DEVELOPNATIONWIDE FACILITY FOR PMSASTAINING OF PROSTATE CANCERS

—Cytogen, Progenies to Collaborate on

Immunotherapy for Prostate Cancer; CytogenAcquires Prostagen, Proprietary Rights to PSMAPRINCETON, N.J. 8/12/99-This summer saw

several announcements from Cytogen Corp. detail-ing expansion of its activities directed at the diag-nosis and treatment of prostate cancer. The firmalready has two marketed products for this disease.

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Biotechnology Law Report • Volume 18, Number 5

ProstaScint, a radiolabeled monoclonal anti-body against prostate-specific membrane antigen(PSMA), is used to detect métastases of prostatecancer. Quadramet is used to relieve pain caused bybony métastases from prostate and other cancers.

MAKING PSMA STAINING AVAILABLE

On August 10, Cytogen announced an alliancewith Bostwick Laboratories (Richmond, Va.) to de-velop a service that will stain tissue from anywherein the country for PSMA. The principal use is ex-pected to be for detecting micrometastases in thepelvic lymph nodes of patients with prostate cancer.The presence of such métastases changes the ap-propriate treatment options. Bostwick will employthe 7E11 anti-PMSA monoclonal antibody that isused in ProstaScint to do the histochemical staining.

COMPANY ADDS PATENTATTORNEY-PROSTATE CANCER

ADVOCATE TO BOARD

Today, Cytogen said that S. Leslie Misrock, a se-nior partner with Pennie & Edmonds LLP, hasjoined its Board of Directors. A prominent prostatecancer advocate, Misrock was a founder, chairman,and principal investor in Prostagen, Inc., which Cy-togen recently acquired (see below). He specializesin intellectual property protection for inventions inbiotechnology and chemistry, with emphasis on lit-igation, including trials before the U.S. Court of Ap-peals for the Federal Circuit, the International TradeCommission, and the Board of Patent Appeals andInterferences. He also has prepared many license,consulting, sponsored research, and technologytransfer agreements and founded several biotech-nology companies.Misrock holds an SB in chemistry from MIT and

an AM in chemistry from Columbia University. Heearned his LLB at Fordham University. He is a

member of the Association for the Cure of ProstateCancer (CaPCURE), the Visiting Committees of theDepartments of Biology and Chemistry at MIT, theBoard of Visitors of Fordham Law School, and theHealth Sciences Board of Columbia University Col-lege of Physicians and Surgeons, as well as various

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scientific and bar associations. He has published ex-tensively on both patents and science, being the au-thor of The exercise of patent rights through multi-ple field of use licensing. 11 Rutgers Computerand Technology Law Journal 383, 1985 and Mea-surement of prostate specific membrane antigen(PSMA), a new prognostic marker for prostate can-cer. Prostate 1996;28:266-271, among other arti-cles. He is former member of the Editorial Boardof BLR.

A JOINT VENTURE AND ANACQUISITION

Cytogen Corp. announced on June 16 has formeda joint venture with Progenies Pharmaceuticals, Inc.(Tarrytown, N.Y.) and acquired Prostagen, Inc. (Al-lendale, N.J.).The acquisition of Prostagen restores to Cytogen

exclusive proprietary rights to immunotherapybased on PSMA, which was discovered by re-

searchers at Memorial Sloan-Kettering Cancer Cen-ter in New York. Prostagen has already initiated a

collaboration with NorthWest Biotherapeutics, Inc.,to develop ex vivo therapy for prostate cancer usingPSMA. The goal is to start Phase III trials next year.Cytogen will assume this program, as well as Prosta-gen's partnership with Velos, Inc., a marketer of dis-ease-management software.Cytogen made an upfront stock payment of $2.5

million and will make milestone earn-out paymentsin the future. The deal also gives Cytogen a minor-ity interest in NorthWest and Prostagen's cash, ap-proximately $500,000.The joint venture with Progenies is aimed at de-

veloping vaccines and antibodies against PMSA.Progenies, which has two cancer immunotherapyproducts in clinical trials, will conduct the preclin-ical and clinical studies and will pay licensing feesto Cytogen. Cytogen will have exclusive NorthAmerican marketing rights to any products that re-sult from the joint venture, with an option to mar-ket outside the U.S.

{BLR 2989} Aclara-Alberta Research Council-AntiviralDrugs-Axys Pharmaceuticals-Berkeley National Labora-tory-Biosource Technologies-Boston Life Sciences-Can-