North American Psoriasis Deal Now Completed
Genesis Confirms North American Psoriasis Deal Now Completed
Potential revenues to Genesis from license of PVAC rights to Medicis Pharmaceutical Corporation may exceed US$50 million
AUCKLAND, New Zealand –4th October 2000– New Zealand’s leading biotechnology company Genesis Research and Development Corporation Limited (NZSE and ASX: GEN) today announced that a licensing deal with a major United States pharmaceutical firm for distribution rights to the PVAC™ psoriasis treatment which is jointly owned by Genesis and Corixa Corporation (Nasdaq: CRXA) has been completed.
“The closing of this deal marks a big step for Genesis,“ Dr Watson said. “PVAC is a Genesis discovery. It is very satisfying to see the high market value it commands.”
Under the agreement, Medicis Pharmaceutical Corporation (NYSE: MRX) will pay to Corixa license fees and additional fees upon the completion of certain development and commercialisation milestones for exclusive rights to the development and commercialisation of the treatment in the United States and Canada, which may exceed US$107 million. Genesis will receive its share of these payments.
Further payments will be based on PVAC’s success in clinical trials and on achieving certain commercialisation milestones.
Medicis will also pay Corixa a royalty on any future sales of PVAC. Genesis will also receive its share of these payments, which could be very significant to Genesis.
The deal was executed by Genesis partner, Corixa Corporation. Corixa has already sold the Japanese commercialisation rights for PVAC to Zenyaku Kogyo Pharmaceuticals, and are seeking to sell marketing rights in Europe and the rest of the world, Dr Watson said.
“Under this arrangement with Medicis, Genesis retains certain rights in its intellectual property and gets the opportunity to derive significant income from future sales.”
PVAC is currently undergoing Phase II trials, which are expected to be completed by the end of calendar 2000.
Sales of PVAC will be dependent on
satisfactory completion of Phase III trials currently
anticipated to begin in 2001 and subsequent U.S. regulatory
Medicis is the leading independent pharmaceutical company in the United States focusing primarily on the treatment of dermatological conditions.
Their highly focused dermatology development and marketing expertise as well as their credibility among dermatology leaders in North America are extremely important assets, ” Dr Watson said.
“These were important factors in selecting the optimal marketing path for PVAC treatment, our novel psoriasis immunotherapeutic. This deal is a landmark for Genesis. We believe the decision by Medicis to enter the agreement with Corixa endorses the value in PVAC and the revenues will enable us to continue expanding and progressing our vaccine programmes.”
Psoriasis is estimated to affect one to three percent of the world’s population. There are approximately seven million people in the US with psoriasis, of whom an estimated 30 percent have a moderate to severe form of the disease. The disease is characterised by chronic inflammatory lesions with red scaling plaques and is believed to be an autoimmune phenomenon mediated by T cells.
Genesis and Corixa have developed a potential immunotherapeutic product for psoriasis that is derivative of the bacterium Mycobacterium vaccae (M. vaccae). The product, known as PVAC treatment, is currently in Phase II clinical trials in the US, the Philippines and Brazil. Approximately 20 moderate to severe psoriatic patients were treated in the initial Phase I/II clinical trial with two injections of PVAC administered three weeks apart. Of these, just over half of the patients had complete responses to the therapy for the 52-week duration of the trial, following the two injections given at day zero and day twenty-one. Corixa is currently conducting a 13-site trial involving 240 patients in the US. Patient enrolment into the randomised placebo-controlled trial is completed and Genesis expects the trial to be completed by the end of 2000.
Genesis is a biotechnology company based in Auckland, New Zealand, with genomic programmes in human health, forestry and agriculture. Genesis builds EST databases that provide the genomic platform for discovery of novel genes with commercial value and has considerable experience and expertise in high-throughput DNA sequencing, functional genomics and development of therapeutics. Partnerships with biopharmaceutical, agricultural and forestry companies have been important for funding research to effectively develop potential products. In addition to the extensive forestry gene technology, Genesis is undertaking clinical trials for an asthma therapeutic in Wellington, New Zealand. For more information, please visit www.genesis.co.nz.
Corixa is a research and development-based biotechnology company committed to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system. Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary vaccine components on a stand-alone basis. The company partners with numerous developers and marketers of pharmaceuticals and diagnostics, targeting products that are Powered by Corixa™ technology with the goal of making its products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Wash. For more information, please visit Corixa’s website at www.corixa.com.
Medicis is the leading independent pharmaceutical company in the United States focusing primarily on the treatment of dermatological conditions. Medicis develops and markets leading products for major segments within dermatology, including acne, fungal infections, psoriasis, eczema, rosacea, seborrheic dermatitis, head lice and cosmesis (improvement in the texture and appearance of skin). Primary products include the prescription brands DYNACIN(R) (minocycline HCl), TRIAZ(R) (benzoyl peroxide), LUSTRA(R) (hydroquinone), LOPROX(R) (ciclopirox), OVIDE(R) (malathion), PLEXION(TM) (sodium sulfacetamide/sulfur), LIDEX(R) (fluocinonide), SYNALAR(R) (fluocinolone acetonide), TOPICORT(R) (desoximetasone), NOVACET(R) (sodium sulfacetamide/sulfur) and A/T/S(R) (erythromycin); the over-the-counter brand ESOTERICA(R); and BUPHENYL(TM) (sodium phenylbutyrate), a prescription product indicated in the treatment of Urea Cycle Disorder.