Medeva Acquires Worldwide Rights to Gene Therapy for Cystic Fibrosis From Targeted Genetics
08:00 a.m. Nov 24, 1998 Eastern
LONDON--(BUSINESS WIRE)--Nov. 24, 1998--Medeva PLC (NYSE:MDV), the international pharmaceutical company, today announced that it has acquired from Targeted Genetics Corporation (NASDAQ: TGEN) ("Targeted Genetics") the worldwide commercial rights to tgAAV-CF, a gene therapy being developed for the treatment of cystic fibrosis, under a joint development and supply agreement. Gene therapy represents leading edge technology in the field of biotechnology today. The tgAAV-CF product has the potential to be one of the first products utilizing this technology to reach the market.
Commenting on the announcement, Medeva's Chief Executive, Dr. Bill Bogie, said: "This product offers the potential to treat patients in an area of unmet medical need and fits well within our respiratory portfolio. As our recent regulatory submission for Hepagene as a vaccine has shown, Medeva has considerable expertise in the evaluation, development and manufacture of complex biological products. The agreement announced today shows that, because of this, we can attract leading edge development projects from among the key biotechnology platforms."
President and CEO of Targeted Genetics, H. Stewart Parker said: "We believe that Medeva represents an optimal partner for Targeted Genetics and tgAAV-CF. We have been very impressed with the infrastructure Medeva has created for the development and marketing of products for the pulmonary market as well as with their aggressive and entrepreneurial style. We believe these attributes are essential for the rapid development and commercialization of tgAAV-CF."
Cystic fibrosis is the most common fatal hereditary disease in Caucasians and occurs in approximately one in every 2,500 - 4,500 births in this population. The disease is monogenetic, that is, caused by a single defective gene. Overall, there are estimated to be 60,000 people worldwide suffering from cystic fibrosis, of which approximately 24,000 are in the USA and 20,000 are in Europe.
There is, at present, no cure for the disease, although currently available therapies can relieve symptoms, for example by thinning mucus and by controlling infection, and so help to extend life expectancy. Unlike current therapies, tgAAV-CF offers the potential to treat the underlying cause of the disease.
Therapy with tgAAV-CF involves delivery to the lungs of a normal copy of the cystic fibrosis gene using a proprietary adeno-associated virus vector. Utilizing a virus as a carrier has been shown to be the most effective way to transport a gene into the appropriate target tissue. The adeno-associated virus vector is widely regarded as a safe viral vector for this purpose. The use of the vector is protected by a portfolio of patents, the rights to which are held by Targeted Genetics.
Under the agreement Targeted Genetics will undertake certain pre-clinical and process development work in the U.S.A. Medeva will conduct the later development stages in the U.S.A., all development work outside the U.S.A. and all applications for marketing authorizations, the first of which is scheduled to be filed in 2002. Once appropriate regulatory approvals are received, Medeva will launch the product internationally. The market for current therapies is estimated at approximately $800 million per annum. Phase I trials of an aerosolized formulation of tgAAV-CF are due to commence before the end of this year.
The target prescribing group for the new product fits well with Medeva's niche marketing capabilities in the countries where it has infrastructure. For example in the USA, where Medeva has an existing franchise in the respiratory market, patients are commonly treated at a focused group of cystic fibrosis centers across the nation.
The consideration being paid by Medeva to Targeted Genetics comprises: a technology license fee of $5 million; clinical and regulatory milestone payments totaling $19 million; a loan of $2 million; investment in Targeted Genetics equity totaling $3 million; and up to a maximum of $15 million in research and development funding for this project over a three year period. Under certain conditions, Medeva will also make available to Targeted Genetics a loan of $10 million towards the building of a manufacturing facility for the production of tgAAV-CF. Of the above amounts, a total of $8.5 million is payable on signing of the agreement. Following launch, Targeted Genetics will be responsible for the manufacture and supply of the product to Medeva.
Medeva PLC is an international company developing, manufacturing, and marketing prescription pharmaceutical products in the following main therapeutic areas: respiratory care, vaccines, CNS therapies (attention deficit disorder and anti-obesity), gastroenterology, hospital products (pain management and anaesthetics) and dermatology. In the UK, Medeva is the sole producer of human vaccines, including flu, childhood and traveler's vaccines. In the US, Medeva is the leading manufacturer and distributor of methylphenidate. Medeva also has operations in France, Spain, Belgium, the Republic of Ireland and a further subsidiary in Switzerland specializing in gastro-intestinal products.
Medeva's ordinary shares trade on the London Stock Exchange and its ADRs, each equal to four ordinary shares, trade on the New York Stock Exchange under the symbol MDV. Additional information on Medeva can be accessed on the company's home page: http://www.medeva.com
Targeted Genetics Corporation develops gene and cell therapy products for the treatment of certain acquired and inherited diseases. The Company has three lead product development programs targeting cystic fibrosis, cancer, and infectious disease, as well as an extensive technology platform. Additional information about Target Genetics can be accessed on the company's home page: www.targen.com. This release contains certain forward looking statements made pursuant to he US Private Securities Litigation Reform Act of 1995. In particular certain statements with regard to (a) product development (including particularly to the conduct of clinical trials, and the filing of product license applications), (b) the likelihood of securing new products to develop and (c) anticipated levels of demand for products are all forward looking in nature. By their nature forward looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward looking statements. The following factors, although not exhaustive, could cause actual results to differ materially from those the Company expects: (1) pricing and product initiatives of the Company's competitors, (2) legislative and regulatory changes relating to pharmaceutical products, (3) unanticipated difficulties in the implementation of clinical trials, failure to obtain required approval from governmental authorities, and results from such trials that are inconsistent with previous results and the Company's expectations, (4) the failure of demand to develop as anticipated and (5) the failure of the Company's development partners to perform their contractual obligations. The forward looking statements included in this document represent the Company's best judgment as of the date hereof based in part on preliminary information and certain assumptions which management believes to be reasonable. The Company disclaims any obligation to update these forward looking statements.
BACKGROUND NOTES FOR EDITORS Cystic fibrosis is a chronic, progressive and generally fatal disease. It results from the loss of function of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene and is an inherited, autosomal recessive condition. Although other organs of the body are affected by cystic fibrosis, it is progress of the disease in the respiratory tract that generally leads to early death. Targeted Genetics' proprietary tgAAV-CF uses adeno-associated virus (AAV) to deliver a normal copy of the gene that is non-functional in CF patients to the lungs. Normally, the protein encoded by this gene is found in the respiratory passageways, pancreas, and salivary and sweat glands where it helps to regulate the cellular concentration of chloride ions and water. In cystic fibrosis patients, the loss of this gene function causes the production and build-up in the lungs of thick mucus, which is readily colonized by bacteria. The thickness of the mucus prevents clearance of bacteria and reduces the efficacy of antibiotics. Repeated infections produce scarring in the lung, which ultimately results in loss of respiratory function. It is estimated that 60,000 people worldwide have cystic fibrosis including approximately 24,000 people in the U.S. and 20,000 in Europe.
Copyright 1998, Business Wire
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