October 18, 2000
GENEVA, and OXFORD, England, Oct. 17 /PRNewswire/ via NewsEdge Corporation -
Serono S.A. (SWX: SEO and NYSE: SRA) and British Biotech plc (LSE: BBG and Nasdaq: BBIOY), today announced that they have entered into an exclusive agreement to jointly research, develop and commercialize metalloenzyme inhibitors (MEIs) for the treatment of serious inflammatory diseases.
Serono and British Biotech will work together under the agreement to identify new compounds for clinical development based on British Biotech's proprietary MEI platform technologies. Any compounds selected for clinical development will then be progressed under the terms of an exclusive licence, development and commercialization agreement. Included within the scope of the agreement is an option for Serono to obtain exclusive rights to develop and commercialize BB-2827, a collagenase inhibitor that is a potential treatment for rheumatoid arthritis, following completion of certain clinical studies by British Biotech which began in October 2000. Serono also gains rights to BB-76163, an aminopeptidase inhibitor with potential application in multiple sclerosis, which is currently in pre-clinical testing.
"This partnership brings together Serono's expertise in multiple sclerosis and other inflammatory diseases with British Biotech's leading position in metalloenzyme inhibition," commented Silvano Fumero, Senior Executive Vice President of Research & Pharmaceutical Development at Serono. "We will continue to enhance our competitive advantages in strategic research areas and to strengthen our early stage development pipeline by partnering in the drug discovery process."
Dr Elliot Goldstein, Chief Executive Officer of British Biotech, said, "This is an important, long-term research and development collaboration to bring new compounds to market with an emerging world leader in inflammatory disease. The relationship with Serono continues our strategy of collaboration with excellent partners to exploit our MEI platform, develop new drugs in inflammatory disease and expand our portfolio of commercialization rights. In addition we have met the important objective of starting clinical trials with BB-2827."
Under the terms of the agreement, British Biotech will receive from Serono an initial payment of USD 5 million, a series of undisclosed milestone payments, and eventual royalties on any commercialized products. The companies will share the costs of research equally. Costs of product development will be borne by Serono, but British Biotech has the right to fund half of such costs and, in certain circumstances, may co-promote products with Serono, for an improved return on sales. Depending on the achievement of certain milestones, cash payments and research funding to British Biotech during the term of the collaboration could total between USD 30 million and USD 80 million.
Some of the statements in this press release are forward looking. Such statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of the Company to be materially different from those expected or anticipated in the forward-looking statements. Forward-looking statements are based on the Company's current expectations and assumptions, which may be affected by a number of factors, including those discussed below and more fully described in the Company's Form F-1 filed with the U.S. Securities and Exchange Commission on July 26, 2000. These factors include any failure or delay in the Company's ability to develop new products, any failure to receive anticipated regulatory approvals, any problems in commercializing current products as a result of competition or other factors, our ability to obtain reimbursement coverage for our products, and government regulations limiting our ability to sell our products. The Company has no responsibility to update the forward-looking statements contained in this press release to reflect events or circumstances occurring after the date of this press release.
Serono, headquartered in Geneva, Switzerland, is a global biotechnology leader. The Company has four recombinant products on the market, Gonal-F(R), Rebif(R), Serostim(R) and Saizen(R). In addition to being the world leader in reproductive health, Serono has strong market positions in neurology, metabolism and growth. The Company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are seven products in development including six recombinant proteins.
In 1999, Serono achieved worldwide sales of USD 1.054 billion and a net income of USD 183.7 million, making it the third largest biotech company based on revenues. The Company operates in 45 countries, and its products are sold in over 100 countries. Bearer shares of Serono S.A., the holding company, are traded on the SWX Swiss Exchange (SEO) and its American Depositary Shares are traded on the New York Stock Exchange (SRA).
British Biotech is a research and development stage company (LSE: BBG, Nasdaq: BBIOY). Its strategy is to build shareholder value by exploiting its proprietary programmes in metalloenzyme inhibition; discovering and developing new classes of antibiotics; developing specialist drugs for the treatment of cancer and inflammation; and operating in both the USA and Europe. The Company has six products in development and is actively expanding its portfolio through its own research and collaboration with third parties. Value from products will be realized via development and marketing collaborations with pharmaceutical and biotech companies, and by retaining commercialization rights to niche markets. Four products are in clinical development. Marimastat, a matrix metalloproteinase inhibitor, is in Phase III development for the treatment of cancer, BB-3644, a follow-on to marimastat, is in Phase I development for cancer, BB-10153 has completed Phase I development for cardiovascular disease; and BB-2827, a collagenase inhibitor for inflammation is in Phase I development. huN901-DM1, a targeted cytotoxic for small cell lung cancer, and BB-76163, an aminopeptidase inhibitor for chronic inflammatory disease, are in preclinical development. British Biotech has developed a propriety compound library, targeted at metalloenzyme inhibition which lends itself to exploitation in a number of different therapeutic areas. This metalloenzyme inhibitor platform is being exploited in-house in the area of bacterial infections and by collaboration in other therapeutic areas.
Notes to Editors
Metalloenzymes are characterized by one or more active site catalytic metal ions. They have a wide range of specific biological activities including peptidase and non-peptidase activity residing in the intra- and extra-cellular environments. They are implicated in a wide range of diseases, including hypertension, cancer, bacterial infection and inflammation.
Multiple Sclerosis, or MS, is a chronic and often progressive debilitating disease of the central nervous system that primarily affects young adults. It is an autoimmune disease in which the body's immune system reacts against its own cells, thereby destroying the myelin sheath that protects the axons in the central nervous system. Damage to the myelin sheath impedes the normal transmission of nervous impulses. These interruptions of transmission cause motor and sensory difficulties. The progress of the disease is highly variable. However, in its most severe forms, MS leads to rapidly progressive disability and death.
Over one-half of the world's estimated one million people with MS suffer from the relapsing-remitting form of this disease, or RRMS, and nearly 80% of all MS cases start with RRMS. RRMS patients suffer from relapses or exacerbations, which are unpredictable occurrences of new symptoms or worsening of old symptoms punctuated by remissions.
MS represented an approximately $1.4 billion global market in 1999, based on publicly reported sales data for Rebif(R) ($143 million), and three competing products. Rebif is a recombinant interferon beta-1a that helps strengthen the body's immune system, and is identical to the interferon beta produced by the body in response to viral infections. Rebif is offered in two dosing regimens, 22 mcg three times per week, and 44 mcg three times per week, as a unique liquid formulation in a pre-filled syringe. The 44 mcg dose is the highest dose of interferon beta-1a currently approved for RRMS. Rebif is the fastest-growing treatment for MS outside of the US with a patient market share of approximately 28% for the first half of 2000.
Rheumatoid arthritis (RA) is a systemic autoimmune disease that affects various parts of the body and is one of the most common forms of arthritis. It is characterized by the inflammation of the membrane lining the joint, which causes pain, stiffness, warmth, redness and swelling. The inflamed joint lining, the synovium, can invade and damage bone and cartilage. Inflammatory cells release enzymes that may digest bone and cartilage. The involved joint can lose its shape and alignment, resulting in pain and loss of movement. RA is often chronic, and can be a disease of flares (active) and remissions (little to no activity). Current treatment of rheumatoid arthritis focuses on reducing swelling, relieving pain and stiffness, reducing inflammation and maintaining normal joint function.
Worldwide, RA affects between 1-2% of the total adult population. Its incidence ranges from 0.3 to 1.5% in most populations of the world, with women being three times more likely to get rheumatoid arthritis than men. Western countries generally see between 1-3% of their populations affected.
Serono is active in the area of rheumatoid arthritis, and is conducting two phase II trials in this disease area, looking at recombinant human interferon beta-1a and recombinant human tumour necrosis factor-binding protein (r-hTBP-1) as potential treatments.
Contact Serono International S.A., Geneva, Switzerland, media relations, +41-22-739-36-00, or fax, +41-22-739-30-85; or investor relations, +41-22-739- 36-01, or fax, +41-22-739-30-22; or Noonan/Russo Communications for Serono S.A., +44-207-726-4452, or fax +44-207-726-4453; or Tony Weir, Finance Director of British Biotech plc, +44-1865-781166, or fax, +44 1865 781047; or Jonathan Birt or David Yates both of Financial Dynamics, London, UK, + 44-207-831-3113, or fax + 44-207-242-8695
SOURCE Serono S.A
CONTACT: Serono International S.A., Geneva, Switzerland, media relations, +41-22-739-36-00, or fax, +41-22-739-30-85; or investor relations, +41-22-739-36-01, or fax, +41-22-739-30-22; or Noonan/Russo Communications for Serono S.A., +44-207-726-4452, or fax +44-207-726-4453; or Tony Weir, Finance Director of British Biotech plc, +44-1865-781166, or fax, +44 1865 781047; or Jonathan Birt or David Yates both of Financial Dynamics, London, UK, + 44-207-831-3113, or fax + 44-207-242-8695
Web site: http://www.serono.comhttp://www.britishbiotech.com