Medeva PLC Reports FDA Requires Further Information for Hepagene Vaccine Filing Review
LONDON (April 12) BW HEALTHWIRE -April 12, 1999--Medeva PLC (NYSE: MDV), the international pharmaceutical company, today announced that it has been advised by the US Food and Drug Administration ("FDA") that additional information is required before they accept its license application for Hepagene(TM) as a vaccine against hepatitis B for review. This follows the submission of the application by Medeva on February 10, under the new Biologics License Application ("BLA") process for preventive vaccines introduced earlier this year.
In October 1998, Medeva filed a pan-European license application for Hepagene(TM) as a vaccine against hepatitis B, which was accepted for review, with The European Agency for the Evaluation of Medicinal Products.
Following a preliminary review of Medeva's license application, the FDA has questioned the number of subjects in the clinical database for safety evaluation and advised that it requires further information on, and modifications to, current manufacturing processes. The FDA also requires further information on protocols relating to validation of equipment, processes and systems, and comparative clinical data on final manufacturing lots.
Medeva will be holding a meeting with the FDA to address the issues raised and will provide an update on the position at the end of May.
Commenting on the announcement, Medeva's Chief Executive Dr. Bill Bogie said: "We remain confident of the clinical merits of Hepagene(TM) as a vaccine and the potential contribution it will make to medicine. Our filing in Europe is moving along, and in the USA, we will work with the FDA to address the matters they have raised." NOTES FOR EDITORS HEPAGENE(TM) AS A NEW THIRD GENERATION VACCINE AGAINST HEPATITIS B HEPAGENE(TM) CAN WORK WHERE CURRENT VACCINES FAIL
Current hepatitis B vaccines given as three doses over six months, whilst safe and efficacious in most people, are only effective in 70 - 90% of people vaccinated, even when all three doses are taken. Furthermore, non-compliance with the critical third dose ranges from 15% to 50%. This is a significant problem in high risk groups such as healthcare workers, people travelling to high risk areas, patients attending Sexually Transmitted Disease clinics, and injectable drug users, where adequate and rapid protection is highly desirable.
Clinical studies involving over 4000 subjects have shown that in comparison with existing second generation vaccines, Hepagene(TM): a) is effective in protecting adults who have not previously
responded to repeated doses of other currently available hepatitis B vaccines. b) provides the first two-dose regimen for hepatitis B vaccination.
This one month regimen protects more rapidly and can match the efficacy of present vaccines' (Engerix B(TM) and Recombivax
HB(TM)) standard three-dose regimen which takes six months to complete.
In late 1998 Medeva submitted a pan-European product license application for Hepagene(TM) as vaccine against hepatitis B which was accepted for review by The European Agency for the Evaluation of Medicinal Products (EMEA).
On February 10, 1999 Medeva announced that a filing had been submitted to the FDA in the USA for Hepagene(TM) as a vaccine against hepatitis B. The FDA's response to this filing is the subject of the attached press release dated April 12, 1999. HEPATITIS B
Hepatitis B is a highly infectious agent. The virus can be transmitted "horizontally" through exchange of body fluids with an infectious carrier, or "vertically" from an infected mother to her baby, either at birth or shortly thereafter.
Hepatitis B is the most prevalent chronic viral infection in the world. At least 1 million people are infected each year in Europe alone and it is estimated that there are over 350 million chronic carriers worldwide. The disease leads to substantial costs for society and many deaths. Healthcare bodies have long been aware of this major public health problem and there is a growing recognition of the need for effective prevention and treatment of the disease. This is reflected in the increasingly widespread requirement for healthcare workers to be vaccinated in order to practice. HEPAGENE(TM) IS A NOVEL AND COMPLEX BIOTECHNOLOGY PRODUCT
Hepagene's(TM) novelty and complexity as a biotechnology product derives from the fact that it is the first recombinant hepatitis B vaccine to incorporate significant levels of all three of the hepatitis B virus' own surface antigens: pre-S1, pre-S2 and S. Together, these three surface antigens comprise the major part of the hepatitis B viral envelope. Current second generation vaccines contain only one of the surface antigens (S) of the virus. Further, like the surface of the virus itself, Hepagene's(TM) surface proteins are glycosylated. The result is that Hepagene(TM) closely mimics the surface of the hepatitis B virus and, as a result, produces an immune response superior to that of the present recombinant vaccines.
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 anesthetics) 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, and the Republic of Ireland.
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. This release contains certain forward looking statements made pursuant to the US Private Securities Litigation Reform Act of 1995. In particular, statements with regard to product development (including particularly the conduct of clinical trials, studies and investigations, the filing of product license applications and the anticipated launch of products) are 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: legislative and regulatory changes relating to pharmaceutical products, unanticipated difficulties in the design or implementation of clinical trials, studies and investigations, failure to obtain required approval from governmental authorities, including the US Food & Drug Administration, and results from such trials, studies and investigations that are inconsistent with previous results and the Company's expectations. 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.
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CONTACT: Alexandra Hockenhull
Medeva PLC
011-441-71-839-3888
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James P. Prout
Taylor Rafferty Associates
212-889-4350
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