North American Vaccine Issues Update on Certiva(TM) Launch And Development Pipeline at 17th Annual H&Q Healthcare Conference
Certiva(TM) Sales Achieve 6% Public Market Penetration in Fourth Quarter
Three Products, Including Groups B and C Meningococcal Vaccines, Slated for
1999 Clinical Trials
COLUMBIA, Md., Jan. 11 /PRNewswire/ -- North American Vaccine (Amex: NVX) is presenting an update this week on the progress of the launch of Certiva(TM), its proprietary vaccine for the prevention of diphtheria, tetanus and pertussis, and its clinical development plans for several of its pediatric and adult vaccines at the 17th Annual Hambrecht & Quist Healthcare Conference opening today in San Francisco, California. In addition, North American Vaccine will report on the results of a Phase II clinical study in toddlers of its group C meningococcal conjugate vaccine completed during 1998 in the United Kingdom. Finally, North American Vaccine will provide an update on its overall development pipeline including plans to concentrate on completing collaborative and licensing agreements for other key products in its vaccine portfolio, including its group B streptococcal conjugate vaccine.
"Each of these conjugate vaccines is targeted at the prevention of very serious illnesses affecting thousands of infants, children and adults," stated Randal Chase, Ph.D., the newly appointed Chief Executive Officer and President of North American Vaccine. "And each of these vaccines also has a market potential in the hundreds of millions of dollars."
Certiva(TM) Launch
A significant milestone was achieved in 1998 with the much anticipated licensure of Certiva(TM) (a unique triple-toxoid diphtheria, tetanus, and acellular pertussis vaccine) in the United States. The launch of CertivaO began in October in the private market through a distribution agreement with the Ross Product Division of Abbott Laboratories, Inc. In November, 1998, North American Vaccine began its launch of Certiva(TM) through initial sales to government purchasers under the Vaccines for Children Program. During late November and December, 1998, sales were made to Alabama, Florida, Iowa, Indiana, Maryland, Missouri, Mississippi, New York, South Carolina, Texas and West Virginia and to the city of San Antonio. The net revenues generated during that period from Certiva(TM) sales were $1.2 million, representing a 6% market penetration for this sector.
"This is an impressive showing given that the launch did not begin until late in the fourth quarter and considering the number of holidays during that period," stated Stephen Keith, MD, MSPH, Vice President - Marketing and Sales. "We will focus our attention throughout 1999 on continuing to promote and grow sales of Certiva(TM) in the United States and supporting the efforts of our partners in Europe to sell products containing our acellular pertussis vaccine."
Results from Phase II Studies of Group C Meningococcal Conjugate Vaccine
North American Vaccine will also present comparative data from a safety and immunogenicity study of its group C meningococcal conjugate vaccine conducted by the Public Health Laboratory Service in toddlers in the United Kingdom as reported at the Neisseria '98 conference last November. In that study the company's vaccine was compared, head to head, against group C meningococcal conjugate vaccines manufactured by Chiron Corporation and Wyeth- Lederle. The results of the study indicate that, after a single dose, the Company's group C meningococcal conjugate vaccine significantly outperformed the competitor vaccines in generating bactericidal antibodies, anti-group C meningococcal IgG antibodies and in the percent of subjects that experienced a four-fold rise in functional antibodies. In addition, the results from this study revealed no serious adverse events and minimal local injection site reactions, which is consistent with results published from other clinical studies of this vaccine.
In earlier studies, North American Vaccine had reported the results of a study conducted in the United Kingdom involving 30 adults, each of whom received a single dose of the group C meningococcal conjugate vaccine. The results from this study revealed no serious adverse events and minimal local injection site reactions. Further, 97% of the subjects developed a greater than ten-fold increase in bactericidal antibodies and more than a four-fold increase in IgG antibodies specific to group C meningococcus. Over a six month follow-up period, antibody avidity increased indicating the successful induction of a T-cell dependent antibody response. The data also demonstrated that the Company's group C meningococcal conjugate vaccine induces functional antibody responses which exceed those elicited by a group A/C meningococcal polysaccharide vaccine.
North American Vaccine's group C meningococcal vaccine is included in a school-leaver clinical study being conducted this year in the United Kingdom and the Company is discussing with the regulatory authorities the requirements for securing approval of the group C meningococcal conjugate vaccine in the United Kingdom. Based on discussions to date, the Company anticipates that regulatory approval could be secured in that market in 2000.
Other Developments
North American Vaccine will also report on other key developments slated for 1999 including the start of a pivotal immunogenicity study in adults for Amvax(R) (a combined tetanus, diphtheria and acellular pertussis vaccine for adolescents and adults) and Certiva(TM) combination vaccines for the U.S. market. Additionally, North American Vaccine anticipates greater focus on collaborating and partnering in the further development of several other proprietary products.
Key examples of prime collaborative projects are identified, including a group B streptococcal vaccine, which has completed proof-of-principal clinical studies conducted by Harvard University, Baylor College of Medicine and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
"I am pleased with the progress that has been made in the launch of Certiva(TM) and with respect to the Company's near term pipeline, particularly the group C meningococcal vaccine and Amvax(R)," stated Dr. Randal Chase. "In addition to the products that have been specifically referred to, we expect to begin clinical trials in the United States on Certiva(TM)-IPV in the near term and to commence a Phase I clinical trial on the Company's group B meningococcal conjugate vaccine in collaboration with Pasteur Merieux Connaught during late 1999. I believe that the strength and diversity of this pipeline should enable us to meet many of our near and long term strategic goals and objectives." |
