BURLINGTON, ON, Aug. 22 /CNW/ - Boehringer Ingelheim has offered the
Canadian generic pharmaceutical manufacturer Apotex Inc. a royalty free,
voluntary licence to manufacture and export products containing nevirapine to
Rwanda as requested by Apotex.
Boehringer Ingelheim has also offered to extend the license to other
developing countries as identified by the World Health Organization.
"This licence is one part of Boehringer Ingelheim's ongoing commitment to
provide access to nevirapine in the developing world," states President and
CEO of Boehringer Ingelheim (Canada) Ltd. Ian Mills. "For example, through its
Viramune Donation Program for the Prevention of Mother-To-Child Transmission,
Boehringer Ingelheim currently donates nevirapine to close to 60 countries to
help prevent the transmission of HIV to new born children."
If Apotex accepts the voluntary licence, it will be free to manufacture
product containing nevirapine for export to the developing world to help those
patients suffering from HIV/AIDS. The terms of the licence offer are more
favourable terms than those required under the access to medicines provisions
of Canadian Legislation.
The licence offer contains the following terms and conditions:
- The licence is totally royalty free thereby Apotex is not required to
pay anything to Boehringer Ingelheim for the licence.
- Apotex is permitted to extend the licence to other WHO defined
developing countries in addition to Rwanda by way of a simple letter
of intent to Boehringer Ingelheim.
- The licence permits Apotex to use nevirapine for the entire patent
life of the product as opposed to the minimum two year term provided
by Canadian law.
- Apotex agrees to clearly mark its product that it is solely for use
in the importing country and to differentiate its product as required
under Canadian legislation
- Apotex agrees to also provide details to Boehringer Ingelheim of the
quantity manufactured and exported for tracking purposes in the case
of diversion of the product to a non approved importer as required
under Canadian law.
- The Apotex product containing nevirapine must also meet any
requirements of Health Canada for such an exported product as
required under Canadian law.
"Boehringer Ingelheim continues to play a role in helping those in the
developing world who suffer from HIV/AIDS. It is now time for Apotex to take
action as they have the opportunity to manufacture and export products
containing our patented substance without any concerns of legal action from
Boehringer Ingelheim," said Mr. Mills. "With the offered licence we sincerely
believe there are no obstacles to Apotex with regard to nevirapine to supply
Rwanda, or any other designated country , with the quantities requested so
that patients can benefit from effective HIV medicines."
Mr. Mills further states that "if Apotex finds the terms unacceptable
then we would be concerned as to whether Apotex is serious in its plans to
manufacture and export such a product so that patients in developing countries
DONATING TO FURTHER PREVENT SPREAD OF HIV
Since 2000 Boehringer Ingelheim has also given free access to single-dose
nevirapine, used alone or in combination with other drugs, to prevent
mother-to-child transmission of the HI virus during birth. The company is
currently donating the product to 60 countries in Africa, Asia, Latin America
and Eastern Europe. In total more than 1 million mother/child doses were
supplied free of charge so far. Just one nevirapine tablet taken by the mother
during labour and a dose of nevirapine suspension given to the baby within the
first 72 hours of birth can reduce the rate of transmission of the virus by
approximately 50 percent, as demonstrated in clinical studies(xx).
(xx)Monotherapy with Viramune in the prevention of mother-to-child
transmission of the HI-virus during birth has been associated with the
potential development of NNRTI resistance. According to the latest WHO
guidelines for MTCT, where other ARV medicines are accessible, single-
dose Viramune should be combined with additional effective antiretroviral
ABOUT BOEHRINGER INGELHEIM
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates
globally with 137 affiliates in 47 countries and 38,400 employees. Since it
was founded in 1885, the family-owned company has been committed to
researching, developing, manufacturing and marketing novel products of high
therapeutic value for human and veterinary medicine. In 2006, Boehringer
Ingelheim posted net sales of 10.6 billion euro while spending one fifth of
net sales in its largest business segment Prescription Medicines on research
and development. Boehringer Ingelheim employees over 720 people across Canada.
Its head office is located in Burlington, ON and also has a Global R&D
facility located in Laval, Quebec which specializes in Virology.
For further information:
For further information: Derek O'Toole, Director of Market Access and
Communications, Boehringer Ingelheim (Canada) Limited, (905) 631-4757 (B)