GW Pharmaceuticals plc (“GW”) and Bayer Healthcare AG (“Bayer”) announce that they have extended their marketing agreement for Sativex®, GW’s cannabis-based medicinal extract product, to the Canadian market.
Bayer obtained exclusive rights to market Sativex in the UK in May 2003 at which time Bayer also secured an option to negotiate the marketing rights in selected other countries. This new agreement for Canada is the first extension concluded under these option arrangements.
As with the UK agreement, the financial terms of the new partnership have been established to yield equal long term value to each partner. GW has maintained a significant share of long term product revenues in Canada and will receive additional milestone payments totalling up to £7.75 million.
Negotiations to extend the partnership to other countries, as detailed in the original agreement, are continuing.
Sativex has been developed by GW to provide a medically acceptable cannabis-derived product for the treatment of the debilitating symptoms of Multiple Sclerosis (“MS”) and severe neuropathic pain. The product is a whole plant medicinal cannabis extract containing TetranabinexTM (tetrahydrocannabinol (“THC”)) and NabidiolexTM (cannabidiol (“CBD”)) as its principal components. The medicine is administered by means of a spray into the mouth.
Approximately 50,000 people in Canada are diagnosed with MS. Pain occurs in 80% of MS patients and 20 to 50% report experiencing significant pain (O’Connor 2002). A Canadian survey of patients with neuropathic pain found that 73% suffered from inadequate pain control (Boivie 1999).
Discussions have commenced with Health Canada regarding a New Drug Submission for Sativex. GW submitted a product licence application for Sativex, to the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) in March 2003.
Dr Geoffrey Guy, Executive Chairman of GW, said: “I am delighted to be announcing a further extension of our partnership with Bayer, as envisaged at the time of our original agreement earlier this year. Over the last few years, GW has held positive discussions with officials in Canada regarding the introduction of Sativex and we look forward to working with Bayer to bring Sativex to market in Canada at the earliest opportunity.”
Philip Blake, Head of Bayer HealthCare, Pharmaceuticals Division and President of Bayer Inc., said, “We are pleased to partner with GW to bring this innovative cannabis-based product to the Canadian market. We believe that by offering a safe, effective and legal alternative to medicinal marijuana, Sativex can make a substantial difference in the lives of patients with MS and those who suffer from neuropathic pain.”
In respect of the UK regulatory submission for Sativex, GW and Bayer report that the assessment by the MHRA continues to proceed according to the normal regulatory process. The precise timing for completion of the assessment is at the sole discretion of the MHRA.
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Notes to editors:
Bayer HealthCare, a subgroup of Bayer AG, is one of the world’s leading innovative companies in the health care and medical products industry. More than 34,000 employees work for Bayer HealthCare worldwide.
Bayer HealthCare combines the global activities of the Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals divisions. Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
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