By Mary Welch
Allergan Inc. entered into a $30.1 million license and research agreement with the Centre for Applied Microbiology & Research (CAMR) to speed up the development of CAMR's neurotoxin-based technology for the treatment of acute and chronic pain conditions.
Irvine, Calif.-based Allergan will fund the multiyear joint research project with CAMR in return for future royalties on worldwide net sales of any products. Allergan will have exclusive rights to commercialize the technology. CAMR, based in Salisbury, UK, will receive research fees, technology fees and milestone payments.
"This is a great collaboration," said Les Kaplan, Allergan's president, research and development. "This collaboration adds to the dimension of pain management and takes Botox [Botulinum Toxin Type A] in a different direction, permitting Allergan to try to identify a whole new host of applications aimed at the pain market with Botox."
CAMR's technology is centered on neurotoxins produced by Clostridium botulinum, which produces seven distinct toxins, including Type A. Minute quantities of the bacterium offer significant potential in treating a wide variety of disorders associated with muscle overactivity, the company said.
CAMR removed the binding portion of the neurotoxin, which targets motor-nerve fibers, and attached it to ligands that target peripheral nerves responsible for tansmitting pain signals. In so doing, CAMR has developed a treatment designed to have few, if any, of the side effects of the opiate products now used to treat pain. Initial laboratory studies have shown that this new class of analgesic product has a long-term effect of pain cessation without inducing muscle weakness, the company said.
Botox purified neurotoxin complex is used in the treatment of certain neuromuscular disorders that are characterized by involuntary muscle contractions.
The rights to a form of botulinum toxin type A, now marketed as Botox, were acquired by Allergan in 1989 from the Smith-Kettlewell Eye Research Foundation and the University of Wisconsin. That same year, it was approved for use in strabismus and blepharospasm associated with dystonia in patients 12 years of age or older. Blepharospasm is the uncontrollable contraction of the eyelid muscles that can force the eye closed and result in functional blindness. Strabismus is a misalignment of the eyes.
Last year the company filed with the FDA to expand the approved indications to include cervical dystonia. It also is conducting Phase III trials in cerebral palsy, low back pain associated with muscle spasm, cosmetic brow furrows and adult spasticity.
Botux is in Phase II studies for the treatment of migraine headache, with a pivotal Phase III trial expected to start later this year, and another supplemental filing expected late this year.
Early studies of Botox should start this year for the treatment of chronic tension-type headache.
Outside the U.S., Botox is approved for several indications, including cervical dystonia, hemifacial spasm and lower limb spasiticity.
Botox had global sales of $175.8 million in 1999, an increase of 43.5 percent over 1998 sales. Global market share is about 88 percent, Allergan said.
CAMR is a Special Health Authority governed by the UK Department of Health through the Microbiological Research Authority Board.
Allergan's stock (NYSE:AGN) closed Monday at $60.312, up 62.5 cents.