Plants are becoming important on a number of fronts in biotechnology research, and North Carolina is something of a leader in developing unique plant-derived products.
Here are looks at two promising developments – at Endeavor and at Biolex.
Wilmington-based Endeavor Pharmaceuticals Inc. has reported pivotal study results that showed its plant-derived estrogen tablets help prevent menopause symptoms in women even at low doses.
The Endeavor product, called Enjuvia, which is currently under review by the Food and Drug Administration, reduced the number and severity of hot flushes with once daily dosing at all dosage strengths tested in the trial.
The company presented the results at the 13th annual meeting of the North American Menopause Society (NAMS) in Chicago Thursday.
“Recent controversy surrounding the Women’s Health Initiative has heightened interest in lower dose estrogens,” said Wulf Utian, M.D., executive director of NAMS.
“Enjuvia’s wide range of effective doses, including the low dose 0.3 mg, would allow physicians the flexibility to individualize treatment for women who seek relief from potentially debilitating hot flushes but who are concerned about potential side effects.”
This could mean big bucks for Endeavor if Enjuvia gets FDA approval.
Women spend up to one-third of their lives in a post-menopausal state, and 85 percent experience unpleasant and often debilitating symptoms. The controversy over estrogen replacement therapy side-effects has only increased the need for alternatives to conventional treatment with estrogen derived from horse urine and associated impurities.
Charlotte’s Wakefield Group is among Endeavor’s venture-backers. The company has two other estrogen products derived from plants in its pipeline.
Its major competitor, Wyeth, markets Premarin, an estrogen derived from mare urine, but the reports about the risks of hormone replacement therapy make the billion-dollar product vulnerable to alternatives.
Biolex gets Bayer deal
Biolex Inc., announced Thursday that it has signed a research collaboration and development option agreement with Bayer Corp. to make human proteins and plasminogen via its Lemna system.
Lemna is a fast-growing acquatic plant that reproduces clonally, so it has neither pollen nor seeds. It’s mass doubles every 36 hours and it has a high protein content. It can be genetically manipulated to produce human proteins.
Biolex senior VP John Irick tells Local Tech Wire: ” Bayer is one of the largest therapeutic protein companies in the world. This is the second such deal that Biolex has publicly announced, the first one being our collaboration with Debiopharm in September.
“We see these agreements as indicative of the industry’s desire to move to alternative expression technologies, such as the Lemna SystemTM, and as further validation of our business model.”