Feb
29
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colorectal cancer,
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Boston Biomedical's focus on targeting cancer stem cells has paid off. Japan's Dainippon Sumitomo has snapped up the biotech for $200 million down, $540 million in development milestones for its two clinical-stage programs and close to $1.9 billion in commercial milestones, provided the drugs can achieve mega-blockbuster status.
In exchange for the cash and the promise of biobucks to come, Dainippon gets BBI608 and BBI503 and a new subsidiary in the U.S. which will spearhead its expansion in the cancer drug R&D field. The pharma company boasts that the two drugs are "likely to become the first anticancer drugs in the world targeting cancer stem cells." BBI608 is being prepped for a Phase III clinical trial for colorectal cancer in North America and in Phase Ib and II clinical trials for various solid tumors. BBI503 is in Phase I clinical trial for patients with various advanced solid tumors in North America.
Dainippon is following a common practice among Japanese pharma companies. Rather than absorb the biotech into its business, it's keeping BBI's operation in the Boston area and planning to beef up its work in the cancer field as it embraces new approaches to treating metastatic cases.
"Acquisition of BBI is not only an acquisition of an innovative pipeline in the oncology area, it also represents obtaining an excellent drug discovery/development platform with the capabilities of BBI, enabling us to continuously create candidate compounds likely to advance into later development stages," says Dainippon CEO Masayo Tada. "Subsequently we intend to establish our R&D base in the US to expand our presence in cancer treatment globally. We are aiming to make the oncology area one of our future focus therapeutic areas next to the CNS area."
Dainippon licensed regional rights to BBI608 back in April, 2011. Evidently they like what they've been seeing since.
- here's the press release
Dec
22
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Chelsea Therapeutics,
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Chelsea Therapeutics ($CHTP) has racked up some more positive efficacy data for its lead drug droxidopa, which is now up for review at the FDA. Investigators reported the drug spurred a statistically significant response on some key measures of fibromyalgia in the Phase II study, which was designed to test a range of doses as well as a combo approach with carbidopa. The biotech recruited 120 patients for the study, ultimately zeroing in on 7 separate arms.
Charlotte, NC-based Chelsea designed the trial with the understanding that droxidopa, a synthetic amino acid, is converted by the body into norepinephrine. By boosting levels of norepinephrine, Chelsea believes it can directly address some of the disease's severe side effects. Shares of Chelsea were up slightly this morning.
"Since norepinephrine is a key neurotransmitter involved with the modulation of chronic pain, we were not surprised to see evidence of droxidopa's therapeutic benefit in treating patients with fibromyalgia," stated Dr. Art Hewitt, Chelsea's chief scientific officer. "As we continue to evaluate potential indications for droxidopa such as fibromyalgia and adult attention deficit disorder, trials like this provide insight into how to optimize dosing for more robust future clinical evaluations. Given the broad biologic activity of norepinephrine, we continue to believe there are wide-ranging therapeutic applications for a first-in-class oral prodrug of norepinephrine. We also continue to be encouraged by the remarkable safety profile of droxidopa which, even at its highest dose, again proved not to be associated with any serious or significant adverse events."
A few weeks ago the FDA accepted Chelsea's application for droxidopa as a new treatment for hypotension. The drug, in-licensed from Japan's Dainippon Sumitomo 5 years ago, flunked its first Phase III, but Chelsea regrouped and announced positive data in 2010. Regulators are expected to make its final decision on the program by March 28 under a priority review.
- here's the press release
- read the Reuters story
Related Article:
Chelsea shares rocket up after lead drug clears PhIII