Abbott announces EC approval of Humira for psoriasis
ABBOTT PARK, Ill. Abbott Laboratories announced that the European Commission approved the marketing of Humira as a treatment for moderate to severe forms of the skin disorder plaque psoriasis, according to published reports. The drug is approved in the U.S. to treat rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis, a spinal disorder; and Crohn’s disease, a bowel disorder.
Humira was effective in more than 80 percent of patients in one clinical trial at clearing skin lesions 75 percent or better, according to the company. About three-quarters of patients in another trial had a similar response. About half of all the patients injecting Humira had 90 percent clearance within 16 weeks, Abbott said.
Psoriasis is a noncontagious, chronic autoimmune disease that causes the body to attack itself. Psoriasis is the fifth approved use of Humira in the European Union, and the drug is still under review for treating the skin disease in the U.S., Abbott said. Global sales of Humira totaled $803 million in the third quarter.
BioSante makes milestone payment of $875,000 to Antrares for Elestrin
EWING, N.J. Antares Pharma has received an additional payment of $875,000 from BioSante Pharmaceuticals in relation to a marketing agreement with Bradley Pharmaceuticals for the drug Elestrin.
Elestrin is a low dose transdermal estradiol therapy that is used for the treatment of hot flashes in menopausal women. Antares allowed BioSante to use its advanced transdermal delivery gel system for the drug. Additional sales based milestone payments could bring the deals total value to more than $13 million, not including royalties based on third party sales.
“We look forward to continued marketing progress with Elestrin in 2008. The December 2006 FDA approval of this product has validated our ATD gel system and that has been a significant milestone for Antares and our potential pipeline products including Anturol—our proprietary ATD gel based overactive bladder product—currently in pivotal trials,” said Jack Stover, president and chief executive officer of Antares Pharma.
GSK, Santaris ink deal worth a potential $700 million
LONDON GlaxoSmithKline has signed a deal with the biotech company Santaris Pharma to develop new antiviral medicine, in a deal that could be worth more than $700 million, according to Reuters. The deal involves drug candidates discovered and developed under the agreement in up to four different viral disease programs.
As part of the deal, Santaris will receive an upfront payment of $3 million for the first antiviral program and an equity investment of $5 million. The deal could be worth more than $700 million based on upfront payments and development and regulatory milestone payments, depending on the success on early-stage research in RNA antagonist compounds.
Santaris will also get high single- to double-digit percentage royalties on worldwide sales of marketed products. GSK will have the option to develop drug candidates in up to four different viral disease programs. It also has an option to include as an additional program Santaris’ pre-clinical hepatitis C compound SPC3649.