Research Triangle Park, U.S.A. – Stiefel, a GSK company, and Welichem Biotech, Inc., have entered into an agreement for the acquisition by Stiefel of exclusive development and commercialization rights to the novel anti-inflammatory agent, WBI-1001, in all territories outside of China, Taiwan, Macao and Hong Kong. WBI-1001 is currently in Phase II clinical development for the treatment of psoriasis and atopic dermatitis. The transaction is subject to approval by Welichem shareholders.

Stiefel, a GSK company, is a company interested in dermatology and skin science around the world. Stiefel’s focus is on research as well as pharmaceutical, over-the-counter and aesthetic dermatology products.

Welichem will receive an initial payment of CAD$35 million and is eligible to receive additional milestone payments upon achievement of certain clinical development milestones and upon commercialization in certain countries following marketing approval from the corresponding regulatory agencies.

Under terms of the agreement, Stiefel has also received a conditional right to acquire further exclusive rights to develop and commercialize WBI-1001 in China, Taiwan, Macao and Hong Kong, collectively. Upon satisfaction of certain conditions, Welichem will receive an additional payment of CAD$15million.

“I’m delighted to build upon Stiefel’s clinical pipeline of novel dermatology assets with the acquisition of WBI-1001,” said Barbara White, Senior Vice President and Head of Research and Development, Stiefel. “We have a strong commitment to patients with skin conditions and are excited to undertake development of this innovative agent.”

WBI-1001 is a novel, non-steroidal, topical anti-inflammatory new chemical entity (NCE) that has demonstrated efficacy and safety in Ph1 and Ph2 clinical trials for the treatment of mild to moderate psoriasis[i] and moderate to severe atopic dermatitis[ii] for up to 12 weeks as a single therapy. However, Stiefel notes that WBI-1001 is still in development and there are still risks and uncertainties to which the NCE is subject.

Image Courtesy of  andras_csontos / Shutterstock.com

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The Food and Drug Administration (FDA) approved a new drug, Horizant Extended Release Tablets, on Wednesday to treat moderate to severe primary Restless Legs Syndrome in adults.  Horizant is a patented new chemical entity discovered and developed by both GlaxoSmithKline and XenoPort.

Restless Legs Syndrome affects up to 10 percent of the U.S. population and is a disorder of the nervous system that causes an urge in the body to move one’s legs.  This disorder is classified as a sleeping disorder because it affects and interferes with a person’s sleeping habits.  The irresistible need to move one’s legs in attempt to relieve the sensations is often described as uncomfortable, “pins and needles,” or a “creepy crawly” feeling.  The sensations are often made worse when laying down, sitting or when legs are trying to rest.

“People with Restless Legs Syndrome can experience considerable distress from their symptoms,” Russell Katz, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, states in an FDA news release.  “Horizant provides significant help in treating these symptoms.”

The drug was approved based on two studies that were done in more than 2,300 adults.  These 12-week studies showed improvement in Restless Legs Syndrome patients trying Horizant that was considerably greater than those patients who were receiving a placebo.  Patients received oral daily doses in a range from 600 to 3,600 mg.

According to the full Prescribing Information provided on Horizant’s website, the recommended doze of this drug is 600 mg once daily taken with food.  The drug is not to be cut, crushed or chewed. Horizant is a prodrug of gabapentin and is described as an acetic acid.  It’s molecular formula is C16H27NO6.

This drug is administered orally and contains 600 mg of gabapentin enacarbil and the following other inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, glyceryl behenate, magnesium sterate, sodium lauryl sulfate, and talc.

The FDA states that Horizant “may cause drowsiness and dizziness and can impair a person’s ability to drive or operate complex machinery.”  Horizant’s website also confirms that this drug causes significant driving impairment.  It is an antiseizure medicine, and like all drugs of this type, Horizant holds a warning label about the risk of suicidal thoughts and actions in a small number of people.

According to a news release from GlaxoSmithKilne and XenoPort, do not take Horizant if you sleep during the daytime and remain awake at night.

This is a significant milestone in XenoPort and GlaxoSmithKline’s efforts to develop a non-dopaminergic therapy.  “We hope that we can continue to develop other important medicines that can provide meaningful treatment benefit to sufferers of central nervous system disorders,” Ronald Barett, CEO of XenoPort said.

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The first new drug to treat Lupus Erythematosus in more than 50 years was approved this month by the U.S. Food and Drug Association (FDA).  Lupus is a chronic, inflammatory, multi-system disorder of the immune system, which causes fibrous tissue and inflammation of internal organs, skin rashes and joint pain.  A facial rash that resembles a wolf bite often accompanies lupus and is what gave the disorder it’s name, lupus meaning “wolf” and erythematosus meaning “redness.”

The new drug, Belimumab (Benlysta), is an injectable drug that was designed to relieve flare-ups and pain.  Benlysta was created — after 15 years of development — by Human Genome Sciences Inc. and GlaxoSmithKline PLC.  The drug is a monoclonal antibody that targets the B-lymphocyte stimulator protein (BLyS).  According to the FDA, this is the first drug designed to target a protein that may reduce the number of abnormal B cells believed to be at the root of lupus.

“Benlysta, when used with existing therapies, may be an important new treatment approach for healthcare professionals and patients looking to help manage symptoms associated with this disease,” said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

The last drugs to be approved by the FDA for lupus was Plaquenil (hydroxychloroquine), a malaria drug, and corticosteroids in 1955.  Before that, aspirin was approved as a treatment.

Benlysta was approved by the FDA after an advisory committee of independent experts voted 13-to-2 in November to recommend its approval.  At that time, there was some reservations about the effectiveness of the drug.  Most of the drug’s benefit came from relieving muscle inflammation, not organ problems.

A clinical study showed that Benlysta, after one-year of monitoring response rates, was more effective than placebo.  In the study, to be credited with a response, patients had to have at least a four-point improvement in SELENA-SLEDAI score, have no increase in Physician Global Assessment scores of 0.3 points or more, and have no new flares meeting the British Isles Lupus Assessment (BILAG) 1A-2B standard.  That being said, a relatively small proportion of patients met the study’s criteria for a response after one year (43% with the drug vs. 32% with the placebo).

More clinical trials need to be conducted with Benlysta because thus far the drug has been shown to be less effective in African Americans — who are twice as likely as Caucasians to be diagnosed with lupus.  Studies to date were not extensive enough to make any conclusions about whether the drug will be ineffective for all African Americans or not.  Also, the new drug was not effective for any trial patients with the deadliest form of lupus.

Benlysta, even though only modestly effective, should provide encouragement that after more than 50 years of no new approved drugs, there is still a future for drug advancement for lupus.  The drug “will send out the message that it’s possible to conduct a successful clinical trial in lupus and that’s tremendously important to keep the pharmaceutical industry interested in this disease,” Dr. Betty Diamond, a researcher at the Feinstein Institute in New York said.

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