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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Indianapolis, U.S.A. – Eli Lilly and Company applauded law enforcement officials for their successful investigation and the recovery of more than $70 million in pharmaceuticals stolen from its United States distribution center located in Enfield, Connecticut, on Sunday, March 14, 2010.

“For more than two years, Lilly has cooperated with this criminal investigation – providing important information to federal and local authorities to help piece together the details of the theft,” said Maria Crowe, President, Manufacturing Operations, Eli Lilly and Company.

“We applaud the dedication of the Enfield Police Department, the Federal Bureau of Investigation, Department of Justice prosecutors in New
Haven, Newark, and Miami, and the Miami Organized Crime Drug Enforcement Task Force,  who have worked tirelessly to identify and apprehend those suspected of being involved in the March 2010 burglary,” said Crowe.

The pharmaceuticals taken from Lilly’s warehouse have been successfully recovered, preventing them from entering pharmaceutical distribution channels. Lilly plans to destroy the products when they are no longer needed as evidence.

Crowe added that Lilly is committed to partnering with the Food and Drug Administration, law enforcement, and other officials and organizations to help ensure patient safety and the secure distribution of Lilly medicines.

To that end, in addition to strengthening security for its facilities and pharmaceutical transportation, Lilly is one of seven pharmaceutical companies that formed the Coalition for Patient Safety and Medicine Integrity in 2011. Two primary goals of the coalition are to protect patients from risks posed by stolen and inappropriately handled medical products that enter legitimate distribution channels and increase the associated federal criminal penalties for crimes involving stolen medical products.

Image Courtesy of    http://www.lilly.com

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Former pharmaceutical representative Timothy Brennantoday filed a lawsuit in federal court in Manhattan against Warner Chilcott charging the drug corporation with illegally denying him compensation for overtime hours. The law firm of Joseph, Herzfeld, Hester & Kirschenbaum LLP represents Brennan.

The suit charges that during his four-and-a-half years of employment, Brennan often worked in excess of 40 hours a week but received an annual salary without overtime pay. The New York class action was filed on behalf of Brennan and all other pharma reps who worked for Warner Chilcott in New York during the last six years.

New York overtime law requires that employees be paid time-and-a-half overtime when they work more than 40 hours in a week, unless they are specifically exempt.

Attorney Charles Joseph, a partner with Joseph, Herzfeld Hester & Kirschenbaum LLP, stated, “The US Department of Labor recognizes that pharmaceutical reps are not exempt from overtime pay under the Federal Fair Labor Standards Act (FLSA), and New York overtime law is consistent with the FLSA.”

Joseph explained that the precedent for Brennan’s claim was set in the U.S. Court of Appeals for the Second Circuit, which found that Novartis pharma reps were entitled to overtime compensation on the same basic grounds alleged against Warner Chilcott.  (Novartis recently settled the overtime lawsuit for$99 million.) The Second Circuit issued a similar ruling in a case brought by pharma reps against Schering Plough, as have district courts in Connecticut and Illinois in cases against Boerrhinger Ingelehein and Abbott.

Brennan, who worked for the company in Manhattan, said, “For years, this company failed to pay representatives their earned overtime.  This lawsuit holds them accountable.”

“Our view is that Mr. Brennan and other Warner Chilcott reps are owed a great deal of money for working extraordinarily long hours with no additional compensation,” Joseph said. “This is a chance to achieve justice for the reps.”

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