PHARMACY

DiaKine announces patent for diabetes drug at JPMorgan Healthcare Conference

BY Adam Kraemer

SAN FRANCISCO DiaKine Therapeutics, a development-stage company with a concentration on the treatment of autoimmune and inflammatory diseases, announced at the 26th annual JPMorgan Healthcare Conference that it has been granted a patent for developmental drugs that could potentially cure diabetes and reverse its complications.

The patent covers novel tricyclic compounds that regulate cytokines, proteins that may mistakenly attack normal organs and tissue and cause diseases such as diabetes and related complications such as kidney and eye disease.

“These drugs were designed to prevent or treat diseases—such as Type 1 diabetes and multiple sclerosis—that are affected by intracellular cytokine signaling,” said Jerry Nadler, DiaKine’s chief scientific officer. “Our research has shown that by selectively modulating certain cytokines with our current library of methylxanthine-based drugs, type 1 diabetes can be prevented or even reversed. This library provides for compounds with a new, non-xanthine skeleton.”

The patent states that the tricyclic compounds are useful for the treatment or prevention of symptoms or manifestations associated with diseases or disorders—such as chronic inflammatory disease, arthritis, psoriasis, asthma, Type-1 diabetes, multiple sclerosis and lupus disorders—that are affected by intracellular cytokine signaling.

“This patent is an important asset in our portfolio of intellectual property,” said Keith Ignotz, president and chief executive officer of DiaKine. “It provides for novel therapeutic compounds, pharmaceutical compositions and methods that can limit the inflammatory, or anti-inflammatory, response of a patient without using an immune suppressant or ‘sledge-hammer’ approach to treatment.”

DiaKine therapies may improve the function of insulin-producing cells and preserve any that remain in the pancreas after initial diagnoses, thereby halting the progression of newly diagnosed diabetes. Those patients with established diabetes may be relieved from the lifelong burden that results from this disease by providing them with new insulin producing cells through either transplantation or regeneration and modulating the immune system with these new medications. In addition, protecting new insulin-producing cells from a new immunological attack may, in fact, reverse the diabetes and prevent the resulting complications associated with this dreadful disease, the company stated.

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House investigates possibly misleading Lipitor advertisement

BY Drew Buono

WASHINGTON Democrats in the House of Representatives are investigating as to whether or not consumers are being misled by advertisements for Lipitor featuring Dr. Robert Jarvik, the inventor of the artificial heart, the Associated Press reported.

Michigan Reps. John Dingell and Bart Stupak sent a letter to the drug’s manufacturer Pfizer on Monday, questioning the credibility of Jarvik, whom they believe is not certified to practice or prescribe medicine because he might not have taken the necessary tests or performed an internship.

Pfizer spokesman Chris Loder said Jarvik’s presence in the advertisements is meant to educate consumers on the importance heart health. “Dr. Jarvik is a respected health care professional and heart expert who knows how imperative it is for patients to do everything they can to keep their heart working well,” Loder said in a statement.

The representatives have requested that Pfizer turn over all of its information concerning Jarvik including its contract with him and any information about his professional qualifications.

Lipitor is the most prescribed drug in the U.S., with sales of $13.6 billion in 2006.

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King ends five-year Skelaxin patent suit against CorePharma

BY Drew Buono

BRISTOL, Tenn. & MIDDLESEX, N.J. King Pharmaceuticals has ended is patent lawsuit with CorePharma regarding its muscle relaxant drug Skelaxin and has signed an agreement with CorePharma related to the drug, according to Forbes.

On Jan. 2, the two companies signed an agreement under which, CorePharma will gain certain exclusive rights to Skelaxin 800 mg to market a generic version, called metaxalone and have also gained a non-exclusive license to produce and market a 400 mg version of the drug. This license will come into effect on Jan. 1, 2012.

Back in 2003, CorePharma was one of several biopharmaceutical companies to file with the Food and Drug Administration seeking permission to produce a generic. King countered by suing CorePharma and later Eon Labs and Mutual Pharmaceuticals, who also sought permission to produce a generic.

As of now, CorePharma is the only company that King Pharmaceuticals has an agreement with concerning Skelaxin. The drug is estimated to account for about $400 million in sales in 2008, according to Morgan Stanley.

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