Pfizer gets exclusive deal on heart drug

An experimental drug that attracted the eye of Pfizer Inc. six years ago - leading to the $1.3 billion acquisition of the discovering company, Esperion Therapeutics - has been licensed to a small New Jersey firm for an upfront fee of only $10 million.

The Medicines Company, which announced the deal Wednesday, said Pfizer has signed an exclusive worldwide licensing agreement for the drug, ApoA-I Milano, named for an area in Italy where the first carriers of a gene mutation that lowers the risk of heart problems were discovered.

"The potential to provide disease modification for patients with high-risk (cardiac problems) represents a major innovation opportunity," said Clive Meanwell, chief executive of The Medicines Company, in a statement.

David K. Rosen, head of out licensing for Pfizer, said the company welcomes The Medicines Company agreement, one of the first signs that the pharmaceutical giant is following through on its intention to license programs it no longer intends to pursue internally.

"The ApoA-I Milano program has the potential to become a valuable and innovative medicine for the treatment of cardiovascular diseases," Rosen said in a statement. "We look forward to seeing it progress, thanks to The Medicines Company's experience in conducting large clinical trials in cardiovascular patients as well as their expertise in treating critical and intensive care patients."

The agreement calls for milestone payments of up to $20 million during the drug development stage and up to $90 million upon approval. Commercialization payments of $50 million, plus an undisclosed single-digit royalty fee, would be due for every $500 million in worldwide sales up to $1.5 billion.

"The Medicines Company believes it can succeed where Pfizer's R&D team has failed," commented the Fierce Biotech blog, found at www.fiercebiotech.com.

Six years ago, when Pfizer announced its intention to buy the compound and its developer, the New York-based pharmaceutical giant heralded the experimental drug as a possible replacement for Lipitor, the cholesterol fighter that stands as the world's leading medicine with about $12 billion in sales.

"Esperion's drug, which raises 'good' cholesterol and has completed midstage clinical trials, is the only medicine ever shown to reverse clogging of the heart arteries," said a Reuters news report at the time.

Since Pfizer's acquisition of Esperion, though, development of ApoA-I Milano went on an unexplained hiatus. In the past year, Pfizer announced that it would no longer be concentrating on cardiac therapies.

But The Medicines Company said development of the drug has continued, including preclinical work, manufacturing and formulation. It could not immediately be determined where Pfizer had been headquartering its work on the medicine.

The drug targets people with acute coronary syndrome, which Medicines Company officials called the leading cause of death worldwide. It said the syndrome costs people in the United States $165 billion a year in medical costs and lost productivity, and the economic effect worldwide could be double that total.

Drug trials completed in 2003 showed that ApoA-I Milano, over only a five-week period, reduced the buildup of arterial fatty plaque by more than 4 percent. The drug is injected in weekly doses, and The Medicines Company said it appeared to have a potentially profitable niche in treating patients soon after a heart attack, since anywhere from 10 to 25 percent of acute coronary syndrome patients experience similar episodes within the next year.

Medicines Company officials said the technology transfer required as part of the licensing agreement would start in January.

In an unrelated development, Pfizer announced Wednesday that it had signed a collaboration agreement with Israeli drug developer Compugen Ltd. The deal covers three experimental drugs, but financial details were not released.

l.howard@theday.com