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Well-Funded Amira Focuses on New Drug Discoveries

Pharmaceutical giant Merck & Co. Inc. withdrew its research laboratories from San Diego five years ago, but some of its top scientists kept their heels dug into the sands of biotech beach.

Among them, a trio of drug hunters once responsible for asthma treatment Singulair and arthritis drug Vioxx, both blockbusters, stuck together to form privately held Amira Pharmaceuticals, a San Diego-based biotechnology company focused on discovering new treatments for asthma, chronic obstructive pulmonary disease, or COPD, and other inflammatory conditions.

The scientific team, led by Merck San Diego’s former head of medicinal chemistry, Peppi Prasit, soon attracted a group of venture investors who helped the company secure major pharmaceutical partnerships with F. Hoffmann-La Roche Ltd, better known as Roche, and GlaxoSmithKline plc. in just a few years.

Prasit, who admits he didn’t know a single venture capitalist when the company formed, said he felt confident the team’s experience would drive new drug discoveries.

“I just felt at that time we could do as well as anybody could in the biotech industry,” he said.

No Shortage Of Funds

In five years, the company has successfully demonstrated it could raise money — $28 million in venture funding — and secure major pharmaceutical partnerships.

The Roche research collaboration, valued at $287 million plus royalties, ended in 2008. But its partnership with GSK, worth a potential $425 million if all the regulatory and developmental benchmarks are met, continues to help finance the young company.

Amira, which has 50 employees, said Jan. 7 that it successfully developed experimental asthma treatment AM103 in pill form, triggering an undisclosed milestone payment.

CEO Bob Baltera said the GSK deal, struck in early 2008 before the collapse of the financial markets, has allowed Amira to focus on its drug discovery efforts without worrying about raising additional capital.

“We haven’t had to raise money the whole time I’ve been here because of this deal,” he said.

Going Public

Baltera, who recently returned from the annual J.P. Morgan Healthcare Conference in San Francisco, said he’s encouraged by all the recent biotech investment activity and would consider taking the company public.

“It’s not 2010, I think, but it’s probably not far beyond that,” said Baltera, a former Amgen Inc. veteran who came to Amira in 2007.

Eventually, he said, Amira will look to the public markets to fund costly clinical trials of a drug for treating idiopathic pulmonary fibrosis, a deadly buildup of tissue deep in the lungs that can lead to respiratory failure. The condition has also shown up in some of the survivors of the Sept. 11 attacks.

Unlike its drugs for asthma and COPD, Baltera said Amira intends to take the pulmonary fibrosis drug to the market on its own, where it could target lung specialists with a small sales force.

Baltera, who spent 17 years at Amgen before taking the helm at Amira, said the company will have to demonstrate the drug’s effectiveness first, and make sure its safety is well profiled. Vioxx, a $2.5 billion drug withdrawn from the U.S. market in 2004 due to increased risk of heart attack, brought attention to the importance of toxicology studies, he said.

But the promise of filling a void in current treatment options offers Amira’s scientists hope for the roughly 200,000 people living with the condition. Doctors know little about what causes the lung scarring, so finding an effective treatment has proven elusive.

Promising Drug

A paper published in Nature Medicine in 2008 by Dr. Andrew Tager, a pulmonologist, and his colleagues at Massachusetts General Hospital shed light on some of the mechanisms of fibrosis, which he described as a “repair gone awry.”

Tager hypothesized that, in some people, a receptor known as LPA1 has an overactive response to injury, leading to the buildup of scar tissue.

“You have too much repair and you develop a scar and that causes a loss of tissue function,” he said.

Amira’s drug, which targets the LPA1 receptor, demonstrated last year that it could reduce lung scarring in mice.

Tager said the drug has also shown promise against other fibrotic conditions, such as cirrhosis of the liver and some forms of kidney disease, making it an even bigger product if approved.

The next big step will be to test the drug in humans, which Amira’s Baltera said is planned for the second half of the year.

Meanwhile, Baltera said the company is engaged in talks with a partner for its early stage Phase 1 asthma and COPD programs.

“Big Pharma still has relative need for big products,” he said. “A lot of the source of that is still going to come from small biotech companies.”

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