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October 28, 2015
By Mark Terry, Breaking News Staff

Thousand Oaks, Calif.-based Amgen announced today that the U.S. Food and Drug Administration (FDA) had approved Imlygic (talimogene laherparepvec, or T-Vec) for use in patients with melanoma.

The drug is generally touted as the first viral-based cancer therapeutic. Imlygic is an engineered version of the herpes virus. It simultaneously attacks the cancer cells while stimulating the immune system to attack those cells.

“This is huge for the whole field, and for cancer patients,” John Bell, a senior scientist at the Ottawa Hospital Research Institute in Canada, told the Boston Globe. “The field is exploding, and this would be another arrow in the quiver that oncologists use.”

Amgen indicates the therapy will be available to patients in the U.S. within a week. The projected price is $65,000 for a round of treatment, although the company indicates it will vary from patient to patient because of differences in dosing. It also plans to work with patient assistance programs such as The Safety Net Foundation, and its own co-pay coupon program called Amgen FIRST STEP Program, to make the drug accessible to patients whose insurance won’t cover the medication.

“These days in oncology we’ve seen some prices quite a bit higher than that,” said Eric Schmidt, an analyst with Cowen and Company to The Boston Globe. “And Amgen’s not a company that likes to price gouge.”

European drug regulators have also thrown their support behind the therapy, which is likely to lead to approval in the next couple months.

Although Imlygic is something new, it faces some competition for melanoma treatments, including Bristol-Myers Squibb Company ’s Opdivo, and Merck & Co. ’s Keytruda.

“Imlygic is the fist clinical and regulatory validation of an oncolytic virus as a therapy,” said Sean Harper, executive vice president of Research and Development at Amgen in a statement, “which Amgen is proud to bring to patients with a serious form of skin cancer. Not all melanoma patients currently benefit from available therapies, and Imlygic represents an important new option that can provide meaningful durable response for patients wit this aggressive and complex disease. Immunotherapy is an exciting area for cancer research, and we are currently studying Imlygic in combination with other immunotherapies in advanced melanoma and other solid tumors.”

Despite its breakthrough as a new technique, analysts expect modest sales, particularly as a standalone drug. Eric Schmidt told The Boston Globe that its potential as a standalone was “very, very modest. It’s being developed in combination with other immunotherapies, where we think there’s a little more of a commercial opportunity, but we still need to see more data.”

Thomson Reuters Cortellis predicts peaks sales of $387.5 million by 2020. Cory Kasimov, an analyst with J.P. Morgan, projects $50 million in sales in 2016, reaching less than $300 million at its highest. Amgen’s 2016 total revenue will likely exceed $22 billion. The company’s third quarter results will be released tomorrow.

Amgen acquired BioVex in 2011, the company that created Imlygic. “It’s a low-toxicity treatment, and for the right patients you see quite stunning results,” Robert Coffin told The Boston Globe. Coffin was the virologist and co-founder of BioVex who created Imlygic.

“I think we’re on the cusp of potentially curing patients,” using oncolytic viruses and onco-immunology therapies, said Howard Kaufman, chief surgical officer of the Rutgers Cancer Institute of New Jersey to The Boston Globe. “But short of that, this might be like diabetes, where we can control it and people live normal lives.”

Amgen took a bounce on the news, going from $160.49 on Oct. 27 to $162.87 early this morning. Shares are currently trading for $162.13. The year’s low was $132.27 on Sept. 28.