Since taking over Agile Therapeutics two years ago, Al Altomari has shepherded the company through a dreary fiscal environment, beating the odds to raise $85 million in two rounds of fundraising.
Now, with Agile's lead product at the Food and Drug Administration's doorstep, the firm stands poised to enter a decidedly sunnier marketplace, one brightened by the dawn of a new health care law that could prove a boon to women's health companies like Agile.
The Princeton firm filed a new drug application for its low-dose, once-weekly contraceptive patch in July. That same month, it announced the completion of a $40 million round of fundraising, enough to prepare the commercial launch of the patch, called Twirla, and move the firm's second product, a progesterone-only patch, into Phase 3 clinical trials.
And while internal advancement has progressed mostly according to plan, an even bigger factor may be the implementation of the Affordable Care Act, which requires nearly all insurance plans to include contraceptive coverage without a co-pay.
"It's almost too good to be true," Altomari said. "It's a remarkable breakthrough for the category. The idea in the ACA is that women should have access to all forms of contraception, regardless of whether it's on the formulary or not, with no co-pays. I think that could be really big."
The new requirement took effect Aug. 1, but insurance plans "that existed before the health care law are considered to be grandfathered in, and don't have to follow the preventative services guidelines and rules until they make significant changes to the plan," said Michele Jaker, a spokeswoman for Planned Parenthood Affiliates of New Jersey. Jaker said she expects that to happen within the next couple years.
While it's bound to have a big impact on women's health, it could also have a major impact on contraceptive companies like Agile. About 90 million birth control prescriptions are written each year, and Altomari said women pay an average of $30 per month for them. The coverage requirement applies to the full range of FDA-approved birth control methods, though Jaker said some patients might still see a co-pay for brand-name drugs if a generic is available.
That's not the only potential opening for Agile, though, Altomari said. Ortho Evra, a contraceptive patch Altomari helped launch while at Johnson & Johnson, has come under fire for a risk of blood clots; Altomari said he hopes low-dose Twirla will be seen as a safer alternative.
"It's a good time to be on the side of safety, if you will, in this category," he said.
But timing hasn't always come so easily for Altomari: His first task two years ago was to raise $45 million at a time when the financial crisis was acute.
"There was still perceived to be a lot of risk — we still hadn't done clinical trials — and it was the worst of the worst time" to be raising money, he said. The company's most recent round of fundraising — a $40 million Series C financing — was somewhat easier, though Altomari said the fiscal environment remains choppy. Though the new mandate could have a huge impact on sales, Altomari is sticking to his conservative posture, preferring to focus on certainties when meeting with investors.
"From a style perspective, that helped our credibility," he said. "We showed them what the upside is, but we didn't bank on it."
That's a common strategy, said Debbie Hart, president of the biotech trade group BioNJ. She said industry executives are closely watching the elections — Republican candidates have campaigned on repealing all or part of the health care reform law.
The presidential election, she said, "really does put a big question mark on it."
Hart said it's possible implementation of the ACA will comfort investors, but she said it's too soon to be sure.
"If it does, in fact, stay in place, and all the implementation is figured out … we'll see the impact on investors' mindsets," she said.
In the meantime, Altomari is preparing to launch Twirla. He said the firm will likely bring in marketing personnel and other home office staff by year's end, but he said they'll wait to hire sales reps until the FDA issues its ruling on Twirla in the first quarter of 2013.
Though there's plenty of reason for optimism, Altomari said he's not counting on anything just yet. "We're making all our plans and all our projections based on the status quo," he said.
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