A high-stakes biotech turf war is about to break out over a very lucrative market, and at the same time, a big check is on its way to Watertown, MA-based Enanta Pharmaceuticals (NASDAQ: [[ticker:ENTA]]).
The FDA today approved a double-pill regimen for hepatitis C to be sold by Chicago-area pharma giant AbbVie (NYSE: [[ticker:ABBV]]), for people with a certain specific genotype of the virus. The two pills, which will be marketed under the name “Viekira Pak,” consist of the already approved drug ritonavir combined with paritaprevir and ombitasvir (that’s one pill), and the second pill in the pack is called dasabuvir.
Enanta, which helped AbbVie develop paritaprevir through a long-standing partnership, is getting a $75 million milestone payment because of the FDA’s decision.
Like two blockbuster drugs sold by Foster City, CA-based Gilead Sciences (NASDAQ: [[ticker:GILD]]), Viekira Pak represents a new wave of treatments for hepatitis C. They’re all pills that cure most patients in a matter of months, in many cases without the need for injections of interferon, which cause troublesome flu-like symptoms that cause many people to drop their treatment or not even seek treatment in the first place.
Viekira Pak can be used with or without ribavirin, a staple of old hep C regimens. The FDA said that use of ribavirin with Viekira Pak isn’t recommended for people whose livers aren’t functioning properly. The most common side effects associated with Viekira Pak are drowsiness, itching, nausea, trouble sleeping, and a lack of energy.
Though long expected at this point, the FDA nod is a big deal for Enanta. The company was once a floundering biotech based on a peptide-morphing technology, but it reshaped itself through a series of strategic partnerships and reinventions—a transformation I chronicled back in January—to become a player in the hep C field.
Those moves are now paying dividends. Enanta had already pocketed $152 million from AbbVie before today, with another $80 million on the way should Viekira Pak win approval in Europe (a decision is expected early next year). Though it won’t benefit nearly on the scale that AbbVie will—the company traded worldwide rights to paritaprevir for milestone payments long ago—it’ll still bank royalties on future sales of the product.
Enanta and AbbVie are also partnered on another hep C prospect called ABT-493; some $80 million in potential milestone payments for Enanta are tied to that drug’s advancement.
The FDA’s approval of Viekira Pak Friday also kickstarts what’s sure to be a closely watched battle between Gilead and AbbVie for control of the hep C market. The Centers for Disease Control and Prevention estimates that about 3.2 million Americans alone are infected with hep C; anywhere from 15 to 30 percent of them end up with cirrhosis. Gilead’s sofosbuvir (Sovaldi) and sofosbuvir-ledipasvir combination pill (Harvoni) have quickly become massive sellers because of how they’ve helped transform the treatment landscape for hep C. Those drugs have also come under fire from U.S. Congress and payers for their high price tags: a standard course of treatment with Sovaldi costs $84,000; for Harvoni, $94,500.
In big Phase 3 trials, the AbbVie/Enanta regimen has posted efficacy rates on par with Gilead’s drugs. The biggest difference between the two rivals is convenience. The recommended regimen for Viekira Pak is four pills: two of the combination ombitasvir, pariaprevir, and ritonavir pills once a day in the morning, and one dasabuvir pill twice a day (once in the morning, and once in the evening). Harvoni is a single pill taken once daily. That difference is why many have expected AbbVie to try to undercut Gilead on price.
A spokesperson said Friday that AbbVie will price the drug at $83,319 per patient, per 12-week course of treatment—coming in almost exactly identical to Sovaldi.
