FDA readies final decisions on four big biotech drugs

The federal spending cutbacks required by sequestration may have added a big question mark to every FDA deadline on the schedule, but there are four big developers holding their breath right now in anticipation of a formal marketing decision on their experimental drugs.

As Investor's Business Daily notes in its roundup today, Biogen Idec's ($BIIB) multiple sclerosis drug BG-12 is the first up with a March 28 PDUFA deadline. Analysts have consistently endorsed Biogen's hefty data package on BG-12, Exhibit A in CEO George Scangos' case that the company was able to quickly mount a turnaround after he took the helm. Of course, Scangos inherited BG-12 from an earlier administration, but a compelling Phase III program quickly made it one of the top potential blockbusters in the late-stage pipeline. BG-12 consistently earns blockbuster forecasts, overshadowing new arrivals like Aubagio and the prospective Lemtrada from Sanofi's Genzyme division. 

Now that Biogen Idec has locked up all the Tysabri rights at Elan ($ELN), the company is a convincing market powerhouse in multiple sclerosis. BG-12 is likely to help consolidate that rep, though there remains considerable speculation about the prospects of some severe safety warnings. Still, MS drugs with serious safety concerns have done extremely well on the market, giving Biogen a clear inside track on an important new franchise.

United Therapeutics ($UTHR) is next up on March 31 with a potential surprise twist in a key market race against some strong rivals. Just a few months after being handed a complete response letter for oral treprostinil for pulmonary arterial hypertension, United Therapeutics is back at the decision line. With big questions about efficacy in light of a failed 6-minute walk test, the company started to outline a four-year comeback plan after the agency handed out its dread CRL. Instead, the FDA had accepted the resubmission in less than four months for the oral drug, a new twist on Remodulin that would likely compete against new therapies from Bayer (riociguat) and Actelion (macitentan). 

On the same day Johnson & Johnson ($JNJ) will hit the FDA's deadline on Invokana (canagliflozin), the latest from a new class of SGLT2 diabetes drugs that was recently waved through an FDA advisory committee. The advisory vote is particularly significant because of the FDA's stringent standards on diabetes drugs, as Novo Nordisk ($NVO) was reminded when the agency recently rejected its application on Tresiba. Invokana was picked by Reuters' top biopharma reporters recently as one of the top therapies in the industry's late-stage pipeline. And as a direct competitor to Merck's ($MRK) Januvia, it could roil the entire diabetes segment of the market. 

Rounding out the Big Four is Allergan's Levadex, an inhaled therapy for migraine headache up for a decision by April 15, tax day. Allergan ($AGN) nabbed rights to Levadex two years ago in a $157 million licensing deal with MAP Pharmaceuticals. And last January it stepped up with a $1 billion deal to buy out MAP, confident that it is on a straight path to an approval.

- here's the story from Investor's Business Daily

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