Last week’s biotech recap covered the release of briefing documents from Vertex Pharmaceuticals’ (VRTX) advisory panel, which took place this Tuesday. The FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 12 to 1 in support of approving Orkambi, a combination of Vertex’s lumacaftor and ivacaftor, for the treatment of cystic fibrosis patients with the F508del mutation. The panel voted 13 to 0 that the product was safe, but on the question “Do the data show that lumacaftor contributes positively to the clinical efficacy of Orkambi?” the panel voted 3-Yes, 4-No, and 6-Can’t determine.
Ivacaftor is already approved (marketed as Kalydeco), thus the panel members were stuck on whether adding lumacaftor, a “corrector” improves on Kalydeco alone. Vertex did not make this comparison in the trials supporting the new drug application.
The FDA will make a formal decision on Orkambi by July 5. The FDA is not required to follow the panel’s vote, though it usually does. VRTX ended the week flat.
This week’s biggest event: the release of abstracts for the upcoming ASCO annual meeting (American Society of Clinical Oncology). The meeting takes place at the end of the month and these abstracts contain preliminary data that will be presented at the conference. The obvious loser coming away from the abstract release is Puma Biotech (PBYI), which dropped 15% into the end of the week.
In April we suggested a handful of smid-cap names to have on your watchlist going into ASCO. Of these, Oncothyreon (ONTY) has been the obvious winner. In a note to PropThink’s Premium members this week, we explained why the stock was moving and why it was still worth getting long the stock. ONTY closed the week up 65%. The company will present updated results from two trials of ONT-380, a selective HER2 inhibitor, at the end of the month.
On Friday Sorrento Therapeutics (SRNE) announced the sale of its lead drug candidate Cynviloq to NantPharma, a company founded by healthcare entrepreneur and SRNE’s largest investor Patrick Soon-Shiong. Sorrento gave the drug up for $90 million in cash and $1.2 billion in potential milestones.
Soon-Shiong is the inventor of Abraxane, which was sold to Celgene in 2010 for almost $3 billion. Sorrento compares Cynviloq to Abraxane (a paclitaxel re-formulation and a $1 billion drug annually), and recently completed a bio-equivalence study comparing the two. Sorrento planned to pursue approval through the FDA’s 505b2 pathway. Detailed results from that study are non-existent, but Sorrento said earlier this month that analysis “suggests that Cynviloq meets the bioequivalence (BE) criteria for both total and unbound paclitaxel.”
That’s enough for Patrick Soon-Shiong, apparently. NantPharma is putting up the capital to buy the drug outright.
Interestingly, as SRNE’s largest shareholder, Soon-Shiong isn’t losing out on either end of this deal. Keep reading . . .
