Epizyme (EPZM) rallies 32% (low volume) in premarket action.
Monday evening, the company reported that it has achieved the "POC milestone in the EPZ-5676 DOT1L inhibitor clinical program," an event which triggers a $25M payment from partner Celgene (CELG).
Objective responses in patients with translocations of the MLL-r observed in the fourth dose cohort of an ongoing Phase 1 study were the triggering event.
Additionally, the company says "a development candidate milestone has been achieved for one of the three HMT targets included" in the GlaxoSmithKline (GSK) partnership, triggering another $4M milestone payment.
2013 end-of-year cash now seen at $145M versus $115M previous. (PR)
In a lawsuit filed last summer, the hospital claims the company violated a 2002 contract when it ceased paying royalties on Revlimid and Pomalyst — the hospital apparently helped discover their cancer fighting abilities.
The case is further complicated by the fact that the hospital sold most of its Revlimid rights to an unnamed third party for $130.5M.
In any event, an unfavorable ruling would likely cost CELG millions, as "court filings [show] Children's [believes] it is owed $3M in unpaid royalties for the first quarter alone."
A NY Times feature looks at drug companies' wildly successful and wildly aggressive marketing campaign for A.D.H.D. treatments like Adderall (made by Shire (SHPG)) and Ritalin (made by Novartis (NVS)). Recently, companies have begun targeting adults.
Recent data show that 15% of high school-age children are now diagnosed with A.D.H.D., and that the number of children taking medication has soared to 3.5M from 600K in 1990. One doctor calls the rising rates of diagnosis "a national disaster of dangerous proportions."
The FDA has cited every major A.D.H.D. drug - including Adderall, Concerta (JNJ), Focalin (NVS, CELG) and Vyvanse (SHPG) - for false and misleading advertising since 2000, some multiple times.
Credit Suisse upgrades Celgene (CELG) to Outperform from Neutral in a move analyst Ravi Mehrotra says "is as much about relative growth as revenue and EPS upgrades."
Mehrotra sees 2017 total sales and EPS of $13B and $16 (up from $11B and $13.57).
The new estimates are largely attributable to an increase in the projection for Revlimid sales, which are now seen at $7.6B, up from $6.8B. The more upbeat assessment is due to "lengthening of treatment duration and increasing penetration in the first-line setting."
CAGR projections from 2013-2017: 19% top-line and 28% bottom-line.
Celgene (CELG) says results (presented at ASH) from an ad hoc analysis of an MDS subset from two Phase 1/2 studies of oral azacitidine show 11 of 23 patients achieved an OR, while four of 23 achieved CR.
Other results: 30% achieved hematologic improvement, red-blood cell TI achieved in five of 12 patients, platelet TI achieved in two of five patients.
Four patients discontinued treatment due to AEs. (PR)
Likely behind the move is UBS, where analyst Matthew Roden has upgraded the stock to Buy from Neutral.
"We find CELG compares favorably to other names in healthcare and the broader markets on the basis of EPS growth (26% vs 16% HC and 13% S&P500), and operating margin (49% vs 13% and 16% in Q3 2013, and 60% achievable for CELG by 2017)," Roden notes.