|Healthcare Review: Theravance, Sarepta Therapeutics, Prosensa Holding, AstraZeneca, Aastrom Biosciences|
|By Staff and Wire Reports|
|Monday, 21 April 2014 13:56|
In preparation for the spin-off of Theravance Biopharma, Theravance ($THRX) wholly-owned subsidiary LABA Royalty Sub LLC secures $450M 9% notes via private placement. The net proceeds of $434.3M will be used to pay off THRX shareholders, to pay the remaining product approval and launch milestones to GlaxoSmithKline (GSK) and to fund post-split Theravance. The notes are secured by a 40% royalty rate from global net sales of RELVAR/BREO ELLIPTA, ANORO ELLIPTA and, if developed, VI monotherapy.
Based on updated guidance from the FDA regarding an early approval pathway for eteplirsen, Sarepta Therapeutics ($SRPT) plans to file an NDA by the end of 2014.The agency provided specific examples of additional safety and efficacy data for Duchenne muscular dystrophy that would enhance the acceptability of the NDA. The company will conduct several open label confirmatory studies later this year on patients with exon-51 amenable genotypes. The company plans to conduct three studies: 1) ambulatory patients between the ages 7 and 16 years who can walk a minimum distance, 2) patients younger than 7 years, 3) DMD patients who cannot walk a minimum distance or who are non-ambulant.
Nano cap Prosensa Holding N.V. ($RNA) is up 28% apparently riding on Sarepta's coattails. Prosensa has its own product candidate, drisapersin, for Duchenne Muscular Dystrophy. A Phase 3 clinical trial failed, however, to meet its primary endpoint of demonstrating a statistically significant or clinically meaningful treatment difference compared to placebo. The drug also failed to meet the majority of its secondary endpoints.
The most alluring aspect of AstraZeneca ($AZN) for Pfizer ($PFE) is the former's cancer franchise and pipeline of promising drugs, especially the immunotherapies. Pfizer's cancer pipeline is relatively weak other than its breast cancer candidate palbociclib. Cost savings is another significant benefit. Analysts perceive that a takeout price of a 25% premium funded by cash, cheap debt and stock would be immediately accretive to earnings.
Aastrom Biosciences ($ASTM) acquires Sanofi's Cell Therapy and Regenerative Medicine business for $6.5M.Current revenue for the business is $44M driven by Carticel (autologous cultured chondrocytes), Epicel (cultured epidermal autografts) and MACI (matrix-induced autologous chondrocyte implant). Sanofi acquired the business when it bought Genzyme several years ago.