It’s been an eventful week on the pipeline front with companies like Biogen (BIIB -Analyst Report), Prothena (PRTA - Snapshot Report) and Vertex (VRTX - Analyst Report) coming out with data. Meanwhile, Gilead (GILD - Analyst Report) was back in the news once again due to its hepatitis C virus (HCV) franchise.
While Biogen’s shares were up on the data and the news resulted in a lot of excitement among the investor and medical community, we note that the data is from an early-stage study. Moreover, developing treatments for Alzheimer’s is pretty challenging with quite a few companies failing in late-stages of development (read more: Biogen Gains on Positive Alzheimer's Drug Interim Results).1. Hopes for a new Alzheimer’s treatment are up with Biogen reporting positive data from a pre-specified interim analysis of a phase Ib study on aducanumab (BIIB037). Aducanumab was found to have an acceptable safety profile and the candidate delivered positive results on radiologic and clinical measurements in patients with prodromal or mild Alzheimer’s disease (AD). Aducanumab showed a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease – this is promising news in the field of Alzheimer’s disease.
2. It’s been a mixed week for Vertex – the company gained FDA approval for yet another label expansion for Kalydeco (read more: Vertex's Kalydeco Gets FDA Nod for Additional Indication) but failed to impress the investment community with phase II data on its Kalydeco-VX-661 combination (read more: Vertex Falls on Disappointing Kalydeco+VX-661 Combo Data).
3. Amgen’s (AMGN - Analyst Report) efforts to block the entry of Novartis’ Zarxio, a biosimilar of the former’s blockbuster drug Neupogen, were hit by a roadblock with a judge in the U.S. denying the company’s motion. Sandoz, Novartis’ generic arm, gained FDA approval for Zarxio earlier this month in what was a landmark decision marking the approval of the first biosimilar in the U.S.
It remains to be seen when Novartis will launch its biosimilar and what the impact on the launch on Neupogen sales will be. Meanwhile, Amgen is now looking to get its PCSK9 inhibitor Repatha approved in Japan where a regulatory application was submitted late last week (read more: Amgen Seeks Approval for PCSK9 Inhibitor Repatha in Japan).
4. Is Gilead’s HCV franchise in trouble? A “Dear Healthcare Provider” letter from the company provided information regarding 9 cases of symptomatic bradycardia being reported during post-marketing in patients receiving amiodarone with either Harvoni or Sovaldi in combination with another direct acting antiviral -- DAA (daclatasvir, an investigational DAA, or Olysio (simeprevir)). Seven of these patients were on a beta blocker. While one patient died of a heart attack, three had to be provided with pacemakers.
The FDA has approved changes to the “Warnings and Precautions, Adverse Reactions, and Drug Interactions” sections of the Harvoni and Sovaldi labels. The sections now include information regarding these cases.
Sovaldi ($10.3 billion) and Harvoni ($2.1 billion) combined accounted for half of Gilead’s product sales in 2014. We do not expect Gilead’s HCV drug sales to be impacted significantly by this label update. AbbVie’s (ABBV - Analyst Report) Viekira and Johnson & Johnson’s Olysio labels also contain information about drug interaction with amiodarone.
5. Prothena saw its shares soaring 32.3% on positive early-stage data on PRX002, a monoclonal antibody for the potential treatment of Parkinson's disease and other related synucleinopathies (read more:Prothena's PRX002 Positive in Parkinson's Disease Study).
Performance
Over the last five trading days, Biogen’s shares were up the most (6.24%) among major biotechs, thanks to the Alzheimer’s disease data. Vertex was the biggest loser (down 3.73%) among major biotechs during this period due to the disappointing Kalydeco-VX-661 data. Biogen has been the highest gainer (30.73%) over the last six months as well. Gilead lost 6.72% during this period.
Overall, the NASDAQ Biotechnology Index declined slightly (0.06%) over the last five trading days (see the last biotech stock roundup here: Amgen & Regeneron Shine at ACC, Nektar Drug Disappoints).
| Company | Last Week | Last 6 Months |
| AMGN | 1.80% | 17.78% |
| BIIB | 6.24% | 30.73% |
| GILD | 0.97% | -6.72% |
| CELG | 0.93% | 26.96% |
| REGN | 1.27% | 30.00% |
| ALXN | -0.37% | 8.74% |
| VRTX | -3.73% | 11.03% |
What's Next in the Biotech World?
Regeneron (REGN - Analyst Report) should hear back from the FDA by Mar 30 on the approval status of Eylea for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
No comments:
Post a Comment