The hepatitis C virus (HCV) market is back in the limelight with AbbVie (ABBV) gaining approval for its HCV cocktail treatment and being signed on by pharmacy benefit manager Express Scripts. Achillion (ACHN), which is focused on the development of HCV treatments, also came out with data on a couple of HCV candidates. Meanwhile, ImmunoGen (IMGN) saw its shares plunging on disappointing late-stage data.
Recap of the Week’s Most Important Stories
1. AbbVie has a potential blockbuster in its portfolio with the FDA approving its all-oral, interferon-free HCV treatment Viekira Pak (Read more: AbbVie's All-Oral, Interferon-Free HCV Treatment Approved). What is even more important is that Express Scripts has decided to add Viekira Pak to its formulary and offer it as an exclusive option for genotype 1 HCV patients, starting Jan 1, 2015 (Read more: Express Scripts Picks AbbVie's Hepatitis C Drug).
The pharmacy benefit manager also announced that HCV treatments like Gilead’s (GILD) Sovaldi and Harvoni and Johnson & Johnson’s Olysio will be removed from the National Preferred Formulary. While high rates of response and tolerability coupled with low discontinuation rates should help Viekira Pak gain share, pricing will play an equally important role considering the concerns regarding Gilead’s pricing of its HCV treatment. Gilead’s shares were down 14% on the Express Scripts announcement.
2. Achillion, which saw its shares surging 9% on interim data on a couple of experimental candidates, recorded a decline of almost 24% in the subsequent trading session on concerns that the data may not have been as good as it seemed on first glance. Moreover, shares were impacted by the AbbVie-Express Scripts announcement.
3. ImmunoGen’s shares fell 43% on disappointing top-line data from a late-stage breast cancer study evaluating Kadcyla. The study, conducted by Roche, showed that none of the Kadcyla treatment arms significantly improved progression free survival compared to Herceptin and chemotherapy. Kadcyla uses ImmunoGen’s antibody-drug conjugate (ADC) technology (Read more: ImmunoGen/Roche's Kadcyla Fails in Study, Shares Plunge).
4. Cubist’s (CBST) antibiotic, Zerbaxa, gained FDA approval for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal infections caused by designated susceptible Gram-negative bacteria. This makes Zerbaxa the first new antibiotic to gain FDA approval under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria.
This means Zerbaxa will enjoy an additional five years of marketing exclusivity (Read more: Cubist's Antibiotic Zerbaxa Wins FDA Nod for cUTI and cIAI). Zerbaxa is the second antibiotic in Cubist’s portfolio to gain FDA approval this year – Sivextro was approved earlier this year.
5. Gilead is tying up with Japan-based ONO Pharmaceutical as it works on expanding its oncology pipeline. The companies are collaborating for the development and commercialization of ONO-4059, ONO’s oral Bruton’s tyrosine kinase (BTK) inhibitor which is being evaluated for the treatment of B-cell malignancies and other diseases (Read more:Gilead/Ono Pharmaceutical Ink Deal for Blood Cancer Drug).
Performance
Over the last five trading days, Gilead’s shares declined the most (10.96%) among major biotechs on concerns regarding AbbVie’s HCV treatment's approval and the Express Scripts announcement. Biogen (BIIB) gained the most (up 3.27%) among major biotechs during this period.
Vertex (VRTX) recorded the highest gain (70.77%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was up slightly (0.38%) over the last five trading days (See the last biotech stock roundup here: Sophiris & Cyclacel Plunge on Data, ChemoCentryx Gains on Positive Results).
| Company | Last Week | Last 6 Months |
| AMGN | -1.20% | 33.37% |
| BIIB | 3.27% | 7.11% |
| GILD | -10.96% | 10.71% |
| CELG | -3.61% | 24.12% |
| REGN | -0.53% | 40.62% |
| ALXN | 0.64% | 10.65% |
| VRTX | 2.61% | 70.77% |
What's Next in the Biotech World?
A decision regarding the approval status of Vertex’s cystic fibrosis drug, Kalydeco, for use in patients with the R117H mutation should be out by Dec 30.
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