It’s been a pretty slow week as companies gear up for fourth quarter announcements. Highlights include the removal of a partial clinical hold by the FDA and EU approval for a couple of drugs with blockbuster potential.
Recap of the Week’s Most Important Stories
1. CytRx Corporation (CYTR) received some encouraging news with the FDA lifting a partial clinical hold on the company’s trials on aldoxorubicin. With the FDA lifting the hold, the company will be allowed to enroll and dose new patients once the Institutional Review Boards (IRBs) approve the revised trial protocols. The partial clinical hold was announced in Nov 2014.
The FDA had placed the partial clinical hold due to the reported death of an advanced-stage cancer patient who had received the experimental treatment under the company's compassionate use program. The oncology focused company said that enrollment rates and timelines for its trials remain materially unchanged.
2. AbbVie’s (ABBV) much talked about hepatitis C virus (HCV) treatment has been approved in the EU as well. Approval was in line with expectations considering the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion late last year. With Viekirax + Exviera getting EU approval, competition in the HCV market in the EU will increase (Read more: AbbVie Gains EU Approval for Hepatitis C Virus Treatment).
3. Pricing competition in the HCV market is heating up with Gilead (GILD) signing up with quite a few pharmacy benefit managers and health care benefit companies for Sovaldi and Harvoni. Gilead’s most recent agreement is with Aetna which will result in lower pricing for Harvoni and Sovaldi for Aetna customers.
We remind investors that shortly after AbbVie’s HCV treatment gained FDA approval, pharmacy benefit manager Express Scripts had announced its decision to add AbbVie’s Viekira Pak to its formulary and offer it as an exclusive option for genotype 1 HCV patients, starting Jan 1, 2015. Gilead’s pricing of its HCV drugs had been a source of concern and a matter of intense debate ever since the drugs were approved and launched. The HCV pricing battle will remain in focus in 2015.
4. Celgene (CELG) also gained EU approval for its potential blockbuster drug, Otezla, for psoriatic arthritis and psoriasis. Otezla was approved in the U.S. last year (Read more: Celgene Up as Otezla Gains EU Approval for Two Indications). Although the market is highly crowded given the presence of treatments like Humira and Remicade, Otezla could gain share considering it is an oral treatment.
Performance
Over the last five trading days, Gilead’s shares were up the most (6.76%) among major biotechs. Celgene recorded the highest gain (44.9%) among major biotechs over the last six months.
Overall, the NASDAQ Biotechnology Index was up (2.49%) over the last five trading days (See the last biotech stock roundup here: Shire to Acquire NPSP, Celgene & Pharmacyclics Give Strong Outlook).
| Company | Last Week | Last 6 Months |
| AMGN | 1.59% | 34.37% |
| BIIB | 2.99% | 19.46% |
| GILD | 6.76% | 16.36% |
| CELG | 2.73% | 44.90% |
| REGN | 3.60% | 37.65% |
| ALXN | 2.15% | 13.53% |
| VRTX | 3.43% | 28.33% |
What's Next in the Biotech World?
Early next week, companies like Amgen (AMGN) and Biogen (BIIB) will be reporting fourth quarter results. Meanwhile, a FDA decision on NPS Pharmaceuticals’ (NPSP) Natpara (long-term treatment of hypoparathyroidism) should be out shortly.
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