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It was business as usual for the biotech sector last week with highlights including a deal for the acquisition of product rights, encouraging study results and the granting of breakthrough therapy status for an experimental cancer treatment. However, the event that stood out was the unplanned initiation of data review by a Data Safety Monitoring Board (DSMB) for a late-stage study.

Overall, shares were down last week with the NASDAQ Biotechnology Index declining 3.6% in contrast to the previous week’s performance (Biotech Stock Roundup: Vertex Jumps on Phase III Data, MannKind Scores FDA Approval).

Recap of the Week’s Most Important Stories

1. Regado Biosciences (RGDO - Snapshot Report) saw its shares plunging 58% on news that a data safety monitoring board (DSMB) is conducting an unplanned review of data from the phase III REGULATE-PCI study on Revolixys Kit. While the safety and treatment/benefit risk ratio for all patients will be analyzed, focus will be on serious adverse events related to allergic reactions. Until the analysis is completed and the DSMB’s recommendation is available, new patients will not be enrolled.

The news is disappointing considering Revolixys Kit is the lead candidate in the company’s pipeline. The cropping up of safety issues would be a major setback for the company and would limit the potential of the candidate even if development continues (Read more: Regado Slumps on Revolixys Study Halt).

2. Jazz Pharmaceuticals (JAZZ - Analyst Report) entered into an agreement worth up to $250 million last week to boost its product portfolio. The company will acquire rights to defibrotide in the U.S. and all other countries in the Americas from Sigma-Tau. This means that Jazz will own full rights to defibrotide – the company is already marketing the candidate in the EU under the trade name Defitelio. Jazz’s shares were up almost 7% on the agreement (Read more: Jazz Pharmaceuticals to Buy Rights to Defibrotide, Shares Up).

3. Regeneron Pharmaceuticals’ (REGN - Analyst Report) shares were up more than 7% on news that Sanofi (SNY - Analyst Report) has increased its stake in the company. (Read more: Regeneron Shares Jump as Sanofi Increases Stake).

4. Biotech major Amgen (AMGN - Analyst Report) got breakthrough therapy status from the FDA for its experimental leukemia drug, blinatumomab. Breakthrough status, a new designation that became effective after Jul 9, 2012, is designed to cut short the development time of promising new treatments. Amgen, on its first quarter call, had said that it will be entering into discussions with regulatory authorities to discuss the possibility of filing for blinatumomab’s approval based on confirmatory phase II data (Read more: Amgen Gets Breakthrough Therapy Status for Leukemia Drug).

5. Agenus Inc. (AGEN - Snapshot Report) saw its shares gaining on final results from a phase II study on its Prophage autologous cancer vaccine. The study was conducted in patients with newly diagnosed glioblastoma multiforme (GBM). Results were encouraging – median overall survival, the primary endpoint of the study, was 23.8 months for Prophage compared to 14.6 months for the standard of care alone. 50% of the patients on Prophage lived for two years.

GBM, the most common primary malignant brain tumor, is usually associated with a particularly poor prognosis and very low survival rates – 33.7% and 4.5% at one and five years, respectively (Read more: Agenus Up on Positive Prophage Data).

Performance

Last week, Regeneron once again led the major biotechs. Shares were up 2.35% mainly reflecting the increase in Sanofi’s stake in the company. Celgene was the biggest loser with shares declining 3.14%. Vertex remains the biggest gainer over the last six months (up 26.33%) thanks to the impact of the pivotal phase III data on the Kalydeco-lumacaftor combination.

Company Last Week Last 6 Months
AMGN -0.29% 4.62%
BIIB -2.20% 9.51%
GILD 2.13% 18.58%
CELG -3.14% 2.38%
REGN 2.35% 13.54%
ALXN -2.28% 18.72%
VRTX -0.85% 26.33%

What’s Next in the Biotech World?

While nothing specific is lined up later this week, stay tuned for the usual pipeline and regulatory updates. Moreover, with AbbVie (ABBV - Analyst Report) upping its offer for Shire, these two companies will remain in the news as investors mull the renewed offer.

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