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Industry Outlook

It was yet another slow week for the biotech sector with very few updates making an impact. Newsmakers included Can-Fite (CANF), Amgen (AMGN - Analyst Report) and Cubist (CBST - Analyst Report).

Disappointing Data Pulls Down Can-Fite: Can-Fite ended 2013 on a disappointing note with shares plunging 32.4% on data from a phase III study on CF101. CF101 failed to achieve the primary as well as secondary endpoints in the study that was conducted in patients with moderate-to-severe dry eye syndrome.

Amgen’s Romosozumab Fares Well in Mid-Stage Study: Amgen's shares were up 1.5% on positive data from a mid-stage study on romosozumab. The study was conducted in postmenopausal women with low bone mineral density (BMD). Treatment with romosozumab for 12 months resulted in a significant increase in BMD at the lumbar spine, total hip and femoral neck compared to placebo.

Moreover, exploratory analyses showed that BMD increased significantly at the lumbar spine and hip compared to Fosamax and Forteo (currently approved treatments). The data looks good but it remains to be seen how romosozumab performs in ongoing phase III studies.

Priority Review for Cubist Drug: The FDA agreed to review Cubist’s experimental antibiotic tedizolid phosphate (TR-701) on a priority basis. This means a response should be out by Jun 20. Cubist is looking to get tedizolid approved for the treatment of acute bacterial skin and skin structure infections. The EU marketing application for the antibiotic will be submitted in the first half of this year. Cubist shares gained 1.3% on the news. Tedizolid became a part of Cubist’s pipeline following its Sep 2013 acquisition of Trius.

Patent Protection for Immunomedics (IMMU): IMMU shares have been gaining steadily ever since the company received additional patent protection for its antibody-drug conjugates. This is good news for the company as the patents will cover IMMU-132 and IMMU-130, both phase II oncology candidates.

Orphan Drug Status for NPS’ Natpara: NPS Pharmaceuticals’ (NPSP - Analyst Report) shares inched up 2.1% with the company gaining orphan drug status in Europe for Natpara for the treatment of hypoparathyroidism. Natpara already has orphan drug status for this indication in the U.S. where it is currently under FDA review. Orphan drug status brings several incentives like protocol assistance, scientific advice, and exclusivity once the drug is on the market.

Company Last Week Last 6 Months
AMGN -0.57% 20.49%
BIIB 0.08% 27.54%
GILD -0.17% 42.98%
CELG 0.52% 40.42%
REGN -1.91% 16.67%
ALXN 0.11% 37.15%
^BTK -0.57% 16.50%

 

 

 

 

 

 

 

The Week So Far:

This week has turned out to be pretty eventful so far with Epizyme (EPZM - Snapshot Report) and Pharmacyclics (PCYC - Analyst Report) shares soaring significantly.

Epizyme Shares Shoot Up: Epizyme shares shot up a whopping 75.6% on the achievement of a proof-of-concept milestone related to the development of EPZ-5676. This triggered a $25 million milestone payment from partner Celgene (CELG - Analyst Report). The company will also get a $4 million milestone payment under its agreement with Glaxo regarding small molecule HMT inhibitors. Epizyme now expects to exit 2013 with a cash balance of $145 million, significantly above the earlier forecast of $115 million.

Pharmacyclics Gains on Imbruvica News: With an Independent Data Monitoring Committee unanimously recommending that the phase III RESONATE study, being conducted on Pharmacyclic’s leukemia drug, Imbruvica should be stopped early, the company saw its shares gaining 19.8%. This is a very positive development for the company as the study met its primary and a key secondary goal.

Fast Track Status for Peregrine’s Bavituximab: Peregrine Pharma’s shares gained 14.5% on news that the FDA has granted fast track status to the company’s lead pipeline candidate, bavituximab, for second-line non-small cell lung cancer.

EU Nod for Abraxane Label Expansion: Celgene’s Abraxane gained EU approval for use as a first-line treatment in patients suffering from metastatic pancreatic cancer. It is to be used in combination with Gemzar. Approval was expected as last year the Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion regarding the same.

Synageva Wraps Up Patient Enrolment: Synageva has finished enrolling patients far above its original target in its phase III study (Acid Lipase Replacement Investigating Safety and Efficacy - ARISE) on sebelipase alfa. The study is being conducted in children and adults suffering from lysosomal acid lipase deficiency. Top-line results from this study will be out the second half of the year. Shares were up 1.4%.

FDA Action Date for Orexigen Drug: The FDA issued an action date for Orexigen’s obesity candidate, Contrave. The agency will act on the company’s regulatory submission by Jun 10.

Coming Up:

Pipeline Update from Intercept: Intercept will be providing an update on its pipeline on Jan 9. Information to look out for: updates on the completion of the double-blind phase of the POISE study, top line data from the OBADIAH and PESTO studies and milestones expected this year. Intercept focuses on the development of novel bile acid therapeutics for the treatment of chronic liver diseases.

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