Biotech Stock Roundup: Gilead Nabs FDA Nod for Combo HCV Drug, Auxilium Accepts Endo Offer - Analyst Blog

Mergers and acquisitions continue to make news in the biotech sector. Last week, Auxilium ( AUXL ), which was looking to acquire QLT, Inc., agreed to an acquisition proposal from Endo. Meanwhile, Gilead ( GILD ) made it to the headlines with FDA approval for its new hepatitis C virus (HCV) combination treatment, Harvoni, which is slated to bring in multi-billion dollar sales for the company.

Recap of the Week's Most Important Stories

1. Gilead strengthened its position in the HCV market further with its combination HCV treatment, Harvoni, gaining FDA approval. Harvoni, which consists of ledipasvir 90 mg and Sovaldi 400 mg, is expected to bring in multi-billion dollar sales for Gilead - this looks achievable with HCV patients postponing treatment as they await newer and better treatment options.

A once-daily single tablet dosing regimen, high cure rates, a shorter treatment duration (as short as eight weeks in certain patients), a better tolerability profile and the complete elimination of the need for interferon and ribavirin should see this newly approved combo treatment picking up share rapidly.

However, competition is not far behind. First, there's AbbVie ( ABBV ) which could gain approval for its interferon-free HCV combination later this year. Then there are other companies like Merck and Johnson & Johnson that are also working on bringing improved HCV treatments to market (Read more: Gilead's All-Oral Combo HCV Drug Harvoni Cleared by FDA ).

2. Auxilium has dropped its plans to acquire QLT, Inc. Instead, it has accepted an acquisition offer from Endo International plc. Endo's offer price of $33.25 per share represents a premium of 55% to Auxilium's closing price on Sep 16 (the day on which Endo made public its proposal for Auxilium). The $2.6 billion transaction is slated to close in the first half of next year (Read more: Endo to Buy Auxilium for $2.6B, Diversify Portfolio ).

3. Amgen ( AMGN ) reported impressive top-line results on its biosimilar version of AbbVie's blockbuster drug, Humira. Amgen's biosimilar met the primary endpoint in a late-stage study conducted in patients with moderate-to-severe plaque psoriasis. The company is currently conducting another phase III study with the biosimilar. Amgen's target is to start launching biosimilars (it currently has six in development) from 2017 (Read more: Amgen Up on Positive Phase III Data on Psoriasis Biosimilar ).

Amgen provided another important pipeline update - the FDA has accepted its BLA for experimental blood cancer treatment, blinatumomab. With the FDA granting priority review, a response should be out by May 19, 2015 (Read more: Amgen's Blinatumomab Gets Priority Review in the U.S. ).

4. Alnylam ( ALNY ) reported encouraging mid-stage data from a study evaluating patisiran for a rare genetic disease - transthyretin-mediated amyloidosis (ATTR) in patients with familial amyloidotic polyneuropathy. Alnylam's shares were up almost 19% on the news. (Read more: Alnylam Jumps on Positive Patisiran Data from Phase II Study ).

5. Prosensa, which focuses on the development of RNA-modulating therapeutics for rare diseases with high unmet need, has started submitting a rolling NDA for its experimental Duchenne muscular dystrophy (DMD) treatment, drisapersen. The company expects to complete the submission by year end. However, competition is not far behind as Sarepta ( SRPT ) is also looking to submit a regulatory application for its experimental DMD treatment by year end (Read more: Prosensa Starts Rolling NDA Submission for Drisapersen ).


Last week, Vertex ( VRTX ) was the only stock among the major biotechs to record an increase in share price (up 1.39%).

Regeneron was the biggest loser among the big biotechs last week with its shares declining 7.38%.

Vertex was the biggest gainer over the last six months (up 66.98%). Gilead was also up significantly (45.5%) during this period.

Overall, the NASDAQ Biotechnology Index was down 4.17% last week (See the last biotech stock roundup here: Sunesis Tanks on Study Results, Chimerix Up on Ebola Update ).

Company Last Week Last 6 Months
AMGN -2.82% 17.87%
BIIB -4.54% 7.89%
GILD -6.82% 45.50%
CELG -6.46% 25.28%
REGN -7.38% 13.12%
ALXN -5.06% 12.32%
VRTX 1.39% 66.98%

What's Next in the Biotech World?

Is AbbVie having second thoughts about its upcoming acquisition of Shire? The company's Board of Directors will be meeting soon to reconsider its recommendation to stockholders to adopt the merger agreement. The U.S. Department of Treasury's proposed changes to the tax regulations announced last month is one of the issues that will be discussed at the meeting.

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VERTEX PHARM (VRTX): Free Stock Analysis Report

AUXILIUM PHARMA (AUXL): Free Stock Analysis Report

GILEAD SCIENCES (GILD): Free Stock Analysis Report

AMGEN INC (AMGN): Free Stock Analysis Report

ALNYLAM PHARMA (ALNY): Free Stock Analysis Report

ABBVIE INC (ABBV): Free Stock Analysis Report

SAREPTA THERAP (SRPT): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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