Seeking Alpha's Biotech Weekly: Spark Flies For Pfizer, Sovaldi V. Septa, And More

by: SA Editor Mike Taylor, CFA


Every Friday, SA highlights some of the week's insightful pieces of opinion and analysis as well as noteworthy Breaking News stories.

This week, contributors took a look at Arena Pharmaceuticals, Galena Biopharma, Agenus Bio, and others in the biotech/health care sector.

Did we miss any other big stories? What should Seeking Alpha be tracking in the biotech world? Leave your comments to let us know.

Welcome to a new Seeking Alpha feature, the SA Biotech Weekly. Every Friday, we will highlight the editors' picks of the past week's most interesting and impactful pieces of Seeking Alpha analysis, as well as a list of the top Breaking News stories for the week. Did we miss any other big stories? Anything here seem like it's actually a non-event? What should the Seeking Alpha community be reading and writing about? Please leave a comment to let us know.

Seeking Alpha Analysis You Should Check Out

Here are some of the top breaking news items this week.

Pfizer moves into gene therapy

  • Pfizer (NYSE:PFE) strikes a deal with privately-held Philadelphia, PA-based Spark Therapeutics to develop a treatment for hemophilia based on Spark's gene therapy platform. Spark expects a Phase 1/2 trial in hemophilia B to start in the first half of next year. Pfizer will assume responsibility for the late-stage development.
  • Under the terms of the agreement, Spark will receive a $20M upfront payment and up to $260M in regulatory- and development-based milestones.
  • Kings College London professor Michael Linden will lead the effort under a two-year contract with Pfizer.

Philadelphia transit agency sues Gilead over Sovaldi pricing

  • The Southeastern Pennsylvania Transportation Authority (Septa) files a suit in the U.S. District Court for the Eastern District of Pennsylvania against Gilead Sciences (NASDAQ:GILD). The suit, which accuses Gilead of price gouging with its $84,000 full regimen list price for Sovaldi, seeks class action status. The plaintiff(s) seek monetary damages.
  • Septa has spent $2.4M on Sovaldi this year for members of its health plans it funds for employees and retirees. It does not specify how many people have been treated with the HCV medication, but it is clearly feeling budgetary pain.
  • Sovaldi, which the company began selling in December, is the most successful drug launch in history, generating over $8.6B in revenue in nine months.
  • Although the average discount for Sovaldi in the U.S. is 20% or more, the company will still have to defend its pricing considering that it sells it in Egypt for $900 for a full regimen.

It's official: Merck takes out Cubist

Multiple myeloma patients have a rough time with Celgene's pomalidomide

  • At the American Society of Hematology meeting in San Francisco, data were presented from a Phase 3b study of Celgene's (NASDAQ:CELG) pomalidomide (Pomalyst/Imnovid) plus low-dose dexamethasone in 599 patients with relapsed or refractory multiple myeloma who had previously failed treatment with lenalidomide and bortezomib.
  • The primary endpoint was safety. Secondary endpoints were overall response rate (ORR >=partial response), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and cytogenic analyses.
  • The most frequent grade 3-4 adverse events (AE) were hematologic - neutropenia (42%), anemia (29%) and thrombocytopenia (22%). The most common non-hematologic AEs were infections (29%) and pneumonia (12%). Dose reductions due to AEs were required in 18% of patients and 9% had therapy discontinued.
  • At a median followup of 6.8 months with a median of four treatment cycles, median PFS was 4.2 months, median OS was 11.9 months, ORR was 35% with 8% of patients achieving at least a very good partial response and median DOR was 6.8 months.

Juno Therapeutics on deck for highly-anticipated IPO

  • Seattle, WA-based Juno Therapeutics (NASDAQ:JUNO) is set for its IPO of 9.25M shares of common stock at $15 - 18.
  • The biopharmaceutical firm develops cell-based cancer immunotherapies based on chimeric antigen receptor (CAR) and high-affinity T cell receptor (TCR) technologies to genetically engineer T cells to recognize and kill cancer cells.
  • Before the end of 2015, the company expects to initiate a Phase 2 trial in relapsed/refractory B cell acute lymphoblastic leukemia, a Phase 1/2 trial in relapsed/refractory B cell non-Hodgkin lymphoma and at least five Phase 1 studies for other cancers.
  • Juno's most advanced product candidates, JCAR015. JCAR017 and JCAR014 utilize CAR technology to target CD19, a protein expressed on the surface of almost all B cell leukemias and lymphomas.
  • In the nine-month period ended September 30, the company lost ~$41M in operations and consumed ~$39M. Its cash balance as of the end of September was ~$238M and will be ~$376M after the offering (assuming the above price range).
  • Investor interest in Juno should be robust due to the immense potential of CAR-T therapies.

Novartis' Cosentyx beats Stelara in Phase 3 trial

Other stories of note:

Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.