3 Things In Biotech You Should Learn Today: February 6, 2018

Includes: AGN, AMAG, SPPI
by: Zach Hartman

Allergan scores supplemental approval for hospital-acquired infection.

Spectrum scores on efficacy in a supportive care study.

AMAG Pharmaceuticals scores supplemental approval for Feraheme.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication.

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

Allergan scores supplemental approval for hospital-acquired infection

Company: Allergan (AGN)

Therapy: Avycaz, a combination of antibiotics

Disease: Hospital-acquired pneumonia and ventilator-associated bacterial pneumonia

News: AGN announced that the FDA has granted supplemental approval for Avycaz to include infections caused by multiple Gram-negative microorganisms. This marks the third approval for the drug since its initial authorization in 2015, and the approval was based on non-inferiority to the broad-spectrum antibiotic meropenem, which is associated with serious side effects.

Looking forward: Development of new antibiotic treatment options is incredibly important, especially in the hospital setting, as evidenced by the growing list of multidrug resistant bacteria. Thankfully, science is keeping pace for now from having us fall out of the age of modern medicine, and AGN is likely to reap significant reward.

As with many big pharma drug approvals, I wouldn't base my whole decision on this alone, but it should factor favorably into your due diligence.

Spectrum scores on efficacy in a supportive care study

Company: Spectrum Pharmaceuticals (SPPI)

Therapy: Eflapegrastim

Disease: Chemotherapy-induced neutropenia

News: SPPI announced positive results from their pivotal ADVANCE study, which assessed eflapegrastim in comparison with pegfilgrastim. SPPI's drug showed non-inferiority with pegfilgrastim, and the safety profiles between the drugs were similar. As the enrollees for the RECOVER study roll in, the company also guided that it will submit an application for approval in 2018.

Looking forward: In cancer medicine, it's easy to forget that a lot of good treatment options exist for the complications from the cancer treatments themselves. This study goes a good ways toward getting another version of GM-CSF agonists on the market, whereas straight-out biosimilars of pegfilgrastim have been beset by challenges.

All in all, this move looks good for SPPI, and I'll be quite surprised if they miss their submission mark in 2018.

AMAG Pharmaceuticals scores supplemental approval for Feraheme

Company: AMAG Pharmaceuticals (AMAG)

Therapy: Ferumoxytol

Disease: Iron deficiency anemia

News: AMAG announced that the FDA has broadened the approved label of their anemia drug ferumoxytol (branded Feraheme) from patients with anemia due to chronic kidney disease to all adult patients with iron deficiency anemia and intolerance to or poor response on oral iron supplementation.

Looking forward: AMAG guided that this approval should immediately double the population size that can benefit from Feraheme. Considering this product currently nets some $25 million in sales per quarter, this is no small gain for the company, who currently sit at a market capitalization of around $450 million. Personally, I don't think I'd buy the dip that the stock took after this move.

This approval should help drive AMAG into significant income growth in the coming years, and I think some heavy due diligence here would do you well.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.