3 Things In Biotech You Should Learn Today: December 3, 2017

by: Zach Hartman

Amgen expands the reach of evolocumab.

Grifols and Aradigm face an advisory meeting in mid-January.

Mylan's trastuzumab biosimilar approved in the United States.

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.

Before we get started, since the recent tax bill has moved forward in Congress, it seems a good time to highlight two opposing camps in the debate on tax reform. On one hand, with respect to biotech, many are suggesting that the easing of corporate tax rates will allow companies to bring in capital for a fresh round of partnerships and acquisitions. This may indeed drive speculation in the near- and mid-term. On the other hand, longer-term economic growth may be stymied as companies funnel more business profits into personal income, rather than investment in businesses, as highlighted in John Early's article, "Tax Reform: Worst Policy Since The Great Depression."

Did you happen to miss yesterday's edition? Click here to check it out!

Amgen expands the reach of evolocumab

Company: Amgen (AMGN)

Therapy: Evolocumab

Disease: Dyslipidemia/hypercholesterolemia

News: AMGN announced that evolocumab (marketed as Repatha) has been granted supplemental approval for prevention of heart attack, stroke, and coronary revascularization. This adds to the current approval, initially granted in 2015, for the use of evolocumab to reduce bad cholesterol levels, either alone or as part of a larger strategy.

Looking forward: The inclusion of these data showing that evolocumab can prevent potentially fatal complications is a significant nod from the FDA, and now clinicians will have a much bigger impetus to prescribe this drug, since lowering of LDL cholesterol is a step removed from providing an actual outcome benefit. Now it's etched in stone that evolocumab can save lives, which should factor favorably into AMGN's bottom line.

Grifols and Aradigm face an advisory meeting in mid-January

Company: Grifols SA (GRFS) and Aradigm (OTC:ARDM)

Therapy: Liposomal ciprofloxacin

Disease: Non-cystic fibrosis bronchiectasis

News: ARDM announced that the Antimicrobial Drugs Advisory Committee has scheduled a meeting for January 11, 2018, to discuss the new drug application for the company's liposomal formulation of ciprofloxacin (branded Linhaliq) for the treatment of infection-related bronchiectasis. This meeting will come ahead of a PDUFA of January 28, and it represents the culmination of the review process begun this past July, when the company first submitted its NDA.

Looking forward: Hopefully, ARDM does not face the same issues that Bayer (OTCPK:BAYZF) experienced in its committee review, where its application was shot down due to lack of sufficient efficacy and safety data. A few days before the meeting, we'll be able to get a look at the briefing documents to see what kinds of issues the FDA currently has with the treatment. But it's safe to say that this form of bronchiectasis remains a substantial unmet need.

Mylan's trastuzumab biosimilar approved in the United States

Company: Mylan (MYL)

Therapy: Biosimilar trastuzumab

Disease: Breast cancer and gastric cancer

News: MYL and its partner Biocon (OTC:BCNQY) announced the FDA approval of their biosimilar version of trastuzumab, which will be marketed as Ogivri. This approval comes after a tumultuous developmental process, whereby the application was withdrawn due to manufacturing concerns, followed by a delay from the FDA.

Looking forward: While it took a long time to get this application through, the clinical data for MYL's biosimilar trastuzumab were never really in question, as they were among the first crop of biosimilar antibodies to pretty clearly show similarity and safety. This approval has serious implications in the US, which is now the first country (to my knowledge) to allow a biosimilar trastuzumab, edging Europe out slightly. So it would seem as though we are finally getting serious about biosimilars, which should definitely help to improve access to this important standard therapy in breast and gastric cancers.

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