Biotech Analysis Central Pharma News: Aeterna Zentaris FDA Green Light, Shire's Wall Block, AbbVie's Trial Win

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Includes: ABBV, AEZS, SHPG
by: Terry Chrisomalis
Summary

Aeterna Zentaris achieves FDA approval for Macrilen for diagnosing patients with Growth Hormone Deficiency.

Shire fails to meet on either endpoints of late-stage study in a rare disease.

AbbVie sees success in late-stage study treating patients with Rheumatoid arthritis.

Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry.

Aeterna Zentaris Receives FDA Approval for Adult Growth Hormone Deficiency

News: Recently, Aeterna Zentaris (AEZS) received FDA approval for its Adult Growth Hormone Deficiency (AGHD) Macrilen. Macrilen is an oral ghrelin agonist used for the diagnosis of patients with AGHD. It is estimated that there are are around 60,000 tests done in the U.S., Canada, and Europe for this indication. This FDA approval comes just about a few weeks before the actual PDUFA date for Macrilen. Aeterna Zentaris expects to launch Macrilen in the United States in the first quarter of 2018.

Analysis: The news was good in that it will likely have a positive impact on the stock price in the coming days. There is no doubt about that. In addition, Macrilen offers patients a new option when it comes to being tested for AGHD. The current option involves something known as the insulin tolerance test (ITT) which is an intravenous test. The problem with this testing method is that it requires a lot of blood draws over several hours. In my opinion, that is quite invasive for patients. That's why I believe that Macrilen will sell well as soon as it hits the market. Aeterna Zentaris is a buy on this FDA approval.

Shire Fails Late-Stage Hunter Syndrome Trial

News: Recently, Shire (SHPG) announced that its drug SHP609 failed a late-stage trial. More specifically, it failed to meet on both the primary and secondary endpoints of the study. The primary endpoint of the study was to determine the difference in cognition between SHP609 and the control group. This was done using a measuring score known as "General Conceptual Ability (GCA) scores. The treatment length went on for about 12 months. Unfortunately, Shire was unable to show an improvement in either endpoint of the study.

Analysis: This was a bad outcome for both Shire and the Hunter Syndrome Community. The hope was that SHP609 could improve upon the cognition issue that Hunter Syndrome patients experience due to their disease. In the end, this failure will not hurt shire. That's because Shire still has its drug Elaprase which had received FDA approval to treat Hunters Syndrome since 2006. This drug succeeding would have been a good improvement for patients with the cognition issue associated with the disease, but in the end Shire will not be in too much trouble because of this failure. With that said, Shire is a good buy.

AbbVie Sees Success In Phase 3 Study For Rheumatoid Arthritis

News: Recently, AbbVie (ABBV) announced that its phase 3 study treating patients with Rheumatoid Arthritis (RA) met the primary endpoint of the study. This phase 3 trial used the company's JAK1 inhibitor known as upadacitinib. The phase 3 trial was known as the SELECT-MONOTHERAPY study that only evaluated upadacitinib alone as a monotherapy in patients with moderate to severe RA.

Analysis: The results were remarkable in that patients recruited into the study were those who were not helped by methotrexate (standard of care for RA). In addition, both the 15 mg and 30 mg of upadacitinib were able to achieve both the primary and secondary endpoint of the study. I like the fact that AbbVie has the option to market the lower 15 mg dose of the drug should it choose to do so, which should be easier for patient compliance. The downside for the phase 3 study was that one patient died of hemorrhagic stroke caused by a ruptured aneurysm and the other suffered a pulmonary embolism (PE). The company stated that the patient with PE had pre-existing risk factors for developing pulmonary embolism. The patient that died during the study had pre-existing cardiovascular risk factors. I believe that AbbVie is onto something with its Jak1 inhibitor. It has already achieved positive data in patients with Eczema as well. Having stated all that, AbbVie is a good buy right now.

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.

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