This Week In Biotech 6/26

Jun. 25, 2016 10:10 PM ETIBB, XBI, GILD, LLY, NVO, CLVS, INSYQ
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Last Week Wrap Up:

This past week was a bit quiet. The conferences we pointed out in last week's post didn't yield any info on Twitter. But there were a few other noteworthy events in the biotechnology industry this week that we'll sum up pretty quickly:

Sarepta updated their ESSENCE trial for SRP-4045 and SRP-4053. Of course there was speculation as to what this means. Our view remains that if the FDA intended on issuing a CRL for Eteplirsen, they would have done so long ago. It appears Sarepta wants to hit the ground running with the ESSENCE trial once Eteplirsen is approved. Updating the secondary endpoints, adjusting the maximum patient age, and extending the trial duration are all part of that process.

On Wednesday, the latest Medicare Annual Trustees Report stated that the Independent Payment Advisory Board decided that a drug pricing panel won't be formed until next year. This was a sigh of relief for the biotech industry as it's been under pressure lately regarding pricing. So the drug pricing can gets kicked for another year. Ultimately, Medicare will run out of money and this issue will need to be addressed.

Wednesday we also found out that an expert panel who advises the US government on vaccines recommended that a popular nasal mist influenza vaccine should not be used by US residents this coming flu season. New research has shown that the flu vaccine mist did not protect people who had it puffed up their nostrils over the past three flu seasons.

Thursday, the Florida Keys Mosquito Control District postponed a referendum regarding the use of genetically modified mosquitoes for reducing the population of disease carrying mosquitoes. We wrote last week about Bill Gates' opinion on the matter. Because genetically modified mosquitoes have been used successfully in other countries, it's only a matter of time before we use them in the US. The only question is will we use them out of choice or out of necessity?

This Week In Biotech:

This coming week starting June 26th should be more active than last week in terms of scheduled events. Tuesday will be the big day this week with three PDUFA dates and an imporant FDA Advisory Committee meetings affecting Eli Lilly and Novo Nordisk.

Tuesday June 28th:
  • Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee: The committee will discuss supplemental new drug application for empagliflozin (JARDIANCE), and empagliflozin/metformin hydrochloride (SYNJARDY) tablets. Lilly's Jardiance is already the leader of two drugs approved to reduce heart disease in type-2 diabetes patients. This meeting will be to discuss allowing Eli Lilly to expand the treatment label on those drugs. Expect Novo Nordisk shares to react to the meeting outcome since they have the only other approved drug for reducing cardiovascular events in type-2 diabetes.

  • Gilead PDUFA date for Sofosbuvir/Velpatasvir combo for treatment of all genotypes of Chronic Hepatitis C. Consensus is that Gilead will receive FDA approval.
  • Clovis Oncology's PDUFA date for Rociletinib. After a disappointing FDA Advisory Committee meeting resulting in a 12-1 rejection vote, Clovis is expecting a CRL from the FDA. This will be confirmed good news for Astrazeneca's competing drug Tagrisso.
  • Lipocine's PDUFA date for LPCN-1021 which treats low testosterone in men. According to Mohit Khera, MD, a urologist at the Baylor College of Medicine in Houston, the 52 week data was "very good" and the trial was "well-done."
Friday July 1st:

Insys PDUFA date for dronabinol oral solution for the treatment of AIDS related anorexia. The PDUFA was rescheduled to this date after Insys submitted information related to the scheduling of dronabinol oral solution under the Controlled Substances Act. The FDA determined the information was a major amendment and extended the PDUFA date to July 1st.

Other Expectations This Week:

Can-Fite Biopharma is expected to present phase II data of CF101 for glaucoma treatment by the end of the month (this week).

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

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