Biotech Analysis Central Pharma News: Gilead's New Move, Sarepta's Hold Removal, Alexion's Plan

Includes: ALXN, GILD, SRPT
by: Terry Chrisomalis


Gilead Sciences implements  generic Hepatitis C franchise to boost sales.

Sarepta Therapeutics gets clinical hold by FDA removed.

Alexion looks to a new market for growth.

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

Gilead Sciences Implements Generic Hepatitis C Franchise To Boost Sales

News: Recently, Gilead Sciences (GILD) announced that it will be pushing to sell generic versions of its Hepatitis C combo drugs. It will accomplish this by creating a new subsidiary known as Asegua Therapeutics, and selling Epclusa (sofosbuvir 400mg/velpatasvir 100mg) and Harvoni (ledipasvir 90mg/sofosbuvir 400mg) at a discount. This discount will closely match that of which health insurers and government payers receive. These authorized generics will be priced at launch for $24,000. It will be made available to patients in 2019.

Analysis: This is not good news at all for Gilead Sciences, but I believe it is trying to squeeze out as much revenue as it can for its Hepatitis C products. That's because Epclusa and Harvoni are priced at $75,000 and $94,500 respectively in the United States. This deep discount will not be ideal for Gilead at all, however, it is something that needs to be done to increase sales. The Hepatitis C business has been continuously declining. I believe that there is at least one positive takeaway from doing this authorized generics program. That positive being that it could expand access to those patients who couldn't afford to buy the drug beforehand. Plus, it will open up access to Medicare patients who were denied coverage as well. I think this was the right move, especially since Gilead has faced hardships in the past in other territories. For example, I wrote a Seeking Alpha Article talking about Gilead losing a patent battle in China for its Hepatitis C base compound Sofosbuvir (Sovaldi). The problem with that is that Sofosbuvir is the base compound for both Epclusa and Harvoni. In China, Gilead is selling its Hepatitis C drugs for $9,000. It had no choice but to set it at that price, because generic hepatitis C drugs at a 12-week regimen in China are being sold for $249. I think that Gilead needed to enact this generic authorization program. Will it revive the Hepatitis C franchise? In my opinion, probably not. As long as it can squeeze out as much revenue as possible that should be the ultimate goal. I think Gilead should stay more focused on its NASH programs, and KITE products.

Sarepta Therapeutics Gets FDA Clinical Hold Removed

News: Recently, Sarepta Therapeutics (SRPT) announced that the FDA had removed the clinical hold that was placed on its microdystrophin gene therapy product. This gene therapy product is important because it is the next generation therapeutic being developed to treat DMD. The big issue was that there were trace amounts of DNA fragment found in research-grade third party supplied plasmid in a manufacturing lot. Sarepta and its collaboration partner Nationwide Children's Hospital submitted an action plan to the FDA. In this action plan both entities included an audit of the plasmid supplier and a commitment to use GMP-s plasmid for all future production lots.

Analysis: This is very good news for Sarepta which is trying to expand its presence in the Duchenne muscular dystrophy (DMD) market. I would like to point out that both Sarepta and the Nationwide Children's Hospital did an excellent job submitting their action plan. That's because it has only been about a few months since the FDA had placed the trial on hold. It was important to expedite that information, because now that means Sarepta will be on schedule to begin its pivotal trial by the end of 2018.

Alexion Looks To A New Market For Growth

News: Recently, Alexion Pharmaceuticals (ALXN) announced that it had obtained positive phase 3 results for a study treating patients with a rare disease. This rare disease is known as anti-aquaporin-4 (AQP4) auto antibody-positive neuromyelitis optica spectrum disorder (NMOSD). Patients with NMOSD experience issues with their central nervous system (CNS). This was a phase 3 study that enrolled 148 adult patients with anti-aquaporin-4 (AQP4) auto antibody-positive NMOSD. Patients in the study were randomized 2:1 to receive either Soliris or placebo. The study met the primary endpoint of time to first adjudicated on-trial relapse. In other words, it was shown that Soliris was able to reduce the risk of NMOSD relapse by 94.2% compared to placebo. This gave a statistically significant p-value of p < 0.0001.

Analysis: NMOSD is a highly devastating disease. It is an autoimmune disorder that causes inflammation in the optic nerve and spinal cord. The biggest issue with this disease is that patients experience relapses. Each subsequent relapse leads to further damage. It is often mistakenly misdiagnosed as multiple sclerosis (MS). There are some differences between the two diseases. For instance MS occurs in different parts of the brain. In addition, MS is a T-cell mediated disease whereas NMOSD is mediated by anti-aquaporin 4 antibodies. Taking it one step further those with NMOSD experience attacks in the nerve and spinal cord that are more robust than those patients with MS. I think this is a good target for Alexion, because the market opportunity for this indication could potentially be worth between $500 million to $700 million per year. One more thing to note is that 3/4 of NMOSD patients are those that have the anti-aquaporin-4 (AQP4) auto antibodies. In addition, there are no FDA approved drugs for this indication.

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.