3 Things In Biotech You Should Learn Today: August 8, 2017 – Seeking Alpha

Pfizer gets the thumbs up in psoriatic arthritis from the experts

Pfizer (NYSE:PFE) has been working on its JAK3 inhibitor tofacitinib in the areas of inflammatory disease for years, having first achieved approval in rheumatoid arthritis in 2012. Now it turns its focus toward expanding the indications for this agent.

First up is psoriatic arthritis, a form of arthritis that differs in presentation from rheumatoid arthritis and that has fewer treatment options. After submission to the FDA, PFE faced a meeting with the Arthritis Advisory Committee to discuss the pros and cons of tofacitinib in this disease.

Now, the two entities have met, and PFE came out with flying colors. The panel voted almost unanimously to recommend tofacitinib for approval, with only one panel member giving the thumbs down. This lone dissenter was the patient advocate, who was concerned about insufficient evidence to state the tofacitinib improved radiographic progression.

Looking forward: This should all but cinch the approval for tofacitinib, giving PFE another notch for the agent. It is also exploring the use of this agent in other inflammatory condition, and it's got a submission to the FDA for ulcerative colitis. But psoriatic arthritis will be first up, and the decision is expected in December.

Eli Lilly (NYSE:LLY) is currently in the late stages of work on an agent called lasmiditan, an oral molecule intended to treat acute migraines.

In a previous phase 3 study, SAMURAI, the company divulged at the American Headache Society this past June that lasmiditan could improve the rate of short-term alleviation of migraine-associated pain.

Now, LLY has announced that a wider range of doses can beat placebo in the alleviation of migraines at two hours, per results from the SPARTAN study. In the highest dosing cohort of lasmiditan (200 mg), 38.8% were migraine pain-free at two hours compared with 21.3% in the placebo arm. Each of the dosing arms achieved a significant improvement in this same measure (28.6% for 50 mg, 31.4% for 100 mg).

This positive momentum will be the basis for support of an upcoming submission to the FDA from LLY, with the company stating it plans to file an NDA in the second half of 2018.

Looking forward: These results are impressive and should provide a pretty clean path to approval. Tolerability also appeared to be favorable, which is especially important in a drug that is supposed to help clear out migraines. If you get sick, what's the point? Long-term safety is also the focus of the phase 3 GLADIATOR study, so any potential toxicity should be fleshed out in time for the FDA submission.

In advanced pancreatic cancer, systemic chemotherapy is a mainstay treatment option, since few, if any, targeted therapies have been shown to work.

Needless to say, patients with metastatic pancreatic cancer have a grim prognosis. But thankfully we are making progress, inch by inch. Now, there are two standard chemotherapy regimens in use for newly diagnosed disease: the combination of fluorouracil and irinotecan, often combined with oxaliplatin (FOLFIRINOX) and the combination of gemcitabine and nab-paclitaxel (Celgene's (NASDAQ:CELG) Abraxane).

Many doctors prefer to go up front with gemcitabine/Abraxane combination due to the recent availability of liposomal irinotecan (branded Onivyde, marketed by Ipsen (OTCPK:IPSEY)).

In the UK, uptake might also be advanced by the recent news: NICE has reevaluated its cost/benefit analysis of Abraxane after an initial rejection of the drug in 2015 for reimbursement. This revision comes as CELG provided additional evidence of efficacy as well as an undisclosed discount to the NHS, and the drug is now available for routine use.

Looking forward: From my perspective, I view these kinds of challenging cost/benefit assessments performed by agencies like NICE as a sort of litmus test for the anticipated impact of a drug, and the decisions can be controversial. Some agents have only modest activity with high cost, such as Opdivo in head and neck cancer. This leads the social healthcare systems to reject reimbursement. This kind of vignette also demonstrates the power of a central government-based system to exercise some control of prices by using its large beneficiary base as a cudgel. But everyone wins here if patients are getting more effective treatments for lower cost, and CELG gains access to profits afforded by routine use in the NHS.

So that wraps up another day's news! Join me again tomorrow when we delve ever deeper into the world of biotech and pharma. If you found that this article was helpful to you, then you should consider becoming a follower of mine on Seeking Alpha, as this will let you get email alerts whenever new articles of mine go live!

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3 Things In Biotech You Should Learn Today: August 8, 2017 - Seeking Alpha