5 Highlights in Pharmacy This Week

In case you missed it, here’s the hottest news in pharmacy this week:

1. Remicade’s biosimilar Inflectra (infliximab) hopes to provide cost savings to many patients¹

Last year, Johnson & Johnson’s Remicade generated $4.5 billion in sales. Pfizer’s Inflectra

hopes to take a share of that market by offering a 15% discount to Remicade’s wholesale acquisition cost, or $946.28 per 100 mg vial. This will provide cost savings to many patients with autoimmune diseases such as Crohn’s disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis. But in my opinion, the discount is barely enough and won’t make that much of a difference when you consider the fact that the majority of generic medications cost 80% less than brand named medications. Inflectra plans to be available by the end of next month.

2. New cholesterol-lowering medication sees promising results²

The Medicines Company just announced promising results from day 90 interim analysis in its ongoing ORION-1 phase 2 study of ALN-PCSsc, an investigational first-in-class PCSK9 synthesis inhibitor (PCSK9si).

Proprotein convertase subtilisin/kexin type 9 (PCSK9) is an enzyme that binds to low-density lipoprotein (LDL) receptors that prevent the removal of LDL-cholesterol (LDL-C) in the blood. There are currently 2 PCSK9 inhibitors on the market, alirocumab (Praluent) and evolocumab (Repatha), which are monoclonal antibodies that bind to PCSK9 in blood. PCSK9s are slightly different where they inhibit PCSK9 synthesis in the liver via RNA interference.

In this ongoing study, ALN-PCSsc demonstrated that it has confirmed results from its phase 1 study and demonstrates great efficacy and safety. It also reassures that this medication’s triennial and potentially biannual dosing regimen. In its previous single and multiple ascending dose study, it saw a maximum LDL-C reduction was 79.1% and 83%, respectively. The ongoing study demonstrated no elevation of liver enzymes, neuropathy, or change in renal function. It’s been well tolerated with no serious adverse events and it’s a promising medication for patients who are intolerant or non-adherent to their statin therapy. Detailed results will be presented at the Late-Breaking Clinical Trial Session at American Heart Association meeting on November 15, 2016.

3. Zykadia (ceritinib) keeps showing promising data for ALK-positive non—small-cell lung cancer (NSCLC)³

Last week, Novartis presented its ASCEND-5 phase 3 study results at the European Society for Medical Oncology (ESMO) 2016 Congress which demonstrated that ceritinib provided longer progression-free survival than chemotherapy in crizotinib (Xalkori) treated patients (5.4 vs 1.6 months). However, there was no improvement in overall survival with ceritinib when compared to chemotherapy.

Patients on ceritinib experienced similar adverse effect profiles to those observed in phase 1 and 2 studies such as nausea (7.8%), vomiting (7.8%), and diarrhea (4.3%). Also, ceritinib significantly improved patient-reported outcomes including lung cancer-specific symptoms and overall health status versus placebo. The results open up a new treatment algorithm after crizotinib failure in patients with ALK+ metastatic NSCLC.

Novartis also released its phase 2 study results for the use of ceritinib in ALK+ metastatic NSCLC patients who hadn’t used an anaplastic lymphoma kinase (ALK) inhibitor post-chemotherapy. Ceritinib increased progression-free survival by a median 18.4 months.

4. Cancer vaccines may be available in the next few years!⁴

After more than half a century, the US is finally easing its restrictions on Cuba. Cuba has more to offer than its great cigars and rums. The loosening of these restrictions will allow more collaborations in vaccine research. The Center of Molecular Immunology in Havana (CIM) have developed CimaVax, an effective lung cancer vaccine that has been used in 5,000 patients worldwide. The Roswell Park Cancer Institute in Buffalo, New York, will be implementing CimaVax into US clinical trials. This low-cost vaccine has the potential to save many lives across the globe. The Roswell Park Cancer Institute has reported that they’re on track to acquire another cancer vaccine, racotumomab, from CIM in the near future. Racotumomab is indicated for the treatment of solid tumors. With more collaborations with neighboring countries, we can see the growth of scientific research and the hopes of eradicating the many diseases that are plaguing our everyday life.

5. HPV vaccine for cancer, not just STDs⁵

The CDC is now urging all doctors to persuade their patients to receive the HPV (Human Papillomavirus) vaccine for cancer prevention rather than STD prevention. HPV is the most common sexually transmitting infection that’s been linked to a variety of cancers in the cervix, vagina, penis, or anus. Last year, it was estimated that only 40% of girls and 21% of boys have received the HPV vaccine. The US currently falls behind other high-income countries such as the UK and Australia, which have HPV vaccination rates of more than 60%. Earlier this week, the Advisory Committee on Immunization Practices (ACIP), a key CDC panel voted to change the dosing regimen of the HPV vaccine from a 3-dose regimen to a 2-dose regimen. This will make it easier for patients with hopes of increasing vaccination rates.

References

• Harris R. Small savings for drugs made to mimic biotech blockbusters. NPR website. npr.org/sections/health-shots/2016/10/19/498559386/small-savings-for-drugs-made-to-mimic-biotech-blockbusters.
• Langan M, et al. The Medicines Company announces positive top-line results from day 90 interim analysis in ongoing ORION-1 Phase 2 Study of PCSK9si. businesswire.com/news/home/20161018005864/en/Medicines-Company-Announces-Positive-Top-Line-Results-Day.
• European Society for Medical Oncology. ESMO 2016 press release: Ceritinib provides longer progression-free survival than chemotherapy in phase III trial of ALK rearranged lung cancer treatment. ESMO website. esmo.org/Conferences/ESMO-2016-Congress/Press-Media/Ceritinib-Provides-Longer-Progression-free-Survival-Than-Chemotherapy-in-Phase-III-Trial-of-ALK-Rearranged-Lung-Cancer-Treatment.
• Sagonowsky E. Cuba’s calling vaccine researchers as U.S. clears a path for R&D collaborations. Fierce Pharma website. fiercepharma.com/vaccines/new-rules-bring-opportunity-for-u-s-cuban-collaborators.
• McCullough M. CDC approves the two-dose HPV vaccine, instead of three. The Inquirer website. philly.com/philly/health/CDC-oks-two-HPV-vaccine-doses-instead-of-three.html.