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More shots of potential

By Christiane Truelove (

According to analysts at Evaluate Pharma, the market for vaccines will grow from $25.47 billion in sales in 2012 to $38.88 billion in 2018. The top pharmaceutical company in the vaccines space by 2018 will be Sanofi, with sales of $8.7 billion, or 22.4 percent of the market. These sales include the company’s 50 percent share of the Sanofi Pasteur MSD joint venture with Merck & Co.

The second-largest vaccines company during 2018 will be Merck. Aided by its 50 percent share of Sanofi Pasteur MSD, Evaluate Pharma predicts 2018 sales of $7.84 billion for Merck. GlaxoSmithKline will be No. 3 by 2018, with predicted sales of $6.97 billion. Pfizer will be No. 4, with sales of $6.74 billion. Sales of Pfizer’s Prevnar 13 continue to show strong year-on-year growth of 8 percent and the product is expected to account for 15.6 percent of the vaccine market by 2018. No. 5 in the vaccines market by 2018 will be Novartis, with sales of $2.75 billion.

With Prevnar at the top, Evaluate Pharma predicts that the No. 2 vaccine product in the world by 2018 will be PENTact-HIB, Sanofi’s vaccine against diphtheria, tetanus, pertussis, Haemophilus influenzae B, and polio. The product is forecast to have sales of $2.35 billion by 2018, up from 2012 sales of $1.52 billion. The No. 3 vaccine in terms of sales will be Merck’s HPV product Gardasil, which is expected to hit $2.26 billion in 2018, up from $1.63 billion in 2012.

At No. 4 will be Sanofi’s flu vaccine Fluzone/Vaxigrip, with sales of $1.79 billion in 2018, up from $1.14 billion in 2012.
The No. 5 vaccine in terms of sales is expected to be Merck’s varicella vaccine Varivax, which is expected to achieve $1.48 billion by 2018, up from $1.27 billion in 2012.

The vaccines awaiting approval and in late-stage development represent a spectrum of diseases. Though a large number of them focus on oncology indications, there are ones for infectious diseases such as influenza, smallpox, and hepatitis B, as well as allergic rhinitis.

According to the Pharmaceutical Research and Manufacturers of America, as of April 2012, there were 300 vaccines in development; of them were 170 for infectious diseases, 102 for cancers, and eight for neurological disorders.

One of the anticipated vaccines awaiting approval is Dynavax Technologies’ Heplisav, for the prevention of hepatitis B in patients 18 to 70 years old. In June, however, FDA ordered the company to do a new safety study of the vaccine. According to Dynavax executives, FDA wants the safety database to have additional subjects and analyzing the benefit/risk of the vaccine’s use in discrete patient populations did not fundamentally address the shortfall in the safety database. The additional safety data collected would help the review for an indication in adults 18 to 70 years old.

“We are encouraged by the supportive feedback received from the FDA and appreciate the informative interactions and clarity provided regarding Heplisav’s path toward approval in the broader indication,” says Eddie Gray, Dynavax’s CEO. “We understand the rationale for the Agency’s recommendations and will give full consideration to their feasibility and timing as we advance Heplisav’s development.”

High hopes for Sanofi’s dengue vaccine, which is in Phase III, were lowered in late 2012, after the vaccine showed only a 30 percent effectiveness rate in a clinical trial in Thailand. However, the vaccine remains the only one to have made it to Phase III clinical trials and studies did show it was possible to create a safe dengue vaccine that did not exacerbate the disease.

Prostate cancer is the target of two vaccines on the list: ProstAtak from Polynoma, and Prostvac from Bavarian Nordic.

Prostvac is administered subcutaneously and induces a specific, targeted immune response that attacks metastatic cells in the prostate. The vaccine has been the subject of 13 completed and six ongoing clinical trials involving more than 850 patients. A Phase III trial, PROSPECT, in 1,200 patients with asymptomatic or minimally symptomatic castration-resistant prostate cancer was initiated in November 2011, and is expected to form the basis for approval of the vaccine for this patient population. Positive results from a Phase II clinical trial for Prostvac were presented at the 2012 ASCO meeting, and Bavarian Nordic is continuing to recruit patients for PROSPECT.

Another cancer-targeting vaccine in Phase III trials is talimogene laherparepvec, which is being developed by Amgen for the treatment of metastatic melanoma. Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to work in two important and complementary ways – causing local lytic destruction of tumors while also stimulating a systemic anti-tumor immune response.

In June, Amgen presented Phase III results for the drug, in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor. The study met its primary endpoint of durable response rate, defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in durable response rate with 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm. The overall response rate was 26 percent with talimogene laherparepvec as compared to six percent for GM-CSF. A trend toward overall survival was also observed at a predefined interim analysis.

“These are the first data from a controlled trial of oncolytic immunotherapy to demonstrate activity in melanoma,” says Sean E. Harper, M.D., executive VP of research and development at Amgen. “We are pleased with the results of this pivotal Phase III trial for talimogene laherparepvec and we look forward to the mature overall survival data later this year.”

Another cancer vaccine in Phase III trials, the nonsmall cell lung cancer vaccine Stimuvax from Merck KGaA/EMD Serono, ran into difficulties late in 2012 when the drug failed to improve survival in a pivotal study. The company presented results from the trial at the ASCO meeting in June.

“This is the first time that an antigen-specific cancer immunotherapy has shown this effect in a substantial subgroup of NSCLC patients who are usually only observed following chemoradiotherapy,” says Dr. Annalisa Jenkins, head of Global Drug Development and Medical for the Merck KGaA prescription medicine division. “We believe the results from the START trial offer scientific insights to the medical community on the potential clinical utility of immunotherapy approaches in oncology. As we better understand the biology behind immune responses in patients living with cancer, our learnings can be applied to advance progress in this field.”

Posted: July 2013