Product news from Datamonitor
pharmafile | April 16, 2007 | News story | Research and Development, Sales and Marketing |
Carrington Laboratories to manufacture sublingual vaccines
Carrington Laboratories has reported that its subsidiary DelSite Biotechnologies has entered into an agreement with the International Vaccine Institute to develop sublingual vaccines that could be used to improve immunisation programmes in the developing world.
International Vaccine Institute (IVI) was established to accelerate development and introduction of vaccines to the developing world and to transfer new technologies to vaccine producers.
The development of sublingual vaccines could lead to the use of needle-free immunisation programmes. Under the collaboration, Carrington will formulate vaccine antigens supplied by the IVI for sublingual delivery and IVI will conduct animal testing. The target vaccine antigens and formulation forms will be selected by mutual agreement.
The research will utilise DelSite's polymer delivery technology, known as DelSite. DelSite's polymer has advantages because it can be prepared in different forms including a liquid, a soft gel, a powder, or a dried pad.
Senior scientist Yawei Ni said: "Sublingual technology would allow for needle-free self-administration of the vaccines which should significantly reduce the number of trained professionals typically required for large immunisation programmes. Additionally, vaccines made with DelSite technology could be delivered without cold-chain storage, thereby facilitating vaccine distribution into remote communities where lack of refrigeration rules out the use of most current vaccines."
Related links:
The Vaccines Market Outlook: Market analysis of future growth and leading players by sector
Therapeutic Vaccines: More Trials and Tribulations
Stakeholder Perspectives: Influenza Vaccines – Flying back Into Flu
Hollis-Eden requests approval of metabolic drug trial
Hollis-Eden Pharmaceuticals has filed an investigational new drug application with the FDA to begin a phase I trial with its drug candidate for the treatment of metabolic disorders, which include diabetes, obesity and dyslipidemia.
The phase I trial programme, designed to assess the safety of the drug candidate HE3286, could support both a phase II study in type 2 diabetes patients, as well as a phase II study in rheumatoid arthritis patients.
The company plans to file for autoimmune disorders later this year. In preclinical studies, HE3286 has been shown to regulate signaling pathways of inflammation common to both metabolic and autoimmune disorders.
As previously reported, HE3286 produced glucose lowering activity and increased insulin sensitivity when administered orally in preclinical models of type 2 diabetes.
The company's findings suggest that HE3286 may be the first in a new class of insulin sensitisers, since it appears to regulate the pro-inflammatory NF-kappa B pathway without acting on the PPARgamma receptor, which is the target of insulin sensitising drugs currently being prescribed. By working through this new pathway, HE3286 appears to avoid the side-effect of weight gain commonly seen with existing therapies.
HE3286 has also demonstrated a dramatic benefit in rodent models of both initial-onset and established rheumatoid arthritis. Potential mechanisms of action for HE3286 in this indication include regulation of NF-kappa B and increasing the production of regulatory T cells, or Treg cells. Treg cells play a key role in keeping the immune system from attacking the body itself.
Related links
The Diabetes Market Outlook to 2011
Non-insulin Antidiabetics – Type 2 diabetes unlikely to develop into a switch market
Migraine market: Trexima approval delays benefit generic triptan
Estimated to be worth $3.4 billion in 2005, the migraine market is entering a state of maturity driven by the dominance of the triptan class of drugs. The ongoing approval delays with GlaxoSmithKline and Pozen's Trexima, coupled with triptan genericisation, will result in the migraine market value decreasing by 20% from 2008 to $3.2 billion in 2015.
Migraine is a form of chronic neurovascular headache, in which neural events result in the dilation of blood vessels, which in turn, results in pain and further nerve activation. The pain most often occurs on one side of the head, and is usually accompanied by various combinations of symptoms, including nausea, or vomiting, and/or photophobia (sensitivity to light), phonophobia (sensitivity to sound) and osmophobia (sensitivity to smells/odours). The ideal migraine medication not only needs to be a potent pain reliever, but must also offer a rapid onset of action, sufficient duration of effects, cause minimal side effects and be easy and convenient to deliver.
FDA stalls on Trexima approval: The fate of Trexima (sumatriptan + naproxen sodium combination), GSK and Pozen's single pill combination of the market-leading sumatriptan with naproxen sodium firmly remains in the hands of the FDA. In June 2006, the FDA granted Trexima approvable, determining that Trexima is effective as an acute treatment for migraine. The agency, however, requested additional safety information on the drug, to which GSK and Pozen responded in November 2006 by submitting a complete response letter to the FDA.
In December 2006, the FDA responded to the November filing with the request for additional information, helping compare the newly submitted phase IIIb data with previously submitted phase III data in the original NDA. With Pozen and GSK responding to this latest request in early February 2007, Datamonitor assumes that the FDA is probably most concerned with the potential drug-drug interaction between naproxen and sumatriptan, and anticipate that the February 2007 response was sufficient to gain approval, resulting in a late Q2 to mid Q3-2007 launch.
Imitrex franchise extension: GSK's Imitrex (sumatriptan) franchise dominates the migraine market and posted sales of $1.1 billion in 2005, accounting for 32% of the market share. Imitrex growth has been seen to plateau over the last five years, with price increases counteracting the slight decline in volume sales. With generic manufacturers such as Teva and Dr Reddy scheduled to launch generic sumatriptan in the US in Q4-2008, GSK must rapidly and aggressively market Trexima upon approval in an attempt to convert Imitrex patients over to the new brand and protect their lucrative franchise.
However, Datamonitor forecasts Trexima sales to peak only two years after launch at $329 million in 2009. This forecast value is relatively low due to the availability of generics of both components of the tablet at a significant price reduction, and through offering a greater freedom in personalising the dosing ratio.
Triptan genericisation: The late-stage pipeline for new migraine therapies sees a number of reformulations aiming to capitalise on the maturing market. In addition to Trexima, the most promising abortive medications in development are being investigated under NovaDel, Zogenix and ProEthic. Both NovaDel and Zogenix are developing reformulations of sumatriptan, utilizing their proprietary delivery systems, whilst ProEthic is developing diclofenac potassium (PRO-513), a reformulation of diclofenac.
However, the market success of these pipeline drugs is going to be severely restricted by generic triptan availability. In the US, these are expected to be priced at a 75% discount, and therefore will be able to attract a significant patient population.
While innovation in treating migraine is lacking in a late-stage pipeline stocked largely with reformulations, there are novel formulations in the early stage pipeline which may eventually signal the end of the triptan era. Glutamatergic receptor inhibitors, nitric oxide synthase inhibitors and calcitonin gene-related peptide antagonists have all shown promising results in early stage trials. But with the most advanced of these classes only in phase II trials, the triptans or their generic versions will continue to hold their vice-like grip on the market for some time yet.
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