WASHINGTON (Reuters) - The U.S. government released a new plan on Thursday for cutting red tape and working more closely with companies to prepare for the next big biological disaster — be it a flu pandemic or nuclear attack.
The plan from the Health and Human Services Department directly addresses many of the complaints industry has made about obtuse regulations and convoluted processes for testing new drugs and vaccines.
The biggest winners may be small biotech companies, which often lead the scientific advances but lack the know-how or capacity to get drugs to market.
The report recommends HHS “support the development of at least three influenza vaccine candidates whose manufacture does not depend on virus grown in eggs or cells.”
Some small biotechs working in this direction include Novavax Inc, which uses virus-like particles to make its vaccine; Inovio Biomedical Corp, which is testing a DNA-based vaccine; and Vical Inc.
The plan also follows through on a pledge from National Institutes of Health director Dr. Francis Collins to get his agency’s discoveries translated into medical use more quickly.
“Promising concepts emerging from the research pipeline may not progress to the product candidate stage and into advanced development because their innovators, often academic investigators (e.g., NIH grantees), may fail to recognize that their findings may have important product applications or because investigators lack the wherewithal to proceed to the next stage of concept development,” the plan reads.
The report suggests setting up cross-agency teams to actively seek out good ideas and make sure they get developed.
“Some of these great ideas are going to come from very small companies that don’t really have the capital and wherewithal to get a product from microscope to market,” HHS Secretary Kathleen Sebelius said.
Often, small biotechs rely on partnerships with big pharma to get their drugs developed.
In fighting flu, for instance, Gilead Sciences Inc. teamed up with Roche to develop the flu drug Tamiflu, while small Australian biotech Biota has a sometimes uncomfortable relationship with GlaxoSmithKline to make Relenza.
Biota, which sued Glaxo in 2004 alleging it did not market Relenza hard enough, is seeking partners to develop its new flu drug, laninamivir.
The main weapons against influenza, and most other infectious diseases, are vaccines. Flu is problematic because the vaccine must be changed every year to match the mutation-prone virus.
The vaccine is also made using eggs, an imprecise and dirty process. It took six weeks to make an H1N1 swine flu vaccine last year, during which time the pandemic peaked twice.
The U.S. government has been pushing for cleaner, cell-based technology and strongly supported the opening last November of a new Novartis cell-based influenza vaccine plant in North Carolina.
Wary of uncertain vaccine supplies, HHS has contracted with five companies to make influenza immunizations for the U.S. market — Novartis, Sanofi Aventis, CSL, AstraZeneca unit MedImmune and GlaxoSmithKline, but is keen to have more factories on U.S. soil.
Many experts have cautioned that in a very serious pandemic, countries would be likely to seize any vaccines made within their own territories.
MedImmune may also stand to benefit. The H1N1 swine flu virus proved tricky to work with and did not grow well, but MedImmune’s process using a live but weakened virus produced prodigious amounts quickly.
However, it is delivered by nasal spray and the company did not have enough sprayers to make use of all the bulk vaccine it made.
The HHS report suggests working to use the weakened virus to make vaccines in the future, and helping companies get it into sprayers and syringes.
“HHS should immediately develop a network of existing facilities that are pre-qualified and under contract to fill and finish vaccine for U.S. government-contracted vaccine manufacturers in a public health emergency,” it reads. (Editing by Jerry Norton)