Novel strategies for drug delivery, as well as new twists on old approaches were among the topics of discussion at the annual Roth Capital Partners Conference, recently held in Dana Point, CA.
Citing drivers such as bioterrorism, natural disasters, and global travel, Una Ryan, Ph.D., president and CEO of Avant Immunotherapeutics (www.avantimmune.com), explained how her company’s needle-free oral vaccines are providing answers in a rapidly growing, multibillion-dollar market, especially in the area of public health threats.
Avant’s single-dose, oral typhoid fever vaccine candidate, Ty800, is currently in clinical trials sponsored by the NIH. The vaccine was developed using genetic techniques that delete specific genes known to be essential to the virulence of Salmonella typhi, the cause of typhoid fever, according to Dr. Ryan.
Using fermentation, Avant engineers organisms that are immunogenic but not toxic and develops a “Trojan horse“ into which antigens can be inserted.
The company also has conducted clinical trials on its single-dose, oral cholera vaccine, CholeraGarde.
Avant has partnered with GlaxoSmithKline (GSK; www.gsk.com) on its Rotarix two-dose oral vaccine that protects against rotavirus diarrhea. Approved in 25 countries, Rotarix is the first human rotavirus vaccine derived from a human virus strain. It can be co-administered with all major infant vaccines, including oral polio vaccine. AVANT in-licensed the vaccine to GSK Biologicals in 1997.
Also involved in drug delivery programs, especially those geared toward large molecule drugs, is Bentley Pharmaceuticals (www.bentleypharm.com), which recently signed a product licensing agreement with Biocon (www.biocon.com) for Bentley’s intranasal spray formulation for administering insulin. The intranasal format enhances permeability through membranes while being nontoxic, nonreactive, and nonirritating, notes John Sedor, president of Bentley. The company’s product, for which Phase II and III studies are planned, offers bioavailability of 15% with rapid onset of action, he said.
Bentley is also counting on the favorable demographics and market dynamics of an aging population to develop specialty generics. “Because public and private payers are pressuring the health care companies, generic utilization is promising,“ Sedor said. “In addition, 72 drugs with $67 billion in sales are losing their patent protection between now and 2009.“
Another company involved in “generic products with sustainable profitability“ is Taro Pharmaceutical Industries (www.taro.com),according to Kevin Connelly, CFO. The company, which was established in 1950 in Haifa, Israel, expanded into the U.S. in the 1990s and focuses on topical products for dermatology, pediatric, and neurological applications.
Taro Pharmaceuticals U.S.A. markets Ovide, a prescription product for the control of head lice. Future plans include a Phase III study for a new formulation that has a shorter application time and is easier to use, thus potentially improving compliance. Taro also has received FDA approval for topical preparations for impetigo, inflammatory skin conditions, and fungal conditions, as well as tentative approval for its ANDA for capsules used to treat epilepsy and post-therapeutic neuralgia.