With $15 million from a first round of financing in its pocket, Prestwick Pharmaceuticals Inc. has the venture capital backing it needs to push its late-stage central nervous system disorder programs.
The Washington-based company said it would use the funds to develop and eventually sell its product candidates, several of which are in clinical development. Just last month, its lead product, Xenazine (tetrabenazine), entered a Phase III trial for Huntington's chorea. The molecule already is approved in Europe, Canada and Australia, and sold by UK-based Cambridge Laboratories Ltd.
Prestwick, which in-licenses compounds to minimize early research risks, said it hopes to file a new drug application for Xenazine by late this year or early next.
"I think the investors were attracted because of our late-stage compound that is very close to its NDA," Kathleen Clarence-Smith, Prestwick's founder, president and chief scientific officer, told BioWorld Today. "We have experience in the pharmaceutical industry, in drug development and going through the FDA, and we already have a small sales and marketing group. I think we came across as people who knew the business of pharmaceuticals."
She said the funding would last between 12 months and 15 months. Prestwick was spun out in December from Prestwick Scientific Capital, a group that brought in various compounds it deemed promising and then lumped the central nervous system products into the company. Prestwick plans to continue to license early stage compounds from academic centers and young biotech companies, and to gain access to late-stage compounds such as Xenazine from mid-sized European companies without a presence in the U.S.
"Research is very risky and it's very easy to make a mistake," said Clarence-Smith, a neurologist who has held senior management positions at the neurology divisions of New York-based Sanofi-Synthelabo Inc. and Basel, Switzerland-based F. Hoffmann-La Roche Ltd. "You can go off on one receptor but cannot find a drug or find a drug that's toxic. We'd rather just go to the people who have done all that already."
Xenazine certainly fit the bill. The company said multiple published clinical studies have shown the drug's effectiveness in treating chorea, a problem noted by irregular, spasmodic and involuntary movements for which there is no approved product in the U.S. Prestwick has U.S. rights to the product.
Its multicenter study is scheduled to include 70 patients to 90 patients, with plans for pharmacokinetic studies in the works as well. Clarence-Smith said the company also expects to study the return of chorea in patients after they come off treatment.
"The drug is very selective of the brain," Clarence-Smith explained. "It depletes dopamine in the striatum by binding to a transporter protein called VMAT 2. By binding to it, that prevents the storage of dopamine and the net result is a decrease in dopamine concentration. Patients who have Huntington's disease have relatively too much dopamine in that area, and that's what causes the chorea."
The company's pipeline also includes several other products that have completed Phase IIa development, including a compound for Parkinson's disease and another for schizophrenia. Prestwick also is evaluating a preclinical compound for Alzheimer's disease.
Going forward, the 12-person company expects to expand its staff quickly, especially in sales and marketing. Clarence-Smith said Prestwick would grow that department to 40 employees in the next 18 months. She added that the company's goals include launching a neurology or psychiatry product every year.
"When you're not dependent on a research group, you can very nearly make your objective of one a year or whatever it is," Clarence-Smith added. "In the big picture, that's not the most difficult thing because there are good compounds out there to be found."
The investment was co-led by Palo Alto, Calif.-based BioAsia Investments and San Francisco-based Sofinnova Ventures, with added investments from Boston-based Atlas Venture and BA Venture Partners, whose sole limited partner is Bank of America.
Three of the firms named representatives to Prestwick's board in the process, including Chairman Edgar Engleman, a general partner at BioAsia; Jim Healy, a general partner at Sofinnova; and Joel Besse, the senior principal at Atlas. The board also includes Clarence-Smith and Robert Flanagan, the executive vice president of Clark Enterprises.