Drug Development Time Is Five Years From Target To NDA, Glaxo's Sykes Says

Glaxo SmithKline's development timeline from discovery of a novel target to NDA filing would be as little as five years, Glaxo Wellcome Chairman Richard Sykes maintained during a Jan. 18 briefing on the Glaxo SmithKline merger in New York City.

"The period between discovering targets and bringing a drug to the market is another competitive advantage you can get through scaling technology," Sykes declared. The Glaxo exec would serve as non-executive chairman of Glaxo SmithKline.

Once a promising target is identified from genomic data, use of combinatorial chemistry techniques would allow identification of a lead candidate within three months, Sykes said. Glaxo has synthesized as many as 1.68 mil. chemicals in a two-week period, Sykes noted.

"With the speed of the process today, you could have that molecule in front of regulators certainly within five years," Sykes said.

Applications of pharmacogenomics to the drug development process mean that the current expectation for drug development timelines "could change during that five year period," Sykes added.

SmithKline Beecham R&D Chairman Tadataka Yamada, who is slated for the same role in the combined company, echoed Sykes' point about advances in the drug discovery process.

"We are basically saving two years in the process of identifying the right chemical for the right target," Yamada declared. "This kind of investment in what we'll call intelligent chemistry coupled with extraordinary bioinformatics capability...will allow us to bring the discovery process to its knees."

Similar investments in "predictive" toxicology and pharmacokinetics/ pharmacodynamics could improve the preclinical research phase, Yamada added. Improving on the current "medieval science" will "have a huge impact on how fast we can get products into man."

Finally, "the scale and mass of development capability in our two organizations will allow us to do things that I think [would have been] almost impossible in the past."

Yamada cited SmithKline Beecham's development of the quinolone antibiotic Factive (gemifloxacin), which SB licensed from the Korean firm LG Chemical in May 1997. SmithKline filed an NDA in December, after "we did a study involving thousands of patients in a single flu season. This has never been done with an antibiotic in the past."

SB is facing a tight deadline to retain its presence in the anti-infective market. The company's antibiotic Augmentin loses exclusivity in December 2002.

In addition to the savings in time, Sykes and Yamada said, a larger R&D organization will allow the company to meet the higher standards of regulators and payers worldwide.

"I believe that the kind of scale we can muster with our two organizations...will not only allow us to get to the market quicker, but will allow us to get to the market with a clear commercial message," Yamada declared.

Glaxo SmithKline will begin operations with a $4 bil. R&D budget, including $400 mil. in re-invested savings from combining the two organizations.

The opportunities to invest in new enabling technologies and accelerated development timelines will more than justify that budget, Yamada said. Asked whether a $4 bil. budget would be too big to manage, he replied: "There is no budget that is too big for R&D as far as I'm concerned."

Glaxo SmithKline CEO-designate Jean-Pierre Garnier declined to provide any productivity projections for the new organizations in terms of numbers of NDA approvals. "I don't like to go into the numbers game...because frankly when you get an Avandia or a Seretide...it is a lot better than three small ones," Garnier said. "The key for improving the productivity of R&D...is to look at the quality of the molecules we are putting into the pipeline."

The two companies maintain that the completion of the human genome sequence is providing a unique opportunity to identify and exploit novel drug development targets (¹ (Also see "FTC Will Have Opportunity To Address Genomics In Review Of Glaxo/SB" - Pink Sheet, 24 Jan, 2000.)).