SAN DIEGO -- Genta Inc.said Monday that it filed aninvestigational new drug application for a topical acnetreatment -- the first of five INDs that the company aims to filethis year.
Although outside Genta's primary research focus on antisensetechnology, the acne treatment is one of five products Gentahas licensed to fill its near-term product pipeline and giveimpetus to building a direct sales force in dermatology in twoor three years.
The acne drug, called G-101, has been shown to treat threemajor symptoms of acne in European clinical trials and wouldenter an existing market for topical acne treatments estimatedat $758 million a year.
"G-101 could be available in Europe as early as 1994," WilliamE. Bliss, Genta's president and chief operating officer toldBioWorld on Monday. This and the other four products formthe first phase of Genta's "accelerated commercializationstrategy," which is expected to put a company sales force towork in advance of the Genta's antisense products, due later inthe decade and beyond.
Genta stock (NASDAQ:GNTA), which went public at $10 a sharelast December, closed Monday at $9, up $1 a share for the day.
Genta's big hopes for major growth lies in the antisense andtriple-strand control technologies, which Genta collectively callsits Anticode technology. Anticode drugs for treating viraldiseases (HIV and herpes), cancers (leukemia and solidtumors), inflammatory diseases (arthritis and psoriasis) andcardiovascular diseases (renin inhibition) have an industrywidepotential of more than $20 billion by 2005, according toThomas H. Adams, Genta's chairman and chief executive officer.Genta's primary competitors in antisense drug development areGilead Sciences Inc. of Foster City, Calif., and IsisPharmaceuticals Inc. of Carlsbad, Calif.
Genta's Anticode technology is aimed at inhibiting expression ofunwanted proteins. For example, it plans to file an IND laterthis year on an antisense compound for treating psoriasis byslowing the overproduction of interleukin-1. Another drug,designated G-1128, has entered Phase I clinicals as an ex vivotreatment of chronic myelogenous leukemia, a fatal form ofcancer marked by the overproduction of white blood cells.Other Anticode products are part of collaborations with ChugaiPharmaceuticals and Procter & Gamble.
To load up on near-term products, Genta announced lastNovember that it licensed five products outside the Anticodearena from three unidentified drug-development companies.Genta plans to establish its own clinical staff in Europe thisyear to usher these and future products through the Europeanregulatory process. Previous studies in France showed G-101 tobe "an excellent therapeutic profile" in a Phase II study in 50patients, the company said.
Besides G-101, Genta also licensed G-201, a non-steroidal anti-inflammatory topical compound; G-202 and G-203, two knownsteroidal compounds to be developed in what Genta expectswill be a more effective delivery system; and G-301, a topicalMethotrexate, which is intended to overcome the problem ofliver damage associated with oral administration of the drug intreating psoriasis. G-301 is considered Genta's likely nextcandidate for an IND filing later this year.
Genta's acquisition last year of JBL Scientific has helped thecompany achieve efficient production of antisense compounds,Adams said. Proprietary techniques have improved productionyields and cut production costs of oligomer (antisense)compounds to an estimated $255 per gram this year, fromabout $1,000 per gram two years ago, he said. The company'sgoals is get costs to $150 to $200 per gram.
Genta was formed in 1988 as a spinoff of Gen-Probe Inc., whichwas bought the following year by Chugai Pharmaceuticals ofJapan. Genta acquired rights to an antisense drug-discoveryprogram from Johns Hopkins University in Baltimore. Under anagreement with the university, Genta will pay a royalty onproduct sales resulting from the research and also receivesrights to future related discoveries from Hopkins research.
Genta officials are convinced that the Johns Hopkins connectionhas given the company a leg up on competing antisense drug-development companies' patent positions.
"We feel others in this field are still trying to find a suitableclass of compounds," Adams said. However, "we don't see thisas being a race," Adams said. In fact, he expects there will belittle bumping and shoving among antisense drug developers.The broad array of target product opportunities opened byantisense technology means "it would be an accident if we allend up in the market with the same type of products," Adamssaid.
With help from $27 million raised from its IPO six months ago,Genta has $32 million in cash -- enough, said Bliss, to take thecompany through at least 1993. The company also anticipatessigning up at least one more corporate partner this year.Genta's roster of alliances already includes Procter & Gamble,which last October signed onboard for a $5 million equityinvestment and rights to potential drugs for treating certaininfectious and respiratory diseases, and ChugaiPharmaceuticals, which put up $1 million in equity financing in1988 and has first refusal rights to products in the leukemiaand lymphoma areas.
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.