BALTIMORE -- Following are highlights from the final day ofthe 17th Annual Alex. Brown & Sons Health Care Seminar.
The Palo Alto, Calif., company is developing a new controlled-release oral delivery capsule, called the "push-pill" osmoticsystem, for Warner-Lambert's next-generation cholesterol-regulating drug Lopid SR (gemfribrozil).
The capsule will be manufactured by Alza and marketed byWarner-Lambert under a royalty-bearing license. Warner-Lambert spokesman Peter Wolf said the company hopes toreceive FDA marketing approval by the end of the year.
The capsule will be Alza's first product using the push-pillsystem, which can deliver large quantities of one or moreinsoluble drugs from a capsule taken orally once a day. Thetechnology can deliver drugs together or sequentially, at aconstant rate or in a delayed, patterned or pulsating release,said Martin Gerstel, Alza co-chairman and chief executive. Thecapsule has an osmotic driving agent at one end and a series ofdrug reservoirs inside a rate-controlling membrane.
Alza shares (AMEX:AZA) closed at $44.50, down 25 cents.
Bio-Technology General Corp.
Sim Fass, president and chief executive, said the New Yorkcompany will earn a profit in 1993 as new products enter themarket.
SmithKline Beecham will begin marketing Eskatrope humangrowth hormone to treat short stature in children in severalEuropean countries by September, paying a 20 percent to 30percent royalty to BTGC. The company will earn similarroyalties in Japan, where market approval is expected byOctober, Fass said.
By February, he predicted, marketing partner JCRPharmaceuticals Co. Ltd. will achieve $20 million in annualsales of hGH in Japan, where the total market for short staturetreatments is worth $200 million. The worldwide market isworth $700 million and is growing by more than 10 percentannually, said Fass.
BTGC is expanding Phase I trials of hGH as a treatment thatpreserves body mass in AIDS patients to test whether it alsocauses proliferation and enhancement of immune response to avariety of infections.
Fass predicted that the FDA will approve BTGC's bovine growthhormone this year or in 1993, allowing the company and threecompetitors to divide a $450 million U.S. market and a $100million overseas market.
BTGC expects its hyaluronic acid will be approved in 1993 inEurope as a supplement for eye fluid in eye surgery, and it willreceive a 30 percent royalty on sales.
A Phase II clinical study of its hepatitis B vaccine in childrenwas completed Tuesday. Three injections of BTGC's vaccinecosts $10, compared with $60 to $120 for second-generationvaccines, which should make it competitive with plasma-derived and genetically engineered vaccines, Fass said. Heexpects market approvals in Pacific Rim countries in 1993, forwhich BTGC will get 30 percent royalties.
BTGC has a burn rate of about $8 million per year and had $24million as of December, he said.
The Palo Alto, Calif., company in April received notice from theFDA that its Office of Device Evaluation had found no reason toconsider withdrawing marketing approval for Zyderm CollagenImplant for treating skin wrinkles, scars and other contourdeformities, said Howard Palefsky, president and chiefexecutive.
The agency had been asked to review the marketingapplication, which had been approved in 1981, by acongressional committee investigating alleged misuse ofcollagen-based products.
"The events of the past year have taken a tremendous toll onCollagen's financial performance," said Palefsky, who predictedthat U.S. sales of injectable collagen will drop to $22 million inthe year ending June 30 from $33 million last year.
The company lost $1.5 million on operations in its third quarterended March 31, but netted $5.6 million, or 54 cents a share,because of a $9.4 million gain, primarily from its investment inits Target Therapeutics Inc. subsidiary.
Although domestic demand for dermatology and plasticsurgery products has dropped, unit sales overseas increased 20percent for the nine months ending in March, and "we expect tobe deriving almost 50 percent of our injectable dermatologyand plastic surgery business from outside the U.S. in FY '93,"Palefsky said.
Palefsky expressed "frustration" about obtaining marketingapproval for Contigen Implant injectable collagen treatment forurinary incontinence, developed in collaboration with C.R. Bard.The company expected notification in February, he said, butthere has been no communication with agency. The stock(NASDAQ:CGEN) lost $1 to $19.25 on Wednesday.
Cor Therapeutics Inc.
The South San Francisco, Calif., company (NASDAQ:CORR) willclose by the end of the year Phase II trials of Integrelin, apeptide that can be used to treat unstable angina. It will followwith a Phase II trial to treat abrupt arterial closure followingangioplasty, said Vaughn Kailian, president and chief executive.The company will file in 1993 to begin trials of recombinantfactor Xai, which is used to treat venous thrombosis, Kailiansaid.
Cor expects a burn rate of $15 million to $20 million this year,Kailian said. The company had $56 million in cash on March 31,he said.
Gilead Sciences Inc.
The Foster City, Calif., company on Tuesday began Phase I/IItrials at the University of California, San Francisco, of GS 504,its small-molecule, dinucleotide analog treatment forcytomegalovirus infection in AIDS patients.
The company (NASDAQ:GILD) plans to complete the trials bySeptember, said Michael Riordan, president and chief executive.This and trials of Gilead's GS 393 mononucleotide analogtreatment for AIDS, scheduled to begin before the end of theyear, will contribute to a net cash burn rate of $22 million thisyear, he said. Gilead had $105.4 million in cash on March 31.
Revenues will increase in 1992 because of a collaboration withGlaxo to develop triple-helix code blockers to treat cancer and afive-year, $4.6 million grant from the Defense AdvancedResearch Projects Agency (DARPA) to develop code blockers totreat malaria and dengue fever. This is the first DARPA grantfor development of human therapeutics, Riordan said.
Gilead plans to complete preclinical trials of its GS 522, an anti-coagulant aptamer to be used in cardiopulmonary bypasssurgery, angioplasty, unstable angina, myocardial infarctionand deep venous thrombosis prophylaxis, Riordan said. Thestock closed at $14.50, up 50 cents.
(c) 1997 American Health Consultants. All rights reserved.