The FDA sent an approval letter to Bio-Technology General Corp.Thursday, marking the second recombinant human growth hormoneproduct to get the agency's OK this month.
There now are four players vying for shares of the human growthhormone market in the U.S., which was $340 million in 1994.
Bio-Technology General (BTG), of Iselin, N.J., originally filed itsapplication in 1987, but had to wait until the expiration of Eli Lillyand Co.'s seven-year orphan-drug exclusivity, which came last year.BTG's product, called Bio-Tropin, already is approved in 19countries and is being sold in seven countries, the largest of which isJapan.
The company announced the approval letter in the afternoon. BTG'sstock (NASDAQ:BTGC) still had time to rise 25 percent, or 81 cents,to close at $4.09 in trading of 1.9 million shares.
Lilly, of Indianapolis, and Genentech Inc., of South San Francisco,already have growth hormone products on the market. Novo NordiskPharmaceuticals Inc., a U.S. subsidiary of Denmark-based NovoNordisk A/S, received FDA approval two weeks ago for its growthhormone, Norditropin. (For further details of the market and players,see BioWorld Today, May 10, 1995, p. 1.)
"In terms of the product, the differentiation is minimal," said WilliamPursley, who last month was appointed BTG's senior vice president,marketing, sales and commercial development. That would suggest,he said, that differentiation of BTG's product is going to come fromother areas, such as services, distribution, reimbursement strategies_ wherever the competition is vulnerable.
"We have very good information that our competitors don't knowwhat we're going to do, and we have to take advantage of that,"Pursley told BioWorld. The company still must get an approvalnotice, which encompasses areas such as promotions and labeling."That gives us 30 to 60 days to keep our competition in the dark."
BTG's product is approved for the long-term treatment of childrenwith growth failure due to growth hormone deficiency. Genentech'sProtropin and Nutropin have 75 percent of that market, and Lilly'sHumatrope has the rest. A Novo Nordisk spokeswoman saidNorditropin will be priced similarly to the approved products, whichrange from $5,000 to $20,000 per year for treatment, depending onthe weight of the child.
1995 Launch Planned
The price of BTG's product will be in line with others, said LeahBerkovits, the company's director, corporate communications. "Wehave [marketing] plans well under way, and we plan to launch thisproduct in 1995 at the earliest opportunity. We expect it to happenquite rapidly.
"There are a lot of ways to gain market share," Berkovits toldBioWorld. "Pricing is one way to do it, but that's not necessarily ourstrategy. We do have plans, which I'm not at liberty to discuss."
An example of how BTG differentiates its product in Europe andJapan is by selling it with a needle-free device, which is veryappealing to the children, she said.
The first quarter of this year was BTG's first in which it showed aprofit from operations. It had revenues of $5.7 million, $5.2 millionwhich came from sales. The company showed a net profit of$402,000 for the quarter that ended March 31, and reported $17.8million in cash and equivalents.
"Being able to launch in the U.S. and gain market share is going to bevery important in bringing the company to break-even andprofitability very soon," Berkovits said. "We were projecting 1995 tobe close to or at break-evenwithout any sales of human growth hormone in the U.S."
BTG will market the product itself in the U.S. The only other countryin which it markets Bio-Tropin is Israel, where the growth hormoneis manufactured. Bio-Tropin already is BTG's biggest-sellingproduct, and the Japanese market currently is the largest for theproduct.
Berkovits said BTG's product has about 10 percent of the $250million human growth hormone market in Japan, where Bio-Tropin isbeing sold by JCR Pharmaceuticals Co. Ltd., of Osaka. Of BTG's$18 million to $19 million in non-U.S. sales expected in 1995, $13million will be from Bio-Tropin, Pursley said.
Pursley, who started at BTG on April 16, was one of the originalmember's of Genentech's commercial launch team, and later wasregional marketing manager for growth hormone sales in eightSoutheastern states. In 1990 he went to Genzyme Corp., where hehelped with the launch of Ceredase for Gaucher disease.
Genentech, first on the market with Protropin in 1985, has filedpatent infringement lawsuits against Lilly, Novo Nordisk and BTG,all of which make their product in bacteria. Lilly settled earlier thisyear by paying Genentech $145 million.
Lawsuits are pending between Genentech and the other companies,and BTG has countersued, claiming the process patents are invalidand unenforceable. In the meantime, BTG and Novo Nordisk can selltheir products in the U.S. because of a decision in January by theInternational Trade Commission that let stand an earlieradministrative law judge's dismissal of the Genentech cases. n
-- Jim Shrine
(c) 1997 American Health Consultants. All rights reserved.