First Horizon Acquires Rights to Furadantin

Business Editors/Health & Medical Writers  
Roswell, Ga.--(BUSINESS WIRE)--Jan. 7, 2002--First Horizon 
Pharmaceutical Corporation (Nasdaq:FHRX), a growing specialty 
pharmaceutical company, announced today that it has purchased the U.S. 
rights to the drug Furadantin(R) (Nitrofurantoin suspension) from Elan 
Pharmaceuticals, Inc. Furadantin(R) had U.S. sales of approximately $4 
million in 2001. Furadantin(R) is the only available suspension form 
of Nitrofurantoin, which is approved for the treatment of urinary 
tract infections (UTI). According to IMS HEALTH NPA Plus (TM) data, 
pediatricians were the primary prescriber of Furadantin for the 12 
months ending November 30, 2001.  
Nitrofurantoin is a well-known anti-bacterial agent for specific 
urinary tract infections with no known bacterial resistance. In 
addition, it is not known to cause the allergic side effects that are 
well documented with Sulfa drugs or penicillin. Nitrofurantoin is 
specifically indicated for the treatment of urinary tract infections 
when due to susceptible strains of Escherichia coli, enterococci, 
Staphylococcus aureus, and certain susceptible strains of Klebsiella 
and Enterobacter species.  
"Furadantin(R) is an ideal product for treating children with UTI 
and fits well with our pediatric franchise. The product is formulated 
in a suspension form and has a palatable banana-raspberry-mint flavor 
that children enjoy," said Mahendra G. Shah Ph.D., Chairman & CEO of 
First Horizon Pharmaceutical.  
Under the agreements with Elan, First Horizon has acquired the 
assets relating to Furadantin(R), including the NDA and the trademark. 
Elan has also agreed to a transitional supply agreement whereby they 
will supply Furandantin(R) to First Horizon until May 2003. First 
Horizon is in the process of identifying a contract manufacturer that 
will supply the product for the long term.  
"First Horizon's pediatric franchise now includes Furadantin(R) 
and the Tanafed(R) line products. Tanafed DM(TM), is a new line 
extension of Tanafed(R), containing a cough suppressant. The company 
has filed a patent application with the United States Patent and 
Trademark Office for its Tanafed DM(TM) product. Tanafed DM(TM) is 
expected to share a preferential position relative to Tanafed(R) with 
respect to detailing and marketing promotion. We plan to launch both 
products, Furadantin(R) and Tanafed DM(TM) in the first quarter of 
2002," said Bala Venkataraman, EVP Corporate Development & CFO of 
First Horizon Pharmaceutical.  
"We expect the Furadantin(R) acquisition to be accretive to our 
2002 earnings. Our revised guidance for 2002 net sales is between $87 
million and $89 million with fully diluted earnings per share between 
56 cents and 57 cents," added Mr. Venkataraman.  
"Our business outlook is very exciting to us at this time," 
continued Dr. Shah. "During 2002, we will focus our sales and 
promotion efforts on Furadantin(R), Tanafed DM(TM) and Prenate(TM) GT 
during their critical launch phase as well as continue promotion of 
our other growth drivers, mainly Nitrolingual(R), Robinul(R) line, and 
Ponstel(R). Through our alliances with our two co-promotion partners 
Otsuka and PDI we will seek to increase market share of our products, 
Nitrolingual(R) Pumpspray and PrenateTM GT. First Horizon will 
continue to seek to identify licensing opportunities or acquire 
promotionally sensitive brand-name prescription products that fit our 
four therapeutic franchises, namely cardiology, gynecology, 
gastroenterology, and pediatrics. We're also reviewing opportunities 
to acquire companies that have products that complement and strengthen 
our current product lines. Finally, we will continue to advance our 
clinical development projects."  
Nitrofurantoin is not indicated for the treatment of 
pyelonephritis or perinephric abscesses. Acute, subacute, or chronic 
pulmonary reactions have been observed in patients treated with 
nitrofurantoin. If these reactions occur, Furadantin(R) should be 
discontinued and appropriate measures taken. Chronic pulmonary 
reactions occur rarely and generally in patients receiving therapy for 
six months or longer. Adverse events include, but are not limited to, 
nausea, headache, flatulence, emesis and anorexia. See package insert 
for additional product information.  
First Horizon Pharmaceutical Corporation is a specialty 
pharmaceutical company that markets and sells 15 brand name 
prescription products to high prescribing primary care and select 
specialty physicians through its nationwide sales and marketing force. 
The Company focuses on the treatment of chronic conditions including, 
cardiovascular diseases, and pediatric, gastroenterological and 
gynecological conditions.  
This press release contains statements, which constitute 
forward-looking statements made pursuant to the safe harbor provisions 
of the Private Securities Litigation Reform Act of 1995. Such 
statements include without limitation statements concerning (1) the 
effect of the Furadantin(R) acquisition on 2002 operating results, (2) 
scheduled time to launch Furadantin(R) and Tanafed DM(TM), (3) 
forecasted 2002 net sales and earnings, (4) forecasted increase in 
market share of Nitrolingual(R) Pumpspray and Prenate(TM) GT and (5) 
plans to continue product development projects in 2002. Such 
statements are subject to certain factors, risks and uncertainties 
that may cause actual results, events and performance to differ 
materially from those referred to in such statements. In evaluating 
all forward-looking statements, you should specifically consider 
various factors that may cause actual results to vary from those 
contained in the forward-looking statements. Such risks include the 
fact that (a) the Company may not be able to identify a manufacturer 
to supply Furadantin(R) after May 2003, (b) patent rights do not 
protect Furadantin(R), (c) the Company does not have experience 
marketing and selling prenatal vitamins, which may adversely impact 
the Company's launch of Prenate(TM) GT and the Company's ability to 
maintain sales of Prenate Advance, (d) patent rights do not protect 
the prenate products from competition and (e) the regulatory status of 
prenatal vitamins may make prenate products subject to increased 
competition. Such risks also include, without limitation, those 
identified in the Company's registration statement on Form S-1 filed 
with the Securities and Exchange Commission in the "Risk Factors" 
section under the following headings: "We currently depend on four key 
products for a large portion of our sales, and substantial declines in 
any of them would result in our being unprofitable", "There is no 
assurance of continued commercial acceptance of our products", "Our 
growth will suffer if we do not acquire rights to new products and 
integrate them successfully", "We may encounter problems in the 
manufacture of our products that could limit our ability to sell our 
products", "We face competition from generic products that could lower 
prices and unit sales", "Strong competition exist for our products and 
competitors have introduced new products and therapies that could make 
our products obsolete", "A small number of customers account for a 
large portion of our sales and the loss of any of them, or changes in 
their purchasing patterns, could result in our inability to 
successfully sell our product", "If our products under development 
fail in clinical studies or if we fail or encounter difficulties in 
obtaining regulatory approval for new products or new uses of existing 
products, we will have expended significant resources for no return", 
"Our acquisition of Cognex creates additional risks", "We or third 
parties may violate government regulations and we may incur 
significant expenses to comply with such regulations", "If third-party 
payors do not adequately reimburse patients for our products, doctors 
may not prescribe them", "Product liability claims and product recalls 
could limit our ability to sell products", "We expect to require 
additional funding, and if we cannot obtain it, our sales, profits, 
acquisitions and development projects could suffer", "If we do not 
secure or enforce our patents or other intellectual property rights, 
we could encounter increased competition that could adversely affect 
our operating results", "Our products could infringe the intellectual 
property rights of third parties, which could require us to pay 
license fees or defend litigation that could be expensive or prevent 
us from selling products", "The regulatory status of some of our 
products makes these products subject to increased competition and 
other risks", "We face risks under one of our development agreements 
because the other party to the agreement is a related party", and 
"Pohl-Boskamp can terminate our rights to Nitrolingual(R)". We do not 
undertake to update our forward-looking statements to reflect future 
events or circumstances. 
 
 
Press spacebar to pause and continue. Press esc to stop.