Three articles June 21, 2000 Dow Jones Newswires FDA Grants Orphan Drug Status For Pharmacia's Genotropin Dow Jones Newswires
PEAPACK, N.J. -- Pharmacia Corp. (PHA) received orphan drug status from the Food and Drug Administration for Genotropin, used in the long-term treatment of children with Prader-Willi syndrome.
In a press release Wednesday, Pharmacia said the rare genetic disorder causes short stature, an involuntary, continuous urge to eat, low muscle tone and cognitive disabilities.
Orphan drug status, granted only to treatments for which the potential patient population is less than 200,000, gives Pharmacia exclusive seven-year rights to market Genotropin for Prader-Willi syndrome.
The pharmaceutical company's Genotropin Lyophilized Powder has been approved for the long-term treatment of children with growth hormone deficiency since August 1995. The powder has been approved for adults since November 1997.
Pharmacia said in two random trials of 23 children, Genotropin improved physical growth, increased muscle mass and helped to reduce body fat. Complications included edema, aggressiveness, hair loss and muscle pain.
New York Stock Exchange-listed shares of Pharmacia closed Wednesday at 55 3/8, down 1 3/16, or 2.1%, on volume of 3.6 million shares. Average daily volume is 3.5 million shares.
-Kathy Chu; Dow Jones Newswires; 201-938-5388 ******************** June 22, 2000 Dow Jones Newswires Pharmacia Dn 6%;Analysts Cite Valuation,Ag Unit Concerns Dow Jones Newswires
NEW YORK -- Pharmacia Corp. (PHA) shares fell Thursday as investors re-examined the company's valuation and thought about the impact the agricultural unit has on the whole company, analysts said.
Among Pharmacia's peers, only Pfizer Inc. (PFE) carries a higher price-to-earnings ratio.
"Drug stocks zoomed up in the quarter, strictly for defensive reasons - fears about a (potential) 2001 recession," said Neil Sweig, analyst at Ryan Beck Southeast Research.
Since some of these stocks have performed well, investors are taking profits, according to Hemant Shah, an analyst at HKS & Co. He mentioned Pharmacia and Pfizer specifically.
Pfizer shares recently traded at 45 3/16, down 1 11/16, or 3.6% on composite volume of 14.4 million, compared with average daily volume of 11.1 million.
Pharmacia shares recently traded at 51 15/16, down 3 1/2, or 6.3% on composite volume of 5.2 million compared with average daily volume of 3.5 million.
Pharmacia shares have also weakened on concerns about the company's agricultural business.
Wednesday, the company's Monsanto Co. unit announced it plans to offer a refund of the standard technology fee it charges cotton growers in four southern states, due to extreme drought conditions.
Ryan Beck analyst Sweig said that while analysts may have known about the drought, the refund news emphasizes how uncertain sales and earnings for herbicides can be and how dependent upon the weather the agricultural unit is.
He said dry conditions in the Midwest could lead to similar rebate programs for corn and soybean growers.
When a drought diminishes planting and harvesting opportunities, the amount of herbicides used is significantly reduced, cutting sales of Monsanto's Bollgard insect-protected and Roundup Ready herbicide, Sweig said.
Another reason for the falling stock price may be news that Pharmacia's planned public offering of up to 19.9% of Monsanto won't be held until August, Sweig said.
The industry had hoped the offering might happen earlier, but Monsanto indicated that it would likely hold the offering in August or later.
"Now you have the uncertainty of when they will start to divest pieces of the company. You are heading into August - a dead month ... and it could be into October when the third quarter is reported and who knows what the stock market conditions will be then," Sweig said. "With that postponement comes the uncertainty and people wondering just how bad agricultural sales and profits are."
Analysts dismissed the impact of head-to-head studies comparing Merck & Co.'s (MRK) osteoarthritis medicine, Vioxx, with Pharmacia's Celebrex celecoxib that is co-promoted with Pfizer.
A study found a certain dosage of Vioxx reduced pain at night and at rest to a greater degree than celecoxib and acetaminophen, while Pharmacia said those hypersensitive osteoarthritis patients taking Vioxx experienced statistically more increases in edema and systolic blood pressure compared with those taking Celebrex.
"The war of the world of studies has started," Ryan Beck's Sweig said. "This is the beginning of head-to-head studies this summer and bare-knuckles fighting on the issue. Each company has promised a war of attrition."
Vioxx is important to Merck, as is Celebrex to Pharmacia. The arthritis medicines will directly impact sales and earnings growth between 2000 and 2002. But analysts believe it is too soon to say which drug is in the lead, and that the various study results could cancel out each other.
Also lower, Schering-Plough Corp. (SGP) fell 2, or 4.1%, to 46 15/16 on composite volume of 4.4 million shares, compared with average daily volume of 4.6 million shares.
-By Beth M. Mantz, Dow Jones Newswires; 201-938-5287 ********************* June 21, 2000 Dow Jones Newswires CORRECT:ProMetic To Dev Antibody Tech For Pharmacia Unit Dow Jones Newswires
MONTREAL -- ProMetic Life Sciences Inc.'s (T.PLI) ProMetic BioSciences Inc. unit agreed to develop an isolation and purification technology for Pharmacia Corp.'s (PHA) Integrated Protein Technologies unit.
(A headline at 10:24 a.m. EDT incorrectly stated that ProMetic agreed to develop an antibody for the Pharmacia unit.) ********************* The whole drug sector took a hit due to proposed legislation that won't pass. Jack |