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Bone Care Provides Update On Hectorol Injection Supply.


Business Editors/Health & Medical Writers

MIDDLETON, Wis.--(BUSINESS WIRE)--Dec. 16, 2002

Bone Care International, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:BCII BCII Battle Command and Intelligence Integration ) announced today that due to previously disclosed manufacturing issues, the company is temporarily unable to fill customer orders for Hectorol(R) Injection, although many of the company's wholesalers have inventory on hand and continue to fill customer orders. As previously disclosed, Bone Care has been working toward resolving manufacturing issues with the current supplier of Hectorol Injection and validating an additional supplier. Each manufacturer must complete validation lots and receive FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 clearance before Bone Care can commercially release its product. It now appears unlikely that Bone Care will achieve the necessary criteria to allow commercial release of Hectorol Injection prior to year end. Accordingly, revenues will be limited to approximately $3.5 to $4 million in the December 2002 quarter.

Paul Berns, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , commenting on the manufacturing issues, said, "We have managed shipments to wholesalers in an effort to minimize the effect of this delay in shipments on patients and customers, and we continue to work closely with the FDA to remediate these issues. Although we cannot at this point give assurance as to when we will gain approval to ship product, we believe that we will have commercial supply of Hectorol Injection from one or both of our contract manufacturers no later than the first quarter of 2003. As always, our commitment is to support the needs of our end-users, the clinics and patients that rely on Hectorol Injection and to commence shipments as soon as possible."

Bone Care (www.bonecare.com) is a pharmaceutical company engaged in discovering, developing and commercializing improved vitamin D-hormone therapies to treat secondary hyperparathyroidism secondary hyperparathyroidism Endocrinology ↑ Parathyroid activity with overproduction of PTH due to parathyroid hyperplasia in response to an extraparathyroid defect that results in ↓ Ca2+ Etiology Rickets, vitamin D deficiency, chronic renal failure  in patients with kidney, or renal disease Renal disease
Kidney disease.

Mentioned in: Glycogen Storage Diseases

hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg
, and osteoporosis, and other diseases including psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the  and cancers of the prostate, breast and colon.

This press release contains forward-looking statements. Statements relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 future net sales Net Sales

The amount a seller receives from the buyer after costs associated with the sale are deducted.

Notes:
This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight
, costs of sales, other expenses, profitability, financial resources, or products and production schedules, or statements that predict or indicate future events and trends and which do not relate solely to historical matters identify forward-looking statements. Forward-looking statements are made pursuant to the safe harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management's beliefs as well as assumptions made by and information currently available to management. Accordingly, the Company's actual results may differ materially from those expressed or implied in such forward-looking statements due to known and unknown risks and uncertainties that exist in the Company's operations and business environment, including, among other factors, technical risks associated with the development of new products, regulatory policies in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and other countries, risks associated with our ability to avoid or minimize delays in/or interruption of the manufacture and supply of our products, including the approvals of regulatory authorities in connection there with, reimbursement policies of public and private health care payors, introduction and acceptance of new drug therapies, competition from existing products and from new products or technologies, the failure by the Company to produce anticipated cost savings or improve productivity, the timing and magnitude of capital expenditures and acquisitions, currency exchange risks, economic and market conditions in the United States, Europe and the rest of the world, and other risks associated with the Company's operations. The Company disclaims any obligation to update any such factors or to publicly announce any revisions to any of the forward-looking statements contained herein to reflect future events or developments.
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 16, 2002
Words:588
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