Hydrocodone chemical structure
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Anexsia

Hydrocodone or dihydrocodeinone (marketed as Vicodin, Anexsia, Dicodid, Hycodan, Hycomine, Lorcet, Lortab, Norco, Tussionex, Vicoprofen) is an opioid derived from either of the naturally occurring opiates codeine or thebaine. Hydrocodone is an orally active narcotic analgesic and antitussive. The typical therapeutic dose of 5 to 10 mg is pharmacologically equivalent to 30 to 60 mg of oral codeine. more...

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Sales and production of this drug have increased significantly in recent years, as have diversion and illicit use. Hydrocodone is commonly available in tablet, capsule and syrup form.

As a narcotic, hydrocodone relieves pain by binding to opioid receptors in the brain and spinal cord. It may be taken with or without food, but should never be combined with alcohol. It may interact with monoamine oxidase inhibitors, as well as other drugs that cause drowsiness. It is in FDA pregnancy category C: its effect on an unborn embryo or fetus is not clearly known and pregnant women should consult their physicians before taking it. Common side effects include dizziness, lightheadedness, nausea, drowsiness, euphoria, vomiting, and constipation. Some less common side effects are allergic reaction, blood disorders, changes in mood, mental fogginess, anxiety, lethargy, difficulty urinating, spasm of the ureter, irregular or depressed respiration and rash.

Hydrocodone can be habit-forming, and can lead to physical and psychological addiction. In the U.S., pure hydrocodone and forms containing more than 15 mg per dosage unit are called hydrocodone compounds and are considered Schedule II drugs. Those containing less than 15 mg per dosage unit are Schedule III drugs. Hydrocodone is typically found in combination with other drugs such as paracetamol (acetaminophen), aspirin, ibuprofen and homatropine methylbromide. In the UK it is listed as a Class A drug under the Misuse of Drugs Act 1971.

The presence of acetaminophen in hydrocodone-containing products deters many drug users from taking excessive amounts. However, some users will get around this by extracting a portion of the acetaminophen using hot/cold water, taking advantage of the water-soluble element of the drug. It is not uncommon for addicts to have liver problems from taking excessive amounts of acetaminophen over a long period of time--taking 10–15 grams of acetaminophen in a period of 24 hours typically results in severe hepatotoxicity. It is this factor that leads many addicts to use only single entity opiates such as OxyContin.

Symptoms of hydrocodone overdosage include respiratory depression, extreme somnolence, coma, stupor, cold and/or clammy skin, sometimes bradycardia, and hypotension. A severe overdose may involve circulatory collapse, cardiac arrest and/or death.

How Supplied

Notes

  1. ^  Tarascon Pocket Pharmacopoeia.

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Andrx Corporation Reports Financial Results for the Second Quarter of 2002; Results Include Previously Announced $60 Million Charge for Litigation Settlements
From Business Wire, 7/26/02

Business Editors

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--July 26, 2002

Andrx Corporation (Nasdaq:ADRX) ("Andrx" or the "Company") today announced its financial results for the three and six month periods ended June 30, 2002. For the 2002 second quarter, Andrx reported a net loss of $27.8 million, compared to net income of $15.7 million for the 2001 second quarter. For the three months ended June 30, 2002, net loss of $26.3 million, or $0.37 net loss per diluted share, was allocated to Andrx common stock and $1.5 million of net loss, or $0.23 net loss per diluted share, was allocated to the Cybear class of common stock, which stock was converted into Andrx common stock on May 17, 2002 (the "Conversion"). For the six months ended June 30, 2002, Andrx reported a net loss of $23.3 million, compared to net income of $30.3 million for the six months ended June 30, 2001. For the six months ended June 30, 2002, net loss of $17.9 million, or $0.25 net loss per diluted share, was allocated to Andrx common stock and $5.4 million of net loss, or $0.80 net loss per diluted share, was allocated to the former Cybear class of common stock. Andrx's operating results for the periods ended June 30, 2002 include, among other things, as previously announced, a litigation settlements charge of $60.0 million related to the Cardizem(R) CD antitrust litigation, before the impact of the related income tax benefits of $21.0 million at a 35% expected annual effective tax rate.

Andrx's Chief Executive Officer, Richard J. Lane, commented: "In terms of generating short-term financial results, this was a difficult quarter for Andrx. The difficult operating environment was largely due to the continuing lack of launches of significant products. Furthermore, this quarter's performance was further significantly negatively impacted by a litigation settlements charge related to the Cardizem CD anti-trust lawsuit. We also continued to increase our SG&A as we continued to establish and train our brand sales force and incurred pre-launch promotional and sales training costs related to Altocor(TM), our first internally developed brand product, which we launched in July.

"However, at the same time, our operating foundation - sales of our bioequivalent versions of Cardizem CD and Dilacor XR and our distribution operation - remained solid," Mr. Lane continued. "Frankly, we are fortunate to have a business that affords us the opportunity to aggressively pursue litigation - one of the necessary, but expensive costs of doing business in the generic drug industry - as well as the funding for the development of our brand business and the R&D necessary to aggressively build our product pipeline. Andrx's short-term financial performance is really the result of a series of steps toward the realization of our goal to maintain Andrx's position as a prominent generic company while moving our brand business to the forefront".

Mr. Lane concluded: "We are committed to working diligently to demonstrate our ability to deliver results from our product development efforts. Over time, we truly believe that we can create value for consumers and our stockholders by providing quality healthcare products at affordable prices."

Revenues - Distributed Products

For the second quarter of 2002, net sales of distributed products increased by 14.4% to $123.1 million, compared to $107.7 million for the same quarter in 2001. The increase in sales of distributed products reflects the participation in the distribution of generic products launched by other pharmaceutical companies and an increase in sales to existing and new customers, offset in part by overall price declines, as is common with generic products. On a sequential basis, net sales for the 2002 second quarter of $123.1 million decreased from $128.5 million for the first quarter of 2002 largely due to the January 2002 expiration of the manufacturer's 180 days of marketing exclusivity for generic Prozac(R), which resulted in numerous other generic manufacturers' products entering the market and in a price decline in excess of 90%.

Revenues - Andrx Products

For the second quarter of 2002, net sales of Andrx products were $55.8 million, as compared to $65.5 million for the second quarter of 2001. Second quarter 2002 net sales of Andrx products consisted of $48.4 million of Andrx bioequivalent products and $7.4 million of Andrx brand products, as compared to $59.7 million of Andrx bioequivalent products and $5.8 million of Andrx brand products for the second quarter of 2001.

For the second quarter of 2002, net sales of Andrx bioequivalent products of $48.4 million included Andrx's bioequivalent versions of Cardizem CD, Dilacor(R) XR, Ventolin(R) metered dose inhalers, Glucophage(R) and, starting in April 2002, K-Dur(R); as compared to $59.7 million in net sales of Andrx bioequivalent products in the 2001 second quarter. The decrease in net sales of Andrx bioequivalent products, for the second quarter of 2002, as compared to the second quarter of 2001, resulted primarily from a significant decline in net sales of Andrx's bioequivalent version of Ventolin, partially offset by net sales of Andrx's bioequivalent version of Glucophage, which was launched in January 2002. The decline in net sales of Andrx's bioequivalent version of Ventolin began in the fourth quarter of 2001 following a marked increase in competition which has continued into the 2002 third quarter. Although Andrx launched its bioequivalent version of K-Dur during the second quarter of 2002, Andrx was the fourth entrant into the market and, accordingly, sales of Andrx's bioequivalent version of K-Dur were not a significant contributor to Andrx's results of operations.

For the second quarter of 2002, net sales of Andrx brand products were $7.4 million, as compared to $5.8 million in the second quarter of 2001. Sales in the second quarter of 2002 included sales generated from the Histex(TM) and Entex(R) (cough and cold), Embrex(TM) (prenatal vitamins) and Anexsia(R) (pain) product lines. Sales of Andrx brand products in future periods will include net sales of Altocor which was approved by the FDA in late June 2002, and was shipped into the distribution channel beginning in early July with promotion to physicians starting late July 2002. Sales of Andrx brand products in future periods will no longer include sales of the Histex line of products, which was sold to a third party in June 2002.

Revenues - Other

In the second quarter of 2002, Andrx generated $3.3 million in other revenues, compared to $7.7 million for the same period last year. Other revenues for the 2002 second quarter primarily represented revenues from contract manufacturing at Andrx's Massachusetts facility and also included revenues generated by Andrx's Internet operations, primarily the Physicians' Online (TM) web portal. Other revenues for the 2001 second quarter included $3.0 million per quarter from Geneva Pharmaceuticals, Inc., a member of the Novartis Pharmaceutical Group, of then recurring license fees from an agreement which was terminated in October 2001.

Gross Profit/Gross Margin

During the second quarter of 2002, total gross profit generated from total revenues was $50.7 million, with a total gross margin of 27.8%, compared to total gross profit of $76.0 million, with a total gross margin of 42.0% in the second quarter of 2001.

During the second quarter of 2002, net sales of distributed products generated $22.9 million of gross profit with a gross margin of 18.6%. For the same quarter in 2001, net sales of distributed products generated $19.6 million of gross profit with a gross margin of 18.2%. On a sequential basis, gross profits for the 2002 second quarter were $22.9 million, as compared to $23.3 million in the first quarter of 2002, while gross margins increased from 18.1% to 18.6% from the first quarter of 2002, compared to the second quarter of 2002.

During the second quarter of 2002, net sales of Andrx products generated $27.4 million of gross profit with a gross margin of 49.2%. For the same quarter in 2001, net sales of Andrx products generated $50.7 million of gross profit with a gross margin of 77.5%.

During the second quarter of 2002, within Andrx products, Andrx's bioequivalent products generated $23.6 million of gross profit with a gross margin of 48.9%, as compared to $46.7 million of gross profit with a gross margin of 78.3% in the 2001 second quarter. The decrease in gross profit was largely the result of the decrease in net sales, primarily of Andrx's bioequivalent version of Ventolin, during the second quarter of 2002, and product mix changes. As of June 30, 2002, the Company had approximately $59 million in raw materials, work in process and finished goods inventories of products yet to be approved or launched. In the 2002 second quarter, Andrx recorded a provision through cost of goods sold of $2.1 million related to inventory for products not yet launched. Such provision is primarily due to the aging of the inventory as a result of the delay in FDA product approvals. At its Andrx Park facility in Florida, Andrx commenced its manufacturing operations in phases, with Phase III commencing in September 2001, and with Phase IV operations anticipated to commence in the fourth quarter of this year. As a result, Andrx has experienced and, in the near term, will continue to experience inefficiencies and excess manufacturing capacities in certain areas. Such inefficiencies and excess manufacturing capacities were contributing factors to decreased gross margins in the second quarter of 2002. Andrx incurred costs of approximately $3.7 million in the second quarter of 2002, included in cost of goods sold, relating to unabsorbed manufacturing costs at its Florida and Massachusetts manufacturing facilities.

During the second quarter of 2002, within Andrx products, Andrx's brand products generated $3.8 million of gross profit with a gross margin of 50.9%, as compared to $4.0 million of gross profit with a gross margin of 69.3% in the 2001 second quarter. The decrease in gross margin included Andrx recording an additional inventory allowance through cost of goods sold of $764,000 related to aging issues on currently sold brand products.

Cost of goods sold also included operating costs for Andrx's contract manufacturing business including a provision of $871,000 in the 2002 second quarter related to inventories manufactured at Andrx's Massachusetts facility for a third party with whom Andrx is currently involved in a dispute.

Selling, General and Administrative ("SG&A") Expenses

SG&A expenses were $41.0 million, or 22.5% of total revenues, for the second quarter of 2002, compared to $35.9 million, or 19.9% of total revenues, for the second quarter of 2001. The increase in SG&A expenses in the second quarter of 2002, compared to the second quarter of 2001, was primarily due to the expansion of the brand product sales and marketing infrastructure, changes in the product mix, pre-launch promotional and sales training costs related to Altocor, and an increase in legal costs with respect to patent infringement and antitrust matters. Operating expenses, except cost of goods sold, related to Andrx's Internet operations are classified as SG&A for all periods presented. As of July 26, 2002, Andrx had approximately 280 sales representatives.

Research and Development ("R&D") Expenses

R&D expenses were $11.4 million, or 20.5% of Andrx product sales, in the second quarter of 2002, compared to $14.6 million, or 22.2%, of Andrx product sales, in the second quarter of 2001. R&D expenses reflected Andrx's continued commercialization efforts in its ANDA (bioequivalent) and NDA (brand) development programs. In the second quarter of 2002, the Company submitted four ANDA filings with the FDA, bringing its total to 29 ANDAs pending at the FDA. The Company anticipates filing an NDA for Metformin XT(TM) and filing at least six ANDAs during the balance of 2002.

Litigation Settlements

As previously announced, during the second quarter of 2002, Andrx and Aventis Pharmaceuticals, Inc. ("Aventis") entered into a preliminary settlement with the direct purchaser class of plaintiffs in the Cardizem CD antitrust litigation that is pending for multidistrict proceedings in the United States District Court for the Eastern District of Michigan. The preliminary settlement, which is subject to negotiation and execution of a definitive settlement agreement, as well as final Court review and approval, calls for a cash payment by Andrx and Aventis to this group in an undisclosed amount. In anticipation of potentially reaching settlements with all other plaintiffs in the related consolidated litigations, Andrx's results for the second quarter of 2002 include a litigation settlements charge of $60.0 million. Andrx is committed to vigorously litigating any of the cases that cannot be settled on a reasonable basis.

Gain on Sale of Histex Product Line

In June 2002, the Company sold the Histex cough and cold product line and recorded a gain of $4.5 million, included in Other income.

Income Taxes

In the second quarter of 2002, Andrx reported an income tax benefit of $27.0 million, or 49% of loss before income taxes. Such tax benefit included a $19.8 million tax benefit relating to the second quarter 2002 loss, or 36% of loss before income taxes, and also included the reversal of a $7.2 million valuation allowance on deferred tax assets relating to certain net operating loss carryforwards. The Company believes its 2002 annual effective tax rate will be approximately 35%. For the 2001 second quarter, income taxes were $11.2 million, or 42% of income before income taxes. For the second quarter of 2001, Andrx provided income taxes in excess of the federal statutory tax rate of 35% primarily due to the effect of state income taxes and non-deductible goodwill amortization.

Basic and Diluted Weighted Average Shares Outstanding

The basic and diluted weighted average number of shares of Andrx common stock outstanding for the three and six month periods ended June 30, 2002 were 70.7 million and 70.6 million, respectively. For the 2002 periods, all common stock equivalents were excluded from the diluted share computation as the Company reported a net loss and, accordingly, such common stock equivalents were anti-dilutive. The basic weighted average number of shares of Andrx common stock outstanding for the three and six month periods ended June 30, 2001 were 69.9 million and 69.7 million, respectively. The diluted weighted average number of shares of Andrx common stock outstanding for the three and six months ended June 30, 2001 were 72.2 million and 72.0 million, respectively. The increase in the basic weighted average number of shares of Andrx common stock outstanding in the three and six month periods ended June 30, 2002, as compared to the 2001 three and six month periods, was attributable to exercises of stock options, issuances of shares under the Company's employee stock purchase plan which commenced January 1, 2002, and approximately 65,000 shares of Andrx common stock issued upon conversion of Cybear common stock to Andrx common stock on May 17, 2002.

The basic and diluted weighted average number of shares of Cybear common stock outstanding were 6.7 million for the period from April 1, 2002 to May 17, 2002 and 6.1 million for the quarter ended June 30, 2001. The basic and diluted weighted average number of shares of Cybear common stock outstanding were 6.7 million for the period from January 1, 2002 to May 17, 2002. For the six months ended June 30, 2001, the basic and diluted weighted average number of shares of Cybear common stock outstanding were 5.0 million. For the 2002 and 2001 periods, all common stock equivalents were excluded from the diluted share computation as Cybear was allocated a net loss and, accordingly, such stock equivalents were anti-dilutive. After May 17, 2002, no Cybear common stock was outstanding as a result of its conversion to Andrx common stock. The basic and diluted weighted average number of shares of Cybear common stock included herein give effect to the July 2001 one-for-four reverse stock split of Cybear common stock.

Outlook

Andrx anticipates that it will continue to face a number of difficult operating issues in the second half of 2002, which may adversely affect near term earnings. While the Company is awaiting satisfactory resolution of the patent and/or FDA issues, which have delayed the launches of its bioequivalent versions of Prilosec, Wellbutrin SR/Zyban(R), Tiazac(R) and Naprelan(R), it continues to increase its spending in the areas of R&D, scale-up activities, and brand SG&A, while it continues to work toward the launch of those products and the development of its brand business.

In its distribution business, growth will continue to be primarily a function of new generic products launched by other generic manufacturers. In its bioequivalent products business, growth will come from the launch of significant new products, as sales of Andrx's current bioequivalent products are expected to remain relatively stable or decrease. In its brand product business, as previously mentioned, the Company began to ship Altocor early in July 2002 and will start the promotion to physicians by the end of July 2002. The Company expects to ship approximately $10 million (estimated sales value) of Altocor as initial stocking. Consistent with all brand products, the pull-through of the product in the distribution channel will be the result of the demand created by the sales force and other marketing initiatives. The initiatives include the implementation of a coupon redemption program in the third quarter of 2002. Such sales incentives will be recorded as an allowance against net sales in the statement of operations. The sales recorded will be based on the expected pull-through of the product in the distribution channel, net of among other things, coupon utilization. Accordingly, in the third quarter of 2002, the Company does not expect to realize significant net sales of Altocor in its statement of operations and, in the fourth quarter of 2002, the Company expects to record modest net sales of Altocor.

Andrx continues to incur unabsorbed manufacturing costs in certain areas at its Florida and Massachusetts manufacturing facilities. Such manufacturing costs, currently included in cost of goods sold, will be absorbed in the future as Andrx increases production levels in connection with future launches of Andrx products into the marketplace. In its Massachusetts facility, Andrx is taking measures to reduce certain levels of these unabsorbed manufacturing costs. Andrx plans to continue to scale-up and build inventories of some of its unapproved products and products which are yet to be launched.

Also, consistent with its previously reported 2002 plan, the Company plans to invest $55 million in R&D in 2002. Accordingly, planned R&D expenses will be higher in the second half of 2002 than in the first half of 2002. SG&A will also continue to increase as a result of, among other things, the Altocor launch and the expected commencement of operations at Andrx's Ohio distribution facility in late 2002. SG&A will include the Company's Internet operating expenses, primarily related to its Physicians' Online web portal operation. The Company expects that the Internet businesses, tracked by the former Cybear class of common stock, will generate approximately $5 million in net losses from the May 17, 2002 Conversion through the balance of 2002. The Company will continue to assess its Internet operations in an effort to further streamline and consolidate its operations and potentially divest assets. Andrx's operating results for the second half of 2002 will continue to be highly dependent on net sales of Cartia XT(TM), the uptake of Altocor and whether Andrx launches significant additional generic products. Absent launches of significant additional generic products, third and fourth quarter 2002 results are currently estimated to be generally break-even.

Though the timing remains uncertain, the Company remains optimistic that it will be able to introduce bioequivalent versions of Tiazac, Wellbutrin SR/Zyban, Naprelan and potentially Prilosec during the latter part of the second half of the year. Product introductions in 2002 may also include other generic products which Andrx has pending at the FDA. These product launches are dependent on a number of factors including, among other things, scale-up, receipt of final FDA marketing approval and/or satisfactory resolution of litigation.

Conversion of Cybear Common Stock

During the first quarter of 2002, Andrx determined that while it continued to see the value of Internet access to physicians, its Cybear Group business unit could not survive as a stand alone profit center tracked by a separate class of common stock. Therefore, Andrx Corporation exercised the rights in its Certificate of Incorporation to convert all of the outstanding shares of Cybear common stock into shares of Andrx common stock effective May 17, 2002. Cybear common stock was issued in a September 2000 reorganization to track the performance of Cybear Group, which represented the Internet businesses of Andrx Corporation. In the Conversion, each outstanding share of Cybear common stock was converted into 0.00964 of a share of Andrx common stock, which resulted in the issuance of approximately 65,000 shares of Andrx common stock. The Conversion ratio included a 25% premium on the value of the Cybear common stock, as provided by the terms of the Certificate of Incorporation.

As a result of the Conversion, Cybear business operations have been folded into Andrx Corporation. Andrx only has one class of common stock outstanding with the class including all of the businesses of Andrx Corporation and its subsidiaries. While the premium paid to the holders of Cybear common stock for the 2002 three and six month periods was not included in the Andrx or Cybear operating results, the premium associated therewith increased the total net loss allocated to holders of Andrx common stock by $526,000 in computing Andrx's net loss per share and reduced the total net loss allocated to holders of Cybear common stock by $526,000 in computing Cybear Group's net loss per share.

Through the May 17, 2002 effective date of the Conversion, Andrx Corporation continued to allocate operating results to each class of common stock. For periods subsequent to the Conversion, Andrx Corporation will (i) only report earnings (loss) per share for Andrx common stock which includes all of the former Cybear Group's operating results from the effective date of the Conversion and (ii) will no longer report separate earnings (loss) per share for the former Cybear common stock.

Webcast

Investors will have the opportunity to listen to management's discussion of this release in a conference call to be held on July 26, 2002 at 8:00 AM Eastern Time. This call is being webcast and can be accessed at Andrx's website http://www.andrx.com. The webcast will be available for replay.

About Andrx Corporation

Andrx is engaged in the formulation and commercialization of oral controlled-release pharmaceuticals utilizing its proprietary drug delivery technologies. In its ANDA program, Andrx is developing generic versions of selected high sales volume controlled-release brand name pharmaceuticals. In its NDA program, Andrx is developing its own brand name formulations of certain existing drugs that it believes may be improved by the application of Andrx's drug delivery technologies. Andrx also markets and distributes pharmaceutical products manufactured by third parties.

Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, Andrx notes that there can be no assurance as to the outcome of litigation or whether or when certain products will be launched, and that words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties. Andrx Corporation is subject to the risks and uncertainties described in its filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K, as amended, for the year ended December 31, 2001 and the Form 10-Q for the quarterly period ended March 31, 2002.

This release and additional information about Andrx Corporation is also available on the Internet at: http://www.andrx.com.

COPYRIGHT 2002 Business Wire
COPYRIGHT 2002 Gale Group

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