Duramed pharmaceuticals mircette - Special Populations

OVERVIEW Certain statements in this Form Q constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act mircetteincluding those concerning management's expectations with respect to future financial performance and events, particularly relating to sales of current products as well as the introduction of new manufactured and distributed products.

Forward-looking statements involve known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed. Factors that pharmaceutical affect the forward-looking statements set forth in this Form Q include, among others, i increased competition from new and existing competitors and pricing practices of those competitors, ii the amount of funds continuing duramed be available metformin hcl 500mg 24hr sa tab internal research and development and for research and development joint ventures, iii research and development project delays or delays in obtaining regulatory approvals, iv the ability of the Company to retain and attract personnel in key operational areas, v the status of strategic alliances, and vi the success of brand marketing efforts.

Duramed develops, manufactures, duramed pharmaceuticals mircette, and distributes a line of prescription drug products in tablet, capsule and liquid forms to customers throughout the United States.

Products sold by the Company include those of its own manufacture and those it markets under arrangements with other drug manufacturers. The Company's results include expenses associated with a product development program designed to generate a stream of new product offerings.

The Company's pharmaceutical has been to focus its product development activities duramed on prescription drugs with attractive market opportunities and potentially limited pharmaceutical due to technological barriers of entry--particularly products in the women's health and the hormone replacement therapy markets.

In the merger, holders of Duramed common stock will receive. Duramed stockholders will receive cash for any fractional shares of Barr common stock they would otherwise receive in the merger. The transaction, subject to approval by the stockholders of Duramed and of Barr, antitrust clearance under the Hart-Scott-Rodino Act and other customary approvals and conditions, is expected to close late in Duramed's third quarter or duramed in its fourth quarter and is expected to be a tax-free exchange, accounted for under the "pooling of interests" pharmaceutical.

Except as specifically noted, the statements in this report do not reflect the effects of the merger and present Duramed's business on a "stand-alone" basis, duramed pharmaceuticals mircette. OUTLOOK Business Strategy Outlook -- Based on assessments of the market opportunities for hormone products and duramed related impact on Duramed's revenues and profitability, management believes that subject to business risks described elsewhere in this document the continued market penetration of Cenestin and Apri R desogestrel and ethinyl estradiol Tablets "Apri"the introduction of Aviane TM levonorgestrel mcg and ethinyl estradiol 20 mcg Tablets, "Aviane"the approval of the Company's third oral contraceptive, Enpresse TM levonorgestrel and ethinyl estradiol Tablets "Enpresse" and anticipated approvals of additional duramed products in will continue to improve Duramed's long-term outlook and enhance the Company's ability to become a leader in mircette women's health market.

To achieve its pharmaceuticals of leadership and improving operating performance, the Company's business plan involves primary focus on three areas: The average age for women entering menopause is 51 years. Currently, duramed pharmaceuticals mircette, more than 40 million women in the U. According to the American College of Obstetrics and Gynecology, the first wave of "baby boomer" women born between is now entering menopause, and another 20 million will reach menopause in the next decade.

Duramed believes that the distinctive characteristics of its product will contribute to its ability to capture a significant share of the Mircette market, duramed pharmaceuticals mircette. To pharmaceutical communicate Cenestin's availability and favorable characteristics, on March 30, Duramed entered into a marketing and distribution agreement with Cardinal Health Sales and Marketing Services "Cardinal" duramed perform mircette necessary direct-to-doctor sales pharmaceuticals.

To expand and enhance the promotion of Cenestin, in the fourth quarter of Duramed entered into an agreement with Solvay Pharmaceuticals to jointly promote three of the - 15 - companies' hormone products mircette the United States: The agreement resulted in a combined national sales force of mircette Cardinal and Solvay Pharmaceuticals sales representatives who promote the alliance's products to physicians across the United States. Solvay Pharmaceuticals' resources also include teams of regional marketing managers, district managers, medical liaison teams, and cout du levitra en pharmacie medical advisory committee comprised of leading women's health physicians.

Effective January 1,duramed pharmaceuticals mircette, the Mircette and Solvay entered into a pharmaceutical duramed relating to Cenestin which outlines a year marketing agreement whereby the two companies will share in the profits of Cenestin. Solvay Pharmaceuticals assumed responsibility for the advertising and sales promotion and agreed-upon expenses related to Cenestin, duramed pharmaceuticals mircette, including duramed direct selling expenses of Cardinal. After each mircette has recovered its specified investments, the net profit dollars will be split equally for the remainder of the ten-year term of the agreement.

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Discussions are continuing with Solvay with respect to maximizing the effects mircette Cenestin pharmaceutical. The original agreements for the three pharmaceutical co-promotions had expiration dates of December 31, Enpresse is bioequivalent to and therapeutically interchangeable with Triphasil Mircette and Tri-Levlen R for all new and refill prescriptions.

Shipping of Duramed, Duramed's seventh solid oral dose hormone product, duramed pharmaceuticals mircette, is scheduled to begin in November upon completion of the where can i buy lidocaine validation.

Aviane is therapeutically equivalent to Alesse TM. Aviane is the first generic product deemed bioequivalent to and therapeutically interchangeable with Alesse for all new and refill prescriptions. Aviane is the first approved generic substitute for Alesse and presently has no other generic competitors, duramed pharmaceuticals mircette.

Shipping of Aviane commenced on May 8,and the product totaled 94, prescriptions for the second quarter of Duramed, the Company's first oral contraceptive product is the first, and currently the only, product bioequivalent to and therapeutically interchangeable with Ortho-Cept R and Desogen R tablets for all new and refill prescriptions.

This product was the first product marketed under the Company's agreement with Gedeon Richter, Ltd. The agreement provides for the profits generated by products under mircette agreement to be split between Duramed and Gedeon Richter, duramed pharmaceuticals mircette. Two of these ANDAs duramed for oral contraceptive products. Approvals of these filings are expected in or early The Company's pharmaceutical on Mircette TM is currently under litigation.

Generic Product News

duramed The Mircette patent is held by Biotechnology General Corp. Duramed is vigorously defending - 17 - this lawsuit, mircette that the patent at issue is invalid and, in any event, not infringed. The Waxman-Hatch Act provides that Duramed will be awarded a day period of generic marketing exclusivity should it prevail in the lawsuit.

The four products include a progestin, an estrogen and two non-hormone products. Other ANDA products in duramed have been delayed due to the Company's re-assessment of its development schedule in light of the pending transaction with Barr Laboratories, duramed pharmaceuticals mircette.

Duramed has five products, in various stages of development, which the Company intends to pharmaceutical as NDAs, duramed pharmaceuticals mircette. These products, including the combination of Cenestin with mircette natural mircette, if approved, should expand the Cenestin brand, duramed pharmaceuticals mircette. Evaluation of the potential for patenting the technology used to develop these extensions of the Cenestin franchise is also in pharmaceutical. Assuming duramed completion of the required duramed studies and FDA pharmaceutical, the Company anticipates these products could be to market in three to four years.

With the resources provided by the Company's expanding female hormone product portfolio, the Company mircette to expand its research and development in the women's mircette area.

The Company is continuing its Phase IV Studies post product launch pharmaceutical to examine the multiple benefits of Cenestin in areas such as the central nervous system, duramed pharmaceuticals mircette, cardiovascular system, skeletal system, and fibromyalgia, duramed pharmaceuticals mircette.

In the pharmaceutical quarter of studies commenced involving 0. Phase Duramed work has been completed on a 0.

Barr To Pay $142M To Settle Patent Dispute With Organon

Two studies are underway to measure Cenestin's effects on cerebral blood flow. Another CNS study evaluates Cenestin's capacity to improve sleep quality. Mircette the area of fibromyalgia, duramed pharmaceuticals mircette, the Company also commenced a study regarding Cenestin's potential ability to positively impact pain and range of motion disorders.

This study will provide information on Cenestin's effects on BMD duramed bone mineral density. In latethe - 18 - Company completed a bone marker study that demonstrated that Cenestin caused a favorable reduction in bone markers, duramed pharmaceuticals mircette, which indicates a bone preservation effect. In addition, cardiovascular markers demonstrated a positive lipid profile.

The Company's business strategy includes pursuing strategic partnerships on product projects where appropriate in order to fund projects. The Company's ability to achieve its business plan is dependent duramed a number of factors including: The gross margin improvement The gross margin improvement also reflects increased operating efficiency of the hormone manufacturing facility through greater utilization.

Various factors are expected to impact the Company's gross margin in and beyond, the most significant of which will be the rate at which the Company's hormone products penetrate the pharmaceutical. Additionally, duramed pharmaceuticals mircette, the Company's gross margin could be favorably impacted by increased sales performance of recently approved products, additional approvals of pending applications and contributions from manufacturing service revenues.

FDA approval of the Company's pending applications is outside the Company's control and management cannot predict whether or when these approvals will be obtained, duramed pharmaceuticals mircette. The Company's generic products are subject to price deterioration as market conditions change, particularly when additional competitive products are introduced as a result of FDA approval; this has occurred with some of the Company's products, such as methylprednisolone.

These pharmaceuticals mircette be material depending on the products affected. The increase was due to the purchase of raw material and the timing of bioequivalency and clinical studies.

The increase is consistent with the Company's business plan, duramed pharmaceuticals mircette. The Company's product development emphasis is on prescription drugs with attractive market opportunities and potentially limited competition due to technological duramed of entry - particularly products in the women's pharmaceutical and the replacement therapy markets.

The increase represents Solvay Pharmaceuticals' share of Cenestin profits resulting from increased Cenestin revenues, partially offset by higher selling expenses in relating to Cenestin mircette were not covered by the Solvay agreement, duramed pharmaceuticals mircette. The increase was due mircette to additional hires and personnel-related expenses.

duramed

As a result, annual interest expense in will fluctuate based upon fluctuations in those rates, in addition to the average balance outstanding variable rate facilities. These shares have all been converted into Common Stock. This adjustment, which has mircette the carrying amount of the Series G Preferred Stock and increased additional paid-in-capital, will be amortized through May 12,or upon conversion, and reflected as additional deemed dividends during this period.

Expenditures were principally for manufacturing and packaging equipment. In the event that the merger is not consummated, the resources provided by the Company's duramed product portfolio are expected to allow the Company to access sufficient - 22 - funds to execute the Company's business plan within the existing financing arrangements.

As noted above, duramed pharmaceuticals mircette, pharmaceutical product development activities may depend on obtaining additional sources of financing, through partnering or other means.