Impax Laboratories Inc (IPXL)

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IL MONDO KE VORREI!!
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Qualcuno l'ha seguita????
io purtroppo l'ho solo seguita saltuariamente,,,e mai presa,,,,

Impax says appeals court affirms Wellbutrin ruling
1/29/2004 4:42:28 PM
















NEW YORK, Jan 29 (Reuters) - Impax Laboratories Inc. (IPXL) on Thursday said a federal appeals court upheld a lower court decision allowing it to market generic versions of GlaxoSmithKline Plc's (UK:GSK) Wellbutrin antidepressant.


Impax said on Wednesday the U.S. Food and Drug Administration approved its 100 milligram copycat and gave tentative approval for its 150 mg version.


Generic drugmaker Eon Labs (ELAB) earlier this month said it began shipping its own generic 100 milligram version of the drug. Watson Pharmaceuticals (WPI) then launched its own generic under a supply arrangement with Glaxo.


U.S. sales of the two dosage forms were worth about $1.6 billion in the 12 months ended Nov. 30, 2003, according to Impax.
 

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Risultati da record x IPXL

IMPAX Posts First Profitable Quarter Driven by Record Revenues; Received Five FDA Approvals in First Quarter
5/5/2004 4:00:00 AM
HAYWARD, Calif., May 5, 2004 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (IPXL) today reported financial results for the three months ended March 31, 2004.

Revenues for the first quarter of 2004 were a record $38,853,000, up more than 240% compared with revenues of $11,425,000 in the prior year's first quarter, and up more than 131% over total revenues of $16,829,000 in the fourth quarter of 2003. The year-over-year increase for the first quarter was primarily due to shipments of our generic versions of Wellbutrin(R) SR (Bupropion Hydrochloride) 100 mg and 150 mg Controlled Release Tablets, which were approved by the FDA during the quarter. During the quarter, upon approval from the FDA, we also commenced shipments of Demeclocycline Hydrochloride (generic of Declomycin(R)) 150 mg and 300 mg Tablets. First quarter revenues also include $2,500,000, representing the reversal of the refundable deposit from Teva under its strategic alliance agreement related to its exercise of the exclusivity option for certain products.

Net income for the 2004 first quarter was $9,048,000, or $0.14 per fully diluted share, compared with a net loss of $3,213,000, or $(0.07) per share, in the prior year first quarter. Cash, cash equivalents and short-term investments (unrestricted) were $19.5 million at March 31, 2004, compared to $15.5 million at December 31, 2003. During the first quarter of 2004, we satisfied the remaining $2.5 million refundable deposit obligation to Teva in full by issuing 160,751 shares of our common stock to Teva. As of March 31, 2004, to our knowledge, Teva owns 2,511,752 shares of our common stock, or approximately 4.3% of the outstanding common stock. Also during the quarter, the holders of Series 2 Preferred Stock converted their entire 75,000 preferred shares into 1,500,000 shares of common stock. Subsequent to the end of the quarter, IMPAX closed a private placement of $95,000,000 aggregate principal amount of 1.250% convertible senior subordinated debentures due 2024.

"We are delighted to report our first profitable quarter since IMPAX Laboratories was formed in December 1999," said Barry R. Edwards, Chief Executive Officer of IMPAX. "Our research and development team's steady stream of filings, the subsequent FDA approvals of those ANDAs, positive litigation outcomes, and the dedication and hard work of our employees in all the functional areas of the Company made this goal a reality. The convertible debenture financing completed on April 5, 2004 provides us with additional financial resources going forward."

Commenting on the Company's product pipeline, Larry Hsu, Ph.D., IMPAX's President, said, "The launch of our generic Wellbutrin SR represents IMPAX's single largest product opportunity to date. According to NDCHealth, U.S. sales of Wellbutrin SR 100 mg and 150 mg, marketed by GlaxoSmithKline (GSK) , were approximately $1.4 billion in the twelve months ended February 29, 2004. In addition to the generic Wellbutrin SR, our new product pipeline continues to progress through the FDA. During the quarter, we received final approvals for generic versions of Declomycin and Claritin(R)-D 24-Hour. Our generic versions of Allegra(R)-D and Tricor(R) Tablets have also been granted tentative approvals."

IMPAX currently has seventeen applications pending at the FDA, including five tentatively approved, which address over $5.4 billion in U.S. branded product sales for the 12 months ended February 29, 2004. Thirteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Impax's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, Impax's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, Impax's ability to successfully develop and commercialize pharmaceutical products, Impax's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in Impax's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
 
graditi pareri,,,,,:bow:
 

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trimestrale molto buona

PRESS RELEASE: IMPAX Posts First Profitable Quarter Driven by Record Revenues; R [DHVZRGD]

HAYWARD, Calif.--(BUSINESS WIRE)--May 5, 2004--IMPAX Laboratories, Inc.
(Nasdaq:IPXL) today reported financial results for the three months ended March
31, 2004.
Revenues for the first quarter of 2004 were a record $38,853,000, up more than
240% compared with revenues of $11,425,000 in the prior year's first quarter,
and up more than 131% over total revenues of $16,829,000 in the fourth quarter
of 2003. The year-over-year increase for the first quarter was primarily due to
shipments of our generic versions of Wellbutrin(R) SR (Bupropion Hydrochloride)
100 mg and 150 mg Controlled Release Tablets, which were approved by the FDA
during the quarter. During the quarter, upon approval from the FDA, we also
commenced shipments of Demeclocycline Hydrochloride (generic of Declomycin(R))
150 mg and 300 mg Tablets. First quarter revenues also include $2,500,000,
representing the reversal of the refundable deposit from Teva under its
strategic alliance agreement related to its exercise of the exclusivity option
for certain products.
Net income for the 2004 first quarter was $9,048,000, or $0.14 per fully
diluted share, compared with a net loss of $3,213,000, or $(0.07) per share, in
the prior year first quarter. Cash, cash equivalents and short-term investments
(unrestricted) were $19.5 million at March 31, 2004, compared to $15.5 million
at December 31, 2003. During the first quarter of 2004, we satisfied the
remaining $2.5 million refundable deposit obligation to Teva in full by issuing
160,751 shares of our common stock to Teva. As of March 31, 2004, to our
knowledge, Teva owns 2,511,752 shares of our common stock, or approximately 4.3%
of the outstanding common stock. Also during the quarter, the holders of Series
2 Preferred Stock converted their entire 75,000 preferred shares into 1,500,000
shares of common stock. Subsequent to the end of the quarter, IMPAX closed a
private placement of $95,000,000 aggregate principal amount of 1.250%
convertible senior subordinated debentures due 2024.
"We are delighted to report our first profitable quarter since IMPAX
Laboratories was formed in December 1999," said Barry R. Edwards, Chief
Executive Officer of IMPAX. "Our research and development team's steady stream
of filings, the subsequent FDA approvals of those ANDAs, positive litigation
outcomes, and the dedication and hard work of our employees in all the
functional areas of the Company made this goal a reality. The convertible
debenture financing completed on April 5, 2004 provides us with additional
financial resources going forward."
Commenting on the Company's product pipeline, Larry Hsu, Ph.D., IMPAX's
President, said, "The launch of our generic Wellbutrin SR represents IMPAX's
single largest product opportunity to date. According to NDCHealth, U.S. sales
of Wellbutrin SR 100 mg and 150 mg, marketed by GlaxoSmithKline (NYSE:GSK), were
approximately $1.4 billion in the twelve months ended February 29, 2004. In
addition to the generic Wellbutrin SR, our new product pipeline continues to
progress through the FDA. During the quarter, we received final approvals for
generic versions of Declomycin and Claritin(R)-D 24-Hour. Our generic versions
of Allegra(R)-D and Tricor(R) Tablets have also been granted tentative
approvals."
IMPAX currently has seventeen applications pending at the FDA, including five
tentatively approved, which address over $5.4 billion in U.S. branded product
sales for the 12 months ended February 29, 2004. Thirteen of these filings were
made under Paragraph IV of the Hatch-Waxman Amendments.
IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical
company applying its formulation expertise and drug delivery technology to the
development of controlled-release and specialty generics in addition to the
development of branded products. IMPAX markets its generic products through its
Global Pharmaceuticals division and intends to market its branded products
through the IMPAX Pharmaceuticals division. Additionally, where strategically
appropriate, IMPAX has developed marketing partnerships to fully leverage its
technology platform. IMPAX Laboratories is headquartered in Hayward, California,
and has a full range of capabilities in its Hayward and Philadelphia facilities.:) :)

ti apre in gap da paura:D
 
IMPAX Receives Final FDA Approval for Oxycodone Hydrochloride Controlled Release Tablets, 80mg; Tenth Approval in 2004
9/28/2004 4:00:00 AM

HAYWARD, Calif., Sep 28, 2004 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of OxyContin(R) (Oxycodone Hydrochloride) Controlled Release 80mg Tablets. Purdue Pharma markets OxyContin for the management of moderate to severe pain. According to NDCHealth, U.S. sales of OxyContin Controlled Release 80mg Tablets and its generic equivalent were $688 million for the 12 months ended July 31, 2004.

Included in communications with the FDA related to the final approval is a commitment by the Company not to launch the product until a revised Risk Management Program (RMP) has been submitted to, and is found acceptable by, the FDA. A revised RMP has recently been submitted to the FDA by the Company.

"This is our tenth ANDA approval this year, which exceeds our full year total of nine in 2003," commented Barry R. Edwards, Chief Executive Officer of IMPAX. "We received tentative approval for the product late in 2003 and had anticipated final approval following the expiration of marketing exclusivity for the first ANDA filer. Operationally, we have been making preparations for a market launch, but because of outstanding issues, including pending patent infringement litigation by Purdue, a final decision on timing has not yet been made," Mr. Edwards continued.

IMPAX currently has 14 applications pending at the FDA, including four tentatively approved, which address approximately $4.3 billion in U.S. branded product sales for the 12 months ended July 31, 2004. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

IMPAX Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug-delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.


"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:
To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Impax's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, Impax's ability to obtain sufficient capital to fund its operations, the difficulty of predicting FDA filings and approvals, consumer acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, Impax's ability to successfully develop and commercialize pharmaceutical products, Impax's reliance on key strategic alliances, the uncertainty of patent litigation, the availability of raw materials, the regulatory environment, dependence on patent and other protection for innovative products, exposure to product liability claims, fluctuations in operating results and other risks detailed from time to time in Impax's filings with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.
 
IMPAX Receives Tentative FDA Approval for Generic Version of Ditropan XL
Wednesday February 2, 4:02 am ET

First Approval in 2005

HAYWARD, Calif.--(BUSINESS WIRE)--Feb. 2, 2005--IMPAX Laboratories, Inc. (NASDAQ:IPXL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Ditropan® XL (Oxybutynin Chloride) 5, 10 and 15 mg Extended Release Tablets. Alza Pharmaceuticals markets Ditropan XL for the treatment of urge urinary incontinence. U.S. sales of Ditropan XL were approximately $410 million in the 12 months ended November 30, 2004, according to NDCHealth.

Final approval is contingent upon the earlier of the resolution of pending patent-infringement litigation brought by Alza against IMPAX, or the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration of any generic marketing exclusivity. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval.

"This is our first ANDA approval this year," said Larry Hsu, Ph.D. IMPAX Laboratories, Inc. President. "We are pleased to add this to our product portfolio and will work diligently with our partner to launch this product upon final approval."

IMPAX currently has 16 applications pending at the FDA, including five tentatively approved, which address approximately $5.6 billion in U.S. branded product sales for the 12 months ended November 30, 2004. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
 
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