3SOF

PXL: New 52-Wk Low @ $8.450 dn 3.98%
Tuesday , May 16, 2006 16:55 ET

This is the 1st 52 WEEK LOW alert for IPXL in the past 7 calendar days.
The share price for Impax Laboratories Incorporated (OTC: IPXL) reached a new 52-week low today, trading at $8.450, down $-0.350 (-3.98%) from its previous close of $8.800.
The Company's previous 52-week low of $8.500 was set 162 days ago on December 05, 2005.
One year ago, the Company's shares closed at $16.470. The price has declined more than 48 percent since then.
At the time of this alert, the stock had traded 65,100 shares via 38 trades, 70.20% below it's 20day average of 218,476 shares.
This new 52-week low currently puts the stock:

7.52% below its 20day Moving Average of $9.137
10.51% below its 50day Moving Average of $9.443
15.39% below its 100day Moving Average of $9.987

time for starting a position ??

Quote from: la-onda on May 18, 2006, 06:47:19 AM
time for starting a position ??

I'm going to have to go with "no" on this one. Chart looks brutal.

SEC Filling still not in time... 


IPXL presentation:
http://library.corporate-ir.net/library/67/672/67240/items/190148/Investor_Presentation.pdf

chart  :

little rebound after new 52 week low

Petitions to FDA Sometimes Delay Generic Drugs
Critics Say Companies Misusing Process

By Marc Kaufman
Washington Post Staff Writer
Monday, July 3, 2006; A01

A procedure designed to alert the Food and Drug Administration to scientific and safety issues is getting a hard look from members of Congress, who say they are concerned that it may be getting subverted by the brand-name drug industry.

Some at the FDA, as well as leaders in the generic drug industry, complain that "citizen petitions" -- requests for agency action that any individual, group or company can file -- are being misused by brand-name drugmakers to stave off generic competition.

The simple act of filing a petition, they say, triggers another round of time-consuming and often redundant reviews of the generics by the FDA, which can take months or years. In the process, consumers continue to pay millions of dollars more for the brand-name drugs.

Statistics collected by the staff of Sen. Debbie Stabenow (D-Mich.), who has introduced legislation with Sen. Trent Lott (R-Miss.) that would rein in industry-filed citizen petitions, show that 20 of the 21 brand-name petitions settled by the FDA since 2003 were ultimately rejected.

"The brand-name drug industry has found a major new loophole," Stabenow said in an interview. "The way things stand now, even if the FDA finds that a petition was frivolous and rejects it, [the drug companies] can get hundreds of millions of dollars of profits from the delay."

She and others point to the example of Wellbutrin XL, a hot-selling antidepressant that was facing the prospect of competition from cheaper generics late last year.

By the time Biovail Corp., the drug's maker, filed a citizen petition with the FDA, raising concerns about the safety of its potential rivals, Impax Laboratories Inc. and several other companies had already gone through much of the FDA application and review process for their generic versions of the drug. Impax was looking forward to getting a tentative approval that would bring it considerably closer to making and selling its competing drug.

But because of the citizen petition, the FDA has yet to act, and Biovail still has the market for Wellbutrin XL to itself. Impax is fuming, as are many others in the generic drug industry.

In a letter sent last week to FDA Acting Commissioner Andrew von Eschenbach, Stabenow and Lott estimated that the delay in approving a generic version of the antidepressant Wellbutrin XL is costing consumers $37 million a month.

Impax already sells a twice-a-day version of Wellbutrin; the once-a-day XL version was approved by the FDA in 2003 as the patent on the shorter-lasting formulations was running out.

"Biovail's petition is a sham, designed solely to delay the onset of generic competition for its Wellbutrin XL product," Impax told the FDA in a letter. "Biovail has wasted FDA's and Impax's time and resources and has likely cost the American public millions of dollars in taxes and health care expenditures in selfish pursuit of further undeserved windfall profits."

Biovail rejects the view that it is trying to block generic competition, and in its petition made the case that generic versions of its product may not be biologically equivalent and could be dangerous. As a result, the company -- which has also filed patent infringement suits against its prospective rivals -- asked the FDA to require substantial additional testing before any generic version of Wellbutrin XL is approved.

Pharmaceutical Research and Manufacturers of America (PhRMA), which represents brand-name drugmakers, supports the citizen petition process and says the dozens of similar petitions pending with the FDA raise legitimate concerns.

"Most citizen petitions raise important regulatory, legal or scientific issues," said Caroline Loew, the group's senior vice president. "The fact is, the petitions have played a vital role at the FDA since their adoption almost 30 years ago. They have been responsible for important discussions about health and safety, and have been a catalyst for key agency decisions, such as speeding approval of AIDS medicines and implementing rules to protect children from accidental iron poisoning."

Although citizen petitions have raised many important drug policy issues, the Wellbutrin filing is one of several dozen pending that some call "blocking petitions" because they have the effect of delaying approval of a generic alternative. FDA officials said that about 170 citizen petitions are before the agency -- compared with 90 in 1999 -- and that about 30 percent involve industry challenges to generic applications.

FDA Chief Counsel Sheldon Bradshaw told generic drugmakers at a September conference that the agency has been troubled by the number of such petitions. He said they "appear designed not to raise timely concerns with respect to the legality or scientific soundness of approving a drug application, but rather to delay approval by compelling the agency" to review arguments that could have been made months before.

That response caused PhRMA to write to Bradshaw asking for more information. Scott Lassman, PhRMA's assistant general counsel, said the organization found the comments to be "troubling," especially if they could lead to restrictions on how and when citizen petitions could be filed.

More recently, Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said in an interview that the agency has instituted internal changes that will allow for quicker rulings on citizen petitions, especially if they are filed close to the time when a decision on a new generic is expected. But he said that he did not believe there had been an increase in "what a reasonable person would call a blocking petition."

"It's very hard to decide what's a blocking petition and what has value without taking a serious look," Gottlieb said. "I think citizen petitions are very important and have to be preserved. The last thing we want to do is close off an avenue of discourse with the agency."

By regulation, all generic drugs must be "bioequivalent" to the brand-name drugs they copy and must have the same effects and dependability. Industry-sponsored citizen petitions often challenge the process by which bioequivalence was tested.

Because generics generally cost 25 percent to 75 percent less than brand-name products, the sums of money at stake can be enormous -- for the brand-name company, the generic maker, patients, insurance companies and government programs. Wellbutrin XL (a once-a-day formula of bupropion hydrochloride with fewer side effects than the original) costs $1 to $5 a pill and earns about $800 million a year for Biovail and GlaxoSmithKline PLC, which developed the drug. An Impax spokesman said his company planned to sell its generic version, if approved by the FDA, for "a considerable discount."

Making changes to the citizen petition process is a high priority for the Generic Pharmaceutical Association. Its president, Kathleen Jaeger, said her group considers blocking petitions to be among the greatest obstacles facing the industry.

"Because of the way the system works now, branded companies have every reason to file citizen petitions," she said. "There's a potentially great benefit, and there's no risk. I can't imagine that this is how the originators of the petitions thought they should work."

This is not the first time that the generic industry has complained about citizen petitions that it believed were unfairly blocking generic applications. The Clinton administration responded to those complaints in 1999 with a proposal that would have changed the way the FDA received and handled citizen petitions. PhRMA strongly opposed the rule, and the Bush administration withdrew it in 2003.

Jaeger said the generic industry was working hard with Congress at that time to close other loopholes in the patent system that allowed makers of brand-name drugs to extend their time for exclusive sales. "We were working so hard to get that legislation passed that we didn't really focus on what was happening with the citizen petition rule," she said, "so some of what we won in Congress, we lost to the citizen petitions."

Stabenow and Lott, who are trying, in their bill, to reduce the petitions, said in their letter to von Eschenbach that "the Senate Appropriations Committee recognized the unintended effect citizen petitions were having on the approval of [generic drug applications] and directed the FDA to provide a written report explaining the process and suggesting improvements. . . . It is our understanding the FDA has not moved forward with this request."
link:
http://www.washingtonpost.com/wp-dyn/content/article/2006/07/02/AR2006070200840_pf.html

Solvay wins settlement from Global and Impax
Tuesday July 11, 1:36 pm ET

Global Pharmaceuticals and Impax Laboratories Inc. will pay Solvay Pharmaceuticals Inc. $23 million to settle a lawsuit that alleged the companies falsely advertised and marketed their products as generic equivalents to and substitutes for Solvay's drugs to treat pancreatic exocrine insufficiency.

Marietta, Ga.-based Solvay Pharmaceuticals Inc. said Global and Impax Laboratories have already paid $12 million of the settlement amount.

Global and Impax also must discontinue marketing that states or implies its products are generic equivalents to Creon brand products and must discontinue current product labeling, distribution and sales of Lipram-CR 5, Lipram-CR 10 and Lipram-CR 20. The terms of the settlement further require the companies to disseminate corrective written advertising to customers, database companies and managed care organizations stating that its products are not generic equivalents to Creon products and should not be substituted for Creon products without physician supervision.

"We believe the outcome of this case validates our long-held assertion that these pseudo-generic products are not true generic equivalents to Creon Minimicrospheres and should not be substituted for our products," said Dr. Laurence Downey, president and CEO of Solvay Pharmaceuticals Inc. "More importantly, this settlement will help to ensure that pancreatic enzyme patients -- including thousands of children with cystic fibrosis -- will receive the life sustaining product they've been prescribed in Creon Minimicrospheres."

Creon is used to treat pancreatic exocrine insufficiency, which is often associated with conditions such as cystic fibrosis and chronic pancreatitis. Pancreatic exocrine insufficiency occurs when enzyme output from the pancreas is inadequate to digest fats, proteins and carbohydrates in food.

Solvay Pharmaceuticals first filed lawsuits in April 2003 in the U.S. District Court of Minnesota against Ethex Corp., KV Pharmaceutical Co., Global Pharmaceuticals and Impax Laboratories Inc. The lawsuit filed against Ethex KV Pharmaceutical is ongoing.

any comments would be appreciated

something is moving this stock......

any other opinion  ?

yahoo board quotation (thanks clcl):

IPXL history:

With the push of gWSR, IPXL achieved the historical high, $25.74, on 5/5/04.

Massive insiders-selling occurred in June, 2004 and Impax overstated 1Q04 and 2Q04 income.

Aug. 2004, Impax filed 3Q04 10-Q and restated 1Q04 and 2Q04 Financial.

Dec. 2004, CFO resigned.

4/6/05, Impax officially delayed 4Q04 10-Q and 2004 10-K; symbol changed from IPXL to IPXLE at pps=$17.45.

8/5/05 Impax's stock was delisted by NASDAQ; symbol changed from IPXLE to IPXL.PK at pps=$10.28.

The market acted patiently during Aug. 2005 to Mar. 2006: pps ranged $11 +- $2.

Prior to 10/3/05, Greenlight Capital and Mr. Einhorn purchased 3.9765M shares (6.8% of outstanding) from the open market.

Prior to 2/14/06, Wellington (a well known fund) purchased 4.763115M shares (8.14%) from the open market; and Greenlight and Einhorn aggregated the position to 5.8M shares (9.9%). A potential outcome of these purchases would be a proxy fight in the future (2007?).

April 2006, a decision box around $10 was formed. The decision: negative (i.e., a breakdown).

May 2006, a decision box around $9 was formed. The decision: negative.

June 2006, a decision box around $6.5 was formed. The decision: negative.

It was a clear indication of the growing impatience of the market.

July-Mid August 2006, a decision box around $5 was formed (7/7/06 low $4.25). The decision: positive (a breakout) so far.

Aug. 2006, resignation of CEO announced.

After a painfully long period, Impax may submit 2004 10-K in 2006 Fall.

However, Impax may have half a dozen approvals (including tentative approvals) coming out in the next 6 months.

last company presentation:
http://library.corporate-ir.net/library/67/672/67240/items/190148/Investor_Presentation.pdf

latest news:

IMPAX Names Larry Hsu as CEO Effective October 1, 2006

HAYWARD, Calif.--(BUSINESS WIRE)--Aug. 15, 2006--IMPAX Laboratories, Inc. (OTC:IPXL) today announced that its President, Larry Hsu, Ph.D., will assume the additional position of Chief Executive Officer on October 1, 2006. He will replace Barry R. Edwards, the Company's current CEO, who is also resigning as a director of the Company. Mr. Edwards will serve as a special consultant to the Company through October 2008.

Commenting on the change in management, Charles Hsiao, Ph.D., chairman of the board of directors, said, "Since forming IMPAX, we have assembled a strong leadership team, set a clear strategy, focused on development excellence, created new product opportunities and built a solid infrastructure. We are fortunate to have in Larry Hsu a talented executive who is ready and highly capable to take on the responsibilities of chief executive. We are very sorry that Barry will no longer be managing the day to day activities of the Company, but are delighted that he has agreed to remain involved for the next two years. Barry will long be remembered for his inspired leadership during this remarkable period of growth and transformation. "

"I am extremely gratified by the Board's confidence," Dr. Hsu said. "It is an honor to be asked to lead this company, which I co-founded more than 10 years ago. I am grateful to Barry for his stewardship during the past seven years. Thanks to his vision, IMPAX today is a vastly different and more mature company than the one he was asked to lead in 1999."

"The Board of Directors has great confidence in Larry's leadership and in his vision for IMPAX Laboratories," said Mr. Edwards. "He helped create IMPAX's business strategy and he understands, as I do, that the Company's strength lies in the hundreds of employees who have been and continue to be a critical component of our success. The transition is expected to be orderly as several important functions, in particular sales and finance, have been reporting to Larry for some time. Nevertheless, I intend to work closely with Larry to ensure that the transition is seamless."

better chart:

update:
Impax won the patent case of Ditropan XL based on the US appeals court ruling today. Impax is FTF of the 15 mg stength. Mylan, FTF of the 5 and 10 mg strenths, won as well.
Ditropan XL had $400M market size in 2004.
The last hurdle is the CP JNJ filed on 8/30/2005. Impax can launch 15 mg Ditropan XL immediately following the denial of that CP, and launch 5 and 10 mg 180-day later.

http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20060906:MTFH60982_2006-09-06_21-03-46_N06460777&type=comktNews&rpc=44

updated chart (nice BO today)

cup and handle formed ??

TA feedback is appreciated....


cheers
Oliver

Hi, 

Soory but i don't see where "cup and handle" could be...For me it is not a reversal pattern. I prefer to see a "inverted head and shoulders".

Well, the previous gap is filled + volume low on last uptrend and trending range = sell signal
But "Head and shoulders" + "Flag" + high volume on neckline breakout = Buy signal.

Buy strategy :
1. Waiting for a breakout of the flag pattern
2. Waiting for a pullback near neckline (red trendline) at about 6.00

I hope this analysis can help you in your decisions...With penny, the best as the worst can arrive !

IPXL update:

IMPAX Receives FDA Approval for Generic Version of Colestid(R) Tablets
Company Awarded 180-day Market Exclusivity

HAYWARD, Calif., Oct 26, 2006 (BUSINESS WIRE) -- IMPAX Laboratories, Inc. (OTC:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company's Abbreviated New Drug Application (ANDA) for a generic version of Colestid(R) Tablets (Colestipol Hydrochloride Tablets) 1 gram. The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product under Paragraph IV of the Hatch-Waxman amendments. Pharmacia and Upjohn Company (Pfizer) markets the 1 gram Tablet as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Total brand sales of Colestid(R) Tablets 1 gram in the U.S. were $20 million for the 12 months ended August 31, 2006, according to Wolters Kluwer Health.

"This is our third ANDA approval this year," commented Larry Hsu, Ph.D., IMPAX's President and Chief Executive Officer. "We are looking forward to our Global Pharmaceuticals division marketing our generic Colestid Tablets very shortly."

I didn´t trigger the buy button during the 6$ rest period"

Seems to be that IPXL breakout of the flag pattern was happened 

Sebfr, any comments ?

cheers
O.

Hi la-onda 

You're right. breakout of the flag pattern has happened a few days ago.

We can see a double bottom after market has tested "inverted head and shoulders" neckline. Theorical target at 8.00

Good trades

FYI:
1)
Impax gets FDA OK for urinary retention drug
Friday November 3, 2:45 pm ET

Impax Laboratories Inc. has been granted U.S. Food and Drug Administration approval for generic versions of Urecholine, which is used for post-operative and post-partum urinary retention.

Hayward-based Impax (OTCBB:IPXL - News) said sales of both the branded and generic versions of Urecholine were about $33 million in the 12 months ended Aug. 31.

The company said the approvals strengthen its strategy to develop niche generic pharmaceuticals.

2)
IPXL Partnership with TEVA, DAVA & Shire

3)
General overview