PRX

[mrmarket]

6:39AM Par Pharmaceutical announces positive Phase II results of proof-of-concept study (PRX) 28.62 :PRX announces results of Phase II proof-of-concept study with concentrated megestrol acetate oral suspension, which utilizes NanoCrystal Technology. Co says patients taking concentrated megestrol acetate 575 mg/5 mL gained more weight, on average, than those taking the older megestrol acetate oral suspension 800 mg/20 mL. PRX says that although this study was not powered to achieve statistical significance, there was a substantial difference in mean weight gain, beginning at day 3 and continuing throughout the trial, with the concentrated megestrol acetate group gaining 50% more weight by week 12.

[jiesen]

Ok, so it's not a blockbuster

but it's better than a kick in the teeth. I'm referring to PRX's latest news, of FDA approval for generic Questran.

http://biz.yahoo.com/ap/050829/par_pharmaceutical_generic_questran.html?.v=1

Par Pharma Gets OK for Generic Questran
Monday August 29, 3:17 pm ET Par Pharmaceutical Receives FDA Approval for Generic Version of Cholesterol Drug Questran



SPRING VALLEY, N.Y. (AP) -- Drug maker Par Pharmaceutical Cos. on Monday said it received final approval from the Food and Drug Administration for its generic equivalent of Bristol-Myers Squibb Co.'s Questra treatment for high cholesterol.

The company said the FDA approved its new drug applications for cholestyramine for oral suspension, and that the treatment will begin shipping soon.

U.S. sales of cholestyramine products total about $50 million, according to pharmaceutical research company IMS health. Par Pharmaceutical shares rose 8 cents to $23.61 in afternoon trading on the New York Stock Exchange.

[sisterwin2]

goverment

this drug is use alot in Long term care facilities...... THE goverment will make it mandatory that all on it will switch to the generic drug if its cheaper. If the resident is not switched over.. the facility will pay out of pocket for the drug...

Just a thought,
Dena

[jiesen]

good news for PRX: Approval for arthritis drug

http://biz.yahoo.com/ap/050914/par_pharma_arava.html?.v=1

Par Unit Receives FDA Generic Arava OK
Wednesday September 14, 7:46 am ET Par Pharmaceutical Unit Gets FDA Approval to Market Generic Version of Arava Arthritis Drug


SPRING VALLEY, N.Y. (AP) -- Drug maker Par Pharmaceutical Cos. said Wednesday that its Kali Laboratories Inc. unit received Food and Drug Administration approval to market a generic version of Sanofi Aventis SA's Arava, a rheumatoid arthritis treatment.

The approval allows Kali to market 10 milligram and 20 milligram tablet strengths of leflunomide, the active ingredient in Arava. Par said it will begin shipping the tablets immediately.

The company estimates annual U.S. Arava sales at more than $200 million. Rheumatoid arthritis occurs when the body's immune system mistakenly attacks the linings of joints, causing inflammation, swelling and pain. Par shares rose 60 cents, or 2.4 percent, to $26 in premarket activity

[jiesen]

PRX showing some signs of life

finally!

http://finance.yahoo.com/q/bc?s=PRX&t=5d

[mrmarket]

Earnings due October 27...they expect $0.27/share

[jiesen]

PRX finally gives us some good news

Earnings due October 27...they expect $0.27/share

0.27? Try 0.74! (well, 0.29 excluding one-time items)

Megace has captured 9% of its market... not bad, and still a ways to go.

http://biz.yahoo.com/prnews/051027/nyth049.html?.v=32

Par Pharmaceutical Reports Third-Quarter Sales and Earnings
Thursday October 27, 6:00 am ET
Company Achieves Third-Quarter Total Revenues of $118.7 Million, Net Income of $10.0 Million and Diluted EPS of $.29, Excluding Certain Items
Quarter Marks the Introduction of Megace(R) ES, the First Branded Pharmaceutical Product Developed by Par

SPRING VALLEY, N.Y., Oct. 27 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX - News) today reported total revenues of $118.7 million for the third quarter ended October 2, 2005. For the quarter, reported net income was $25.3 million and diluted earnings per share were $.74. This result includes a $13.3 million after-tax gain on the sale of shares of common stock of New River Pharmaceuticals, Inc., and a $6.4 million tax benefit resulting from the resolution of certain tax contingencies. Third-quarter results also include a non-cash charge of $4.4 million, after tax, for the impairment of assets related to Par's Abbreviated New Drug Application (ANDA) for latanaprost ophthalmic solution. Excluding these items, net income was $10.0 million and diluted earnings per share were $.29. This is compared with reported revenues of $151.6 million and a net loss of $35.1 million, or $1.03 loss per diluted share, in 2004. Excluding a non-cash charge of $51.2 million, after tax, for the write-off of acquired in-process research and development (IPR&D), net income was $16.2 million and diluted earnings per share were $.48 for the same period a year ago. "The third quarter benefited from the introduction of Megace ES and an improving gross margin," said Scott Tarriff, president and chief executive officer. "Contributing to this improvement were new, internally-developed products such as Megace ES and Par's generic version of Ultracet®. Par's financial performance, year-to-date, reflects the considerable investment necessary to build a branded pharmaceutical business. However, with the successful launch of Megace ES now underway, Par has passed an important milestone. We believe that the Megace ES launch will ultimately be viewed as the transforming event that established Par as a successful specialty pharmaceutical company."

Third-Quarter Review

The appetite stimulant, Megace ES (megestrol acetate) concentrated oral suspension, was launched in the third quarter. Sales of Megace ES, Par's first branded pharmaceutical product, were $10.2 million. In just 13 weeks since its launch, Megace ES now holds an 8.8 percent share of new prescriptions in the U.S. market for megestrol acetate oral suspension products, according to the IMS Health national prescription audit for the week ending October 14, 2005.

In the third quarter, Par's leading generic product, tramadol hydrochloride (HCl) and acetaminophen tablets, contributed sales of $23.9 million. The product is the generic version of the analgesic Ultracet and was introduced in April 2005. Par was awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for the product.

For the third quarter, sales of paroxetine HCl tablets, the generic version of the antidepressant Paxil®, megestrol acetate oral suspension, the generic form of Megace, and fluoxetine, the generic equivalent of Prozac®, totaled $19.2 million. This is compared with total sales of $59.0 million in the same period a year ago. The lower sales of these three products primarily reflect the impact of increased generic competition and its corresponding effect on pricing and market share.

Par's third-quarter gross margin was 45 percent of sales, compared to 39 percent in 2004. The increase in the company's gross margin reflects, in part, the introduction of new, internally-developed products. These higher- value products include Megace ES, and tramadol HCl and acetaminophen tablets.

Third-quarter selling, general and administrative (SG&A) expense increased 42 percent to $22.9 million. SG&A expense included $6.8 million of sales and marketing expenses associated with the introduction of Megace ES. Increased legal fees and additional personnel costs across various administrative functions also contributed to the increase in SG&A expense during the quarter.

Research and development (R&D) expense of $15.0 million declined from $17.1 million in the third quarter of 2004. This decline resulted primarily from reduced spending on biostudies, and lower outside product development costs in the quarter.

In the third quarter, Par recognized an investment gain of $13.3 million, after tax, on the sale of Par's remaining shares of common stock of New River Pharmaceuticals, Inc. Par purchased shares of New River in an initial public offering on August 5, 2004.

The third quarter includes a $6.4 million tax benefit resulting from the resolution of certain tax contingencies. Excluding this benefit, Par's effective tax rate would have been 37 percent in the period.

Nine-Month Review

For the nine months ended October 2, 2005, total revenues were $333.2 million, compared with $575.9 million for the same period in 2004. For the first nine months of the year, Par reported net income of $26.6 million and diluted earnings per share of $.77. Results for the first nine months include a $10.1 million, after tax, net gain related to investments, the $6.4 million tax benefit and the $4.4 million, after tax, asset impairment. Excluding these items, net income was $14.5 million and diluted earnings per share were $.42 for the first nine months of 2005. This is compared with reported net income of $25.0 million and reported diluted earnings per share of $.71 for the same period a year ago. Excluding the $51.2 million after-tax write-off of acquired IPR&D, and an after-tax gain of $1.7 million associated with the sale of a company facility, net income was $74.5 million and diluted earnings per share were $2.13 for the first nine months of 2004.

SG&A expense increased 40 percent to $69.4 million for the first nine months of 2005. SG&A expense included $16.8 million of sales and marketing expenses associated with the introduction of Megace ES.

For the first nine months of 2005, investment in R&D increased 43 percent to $48.4 million. This includes $19.6 million for the development of proprietary pharmaceutical products. The substantial increase in R&D underscores Par's commitment to identify, formulate and develop a continuing stream of new branded and generic pharmaceutical products. Par currently has 54 regulatory filings awaiting approval from the U.S. Food and Drug Administration (FDA). This includes 53 ANDAs targeting branded pharmaceutical products with U.S. sales of approximately $29 billion.

For the first nine months, Par recognized a net investment gain of $10.1 million, after tax. This includes a $15.3 million after-tax gain on the sale of shares of common stock of New River Pharmaceuticals, Inc. and an unrealized loss of $5.2 million, after tax, reflecting the impairment of Par's investment in Advancis Pharmaceutical Corporation.

Since the end of the second quarter of 2005:

* Par promoted Michael Graves and John A. MacPhee to the newly created
positions of president, Generic Products Division, and president,
Branded Products Division, respectively. Mr. Graves and Mr. MacPhee
were also elected corporate officers by Par's board of directors;

* Par entered into an agreement with MN Pharmaceuticals, based in
Istanbul, Turkey, to develop and market generic versions of as many as
10 injectable pharmaceuticals;

* Par began shipping leflunomide tablets, cholestyramine regular and light
powder for oral suspension, and clonazepam orally disintegrating tablets
(ODT);

* Par announced that its licensing partner, Amide Pharmaceutical, Inc.,
received final FDA approval and began shipping mirtazapine ODT. The
product was developed by Par's wholly-owned subsidiary, Kali
Laboratories, Inc; and

* Par terminated its partnership agreement with Advancis Pharmaceutical
Corporation. The decision to terminate the partnership followed the
release of disappointing results from Advancis' Amoxicillin PULSYS Phase
III clinical trials.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace® ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 prescription drugs. For press release and other company information, visit http://www.parpharm.com.

Certain statements in this press release constitute "forward-looking statements" within the meaning of 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 essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.

[mrmarket]

Par Unit Gets FDA OK for Generic Zofran
Monday November 21, 1:19 pm ET
Par Pharmaceutical Says FDA Gives Subsidiary Final Approval to Market Generic Version of Zofran


SPRING VALLEY, N.Y. (AP) -- Par Pharmaceutical Cos. said Monday that the Food and Drug Administration gave the drug maker's Kali Laboratories unit final approval to market a generic version of GlaxoSmithKline PLC's nausea treatment Zofran ODT.
ADVERTISEMENT


However, it will be sometime before Kali can release the drug. Kali and GlaxoSmithKline are tied up in lawsuits over patents that will remain valid until December 2006, when the unit expects to launch the drug. The company also said that Kali will get 180 days of market exclusivity when it does launch since it was the first to file for generic approval for the drug.

The approval covers 4 milligram and 8 milligram tablets of ondansetron hydrochloride, the active ingredient in Zofran. The drug is approved to prevent nausea and vomiting associated with chemotherapy, radiotherapy, or certain operations.

Under an agreement with Kali, Pliva Inc. has exclusive U.S. rights to market the generic, and the companies will split the profits.

Annual U.S. sales of Zofran ODT are about $225 million, the company said.

Par Pharmaceutical shares rose 17 cents to $26.30 in afternoon trading on the New York Stock Exchange.

[mrmarket]

This will help sales:

Par Pharmaceutical's Partner Receives Final Approval to Market Ribavirin Tablets
Monday December 5, 2:01 pm ET
Par to Begin Shipping Ribavirin Tablets Immediately


SPRING VALLEY, N.Y., Dec. 5 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX - News) today announced that its marketing partner, Three Rivers Pharmaceuticals, has received final approval by the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for ribavirin 200 mg, 400 mg and 600 mg tablets. Ribavirin, a synthetic nucleoside analogue with antiviral activity, is used in combination with peginterferon alfa-2a for the treatment of hepatitis C. Ribavirin tablets are currently marketed by Roche Pharmaceuticals under the brand name Copegus®. Annual U.S. sales of the product are approximately $200 million.



Under the terms of its agreement with Three Rivers, Par will co-market Three Rivers' ribavirin tablets and the companies will split profits from the sales of the product. Par will begin shipping ribavirin 200 mg tablets immediately.

Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products, the first of which is Megace® ES, for specialty markets. Par currently manufactures, markets or licenses more than 90 prescription drugs. For press release and other company information, visit http://www.parpharm.com.

[jiesen]

PRX going up- at last!

Maybe PRX is starting to turn around after all... it's finally breaking out of its 4-month rut:

http://finance.yahoo.com/q/bc?s=PRX&t=6m&l=on&z=m&q=l&c=

[jiesen]

wow! sure glad I never put a stop on this one!

http://biz.yahoo.com/prnews/051216/nyf015.html?.v=33

[jiesen]

http://www.nasdaq.com/asp/quotes_full.asp?mode=&kind=shortint&symbol=HW&symbol=PRX&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&symbol=&FormType=&mkttype=&pathname=&page=short&selected=PRX

short interest is up around 10% this month, now more than double where it was a year ago. the shorts never thought PRX would make it back over $30 again, but these recent product approvals and acquisitions are likely catching them off guard now. will the ensuing short squeeze take this stock back into the 50s and 60s again? we'll see...

[jiesen]

Par's latest drug approval- generic Cefzil

http://biz.yahoo.com/prnews/051223/nyf007.html?.v=36

Par Pharmaceutical Receives Final Approval to Market Generic Cefzil(R) Tablets
Friday December 23, 6:00 am ET
Par to Begin Shipping Cefprozil Tablets Immediately

SPRING VALLEY, N.Y., Dec. 23 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX - News) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for cefprozil tablets. Cefprozil is the generic version of Bristol-Myers Squibb Company's broad-spectrum cephalosporin antibiotic Cefzil®. Annual U.S. sales of Cefzil® tablets exceed $100 million, according to IMS Health.

Par will begin shipping the product immediately. Cefprozil tablets will be available in 250 mg and 500 mg strengths. Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced Megace® ES, its first branded pharmaceutical product, and expects to launch its second in early 2006. Par's Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 90 generic drugs. For press release and other company information, visit http://www.parpharm.com.

[mrmarket]

Orchid gets U.S. nod for cefprozil oral suspension
Mon Jan 2, 2006 02:13 AM ET
MUMBAI, Jan 2 (Reuters) - India's Orchid Chemicals & Pharmaceuticals Ltd. (ORCD.BO: Quote, Profile, Research) said on Monday it had received approval from the U.S. Food and Drug Administration for a generic of an oral suspension form of Bristol-Myers Squibb's (BMY.N: Quote, Profile, Research) antibiotic Cefzil.
Orchid's shares were up 2.6 percent at 247.5 rupees in afternoon trade.

Earlier this month, the company had earlier got approval for tablets of the generic called cefprozil.

The products will be launched in the United States through Orchid's marketing partner Par Pharmaceuticals Cos Inc. (PRX.N: Quote, Profile, Research) .

[jiesen]

PRX gets 11 more generic drugs, adding $15M annual revenue

This is great news for PRX, check it out:

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh66288_2006-01-23_15-45-59_n23187075_newsm

UPDATE 1-Teva, IVAX say U.S. FTC clears merger
Mon Jan 23, 2006 10:45 AM ET
(Adds details, analyst comment, share prices)

NEW YORK, Jan 23 (Reuters) - The U.S. Federal Trade Commission has cleared Teva Pharmaceutical Industries Ltd's (TEVA.O: Quote, Profile, Research) $7.4 billion acquisition of IVAX Corp. (IVX.A: Quote, Profile, Research) provided the companies divest rights to 15 generic drugs, the generic drugmakers and the agency said on Monday.

The U.S. approval paves the way for the merger to close Jan. 26, the companies said, creating a powerhouse generic pharmaceutical company.


"Teva now represents the largest generic company by far in terms of revenue, breadth of product portfolio and pipeline, and global reach," Richard Watson, an analyst with William Blair & Co, wrote in a research note.

The companies said they will be required to divest certain formulations of 11 overlapping generic drugs with total annual sales of about $15 million, as part of a consent order accepted for public comment by the FTC. They said they also will have to assign distribution agreements regarding four drugs to other companies.

Par Pharmaceutical Cos. Inc. (PRX.N: Quote, Profile, Research) will receive rights to 11 of the divested drugs, while Barr Pharmaceuticals Inc. (BRL.N: Quote, Profile, Research) will receive rights to four of them, according to the FTC.

"The merger as originally proposed likely would have caused significant harm to U.S. consumers," Jeffrey Brennan, associate director of the FTC's Bureau of Competition, said in a statement. "The commission's consent order will protect U.S. consumers from higher prices for these important generic drugs."

One of the drugs, amoxicillin clavulanate potassium, is a penicillin antibiotic with annual sales of about $676 million, according to the FTC. The agency said the acquisition would have left Israel-based Teva with more than half the market. Shares of Teva fell 8 cents to $42.37 in morning trade on the Nasdaq. Barr shares were up 98 cents, or 1.5 percent, at $65.83 on the New York Stock Exchange, where Par shares rose 16 cents, or 0.5 percent, to $31.19.