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Nausea Example 1: Chemotherapy: Ondensatron |
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Please click here if you wish to skip directly to your Table of Contents listing the most recent Abstract Database additions. |
| Table of Contents |
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| Archived Abstracts |
| Ondansetron HCl (Sales Numbers) | |||
| Cipla & Ondansetron | |||
| Emeset/ondansetron & Cipla | |||
| Gedeon Richter Ltd. & Ondansetron | |||
| Emetron/ondansetron & Gedeon | |||
| GlaxoSmithKline & Ondansetron | |||
| Zofran/ondansetron hydrochloride & GSK | |||
| Abstract Title | Lead Author | Publication | Pub Date |
| Diagnosis: Cancer, but hope evolving | Jan Biles | Topeka Capital-Journal | 2008-05-11 |
| Return to ToC | |||
| Zofran ODT/ondansetron & GSK | |||
| Korea United Pharmaceuticals & Ondansetron | |||
| Emodan/ondansetron & Korea United | |||
| Zentiva a.s. & Ondansetron | |||
| Ondemet/ondansetron & Zentiva | |||
| Chemotherapy AND Ondansetron & Ondansetron | |||
| Abstract Title | Lead Author | Publication | Pub Date |
| G2: Wellbeing: One in 10,000 pregnant women has nausea so severe that it can, in rare cases, affect the unborn baby's growth. Is there anything that can help? Zoe Williams reports: Sick to the stomach | Zoe Williams | The Guardian | 2008-05-13 |
| Other News To Note. | [none given] | BIOWORLD Today | 2008-05-12 |
| Q1 2008 Par Pharmaceutical Companies, Inc. Earnings Conference Call - Final. | [none given] | Fair Disclosure Wire | 2008-05-09 |
| Par Pharmaceutical Reports First Quarter 2008 Results. | [none given] | PR Newswire | 2008-05-08 |
| Return to ToC | |||
| Anti-emetic OR Antiemitic & Chemotherapy | |||
| Emesis & Chemotherapy | |||
| Ondansetron HCl (Sales Numbers) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cipla & Ondansetron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Emeset/ondansetron & Cipla | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Gedeon Richter Ltd. & Ondansetron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Emetron/ondansetron & Gedeon | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| GlaxoSmithKline & Ondansetron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Zofran/ondansetron hydrochloride & GSK | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Diagnosis: Cancer, but hope evolving Lead Author: Jan Biles Topeka Capital-Journal, 2008-05-11 New drugs, technology increase survivability Four years ago, Linda Martin's life turned upside down. During a routine examination, her gynecologist found a lump in one of her breasts. *** Click Here to view the full text of this abstract *** It was a smart move. "The surgeon told me it was malignant," she said. "It still threw me for a curve." Martin, 48, of Topeka, wondered if the chemotherapy and radiation she was facing would change her appearance, induce vomiting and zap her energy. She wondered if she would die. "All my worst fears didn't come to fruition," she said. Like many Americans diagnosed with cancer, Martin discovered that new developments in drugs and technology have helped counter the debilitating side effects of cancer treatment, improve treatment modalities and increase survival rates. Anita Leonard, registered nurse and site coordinator of oncology research at Cotton-O'Neil Cancer Center at Stormont-Vail Health Care, said some cancers once thought to be life-ending now are considered chronic conditions. While five-year survival rates for lung and pancreas cancers haven't improved much, the American Cancer Society reports strides have been made in treating colo-rectal and breast cancer and some lymphomas. "You can live with cancer many years if you can control it and it doesn't grow," Leonard said. Treatment modalities Ralph Reymond, director of the radiation oncology department at St. Francis Health Center, has seen many changes in the treatment of cancer since he left John Hopkins Medical Center in Baltimore nearly 36 years ago. Instead of seeing cancer as a single ailment, he said cancer is viewed today as "a whole slew of diseases" with individualized treatments. All cancers have one thing in common - cell division that is out of control. All cells go through a cycle of resting, growth, division and death. Cancerous cells, however, don't die and keep on dividing. "You can have a cell that is immortal, and cancer can be immortal," he said. The biggest breakthrough in the treatment of cancer is high- speed computer technology, Reymond said. Current technology that helps doctors determine the size, location and type of tumor include: n Computer tomography (CT scan), which use X-rays to provide an anatomical description of a tumor. n Magnetic resonance imaging (MRI), which uses magnetic fields and radio waves to create an anatomical description of a tumor. n Positron emission tomography (PET scan), a type of nuclear imaging that shows how the tumor is behaving physiologically, biologically and metabolically. n Ultrasound, where sound waves are used to produce pictures of the inside of the body. n Intensity modulated radiation therapy (IMRT), which uses CT, MRI and PET as databases that can be fused together to get an overlay of various types of information. "An oncologist plugs in sets of goals and constraints of dose on specific organs," Reymond said, referring to the IMRT software. "Then it takes the computer program three to six hours to calculate the information, which results in a dose distribution picture in three dimensions." He said the software also shows an oncologist how much radiation is going to the organs in questions, both diseased and nondiseased. "This in turn maximizes the dose to the tumor while minimizing the dose to surrounding structures," he said. Reymond said a patient typically receives radiation therapy as an outpatient, with the administration of the beam taking about 10 minutes. Radiation often is paired with chemotherapy, which kills cancer cells or stops them from growing. Brandon Vakiner, oncology clinical pharmacist at St. Francis Health Center, said several new drugs have revolutionized cancer treatment. Examples include: n 5-HT3 receptor antagonist, a serotonin inhibitor that is absorbed in the gastrointestinal tract and prevents nausea and vomiting after chemotherapy or radiation. n Granulocid-colony stimulating factor, which stimulates the production of granulocytes, a type of white blood cell, in patients who are undergoing therapy that reduces the white blood cell count. This drug prevents infections and fevers caused by chemotherapy, but it doesn't treat the cancer. "It's keeping more people alive now than anything," Vakiner said, adding the drug also allows patients to have outpatient rather than inpatient therapy. After a lumpectomy in June 2004, Martin underwent four rounds of chemotherapy in about three months. Two drugs -Adriamycin and Cytoxan - were pumped into her body through a "port," or tube inserted into the upper chest to make chemotherapy easier and more comfortable. "Chemo's a weird feeling because you know they're pumping poison into you," she said. Martin, an employee of AT&T for 28 years, was able to work half days during her chemotherapy. Although anti-nausea drugs were available to her, she never experienced vomiting, diarrhea or sores in her mouth. She did lose her hair, but had fun wearing colorful bandanas until it began growing back. Three weeks after her last chemo injection, Martin started receiving radiation treatments - five days a week for seven weeks. She scheduled her radiation appointments in the early morning and was able to work full time. "I had burning but no blisters (from the radiation)," she said, adding she was given salves to help ease the redness and burning. Martin successfully completed her treatment. She now has follow- up visits with her doctor every six months and will take Arimidex, which lowers the amount of estrogen in the body, for about five years. What the future holds In addition to surgery, chemotherapy and radiation, Vakiner said cancer treatment in the future may focus on targeted therapies. In target therapy: n Antibodies attach to receptors on the surface of cells and then signal that it is time for the cell to die; stop a process, which kills the cell; or "tag" the cancer cell so the immune system will destroy it. n Blockers attach to receptors, on the surface or inside the cell, and prevent enzymes from activating the cell process needed to keep the cell alive or from growing. They also keep receptors and other molecules from making contact to prevent the cell process from starting. Vaccines against cancer are being researched, he said, but results "aren't spectacular yet." Vakiner said new discoveries in diagnosis and drug treatment occur every year. "What I knew a month ago has become obsolete," he said. Stormont-Vail Health Care, through Cotton-O'Neil Cancer Center, is a founding clinical research partner of the Midwest Cancer Alliance, a network of cancer professionals dedicated to increasing patients' access to cutting-edge clinical trials, innovative prevention and other services. Leonard said Cotton-O'Neil has 72 clinical research trials open. Most of them involve the treatment of breast, gastrointestinal, genitourinary, gynecologic, lung and head/neck cancers, as well as leukemia, lymphoma, melanoma and myeloma. "It's all due to research that we've improved what we're doing (to treat cancer)," she said. Clinical research trials were helpful in proving the effectiveness and safety of Tamoxifen and Zofran, she explained. Tamoxifen, an anti-hormone pill, can be given to patients after breast cancer surgery or chemotherapy to reduce the risk of the cancer spreading to other sites. Zofran can be used to prevent nausea and vomiting caused by chemotherapy and radiation. When she started working at the cancer center, Leonard said the few drugs available to treat colon cancer weren't very effective. "Now six to eight drugs can be used with colon cancer," she said. "Now, you have choices. If one drug doesn't work, another will." Leonard said her department prescreens every Cotton-O'Neil patient to see if they are available for a clinical trial. About 85 percent to 90 percent of those who are eligible agree to participate. "Every pill you put in your mouth we got through a clinical trial," Leonard said. Beating the odds Martin, the breast cancer survivor, said she is grateful for "the guinea pigs who went before me," the patients who endured tougher treatments years ago and allowed physicians to learn from their experiences. So is Deann Behring, 44, of Meriden, who was diagnosed with brain cancer in March 2006 after getting very ill during a trip to Paris. Behring said she and her daughter, Nichole Jerdee, were visiting the Eiffel Tower when she "turned beet red and started throwing up." She was hospitalized and diagnosed with a brain tumor the size of a grapefruit. "I was told in most cases it was fatal," she said. "I was scared I was going to die, and I didn't want to die." Behring made it back to the United States and underwent surgery to remove the tumor at The University of Kansas Hospital. After her discharge, she began a two-month regimen of daily radiation treatments and Temodar, an oral cancer-fighting medication that is activated by the body's metabolism. The regimen eventually was cut back to one week every three weeks, beginning in June 2006 and continuing through April. Behring, who had returned to her job at Heart of America Hospice on a part-time basis, was told in late April that she is cancer- free. Behring said she beat the odds - most people with her type of brain cancer don't live beyond two years after diagnosis. But beating the odds runs in her family: Her mother was diagnosed with non-Hodgkin lymphoma when Behring was 16 and underwent aggressive chemotherapy. Her mother is still alive. "My mom shouldn't have lived. I shouldn't have lived," she said, "but we did because of advancements in treatment." Jan Biles can be reached at (785) 295-1292 or jan.biles@cjonline.com. MIB Abstract ID Number: 15521 *To access this Factiva article the user must create an account. |
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| Zofran ODT/ondansetron & GSK | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Korea United Pharmaceuticals & Ondansetron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Emodan/ondansetron & Korea United | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Zentiva a.s. & Ondansetron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ondemet/ondansetron & Zentiva | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Chemotherapy AND Ondansetron & Ondansetron | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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G2: Wellbeing: One in 10,000 pregnant women has nausea so severe that it can, in rare cases, affect the unborn baby's growth. Is there anything that can help? Zoe Williams reports: Sick to the stomach Lead Author: Zoe Williams The Guardian, 2008-05-13 The subject of extreme morning sickness has reared its head with a story this week of a young woman named Fiona Shaw, who was so ill with the condition that her baby had to be delivered two months premature, by caesarian section, and weighed a tiny 2lb 5oz. After the baby's first week of life, her weight dropped to just 2lb, the Daily Mail reported. So ginger biscuits are not, after all, an answer to everything.
*** Click Here to view the full text of this abstract *** Shaw suffered from a condition known as hyperemesis gravidarum, which, if we can just strip the mystery out of the medical profession for a second, means "vomiting a lot because you are pregnant". Clearly, the severity of her case was unusual - by her 28th week, she had lost 3st, having been able to swallow nothing on some days but half a biscuit. Even some weeks before the caesarean, she had been admitted to hospital with dehydration. This makes her the one in 10,000 women who suffers from severe HG - regular HG, which affects one woman in a hundred, can be treated with a variety of drugs. It is extremely unpleasant but unlikely to result in the foetus failing to thrive as Fiona Shaw's did. A useful analogy (as well as a side effect, but that's another story) is with depression - think of morning sickness as like feeling a bit miserable; a brisk walk in the sunshine might help. And you would expect to be rid of morning sickness by the start of the second trimester. Regular HG, by contrast, is equivalent to fully fledged depression. There are various drug treatments available, most of them antiemetics. The causes have not been definitely established, but there does seem to be a genetic component, and broadly speaking, it results from an adverse reaction to the flood of pregnancy hormones. It is possible that you might end up in hospital being given fluids by intravenous drip, but unlikely that the baby would have to be induced a long time before term. The foetus is not affected by the illness of the mother, unless she is eating so little that it is getting no nutrients at all, and then we are really talking about half a biscuit a day. Nevertheless, HG can be unutterably demoralising, especially when accompanied, as it sometimes is, by ptyalism, a condition whereby you cannot swallow your own saliva without vomiting. There are no home remedies specific to HG beyond those normally suggested for morning sickness, and HG sufferers are often piqued at the implication that what they are experiencing is just a bit of queasiness. However, used in conjunction with prescribed antiemetics, the following things are all said to help: taking vitamin B6; getting a lot of sleep; homeopathy; acupressure wristbands; eating little and often; only eating things that are very hot or very cold; ginger, peppermint, dry biscuits, pineapple, papaya, cantaloupe and vinegar in hot water. Should you present at the GP with symptoms of frequent vomiting and weight loss, you will probably be started off on an antihistamine. Its only nuisance is tiredness, but you will be so tired anyway, what with the malnutrition and the foetus leaching all your energy, that you might not notice. The main problem is that if you can't keep anything down, tablets won't work. Then you'll end up on suppositories, which are not only icky, they are rarely as strong. So work on keeping that tablet down. One of the defining symptoms of severe HG is that the drugs don't work, and there sadly isn't a whole other stable of drugs that medics are holding back for when things get really bad. One school of thought is that Charlotte Bronte probably died of severe HG, along with her unborn child. Elizabeth Gaskell identified her "sensations of perpetual nausea and ever-recurring faintness" but since, at that time and indeed until the middle of the last century, doctors thought morning sickness was psychosomatic - resulting from ambivalent feelings about becoming a mother - it could have been politeness that caused Bronte's doctor to write TB on her death certificate. Death from HG would probably be the result of kidney or heart failure. Back to these drugs that either don't work or don't exist: there are two, basically nuclear, options, one a steroid, prednisolone, which is widely used in the US, and one an antiemetic, Zofran, which was developed for the after-effects of chemotherapy. Both of these are rarely prescribed in Britain, the first because steroid use during pregnancy has not been thoroughly enough researched to rubber stamp it, the second because it is extremely expensive. One couple managed to persuade their primary care trust that it was cheaper to prescribe Zofran than simply keep the woman in hospital for her full pregnancy, but you would need a pretty flexible and receptive PCT to emerge victorious from a conversation in which you, a layperson, dared to talk about drugs and budgets in the same sentence. It is salutary to note that the tragedy over thalidomide - the anti-nausea drug banned for use by pregnant women in the 1960s after it was shown to be damaging the development of some foetuses - continues to echo through obstetrics. The appetite simply is not there to research pharmaceutical solutions to sickness unless things get phenomenally bad, which they only rarely do. If the drugs will not work or are unavailable, and if the HG is so severe that the mother cannot satisfy her and her baby's nutritional needs, even with IV fluids, the only other option is a termination, a heart-breaking choice considering that the woman has already been fighting the sickness for some weeks. Morning sickness is very unpredictable: you might get it horribly for the first pregnancy and not at all for the second. Hyperemesis gravidarum, however, has a 75% chance of recurring in later pregnancies, according to one study. It really is a frightful business. Jokes about how it is a good way to keep the weight off could not be less appropriate * MIB Abstract ID Number: 15520 *To access this Factiva article the user must create an account. |
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Lead Author: [none given] BIOWORLD Today, 2008-05-12, 1541-0595; Volume 19; Issue 92 BioMS Medical Corp., of Edmonton, Alberta, entered a royalty and assignment agreement with Orcrist Bio. Inc., of Calgary, Alberta, for HYC750, a technology based on hyaluronic acid being developed to treat side effects of chemotherapy. BioMS held an exclusive worldwide license to HYC750 from the University of Alberta. As a result of the agreement, BioMS terminated its license and the university transferred the license to Orcrist. Under the terms, BioMS will receive certain milestone payments in addition to a royalty on net sales of products that otherwise would have infringed on patents related to the HYC750 technology. Specific financial terms were not disclosed. *** Click Here to view the full text of this abstract *** Spectrum Pharmaceuticals Inc., of Irvine, Calif., sold its abbreviated new drug applications for its injectable generic drugs -- ondansetron, carboplatin, fludarabine and mitoxantrone -- to Sagent Pharmaceuticals Inc., of Schaumburg, Ill. Proceeds will be used to advance Spectrum's late-stage clinical programs. Financial terms were not disclosed. COPYRIGHT 2008 A Thomson Healthcare Company Document BIOW000020080513e45c00007 MIB Abstract ID Number: 15525 *To access this Factiva article the user must create an account. |
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Q1 2008 Par Pharmaceutical Companies, Inc. Earnings Conference Call - Final. Lead Author: [none given] Fair Disclosure Wire , 2008-05-09 OPERATOR: Good day, ladies and gentlemen, and welcome to Par Pharmaceutical's first-quarter 2008 earnings call. My name is Jasmine, and I will the operator for today. (OPERATOR INSTRUCTIONS). I would now like to turn the presentation over to your host for today's call, Ms. Allison Wey. You may proceed, ma'am. ALLISON WEY, SENIOR DIRECTOR, IR, PAR PHARMACEUTICAL COMPANIES, INC.: Good morning. Thank you. Welcome to the Par Pharmaceutical's earnings call to discuss the Company's first-quarter 2008 results. I hope you have had a chance to review the press release, which we issued yesterday afternoon. A copy of the press release is also available on our website at www.parpharm.com. In addition, we are conducting a live webcast of this call, which is also available on the website. We're joined this morning by Pat LePore, Chairman, President and CEO; Gerry Martino, Chief Operating Officer; Veronica Lubatkin, Chief Financial Officer; John MacPhee, President of Strativa, and Paul Campanelli, President of Par's Generic Division. *** Click Here to view the full text of this abstract *** Pat will provide opening remarks and comment on our achievements here today. Veronica will provide detail on the first-quarter results and our outlook for 2008. Paul will provide some insight on the potential of Par's generic pipeline through 2012. And after Pat's closing remarks, we will open the call for questions. Please note that today's conference call and webcast may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made on this call contain information that is not historical, these statements are essentially forward-looking and are subject to various risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. I would now like to turn the call over to Pat LePore. PAT LEPORE, CHAIRMAN, PRESIDENT & CEO, PAR PHARMACEUTICAL COMPANIES, INC.: Thank you. Welcome and thank you for joining us today as we review Par's results for the first quarter of 2008. For the first three months of 2008, Par had revenues of $154.9 million and net income of $2.6 million or $0.08. Adjusting for a $5 million payment to Alfacell for the commercialization rights to ONCONASE, earnings per share were $0.17. This is compared with reported revenues of $234.2 million and net income of $41.5 million or $1.19 per diluted share for the same period in 2007. Adjusting for a onetime $20 million gain, earnings per diluted share were $0.84 in the first quarter of 2007. The decrease in revenues primarily reflects a year-over-year decline in new generic product launches and increased pricing pressures on existing generic products. However, we saw a 29% increase in Strativa's revenues from Q1 2007, driven mainly by increased net sales of Megace ES. Before Veronica goes into the details of our first-quarter results and Paul takes you through the generic pipeline opportunities, I want to take a minute to highlight some of the accomplishments we have made in both of our businesses in the first four months of this year. These accomplishments are evidence that we are executing on the strategy which we introduced at our Analyst Day in September, which should help make the case to our investors as to why we believe the value of our Company can grow significantly in 2009 and beyond. Working towards a goal of $250 million in annualized revenues by year-end 2010, Strativa announced in January that it had acquired the commercialization rights to ONCONASE from Alfacell, currently in development for unresectable malignant mesothelioma. Phase III results are currently being analyzed, and we expect to announce the results during the second quarter. If approved, we believe that ONCONASE has the potential to provide Strativa with a unique oncology platform with orphan drug status, strong intellectual property and future expanded indication opportunities. In March Par began bioequivalency studies for Zensana, following the stability tests that were initiated in Q4 of 2007. Assuming successful completion of the studies and discussions with the FDA, we plan to file an NDA around the end of this year. Datamonitor estimates the commercialization potential for Zensana in the United States to be over $110 million in peak annual sales. Last month topline results from a Phase III study were announced for Loramyc, our most advanced branded pipeline product. Loramyc is a local nuclide piece of buckle tablet of miconazole and is in development for oral pharyngeal candidiasis or OPC. Loramyc achieved the protocol specified primary and secondary endpoints that required noninferiority to the Mycelex Troche. These endpoints included clinical cure after seven and 14 days of treatment, clinical improvement and partial response. Analyses of the study continue, and a pre-NDA meeting with the FDA has been scheduled. Assuming a continued favorable review of the data and positive discussions with the FDA, we plan to file a NDA in the fall. At a branded price, this market is worth approximately $500 million in annual net sales, similar in size to the megestrol market in which we compete with Megace ES. The dynamics of the OPC market are similar to the megestrol market in that it is a well-established category that has been genericized for years, and Strativa is bringing to market an innovative new formulation. As with Megace ES, the key to a successful launch are securing reimbursement and generating trial among OPC treaters. Accordingly, we consider Megace ES to be a good proxy with commercial potential of Loramyc. And just earlier this week, we announced that we amended our agreement with Spectrum Pharmaceuticals for $20 million to increase our share profits from the generic versions of GlaxoSmithKline's Imitrex injection. This will be immediately accretive to 2008 earnings and will provide a strong return on the Company's investment. As a result of the agreement, Par's profit share will increase from 38% to 95% from the commercialization of sumatriptan injection. To summarize, we're building a foundation for future growth, and we're excited about the prospects in both businesses and are working diligently at maximizing profitability and improving shareholder value. Now I will turn the call over to Veronica to cover the details of our financial results. VERONICA LUBATKIN, EVP & CFO, PAR PHARMACEUTICAL COMPANIES, INC.: Thank you, Pat. Good morning. I'm taking you through our results for the first quarter of 2008. I will start with a few comments on our revenue and gross margin results. Total revenues for the three months ended March 29, 2008 were $155 million, decreasing 34% from total revenues of $234 million for the same period last year. Revenues for generic products in 2008 were $130 million, decreasing $85 million or 40% from generic revenues of $215 million in 2007. Lower generic revenues in 2008 were driven by competitive pressure, including for fluticasone which declined $32 million, propranolol declining $26 million, amoxicillin down $14 million, tramadol down $6 million, glyburide/metformin declining $4.5 million, cabergoline which decreased $3 million and lower royalties driven by ondansetron tablets, which launched during the fourth quarter of 2006. Partially offsetting these declines were increased sales of metoprolol resulting from the launch of additional strength in the third quarter of 2007 with an increase of $31 million. Revenues for Strativa were $25 million in the first quarter of 2008, increasing almost $6 million or 29% over revenues of $19 million for the first three months of 2007, driven by net sales gains from Megace ES. The Company's gross margin of $49.5 million for the three months ended March 29, 2008 decreased $38 million from $88 million for the three months ended March 31, 2007 and is driven by the sales and royalty impacts just discussed. The Company's gross margin percentage declined from 37.4% to 32%, driven primarily by the increased sales of lower margin metoprolol and lower royalty income and lower sales of higher margin products such as propranolol, which launched in February of 2007, tempered by increased net sales and margins from Megace ES. For gross margin I would like to take a minute to also provide a comparison of first quarter of 2008 versus fourth quarter of 2007. Declines versus fourth-quarter 2007 gross margin are driven by the expected lower sales of higher margin generic megestrol following a fourth-quarter 2007 backorder release, and tramadol following Par's exit from the market impacting the first quarter of 2008, as well as lower expected royalties and other product mix, including increased sales of lower margin metoprolol tempered by higher Strativa net sales for Megace ES. As a percent of net revenues, the gross margin of 32% in the first quarter of 2008 is below 37% in the previous quarter, driven by the sales impacts just discussed. Moving to operating expenses, the Company's research and development expenses of $17 million for the three months ended March 29, 2008 increased $3 million or 22% from $14 million last year. The increase in expense is primarily attributable to the upfront fee paid related to the in-licensing of ONCONASE of $5 million, partially offset by lower costs of roughly $2 million related to PAR-101 development costs. PAR-101 was divested in the first quarter of 2007. Total SG&A expenses of $31 million for the three months ended March 2008 declined $1 million or 4% from $33 million for the same period in 2007. Lower expenses related to sales and marketing of Megace ES, lower finance and accounting costs and lower stock-based compensation related to employment costs, which were tempered by increased legal fees related to ongoing litigation. During the first quarter of 2008, the Company recognized a gain on the sale of product rights of $1 million related to the sale of two ANDAs. In November 2007 the Company entered into an agreement to provide certain information and other deliverables related to Megace ES to enable the formal technology transfer to a third party that is seeking to commercialize Megace ES outside of the US. The Company recorded $625,000 in income in the quarter when the Company's obligations were fulfilled related to this agreement. The Company's effective tax rate for continuing operations for the three months ended March 29, 2008 and March 31, 2007 were 36% and 35% respectively. In summary, reported or GAAP net income for the first quarter of 2008 was $2.6 million or $0.08 per diluted share, which included a $5 million payment related to ONCONASE. Adjusting for this item, earnings per diluted share were $0.17 for the three months ended March 29, 2008. This is compared with reported net income of $41.5 million or $1.19 per diluted share for the same period in 2007, which included a $20 million gain on the sale to Optimer Pharmaceuticals Inc. of marketing rights to PAR-101. Adjusting for this item, earnings per diluted share were $0.84 in the first quarter of 2007. And now a review of liquidity and capital resources. Cash and cash equivalents of $231 million at March 29, 2008 increased $31 million from $200 million at the end of last year. Cash provided by operations was $18 million in the first quarter, driven by net income and adjusted primarily for depreciation and amortization of $6 million and share-based compensation of $3 million. Net accounts receivable increased by $20 million, driven by timing of customer collections, while inventories declined $20 million, driven by lower sales for certain products, some seasonality and the timing of receipts at the end of the year 2007. Payables due to distribution agreement partners increased $9 million, due mainly to higher sales of partnered products in the first quarter driven by metoprolol. First-quarter 2008 DSO of 76 days is about 10 days higher than expected and as compared to the end of 2007. This is driven by a major wholesaler that had overdue invoices of roughly $16 million, and these invoices were paid a few days following the quarter, which has brought the DSO back in line to around the 65-day range that we expect. As of the first-quarter 2008, inventory turns are approximately 4 times per year versus 3 times for Q4 2007. Turns have been proved driven mainly by the timing of receipt of goods and some seasonality in inventory at year-end 2007. Moving on to our 2008 guidance, the Company's projections, although there can be no assurances, are based on its results for the first three months of 2008, as well as management's estimates regarding the impact of product competition on existing products and the market opportunity for certain of Par's generic pipeline products. Full-year 2008 earnings per diluted share are projected to be in the range of $0.65 to $0.85, excluding any potential pre-launch spending and milestones related to Strativa's pipeline products and includes the estimated impact of four new generic product launches. Sumatriptan vials and kits, clonidine, dronabinol and certain strengths of Rispiradone ODT. The new products will have an expected fully diluted EPS impact of between $0.25 to $0.47 in 2008. Impacting 2008 and reflected in its full-year EPS guidance are several additional factors affecting our business, including, R&D spending, which will increase as a run-rate versus what was spent in the first quarter of 2008. On a full-year basis, we expect R&D to be roughly $55 million, excluding the Strativa $5 million milestone paid for ONCONASE or $60 million including the milestone. SG&A is expected to be roughly $121 million and may fluctuate due to legal costs associated with the Company's product litigation related to the success of its first-to-file generic strategy. The estimate does not reflect potential for strategic prelaunch activities, which could be in the range of $2 million to $5 million depending on timing of expected FDA approval. We expect continuing price pressure on the base generic business. However, with respect to erosion expected in 2008, it should be noted that with the exception of cabergoline the majority of our key generic products already have multiple competitors having experienced major pricing pressure in the last several quarters, and such erosion will be tempered by the resumption of sales of tramadol in the second quarter of 2008. As discussed earlier, we had exited the market in the fourth quarter of 2007 pursuant to a settlement agreement, and we were asked to come back into the market unrelated to the patent litigation. And finally, Megace ES is expected to contribute sales and margin growth in the remainder of 2008. I will now turn the discussion over to Paul who will provide an update on the generic business and provide more color around the future generic new product launches. PAUL CAMPANELLI, PRESIDENT, GENERICS DIVISION, PAR PHARMACEUTICAL COMPANIES, INC.: Thank you, Veronica, and good morning, everyone. At this time I would like to provide an update with respect to our current generic strategy, as well as provide some insight on our generic pipeline through 2012. Regarding strategy, we continue to take an aggressive role in maximizing profitability and addressing challenges by focusing on strategic product selection. Specifically first-to-file, first to market, high barrier to entry product targets remains our primary objective. We are continuously placing greater emphasis on internal product development, and our R&D team is delivering first-to-file opportunities. This approach will allow our sales and marketing efforts to drive share and allow us to retain greater revenues and profits. Further, our shift to internal development will allow for maximum agility when having to respond to trading pressures post-day 180. Our business development and licensing teams continue to identify internal Paragraph 4 opportunities and execute on select external development projects that will contribute to our fewer better product strategies. To date in 2008 our team has executed on several potential third-party first-to-file product opportunities, as well as negotiated two authorized generic prospects. Additionally we anticipate four new generic product launches with an estimated impact of $0.25 to $0.47 per fully diluted share. As Veronica mentioned, these products include sumatriptan vials and kits, the clonidine patch, dronabinol and certain strengths of Rispiradone orally disintegrating tablets. As Pat mentioned, we amended our agreement with Spectrum Pharmaceuticals for $20 million in cash to increase our share of profits from the generic version of GSK's Imitrex injection, which will be immediately accretive to 2008 earnings and provide a strong return on the Company's investment. As a result of the agreement, Par's profit share will increase from 38 to 95% from the commercialization of sumatriptan injection. As a result of the acquisition of remaining interest from Spectrum, we anticipate a range in net sales for the first six months from the product launch of 35 to $40 million and a gross margin range from 20 to $24 million. This strategic initiative will allow Par to be self-sufficient and agile when distributing to our trade partners while retaining control of revenue and margin. As pointed out in our press release, the sumatriptan injection line is approximately $20 million in brand sales. You will recall in February 2006 Par and Spectrum entered into a settlement agreement with GSK in order to resolve patent litigation. Under the terms of the agreement, we are permitted to launch with certainly on November 6, 2008, which is three months prior to the compound patent expiration of February 2009. Having said that, I would like to point out that Par is exclusive on the 4 milligram stat dose kit, the 4 milligram prefilled syringe and the 6 milligram stat dose kit. Additionally we are semiexclusive on 6 milligram prefilled syringe. These products will be provided to Par under a multiyear supply agreement from GSK. Lastly, Par has received a license from GSK to bring 6 milligram sumatriptan vial to market under supply agreement from a third-party contract manufacturer, again exclusively starting in November 2008. While generic competition is a fact of life, the promising detail I would like to point out is Par's generic sumatriptan starter kits and prefilled syringes are the exact devices that Imitrex patients have had access to since 1992. Now turning to our R&D efforts and to provide investors with additional information by which to analyze the company, Par is providing a range of value for certain key generic pipeline products. Understanding the volatility of the US generic market, as well as the uncertainty around the timing of product launches, we felt the simplest approach to provide you with reliable estimates of the value of our generic pipeline was by estimating the first six months of net sales and gross margins of each product in the year the product launches. Since each full six-month period may not be in the calender year the product launches, some of the value will be realized in the next calender year. Please note that these estimates do not include value after the initial six months following product launch. However, we do recognize that these product launches will have value past the first 180 days, and in fact, these products were targeted for development due to the higher barrier to entry and fewer expected competitors, therefore providing stronger profits post 180 days compared to lower barrier to entry commodity generics. Additionally while we are confident in our legal position, we need to emphasize to our investors that success is not guaranteed. As a result, we cannot predict with certainty a successful outcome on any given project. Therefore, there are no assurances of litigation success with any Paragraph 4 opportunity. Having said that, in 2009 we anticipate six key product launches that will have a range of net sales in the first six months of launch from 100 to $135 million and a gross margin range from 80 to $110 million. These products include Methylphenidate ER, Alprazolam ODT, Amlodipine in combination with benazepril, Propafenone ER, Nateglinide and Tramadol ER. In 2010 Par anticipates five key generic product launches that have a range of net sales from 60 to $80 million and a gross margin range from 42 to $56 million. These products include [Dexmethylene XR], omeprazole sodium bicarbonate oral suspension, omeprazole sodium bicarbonate capsules, Oxaliplatin and diazepam gel. In 2011 Par anticipates two key generic launches that have a range of net sales from 20 to $28 million and a gross margin range from 7 to $10 million. These products include Rozuvastatin and latanoprost. In 2012 Par anticipates two key generic launches that have a range of net sales from 14 to $21 million and a gross margin range from 12 to $17 million. These products include Amlodipine in combination with valsartan and fluostatin. With respect to future R&D efforts, our generic strategy includes a target of six to 10 first-to-file applications per year. That being said, for 2008 our internal team has their efforts focused on approximately 11 Paragraph 4 targets, and our external partners are focused on approximately five Paragraph 4 targets. Additionally our business development and licensing team are placing great emphasis on continuously identifying first-to-file first to market opportunities, which include in-licensing, additional transdermal patch opportunities, difficult to source API and technically challenging formulations. Authorized generics continue to be core strength of the team. Currently two opportunities have been solidified if and when our planned partners require a generic launch. We have now implemented an aggressive lifecycle management program focused on product longevity, post-day 180, as well as bringing cost savings to our existing base business. In closing, our team continues to execute against our strategic plan. We have been successful in our first-to-file submissions, and our generic business continues to show promising future strength. While our primary objective for 2008 has included refocusing R&D, supply chain and sales and marketing efforts, our current first-to-file status shows we're clearly headed in a positive direction. With that, I will turn the call back to Pat for closing remarks. PAT LEPORE: Thanks, Paul. As you have just heard, we feel very strongly about the value of the generic pipeline and that our strategy for both our generic and Strativa businesses are yielding successes that will generate long-term shareholder value. These successes are in line with those mileposts we laid out for you back in September. The value of our currently marketed products, the addition of the generic pipeline products Paul just described, progress towards FDA approvals for Strativa's exciting product pipeline, and other business development opportunities our teams are working on, we are confident will mean strong financial results in 2009 and beyond. We can now open the call to questions. OPERATOR: (OPERATOR INSTRUCTIONS). Randall Stanicky. RANDALL STANICKY, ANALYST: Just a couple. First, highlighting the 30-month expirations, can you just talk about your strategy there in terms of monetizing your view to at risk launch partnering? And then maybe can you just drill down a little bit, as you talk about some of these products, can you give us a little bit more detail on which products are partnered? And then going forward, your strategy to going alone on first-to-file filings versus partnering on some of these opportunities? PAUL CAMPANELLI: Regarding the 30-month stay and launching at risk, obviously it is fairly early in several of the products. As we build our cases with our internal and external legal teams, we will assess the basis of potentially launching at risk, but at this time I would say it is premature in that regard. Could you just repeat the second part of your question, please? RANDALL STANICKY: Yes, as you look at, for example, your six to 10 first-to-files per year, historically Par has relied or been involved with partners on a lot of those opportunities. Much more of that has changed obviously. So, as you look at that targeted strategy, how much are you going to rely on partners versus internally generated first-to-files? PAUL CAMPANELLI: Right, sure. So historically I would say that about 65% of our pipeline had been external. We are now shifting it actually about 65, 70% to now internal development. So, as we move into the future, clearly the majority of our products are going to be internally developed as first-to-files. RANDALL STANICKY: Okay. Two real specific. First of all, on TOPROL XL, can you just talk about the trends around that product given what we're seeing from a marketshare perspective? PAUL CAMPANELLI: On metoprolol? Currently we're holding about 30% of the market. RANDALL STANICKY: And how are you looking from a pricing perspective? How do we think about that going forward? PAUL CAMPANELLI: Well, right now I would tell you that we are fairly flat. We are not seeing too much price erosion at this particular time. We were monitoring the approvals that were listed at the FDA website in March. I will tell you at that time we had not seen any additional competitors come to the market. While they have approval letters, there were no further entries. So there is no need to erode price. If and when these two other companies eventually come to the market, we're well-poised. We have product, and we plan on defending our share. But at this time we see pricing to remain fairly flat. RANDALL STANICKY: Great. And my last question just on gross margin, the 32%, how do we think about that number -- I'm sorry if I missed it -- throughout the rest of 2008? VERONICA LUBATKIN: Yes, so, for the 2008 outlook, there's a number of things that will impact the rate of gross margin. Obviously the new products will help gross margins on the generic side. And Megace ES sales and growth also will play a role in driving gross margins higher overall. The generic base business will go up a few points, and that is really driven by some non-recurring activities that occurred in the first quarter. So we expect going forward to have lower metoprolol and fluticasone sales, and those are low margin products for us. So that will drive the margin up, as well reentering the market for tramadol, which has a high gross margin will also help. RANDALL STANICKY: As we think about the range going forward for 2008, are you able to quantify that? VERONICA LUBATKIN: Yes, I would say a couple of points higher than where it is now. RANDALL STANICKY: In sort of getting closer to the mid 30% range? VERONICA LUBATKIN: Yes. OPERATOR: Gregg Gilbert. GREGG GILBERT, ANALYST: How are you probability weighting the ANDA approvals in the '08 guidance, and is that covered by the range? Specifically what is your latest commentary on clonidine and level of confidence there specifically? PAUL CAMPANELLI: Sorry, was your question to 2008? GREGG GILBERT: Yes, first on '08. I will ask you about the later years later. But in terms of the specific earnings guidance, how are probability weighting those I think you say said four new approvals you're baking in? Or are you probability weighting those? PAUL CAMPANELLI: Sumatriptan is a date certain, right, so that is somewhat in agreement with GSK. We negotiated the November 6 date, that we are coming to market November 6, 2008. GREGG GILBERT: Right. What about the others? PAUL CAMPANELLI: The other launches are obviously not certain. So if you looked at our range of low-end to high-end, a majority of the low-end ranges is driven by sumatriptan, and the high-end range is driven by the combination of the other products, right? GREGG GILBERT: Right. PAUL CAMPANELLI: So that is kind of (multiple speakers) GREGG GILBERT: What is the latest on clonidine and any back and forth or sense of confidence from the agency there? PAUL CAMPANELLI: Yes, sure. So where we are is, if you go back a little bit in time, our development partners, Aviva, met with the FDA back in 2005 to come up with an agreement on how to handle the clinical trials with respect to irritation and adhesion. So protocol was agreed to, and a trial was run in -- really a trial was run at that time and submitted to the FDA in January 2007. Those results came back passing, and at this stage of the game, there really are no issues. CMC is resolved. Bioequivalence is resolved. The clinical trials are passing, and labeling is complete. So we are anticipating the FDA to at sometime in the very near future approve the application. GREGG GILBERT: Okay. And then beyond '08, I know you are not providing formal guidance at this point, but how are you probability weighting those ANDAs internally? Is there any context you can provide around what you would be building into your own sort of three to five-year plan? PAUL CAMPANELLI: We provided the range, and I think the low range is just giving you the insight that yes, we are risk adjusting, and they are probability weighted. GREGG GILBERT: And lastly, Paul, will you be partnering products that require significant GPO contracting, or is that something you plan to handle internally? PAUL CAMPANELLI: No, I don't. At this time, no, we do not have any plans. OPERATOR: Anant Padmanabhan. ANANT PADMANABHAN, ANALYST, COWEN AND COMPANY: I would like to ask a couple of questions in your Paragraph 4 challenges. First, regarding generic Lotrel, could you tell us when your 30-month stay expires, and is your patent litigation linked in any way to Teva's case. Second, could you give us a sense of where the [Kester] litigation is at the moment? PAUL CAMPANELLI: Sure. Regarding Lotrel, we're not linked to Teva. Obviously we are closely monitoring there, I think they had the marketing schedules for June. Obviously we are watching that very carefully. Regarding our 30-month stay, our 30-month stay I believe expires about two months after the new drug strength code of February 2009. ANANT PADMANABHAN: Thank you. And the Kester litigation? PAUL CAMPANELLI: Kester is very early at this stage of the game. So I think at this stage of the game, we would prefer not to elaborate the details. OPERATOR: Adam Greene. ADAM GREENE, ANALYST: I have a few questions. First, can you comment on Megace ES prescriptions? They have been flat for awhile. Just anything going on there or anything you can do to kind of change that? Then following up on an earlier question on TOPROL XL, you launched the scored tablets not too long ago, have not seen much of a change in share. Any thoughts on that, and then I have a follow-up as well. JOHN MACPHEE, PRESIDENT, STRATIVA: It is John MacPhee. It was hard to hear your first question, but I believe you asked about Megace ES prescriptions trends and any comments we could make. So in regards to that, we do continue to see growth opportunity for Megace ES in 2008. As you know, it is approaching the end of its third year, and it is, of course, our foundational product. Prescriptions for the first quarter of '08, they did exceed Q4 of '07 and were up 9% as compared to Q1 of last year. But our marketshares are showing a slight downward trend. As you see, market growth has been strong. We see growth opportunity in 2008 primarily for two reasons. The first is that we improved our sales force deployment in February of 2007. We were able to align our sales force in a way that reduced territory size, and our representatives as a result are making more calls, and we're seeing that increased productivity here in 2008. And we also see a few opportunities to improve reimbursement for Megace ES with a few key third-party pays. PAUL CAMPANELLI: Regarding metoprolol, the scoring question, the way I think the way we are looking at it is that when we launched the strength over the last year and a half, we were clearly holding in excess of 50% market share. Later towards the end of 2007, the scoring issue became obviously problematic, whereby we started to lose share because of pressure from our trade partners. I think right now the way we are looking at it is we resolved the scoring issue with our partners, AstraZeneca, and we were able to get the scoring back into the trade on the 50, the 100 and 200 milligrams prior to March. I think that was a big win for Par. With that, we are now holding a solid 30%. So I would say that we are really not looking towards growing our share because that will create pricing pressures. We are right now just planning on holding a solid 30%. ADAM GREENE: Okay. And then two questions on the P&L. R&D I think you had mentioned a $55 million target for the year. I just wanted to confirm that that does exclude the $5 million payment in the first quarter. And then secondly, following up on Randall's questions of gross margins, the brand gross margins have been bouncing around in the low 70s to high 70s. How should we think about the branded gross margins for the rest of 2008? VERONICA LUBATKIN: We expect the branded gross margins to stay at about where they are now. And on R&D we do expect it to be $55 million on an annualized basis, excluding the $5 million payment for ONCONASE. ADAM GREENE: Okay. And you said it will increase throughout the year from the Q1 levels? VERONICA LUBATKIN: That is right. There was some timing of biostudies on the generic side in the first quarter. We will recover that as we go through the rest of the year. OPERATOR: Richard Silver. RICHARD SILVER, ANALYST: On metoprolol can you tell us what assumptions you're making for pricing going forward since you said that you have not seen any recent price changes? But what sort of scenario are you looking at in terms of your guidance for competition and pricing? PAUL CAMPANELLI: I would tell you that moving forward we are planning on some modification on pricing, so we're taking it down a little bit at this stage of the game. Obviously our two competitors have yet to launch additional strengths. We're watching what happens with Watson. There's really no need at this time, but maybe a little erosion on the pricing. RICHARD SILVER: So you will just wait until you see what they do, and then you might have to actually build a little bit more erosion or more erosion in, and could that affect the current guidance? PAUL CAMPANELLI: It is built. Rich, we build it in. We built it in already. We're are not seeing it yet, but it is built into the plan. OPERATOR: David Buck. JIM DAWSON, ANALYST: It is Jim Dawson for David Buck. Would you give that SG&A guidance for '08 again? I missed that. VERONICA LUBATKIN: Okay. On a full-year basis, we expect SG&A to be in the range of $121 million. JIM DAWSON: 121, you said? VERONICA LUBATKIN: Right. JIM DAWSON: Okay. And then just also, what was driving the generic TOPROL XL strength during the quarter? PAUL CAMPANELLI: TOPROL XL strength in the quarter? JIM DAWSON: Yes. VERONICA LUBATKIN: Higher sales of metoprolol quarter-over-quarter. PAUL CAMPANELLI: Yes, obviously getting the score tablet, you have to remember that Par was marketing an unscored tablet until March of this year. We got it back right really at the end of February, and that is what is driving it. JIM DAWSON: Okay. And then also just the effective tax rate for the quarter, we have got a low number, and I am wondering what the tax rate was, and if that lower number is a good number to work with and sustainable for the rest of the year? VERONICA LUBATKIN: Yes, the effective tax rate is 35 -- in the 35% range and expected to hold there on a full-year basis. OPERATOR: (OPERATOR INSTRUCTIONS). Gregg Gilbert. GREGG GILBERT: Paul, did you see any of your large wholesale customers destocking in the first quarter? PAUL CAMPANELLI: No, I did not see anything. VERONICA LUBATKIN: Our trade pipeline was around the same level. OPERATOR: Morty Schnerr. MORTY SCHNERR, ANALYST, BNP PARIBAS: BNP Paribas. I had to jump in and out of the call, so you might have addressed this. The guidance in '09 on the new sales, you are able to give projection on that. Are you able to give projections on your sales guidance for this year and next? VERONICA LUBATKIN: I'm sorry, what was the question? MORTY SCHNERR: Are you able to give total sales projections for this year and next for 2008 and 2009? I mean you're giving already for guidance on these new products and new generic sales, and I'm just wondering why you cannot give on the -- you did not put that in the press release, but total sales? VERONICA LUBATKIN: Yes, I mean at this time we're not giving it, but I guess we have given the EPS guidance for the full year. We have given some EPS guidance for the new products. We have given the full-year guidance for the R&D and SG&A lines. MORTY SCHNERR: Okay. And is there any news on the -- are you still holding $200 million of the convertible and current liabilities. Is there any news on that? VERONICA LUBATKIN: There is no change. PAT LEPORE: It is the same. OPERATOR: And at this time you have no questions. PAT LEPORE: Okay. Well, I want to thank everybody for joining the call, and we will look forward to reporting out next quarter. Thank you. OPERATOR: Thank you for attending today's conference. This concludes your presentation. You may now disconnect. Good day. [Thomson Financial reserves the right to make changes to documents, content, or other information on this web site without obligation to notify any person of such changes. In the conference calls upon which Event Transcripts are based, companies may make projections or other forward-looking statements regarding a variety of items. Such forward-looking statements are based upon current expectations and involve risks and uncertainties. Actual results may differ materially from those stated in any forward-looking statement based on a number of important factors and risks, which are more specifically identified in the companies' most recent SEC filings. 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Par Pharmaceutical Reports First Quarter 2008 Results. Lead Author: [none given] PR Newswire , 2008-05-08 Reports First Quarter Adjusted EPS of $0.17 per Diluted Share Provides Full-year 2008 EPS Guidance and Projects its Pipeline Opportunities WOODCLIFF LAKE, N.J., May 8 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. today reported results for the first quarter ended March 29, 2008. Par reported total revenues of $154.9 million and net income of $2.6 million, or $0.08 per diluted share, which included a $5.0 million payment to Alfacell Corporation for the exclusive U.S. commercialization rights to ONCONASE(R) (ranpirnase), a novel product currently in Phase III clinical development. Adjusting for this item, earnings per diluted share were $0.17 for the three month period ended March 29, 2008. This is compared with reported revenues of $234.2 million and net income of $41.5 million, or $1.19 per diluted share, for the same period in 2007, which included a $20.0 million gain on the sale to Optimer Pharmaceuticals, Inc. of marketing rights to the investigational drug Difimicin (PAR 101). Adjusting for this item, earnings per diluted share were $0.84 in the first quarter of 2007. *** Click Here to view the full text of this abstract *** First Quarter Review For the first quarter ended March 29, 2008, total revenues decreased 33.9% compared with the same period in 2007 due primarily to a greater number of 2007 new product introductions in the Company's generics business and increased pricing pressures on existing generic products, partly offset by higher revenues from Par's branded division, Strativa, which increased 28.6% from the same period in 2007 driven by increased net sales of Megace(R) ES. Revenues of the generic division decreased 39.5% in the first three months of 2008 compared to the same period in 2007 primarily due to competitive pressures in the following products: fluticasone, propranolol, various amoxicillin products, tramadol HCl and acetaminophen tablets, glyburide/metformin, cabergoline, ranitidine syrup, as well as lower royalties. Partially offsetting these decreases were increased sales of metoprolol resulting from the launch of additional strengths in the third quarter of 2007. Par's first quarter gross margin was 32.0% of total revenues compared to 37.4% in 2007. The decrease in the Company's gross margin resulted primarily from the non-recurrence of the 2007 launch of propranolol and decreased sales of certain existing generic products and lower royalty income both resulting from competitive pressure, tempered by higher gross margin contribution from Strativa's net sales of Megace(R) ES. Research and development (R&D) expenses increased 22.2% for the first quarter 2008 compared with the first quarter 2007, which was primarily attributed to the initial $5.0 million payment to Alfacell Corporation for an exclusive licensing agreement to acquire the commercialization rights to ONCONASE(R). Selling, general and administrative (SG&A) expenses for the first quarter 2008 decreased 3.7% from first quarter 2007. The decrease is due to lower expenses related to the sales and marketing of Megace(R) ES, lower finance and accounting costs, and lower stock-based compensation employment costs. During the first quarter of 2008, the Company recognized a gain on the sale of product rights of $1.0 million related to the sale of two non-core ANDAs. In addition, the Company recognized a gain of $0.6 million related to providing certain information and other deliverables related to Megace(R) ES to a third party that is seeking to commercialize Megace(R) ES outside of the U.S.. Year-to-date Accomplishments Patrick G. LePore, chairman, president and chief executive officer, states, "2008 is the year to execute on our strategy, and I am pleased with our progress thus far. Par should be measured in large part by the achievement of certain accomplishments and milestones that position the Company for growth in 2009 and beyond." In January, Strativa acquired the U.S. commercialization rights to Alfacell Corporation's Phase III product, ONCONASE, for an initial payment of $5 million. Results from the Phase IIIb clinical trial will be reported by mid-year. Subject to a complete review of the study results and discussions with the FDA, it is anticipated that an NDA could be filed as early as year-end 2008. In March, Par commenced bioequivalence studies for Zensana(TM) (ondansetron) oral spray. Subject to favorable results and discussions with the FDA, it is expected that Strativa could file an NDA around the end of 2008. In April, Strativa announced that its development partner, BioAlliance Pharma, reported positive preliminary, top-line results from a Phase III study of Loramyc(R) (miconazole Lauriad(R)). Subject to a complete review of the study results and discussions with the FDA, it is anticipated that an NDA could be filed by year-end 2008. On May 7, 2008, Par announced that it amended its agreement with Spectrum Pharmaceuticals and paid $20 million in cash to increase its share of profits from the generic versions of GlaxoSmithKline's Imitrex(R) Injection, which will be immediately accretive to 2008 earnings. As a result of the agreement, Par's profit share shall increase from 38% to 95% from the commercialization of sumatriptan injection. Par will be permitted to sell generic versions of certain sumatriptan injection products with an expected launch date no later than November 2008. According to IMS Health, annual U.S. sales of Imitrex(R) are approximately $220 million. 2008 Financial Guidance The Company's projections are based on its results for the first three months of 2008, as well as management's estimates regarding the impact of product competition on existing products, and the market opportunity of some of Par's generic pipeline products. Full year 2008 earnings per diluted share are projected to be $0.65 to $0.85, excluding anticipated pre-launch spending and milestone payments in support of Strativa's business strategy and including the estimated impact of four new generic product launches (i.e., sumatriptan vials and kits, clonidine, dronabinol, certain strengths of risperidone ODT) with an expected fully diluted EPS impact of $0.25 to $0.47. 2009-2012 Generic Pipeline The Company's investment in its generic first-to-file development strategy has lead to a growing pipeline and a track record of first-to-file drugs. The Company anticipates that it will launch as many as 15 new products during 2009 and 2012 based on the expiration of 30 month stay periods or prior settlements. To provide investors with additional information by which to analyze the Company, Par is providing a range of estimated values for certain key generic pipeline products. These values are based on projections regarding the first six months of net sales and the anticipated gross margin of each product in the year the product launches. Since each full six-month period may not be in the calendar year the product launches, we anticipate that some of the value will be realized in the next calendar year. (Please note that these estimates do not include value after the initial six months following product launch). In 2009, Par anticipates six key generic product launches that are expected to have a range of net sales and gross margin of $95-$135 million and $78-$110 million, respectively, to the Company. In 2010, Par anticipates five key generic product launches that are expected to have a range of net sales and gross margin of $60-$80 million and $42-$56 million, respectively, to the Company. In 2011, Par anticipates two key generic launches that are expected to have a range of net sales and gross margin of $20-$28 million and $7-$10 million, respectively, to the Company. In 2012, Par anticipates two key generic launches that are expected to have a range of net sales and gross margin of $14-$20 million and $12-$17 million, respectively, to the Company. These estimates are, of course, subject to future developments, not all of which may be anticipated at this time. See Key Generic Product Pipeline chart at the end of this press release. In addition to these current first-to-file opportunities, Par is diligently working on other promising development products and business development opportunities that it anticipates will continue to enhance the Company's future sales opportunities. Conference Call Par has scheduled a conference call for Friday, May 9 at 9:00 am EDT to discuss results for first quarter of 2008. Par invites investors and the general public to listen to a webcast of the conference call. Access to the live webcast can be made via the Company's website at http://www.parpharm.com/ and will be available for two weeks. The dial-in number is 888-713-4214 for domestic callers and 617-213-4866 for international callers. The access number is 85327955. A replay of the conference call will be available commencing approximately one hour after the call. The replay dial-in number is 888-286-8010 for domestic callers and 617-801-6888 for international callers. The access number is 16325023. For a copy of Par's Form 10-Qs for the quarter ended March 29, 2008, visit Investors/SEC Filings on the Par web site at http://www.parpharm.com/. About Par Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. For press release and other company information, visit http://www.parpharm.com/. Safe Harbor Statement 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. Such forward-looking statements are those that include estimates, projections, statements regarding the plans and objectives of management, as well as the assumptions underlying the forward-looking statements, and other statements that cannot be verified without reference to future developments or events. The forward-looking statements identified in the release include, but are not limited to, the statements that contain the words "expect," "expected," "anticipate," "anticipates," "anticipated," "projections," "projected," "estimate," estimates," "believes," "continue," and growing." The forward-looking statements in the release are subject to risks and uncertainties, including the Company's ability to accurately value its key generic pipeline products, including, but not limited to the vagaries of litigation, securing regulatory approval and uncertainty of exclusivity, the extent and impact of litigation arising out of the accounting issues described in the Company's filings with the Securities and Exchange Commission (SEC), 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 the Company, 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 SEC, such as the Company's reports on Form 10-K, Form 10-Q and Form 8-K, and amendments thereto. Any forward-looking statements included in this press release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements. PAR PHARMACEUTICAL COMPANIES, INC.
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