APOKYN: FDA Approves Mylan's Parkinson's Drug April 22, 2004 The U.S. Food and Drug Administration approved a first of its kind drug to treat a condition of Parkinson's disease produced by a subsidiary of Mylan Laboratories Inc., the company said Thursday. Mylan said the FDA's approval required it to conduct post-marketing studies but said those commitments would not affect introduction of the drug, Apokyn. Mylan said it planned to begin marketing Apokyn in July. The medicine is produced by Bertek Pharmaceuticals Inc., Mylan's brand-name subsidiary. Mylan, based in Canonsburg, Pa., is also a major producer of generic drugs. Apokyn is said to be the first treatment for hypomobility, a condition of Parkinson's disease that leaves sufferers partially or totally immobile. Those so-called off periods occur unpredictably and last for varying periods of time. "This is a significant day for the Parkinson's community and another milestone in Mylan's mission to develop pharmaceutical products that address unmet medical needs," the company's vice chairman and chief executive, Robert Coury, said in a statement Thursday. Apokyn has been given "orphan drug" status, Mylan said. Orphan drugs are designated by the federal government as the only treatments for conditions affecting fewer than 200,000 people in the United States. Apokyn is Mylan and Bertek's third orphan drug. SOURCE: Pittsburgh Business Times, PA http://tinyurl.com/27twv * * * APOKYN: Drug OK'd To Help Patients Immobilized By Parkinson's UPDATED: 9:21 AM EDT April 23, 2004 WASHINGTON -- The Food and Drug Administration has approved a new drug to treat Parkinson's patients who develop periods of immobility. The problem, called hypomobility or "off-periods,'' affects about 10 percent of people with Parkinson's disease, the agency said Wednesday. The drug, apomorphine, to be sold under the name Apokyn, was given priority as an orphan drug. It is the first drug to treat these episodes, which affect about 112,000 people, the agency said. The FDA said that within three years to five years of treatment with standard Parkinson's drugs, about 10 percent of patients develop these episodes, when they are unable to rise from a chair, to speak or to walk. The episodes can occur toward the end of a dosing interval with standard medications or at unpredictable times. Apokyn, which is injected, can cause severe nausea and must be taken with an anti-nausea drug. Certain anti-nausea drugs, such as ondansetron, must be avoided because the combination can lead to very low blood pressure and loss of consciousness. Apokyn is manufactured for Bertek Pharmaceuticals of Research Triangle Park, N.C., by Draxis Pharma Inc. of Canada. SOURCE: The Associated Press / NBC 17.com, NC http://www.nbc17.com/news/3034371/detail.html Reference: Bertek: Apokyn to make small moves in market The FDA has approved the first Parkinson's disease immobility treatment. April 22, 2004 6:00 PM GMT (Datamonitor) - The FDA has approved Apokyn (apomorphine), an injectable dopamine agonist, for the treatment of patients with Parkinson's disease (PD) who develop periods of immobility where patients get 'stuck' or 'frozen'. Bertek can expect to draw modest revenues from this niche market, although the positioning will allow the company to build neurologist relationships while avoiding a clash with big pharma. Bertek Pharmaceuticals, a subsidiary of Mylan Laboratories [MYL], will market Apokyn, which has orphan drug status in the US for the relatively rare PD condition known as hypomobility. Parkinson's is a chronic, progressive condition that leads to tremors, muscle rigidity, slowness, impaired balance and coordination, and difficulty moving. It is estimated that around 4 million people worldwide suffer from the disease and the number of patients is expected to grow by 2% per year until 2006. It afflicts both sexes equally, and symptoms typically appear when people are in their late 50s or early 60s. Hypomobility, also known as "off-periods," is where patients are unable to move or speak. Although around 1.5 million Americans suffer from PD, only about 10% develop hypomobility, usually within three to five years of treatment with standard PD drugs. Given that it is the first drug to be FDA approved for hypomobility, Apokyn will be a welcome addition to the current armory against this debilitating condition. The PD market, which was worth over $2.5 billion in 2003, has been revived over the last few years with recent emphasis on dopamine agonists, which are now recommended as first-line monotherapy. Although it is a dopamine agonist, apomorphine is used in Europe only as a 'rescue therapy' for severe motor fluctuations in patients taking levodopa (the gold standard treatment of PD) and there is a good chance that US usage may follow a similar pattern. Considering the small target population, the inconvenience of an injection, and apomorphine's poor side effect profile, Bertek can only expect to draw modest revenues from the US market. Nevertheless, Bertek will benefit from the orphan drug marketing exclusivity period of seven years, allowing the company time to develop its market presence further. Importantly, positioning its product in this niche sector will allow Bertek to build a relationship with prescribing neurologists while at the same time avoiding direct competition with larger market players, which include Pfizer [PFZ.L], GlaxoSmithKline [GSK.L], and Novartis [NVS]. SOURCE: Datamonitor / UK Comment Wire, UK http://www.commentwire.com/commwire_story.asp?commentwire_ID=5545 - - - Friday, April 23, 2004 Mylan Laboratories said yesterday that it won approval from the Food and Drug Administration to market Apokyn, a drug used in the treatment of Parkinson's disease. The drug, an injection, is used to treat patients who have periods of immobility. It is the first and only therapy approved in the country for treatment of immobility in patients with advanced Parkinson's disease, Mylan said. A Mylan spokeswoman said the company had not yet projected sales for Apokyn, which the FDA classified as an orphan drug because it is used to treat a condition in fewer than 200,000 people. SOURCE: Pittsburgh Post-Gazette http://www.post-gazette.com/pg/04114/304998.stm - - - Orphan Drugs The term "orphan drug" refers to a product that treats a rare disease affecting fewer than 200,000 Americans. The Orphan Drug Act was signed into law on January 4, 1983. Since the Orphan Drug Act passed, over 100 orphan drugs and biological products have been brought to market. The intent of the Orphan Drug Act is to stimulate the research, development, and approval of products that treat rare diseases. This mission is accomplished through several mechanisms: Sponsors are granted seven years of marketing exclusivity after approval of its orphan drug product. Sponsors also are granted tax incentives for clinical research they have undertaken. FDA's Office of Orphan Products Development coordinates research study design assistance for sponsors of drugs for rare diseases [Notice: This link will take you outside the CDER web site]. The Office of Orphan Products Development also encourages sponsors to conduct open protocols, allowing patients to be added to ongoing studies. Grant funding is available to defray costs of qualified clinical testing expenses incurred in connection with the development of orphan products. SOURCE: FDA http://www.fda.gov/cder/handbook/orphan.htm - - - Definitions of Orphan drug on the Web: http://tinyurl.com/28goj * * * PRESS RELEASE: APOKYN: Accredo Health, Inc. Selected by Bertek as a Preferred Specialty Pharmacy Provider for APOKYN MEMPHIS, Tenn.--(BUSINESS WIRE)--April 26, 2004--Accredo Health, Incorporated (NASDAQ:ACDO) announced today that its wholly owned subsidiary, Nova Factor, Inc. has been selected by Bertek Pharmaceuticals, Inc., a wholly owned subsidiary of Mylan Laboratories, Inc. (NYSE: MYL), as a preferred specialty pharmacy provider of APOKYN(TM) (apomorphine hydrochloride injection). APOKYN is used in the acute, intermittent treatment of hypomobility, "off" episodes ("end-of- dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease. APOKYN is the first therapy approved in the United States for use as an acute (rescue) treatment of "off" episodes. "Off" episodes are debilitating periods of partial loss of movement or total immobility experienced by patients with Parkinson's disease. "We are pleased to begin a relationship with such an outstanding drug manufacturer, while assisting patients with Parkinson's disease," said David D. Stevens, Accredo's chairman and chief executive officer. "The addition of this product is another example of the relationships forged by Accredo with the leading manufacturers in the biopharmaceutical industry." "We are very excited to bring APOKYN to market, and look forward to providing this product to the Parkinson's community. Our relationship with Nova Factor, one of three specialty pharmacy providers we have contracted with, ensures both patients and physicians will have their APOKYN prescription needs fulfilled by a highly respected patient focused organization," stated James Mauzey, President, Bertek Pharmaceuticals, Inc. As stated by Bertek, the most common side effects of APOKYN in controlled clinical studies were yawning, dyskinesias, nausea and/or vomiting, sleepiness, dizziness, runny nose, hallucinations, fluid retention, chest pain, increased sweating, flushing, and pale complexion. Accredo's subsidiary, Nova Factor, Inc. has provided specialty pharmaceuticals and quality services for patients with unique medical needs since 1990. The comprehensive services offered by Nova Factor make it easy for physicians and other healthcare providers to help patients with APOKYN therapy. Through Nova Factor's Assignment of Benefits program, an APOKYN-dedicated team of insurance specialists researches patients' insurance, obtains prior authorization when necessary, files claims on patients' behalf, and bills insurers directly. The APOKYN team is available to answer questions about product availability and patient services at 1-866-898- 0104. Nova Factor also has an easy fax referral system that can be accessed when the drug is available (fax 1-866-898- 0069). As part of its service model, Nova Factor's pharmacy team dispenses the drug to the administration location of the healthcare provider's choice. During a patient's course of therapy, Nova Factor's APOKYN-dedicated team will be a resource for patients, caregivers, and healthcare professionals to provide information support. Accredo Health, Incorporated provides specialized pharmacy and related services pursuant to agreements with biotechnology drug manufacturers relating to the treatment of patients with certain costly, chronic diseases. The Company's services include collection of timely drug utilization and patient compliance information, patient education and monitoring through the use of written materials and telephonic consultation, reimbursement expertise and overnight drug delivery. In addition to historical information, certain of the statements in the preceding paragraphs, particularly those anticipating future financial performance, business prospects and growth and operating strategies constitute forward- looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such statements may be identified by words such as anticipate, believe, estimate, expect, intend, predict, hope or similar expressions. Such statements, which include estimated financial information or results and the quoted comments of Mr. Stevens above, are based on management's current expectations and are subject to a number of factors and uncertainties which could cause actual results to differ materially from those described in the forward-looking statements, including, without limitation, the loss of a biopharmaceutical relationship, our inability to sell existing products, difficulties integrating acquisitions, the impact of pharmaceutical industry regulation, the difficulty of predicting FDA and other regulatory authority approvals, the regulatory environment and changes in healthcare policies and structure, acceptance and demand for new pharmaceutical products and new therapies, the impact of competitive products and pricing, the ability to obtain products from suppliers, reliance on strategic alliances, the ability to expand through joint ventures and acquisitions, the ability to maintain pricing arrangements with suppliers that preserve margins, the need for and ability to obtain additional capital, the seasonality and variability of operating results, the Company's ability to implement its strategies and achieve its objectives and the risks and uncertainties described in reports filed by Accredo with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation, cautionary statements under the heading "Risk Factors" made in Accredo's Annual Report on Form 10-K for its year ended June 30, 2003. Contacts: Accredo Health Inc., Memphis Financial Contact: Joel Kimbrough, 901-385-3621 or Investor Relations Contact: Kerry Finney, 901-381-7442 http://www.accredohealth.com SOURCE: Business Wire (press release) http://tinyurl.com/2olac * * * PRESS RELEASE: APOKYN: Priority Healthcare is a Preferred Specialty Pharmacy Provider Of Apokyn tm, a New Therapy for Patients With Parkinson's Disease. LAKE MARY, Fla., Apr 26, 2004 /PRNewswire-FirstCall via COMTEX/ -- Priority Healthcare Corporation (Nasdaq: PHCC) has signed an agreement with Bertek Pharmaceuticals, a wholly owned subsidiary of Mylan Laboratories Inc., (NYSE: MYL), to be a preferred specialty pharmacy provider of Apokyn(TM) (apomorphine hydrochloride injection). Apokyn, approved April 20, 2004 by the FDA, is the first and only therapy in the United States indicated as an acute intermittent treatment of hypomobility, or "off" episodes, in patients with advanced Parkinson's disease. Apokyn will be available for patient use in July. "As both a chronic and progressive disease, Parkinson's disease has a profound affect on the lives of sufferers. Priority Healthcare is pleased to provide specialty pharmacy services for Apokyn," said Steve Cosler, President and CEO of Priority Healthcare. "We are happy to establish a relationship with Bertek with this new therapy and pleased to strengthen our continuing relationship with Mylan Laboratories. Neurology has always been an important area for Priority Healthcare and this therapy expands our relationship with neurologists and movement disorder specialists." "We are very excited to bring Apokyn to market, and look forward to providing this product to the Parkinson's community. Our relationship with Priority Healthcare, one of three specialty pharmacy providers we have contracted with, ensures both patients and physicians will have their Apokyn prescription needs fulfilled by a highly respected patient focused organization," stated James Mauzey, President of Bertek Pharmaceuticals, Inc. Priority Healthcare's specialty pharmacy services for Apokyn will include: * Caring Paths(TM) disease treatment management process, specific to Parkinson's disease. * Expert treatment preparation by clinical pharmacists. * Express shipping direct to homes, physician offices, or other convenient locations. * Detailed personal instruction and educational materials for self-administration. * Access to pharmacists and nurses 24 hours a day, 7 days a week, 365 days a year. * Insurance counseling and assistance through reimbursement specialists who oversee the submission and approval process. * Coordination of all aspects of patient care with the physician's office. About Parkinson's disease Afflicting the central nervous system, Parkinson's disease is characterized by resting tremors, stiffness in limbs, slowness of movement, and postural instability. Parkinson's is estimated to affect 1-1.5 million Americans, with incidence increasing with age. As the disease progresses, patients become less responsive to their medications, such as levodopa, and may develop motor fluctuations referred to as "off" episodes. "Off" episodes are debilitating periods of partial loss of movement or total immobility experienced by patients with advanced Parkinson's disease. These episodes are characterized by stiffness of the limbs, slowness, immobility and, in most cases, tremor. Because patients with Parkinson's disease lose motor control during "off" episodes, walking, eating, bathing, and even speaking may be more impaired during an "off" episode. About Apokyn Apokyn does not prevent off episodes and does not replace other Parkinson's disease medications, but rather it is used as an acute (rescue) therapy to effectively treat an off episode when it occurs. Apokyn is given by injection under the skin. Apokyn should not be used by patients who are being treated with certain drugs to treat nausea and vomiting or irritable bowel syndrome. These medications (including, for example, ondansetron, granisetron, dolasetron, palonesetron, and alosetron) called 5HT3 antagonists or blockers. In addition, Apokyn should not be used by patients who have an allergic reaction to the drug or its ingredients (notably sodium metabisulfite). Apokyn should be injected under the skin only, and not into a vein. Because Apokyn can cause severe nausea and vomiting, it is taken with an oral medicine that helps to prevent these effects. Apokyn may lower blood pressure (orthostatic hypotension), cause fainting, and increase the risk of falling. At recommended doses minimal increases in QTC were observed. Caution should be used when prescribing apomorphine with drugs that prolong the QT/QTC interval. Some patients treated with Apokyn may get sleepy during the day or fall asleep without warning while doing everyday activities. The most common side effects of Apokyn are yawning, dyskinesias, nausea and/or vomiting, sleepiness, dizziness, runny nose, hallucinations, fluid retention, chest pain, increased sweating, flushing, and an unusually pale complexion. Additional information on Apokyn is available from Bertek Pharmaceuticals at: www.bertek.com About Priority Healthcare Corporation Priority Healthcare Corporation is a national specialty pharmacy and distributor that provides biopharmaceuticals, complex therapies, and related disease treatment programs and services. Priority Healthcare provides comprehensive programs for patients, payors, physicians, and pharmaceutical manufacturers for a growing number of disease states including cancer, hepatitis C, respiratory and pulmonary conditions, infertility, rheumatoid arthritis, hemophilia, multiple sclerosis, Parkinson's, and age-related macular degeneration. Additional information regarding Priority Healthcare is available at www.priorityhealthcare.com Certain statements included in this press release, which are not historical facts, are forward-looking statements. Such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements represent our expectations or beliefs and involve certain risks and uncertainties, including those described in our public filings with the United States Securities and Exchange Commission; also including, but not limited to, changes in interest rates, competitive pressures, changes in customer mix, changes in third party reimbursement rates, financial stability of major customers, changes in government regulations or the interpretation of these regulations, changes in supplier relationships, growth opportunities, cost savings, revenue enhancements, synergies and other benefits anticipated from acquisition transactions, difficulties relative to integrating acquired businesses, the accounting and tax treatment of acquisitions, and asserted and unasserted claims, which could cause actual results to differ from those in the forward-looking statements. The forward- looking statements by their nature involve substantial risks and uncertainties, certain of which are beyond our control, and actual results may differ materially depending on a variety of important factors. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date herein. SOURCE: Priority Healthcare Corporation CONTACT: Financial: Stephen Saft, Chief Financial Officer, +1-407-804-6700 Priority Healthcare Corporation Media: Kirsten Ayars, Public Relations Manager, +1-407-804-5826 Priority Healthcare Corporation /Photo: http://www.newscom.com/cgi-bin/prnh/20030417/PHCLOGO URL: http://www.priorityhealthcare.com http://www.prnewswire.com SOURCE: PRNewsWire / Macro*World Investor http://www.mworld.com/m/m.w?lp=GetStory&id=92909261 * * * PRESS RELEASE: Mylan Announces FDA Approval Of APOKYN NDA; A Novel Treatment in Parkinson's Disease. PITTSBURGH, Apr 22, 2004 (BUSINESS WIRE) -- Mylan Laboratories Inc. (NYSE: MYL) announced that its branded-drug subsidiary, Bertek Pharmaceuticals Inc., received notice from the Food and Drug Administration (FDA) following their priority review that APOKYN(TM) (apomorphine hydrochloride injection) has been approved as the first and only therapy in the United States for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease. "This is a significant day for the Parkinson's community and another milestone in Mylan's mission to develop pharmaceutical products that address unmet medical needs," said Robert J. Coury, Mylan Vice Chairman and CEO. The FDA approval clears the way for Bertek to market APOKYN and provides a new therapy for "off" episodes, one of the most debilitating aspects suffered by patients with Parkinson's disease. The approval includes post marketing study commitments, but will not impact market introduction of this important product. The product will be available by July 2004 and distributed through a limited specialty pharmacy network. APOKYN has orphan drug status, a federal designation to indicate the drug's exclusive use in treating a condition affecting fewer than 200,000 people in the United States. APOKYN will be the third orphan drug marketed by Mylan and Bertek. About APOKYN APOKYN provides patients with an effective treatment to use during an 'off' episode. "Off" episodes are debilitating periods of partial loss of movement or total immobility experienced by patients with advanced Parkinson's disease. As Parkinson's disease progresses, patients begin to experience immobilizing "off" episodes despite treatment with drugs used to increase or replace dopamine. APOKYN is not used to prevent "off" episodes and it does not replace other Parkinson's disease medications, but rather treats an existing "off" episode when it occurs. As an acute, rescue treatment, APOKYN helps patients experiencing a debilitating "off" episode to walk, talk or move around easier. The intensity, duration and frequency of "off" episodes vary for each sufferer. Patients with Parkinson's disease lose motor control during "off" episodes, making routine tasks such as walking and even speaking extremely difficult. Patients with Parkinson's or their caregivers administer the medication via injection under the skin. "These debilitating effects are known all too well by patients experiencing 'off' episodes," said Dr. Mark Stacy, director of the Movement Disorders Section at Duke University Medical Center. "With the FDA approval of APOKYN, I can now offer patients an effective treatment to relieve them from these immobilizing 'off' episodes." In clinical trials conducted by Bertek, APOKYN was effective in improving an overall measurement of patient movement. "The data from clinical trials show that APOKYN, when used in conjunction with standard pharmacological therapies for Parkinson's disease, has the ability to provide relief from an 'off' episode," said Dr. James H. Sherry, Vice President of Clinical Affairs at Bertek Pharmaceuticals Inc. "This is a new way for Parkinson's patients to reduce some of the burden of their disease." The effectiveness of APOKYN for the acute treatment of "off" episodes associated with advanced Parkinson's disease was established in three randomized controlled clinical trials. Patients who received APOKYN demonstrated statistically significant improvement in their Unified Parkinson's disease Rating Scale part III (UPDRS) motor score at 20-minutes following the administration of the drug compared to a placebo injection. The UPDRS is used by researchers and clinicians around the world to measure disease severity in patients. Important Information APOKYN should not be used by patients who are being treated with certain drugs to treat nausea and vomiting or irritable bowel syndrome. These medications (including, for example, ondansetron, granisetron, dolasetron, palonesetron, and alosetron) called 5HT3 antagonists or blockers. In addition, APOKYN should not be used by patients who have an allergic reaction to the drug or its ingredients (notably sodium metabisulfite). APOKYN should be injected under the skin only, and not into a vein. Because APOKYN can cause severe nausea and vomiting, it is taken with an oral medicine that helps to prevent these effects. APOKYN may lower blood pressure (orthostatic hypotension), cause fainting, and increase the risk of falling. At recommended doses minimal increases in QTC were observed. Caution should be used when prescribing apomorphine with drugs that prolong the QT/QTC interval. Some patients treated with APOKYN may get sleepy during the day or fall asleep without warning while doing everyday activities. The most common side effects of APOKYN are yawning, dyskinesias, nausea and/or vomiting, sleepiness, dizziness, runny nose, hallucinations, fluid retention, chest pain, increased sweating, flushing, and an unusually pale complexion. About Bertek Bertek Pharmaceuticals Inc., based in Research Triangle Park, N.C., develops and licenses proprietary pharmaceuticals, with a current focus on dermatology, neurology and cardiology. For more information, visit http://www.bertek.com About Mylan Mylan Laboratories Inc. is a leading pharmaceutical company with four subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., UDL Laboratories Inc. and Bertek Pharmaceuticals Inc., that develop, manufacture and market an extensive line of generic and proprietary products. For more information about Mylan, visit www.mylan.com. This press release includes statements that constitute "forward-looking statements," including with regard to the availability and use of APOKYN. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: delays in the product launch, including due to matters outside of the Company's control; the Company's exposure to lawsuits and contingencies associated with its business; other uncertainties and matters beyond the control of management and the other risks detailed in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release. SOURCE: Mylan Laboratories Inc. CONTACT: Mylan Laboratories Inc. Public Relations: Heather Bresch 724-514-1800 or: Investor Relations: Kris King, 724-514-1800 SOURCE: Business Wire / Macro*World Investor http://www.mworld.com/m/m.w?lp=GetStory&id=92318161 * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn