Healthcare Industry News:  Central Venous Catheter 

Biopharmaceuticals FDA

 News Release - September 6, 2006

OVATION and Cardinal Health Announce FDA Approval Letter for Manufacturing of Biologic Therapy To Treat Rare Genetic Disorder

DEERFIELD, Ill. and DUBLIN, Ohio, Sept. 6 (HSMN NewsFeed) -- OVATION Pharmaceuticals, Inc. and Cardinal Health, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued an approval letter for Cardinal Health's new sterile facility in North Raleigh, N.C. to manufacture Panhematin® (hemin for injection), an Ovation biologic therapy used to treat acute porphyria, a rare genetic disorder.

Panhematin is the first drug to be approved by the FDA for commercial production at the new facility. The manufacturing relationship with Cardinal Health is part of Ovation's ongoing global commitment to ensure that patients suffering from severe illnesses have access to life-saving therapies. In addition, Ovation is making investments to support drug substance manufacturing. Panhematin is the only FDA-approved therapy for acute porphyria, a rare disorder that if left untreated may lead to long-term or permanent paralysis, coma or even death.

"Acute porphyria is a very rare condition and few companies would be willing to invest in the area," said Joseph Bloomer, M.D., Professor of Medicine and Director of the University of Alabama Liver Center. "The support from Ovation and Cardinal Health is critical to ensuring product supply, as Panhematin is the mainstay of treatment."

Jeffrey S. Aronin, president and chief executive officer of OVATION Pharmaceuticals said, "We felt it was important to invest in sustaining ongoing supply of this life-saving medication. This new, state-of-the-art manufacturing facility will ensure that patients suffering from this rare enzymatic disease get the treatment they need. With Ovation's commitment to this underserved patient population and Cardinal Health's sterile manufacturing expertise, we are well positioned to provide patients with an uninterrupted supply of Panhematin well into the future."

Many pharmaceutical companies choose to form strategic manufacturing relationships because of the complexities associated with the sterile manufacturing and specialized expertise required. Capabilities of the new manufacturing facility include biopharmaceuticals compounding, fill/finish of glass vials and lyophilization. Pre-filled syringe capabilities will be available in 2007.

"Ovation is leveraging multiple capabilities within Cardinal Health to simplify the manufacturing and packaging processes and get Panhematin into the hands of those who need it," said Shawn Gallagher, vice president and general manager of Cardinal Health's North Raleigh facility. "Panhematin is the first commercial drug to be manufactured at the new facility in North Raleigh, and this helps prepare the site for additional commercialization of products. The facility has capacity to support production of a range of other biopharmaceutical products."

The new facility currently has 82 employees and is expected to grow to 200 jobs for the Raleigh area when it reaches full capacity.

About the Acute Porphryias

Acute porphyria is designated as an orphan disease by the FDA. Approximately 5,000 people nationwide in the U.S. have the genetic predisposition for the condition and only 20 percent of this population actually develops symptoms. Acute porphyrias are a group of four closely related diseases, all caused by deficiencies of specific enzymes in the heme biosynthetic pathway. The combination of this enzyme deficiency with environmental triggers causes an overproduction of porphyrins and porphyrin precursors. A build-up of these chemicals causes an acute attack, which can present with some or all of the following signs or symptoms: sudden onset of acute neuropathic abdominal pain, tachycardia, systemic arterial hypertension, dark urine, peripheral neuropathy, gastrointestinal disturbances (nausea, vomiting, diarrhea, or constipation), and mental changes.

Left untreated, acute porphyric attacks can result in respiratory failure, peripheral neuropathy, quadriplegia, life-threatening paralysis, irreversible neuronal damage and death. Panhematin reduces the production of porphyrin precursors and corrects the imbalance in the heme biosynthetic pathway, thereby addressing the underlying pathophysiology as a means of controlling acute attacks.

"Porphyria is a devastating disease that is often misdiagnosed and mistreated," said Desiree Lyon Howe, Executive Director of the American Porphyria Foundation. "Historically, porphyria has not been a focus of large pharmaceutical companies. With Ovation's leadership and its partnership with Cardinal Health for manufacturing, Panhematin is getting the attention it needs to ensure patients have access to a steady supply of product to treat the disease."

About Panhematin

Panhematin (hemin for injection) is indicated for the amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women. Panhematin is not indicated in porphyria cutanea tarda.

Panhematin (hemin for injection) should only be used by physicians experienced in the management of porphyrias in hospitals where the recommended clinical and laboratory diagnostic and monitoring techniques are available. Panhematin therapy should be considered after an appropriate period of alternate therapy (ie, 400 g glucose/day for 1 to 2 days). Panhematin is made from human blood and therefore may contain infectious agents, such as viruses, that can cause disease, including Creutzfeldt-Jakob disease.

Drugs such as estrogens, barbituric acid derivatives, steroid metabolites, and anticoagulants should be avoided during Panhematin therapy. Because phlebitis has been reported after administration of Panhematin through small arm veins, a large arm vein or a Central Venous Catheter should be used for administration.

Manifestations such as pain, hypertension, tachycardia, abnormal mental status and mild to progressive neurologic signs may be controlled in selected patients with porphyria. Please see full prescribing information for Panhematin at www.ovationpharma.com/prod_onc_panhe.htm .

About OVATION Pharmaceuticals

OVATION is a fully integrated pharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs of underserved populations of patients. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on hematology/oncology, central nervous system (CNS), and hospital-based therapies. The company's hematology/oncology portfolio is largely focused on rare pediatric and hematologic malignancies for which there are few, if any, alternative therapies available. Four of the company's anticipated five new product launches in the next five years will be therapies for rare disorders fueled by the company's late-stage CNS pipeline, which is one of the most robust in the industry. More information about the company may be found at www.ovationpharma.com.

About Cardinal Health

Headquartered in Dublin, Ohio, Cardinal Health, Inc. (NYSE: CAH ) is an $81 billion, global company serving the health-care industry with a broad portfolio of products and services. It manufactures, packages, and distributes pharmaceuticals and medical supplies, offers a range of clinical services and develops automation products that improve the management and delivery of supplies and medication for hospitals, physician offices and pharmacies. Through this diverse offering, Cardinal Health delivers integrated health-care solutions that help customers reduce their costs, improve efficiency and deliver better care to patients. Ranked No. 19 on the Fortune 500, Cardinal Health employs more than 55,000 people on six continents. More information about the company may be found at www.cardinalhealth.com.

Except for historical information, all other information in this news release consists of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. The most significant of these uncertainties are described in Cardinal Health's Form 10-K, Form 10-Q and Form 8-K reports (including all amendments to those reports) and exhibits to those reports, and include (but are not limited to) the following: competitive pressures; the loss of one or more key customer or supplier relationships or changes to the terms of those relationships; changes in the distribution patterns or reimbursement rates for health-care products and/or services; the results, consequences, effects or timing of any inquiry or investigation by or settlement discussions with any regulatory authority or any legal and administrative proceedings; costs and effects of shareholder litigation and other legal proceedings; difficulties in opening new facilities or fully utilizing existing capacity; the costs, difficulties and uncertainties related the integration of acquired businesses; and general economic and market conditions. Cardinal Health undertakes no obligation to update or revise any forward-looking statement.


Source: Cardinal Health

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