2008
2007
2006
2005
2004
2003
History

 

 

2008
    

     UNITED STATES:

Acquisition of Tercica, Inc.: In 2008, Ipsen acquired full control of its partner Tercica, Inc. With this acquisition, Ipsen has extended its Endocrinology franchise and now has a global reach with Somatuline® Depot and Increlex®. These products help to treat an underserved population suffering from complex Endocrinology Disorders, such as Acromegaly and Short Stature.

 

Acquisition of Vernalis: In 2008, Ipsen acquired Vernalis, Inc. With this acquisition, Ipsen gained one new product, Apokyn®. Apokyn® is used to treat off-episode motor symptoms associated with advanced Parkinson's Disease (PD).

 

 

2007

     UNITED STATES:

Development of commercial presence: Marketing approval for Somatuline® Depot in the treatment of acromegaly. This drug, which was already marketed under the name Somatuline® Autogel® outside the United States, becomes the first product originating from the Group's R&D to be approved by the FDA.

 

FDA accepted the filing of the Biologics License Application for Dysport® in cervical dystonia.

 

Fundamental Research Program in Life Sciences with the Salk Institute: Ipsen gains access to cutting-edge technologies and advanced knowledge in the field of proliferative and degenerative diseases.

 

 

EUROPE AND LATIN AMERICA:

Botulinum Toxin's market penetration boosted: Ipsen granted Galderma the right to promote and distribute the Group's botulinum toxin product for aesthetic indications in Brazil, Argentina, and Paraguay; and also the right to develop the product in the European Union, Russia and certain Middle East and European countries.

 

Product portofolio extended: Marketing authorization of Increlex®, for which Tercica granted Ipsen the development and commercialization rights in Europe and certain other territories in October 2006.

 

The European Medicines Agency (EMEA) recommends marketing authorization of Ipsen's Adenuric® (febuxostat, in partnership with Teijin) for the treatment of chronic hyperuricaemia in gout.

 

€55 million to be invested at the Dreux site by 2011: This program will enable the Group to strengthen its Research and Development activity, as the Dreux site specializes in three strategic activities: formulation, analytical development and production of batches for preclinical and clinical research.

 

Optimizing the primary care product portofolio: Agreement with MSD for the co-marketing of Adrovance® in the treatment of post-menopausal osteoporosis.

 

Transfer of the marketing authorizations of Ginkor Fort® to GTF for France, Monaco and Andorra as from 1 January 2008.

 

Product portofolio extended: Extended collaboration agreement with the Erasmus University Medical Center Rotterdam. Creation of the Erasmus Research Institute for NeuroEndocrinology (ERINE) in partnership with the Erasmus University Medical Center Rotterdam to identify and progress therapeutic concepts and innovative products within the fields of endocrinology, diabetes and metabolism.

 

Wrexham, UK, site production capacity increased: Representing an investment of e55 million, a new building should be operational in 2010. Ipsen thereby significantly increases its production capacity of Dysport®/Reloxin®. The site is also preparing for the inspections due in 2008 within the context of the FDA approval process.

 

 

     ASIA

16.1% growth in 2007: In 2007, sales generated in Asia rose 16.1% namely due to the performance of Smecta® and Decapeptly® in China.

 

 

2006

Ipsen and Tercica Complete Worldwide Strategic Collaboration Agreement in Endocrinology (October 2006): The transaction was finalized in October following approval by Tercica stockholders at a special meeting of stockholders.

     * Cross licensing agreements for Somatuline® Autogel® and Increlex™

     * Ipsen to acquire initial 25% stake in Tercica, with the potential to increase to up to 40%ownership via convertible notes and warrant

     * Joint product development rights for endocrine pipelines

     * Somatuline® Autogel® gets marketing approval in Canada; Tercica expects to launch in early 2007

     * EMEA's validation of febuxostat's: Marketing Authorization Application in the European Union

 

Ipsen announced the European Medicines Agency (EMEA) has validated its application to market febuxostat in the European Union (EU), for the management of symptomatic hyperuricaemia (October 2006): Further to the development and marketing agreement signed in July 2003 between Ipsen and Teijin, holder of the product's rights, Ipsen was endorsed to develop and market febuxostat in Europe.

 

Ipsen and GTx enter into partnership agreement for the European rights of Acapodene® (September 2006): Ipsen, a European pharmaceutical group and GTx, Inc. (Nasdaq: GTXI), the Men's Health Biotech Company announced that they have entered into a definitive agreement under which Ipsen will have an exclusive license to develop and market GTx's Acapodene® (European Union, Switzerland, Norway, Iceland, Lichtenstein and the Commonwealth of Independent States) ("European Territory").

 

Roche exercises its option on Ipsen's anti-diabetic medicine for type 2 diabetes (July 2006): Further to the agreement signed in October 2003, Roche announced its decision to exercise its option to exclusively license, develop and market Ipsen's patented anti-diabetic drug BIM 51077. This GLP-1 medicine has shown a good efficacy potential to be more conveniently administered than existing members of the class, which would facilitate patient compliance. Roche has been granted worldwide rights, except in Japan where these rights are shared with Teijin (Ipsen's Japanese partner), and in France where Ipsen may elect to retain co-marketing rights.

 

Type 2 diabetes therapy: Ipsen is currently testing an innovative sustained release formulation of its GLP-1 analogue based on its proprietary drug delivery system technologies (June 2006): Ipsen announced that it is currently testing an innovative and convenient sustained release formulation of BIM 51077 for the treatment of type 2 diabetes. This GLP-1 analogue consists of an aqueous solution without organic solvent for excipient. The low volume solution can be injected subcutaneously with a small 29-gauge needle insulin syringe. This formulation is based on Ipsen proprietary drug delivery system technologies.

 

Ipsen chooses Medicis to promote and distribute Ipsen's botulinum toxin product to the aesthetic market (March 2006): Ipsen announces the signing of an agreement whereby Ipsen will grant Medicis rights to develop, distribute and commercialize Ipsen's botulinum toxin product in the United States, Canada and Japan for aesthetic use by physicians. The product is commonly referred to as Reloxin® in the U.S. aesthetic market and Dysport® for medical and aesthetic markets outside the U.S.

 

 

2005

Ipsen Announces Licensing Agreement with Radius for Ipsen Osteoporosis Proprietary Molecule BA058 (December 2005): Ipsen announces that in September 2005 it entered into a licensing agreement with Radius (formerly known as Nuvios) through which Radius has acquired the exclusive worldwide rights to develop, manufacture and distribute the molecule BA058 (formerly known as BIM 44058) and its analogs, along with rights to several Ipsen novel formulation technologies. The license is on a worldwide basis with the exception of Japan, where Ipsen previously granted an exclusive license for BA058 to the Japanese group, Teijin. Radius will pay Ipsen upfront and milestone payments linked to development and registration of the product, as well royalties calculated on a pro rata sales basis. BA058 is an analog of PTHrP (parathyroid hormone-related protein) and is currently in phase 1 clinical trials for the treatment of osteoporosis.

 

Ipsen and Pfizer enter into an agreement to promote Artotec® in France (November 2005): Ipsen and Pfizer announce the signature of an agreement according to which Pfizer will transfer promoting rights for its Artotec® product to Ipsen in France as of 1 January 2006. Artotec® is a nonsteroidal anti-inflammatory drug which is a diclofenac- and misoprostol-based product (protective gastric agent). It achieved sales of over €9 million in France in 2004 (source: Gers Officine 2004) and is indicated for the symptomatic treatment of rheumatic disorders. The agreement has been signed for an initial period of two years.

 

Ipsen grants to Recordati marketing and sellings rights to sell Tenstaten® in France (October 2005): Ipsen and Recordati have announced the signature of an agreement by which Ipsen grants to Recordati the exclusive marketing and selling rights in France of Tenstaten® (Cicletanine), a diuretic indicated for the treatment of hypertension developed by Ipsen. The drug is currently marketed in France by Ipsen with sales of over €12 million in 2004. The consideration paid is slightly more than one time annual sales. Ipsen will supply Tenstaten® to Bouchara Recordati (Recordati subsidiary in France), who will market it for an initial period of seven years. Ipsen will also provide to Bouchara Recordati various services during the hand-over period.

 

Ipsen transfers the primary care division of its Spanish subsidiary to the Faes Group (October 2005): The Ipsen Group announces that its Spanish subsidiary has signed an agreement with Faes Pharma SA. This agreement concerns the transfer of assets belonging to Ipsen's subsidiary relating to the marketing and sales of primary care products - analgesics and generics under tha Lasa brand. It does not cover Tanakene® (product marketed as Tanakan® in France), which remains in the Group's product portfolio. These products were previously marketed by Ipsen in Spain only, and represented a turnover of 15.5 million euros for the financial year ending on December 31, 2004, and 8.2 million euros for the half-year ending on June 30, 2005.

 

Opening of a new biotechnology unit in Boston (March 2005):
Ipsen opens a dedicated biotechnology unit to complement the activities of its R&D centre in Boston (USA). It will henceforth be known as the Albert Beaufort Research Institute. This extension includes two GMP-compliant manufacturing units, as well as laboratories. It will be a new base for the biotechnology team who has expertise in development processes, specific to genetic engineering, industrial scale-up, protein analysis, production operations, quality assurance and quality control. This facility will allow Ipsen to produce recombinant proteins for clinical development and in some cases products such as OBI-1 has been developed from a close collaboration between Octagen and the Ipsen R&D centre in Boston. Massachusetts was selected as it has a high concentration of biotechnology resources due to the location of many specialized leading companies in the area. The proximity to many world-class research institutions - Harvard, MIT (Massachusetts Institute of Technology), and MGH (Massachusetts General Hospital) - is also beneficial to the implementation of Ipsen's alliance strategy in the biotechnology area.

 

 

2004

Testim® 50 mg Gel available in Europe at the beginning of 2005 (December 2004): Paris (France), 7 December 2004 - The Ipsen Group announces today that Testim® 50mg Gel (testosterone) has obtained a marketing authorization (MA) in 15 European countries, through the Mutual Recognition Procedure (MRP). Pursuant to the licensing agreement signed in March 2004 with the U.S.-based company Auxilium Pharmaceuticals Inc., Ipsen has obtained the rights to market Testim® 50mg Gel in all countries except the United States of America, Canada, Mexico and Japan.

 

Ipsen and Octagen progress OBI - 1, recombinant Factor VIII, to Phase II (November 2004): Ipsen and Octagen announced today that OBI-1, recombinant porcine Factor VIII, has received FDA agreement to enter Phase II clinical studies in the United States. The two companies are developing OBI-1 for the treatment of congenital and acquired hemophilia in patients who develop inhibitory antibodies to human Factor VIII. Ipsen and Octagen also have a program for the development of OBI-2, a novel recombinant Factor VIII molecule based on human Factor VIII but engineered to have reduced immunogenicity. This program is at the stage of lead optimization.

 

Signing of an R&D agreement with Genentech for the development of sustained-release formulations for recombinant human growth hormone (November 2004): Ipsen and Genentech sign a R&D agreement for the development of sustained-release formulations for Genentech's recombinant human growth hormone (somatropin, recombinant DNA origin). This partnership extends and complements the previous agreement signed in 2002, which granted Ipsen exclusive marketing rights for NutropinAq® Pen in Europe and the rest of the world, apart from North America and Japan. Ipsen already markets NutropinAq® Pen in more than 15 European countries.

 

Ipsen, Prix Galien 2004 de la Recherche Pharmaceutique

 

Ipsen and Auxilium sign a licensing agreement to market Testim® 1% testosterone gel (April 2004): Ipsen and the American firm Auxilium sign a licensing agreement to market testosterone gel developed by Auxilium, Testim® 1%. Under the agreement, Ipsen holds the rights to market the product in all countries except for the United States of America, Canada, Mexico and Japan. Testim® 1% is a gel which is applied to the shoulders and normalizes low levels of testosterone. In particular, it is indicated for the treatment of hypogonadism in men, and has already been approved in the United Kingdom.

 

2003

Ipsen obtains FDA authorization to launch clinical trials in the United States of America with Somatuline® Autogel® (December 2003): The Group receives FDA authorization to launch phase III clinical trials with Somatuline® Autogel®, a somatostatin analogue for the symptomatic treatment of neuroendocrine tumors mainly affecting the gastrointestinal tract.

 

Roche acquires the rights from Ipsen for an antidiabetic molecule (October 2003): Roche and Ipsen announce they have entered into an agreement relating to BIM 51077, an antidiabetic agent developed by Ipsen. BIM 51077 is an analogue of GLP-1 (Glucagon-Like-Peptide-1) currently undergoing phase I clinical trials in the treatment of type 2 diabetes. BIM 51077, a molecule discovered by Ipsen Research, is a GLP-1 receptor agonist, a new class of compounds being studied in the treatment of type 2 diabetes. GLP-1 is a hormone naturally secreted by the body in response to food intake. It stimulates insulin production, suppresses glucagon secretion and slows gastric emptying in order to restore and sustain physiological blood glucose levels. The structure of BIM 51077 was optimized to provide extended duration of action while retaining the potency of the endogenous hormone.

 

Ipsen obtains FDA approval to launch clinical trials with diflomotecan in the United States of America (October 2003): Ipsen obtains Food and Drug Administration (FDA) authorization to launch phase II clinical trials in the United States of America with diflomotecan (BN 80915), a new topoisomerase inhibitor, for the treatment of small-cell lung cancer. Diflomotecan is the subject of a partnership with Roche, awarded a license by Ipsen for this group of molecules (homocamptothecins) since December 2002.

 

Initiation of clinical trials for a joint Ipsen and Octagen product for the treatment of hemophilia (September 2003): Ipsen and Octagen, an American biotechnology firm based in Philadelphia, announce the start of phase I clinical trials on their recombinant porcine factor VIII for the treatment of haemophilia A. The product, code name OBI-1, is being jointly developed Ipsen and Octagen with Emory University (United States of America) within the framework of a global sub-license, which Ipsen was granted in Spetember 1998 by Octagen, an Emory University licensee and inventor of molecules. The phase I clinical trials will be conducted in approximately 20 centers throughout the United States of America and the United Kingdom.

 

Ipsen and Pfizer work together on three large phase III studies in early-stage breast cancer (September 2003): Ipsen and Pfizer sign an agreement for the phase III clinical evaluation of the combination Decapeptyl® and Aromasin® in pre-menopausal women with breast cancer. This study, expected to recruit more than 7,000 patients with a follow-up period of at least five years, is being conducted under the auspices of International Breast Cancer Study Group (IBCSG). The objective is to demonstrate that a purely hormonal approach to the adjuvant treatment of breast cancer may supposedly act as a substitute for traditional chemotherapy, thus providing better quality of life for this patient group.

 

Agreement between Ipsen and Teijin to develop and market four Ipsen products in Japan and a new agent resulting from Teijin research in Europe (July 2003): Ipsen and Teijin sign a series of agreements to develop and market four Ipsen products, including Somatuline® Autogel®, in Japan. Through this agreement, Teijin also grants Ipsen development and marketing rights for its new agent for the treatment of hyperuricaemia, TMX-67, in Europe. Teijin will therefore promote Ipsen's development in Japan and Ipsen will do likewise for Teijin in Europe. This collaboration will ensure that product sales in Japan and Europe will return to Ipsen and Teijin, respectively, once both companies have locally established a commercial presence.

 

Ipsen develops specific analogues of ghrelin, a hormone implicated in weight control (June 2003): Ipsen announces the discovery of specific analogues of ghrelin (hormone implicated in weight control), which, for the first time, do not stimulate growth hormone secretion. This discovery was made in Boston (United States of America), one of the Ipsen Group's four research centers, which focuses on the development of new medicinal products in the field of endocrinology.

 

Worldwide partnership in the field of oncology with the biotechnology company Spirogen (May 2003): Ipsen acquires the rights to develop, on a global scale, a new innovative anticancer agent, SJG-136, discovered by Spirogen, a British biotechnology company. The agreement also allows Ipsen to acquire 20% equity state in Spirogen. SJG-136, destined for the treatment of tumors resistant to conventional agents such as cusplatin, is currently undergoing phase I clinical trials in the United Kingdom, conducted by Cancer Research, and in the United States of America, conducted by the National Cancer Institute (NCI).

 

Agreement between Ipsen and Novartis to market two antihypertensive agents, Nisis® and Nisisco®, in France (March 2003): The Group signs a series of agreements with Novartis, granting the rights to two antihypertensive agents, Nisis® (valsartan) and Nisisco® (valsartan and hydrochlorothiazide). Already involved in the field of hypertension with Tenstaten® (cicletanine), Ipsen reinforces its expertise in cardiovascular diseases in France. This partnership is aligned with the Group's strategy to support its international development based on solid position in France.

 

European marketing autorization for NutropinAq™, a recombinant growth hormone (February 2003): Ipsen obtains the European marketing authorization for the growth hormone NutropinAq™ (recombinant domatropin, solution for injection), further to the decision by the European agency for the evaluation of medicinal products (EMEA). This decision follows the agreement signed in September 2002 with Genentech, an American biotechnology company. NutropinAq™ is produced by means of recombinant DNA technology and is used in the treatment of growth hormone deficiency. Marketing began in the European Union in 2004.

 

Initiation of phase II clinical trials for Ipsen botulinum toxin in the field of dermo-cosmetic area (January 2003): Ipsen announces the start of phase II clinical trials in the United States of America with its botulinum type A toxin (active substance of Dysport®), for dermo-cosmetic use. The trials are being conducted by the American firm Inamed, to whom in July 2002 Ipsen granted the rights for a 17-year period for the development and distribution of Dysport®, in North America and Japan. In the past few years, the purified form of botulinum type A toxin has revolutionized dermo-cosmetic. This non-invasive reproducible procedure, which is safe and simple to use, could be administered successfully in various cosmetic applications, subject to registration in the United States of America.

 

History

 

Ipsen's history can be traced back to 1929, when Doctor Henri Beaufour set up Laboratoires Beaufour in Dreux for the launch of Romaréne®, a naturally occurring product derived from rosemary used in the treatment of digestive disorders.

 

1954: Ipsen launched Citrate de Betaïne®, a product used in the symptomatic treatment of dyspepsia. Following the opening in 1969 of the Institut Henri Beaufour, the Group's research facility in France, the 1970s represented a period of expansion for the Group's activities in products of natural origin, since it launched Ginkor®, Tanakan® and Smecta®, which all remain major products for the Group and draw on its specific expertise.

 

1970s: Ipsen decided to focus its activities on peptide engineering products. The Group forged close relationships with universities in the United States and set up its peptide product research facility based close to the Boston universities.

 

1980s: Ties were forged with Debiopharm. These partnerships, led to the marketing of Decapeptyl®, which was launched in 1986 and has driven the Group's international expansion.

 

During the mid-1980s: Creation of the Ipsen Foundation for Therapeutic Research. It aims to foster exchanges between top-ranking scientists in life sciences.

 

Late 1980s and early - 1990s: Ipsen's international expansion continued with subsidiaries and offices being set up outside France and the acquisition of foreign companies.

 

To strengthen its presence in the United Kingdom, Northern Europe and the United States and to build a sales platform for its biological products, Ipsen acquired the UK-based company Speywood, which is responsible for developing Dysport®. During this period, the Group also launched in France Somatuline®, and Forlax®, in February 1996.

 

1992: Expansion in China, initially by setting up representative offices and then in 1997 by setting up a subsidiary. In 2000, the Group opened a manufacturing facility at which it produces Smecta® for the Chinese market.

 

In 1998: The PAI FBO Fund, Paribas (now BNP Paribas), CDC Participations and the Schwabe family acquired a significant shareholding in the capital of Mayroy, the holding company that controls the Group.

 

In December 2001 and January 2002: Ipsen launched Somatuline® Autogel® in the United Kingdom and in France. This launch was then extended to various other countries, strengthening the Group's position vis-á-vis Novartis, its principal rival in this product segment.

 

2004: Ipsen launched NutropinAq® in 12 European countries and Decapeptyl® in Germany.

 

In March 2005: Ipsen inaugurated, at its campus near Boston, a biotechnology facility. This complements the Research and Development center's activities already present at the same location.

 

June 2005: Ipsen reorganized its operations by transferring to the Company all the assets and operational holdings hitherto held by Mayroy, its majority shareholder. In October 2005, Ipsen sold assets belonging to its Spanish subsidiary to Faes Farma. The assets were used to promote and sell primary care products, with the exception of Tanakene®, which remains with Ipsen.

 

December 2005: The shares in the company were listed on the Eurolist by Euronext™. In June 2006, Ipsen received its first marketing authorization for its botulinum toxin in aesthetic medicine indications in Western Europe with Germany.

 

July 2006: The Canadian Health Authorities granted marketing authorization for Somatuline® Autogel® for the treatment of acromegaly. This is the first marketing authorization obtained in North America for Somatuline.

 

In addition since 2002: Ipsen has forged a number of partnerships to enrich its Research and Development portfolio and extend its product range: Genentech, Novartis, Spirogen, Teijin, Sterix, Auxilium, Pfizer, Rocher, GTx Inc., Tercica, MSD, and Galderma.

 

 

 

Important Safety Information for Somatuline® Depot

Somatuline Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

 

Lanreotide may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose levels monitoring is recommended and antidiabetic treatment adjusted accordingly. Lanreotide may lead to a decrease in heart rate. Use with caution in at-risk patients.

 

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60mg.

 

There are no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies risk to the fetus. A decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

 

Somatuline Depot may decrease the bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.

 

Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments. Somatuline Depot may reduce the intestinal absorption of co-administered drugs. Caution should be used.

 

The most common adverse reactions (incidence > 5%) are diarrhea, cholelithiasis, abdominal pain, nausea, injection site reaction, flatulence, arthralgia, and loose stools.

 

Please see Full Prescribing Information for additional important information

 

 

Important Safety Information for Increlex®

INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to GH. Primary IGFD is defined as height and IGF-1 SDS ≤ -3 and normal or elevated growth hormone.

 

In clinical studies of 71 subjects with Severe Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy.

 

Almost half of these patients had hypoglycemia prior to IGF-1 treatment. Most cases were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion, and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Of the 30 subjects reporting hypoglycemia, 14 (47%) had a history of hypoglycemia prior to treatment. The frequency of hypoglycemia was highest in the first month of treatment, and episodes were more frequent in younger children. Hypoglycemia was generally avoided when a meal or snack was consumed either shortly before or shortly after administration.

 

Tonsillar hypertrophy was noted in 11 subjects (15%) in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years.

 

Intracranial hypertension occurred in three subjects. In two subjects, the events resolved without interruption of Increlex treatment. Increlex treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

Please see Full Prescribing Information for additional important information
 

 

Important Safety Information for Apokyn®

Important Safety Information for Patients and Care Partners

You should not take APOKYN® if you are allergic to APOKYN or its ingredients, notably the sulfite called metabisulfite. Do not take APOKYN if you are being treated with certain drugs called 5HT3 antagonists (such as Anzemet®*, Kytril®†, and Zofran®‡) that are used for nausea and vomiting or irritable bowel syndrome. People taking this type of drug with apomorphine had severely low blood pressure and "blacked out."

 

APOKYN must be injected just under the skin and not into a vein.

 

Your doctor may prescribe a medicine called Tigan®§ to help prevent nausea and vomiting. Some patients can stop taking Tigan after using APOKYN for some time. Some patients may need to continue taking Tigan to help prevent nausea and vomiting. Talk to your doctor before you stop taking Tigan.

 

If you experience shortness of breath, fast heartbeat, or chest pain while taking APOKYN, you should call a doctor right away.

 

APOKYN may lower blood pressure and cause dizziness and fainting, especially when starting treatment or if the dose is increased. Patients should not get up too fast from sitting or after lying down to minimize these problems.

 

Some patients taking APOKYN may get sleepy during the day or fall asleep without warning doing everyday activities. Until it is known how APOKYN affects your ability to stay alert, you should not drive a car or operate machinery.

 

Some patients may notice soreness, redness, bruising, or itching at the injection site. Changing the injection site with each injection and putting ice on the site before and after the injection may lessen these effects.

 

The most common side effects seen in clinical studies with APOKYN were: yawning; sudden uncontrolled movements; nausea and/or vomiting; sleepiness; dizziness; runny nose; seeing and hearing things that are not real; swelling of hands, arms, legs, and feet; chest pain; increased sweating; flushing; and unusually pale complexion. 

 

Please see Full Prescribing Information for additional important information

 

* Anzemet® (dolasetron mesylate) is a registered trademark of sanofi-aventis.
† Kytril® (granisetron HCl) is a registered trademark of Roche Laboratories Inc.
‡ Zofran® (ondansetron HCl) is a registered trademark of GlaxoSmithKline.
§ Tigan® (trimethobenzamide HCl) is a registered trademark of Monarch Pharmaceuticals, Inc.

 

Important Safety Information for Healthcare Professionals

 Contraindications: APOKYN® is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients (notably metabisulfite). Concomitant use of APOKYN with 5HT3 antagonists is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron.

 

Nausea and Vomiting: At recommended doses of apomorphine, severe nausea and vomiting can be expected. Therefore, trimethobenzamide hydrochloride should be started 3 days prior to the initial dose of APOKYN and continued for at least 2 months. In clinical trials, 50% of patients (262/522) discontinued trimethobenzamide hydrochloride after 2 months of APOKYN.

 

Symptomatic Hypotension: Dopamine agonists, including APOKYN, can cause hypotension, orthostatic hypotension, and syncope. These adverse events occurred with initial dosing and long-term treatment. Whether hypotension contributes to other significant events seen (eg, falls) is unknown.

 

SC Injection: APOKYN should be administered by subcutaneous injection, NOT intravenously, because serious adverse events may occur.

 

Cardiac Effects: QT Prolongation—Caution is recommended when administering APOKYN to patients with increased risk of QT prolongation, such as those with hypokalemia, hypomagnesemia, bradycardia, or a genetic predisposition, or who use other drugs that prolong the QT/QTc interval. Coronary Events—APOKYN reduces resting systolic and diastolic blood pressure and has the potential to exacerbate coronary (and cerebral) ischemia. Therefore, exercise caution when prescribing APOKYN for patients with known cardiovascular and cerebrovascular disease.

 

Falling Asleep During Activities of Daily Living (ADL): There have been literature reports of patients treated with apomorphine subcutaneous injections who suddenly fell asleep while engaged in ADL. Patients should be advised not to drive or participate in potentially dangerous activities until it is known how APOKYN affects them. Patients should be continually reassessed for daytime drowsiness or sleepiness.

 

Adverse Events: Injection site reactions, including bruising, granuloma, and pruritus, have been reported. The most common adverse events seen in controlled trials were yawning, dyskinesias, nausea and/or vomiting, somnolence, dizziness, rhinorrhea, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.

 

Treatment-emergent adverse events (incidence greater than or equal to 10%) and associated rate of treatment discontinuation during open-label, long-term use (N=550)

 

Please see Full Prescribing Information for additional important information