Carbatrol: profile and news

Shire plc: Strong 2005 Performance Supports Positive Outlook  Feb 23, 2006
Patent litigation continues and settlement discussions with Barr Laboratories Inc., (Barr) are progressing; - CARBATROL for Epilepsy. ... - PR Newswire (press release),

Shire Plc: Strong 2005 Performance Supports Positive Outlook  Feb 23, 2006
CARBATROL for Epilepsy. A promotional services agreement for the US market with Impax was signed in January. ... (Nostrum) relating to CARBATROL are ongoing. ... - International News Service,

/FIRST AND FINAL ADD -- LNTH005 -- Shire plc: Strong 2005 ...  Feb 23, 2006
US$'000 US$'000 % change % of total revenue Net product sales: CNS ADDERALL XR 214,010 183,660 +17% 46% ADDERALL 12,078 12,074 0% 2% CARBATROL 17,275 15,468 +12 ... - PR Newswire (press release),

SHIRE PLC: Shire and Impax Settle All Pending Litigation  Jan 20, 2006
Shire and Impax Settle All Pending Litigation Concerning ADDERALL XR® Enter into Agreements for Generic ADDERALL XR and Promotion of CARBATROL® in the United ... - FinanzNachrichten.de,

Shire and Impax Settle all Pending Litigation Concerning ADDERALL ...  Jan 19, 2006
Enter Into Agreements for Generic ADDERALL XR and Promotion of CARBATROL(R) in the United States BASINGSTOKE, England and PHILADELPHIA, Pennsylvania, January ... - PR Newswire (press release),

IMPAX Settles Patent Suit and Signs Marketing and Promotion ...  Jan 19, 2006
In a separate agreement, IMPAX will promote Carbatrol(R) (carbamazepine extended release capsules), Shire's product for the treatment of epilepsy beginning ... - Genetic Engineering News,

Shire and Impax Settle all Pending Litigation Concerning ADDERALL ...  Jan 19, 2006
Shire and Impax have also entered into an agreement to promote Shire's CARBATROL® (carbamazepine) for the treatment of epilepsy in the United States. ... - Yahoo! News (press release)

Shares up after Shire Pharma settles legal dispute  Jan 20, 2006
...dispute.". In a separate agreement Impax will promote Shire’s Carbatrol drug for epilepsy in the US for three years from July 2006. ... - Telegraph.co.uk,

Shire says deal to let Impax sell generic Adderall  Jan 19, 2006
Under another agreement, Shire said it will pay Impax to promote Shire's epilepsy treatment Carbatrol in the United States for three years, beginning around ... - Scotsman,

Shire agreement lifts shares  Jan 20, 2006
...that Shire's drug patents were valid. The pair also entered an agreement to promote Shire's epilepsy treatment Carbatrol in the US. - Virgin.net,

Supernus Pharmaceuticals Acquires Drug Formulation Business of ...  Jan 12, 2006
...and development business was based on SLI's success and proven track record in developing advanced products such as Adderall XR(R), Carbatrol(R), Equetro(R ... - PharmaLive.com (press release),

Shire Settles Adderall Patent Dispute  Jan 19, 2006
The companies also made a separate deal under which Shire will pay Impax to market its epilepsy drug Carbatrol to US neurologists over the next three years ... - MSN Money

UPDATE 2-Shire says deal to let Impax sell generic Adderall  Jan 19, 2006
Under another agreement, Shire (SHP.L: Quote, Profile, Research) said it will pay Impax to promote Shire's epilepsy treatment Carbatrol in the United States ... - Reuters

Shares hit four-year high as Adderall litigation settled  Jan 20, 2006
But the companies have agreed a separate promotional arrangement under which Shire will pay Impax for US promotion of its Carbatrol epilepsy treatment. ... - MarketWatch

Shire settles ADHD-drug dispute  Jan 19, 2006
But Shire will pay Impax through a separate marketing agreement, also announced Thursday, that calls for Impax to promote Shire's Carbatrol drug for seizures ... - Philadelphia Business Journal,

Pearson Top of the Class in Textbook Performance ; MARKET REPORT  Jan 20, 2006
...generic. In return, Impax will promote Carbatrol, Shire's treatment for epilepsy in the US, in return for payments on current sales. - Black Enterprise,

Supernus buys Shire Labs’ drug making outfit  Jan 16, 2006
...and development business was based on SLI's success and proven track record in developing advanced products such as Adderall XR, Carbatrol, Equetro and Oracea ... - In-PharmaTechnologist.com,

Buyout ends 2-year saga as Rockville drug firm stays  Jan 19, 2006
...and development business was based on [its] success and proven track record in developing advanced products such as Adderall XR, Carbatrol, Equetro and Oracea ... - Business Gazette,

CARBATROL Paragraph IV Litigation Update  Jul 18, 2005
...filed an Abbreviated New Drug Application (ANDA) seeking approval from the Food and Drug Administration (FDA) for Nostrum's generic version of CARBATROL(R). In ... - PharmaLive.com (press release)

Shire Pharmaceuticals Group plc: Good Second Quarter Results With ...  Jul 28, 2005
...salts) ADDERALL® (mixed amphetamine salts) AGRYLIN® (anagrelide hydrochloride) CALCICHEW® (calcium carbonate) CARBATROL® (carbamazepine) COLAZIDE ... - Yahoo News (press release)

Shire says patent suit to go to trial  Jul 18, 2005
Shire said it sued Nostrum in 2003 after Nostrum filed a new drug application seeking regulatory approval for a generic version of Carbatrol, Shire's leading ... - BusinessWeek

SHIRE PHARMACEUTICALS GROUP PLC: GOOD SECOND QUARTER RESULTS WITH ...  Jul 28, 2005
CARBATROL had a 43% share of the total US extended release carbamazepine prescription market in June 2005 (June 2004: 45%). Patent ... - ITNews

Shire Risks Court Cost On Nostrum >SHPGY  Jul 18, 2005
But the move highlights Shire's desire to keep tight control on Carbatrol and, if it proves successful, should dissuade other company's from following Nostrum. ... - New Ratings

Nostrum Pharmaceuticals Confident Regarding Outcome of Shire ...  Jul 26, 2005
Carbamazepine capsule infringes US Patent No. 5,326,570, one of Shire's patents for its product Carbatrol®. Nirmal Mulye, Ph.D., founder ... - Yahoo News (press release)

Shire says Nostrum denied motion for summary judgment in patent ...  Jul 18, 2005
The lawsuit results from an Abbreviated New Drug Application filed by Nostrum for a generic version of the 300 mg dosage strength of Carbatrol, Shire's leading ... - Forbes

Shire Pharmaceuticals: First Quarter Results - Strong Underlying ...  Apr 29, 2005
...amphetamine salts) ADDERALL(R) (mixed amphetamine salts) AGRYLIN(R) (anagrelide hydrochloride) CALCICHEW(R) (calcium carbonate) CARBATROL(R) (carbamazepine ... - PR Newswire

Shire Pharmaceuticals: First Quarter Results - Strong Underlying ...  Apr 29, 2005
...salts) ADDERALL® (mixed amphetamine salts) AGRYLIN® (anagrelide hydrochloride) CALCICHEW® (calcium carbonate) CARBATROL® (carbamazepine) COLAZIDE ... - Yahoo News

Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following:

Agents Highly Bound to Plasma Protein

Carbamazepine is not highly bound to plasma proteins; therefore, administration of EQUETRO^TM to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug.

Agents that Inhibit Cytochrome P450 Isoenzymes and/or Epoxide Hydrolase

Carbamazepine is metabolized mainly by cytochrome P450 (CYP) 3A4 to the active carbamazepine 10,11-epoxide, which is further metabolized to the trans-diol by epoxide hydrolase. Therefore, the potential exists for interaction between carbamazepine and any agent that inhibits CYP3A4 and/or epoxide hydrolase. Agents that are CYP3A4 inhibitors that have been found, or are expected, to increase plasma levels of EQUETRO^TM are the following:

Acetazolamide, azole antifungals, cimetidine, clarithromycin⁽¹⁾, dalfopristin, danazol, delavirdine, diltiazem, erythromycin⁽¹⁾, fluoxetine, fluvoxamine, grapefruit juice, isoniazid, itraconazole, ketoconazole, loratadine, nefazodone, niacinamide, nicotinamide, protease inhibitors, propoxyphene, quinine, quinupristin, troleandomycin, valproate⁽¹⁾, verapamil, zileuton.

Thus, if a patient has been titrated to a stable dosage of EQUETRO^TM, and then begins a course of treatment with one of these CYP3A4 or epoxide hydrolase inhibitors, it is reasonable to expect that a dose reduction for EQUETRO^TM may be necessary.

Agents that Induce Cytochrome P450 Isoenzymes

Carbamazepine is metabolized by CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent that induces CYP3A4. Agents that are CYP inducers that have been found, or are expected, to decrease plasma levels of EQUETRO^TM are the following:

Cisplatin, doxorubicin HCL, felbamate, rifampin, phenobarbital, Phenytoin⁽²⁾, primidone, methsuximide, and theophylline

Thus, if a patient has been titrated to a stable dosage on EQUETRO^TM, and then begins a course of treatment with one of these CYP3A4 inducers, it is reasonable to expect that a dose increase for EQUETRO^TM may be necessary.

Agents with Decreased Levels in the Presence of Carbamazepine due to Induction of Cytochrome P450 Enzymes

Carbamazepine is known to induce CYP1A2 and CYP3A4. Therefore, the potential exists for interaction between carbamazepine and any agent metabolized by one (or more) of these enzymes. Agents that have been found, or are expected to have decreased plasma levels in the presence of EQUETRO^TM due to induction of CYP enzymes are the following:

Acetaminophen, alprazolam, amitriptyline, bupropion, buspirone, citalopram, clobazam, clonazepam, clozapine, cyclosporin, delavirdine, desipramine, diazepam, dicumarol, doxycycline, ethosuximide, felbamate, felodipine, glucocorticoids, haloperidol, itraconazole, lamotrigine, levothyroxine, lorazepam, methadone, midazolam, mirtazapine, nortriptyline, olanzapine, oral contraceptives⁽³⁾, oxcarbazepine, Phenytoin⁽⁴⁾, praziquantel, protease inhibitors, quetiapine, risperidone, theophylline, topiramate, tiagabine, tramadol, triazolam, valproate, warfarin⁽⁵⁾ , ziprasidone, and zonisamide.

Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with EQUETRO^TM, it is reasonable to expect that a dose increase for the concomitant agent may be necessary.

Agents with Increased Levels in the Presence of Carbamazepine:

EQUETRO^TM increases the plasma levels of the following agents:

Clomipramine HCl, Phenytoin⁽⁶⁾, and primidone

Thus, if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of the treatment with EQUETRO^TM, it is reasonable to expect that a dose decrease for the concomitant agent may be necessary.

Pharmacological/Pharmacodynamic Interactions with Carbamazepine

Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.

Given the anticonvulsant properties of carbamazepine, EQUETRO^TM may reduce the thyroid function as has been reported with other anticonvulsants. Additionally, anti-malarial drugs, such as chloroquine and mefloquine, may antagonize the activity of carbamazepine.

Thus if a patient has been titrated to a stable dosage on one of the agents in this category, and then begins a course of treatment with EQUETRO^TM, it is reasonable to expect that a dose adjustment may be necessary.

Because of its primary CNS effect, caution should be used when EQUETRO^TM is taken with other centrally acting drugs and alcohol.