Epilepsy, Complex Partial

The FDA approved an oral liquid formulation of the drug zonisamide, originally made by Eton Pharmaceuticals and currently owned by Azurity Pharmaceuticals. The nod gives Azurity the ability to market Zonisade as an adjunctive therapy for treating partial seizures in adults and kids 16 years and older who have epilepsy. The green light comes after three double-blind and placebo-controlled clinical studies of the drug, which is administered once or twice a day. Zonisamide was originally approved in the early 2000s as a capsule for treating partial epileptic seizures and has been marketed by a variety of companies, including the former Irish biotech Elan Pharmaceuticals, Japanese drugmaker Eisai and Sumitomo Dainippon. In 2010, Elan and Eisai agreed to pay $214.5 million to resolve allegations of off-label marketing of Zonegran. Eton sold the oral liquid formulation of the drug to Azurity as part of a February 2021 deal, worth up to $45 million in payments, including $5 million when the drug is launched. “This is now the eighth product approval that our team has contributed to, and we are excited for Azurity to bring the product to patients. The proceeds from the launch milestone will be used to further grow our rare disease portfolio,” Eton CEO Sean Brynjelsen said in a statement. For Azurity, the nod adds to a long list of FDA-approved products across cardiovascular, CNS, endocrinology and orphan diseases. — Kyle LaHucik PMV Pharmaceuticals will test its small molecule targeting p53 in combination with Merck’s Keytruda as part of the biotech’s ongoing Phase I/II PYNNACLE trial in patients with advanced solid tumors. The combo arm will enroll about 36 patients whose solid tumors have a p53 Y220C mutation. PMV will lead the trial and Merck will provide its anti-PD-1 therapy. Shares of the Cranbury, NJ-based biotech skyrocketed in late May when PMV said initial data on the monotherapy arm of the trial showed a partial response in 3 out of 10 patients in the higher dose cohort. At ASCO in early June, the company presented more detailed data showing six confirmed partial responses among 25 patients. Two more patients had unconfirmed partial responses. — Kyle LaHucik Jonathan Lim’s cancer play Erasca, which is funded by some deep VC pockets , announced on Monday that it has netted a clinical trial collaboration with Eli Lilly to test another one of its candidate alongside Lilly’s anti-EGFR antibody Erbitux (cetuximab). The deal will see Erasca, which stands for “erase cancer,” get support for its ongoing Phase I/IIb trial, a proof-of-concept trial evaluating its candidate ERAS-601, an oral SHP2 inhibitor, alone and with Erbitux for both the treatment of triple wild-type metastatic colorectal cancer and HPV-negative advanced head and neck squamous cell carcinoma. For the trial, Lilly is supplying Erbitux at no cost. This is not the first deal that Erasca has netted with larger pharmas as the biotech has previously signed similar agreements with Lilly and Pfizer, respectively, to evaluate Erbitux and Braftovi (encorafenib) in combination with Erasca’s ERK1/2 inhibitor. “We are pleased to enter another clinical trial collaboration with Lilly to explore cetuximab in combination with ERAS-601, our SHP2 inhibitor, in EGFR-driven cancers that are highly dependent on RAS/MAPK signaling,” Lim said. — Tyler Patchen

WILMINGTON, Del., May 19 /PRNewswire-FirstCall/ -- AstraZeneca has launched an educational campaign to promote and reinforce accurate prescribing and dispensing of TOPROL-XL. TOPROL-XL is indicated for the treatment of hypertension, the long-term treatment of angina pectoris, and the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. In heart failure, it was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. The campaign is prompted by reports of name confusion between TOPROL-XL, Topamax(R) (topiramate), a medication produced by Ortho-McNeil Neurologics Inc. to treat epilepsy and prevent migraines, and Tegretol(R)/Tegretol-XR(R) (carbamazepine), produced by Novartis Pharmaceuticals Corporation to treat complex partial seizures, generalized tonic-clonic seizures, and trigeminal neuralgia. TOPROL-XL is not the first prescription drug to ever encounter this name confusion, and it is important to note the Food and Drug Administration (FDA) does not question the established efficacy, safety profile, or tolerability of TOPROL-XL when used to treat its approved indications. This program is directed to a broad audience including pharmacists and pharmacy technicians, physicians, physician assistants, nurse practitioners, nurses, and patients. Steps that AstraZeneca is taking include changing the appearance of the package label for TOPROL-XL(R) (metoprolol succinate) to provide differentiation in a new font and colors; running monthly journal ads raising awareness of the medication errors in key pharmacist, physician, and nursing journals; sending ongoing direct mail communications; developing "shelf- shouters" to remind physicians, pharmacists, pharmacy technicians, and prescribers of the potential for name confusion; and promoting legible handwriting on prescription forms, as well as updating both the TOPROL-XL brand professional and patient web sites with information about the medication errors and the importance of knowing one's medications. Furthermore, the AstraZeneca sales force is visiting physicians and pharmacists to personally deliver this important message. The FDA's Division of Cardiovascular and Renal Products recommended these actions, among others implemented by the company, in response to reports of medication errors. "Our priority at AstraZeneca is to ensure our products are administered appropriately and safely, and we are working together with the FDA to support this goal," said Tony Zook, the U.S. President and Chief Executive Officer of AstraZeneca. This awareness campaign is in addition to the steps AstraZeneca already took in September 2005 to immediately alert health care professionals and consumers about these medication errors, including the distribution of "Dear Health Care Professional" and "Dear Pharmacist" letters and the creation of a 1-800 number for further information. The additional, forthcoming components of this program are aimed at further increasing awareness about proper medication dispensing, and are launching throughout the first half of 2006. AstraZeneca will evaluate the programs to ensure messages regarding medication errors are received and result in an increased awareness of the potential for medication errors with TOPROL-XL, in the hope that this knowledge will empower physicians and patients to double-check prescriptions to ensure they are accurate and correct. Important Information About TOPROL-XL (R) (metoprolol succinate) Extended- Release Tablets TOPROL-XL is a beta1-selective (cardioselective) adrenoceptor-blocking agent, for oral administration, available as extended-release tablets. TOPROL- XL has been formulated to provide a controlled and predictable release of metoprolol for once-daily administration. Indications for TOPROL-XL include the treatment of hypertension, alone or in combination with other antihypertensives; the long-term treatment of angina pectoris; and the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. It was studied in patients already receiving ACE inhibitors, diuretics, and, in the majority of cases, digitalis. TOPROL-XL is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, and sick sinus syndrome (unless a permanent pacemaker is in place) and in patients who are hypersensitive to any component of this product. Patients taking TOPROL-XL should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. The dosage should be reduced gradually over a one-to-two-week period, and the patient should be carefully monitored. For full Prescribing Information for TOPROL-XL including boxed WARNING, call 1-800-236-9933 or visit . TOPROL-XL should be used with caution in patients who have bronchospastic disease, diabetes, thyrotoxicosis, peripheral vascular disease, who are undergoing major surgery, or who take calcium channel blockers of the verapamil and diltiazem type. There is a risk of worsening cardiac failure during up-titration of the dose of TOPROL-XL(R) (metoprolol succinate). Patients need to consult their physicians if they experience signs or symptoms of worsening heart failure such as weight gain or increased shortness of breath. Patients should be advised to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient's response to therapy has been determined. In patients with hypertension and angina pectoris the most common adverse events reported with immediate-release metoprolol tartrate are tiredness (10%), dizziness (10%), depression (5%), diarrhea (5%), pruritus or rash (5%), shortness of breath (3%), diabetes, and bradycardia (3%). In patients with heart failure, serious adverse events and adverse events leading to discontinuation of study medication in MERIT-HF at an incidence greater than or equal to 1% in the group receiving TOPROL-XL and greater than placebo by more than 0.5% were dizziness/vertigo (1.8% vs 1.0%), bradycardia (1.5% vs 0.4%), and accident and/or injury (1.4% vs 0.8%). For more information, visit or contact AstraZeneca at 1-800-236-9933. About AstraZeneca AstraZeneca is a major international health care business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals and the supply of health care services. It is one of the world's leading pharmaceutical companies with health care sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection products. In the United States, AstraZeneca is a $10.77 billion health care business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: . AstraZeneca CONTACT: Jim Minnick of AstraZeneca LP, +1-302-886-5135,jim.minnick@astrazeneca.com, or Elizabeth Shaheen-Dumke of AstraZeneca LP,+1-302-885-6684, elizabeth.shaheen-dumke@astrazeneca.com Web site: Company News On-Call: