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PHARMACY

Teva is introducing generic Cialis

BY Sandra Levy

Teva has announced the exclusive first-to-file launch of a generic version of Eli Lilly’s Cialis (tadalafil) tablets (2.5 mg, 5 mg, 10 mg, 20 mg) in the United States.

Tadalafil tablets are a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia, and both ED and the signs and symptoms of BPH.

“We’re proud to offer an affordable treatment option for the estimated 30 million men affected by ED, many of whom will also have symptomatic BPH which is estimated to affect 15 million men in the United States,” Teva’s executive vice president and head of global R&D Hafrun Fridriksdottir said in a statement.

“This launch represents an important addition to our generics portfolio, building on our exclusive launch of a generic version of Viagra (sildenafil) tablets last year. We’re committed to ensuring that patients are able to access this medicine.” Teva executive vice president and head of North America commercial Brendan O’Grady said in a statement.

Cialis had a market value of nearly $1.93 billion in the United States as of July 2018, according to IQVIA.

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PHARMACY

Eisai gets FDA nod for expanded indication of Fycompa

BY Sandra Levy

Eisai has received the Food and Drug Administration’s clearance for an expanded indication of its antiepileptic drug Fycompa (perampanel) CIII for monotherapy and adjunctive use in pediatric patients age 4 years old and older for the treatment of partial-onset seizures with or without secondarily generalized seizures.

The approval includes both Fycompa tablet and oral suspension formulations.

“Eisai is working tirelessly to provide treatment options for patients of all ages to help better control seizures and achieve the ultimate goal of seizure freedom,” Eisai chief clinical officer and chief medical officer of neurology business group Lynn Kramer said in a statement. “We are excited about the potential of Fycompa as an important tool to reduce the incidence of seizures among pediatric patients living with epilepsy. This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need.”

Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. An estimated 470,000 children in the United States are living with epilepsy. Up to 40% will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures, according to the company.

Fycompa was initially approved for adjunctive use in POS in 2012 and was later approved as adjunctive therapy for PGTC seizures in patients with epilepsy age 12 years old and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy age 12 years old and older.

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PHARMACY

AAM highlights barriers to generics, biosimilar access in proposed USMCA

BY Sandra Levy

The Association for Accessible Medicines is strongly opposed to the proposed trade agreement USMCA, stating that it fails to achieve one of the principal objectives of the Bipartisan Congressional Trade Priorities and Accountability Act of 2015. AAM said that the proposed provisions will “almost uniformly protect and extend the monopolies of brand-name drug companies,” and do not adequately balance innovation with access to medicine.

AAM also said the approach extends monopoly protections for manufacturers of brand-name drugs and biologics that will stifle biosimilar competition, hurt American exporters and decrease patient access to medicines.

Generic drug and biosimilar manufacturers strongly support the Administration’s efforts, as stated in President Trump’s drug pricing blueprint to enhance the “availability, competitiveness, and adoption of biosimilars as affordable alternatives to branded biologics.”

“Yet we are deeply concerned that increasing branded biologic exclusivity to 10 years in a revised trade agreement, as well as adding other patent barriers to generic and biosimilar access, will have the exact opposite effect, slowing the development of biosimilars that we need in the U.S. and decreasing prescription drug competition,” the organization said.

In a separate, but related development, the Canadian Generic Pharmaceutical Association expressed its opposition to USMCA.

“Canada was not at the table when harmful intellectual property provisions were negotiated between the United States and Mexico,” CGPA president Jim Keon said. “The pharmaceutical provisions in USMCA will delay access to competition from biosimilar biologic drugs. Biologic medicines represent the fastest-growing cost segment of healthcare spending, and these delays will be costly to patients, businesses that sponsor employee drug plans, private payers and our industry.”

“The United States-Mexico-Canada Agreement is disappointing for the vast majority of Canadians who feel access to more affordable prescription medicines is the most important aspect of the negotiations. A recent poll found that 4-in-5 Canadians feel that it is important that the negotiations should not delay Canadians access to more affordable versions of expensive biologic drugs,” CGPA said.

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