News Briefs

05/12/2022

Generic firms working on Paxlovid access for low-, middle-income countries

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White pills spilling out of a medicine bottle

The Clinton Health Access Initiative has reached agreements with several leading generic manufacturers to make generic Paxlovid (nirmatrelvir/ritonavir – NIR/r) available to low- and middle-income countries at under $25 per treatment course for the treatment of COVID-19 in high-risk patients.

The manufacturers have signed agreements with the Medicines Patent Pool to make and supply the generic version of Pfizer’s oral COVID-19 treatment NIR/r to 95 LMICs. As these manufacturers are in the early stage of product development and have not received regulatory approval, their names cannot be shared publicly, CHAI said on its website. 

Participating companies are well established and trusted suppliers to the U.S. President’s Emergency Plan for AIDS Relief program. As leaders in the HIV antiretroviral market, they represent over 25% of global low- and middle-income public sector procurement volumes per year.

CHAI interim co-CEO Joy Phumaphi announced the new ceiling price agreements at the White House Global COVID-19 Summit, stating, “Today’s agreements represent a significant step toward ensuring equitable access to a proven COVID-19 treatment that will save lives and reduce the burden on struggling health systems.”

Paxlovid is a highly effective and safe treatment that has received emergency sse authorization in the United States, Europe and many other countries.

Under the agreements, the companies will guarantee the production of an affordable generic version of the drug and dedicate capacity for 4.5 million treatment courses per month for low- and middle-income countries covered under their licensing agreements with the Medicines Patents Pool, pending provision of demand forecasts. Manufacturers will work to file for World Health Organization prequalification or approval from a stringent regulatory authority by the first quarter of 2023 and will register the product widely across licensed territories.

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05/12/2022

PharmaCare US makes 3 exec appointments

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A puzzle piece with a stick figure.

PharmaCare US announced three executive leadership appointments. Javier Aste will serve as president of the Americas and Jeff Dotzler will serve as vice president of sales for North America. Art Rowe-Cerveny, founding member of the company’s U.S. division, will now lead as executive vice president of marketing for the Americas. 

PharmaCare US said Aste brings a wealth of experience from his senior roles around the globe, most recently at Coty and Procter & Gamble. He prides himself on being a results-oriented senior leader, with a core focus on growing market share, sales and profit. He will be ushering in the next chapter of growth and innovation, the company said.

“Retailers and consumers are pushing for purposeful innovation,” Aste said. “Our core brand, Sambucol, is primed for its next phase of growth. Product innovation will be central to our next chapter.”

Aste succeeds Brad Olsen, who served as the Americas leader from 2013 before his retirement in April 2022.

Dotzler joined the PharmaCare team on May 1, 2022, bringing his years of leadership experience from IRI, Crossmark and, most recently, Coty’s beauty division. “He will finesse and bolster the PharmaCare go-to-market strategy to deliver new competitive advantages for the company,” PharmaCare said.

“PharmaCare is at an exciting stage in its history. I’m eager to create new sales opportunities to boost the company’s already impressive growth trajectory,” Dotzler said.

 

05/12/2022

Lannett to be exclusive distributor of generic Fludara

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Injectables

Lannett has entered into an agreement with Areva Pharmaceuticals to be the exclusive U.S. distributor of fludarabine phosphate for injection 50 mg/2 ml, single-dose vials.

The medication is the generic of Bayer AG's Fludara.

"Fludarabine phosphate for injection represents a continuation of our push to new dosage forms with attractive market opportunities," said Lannett CEO Tim Crew.

"Moreover, a drug market shortage has recently existed for fludarabine phosphate for injection, so our goal, subject to FDA clearance, is to commence marketing as soon as possible, targeting later this calendar year, to help patients gain access to this important oncology medicine," Crew said. "We are pleased to establish a new strategic relationship with Areva Pharmaceuticals and look forward to launching this product."

Fludarabine phosphate for injection had a market value of roughly $4.9 million for the 12 months ending March 2022, according to IQVIA. However, the current market value is believed to be higher due to recent market disruptions.

Under the agreement, Lannett will provide sales, marketing and distribution support for the medication, for which it will receive a share of the profits. Other financial terms were not disclosed.

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05/11/2022

Amber Specialty Pharmacy added to Eisai’s Lenvima network

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Injectables

Amber Specialty Pharmacy, a subsidiary of Hy-Vee, will begin dispensing Eisai’s Lenvima (lenvatinib).

Used by itself, Lenvima treats differentiated thyroid cancer when it can no longer be treated with radioactive iodine and hepatocellular carcinoma when it cannot be removed by surgery.

Lenvima is used with other medications to treat additional types of cancers, including advanced renal cell carcinoma and advanced endometrial carcinoma.

Amber Specialty Pharmacy’s high-touch service model will support patients, caregivers and oncology specialists throughout the country. Its Oncology Center of Excellence provides an enhanced level of care throughout a patient’s treatment journey, the company said.

"Supporting patients who are navigating a cancer diagnosis is one of the most important things we do,” said Kristin Williams, president of Amber Specialty Pharmacy. “We are honored Eisai recognizes the value our whole-health approach offers oncology patients. From reducing or eliminating financial barriers to one-on-one counseling with our registered dietitian — and everything in between — oncology professionals can trust Amber Specialty Pharmacy to make sure patients have the medicine and support they deserve.”

 

05/11/2022

Aurobindo receives FDA OK for generic Sabril

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White pills spilling out of a medicine bottle

The Food and Drug Administration has given the green light for Aurobindo’s vigabatrin tablets in a dosage strength of 500 mg.

The medication is the generic of Lundbeck’s Sabril, which is indicated as adjunctive therapy for adults and pediatric patients aged 2 years old and older with refractory complex partial seizures.

Vigabatrin tablets had a market value of roughly $138 million for the 12 months ending March 2022, according to IQVIA.

05/11/2022

Camber launches generic Reyataz

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camber atazanavir

Camber is introducing atazanavir capsules.

The medication is the generic of Bristol Myers Squibb's Reyataz.

It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients aged 6 years old and older weighing at least 33 lbs.

Camber’s atazanavir capsules are available in 150 mg and 200 mg 60-count bottles and a 300 mg 30-count bottle.