PHARMACY

Teva simultaneously launches AirDuo RespiClick and its authorized generic

BY Brian Berk

JERUSALEM — Teva Pharmaceutical Industries on Thursday announced the simultaneous launch of AirDuo RespiClick (fluticasone propionate and salmeterol) inhalation powder and its authorized generic for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist (LABA) combination.

AirDuo RespiClick and its authorized generic are fixed-dose combination asthma therapies containing an ICS and a LABA, the same active ingredients as Advair. The authorized generic is known as fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler). Teva is launching both products at the same time in an effort to address the need for more affordable asthma treatment options in the U.S. Teva expects that sales of the authorized generic will represent most of the sales of the two products.

“With the launch of AirDuo RespiClick and its authorized generic, our intent is to meet the needs of patients, providers, and payers in the U.S. seeking greater access to lower-cost asthma inhaler technology, while also allowing Teva to compete in the highly competitive asthma combination controller market,” said Rob Koremans, M.D., president and CEO of Global Specialty Medicines at Teva. “This important launch marks not only the first available generic ICS/LABA product in the United States, but also the continued expansion of our RespiClick family of products, which now includes breath-activated inhaler options for both maintenance treatment and rescue medication.”

AirDuo RespiClick was approved by the Food and Drug Administration in January in three doses: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. AirDuo RespiClick contains medication delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler, which is used with other approved medicines in Teva’s respiratory product portfolio.

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Diplomat to dispense Zejula

BY David Salazar
FLINT, Mich. — Diplomat Pharmacy on Wednesday announced that it had been selected to the specialty pharmacy panel dispensing Zejula (niraparib). The drug is a once-daily oral maintenance treatment indicated to treat women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
 
Zejula is the first poly ADP-ribose polymerase inhibitor approved by the Food and Drug Administration that doesn’t require BRCA mutation or other biomarker testing, Diplomat said.
 
“For women living with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, Zejula (niraparib) offers new hope as a promising treatment option,” said Paul Urick, Diplomat’s president.
 

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Upsher-Smith to sell generics business for $1.05B

BY Brian Berk

MAPLE GROVE, Minn. — Japanese generic pharmaceutical manufacturer Sawai Pharmaceutical will purchase the generic pharmaceuticals business of Upsher-Smith Laboratories, from its parent, Acova, for $1.05 billion.

Under Thursday’s agreement, expected to close near the end of June 2017, Rusty Field, the current President of Upsher-Smith, will continue leading the company. Following the closing, Upsher-Smith’s non-generic pharmaceuticals businesses will remain with Acova.

The acquisition will mark a major expansion of Sawai’s presence in the U.S. market. Sawai plans to build a U.S. business that leverages its intellectual property and combines research and development capabilities with Upsher-Smith’s manufacturing base, strong distribution network, established commercial relationships and highly respected brand. For Upsher-Smith, the acquisition brings access to Sawai’s state-of-the art manufacturing technology and opportunities to bring its medicines to exciting new markets, like Japan, according to a news release.

Upsher-Smith is a privately-held U.S. pharmaceutical company, owned by the Evenstad family through their company, ACOVA. Mark Evenstad is the CEO of Upsher-Smith, and his father, Ken Evenstad is the chairman.

“We all want to thank the Evenstad family for their excellent stewardship of the company,” said Field. “I speak for the entire management team when I share how excited we are to be entering a new phase of our growth as a global company. In the dialogue we have had with the Sawai management team over recent months, it is clear that our two companies are an excellent fit in terms of philosophy and vision, with an equal focus on the importance of quality. Together we look forward to achieving recognition as a global contributor to the growth of generics, with a firm grounding in ‘Patients First.’”

“Upsher-Smith has developed and delivered crucial therapies to patients, from infants to the elderly, with a broad array of on-market generic pharmaceuticals. We have also built a pipeline that will enable even more patients to get life-changing therapies over the next several years. After owning and operating Upsher-Smith for the past 47 years, my family and I made the decision to sell the largest part of our company, the generic pharmaceuticals business, to Sawai,” said Mark Evenstad, CEO. “It was extremely important for us to find a buyer that shared Upsher-Smith’s values, was completely committed to its long-term success and was looking for a strong and fully operational U.S. platform for growth. Sawai is a compelling strategic fit and we are delighted that the generics business is poised to benefit from the extensive resources and management focus that Sawai will bring.”

No changes to Upsher-Smith’s operations are currently anticipated, and under the leadership of Field, the current management team will continue to lead Upsher-Smith from its current headquarters in Minneapolis.

“We are delighted to sign this agreement today with Acova to acquire Upsher-Smith, which is our first overseas investment. Upsher-Smith, like Sawai, has a long history as a private family-owned generic pharmaceuticals company that is also focused on patient needs, centered on our philosophy of “Patients First.” We look forward to working closely with Rusty and the talented management team to forge a new global chapter in Upsher-Smith’s future together. Most importantly, we are committed to the entire team at Upsher-Smith, and to expanding the opportunities for the U.S. workforce at Upsher-Smith,” said Sawai President Mitsuo Sawai.

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