FDA declines to approve Pfizer’s tafamidis meglumine
NEW YORK — The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.
The FDA issued a complete response letter to Pfizer pertaining to the company’s new drug application for tafamidis meglumine, requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The agency also has asked for additional information on the data within the current tafamidis NDA.
Tafamidis meglumine is a novel, investigational medication designed to treat transthyretin familial amyloid polyneuropathy, or TTR-FAP, in adult patients with symptomatic polyneuropathy to delay neurologic impairment. Currently, there is no FDA-approved treatment for this disease.
Pfizer said it will work with the FDA to address the content of the CRL.
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AstraZeneca, Rigel partner on worldwide license agreement for chronic asthma treatment
SOUTH SAN FRANCISCO, Calif. — AstraZeneca and Rigel Pharmaceuticals have entered an exclusive worldwide license agreement for the global development and commercialization of an investigational treatment for moderate to severe chronic asthma.
Under the terms of the agreement, Rigel will receive an upfront payment of $1 million, with an additional $8.25 million in early milestone payments anticipated by the end of 2013, for R256, the company’s inhaled JAK inhibitor that has been shown to reduce airway inflammation and improve lung function. Meanwhile, AstraZeneca will have exclusive rights to commercialize R256 around the world. Together with other specified developmental, regulatory and launch milestone payments, the R256 collaboration could be worth up to $100 million. Additionally, upon marketing approval of R256, Rigel will be eligible to receive tiered royalty payments on product sales.
Additionally, AstraZeneca will be responsible for beginning first-in-human clinical studies for R256 and for designing and conducting the clinical development of the compound.
"We are pleased to be expanding our relationship with Rigel and to develop and commercialize this novel asset, R256," AstraZeneca EVP innovative medicines Mene Pangalos saod. "Despite the number of medicines available to asthma patients today, there remains a need for more targeted therapies for moderate to severe chronic asthma. Through this agreement, R256 will benefit from the wealth of experience AstraZeneca has in bringing innovative treatments for respiratory diseases to millions of patients around the world."
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Walgreens, Alliance Boots to merge
DEERFIELD, Ill. — Walgreens and Alliance Boots took the first step in creating what will be the first and largest global retail pharmacy player, the two companies announced Tuesday. "This creates an opportunity for us together to create an international expansion platform," Walgreens president and CEO Greg Wasson told reporters and analysts early Tuesday morning.
Beyond marrying two iconic health brands, the Walgreens-Boots alliance creates a retail pharmacy operation with much broader economies of scale and with an opportunity to cross-pollinate brands — including Boots’ No7 and Walgreens’ Delish — across new markets. "We’re going to bring the two [retail] brands together to create the first global pharmacy-led healthcare platform," Wasson said. "We’ll become a supply chain unmatched in the world."
"I had always believed that our industry needed a global player," commented Stefano Pessina, executive chairman of Alliance Boots. "I have tried to do this deal … for 10 years. And I’ve spoken to a lot of people and they were not very receptive," Pessina said. "And finally when we [began] our discussions with Greg, we understood each other and we saw the big picture, and [now] we are here. And you will see that this company will develop far beyond the [United States]."
Looking down the path of where a Walgreens/Boots combination will lead, both Wasson and Pessina identified further expansion into new emerging markets, including China, Turkey, North Africa and Egypt.
The two companies together will be:
- The global leader in pharmacy-led, health and well-being retail, with more than 11,000 stores in 12 countries;
- The largest global pharmaceutical wholesale and distribution network with more than 370 distribution centers delivering to more than 170,000 pharmacies, doctors, health centers and hospitals in 21 countries; and
- The world’s largest purchaser of prescription drugs and many other health and well-being products.
Walgreens will invest approximately $6.7 billion in cash and stock — comprised of $4 billion in cash and 83.4 million shares — in exchange for a 45% equity ownership stake in Alliance Boots. Walgreens will have the option to proceed to a full combination by acquiring the remaining 55% of Alliance Boots in approximately three years’ time. At the current Walgreens share price and at a $1.55=£1 exchange rate, the second step of the transaction would be valued at approximately $9.5 billion in cash and stock, plus the assumption of Alliance Boots’ then-outstanding debt.
Completion of the initial investment, which is subject to various regulatory approvals, is expected to take place by Sept. 1.
Upon the completion of Walgreens’ initial investment in Alliance Boots, Wasson; Wade Miquelon, Walgreens EVP and CFO; Thomas Sabatino, Walgreens EVP and general counsel; and Robert Zimmerman, Walgreens SVP and chief strategy officer, will join the Alliance Boots board of directors. In addition, Pessina and Dominic Murphy, Boots’ director, will join the Walgreens board of directors.
The transaction is expected to be accretive to Walgreens’ net earnings per diluted share in the first year following completion of the initial step of the transaction, by approximately 23 cents to 27 cents, excluding one-time transaction costs. Walgreens expected combined synergies across both companies to be between $100 million and $150 million in the first year, and $1 billion by the end of 2016.
WOW---Congratulations Greg. THIS IS A BOLD AND EXCITING VENTURE John Denis