AstraZeneca's Diabetes Drug Gets CRL; Expands Cancer Deal
by Zacks Equity Research Published on October 19, 2015 | 0
AZN NVO MRK PPHM
AstraZeneca plc (AZN - Analyst Report) announced that the FDA has issued a complete response letter (CRL) for the new drug application seeking approval for the fixed-dose combination of its diabetes drugs, Onglyza (saxagliptin) and Farxiga (dapagliflozin). The company is looking to get the fixed-dose combination approved for the treatment of adults suffering from type II diabetes.
In the CRL, the FDA has asked AstraZeneca to provide additional data on the combination including data from ongoing or completed studies and may need information from new studies. The company stated that it will coordinate with the agency regarding the path forward.
AstraZeneca clarified that the CRL is not expected to affect its approved drugs, Onglyza and Farxiga, which are separately approved for the treatment of adults with type II diabetes. We note that Onglyza is a DPP-4 inhibitor while Farxiga is an SGLT-2 inhibitor.
The CRL on the fixed-dose combination comes as a disappointment for AstraZeneca. Moreover, there is low visibility on how long the candidate would be delayed in the U.S. We note that the diabetes market is heavily crowded given the presence of companies like Novo Nordisk A/S (NVO - Analyst Report). Several companies are also working on bringing new and improved treatments to market.
Expands Immuno-Oncology Deal with Peregrine
Meanwhile, AstraZeneca expanded its existing cancer immunotherapy partnership with Peregrine Pharmaceuticals, Inc. (PPHM - Snapshot Report). Under the expanded deal, Peregrine’s bavituximab will be evaluated in combination with AstraZeneca’s durvalumab (formerly known as MEDI4736) in a randomized phase II study for the treatment of patients suffering from previously treated squamous or non-squamous non-small cell lung cancer.
While the phase II study will be conducted by Peregrine, we note that the deal between the two companies was struck in Aug 2015. The original deal allowed the companies to collaborate on a non-exclusive basis to evaluate the combination of bavituximab and durvalumab with chemotherapy for the treatment of multiple solid tumors.
AstraZeneca’s durvalumab is an anti-PD-L1 immune checkpoint inhibitor while bavituximab is a phosphatidylserine-signaling pathway inhibitor. The expansion of the agreement shows the growing interest in immuno-oncology. Recently, Merck & Co. Inc. (MRK - Analyst Report) was in the news for expanding its immuno-oncology partnership for anti-PD-1 therapy, Keytruda.
AstraZeneca is a Zacks Rank #1 (Strong Buy) stock. Another favorably ranked stock in the health care sector is Novo Nordisk, carrying a Zacks Rank #2 (Buy).
