Pharma Stock Roundup: AZN's Imfinzi Gets 2nd FDA Nod, MRK To Buy Australian Firm

Key announcements this week included the FDA approval for a second indication of AstraZeneca’s (NYSE:AZN) Imfinzi and an acquisition offer by Merck (NYSE:MRK) . AbbVie (NYSE:ABBV) presented new data on two pipeline candidates and announced an Alzheimer’s deal with a small biotech.

Recap of the Week’s Most Important Stories

AstraZeneca’s Imfinzi Gains FDA Nod in Second Indication: AstraZeneca’s PD-L1 inhibitor, Imfinzi gained FDA approval for an early-stage lung cancer indication, making it the drug’s second FDA approval. With the latest approval, Imfinzi can now be prescribed to treat unresectable Stage III non-small cell lung cancer (“NSCLC”) in patients whose disease has not progressed following chemoradiation therapy. Imfinzi was launched in the United States for the first indication – second line advanced bladder cancer - in May 2017 and is also being developed for several other cancer indications. (Read more: AstraZeneca's Imfinzi Gets FDA Nod for Label Expansion)

Meanwhile, AstraZeneca in-licensed a new antisense drug for kidney disease, IONIS-AZ5-2.5Rx, from Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) . Going forward, AstraZeneca will be responsible for developing and commercializing IONIS-AZ5-2.5Rx. (Read More: Ionis Out-Licenses Second Candidate to AstraZeneca, Earns $30M)

Merck Looks to Buy Innovative Immuno-Oncology Candidate: Merck proposed to buy an Australian oncolytic immunotherapies maker Viralytics Limited for $394 million (502 million Australian dollars). We believe the deal, if it gets through, will strengthen Merck’s presence in the fast growing immuno-oncology market. With the deal, Merck will gain Viralytics’s lead pipeline candidate, Cavatak, an oncolytic virus, which engages the innate immune system to attack and kill cancer cells. The transaction is expected to be completed by the second quarter of 2018, contingent on Viralytics shareholder approval. (Read more: Merck to Buy Australian Firm to Boost Immunotherapy Pipeline)

AbbVie Reports New Mid-Stage Data on Upadacitinib: AbbVie announced new data from the phase II CELEST study, which evaluated multiple dosing regimens of its JAK1 inhibitor, upadacitinib for Crohn's disease through week 52. Data from the study showed that patients who clinically responded to upadacitinib treatment in the 16-week induction phase maintained their response after the 36-week extension phase of the study. Please note that results from the 16-week induction phase from the CELEST study were previously announced in May last year (read more: AbbVie Presents New Data on Upadacitinib for Crohn's Disease).

Separately AbbVie and Neurocrine Biosciences’ first of the two pivotal phase III studies on pipeline candidate elagolix met the primary endpoint. The ELARIS UF-I study was evaluating elagolix for reducing heavy menstrual bleeding in premenopausal women with uterine fibroids. Data from the study demonstrated that elagolix, in combination with low-dose add-back therapy, reduced heavy menstrual bleeding compared to placebo. (Read more: Abbvie's Uterine Fibrosis Candidate Meets Goal in Study)

Elagolix is already under review in the United States for management of endometriosis with associated pain.

AbbVie also announced a global strategic collaboration with small biotech Voyager Therapeutics, Inc. (NASDAQ:VYGR) to develop potential new treatments for Alzheimer's disease and other tau-related neurodegenerative diseases.

Novo Nordisk’s Oral Ozempic Succeeds in Study: Novo Nordisk (NYSE:NVO) announced that a phase III study, PIONEER 1, evaluating the tablet (oral) formulation of its newly approved diabetes treatment, Ozempic (semaglutide) achieved its primary objective. Data from the study showed that people with type II diabetes, who are treated with once-weekly oral semaglutide (GLP-1 receptor agonist), experienced significant and superior blood glucose control compared to placebo for all three doses (3, 7 and 14 mg) evaluated. Meanwhile, significant and superior weight loss versus placebo was observed in patients who were given the highest dose (14 mg). Novo Nordisk expects to file for approval of the oral formulation of Ozempic in 2019, pending data from the remaining nine PIONEER studies.

Ozempic (semaglutide) was approved last year in December as a once-daily pre-filled pen to improve glycaemic control in type II diabetes patients. The approval of Ozempic was based on results from the phase III SUSTAIN study.

FDA Accepts Acorda’s Inbrija NDA: Accorda Therapeutics, Inc.’s (NASDAQ:ACOR) NDA for its Parkinson’s disease candidate Inbrija was accepted by the FDA. This marked the resubmission of the NDA for Inbrija. The FDA had issued a refusal-to-file letter to Inbrija in August last year, declaring the NDA application to be incomplete after a preliminary review. The FDA is expected to give its decision on the candidate on Oct 5, 2018. (Read more: FDA Accepts Acorda's NDA for Parkinson's Disease Candidate).

The NYSE ARCA Pharmaceutical Index declined 0.9% in the last five trading sessions.

Here is how the seven major stocks performed:

In the last five trading sessions, all the seven major stocks declined. While AstraZeneca declined 0.7%, Bristol-Myers Squibb (NYSE:BMY) went down 4.4%.

In the last six months, AstraZeneca has gained 15.6% while Merck declined 12.2% (See the last pharma stock roundup here: Merck's Keytruda Shines in Study, Priority Review for Kymriah Label Expansion).

What's Next in the Pharma World?

Watch out for regulatory and pipeline news from pharma stocks.

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