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Thursday, December 12, 2019

Walgreens Boots Alliance and McKesson team up in Germany

Aimed at achieving better scale, Walgreens Boots Alliance (NASDAQ:WBA) and McKesson (NYSE:MCK) will combine their respective wholesale businesses in Germany, Alliance Healthcare Deutschland and GEHE Pharma Handel.
WBA will own 70% of the joint venture (JV) while MCK will own 30%.
The transaction should close in six months or more. Financial terms are not disclosed.
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Merck’s Keytruda extends survival in first-line lung cancer

An exploratory analysis of the Phase 3 KEYNOTE-042 clinical trial evaluating Merck’s (NYSE:MRK) Keytruda (pembrolizumab) as monotherapy versus chemo for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) with at least 1% PD-L1 expression regardless of KRAS mutation status showed improvements in overall survival (OS), progression-free survival (PFS) and overall response rate (ORR). The results were presented at ESMO IO in Geneva.
In patients with any KRAS mutation (present in ~20% of NSCLC cases), median OS in the Keytruda group was 28 months compared to 11 months for chemo. In patients with no KRAS mutations, OS also favored Keytruda, 15 months vs. 12 months.
Median PFS in patients with any KRAS mutation was 12 months for Keytruda compared to six months for chemo. Median PFS was six months for both in patients with no KRAS mutations.
ORR was 56.7% for Keytruda vs. 18.0% for chemo in patients with any KRAS mutation. ORR was higher for Keytruda, 29.1% vs. 21.0%, in patients with no KRAS mutations.
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Analyst action, Dec. 12

Amyris (NASDAQ:AMRS) initiated with Outperform rating and $8 (147% upside) price target at Oppenheimer. Shares up 8% premarket.
Bausch Health Companies (NYSE:BHC) upgraded to Overweight with a C$50.04 (30% upside) price target at JPMorgan. Shares up 2% premarket in the U.S.
Globus Medical (NYSE:GMED) upgraded to Overweight with a $63 (11% upside) at Wells Fargo. Shares up 1% premarket.
Healthcare Realty Trust (NYSE:HR) upgraded to Buy at Citigroup.
MEDNAX (NYSE:MD) upgraded to Buy with a $33 (23% upside) price target at Stifel. Shares up 1% premarket.
Shockwave Medical (NASDAQ:SWAV) upgraded to Overweight with a $49 (17% upside) price target at Wells Fargo. Shares up 3% premarket.
Merit Medical Systems (NASDAQ:MMSI) downgraded to Underweight with a $26 (13% downside risk) price target at Baird. Shares down 4% premarket.
Miragen Therapeutics (NASDAQ:MGEN) downgraded to Neutral with a $1 (45% upside) price target at Baird. Shares down 19% premarket on change in strategy and downsizing.
West Pharmaceutical Services (NYSE:WST) downgraded to Underperform with a $135 (8% downside risk) at BofA Merrill Lynch.
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Puma Bio up on Nerlynx data in heavily pretreated breast cancer patients

Puma Biotechnology (NASDAQ:PBYI) is up 5% premarket on light volume in response to results from an ongoing open-label Phase 2 basket study, SUMMIT, evaluating Nerlynx (neratinib), combined with Roche’s Herceptin (trastuzumab) and AstraZeneca’s Faslodex (fulvestrant), in patients with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer. The data were presented at the San Antonio Breast Cancer Symposium.
28 HER+/HR+ patients who had received a median of four prior lines of therapy (range: 0-10) for their metastatic cancer received 240 mg of neratinib each day plus trastuzumab and fulvestrant.
In 17 evaluable patients the overall response rate (ORR) was 53% (=9/17), all partials, while one experienced stable cancer for at least 24 weeks implying a disease control rate of 59% (n=10/17). Median duration of response had not been reached at data cutoff. Median progression-free survival was 9.8 months.
No new safety signals were observed.
The FDA approved Nerlynx in July 2017 for early-stage HER+ breast cancer.
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ATyr Pharma down on (lack of) safety data on lead candidate

Thinly traded nano cap aTyr Pharma (NASDAQ:LIFE) was down 17% premarket on increased volume, 65K shares, in reaction to its announcement of safety and tolerability results from a multiple-ascending dose Phase 1b/2a clinical trial evaluating lead candidate ATYR1923 in patients with pulmonary sarcoidosis (PS), a rare lung disorder caused by inflammation that can lead to pulmonary fibrosis (scarring in the lungs).
The company says ATYR1923, a fusion protein designed to downregulate the immune response to inflammatory disease states, was “generally safe and well-tolerated” in 15 PS patients but provides no specifics, only saying the results were consistent with a Phase 1 study in healthy volunteers. Adverse events were “mostly” mild or moderate.
CEO Sanjay Shukla, M.D., M.S. says the trial will now advance to the efficacy stage.
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Provention Bio reaffirms PRV-031 application timeline

Provention Bio (NASDAQ:PRVB) perks up 5% premarket on modest volume in reaction to its announcement that it continues to expect to start its rolling U.S. marketing application in mid-2020 for lead candidate PRV-031 (teplizumab) for the prevention or delay of type 1 diabetes (T1D) in at-risk people. The filing should be completed by Q4 2020.
A recent meeting with the FDA clarified the required contents of the application.
Teplizumab is a CD3-targeted monoclonal antibody designed to slow the loss of insulin-producing beta cells in the pancreas while preserving beta cell function as measured by C-peptide.
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FDA OKs Amneal ANDA for EluRyng

Amneal Pharmaceuticals (NYSE:AMRX) is up 31% premarket on receiving Abbreviated New Drug Application (ANDA) approval from the FDA for EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the first generic version of Merck’s NuvaRing.
According to IQVIA, NuvaRing U.S. annual sales for year ended October 31, 2019 were ~$976M.
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