Mylan (MYL - Analyst Report) was in the news again with the company agreeing to a settlement related to Medicaid rebate classification for EpiPen. Meanwhile, several pharma companies were present at the congress of the European Society for Medical Oncology (ESMO) with data on their cancer treatments.
Recap of the Week’s Most Important Stories
Mylan Settles with DoJ for EpiPen: Mylan has agreed to pay $465 million to the U.S. Department of Justice (DoJ) and other government agencies to settle the investigation into the classification of its life saving combination product, EpiPen Auto-Injector and EpiPen Jr Auto-Injector, for purposes of the Medicaid Drug Rebate Program. While shares were up with the settlement agreement being announced, concerns remain about ongoing investigations and continued political, public and media focus on drug pricing. Mylan said that it received a document request from the Division of Enforcement at the Securities and Exchange Commission (SEC) seeking communications with the CMS and documents regarding Mylan products sold and related to the Medicaid Drug Rebate Program, and any related complaints. Mylan has cut its earnings outlook for 2016 and expects to report third quarter results on Nov 9 (Read more: Mylan Up on EpiPen Medicaid Settlement, Cuts 2016 Outlook).
UK Court Ruling Unfavorable for Pfizer: Pfizer (PFE - Analyst Report) got an unfavorable decision in the Court of Appeal in the UK for its blockbuster drug, Lyrica. The Court upheld the decision of the High Court that found that the patent covering Lyrica for pain is not infringed by Actavis and patent claims directed generally to pain and neuropathic pain are invalid. Pfizer intends to appeal the decision to the Supreme Court. Lyrica brought in worldwide sales of $4.8 billion in 2015 and $2.5 billion in the first half of 2016.
Meanwhile, Pfizer was at ESMO with data on Inlyta and Sutent. Data from a phase Ib study evaluating a combination of Inlyta and Merck’s Keytruda provided additional support for novel immunotherapy combinations in renal cell carcinoma (RCC). Preliminary results from another study combining Inlyta with Merck KGaA’s avelumab suggested evidence of anti-tumor activity for this combination. Both combinations are currently in late-stage studies for first-line advanced RCC.
Pfizer also presented data on Sutent from a late-stage study evaluating the drug in an adjuvant setting in patients at high risk for recurrence after surgical resection of RCC. Results showed that Sutent extended disease-free survival (DFS) by more than a year compared to placebo, resulting in an overall risk reduction of 24%. Pfizer is in discussions with regulatory authorities regarding the next steps.
Roche’s Tecentriq Lung Cancer Data Looks Good: Roche (RHHBY - Analyst Report) presented data on its PD-L1 inhibitor, Tecentriq, at ESMO. Results from a phase III study showed that Tecentriq demonstrated significant survival advantage compared to chemotherapy regardless of PD-L1 status in a specific type of lung cancer. Patients on Tecentriq lived 4.2 months longer than those treated with docetaxel chemotherapy. Tecentriq is currently under FDA review for a lung cancer indication and could gain approval for the label expansion shortly as the agency is expected to respond by Oct 19.
Merck Presents Keytruda Data at ESMO: Merck (MRK - Analyst Report) was also present at ESMO with data on Keytruda from different studies. The company reported positive data on Keytruda for front-line bladder cancer – overall response rate was 24% in patients with and without PD-L1 expression. Meanwhile, results from KEYNOTE-024, which evaluated squamous and non-squamous non-small cell lung cancer (NSCLC) patients whose tumors expressed high levels of PD-L1, showed that Keytruda led to a 50% reduction in the risk of disease progression or death and a 40% reduction in the risk of death compared to platinum doublet, the current standard of care. Median progression free survival (PFS) for Keytruda was 10.3 months compared to 6.0 months for chemotherapy.
Keytruda, which posted sales of $563 million in the first half of 2016, is in more than 350 studies across more than 30 tumor types. Keytruda is currently under FDA review for the first-line treatment of patients with advanced NSCLC whose tumors express PD-L1, with a target action date of Dec 24, 2016. Merck is a Zacks Rank #2 (Buy) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bristol-Myers at ESMO: Bristol-Myers (BMY - Analyst Report) presented data on Opdivo at ESMO from several studies including updated data from CheckMate-057 and -017 -- results showed that previously treated metastatic NSCLC patients had tripled the duration of response with Opdivo compared to those treated with docetaxel, with a minimum follow-up of two years. Data was also presented on Yervoy.
Large Cap Pharmaceuticals Industry Price Index
All major pharma stocks lost some ground over the last five trading days with the NYSE ARCA Pharmaceutical Index declining 2.2%. Bristol-Myers and AstraZeneca (AZN - Analyst Report) declined 8.7% and 4.4%, respectively. Over the last six months, Bristol-Myers declined 25.7% while Merck was up 11.7% (See the last pharma stock roundup here: Lilly Inks Animal Health Deal, J&J's Psoriasis Data Looks Good).
What's Next in the Pharma World?
Johnson & Johnson’s (JNJ - Analyst Report) earnings results will be in focus with the company slated to release results on Oct 18. A decision from the FDA regarding Roche’s Tecentriq for a lung cancer indication should also be out by Oct 19.
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