* Stada-Arzneimittel AG said it would support a €66 per share takeover offer from private equity firms Bain Capital and Cinven Partners LLP, an offer that the German drugmaker believes was "the most financially appealing" and values it at €5.32 billion. Stada CEO Matthias Wiedenfels said he hopes to retain his role following the takeover, Bloomberg News wrote.
* S&P Global Ratings revised its outlook on the pharmaceutical industry to stable from negative for 2017, reflecting improving product pipelines and a further return to sales and EBITDA growth for a number of pharma and biotech majors. S&P added that any negative legislative measures, such as drug pricing controls, is likely to occur later than sooner, leaving pharma companies with a mostly benign environment for at least the next few months.
* According to a report by S&P Global Ratings, the Affordable Care Act individual market is showing signs of improvement as insurers in the marketplace reported better 2016 year-over-year results. S&P expects that the continued pricing correction and network design changes, along with regulatory fine-tuning of ACA rules, will lead to closer to break-even underwriting results on average for the individual market this year. The insurers' 2016 results and the market enrollment in 2017 so far exhibit that the marketplace is not in a "death spiral," S&P added.
M&A and capital markets
* Biohaven Pharmaceutical Holding Co. Ltd. filed for an IPO of up to $100 million with the U.S. SEC. The New Haven, Conn.-based biopharmaceutical company applied to list its common shares on the NYSE under the symbol BHVN.
* Strides Shasun Ltd. completed its previously announced acquisition of a U.S. FDA-approved API facility in India from Perrigo Co. PLC. As part of the deal, Strides acquired all the issued share capital of Perrigo API India Private Ltd. for a consideration of 1 billion Indian rupees.
* India-based Torrent Pharmaceuticals Ltd. is reportedly nearing a deal to buy Switzerland-based Novartis AG's women's healthcare portfolio in the country, including anti-dysfunctional uterine bleeding products. The deal is said to be valued at about 3 billion Indian rupees and could be finalized within the coming eight weeks.
* Fresenius SE & Co KGaA and Akorn Inc. confirmed that they are in discussions for a deal. Fresenius CEO Stephan Sturm had previously indicated that the company was still on the lookout for more M&A activity even after announcing the €5.8 billion purchase of Spain's private hospital chain Quironsalud in 2016, Handelsblatt noted.
* Chinese investment firm Creat Group Corp. will make a voluntary public takeover offer for all outstanding publicly traded ordinary and preference shares of Biotest AG under a five-year business combination agreement. Biotest shareholders will be offered €28.50 in cash per ordinary share and €19 in cash per preference share in a deal that values Biotest at €1.3 billion, including net debt.
Drug and product pipeline
* AbbVie Inc.'s Elagolix met its primary endpoint in a phase 2b clinical trial in patients with uterine fibroids, significantly reducing heavy menstrual bleeding over a period of six months.
* Roche Holding Ltd.'s Alecensa met its primary endpoint in a phase 3 study involving patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer. The study is the second phase 3 trial to show that Alecensa was superior as an initial treatment compared to crizotinib in ALK-positive NSCLC.
* Johnson & Johnson unit Janssen Pharmaceuticals is collaborating with Japanese biopharma PeptiDream Inc. to discover therapies against multiple metabolic and cardiovascular targets. PeptiDream will use its proprietary technology to identify macrocyclic/constrained peptides against targets of interest selected by Janssen.
* Fujian Cosunter Pharmaceutical Co. Ltd. failed to secure approvals for its second applications for registries and clinical trials of tadalafil tablets and the drug's active pharmaceutical ingredients, according to money.163.com. The drug can be used to treat benign prostatic hyperplasia, erectile dysfunction and pulmonary arterial hypertension.
* The European Medicines Agency concluded the safety review of Uptravi, Actelion Ltd.'s pulmonary arterial hypertension drug, marking it safe for usage by existing and new patients. Uptravi — which is among the pulmonary arterial hypertension treatments Johnson & Johnson is acquiring — was flagged by the EMA in February after the death of five patients in France.
* The U.S. FDA rejected Merck & Co. Inc.'s supplemental new drug applications for its diabetes drugs Januvia, or sitagliptin, Janumet — a combination product with sitagliptin and metformin hydrochloride — and its extended-release version, Janumet XR. The company was seeking to include heart safety data from a clinical study in the prescribing information of sitagliptin-containing medicines.
* Meanwhile, the FDA expanded the indications for Gilead Sciences Inc.'s Harvoni and Sovaldi 400 milligram tablets, approving it as a treatment of chronic hepatitis C virus infection in adolescents without cirrhosis or with compensated cirrhosis. Harvoni was approved for pediatric patients with genotype 1, 4, 5 or 6 chronic HCV infection, while Sovaldi, in combination with ribavirin, was approved for pediatric patients with genotype 2 or 3 chronic HCV infection.
The day ahead
Early morning futures indicators pointed to a mixed opening for the U.S. market.
In Asia, the Hang Seng declined 0.02% to 24,262.18, while the Nikkei 225 increased 0.71% to 18,797.88.
In Europe, around midday, the FTSE 100 was down 0.15% at 7,337.60 and the Euronext 100 was 0.44% lower at 985.86.
The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.
S&P Global Ratings and S&P Global Market Intelligence are owned by S&P Global Inc.