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MS drug patents showdown; US Zika vaccine moves forward; Mylan recalls EpiPen


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MS drug patents showdown; US Zika vaccine moves forward; Mylan recalls EpiPen

* The U.S. government's top infectious disease expert said he was confident in the National Institutes of Health's experimental Zika vaccine and has launched it into the next phase of human testing — a significant step for the product. Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases, told reporters on March 31 that the initial findings of the vaccine's phase 1 trial indicated the product was safe and able to induce a neutralizing antibody response against Zika.

* Mylan NV's manufacturing partner for EpiPen, Meridian Medical Technologies, expanded the voluntary recall of EpiPen devices to include additional lots distributed in the U.S. and other markets. The company's unit Alphapharm Pty Ltd. previously recalled several batches of EpiPen devices in several countries outside the U.S. over two global reports of device failure.

* The U.S. Patent and Trademark Office's Patent Trial and Appeal Board upheld the validity of Biogen Inc.'s patents on its multiple sclerosis drug Tecfidera in a patent interference proceeding against Forward Pharma A/S. Under the ruling, the exclusivity of Biogen's Tecfidera patents will remain in force until 2028.

* Reuters produced a feature on the debate in the U.S. around oncology drug pricing, ahead of new data to be presented at the American Association for Cancer Research's annual meeting this week.

* The Washington Post carried a feature on the U.S. Drug Enforcement Agency’s efforts to target opioid manufacturer Mallinckrodt PLC for alleged violations of laws around oxycodone distribution. The paper called it the “largest prescription-drug case the agency has pursued.” It noted that the government has taken no legal action against the pharmaceutical company six years after four investigations spanning five states were launched. The company reportedly reached a tentative settlement with federal prosecutors under which it will agree to pay a $35 million fine and admit to no wrongdoing.

M&A and capital markets

* Sucampo Pharmaceuticals Inc. acquired privately-held rare disease company Vtesse Inc. for $200 million. Sucampo used $170 million from cash on hand and issued 2,782,678 common shares to fund the transaction, which gives it access to VTS-270, a treatment being developed for the Niemann-Pick Disease Type C1.

* Galenica Ltd. narrowed the price range of its Santé subsidiary IPO to between CHF37 and CHF39, implying a market capitalization of about CHF1.85 billion to CHF1.95 billion for the unit. The company upsized the base offering to 42,391,300 ordinary registered shares due to strong demand from investors.

* Japanese drugmaker Astellas Pharma Inc. agreed to acquire Ogeda SA, a Belgian drug discovery company, for up to €800 million. The deal is expected to bolster Astella's late-stage pipeline and contribute to its mid-to-long-term growth and is expected to close in the second quarter of 2017.

Drug and product pipeline

* Roche Holding Ltd.'s Alecensa met the primary endpoint in a phase 3 study for patients with advanced anaplastic lymphoma kinase-positive non-small cell lung cancer. The drug was evaluated for progression-free survival in patients as compared to chemotherapy.

* Bayer AG's investigational compound copanlisib met the primary endpoint in a phase 2 study for patients with relapsed or refractory indolent non-Hodgkin lymphoma, a blood cancer. The company is seeking an accelerated approval from the U.S. FDA of the compound in patients who have received at least two prior therapies.

* NovoCure Ltd.'s Optune, combined with temozolomide chemotherapy, showed improvement in overall survival in a phase 3 trial of patients with newly diagnosed glioblastoma, a brain cancer.

* The U.S. FDA shot down Oxford Pharmascience Group PLC's proposed phase 3 study design for OXPzero, the company's reformulated version of ibuprofen. The regulator disagreed with the proposed primary endpoints of the study and asked that the company undertake a clinical trial to back claims of improved gastrointestinal safety.

* The European Commission approved Novartis AG's Tafinlar in combination with Mekinist to treat patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer in the EU, Iceland and Norway.

* The U.S. FDA approved a supplemental new drug application for Pfizer Inc.'s Ibrance based on the results of a phase 3 trial. Ibrance now is indicated in combination with an aromatase inhibitor, expanding on its earlier indication in combination with letrozole to treat certain forms of breast cancer in postmenopausal women.

Operational activity

* The U.S. Patent and Trademark Office's Patent Trial and Appeal Board ruled against United Therapeutics Corp.'s claims to patent the active pharmaceutical ingredient in its hypertension drug Remodulin. The patent was challenged by SteadyMed Ltd. in an inter partes review started in October 2015 and instituted in April 2016.

* The U.S. District Court of Delaware invalidated four of Acorda Therapeutics Inc.'s U.S. patents related to its multiple sclerosis drug AMPYRA. The company plans to appeal the decision.

Now featured on S&P Global Market Intelligence:

* With Mylan's FDA delay, the race is on for generic Advair launch: According to analyst commentary, the FDA rejection of Mylan NV's generic form of GlaxoSmithKline PLC's Advair asthma drug opens a window for several other companies to be first to market asthma drug generics.

The day ahead

Early morning futures indicators pointed to a mixed opening for the U.S. market.

In Asia, the Hang Seng rose 0.62% to 24,261.48, while the Nikkei 225 increased 0.39% to 18,983.23.

In Europe, around midday, the FTSE 100 was up by 0.06% at 7,327.43 and the Euronext 100 had risen 0.02% to 986.43.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.