Genentech and AbbVie report positive Leukemia data

Genentech says Venclexta, Rituxan reduces risk of disease progression or death in Leukemia patients

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Venclexta is being developed by AbbVie (ABBV) and Genentech

Genentech, a member of the Roche Group (RHHBY), announced the first results from the pivotal Phase III MURANO study evaluating Venclexta plus Rituxan compared to bendamustine plus Rituxan for the treatment of people with relapsed or refractory chronic lymphocytic leukemia.

The results showed that a fixed duration of treatment with Venclexta plus Rituxan significantly reduced the risk of disease progression or death by 83% compared with BR.

No new safety signals were observed. Venclexta is being developed by AbbVie (ABBV) and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

Data from the MURANO study will be submitted to global health authorities, including the U.S. Food and Drug Administration, which has granted Breakthrough Therapy Designation for Venclexta in combination with Rituxan for the treatment of relapsed or refractory CLL based on promising results from the Phase Ib M13-365 study.

Venclexta was granted accelerated approval by the FDA in April 2016 for the treatment of people with CLL with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy.

The MURANO study is part of the company’s commitment in the United States to convert the current accelerated approval of Venclexta to a full approval.

MURANO is a Phase III open-label, international, multicenter, randomized study evaluating the efficacy and safety of Venclexta in combination with Rituxan compared to bendamustine in combination with Rituxan.

All treatments were of fixed duration. The study included 389 patients with relapsed or refractory chronic lymphocytic leukemia who had been previously treated with at least one, but not more than three, lines of therapy.

Patients were randomly assigned in a 1:1 ratio to receive either Venclexta plus Rituxan or BR.

The primary endpoint of the study is investigator-assessed progression-free survival. Secondary endpoints include PFS assessed by independent review committee, overall response rate, complete response rate, overall survival, minimal residual disease status, duration of response, event-free survival and time to next CLL treatment.

RHHBY closed at $30.26. ABBV closed at $96.47.


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FDA approves OMIDRIA for use in pediatric patients

Omeros secures FDA approval of OMIDRIA for use in pediatric patients

Omeros jumps after detailing FDA meeting on IgA nephropathy program. See Stockwinners.com for details
Omeros secures FDA approval of OMIDRIA for use in pediatric patients
Omeros Corporation (OMER) announced that the U.S. Food and Drug Administration approved Omeros’ supplemental new drug application following review of efficacy and safety data from a pediatric clinical trial, expanding the indication for OMIDRIA 1% / 0.3% to include use in pediatric patients.
OMIDRIA, used during cataract surgery or intraocular lens replacement, prevents intraoperative miosis and reduces postoperative pain.
FDA approved the sNDA for OMIDRIA under priority review.
The successful clinical trial was conducted in 78 pediatric patients randomized to either OMIDRIA or phenylephrine administered intraoperatively.
Together with the label expansion now including both pediatric and adult patients, FDA also granted OMIDRIA an additional six months of U.S. market exclusivity.
Under section 505A of the Federal Food, Drug, and Cosmetic Act, this six-month extension of market exclusivity is attached to the term of the drug’s patents listed in FDA’s Orange Book.
OMER closed at $18.69. It last traded at $21.50.


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Repros Therapeutics sold for about $20 million

Allergan to acquire Repros Therapeutics for 67c per share

Repros sold for $20M. Stockwinners.com
Repros sold for $20M.

Repros Therapeutics (RPRX) announced that it has entered into a definitive agreement under which Allergan (AGN), through a subsidiary, will acquire Repros for a cash payment of 67c per share.

The company’s Board of Directors has unanimously approved the transaction.

Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Repros common stock for 67c per share. T

he closing of the tender offer is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Repros common stock.

The merger agreement contemplates that Allergan, through its subsidiary, will acquire any shares of Repros that are not tendered into the offer through a second-step merger, which will be completed as soon as practicable following the closing of the tender offer.

Pending approvals, Repros anticipates the transaction will close during the first quarter of 2018.

RPRX closed at $0.47.


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ANZ’s life insurance businesses sold for $2.14 billion

Zurich enters agreement to acquire ANZ’s life insurance businesses in Australia 

ANZ's life insurance businesses sold for $2.14B. See Stockwinners.com
ANZ’s life insurance businesses sold for $2.14B

Zurich Insurance Group (ZURVY) yesterday announced that it has entered into an agreement to acquire 100% of ANZ’s (ANZBY) life insurance businesses, OnePath Life, in Australia for A$2.85B, or $2.14B.

Both parties expect the transaction, which is subject to regulatory approval, to be completed by the end of 2018.

The transaction price comprises A$1B of upfront reinsurance commissions, expected to be paid subject to regulatory approval in May 2018 with the remaining balance paid on completion.

The acquisition is expected to contribute to the Group’s profitability from day one, generating strong cash flows which will support future dividend growth.

The transaction will also increase the proportion of stable life protection-based earnings, reducing overall Group earnings volatility and increasing the proportion of life earnings remitted as cash back to the Group.

In view of these earnings benefits, Zurich expects to raise its current BOPAT ROE target by 50 basis points by 2019.

The transaction is also expected to increase the level of overall cash remittances over the 2017-2019 planning period by A$300M.

As part of the transaction, Zurich will enter into a 20-year distribution agreement with ANZ in Australia to distribute life insurance products through bank channels.

The acquisition is expected to be funded through a mixture of Zurich’s internal cash resources and senior debt, and is expected to reduce Zurich’s capital position only modestly.

ZURVY closed at $30. ANZBY closed at $21.53.


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Autoliv to spin off its electronics segment

Autoliv to spin off its electronics segment

Autoliv to split into two companies

Autoliv (LIV) announced that its Board of Directors has concluded its strategic review and decided to prepare for a spin-off of its Electronics business segment, creating a new, independent publicly traded company during the third quarter of 2018.

The analyses conducted under the strategic review concluded that the assumptions made at the time of the initial announcement in September 2017 to separate the company hold true.

Through the separation, additional value for shareholders and other stakeholders will be created by the ability to better address two distinct, growing markets with leading product offerings.

The spin-off will be by a payment of a dividend of the common stock of the new Electronics company on a pro rata basis to the holders of common shares of Autoliv as of a yet to be determined record date.

As part of the preparation for the spin-off, the Electronics business is expected to receive a cash injection from Autoliv, with the underlying objective of Autoliv to remain strong investment grade.

The intent is for the spin-off to be tax free to stockholders both in the US and Sweden.

A Form 10 registration statement for the transaction will be filed with the Securities and Exchange Commission during the first half of 2018.

It will include historical financial information for the Electronics business on a stand-alone basis for the fiscal years 2015-2017 and other details regarding the proposed spin-off.

After the spin-off, Autoliv’s current Passive Safety segment would continue to operate under the Autoliv name, with continued listings on the New York Stock Exchange and Nasdaq Stockholm.

The Electronics business will assume a new company name to be announced at a later stage.

It is also expected to be listed in the United States and Sweden.

Both companies are to be headquartered in Stockholm, Sweden.

Forward looking full year 2018 indications for the stand-alone entities are expected to be given in connection with Autoliv’s Q4 2017 earnings release.

The spin-off is expected to be completed during the third quarter of 2018 subject to market, regulatory and certain other conditions, including approval by Autoliv’s board of directors.

There can be no assurance regarding the ultimate timing of the spin-off or that the spin-off will ultimately occur. Further updates to the progress of the separation and stock market listing process will be provided in a timely manner.

LIV closed at $127.75. It last traded at $129.25.


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