FDA Approves Innoviva’s drug for COPD

Innoviva, GlaxoSmithKline confirm FDA approval of Trelegy Ellipta

GlaxoSmithKline (GSK) and Innoviva (INVA) announced that the U.S. FDA has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or patients who are on umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol.

COPD is a disease that affects the lungs, causing reduced airflow, which makes it hard to breathe. It is also progressive, which means it worsens over time. COPD can include emphysema, chronic bronchitis, or both. Roughly 15 million adults in the U.S. have been diagnosed with COPD, while millions more who have it may not even know it.

Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.

Following this approval by the FDA, Trelegy Ellipta will be available in the US shortly.

Regulatory applications have been submitted and are undergoing assessment in a number of other countries, including the European Union, Australia and Canada.

INVA closed at $13.81. The stock has a 52-week trading range of $8.67 – $14.20. GSK closed at $40.05.


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Dimension Therapeutics sold for $138 million

Ultragenyx to acquire Dimension Therapeutics for $5.50 per share in cash

Ultragenyx to acquire Dimension Therapeutics for $5.50 per share in cash. See Stockwinners.com for details

Ultragenyx Pharmaceutical (RARE) announced that it has made a proposal to acquire all of the outstanding shares of common stock of Dimension Therapeutics (DMTX) for $5.50 per share, or approximately $138 million, in cash at close to be effectuated via a tender offer.

The Ultragenyx offer represents a premium of over 358% to Dimension’s unaffected share price as of August 24, 2017 and premiums of 24% and 48% over the implied value of the all-stock consideration to be received by Dimension stockholders pursuant to the announced acquisition of Dimension by REGENXBIO (RGNX), based on REGENXBIO’s last closing price and trailing 20-trading day volume-weighted average price as of September 15, 2017, respectively.

As such, the proposal would provide Dimension stockholders with an immediate and certain return on their investment in Dimension and constitutes a superior alternative to the REGENXBIO transaction.

The proposal has been approved by the Board of Directors of Ultragenyx. Ultragenyx would fund the transaction from cash resources on its balance sheet and anticipates that customary closing conditions to the transaction could be satisfied so that the tender offer could complete as soon as 25 business days after merger agreement signing.


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Teva sells its women’s health portfolio assets for $1.38B

Teva announces sale of global women’s health portfolio assets for $1.38B

Teva rallies after finding experienced CEO. See Stockwinners.com for details

Teva Pharmaceutical (TEVA) announced it has entered into two agreements to sell the remaining assets of its specialty global women’s health business for $1.38B.

Proceeds from these sales, combined with proceeds from the recently announced sale of PARAGARD total $2.48B and will be used by Teva to progress repayment of term loan debt.

Teva has entered into a definitive agreement under which CVC Capital Partners Fund VI will acquire a portfolio of products within its global women’s health business across contraception, fertility, menopause and osteoporosis for $703M in cash.

The portfolio of products, which is marketed and sold outside of the U.S., includes Ovaleap, Zoely, Seasonique, Colpotrophine, Actonel and additional products.

Teva has also entered into a definitive agreement under which Foundation Consumer Healthcare will acquire Plan B One-Step and Teva’s value brands of emergency contraception, Take Action, Aftera, and Next Choice One Dose for $675M in cash.

Completion of the transactions is subject to customary conditions, including antitrust clearance in the U.S. and EU respectively, together with employee consultations.

The transactions are expected to close before the end of 2017. Until the transactions are completed, Teva will continue to market the products in the normal course, providing full support to manage the business and to meet the needs of customers and patients.- Teva Pharmaceutical announced it has entered into two agreements to sell the remaining assets of its specialty global women’s health business for $1.38B.

Proceeds from these sales, combined with proceeds from the recently announced sale of PARAGARD total $2.48B and will be used by Teva to progress repayment of term loan debt.

Teva has entered into a definitive agreement under which CVC Capital Partners Fund VI will acquire a portfolio of products within its global women’s health business across contraception, fertility, menopause and osteoporosis for $703M in cash.

The portfolio of products, which is marketed and sold outside of the U.S., includes Ovaleap, Zoely, Seasonique, Colpotrophine, Actonel and additional products. Teva has also entered into a definitive agreement under which Foundation Consumer Healthcare will acquire Plan B One-Step and Teva’s value brands of emergency contraception, Take Action, Aftera, and Next Choice One Dose for $675M in cash.

Completion of the transactions is subject to customary conditions, including antitrust clearance in the U.S. and EU respectively, together with employee consultations.

The transactions are expected to close before the end of 2017. Until the transactions are completed, Teva will continue to market the products in the normal course, providing full support to manage the business and to meet the needs of customers and patients.


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Silver Spring Sold for $830 million

Itron to acquire Silver Spring  Networks for $16.25 per share in cash, or approx. $830M

 

Itron to acquire Silver Spring for $16.25 per share in cash. See Stockwinners.com for details

Itron, Inc. (ITRI) and Silver Spring Networks (SSNI) announced that they have signed a definitive agreement for Itron to acquire all outstanding shares of Silver Spring for $16.25 per share in cash.

The transaction is valued at approximately $830M, net of $118M of Silver Spring’s cash.

This represents a premium of 25% to Silver Spring’s closing share price on Sept. 15, 2017, the last trading day prior to the announcement of the transaction.

The transaction has been unanimously approved by the boards of directors of both companies.

Itron anticipates approximately $50M in annualized cost synergies to be substantially realized within three years of completing the transaction by optimizing combined operations and expenses.

The acquisition is expected to have a positive impact on Itron’s long-term growth rate, be accretive to gross margin in the first year after completing the transaction and be accretive to non-GAAP EPS and adjusted EBITDA in the second year, excluding one-time, transaction-related costs and including stock-based compensation costs that Silver Spring currently excludes from its reported non-GAAP results.

Itron plans to finance the transaction using a combination of cash and approximately $750 million in incremental new debt.

Fully committed financing has been provided by Wells Fargo. The transaction is expected to close in late 2017 or early 2018 and is subject to customary closing conditions, including regulatory approval and the approval of Silver Spring’s stockholders.

Centerview Partners and Credit Suisse are acting as financial advisors to Itron, and Jones Day is acting as its legal advisor. #Evercore is acting as financial advisor and Fenwick & West LLP as legal advisor to Silver Spring.


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Wabco to exit Meritor WABCO joint venture

Wabco agrees to buyout of Meritor WABCO joint venture

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WABCO Holdings (WBC) announced that it will further expand its commitment and operations in the commercial vehicle market in North America by taking full ownership of the Meritor WABCO joint venture. WABCO has signed an agreement to purchase Meritor (MTOR) stake in the joint venture business.

WABCO’s purchase price is $250M. The transaction is expected to close on October 1, 2017 and immediately prior to closing, Meritor will receive a final closing partnership distribution.

Meritor WABCO, employing approximately 200 persons, is headquartered in Troy, Michigan, U.S.A. and had sales of $300M in fiscal year 2016.

It currently sells and distributes a range of WABCO’s leading safety and efficiency technologies for commercial vehicles in North America.

With this agreement, WABCO will take over the former joint venture’s application engineering and supply chain operations, including the distribution center and customer service hub in Hebron, Kentucky.

In addition, WABCO will continue to have exclusive access to a winter test track in Sault St. Marie, Michigan, and joint access to a year-round test track in East Liberty, Ohio to support local customers.

Following closure of the buyout, WABCO has agreed for Meritor to continue to be its exclusive distributor for a certain range of WABCO’s Aftermarket products in the U.S. and Canada, and its non-exclusive distributor in Mexico.

In connection with the purchase transaction, both parties have the option to terminate the distribution arrangements at certain points during the first three and half years, for an exercise price between $225M-$265M based on the earnings of the business.


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Orbital ATK Sold for $9.2 billion

Northrop Grumman Corp. to buy Orbital ATK for $134.50 a share

Orbital ATK Sold for $7.5 billion. See Stockwinners.com Market Radar to read more

Northrop Grumman (NOC) and Orbital ATK (OA) announced they have entered into a definitive agreement under which Northrop Grumman will acquire Orbital ATK for approximately $7.8B in cash, plus the assumption of $1.4B in net debt.

Orbital ATK shareholders will receive all-cash consideration of $134.50 per share.

The agreement has been approved unanimously by the boards of both companies. The transaction is expected to close in the first half of 2018 and is subject to customary closing conditions, including regulatory and Orbital ATK shareholder approval.

Upon completion of the acquisition, Northrop Grumman plans to establish Orbital ATK as a new, fourth business sector to ensure a strong focus on operating performance and a smooth transition into Northrop Grumman.

On a pro forma 2017 basis, Northrop Grumman expects to have sales in the range of $29.5B-$30B based on current guidance.

Northrop Grumman expects the transaction to be accretive to earnings per share and free cash flow per share in the first full year after the transaction closes, and to generate estimated annual pre-tax cost savings of $150M by 2020.

Northrop Grumman has received fully committed debt financing and expects to put in place permanent financing prior to closing.

Northrop Grumman remains committed to maintaining a solid investment grade credit rating and will use its strong cash flow to support debt reduction, while continuing to pay a competitive dividend and repurchase shares.


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