Vertex reports positive acute pain control data

Vertex’s Phase 2 study of NaV1.8 inhibitor VX-150 meets primary endpoint

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Vertex reports positive Phase 2 results

Vertex Pharmaceuticals (VRTX) announced positive results of a Phase 2 study of the NaV1.8 inhibitor VX-150 in patients with acute pain following bunionectomy surgery.

Treatment with VX-150 showed statistically significant relief of acute pain compared to placebo, as determined by the time-weighted Sum of the Pain Intensity Difference over the first 24 hours of treatment, a standard measure of acute pain relief.

The study also included a standard-of-care reference arm of the commonly prescribed opioid medicine hydrocodone+acetaminophen to support the evaluation of a potential treatment effect for VX-150.

VX-150 was generally well tolerated, and there were no discontinuations for adverse events in any arm of the study.

This Phase 2 study is the second positive proof-of-concept study for VX-150 and provides further validation for the use of a NaV1.8 inhibitor for the treatment of pain.

A third Phase 2 study of VX-150 is currently ongoing in neuropathic pain with data expected in early 2019.

Vertex also recently initiated a Phase 1 study of a second NaV1.8 inhibitor, VX-128, in healthy volunteers.

The data announced were from a Phase 2 randomized, double-blind, placebo-controlled study that evaluated two days of treatment with VX-150, hydrocodone+acetaminophen or placebo in 243 patients with acute pain following bunionectomy surgery. 82 patients received placebo, 80 patients received VX-150 and 81 patients received hydrocodone+acetaminophen.

Hydrocodone+acetaminophen was included as a standard-of-care reference arm to enable better evaluation of a potential treatment effect for VX-150.

The reference arm was not included to make statistical comparisons to VX-150. VX-150 was dosed orally as 1500 mg for the first dose, followed by 750 mg every 12 hours over the 48-hour treatment period.

The primary endpoint of the study was the time-weighted Sum of the Pain Intensity Difference over the first 24 hours of treatment, as recorded on a Numeric Pain Rating Scale, for those treated with VX-150 compared to placebo.

Increases in SPID24 values represent improvements in pain relief. Secondary endpoints included safety and tolerability assessments as well as other efficacy measurements, including SPID over the first 48 hours of treatment for those treated with VX-150 compared to placebo.

Additional pre-specified analyses of other endpoints included SPID24 and SPID48 for hydrocodone+acetaminophen compared to placebo. The study met its primary endpoint, showing a statistically significant improvement in SPID24 for those treated with VX-150 compared to placebo.

The SPID24 values for those treated with VX-150 and placebo were 36.14 and 6.64, respectively. The SPID24 value for hydrocodone+acetaminophen was 40.16. In this study, VX-150 was generally well tolerated. More than 90 percent of patients in each arm of the study completed treatment.

There were no discontinuations due to adverse events and there were no serious adverse events in any arm of the study. The majority of adverse events were mild or moderate.

Adverse events were observed in 35 percent, 31 percent and 37 percent of patients who received placebo, VX-150 or hydrocodone+acetaminophen, respectively.

The most common adverse events were nausea, headache, vomiting and dizziness. Based on these data, Vertex plans to initiate a Phase 1 study of VX-150 using an intravenous formulation for the treatment of acute pain.

This study is planned to begin in the second half of 2018. An additional Phase 2 proof-of-concept study of VX-150 dosed orally is currently ongoing in patients with neuropathic pain caused by small fiber neuropathy.

Vertex expects to obtain data from the study in neuropathic pain in early 2019.

VRTX closed at $154.14.


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Nektar receives $1.85 billion from Bristol-Myers

Bristol-Myers to pay Nektar $1.85B in cash, stock as part of collaboration pact

 

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Bristol-Myers to pay Nektar $1.85B in cash

Bristol-Myers Squibb (BMY) and Nektar Therapeutics (NKTR) announced the companies have executed a global strategic development and commercialization collaboration for Nektar’s lead immuno-oncology program, NKTR-214.

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Bristol-Myers to pay Nektar $1.85B in cash

Under the collaboration, the companies will jointly develop and commercialize NKTR-214 in combination with Bristol-Myers Squibb’s Opdivo and Opdivo plus Yervoy in more than 20 indications across 9 tumor types, as well as potential combinations with other anti-cancer agents from either of the respective companies and/or third parties.

NKTR-214, a CD122-biased agonist, is an investigational immuno-stimulatory therapy designed to selectively expand cancer-fighting T cells and natural killer cells directly in the tumor micro-environment and increase PD-1 expression on those immune cells.

Bristol-Myers Squibb and Nektar have agreed to a joint clinical development plan to evaluate NKTR-214 with Opdivo and Opdivo plus Yervoy in registration-enabling clinical trials in more than 20 indications in 9 tumor types including melanoma, renal cell carcinoma, non-small cell lung cancer, bladder and triple negative breast cancer.

Pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront cash payment of $1.0B and an equity investment of $850M, or 8,284,600 shares of Nektar’s common stock at $102.60 per share.

Bristol-Myers Squibb has agreed to certain lock-up, standstill and voting provisions on its share ownership for a period of five years subject to certain specified exceptions.

Nektar is also eligible to receive an additional $1.78B in milestones, of which $1.43B are development and regulatory milestones and the remainder are sales milestones.

Nektar will book revenue for worldwide sales of NKTR-214 and the companies will split global profits for NKTR-214 with Nektar receiving 65% and Bristol-Myers Squibb 35%.

Bristol-Myers Squibb will retain 100% of product revenues for its own medicines.

The parties also will share development costs relative to their ownership interest of medicines included in the trials. For trials in the joint clinical development plan that include NKTR-214 with Opdivo only, the parties will share development costs with 67.5% allocated to Bristol-Myers Squibb and 32.5% allocated to Nektar.

For trials in the joint clinical development plan that include NKTR-214 with Opdivo and Yervoy, the parties will share development costs with 78% allocated to Bristol-Myers Squibb and 22% allocated to Nektar.

Both Bristol-Myers Squibb and Nektar have agreed for a specified period of time to not commence development with overlapping mechanisms of action in the same indications as those included in the joint clinical development plan.

The parties are otherwise free to develop NKTR-214 with their own pipeline assets and/or any other third party compounds. Both parties have agreed to initiate registration-enabling studies in the joint clinical development plan within 14 months of the effective date of the agreement, subject to allowable delays.

Both parties will jointly commercialize NKTR-214 on a global basis. Bristol-Myers Squibb will lead global commercialization activities for NKTR-214 combinations with Bristol-Myers Squibb medicines and Nektar will co-commercialize such combinations in the US, major EU markets and Japan.

Nektar will lead global commercialization activities for NKTR-214 combinations with either Nektar medicines and/or other third-party medicines.

For Bristol-Myers Squibb, the transactions are expected to be dilutive in 2018 and 2019 to the company’s non-GAAP EPS by 2c and 10c, respectively.

Nektar and Bristol-Myers Squibb currently expect to complete the transaction during the second quarter of 2018, subject to the expiration or termination of applicable waiting periods under all applicable US antitrust laws and the satisfaction of other usual and customary closing conditions.

Further details of the agreement can be found in Nektar’s Form 8-K filed today with the Securities and Exchange Commission. Nektar and Bristol-Myers Squibb entered into a clinical collaboration in September of 2016 to evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care.

The Phase 1/2 PIVOT clinical study is ongoing in over 350 patients with melanoma, kidney, non-small cell lung cancer, bladder, and triple-negative breast cancers.

NKTR closed at $75.66, it last traded at $69.97. BMY closed at $63.87. It last traded at $62.51.


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Layne Christensen sold for $565M

Granite Construction to acquire Layne Christensen in $565M stock merger

Granite Construction to acquire Layne Christensen. Stockwinners.com
Granite Construction to acquire Layne Christensen 

Granite Construction Incorporated (GVA) and Layne Christensen Company (LAYN) announced that they have entered into a definitive agreement whereby Granite will acquire all of the outstanding shares of Layne in a stock-for-stock transaction valued at $565 million, including the assumption of net debt.

The transaction, which was unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2018.

Granite Construction to acquire Layne Christensen. Stockwinners.com
Granite Construction to acquire Layne Christensen

Under the terms of the agreement, Layne shareholders will receive a fixed exchange ratio of 0.270 Granite shares for each share of Layne common stock they own. This represents $17.00 per Layne share, or a premium of 33%, based on the volume-weighted average prices for Granite and Layne shares over the past 90 trading days.

Following the close of the transaction, Layne shareholders will own approximately 12% of Granite shares on a fully diluted basis, and Granite’s Board will be expanded to include one additional director from Layne.

The transaction represents an enterprise value multiple of 8.2x 2018 expected EBITDA.

Granite expects to achieve approximately $20 million of annual run-rate cost savings by the third year following the close of the transaction, with approximately one-third realized in 2018.

Granite expects to incur approximately $11 million in one-time costs to achieve these savings.

The transaction is expected to be accretive to Granite’s adjusted earnings per share, and high single-digit accretive to Granite’s adjusted cash earnings per share in the first year after closing.

Granite expects to assume outstanding Layne convertible debt with principal value of $170 million and honor the terms and existing maturity date provisions of the indentures.

The transaction is not expected to trigger any change of control provisions under Layne’s indentures.

Granite also expects to fund the cash financing requirements of the transaction of approximately $70 million through a combination of existing cash on hand and availability under Granite’s revolving credit facility.

Following close, Granite will maintain an investment grade credit profile and significant financial flexibility.

The transaction, which is expected to close in the second quarter of 2018, is subject to the satisfaction of customary closing conditions, including applicable regulatory approvals and the approval of the shareholders of Layne.

Wynnefield Capital, which has an approximate 9% voting interest in Layne, has agreed to vote in favor of the transaction.

In connection with the transaction, Granite will issue approximately 5.4 million shares of Granite common stock to Layne common stockholders.

LAYN closed at $12.62. GVA closed at $60.08.


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