Spark Therapeutics to improve patient access to Luxturna

Spark Therapeutics announces programs to improve patient access to Luxturna

Spark Therapeutics announced three new payer programs. Stockwinners.com
Spark Therapeutics announced three new payer programs

Spark Therapeutics (ONCE) announced three new payer programs:

  1. an outcomes-based rebate arrangement with a long-term durability measure,
  2. an innovative contracting model
  3. and a proposal to CMS under which payments for Luxturna would be made over time.

Together, these initiatives aim to help ensure eligible U.S. patients have access to Luxturna, a one-time gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.

Luxturna should only be administered to patients who have viable retinal cells as determined by their treating physicians.

Spark Therapeutics has reached agreement in principle with Harvard Pilgrim to make Luxturna available under the outcomes-based rebate arrangement and the innovative contracting model that aims to reduce risk and financial burden for payers and treatment centers.

Spark Therapeutics also has reached an agreement in principle with affiliates of Express Scripts (ESRX) to enable the innovative contracting model. Luxturna and other potential one-time therapies face unique health insurance challenges given current practices and regulations in the U.S. health care system.

Barriers to offering alternate models include the system’s focus on short-term value, largely because most patients switch health insurance companies on average every three years; government price reporting requirements that are not designed to reflect certain outcomes-based arrangements, therefore limiting a manufacturer’s ability to offer significant performance-based rebates, particularly for diseases with small patient populations; and complicated distribution models, which add costs and financial risk to parties involved in the delivery and reimbursement of specialty drugs and specialized medical care.

“Over these past few months, we have been working with health insurers to create innovative pathways for access to Luxturna that may serve as models for other one-time administered gene therapies in the future,” said Marrazzo.

“Our work is not done, but we believe that the offerings we are announcing today will help ensure that eligible U.S. patients have the coverage and financial support they need to gain access to both Luxturna and the specialized medical care required to deliver the product at treatment centers.”


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Casey’s General Stores encouraged to explore options

Casey’s General Stores shareholder JCP encourages exploration of alternatives

Casey’s General Stores encouraged to explore options
Casey’s General Stores encouraged to explore options

JCP Investment Management, BLR Partners and Joshua Schechter, which together are “significant shareholders” of Casey’s General Stores (CASY) that collectively own approximately $45M of the company’s common stock, issued an open letter to Casey’s shareholders, stating in part:

“We believe Casey’s shares are significantly undervalued as they do not reflect the true earnings power and full real estate value of the Company’s irreplaceable fleet of 2,000+ stores…Rapid consolidation has been ongoing in the convenience store industry over the past five years. We have played a constructive role in this consolidation while serving as directors during the successful sale of The Pantry, Inc. to ATD in 2014 and as part of a settlement agreement with CST Brands, which resulted in a sale to ATD in 2016.

Based on the above transaction multiples, we believe Casey’s shares could be worth from $150 to greater than $170 per share to a potential acquirer. We believe this is realistic given the significant synergies and real estate value that Casey’s offers.

We note that ATD is projecting $125M in synergies for its acquisition of Pantry and between $150-200M in synergies for its acquisition of CST, both of which were smaller than Casey’s and owned less real estate…We do not believe that waiting for an increase in share price in the face of significant declining EBITDA is the prudent path to take considering that we believe that Casey’s could potentially realize $150 to greater than $170 in a sale today.

We believe that Casey’s Board should immediately engage a financial advisor to explore all strategic alternatives, including a potential sale, merger or similar transaction in order to maximize shareholder value.”

CASY last traded at $112.39.


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Paratek Pharmaceuticals is in focus

Paratek Pharmaceuticals provides update on pipeline progress

Paratek Pharmaceuticals provides update

Paratek Pharmaceuticals (PRTK) announced recent progress across its product pipeline.

Paratek has initiated the rolling submission of a New Drug Application to the FDA for the indications of acute bacterial skin and skin structure infections, or ABSSSI, and community-acquired bacterial pneumonia, or CABP, and is on track to submit the final components during the first quarter of 2018.

Rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis.

The FDA had previously granted omadacycline Qualified Infectious Disease Product designation and Fast Track designation, which provides for a Priority Review of the NDA, once accepted.

In addition, The company has initiated sites for the first of the two planned Phase 2 studies evaluating its investigational antibiotic, omadacycline, for the treatment of urinary tract infections, or UTI.

This first study will evaluate the safety, tolerability and pharmacokinetics of omadacycline in female patients with uncomplicated UTI.

The second study, which will be initiated later this year, will evaluate the safety, tolerability and pharmacokinetics of omadacycline in patients with acute pyelonephritis.

The Company plans to enroll approximately 200 patients in each study at multiple sites. Paratek also announced that it has earned a $5 million milestone payment from Allergan (AGN) under the terms of the parties’ collaboration for the development of Seysara, a new, narrow-spectrum oral antibiotic for the treatment of moderate to severe acne.

The milestone payment became payable upon the FDA’s acceptance of Allergan’s NDA for Seysara, announced in December 2017.

Allergan (AGN) plans to commercialize Seysara in the U.S. Paratek retains all ex-U.S. rights to the product.


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Scana Corporation sold for $14.6 billion

Dominion, Scana announce all-stock merger valuing Scana at $55.35 a share

 Scana Corporation sold for $7.9 billion. Stockwinners.com
Scana Corporation sold for $7.9 billion.

Dominion Energy (D) and Scana Corporation (SCG) announced an agreement for the companies to combine in a stock-for-stock merger in which Scana shareholders would receive 0.6690 shares of Dominion Energy common stock for each share of Scana common stock, the equivalent of $55.35 per share, or about $7.9B based on Dominion Energy’s volume-weighted average stock price of the last 30 trading days ended Jan. 2.

Including assumption of debt, the value of the transaction is approximately $14.6B.

The agreement also calls for significant benefits to Scana’s South Carolina Electric & Gas Company subsidiary electric customers to offset previous and future costs related to the withdrawn V.C. Summer Units 2 and 3 project.

After the closing of the merger and subject to regulatory approvals, this includes: A $1.3B cash payment within 90 days upon completion of the merger to all customers, worth $1,000 for the average residential electric customer.

Payments would vary based on the amount of electricity used in the 12 months prior to the merger closing; An estimated additional 5% rate reduction from current levels, equal to more than $7 a month for a typical SCE&G residential customer, resulting from a $575M refund of amounts previously collected from customers and savings of lower federal corporate taxes under recently enacted federal tax reform; A more than $1.7B write-off of existing V.C. Summer 2 and 3 capital and regulatory assets, which would never be collected from customers.

This allows for the elimination of all related customer costs over 20 years instead of over the previously proposed 50-60 years; Completion of the $180M purchase of natural-gas fired power station at no cost to customers to fulfill generation needs.

Scana would operate as a wholly owned subsidiary of Dominion Energy.

It would maintain its significant community presence, local management structure and the headquarters of its SCE&G utility in South Carolina.

The transaction would be accretive to Dominion Energy’s earnings upon closing, which is expected in 2018 upon receipt of regulatory and shareholder approvals.

The merger also would increase Dominion Energy’s compounded annual earnings-per-share target growth rate through 2020 to 8% or higher.

The merger is contingent upon approval of Scana’s shareholders, clearance from the U.S. Federal Trade Commission/the U.S. Department of Justice under the Hart-Scott-Rodino Act, and authorization of the Nuclear Regulatory Commission and Federal Energy Regulatory Commission.

Scana and Dominion Energy also will file for review and approval from the public service commissions of South Carolina, North Carolina, and Georgia.


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