It's 9-7 For Withdrawal Of Makena, Roche-Spark Deal Delayed Again, MRK On Watch

(RTTNews) - Today's Daily Dose brings you news about the FDA panel recommendation related to Makena; Merck's Q3 financial results; and extension of the tender offer for shares of Spark Therapeutics, to name a few.

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An FDA panel, which met to review whether or not to allow AMAG Pharmaceuticals Inc.'s (AMAG) Makena, a drug indicated for the prevention of preterm birth in pregnant women, to remain in the market, has voted 9-7 recommending withdrawal of the drug.

However, seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. Now that the panel has made its recommendation, it is for the FDA to make a final decision.

Makena received accelerated approval from the FDA in 2011 for the prevention of preterm birth in pregnant women. Companies whose drugs are approved under the "accelerated approval pathway" are required to conduct a post-approval confirmatory clinical trial to verify and describe clinical benefit. Only then, will the accelerated approval be converted into a full approval.

In the case of Makena, the completed confirmatory trial, dubbed PROLONG, has not demonstrated a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity.

AMAG developed the Makena auto-injector with its device partner Antares Pharma Inc. (ATRS), which holds issued patents on the auto-injector device and drug-device combination, the last of which expires in 2034.

Sales of Makena in 2018 were $322 million - down from $387 million in 2017. In the first half of 2019, sales of the drug slipped to $62 million from $195 million in the comparable year-ago period.

Exact Sciences Corp. (EXAS) reported a narrower-than-expected loss for the third quarter ended September 30, 2019, and provided its revenue outlook for the year.

Net loss for the third quarter of 2019, narrowed to $40.5 million or $0.31 per share from $45 million or $0.37 per share in the year-ago quarter. Analysts were expecting the Company to incur a loss of $0.41 per share.

Exact Sciences is a molecular diagnostics company, marketing a non-invasive, patient-friendly screening test called Cologuard for the early detection of colorectal cancer and pre-cancer.

The Company generated revenue of $218.8 million and screened approximately 456,000 people with Cologuard during the quarter ended September 30, 2019. Revenue in the third quarter of 2018 was $118.3 million and the number of people screened with Cologuard was approximately 241,000.

Looking ahead, the Company anticipates revenue of $802-$810 million during 2019, while the consensus analysts' estimate for the year is $810.87 million. The revenue guidance does not include the impact of the pending combination with Genomic Health.

In July of this year, Exact Sciences announced it is acquiring Genomic Health for $72.00 per share in a cash and stock transaction valued at $2.8 billion. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to be completed by the end of 2019.

EXAS closed Tuesday's trading at $90.61, down 2.44%.

Merck (MRK) reported strong revenue and earnings growth for the third quarter of 2019, besides narrowing and raising its full-year 2019 outlook.

On a non-GAAP basis, the net income for the third quarter of 2019, was $3.87 billion or $1.51 per share compared to $3.18 billion or $1.19 per share in the year-ago quarter. Total sales for the recent third quarter were $12.4 billion, up from $10.8 billion in the third quarter of 2018.

Keytruda contributed $3 billion to the total sales, an increase of 62% over the year-ago quarter.

Looking ahead, Merck narrowed and raised its full-year 2019 non-GAAP EPS range to be between $5.12 and $5.17 from its prior forecast range of $4.84 and $4.94 per share. Merck also narrowed and raised its full-year 2019 revenue range to be between $46.5 billion and $47.0 billion from its prior revised forecast range of between $45.2 billion and $46.2 billion.

Analysts expect the Company to earn $4.94 per share on revenue of $46.13 billion.

MRK closed Tuesday's trading at $85.10, up 3.53%.

Roche (RHHBY.OB) has again extended the offering period of its previously announced tender offer to purchase all of the outstanding shares of common stock of Spark Therapeutics Inc. (ONCE) to November 25, 2019. The tender offer was previously scheduled to expire on October 30, 2019.

Roche signed a deal to fully acquire Spark Therapeutics at a price of $114.50 per share in an all-cash transaction in February 2019, and was expecting to close the transaction by the end of June 2019.

This is for the eighth time that the tender offer period has been extended to provide additional time for the U.S. Federal Trade Commission (the "FTC") and the UK Competition and Markets Authority (the "CMA") to complete their previously disclosed reviews of Roche's pending acquisition of Spark.

RHHBY.OB closed Tuesday's trading at $36.95, down 0.19%.

Sesen Bio (SESN) announced that it has modified its 2017 and 2018 common stock warrants, which enhance its capital raising optionality by allowing for future at-the-market (ATM) programs.

Commenting on the development, Thomas Cannell, president and chief executive officer of Sesen Bio, said, " This was an important strategic decision to position the Company with the greatest optionality as we prepare for upcoming FDA engagements, our planned BLA submission and a potential future approval of Vicinium for patients with non-muscle invasive bladder cancer. The remainder of 2019 will be a critical period for Sesen Bio, and we look forward to continued progress across the organization."

The Company's lead drug candidate is Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer.

Two meetings with the FDA related to Vicinium are planned for the coming months - one is a Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium, slated for November 4, 2019, and the other is a Type B CMC meeting to discuss the submission strategy of the CMC module 3, slated for December 4, 2019.

The Company plans to initiate submission of the Biologics License Application for Vicinium in December 2019.

SESN closed Tuesday's trading at $1.42, down 5.33%.