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FDA Turns Down AMGN's Osteoporosis Drug, EBS Opens Wallet, TROV Plunges


Today's Daily Dose brings you news about FDA's rejection of Amgen's osteoporosis drug EVENITY; Trovagene's stock offering and Emergent Bio's acquisition of smallpox vaccine business from Sanofi.

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The FDA has rejected Amgen Inc.'s (AMGN) investigational drug EVENITY, proposed for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

The U.S. regulatory agency has asked the Company to integrate the efficacy and safety data from an active comparator study of EVENITY in postmenopausal women with osteoporosis, dubbed ARCH, which was announced as recently as May of this year. It should be noted that the regulatory submission for EVENITY was made to the FDA last July based on data from a pivotal phase III study, dubbed FRAME.

In the new study, dubbed ARCH, treatment with EVENITY for 12 months followed by Merck & Co.'s (MRK) Fosamax significantly reduced the incidence of new vertebral, clinical and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture, compared to Fosamax alone.

However, the rate of cardiovascular serious adverse events was higher in patients treated with EVENITY compared to Fosamax (2.5 percent EVENITY versus 1.9 percent Fosamax at 12 months) in the ARCH study, raising a concern. Amgen has itself said in May that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization, and that it does not expect approval of EVENITY in the U.S. to occur in 2017.

Besides the ARCH data, the FDA has also requested the Company to submit efficacy and safety data from a phase III trial evaluating EVENITY in men with osteoporosis, dubbed BRIDGE.

Amgen is collaborating with Belgium-based UCB SA for the development of EVENITY for the treatment of osteoporosis.

AMGN closed Friday's trading at $177.13, up 1.19%.

Emergent BioSolutions Inc. (EBS) has agreed to acquire the ACAM2000 business of Sanofi (SNY) for $125 million in cash, diversifying its portfolio and broadening its countermeasure franchise with a vaccine that is being stockpiled both in the U.S. and internationally.

The purchase price consists of $97.5 million upfront and up to $27.5 million in near-term contingent regulatory and manufacturing-related milestones.

The deal results in Emergent BioSolutions acquiring:

-- ACAM2000, (Smallpox (Vaccinia) Vaccine, Live), the only vaccine licensed by the FDA for active immunization against smallpox disease for persons determined to be at high risk for smallpox infection;
-- An existing 10-year contract originally valued at up to $425 million with the Centers for Disease Control and Prevention (CDC) with a remaining value of up to approximately $160 million for deliveries of ACAM2000 to the Strategic National Stockpile (SNS) and
-- A cGMP bulk manufacturing facility and a lease to a cGMP fill/finish facility, both U.S.-based, along with the existing staff of approximately 100 employees.

Emergent Bio expects the acquisition to meaningfully contribute to revenue growth in 2018 and accelerate its efforts towards achieving the goal of $1 billion in total revenue by 2020.

EBS closed Friday's trading at $34.50, up 0.26%.

Shares of Trovagene Inc. (TROV) plunged over 20% on Friday, following the Company's announcement of a $7.1 million registered direct offering.

Under the terms of a securities purchase agreement with certain accredited investors, the Company has agreed to sell 6.19 million shares of its common stock. In a concurrent private placement, Trovagene has agreed to issue warrants to purchase up to 4.64 million shares of its common stock.

The warrants will be exercisable six months following the date of issuance, will expire on the fifth anniversary of the initial exercise date and have an exercise price of $1.41 per share. The combined purchase price for one registered share of common stock and one unregistered warrant to purchase 0.75 of an unregistered share of common stock will be $1.15, the Company noted.

The registered direct offering and concurrent private placement are expected to close on or about July 19, 2017.

TROV closed Friday's trading at $1.12, down 20.57%.

by RTTNews Staff Writer

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