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ACET

Aceto

$7.45

-0.06 (-0.80%)

17:08
02/27/18
02/27
17:08
02/27/18
17:08

Aceto to appeal Trade Agreement Act violation for 11 generic drugs

Aceto has been notified by the U.S. government that 11 generic drug products it acquired through its Acetris Health subsidiary in a product purchase agreement with an entity formerly known as Lucid Pharma are not in compliance with the federal Trade Agreement Act, or TAA, country-of-origin provisions of a clause contained in the government supply contracts. The 11 finished dosage form products purchased by the U.S. government are manufactured by Aurolife Pharma which is located in Dayton, New Jersey using APIs sourced from India. In conjunction with this finding, the U.S. Department of Veterans Affairs, or VA, has requested that Aceto supply new TAA-compliant sources for the referenced products by March 9 and supply new TAA-compliant drugs to the government purchasers under the contracts by March 26.Commenting on this matter, William Kennally, CEO of Aceto, said, "We are concerned about the VA's request since Acetris' U.S. manufacturing partner has sourced APIs from India for the 11 products in question at least since ACETO assumed its supply contracts with the VA. We have also heard from other suppliers to the VA who report that they too source APIs from India and have the finished dosage form manufactured in the United States. Finally, we do not believe that supplying the U.S. government with product containing an API originating in India is a deviation from industry practice." Under current longstanding law, the government, under the Buy America Act, is permitted to buy domestic end products, including commercial off-the-shelf, or COTS, products like generic drugs that are manufactured in the U.S. even if their components are not all manufactured in the US. Aceto thus believes that the government was and is permitted to buy Acetris' products, because they are COTS items manufactured in the U.S. As a result, Aceto disputes the determination that the 11 products sold pursuant to novated contracts with the VA originate in India rather than the United States and intends to appeal the decision that it is not currently compliant with contract sourcing requirements. To further pursue remedies, Aceto has asserted an indemnification claim against the sellers under the product purchase agreement dated December 21, 2016.

ACET Aceto
$7.45

-0.06 (-0.80%)

05/08/17
CHLM
05/08/17
NO CHANGE
Target $12
CHLM
Hold
ACETO price target lowered to $12 from $18 at Craig-Hallum
Craig-Hallum analyst Matt Hewit lowered his price target for ACETO to $12 from $18 as the rising Q3 price/volume erosion has him incrementally concerned about acquired Citron/Lucid assets. The analyst reiterates a Hold rating on the shares.
07/31/17
ADAM
07/31/17
INITIATION
Target $19
ADAM
Buy
Aceto initiated with a Buy at Canaccord
Canaccord Genuity analyst Dewey Steadman started Aceto with a Buy rating and $19 price target. The analyst likes the company's "unique" asset-light business model strategy.
08/28/17
ADAM
08/28/17
NO CHANGE
Target $15
ADAM
Buy
Aceto price target lowered to $15 from $19 at Canaccord
Canaccord analyst Dewey Steadman lowered his price target on Aceto to $15 from $19 following Q3 earnings. The analyst said its bottom-line performance was disappointing due to a meaningful step-down in gross margins due to low-margin launches and continued contributions from its Citron acquisition. Steadman maintained his Buy rating on Aceto shares as he is still positive on its potential for growth driven by new product launches and product approvals.

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BOX

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ALDX

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